Impacts of REACH Authorisation - Europa
Transcript of Impacts of REACH Authorisation - Europa
November 2017
Impacts of REACH Authorisation
Final Report
EUROPEAN COMMISSION
Directorate-General for Internal Market Industry Entrepreneurship and SMEs
Directorate D mdash Consumer Environmental and Health Technologies Unit D1 mdash REACH
Contact Valentina Bertato
E-mail ValentinaBERTATOeceuropaeu
European Commission B-1049 Brussels
Impacts of REACH
Authorisation
Final Report
Directorate-General for Internal Market Industry Entrepreneurship and SMEs
Study on the Impacts of REACH Authorisation
2017 EUR 20177084 EN
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Impacts of REACH Authorisation Final Report
eftec November 2017
i
This document has been prepared for Unit GROWD1 REACH by
Economics for the Environment Consultancy Ltd (eftec)
4 City Road
London
EC1Y 2AA
wwwefteccouk
In association with Apeiron-Team NV Peter Fisk Associates Limited (PFA) and The Economics
Interface Limited
Study team
Rohit Mistry (eftec)
Hiram Moerman (Apeiron-Team NV)
Andreas Novak (Apeiron-Team NV)
Richard Dubourg (The Economics Interface Limited)
Oliver Warwick (PFA)
Sarah Krisht (eftec)
Sebastiana Hard (eftec)
Rachel London (PFA)
Elke Van Asbroeck (Apeiron-Team NV)
Reviewers
Ece Ozdemiroglu (eftec)
Acknowledgements
The study team would like to thank the project steering group made up of members from the
European Commission (EC) and the European Chemicals Agency (ECHA) for the inputs received
Disclaimer
Whilst eftec has endeavoured to provide accurate and reliable information eftec is reliant on the
accuracy of underlying data provided and those readily available in the public domain eftec will
not be responsible for any loss or damage caused by relying on the content contained in this report
Document evolution
Interim report 20042017 Reviewed by Ece Ozdemiroglu
Final interim report 14072017 Reviewed by Rohit Mistry
Draft final report 04092017 Reviewed by Ece Ozdemiroglu
Final report 31102017 Reviewed by Ece Ozdemiroglu
Final report ndash Reissued 28112017 Reviewed by Rohit Mistry
eftec offsets its carbon emissions through a biodiversity-friendly voluntary offset purchased from the World Land Trust (httpwwwcarbonbalancedorg) and only prints on 100 recycled paper
Impacts of REACH Authorisation Final Report
eftec November 2017
ii
EXECUTIVE SUMMARY
This document reports on a study on the impacts of REACH Authorisation The process of
Authorisation within REACH (Regulation (EC) No 19072006 of the European Parliament and of the
Council on the Registration Evaluation Authorisation and Restriction of Chemicals) has aims to
ensure the good functioning of the internal market while assuring that the risks from Substances of
Very High Concern (SVHCs) are properly controlled and that these substances are progressively
replaced by suitable alternative substances or technologies where these are economically and
technically viable (REACH Article 55) This present study considered a number of key elements in
order to understand the specific contribution of the authorisation process to achieving this aim
It has been ten years since REACH came into force on the 1st June 2007 and it is one of the most
comprehensive regulations on chemicals ever to be introduced anywhere in the world The
European Commission (EC) is required to review REACH every five years to monitor its operation
The first REACH review was carried out in 20121 and a second review is due in 2017 into which this
study feeds
Since the 2012 review several studies examining specific aspects of REACH Authorisation have been
carried out by the EC the European Chemicals Agency (ECHA) Member State Competent
Authorities (MSCAs) NGOs and industry associations The previous studies typically relied on
anecdotal evidence and lacked quantified (and monetised) information on the costs and benefits of
REACH Authorisation
The present study sought to build on available information as well as compare its findings with the
previous studies It is the first comprehensive study to attempt to obtain reliable quantitative
evidence on the overall impacts of Authorisation and particularly to focus on aspects for which
there has been limited information to date This includes the role of Authorisation in influencing
the decisions to substitute away from SVHCs The study involved a review of the existing literature
surveys with industry NGOs the EC ECHA and MSCAs in-depth follow-up interviews with industry
(see Table ES1) and both in-depth (Tier 1) and shorter (Tier 2) case studies on specific chemicals
or issues Some of the key findings from the study are consistent with previous studies which adds
credibility to both this study and existing literature it contributes to
Members of the project team presented at various REACH-related events spoke to industry sector
groups and NGOs (in person or over the phone) to raise awareness of the project and encourage
stakeholders to take part in the survey This was supported by efforts made by ECHA and the EC
Rather than contacting as many stakeholders as possible consultation was targeted at stakeholders
who may have been impacted by REACH Authorisation and who might be able to provide the
required data In particular any companies that had substituted from an SVHC (or were in the
process of doing so) were prioritised as this was a particular data gap needed to be addressed in
this study Therefore the sampling strategy was intentionally unrepresentative of industry as a
whole and this should be borne in mind when interpreting the results
1 httpeceuropaeuenvironmentchemicalsreachreview_2012_enhtm
Impacts of REACH Authorisation Final Report
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iii
Table ES11 Approaches to collecting new information
Data collection method Statistics
No Contacted No Respondents
NGO survey 29 4 (+2 partial responses)
Industry survey 240 63 (+21 partial responses)
ECHA teleconferences and emails 3 webinars and 20-30 emails
(different types of data or contacts provided)
MS CA Questionnaire 20 16
EC Questionnaire 1 1
Industry interviews 64 49
Based on the information gathered the key findings are summarised below for the five key areas of
investigation
EU market changes for SVHCs (and their alternatives) ndash examined whether there were
any major changes in the market for SVHCs compared to overall market trends observed
in the EU chemicals market
According to CEFIC statistics the value of sales of the EU chemicals sector generally increased over
the period 1995-2012 with a significant dip in 2008 coinciding with the global financial crash Since
then the value of sales has declined slightly As a share of the global chemicals market however
EU sales declined over this period slowly until 2004 and more quickly since then Since 2008
exports have increased as a share of total sales in the EU chemicals sector but remain a minor (28)
proportion of the total
The best publicly available data on changes in substance volumes and sales values in the EU over
time was from Eurostat (PRODCOM) which showed that EU sales of SVHCs have generally followed
the same market trend as the overall EU chemicals market However limitations in the data means
it is not possible to assess as one might expect whether REACH Authorisation has led to a
reduction in EU sales of SVHCs and an increase in sales of alternative substances in line with the
goal of REACH to progressively replace SVHCs with suitable alternative substances or technologies
PRODCOM data were only available to 2015 and for some SVHCs most of the volume was used as
intermediate uses2 (which are exempt from Authorisation) For instance of Annex XIV substances
only 12-dichloroethane is in a PRODCOM category of its own but 99 of the use of this substance is
as an intermediate
There are a number of other factors why there has not been an apparent reduction in the market
for SVHCs Firstly substitution away from an SVHC can take time and it might still be too early to
observe changes in the EU market due to REACH Authorisation Secondly for some companiesuses
alternatives being tested may continue to prove to be unsuitable despite continued efforts to find
an alternative Finally for those uses where Authorisation has been granted (for a given review
period) there could be increased demandsales from the continued use of the SVHC after the
sunset date Overall this means that PRODCOM data are not suitable to observe any market
changes due to REACH Authorisation for only those uses of SVHCs that are subject to Authorisation
What is possible to note is that using REACH registration data as of November 2016 ECHA had
2 REACH Article 3(15) Intermediate means a substance that is manufactured for and consumed in or used for
chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)
Impacts of REACH Authorisation Final Report
eftec November 2017
iv
identified 103 registrants who have ceased manufacturing or importing a SVHC 69 of which
occurred to substances on the Candidate List (the remainder to Annex XIV substances)
One of the aims of the online survey for this study was to collect information on whether REACH
Authorisation is having a market impact (eg changes in sales prices demand and
competitiveness) Whilst the results can only provide a partial view of the EU market the
responses provide some interesting insights on the types and scale of impacts for individual
companies (rather than for the whole EU economy)
Most respondents (57) to the online industry survey indicated that they experienced lsquosignificantrsquo
market related impacts due to Authorisation for downstream user markets that use SVHCs but that
REACH Authorisation has not had a lsquosignificantrsquo impact yet on the market for known alternative
substances for SVHCs or alternative products made without an SVHC The main impacts were (i) a
reduction in the number of suppliers of SVHCs (ii) reduced availability of the SVHC for their use
(iii) an increase in the price of the SVHC and (iv) conditions being imposed on safe handling and
use of an SVHC Whilst respondents were only asked to indicate impacts due to REACH
Authorisation some of these impacts could also be due to requirements under REACH Registration
rather than solely due to Authorisation
The online survey found limited cases of where companies have ceased production andor relocated
outside the EU This is in contrast to the existing literature which reports such risks However
given that all Authorisation applications to date have been granted (or recommended to be
granted) closures andor relocations due to REACH Authorisation are likely to be rare Just under
half of survey respondents did find that selling products made with SVHCs to EU companies was
ldquomore difficultrdquo but overall most respondents said REACH Authorisation had not had a significant
net impact on sales revenue (to date) The online survey also found evidence that REACH
Authorisation has led to an increase in RampD spending on finding an alternative to an SVHC but this
increase often diverts funds from other investment opportunities (eg in production capacity and
developing new markets) More detail on such market trends can be found in Section 4 of the main
report
Finally lsquominirsquo case studies were undertaken of diarsenic trioxide and arsenic acid and HBCDD The
market picture for the first two substances is complicated by the fact that significant proportions
of total use have been identified as intermediate by industry but not by ECHA Some disruption to
supply was reported in the arsenic acid market but the view expressed about diarsenic trioxide
was that the market was already on a downward trend due to earlier restrictions The HBCDD case
described a large-scale switch to an alternative with an authorisation to provide temporary
support to one use while supply capacity of the alternative increased It highlights the importance
of applying for a lsquobridgingrsquo Authorisation (eg 2 years) until it is possible for all users of HBCDD to
fully substitute to the identified alternative
Instances of substitution ndash investigated in terms of actual examples of substitution
covering what was substituted for what use the alternative used how long it took
and the costs and benefits of this substitution
As noted earlier a deliberate attempt was made to target stakeholders who may have been
impacted by REACH Authorisation and those that may have substituted a SVHC Whilst the AfA
process provides a good indication of companies and uses that require continued use of a SVHC
prior to this study little was known about the instances of substitution In this respect the online
survey for this study has been very successful with 43 of respondents indicating they have
substituted a use of a SVHC (and therefore avoided the need to apply for Authorisation) These
respondents (n=3783) provided 61 examples of substitution of SVHCs
Impacts of REACH Authorisation Final Report
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v
There were also 44 respondents providing 71 examples of no substitution yet but actively seeking
to substitute and investin substitution related activities In some instances companies have been
successful at substituting the use of one SVHC but are still trying to phase out use of another
SVHC Whilst the specific targeting of respondents may have lead to a higher percentage of
respondents who have substituted (43) the survey provides evidence that substitution of SVHCs is
occurring Based on survey responses REACH Authorisation seems to be a major (but not the only)
driver for substitution
The survey data suggest that in 53 of the cases substitution took between one and four years In
27 of cases it took 5 to 10 years 12 took longer (11 to 20 years) 2 took over 20 years and 6
are finalising their substitution activities but do not know exactly when this will be fully
completed
The present study found that the Authorisation process leads to substitution where it is technically
feasible even if the cost of applying for Authorisation could have been cheaper This report sets
out several drivers for these substitutions with numerous case study examples Authorisation might
not necessarily be the only motive as some of the substances that have been through the entire
Authorisation process have previously been regulated by other parts of REACH and related
legislation (such as harmonised classification amp labelling and Evaluation) as well as being subject
to other regulation prior to REACH and therefore in some instances substitution related activities
have been ongoing for many decades
Where substitution was technically feasible drivers most commonly cited by companies include
their desire to avoid the lsquostigmarsquo of using SVHCs costs of regulation and uncertainty associated
with having to apply for Authorisation (and whether it is granted) Companiesrsquo internal policy to
avoid using a SVHC is also given as a reason Taking the initiative to substitute allowed these
companies to agree long-term contracts with customers and not delay investment plans (eg new
production capacity or new types of products) Interviews done for this study suggested that these
plans and contracts could otherwise have been postponed pending the outcome of the application
or companies could have even moved their part of production using SVHCs to outside the EU More
detail on substitution can be found in Section 5 of the main report
Costs of Authorisation ndash were assessed reflecting the different activities carried out by
different stakeholders along the Authorisation process administration application risk
management measures introduced because of authorisation and participating in public
consultations as well as costs of substitution and related activities
Administrative costs of running the entire Authorisation process incurred by ECHA MS CAs and the
EC appear to be around euro84million per year in total (euro43m for MS CAs euro3m for ECHA and euro11m
for the EC ndash based on 2013-2016 data) Application costs (excluding fees) might be estimated at a
similar ballpark figure of euro9m per year (50 uses per year at euro180k per use (see Table 631 in Section
6)) which is subject to significant variation given the variation in the annual number of
applications
The total costs of risk management measures introduced because of authorisation are difficult to
estimate but might add another euro7million per year assuming that all applicants implement them
(50 applicants at euro140k per applicant see Section 612) This figure is extremely uncertain
however given the small sample number of respondents
The total costs of compliance by companies affected by REACH Authorisation RampD activity
substitution and relocation are impossible to calculate because the total number of firms that
Impacts of REACH Authorisation Final Report
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vi
might have engaged in these activities is unknown This also explains why extrapolation of the
costing results to the EU-level is not feasible
Section 67 of the main report suggests the costs of compliance are likely to run into thousands
(possibly tens of thousands) of euros per company which could make them significant at an
aggregate level
Substitution costs are uncertain due to the design of the survey used in the study with a large
proportion of respondents (78) reporting one-off substitution costs in the euro0-euro1m range However
for reasons discussed in Section 681 despite it being cheaper for these companies (at least in the
short term) to apply for authorisation these firms have chosen to substitute away from an SVHC
instead In addition it would take only a relatively small minority of firms to experience very high
costs of substitution to raise the average cost (eg euro15m one-off costs and euro768k operating costs
per year based on proportions reported in the survey) Only one respondent reported a substitution
which had no net costs and none reported cost savings
Authorisation requires that there are no suitable alternatives available to the applicant ndash defined
operationally by ECHA as (amongst other things) not entailing an increase in overall costs All but
one of the examples identified would entail an increase in overall costs and hence the applicant
may have been able to demonstrate they were not suitable ndash meaning that the firms in question
would in principle be eligible for authorisation Despite this they have elected to substitute
suggesting they have placed a premium on regulatory certainty and other factors associated with
avoiding the Authorisation process altogether
It is not possible to provide a reliable estimate of the total costs to third parties associated with
providing comments during the three public consultation stages in the Authorisation process ie
relating to (i) inclusion of a substance on the candidate list (ii) the recommendation of substances
to Annex XIV and (iii) an application for Authorisation The average time spent per submission
varies from up to 1 day to 40 days depending on the type of public consultation and stakeholder
For example tradesector associations can spend a lot of time preparing responses compared to
individual companies and NGOs Due to the small number of responses received to the survey on
this topic and variability in the estimates provided it is too speculative to derive a total cost
Costs of authorisation
Costs to EU public authorities ~euro84million per year
Costs to EU applicants ~euro9million per year
Costs of additional RMMs associated
with these applications
~euro7million per year
Costs of substitution Not possible to estimate the total costs without knowing how
many firms in the EU have substituted One off costs
estimated at lteuro1million per company (mean ~euro15million per
company) and euro768k annual operating costs per company
Costs of compliance Not possible to estimate the total costs without knowing how
many firms are affected The costs of compliance are likely
to run into thousands (possibly tens of thousands) of euros
per company which could make them significant at an
aggregate level
Costs to third parties Not possible to estimate a total cost due to limited
responses The average time spent per submission varies
from up to 1 day to 40 days depending on the type of public
consultation and stakeholder
More detail on the costs of authorisation can be found in Section 6 of the main report
Impacts of REACH Authorisation Final Report
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vii
Benefits of authorisation ndash include reductions in worker exposure to and emissions of
SVHCs improved markets for safer alternatives to SVHCs and improved content and
sharing of relevant information
Several approaches were used to obtain data to assess the benefits associated with the
Authorisation process The most tangible benefits due to REACH authorisation are the reduction of
worker exposure to SVHCs and reduced emissions of SVHCs into the environment (eg air
wastewater and waste) This is either due to (i) improvements in RMMs where SVHCs are still
being used (ii) substitution away from an SVHC (eg to using an alternative substance or
technology) or (iii) avoided exposure and emissions within the EU due to closing andor relocating
EU production sites that previously used SVHCs within the EU
There is evidence from the online survey interviews and evidence presented within AfAs to date
that REACH authorisation is resulting in an improvement in RMMs at all stages in the authorisation
process For example the survey results show that most improvements in RMMs occurred at early
stages in the REACH process The reasons for this could be to build a case so that the SVHC was not
prioritised for inclusion on Annex XIV as well as strengthening companies cases for a possible future
application Many applicants that have submitted an AfA have also indicated that they have
improved RMMs andor have planned investment in place in order to demonstrate minimisation of
emissions Examples of some of the types of RMMs identified by respondents are noted in Table 72
(within Section 73)
Where RAC were not certain that minimisation of emissions was demonstrated in many
appplications conditions were imposed on the applicant as part of granting the application such
as improved monitoring It can (in some cases) also lead to a shorter review period than might
have been possible (eg a normal review period rather than a long review period) had there been
fewer uncertainties concerning minimisation of emissions Survey responses have suggested that at
least in some cases applicants have improved their RMMs further (or are putting further measures
in place) which have led to (or they hope will lead to) further improvements in reducing exposure
to workers and releases of emissions of SVHCs to the environment However most indicated that it
was too soon to be able to provide quantitative data on this benefit
The survey results indicate that the levels of exposure reductions and emissions reductions of
SVHCs achieved by both applicants and those that substituted (ie did not need to apply for
authorisation) seemed to be relatively small (see Section 73) This is not necessarily surprising
since companies should have been reducing their exposure over many yearsdecades While
qualitatively it can be shown that REACH authorisation is having a positive effect due to lack of
detailed data it is currently not possible to quantify these benefits
Despite being 10 years into the REACH process this study suggests it is still too early to be able to
quantify the benefits of REACH authorisation To quantify the benefits historical data on the
number of workers exposed and changes in exposure level over time would be required Some of
this data does exist at Member State (MS) level as some Member States have confidential databases
(for their MS) containing historical values for worker exposure which the study team were unable to
obtain In the future should applicants reapply for authorisation (ie review report) the monitoring
data which is set as a requirement in some of the authorisation decisions could provide some
additional data to assist in assessing the scale of reductions being achieved over time
The authorisation process creates opportunities for alternative substances and technologies In
some cases the alternative is provided by the same company as the Annex XIV substance in other
cases different companies or technologies emerge Granting an authorisation however takes
Impacts of REACH Authorisation Final Report
eftec November 2017
viii
account of the time needed to develop alternative substances and technology in order to allow the
applicant(s) both the users of the Annex XIV substance and the suppliers of the alternatives to
adjust to changes in market demand (and other factors like product requalification)
Whilst there will have been an overall increase in sales of alternatives (substances andor final
products not made with an SVHC) for those companies that have already adopted an alternative
prior to REACH these survey respondents did not attribute any increased sales they achieved to
REACH Authorisation Most respondents who substituted to an alternative due to REACH
authorisation indicated (at least in the short term) either a net loss in sales revenue or no net
change (relative to sales revenue when previously using an SVHC) Further details on these are set
out within Section 7 (eg case study examples)
Specific benefits of closure andor relocation were also investigated Data from existing AfAs with
relocation as a non-use scenario show that the benefits to Europe in terms of reduced exposure or
emissions as a result of relocation would be far less compared to the costs of the relocation
A few other less tangible (but important) benefits were also identified The two main ones are
improved communication within the supply chain and encouraging further development of existing
technologies and in some cases innovation For the authorities the authorisation process provides a
way to collect data on uses of SVHC in a structured way While as such this may not lead to a
reduction in exposure or emissions this information can be used for further policy development and
enforcement
Benefits of authorisation
Human Health benefits Clear evidence of improved RMM and reduced exposure
Benefits of substitution Mainly reduction in exposure and emissions
Benefits from closure and relocation Few case of relocation or closure identified
Benefits to alternative suppliers Authorisation process helps to create a market for
alternatives in a controlled way
Benefits of better information Improved transparency and communication with
authorities
Other benefits Communication between applicants leading to exchange
in experience Driver for innovation
Collection of structured information on the use of SVHC
More detail on the benefits can be found in Section 7 of the main report
Affordability for Small and Medium Sized Enterprises (SMEs) ndash was assessed in terms
of the impact the REACH Authorisation process through a bespoke online survey
The EU chemicals industry and manufacturing sector (ie key downstream users) are made up of
many SMEs but only 35 (18) of 195 applications between 2013 and 2016 were from SMEs The
survey and interviews indicate that the main factors for this are the resource and knowledge
challenges presented by the application process
Financial constraints are an important factor (both for SMEs ability to invest up-front in substitution
activities and costs associated with applying for Authorisation) The application fee charged by
ECHA is low compared to the financial costs of preparing an application finding and implementing
a suitable alternative and the impacts on forgone activities (eg RampD and innovation) as a result of
diverting time and budget to apply for authorisation Due to these factors SMEs have typically
relied on their upstream suppliers to apply for Authorisation (and hence they are covered by their
suppliers)
Impacts of REACH Authorisation Final Report
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ix
The indirect impact of this is that SMEs become more reliant on these suppliers (eg limits who
they can buy the SVHC from) and many of them expect to pay for or have already had to pay for
this lsquoupstreamrsquo Authorisation through higher prices which they indicated they cannot pass through
onto their customers
The main issue with upstream Authorisation applications for downstream users (SMEs and large
firms) however has been that they tended to result in shorter review periods than those that
downstream user applications submit and that it took time for information on the application to
filter down the supply chain with upstream authorisation applications This can create further
business uncertainty as they cannot assure their customers of the long-term supply of their
products More detail on the affordability by SMEs can be found in Section 8 of the main report
Sections 10-12 reinforces these findings through three detailed case studies that cover much of
these impacts for a specific substance Some of the key observations from this study are
There is evidence of substitution of SVHCs within the EU due to REACH Authorisation
There is evidence of substitution despite applying for authorisation being a cheaper option
This seems to be linked to the perceived business continuation risksuncertainties
associated with having to rely on applying for authorisation to continue operating
The authorisation process is resulting in improvements in RMMs at every stage of the
process
It is still too early to be able to quantify the benefits of Authorisation due to a lack of
publicly available historical exposure data This should improve over time but further work
(requiring substantial effort and resources) is required to collect relevant information
required
Impacts of REACH Authorisation Final Report
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x
CONTENTS
1 INTRODUCTION 1
11 Context and rationale of this study 1
12 Project objectives 2
13 Structure of this report 3
2 METHOD OVERVIEW 5
3 AUTHORISATION PROCESS 2007-2016 10
31 Screening of substances and Risk Management Option Assessment (RMOA) 10
32 Inclusion of substances in the Candidate List 12
33 Prioritisation and inclusion of substances in the Authorisation List 13
34 Applications for Authorisation (AfA) 14
35 Review of Authorisation following their review period 18
4 CHANGES IN THE EU MARKET FOR SVHCS (AND THEIR ALTERNATIVES) 19
41 Introduction 19
42 EU chemicals sector general trends and drivers of change 20
43 Summary of literature review 22
44 Survey responses 23
45 Tier 2 case study Diarsenic trioxide and arsenic acid 32
46 Tier 2 case study HBCDD 42
47 Findings using other statistical sources 48
48 Summary of observed market changes 62
5 INSTANCES OF SUBSTITUTION 64
51 Introduction 64
52 Summary of literature review 65
53 Survey responses 66
54 Tier 2 Case studies 76
55 Applicants ndash Future possibilities to substitute 85
56 Summary of instances of substitution 87
6 COSTS OF THE AUTHORISATION PROCESS 88
61 Introduction 88
62 Summary of literature review 89
63 Costs to Member State Competent Authorities (MSCAs) 90
64 Costs to the European Chemicals Agency (ECHA) 95
65 Costs to the European Commission (EC) 100
66 Costs to third parties for responding to public consultations 100
67 Compliance costs 114
68 Costs of substitution 117
69 Costs of RampD innovation and investment 120
610 Costs of closure and relocation 122
611 Costs to apply for authorisation 126
612 Costs to improve risk management 130
Impacts of REACH Authorisation Final Report
eftec November 2017
xi
613 Summary of costs 132
7 BENEFITS FROM THE AUTHORISATION PROCESS 134
71 Introduction 134
72 Summary of literature review 136
73 Survey responses 137
74 Human health benefits from improvement of risk management 142
75 Environmental benefits from improvement of risk management 146
76 Benefits of substitution 148
77 Benefits from closure and relocation 149
78 Benefits to alternative suppliers 151
79 Benefits of better information 152
710 Other benefits 153
711 Summary of benefits 153
8 AFFORDABILITY OF AUTHORISATION FOR SMES 156
81 Introduction 156
82 Summary of literature review 157
83 Applications to date from SMEs 158
84 Survey responses 159
85 Tier 2 Case studies 162
86 Affordability analysis 166
87 SME summary 168
9 EVIDENCE OF THE lsquoANNOUNCEMENT EFFECTrsquo 169
91 Introduction 169
92 Summary of literature review 170
93 Analysis testing the announcement effect 171
94 Case studies 173
95 Summary of the announcement effect 175
10 TIER 1 CASE STUDY SUBSTANCE 1 CHROMIUM TRIOXIDE 177
101 Introduction 177
102 Substance profile 178
103 Case study rationale 179
104 REACH Authorisation timeline 179
105 Market prior to REACH authorisation 180
106 Changes in the market for the substance during the authorisation process 184
107 Substitution 186
108 Changes in the market for alternatives 191
109 Evidence of improved risk management 192
1010 Competition and competitiveness 198
1011 RampD innovation and investment 200
1012 Experience of SMEs 201
1013 Summary of Tier 1 case study 202
11 TIER 1 CASE STUDY SUBSTANCE 2 TRICHLOROETHYLENE 204
111 Introduction 204
Impacts of REACH Authorisation Final Report
eftec November 2017
xii
112 Substance profile 204
113 Case study rationale 205
114 REACH Authorisation timeline 205
115 Market prior to REACH authorisation 206
116 Changes in the market for the substance during the authorisation process 209
117 Substitution 211
118 Changes in the market for alternatives 213
119 Evidence of improved risk management 214
1110 Competition and competitiveness 219
1111 RampD innovation and investment 220
1112 Experience of SMEs 220
1113 Summary of Tier 1 case study 220
12 TIER 1 CASE STUDY SUBSTANCE 3 DIBUTYL PHTHALATE (DBP) 222
121 Introduction 222
122 Substance profile 222
123 Case study rationale 223
124 REACH Authorisation timeline 224
125 Market prior to REACH authorisation 224
126 Changes in the market for the substance during the authorisation process 227
127 Substitution 228
128 Changes in the market for alternatives 229
129 Evidence of improved risk management 230
1210 Competition and competitiveness 232
1211 RampD innovation and investment 232
1212 Experience of SMEs 232
1213 Summary of Tier 1 case study 232
13 SUMMARY AND CONCLUSIONS 234
REFERENCES 241
ANNEX A STEERING GROUP COMMITTEE 246
ANNEX B METHODOLOGY 247
B1 Project scope 247
B2 Assessment approach 248
ANNEX C AUTHORISATION PROCESS 2007-2016 260
C1 Overview 260
C2 Timeline of key events in the authorisation process (2006-2017) 264
C3 Screening of substances and Risk Management Option Assessment (RMOA) 266
C4 Inclusion of substances in the Candidate List 268
C5 Prioritisation and inclusion of substances in the Authorisation List 269
C6 Applications for Authorisation (AfA) 269
C7 Post authorisation decision 269
C8 Review of Authorisation following their review period 270
ANNEX D ACTIVITIES CARRIED OUT ALONG THE AUTHORISATION PROCESS 271
D1 STAGE 1 Screening of substances and RMOArsquos 272
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eftec November 2017
xiii
D2 STAGE 2 Inclusion of substances in the Candidate List 283
D3 STAGE 3 Inclusion of substances in the Authorisation List 290
D4 STAGE 4 Applications for authorisation 296
D5 STAGE 5 Post authorisation decision 305
D6 STAGE 6 Review authorisations following review period 311
ANNEX E LITERATURE REVIEW 314
E1 Introduction 314
E2 EU chemicals market 314
E3 Market changes for SVHCs 323
E4 Instances of substitution 325
E5 Costs of authorisation 330
E6 Benefits of authorisation 335
E7 Impacts on SMEs 345
E8 Announcement effect 348
ANNEX F AUTHORISATION SURVEYS 354
F1 Purpose of the surveys 354
F2 Survey structure and design 354
F3 Respondent profile 357
F4 Data validation 358
F5 Industry survey ndash Statistical summary 359
ANNEX G STAKEHOLDERS CONTACTED 389
G1 Member State Competent Authorities 389
G2 NGOs 390
G3 Industry 391
ANNEX H TIER 1 SUPPORTING ANNEX (FOR SECTION 10) 403
CONFIDENTIAL ANNEX ERROR BOOKMARK NOT DEFINED
LIST OF TABLES
Table ES11 Approaches to collecting new information iii Table 21 Approaches to collecting new information 8 Table 31 Progress on hazard assessment and RMOA development (as of Dec 2016) 11 Table 32 Candidate list of substances (SVHC) by reason for inclusion (as of Jan 2017) 13 Table 33 Authorisation list substances (Annex XIV) by SVHC type (as of 13th June 2017) 14 Table 34 Number of Applications for Authorisation (AfA) (as of Dec 2016) 15 Table 35 Status of decisions of AfArsquos submitted (Dec 2016) 16 Table 36 Review periods applied for (Dec 2016) 16 Table 37 Were applicants given the review period they advocated for (Dec 2016) 17 Table 38 Number of uses applied for defined by Article 57 criteria (Dec 2016) 18 Table 41 Changes in the supply of (possible) SVHCs and alternatives (industry survey) 23 Table 42 Changes in competitiveness - (possible) SVHCs (industry survey) 26 Table 43 Changes in employment (industry survey) 28 Table 44 Changes in employment ndash Type of impact (industry survey) 28 Table 45 Changes in sales revenue (industry survey) 29 Table 46 Changes in sales revenue ndash Type of impact (industry survey) 30
Impacts of REACH Authorisation Final Report
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xiv
Table 47 Changes in quality price availability (industry survey) 30 Table 48 Substance profiles 32 Table 49 REACH authorisation timelines 33 Table 410 Diarsenic trioxide in the EU 2008-2010 34 Table 411 Granted authorisation for uses of diarsenic trioxide 37 Table 412 Applications for authorisation for the use of arsenic acid 38 Table 413 Import and export notifications for diarsenic trioxide 2004-2017 40 Table 414 HBCDD substance profile 42 Table 415 HBCDD REACH authorisation timeline 43 Table 416 Summary of volumes of HBCDD (excludes imports in articles) ndash 2006 data 44 Table 417 Summary table of the different uses of HBCDD EU (20067) 45 Table 418 Demand for HBCDD in the EU (2007) 46 Table 419 Global demand for HBCDD (2011) 46 Table 420 Number of registrants ceasing manufacturing of SVHCs 49 Table 421 Change of registration status for substances on the Authorisation List 49 Table 422Examples of substances with removals of certain uses from registrations during Annex
XIV prioritisation rounds 51 Table 423 Classification of Candidate and Authorisation List substances based on quality of
PRODCOM match 53 Table 424 Authorisation List substances (with complete datasets) in Category 2 53 Table 425 Substances matched to ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM
code 20135125) 57 Table 426 Classification of alternative substances based on the quality of the PRODCOM match 60 Table 427 Assigned PRODCOM categories 60 Table 51 Whether respondents substituted a (possible) SVHC (industry survey) 66 Table 52 Instances of substitution ndash (Possible) SVHCs uses and alternatives (industry survey) 67 Table 53 Substitution activities - (Possible) SVHCs and uses (industry survey) 71 Table 54 Average air concentrations of arsenic at the Murano environmental monitoring station
2014-16 85 Table 55 RampD plans included in AfAs 85 Table 61 Average staff cost per day (euro) for time spent carrying out authorisation activities 90 Table 62 Time for and cost (euro) of carrying out a RMOA per substance 91 Table 63 Time for and costs (euro) of the Annex XV dossier process for SVHC identification 92 Table 64 Time for and costs (euro) of Member State Committee activities on authorisation (per
Member State) 93 Table 65 Time for and costs (euro) of REACH Committee activities on authorisation 93 Table 66 Time for and costs (euro) of ECHA Scientific Committee (RAC and SEAC) non-plenary
activities on authorisation applications per MS CA per AfA case 94 Table 67 ECHA time and cost (euro) spent on and number of substance RMOAs 2014-2016 96 Table 68 ECHA estimates of mean (min max) days and cost (euro) spent on Annex XV dossier
preparation 97 Table 69 Time and cost spent on candidate listing (days euro000 per substance) 97 Table 610 SVHC dossiers by hazard property per year 98 Table 611 Recent Annex XIV recommendations 98 Table 612 Time and cost spent on Annex XIV prioritisation days per year 98 Table 613 ECHA estimates of time and cost (euro000) spent on opinion-making per- use 2014-201699 Table 614 Total authorisation application fees received by ECHA 2013-2016 99 Table 615 Estimates of DG ENV and DG GROW time spent on authorisation activities 2016 100 Table 616 Number of submissions received during the public consultation 101 Table 617 Number of submissions received (per substance level) ndash 2008-2016 102 Table 618 10 substances that received the most public consultation submissions 102 Table 619 Estimated time taken to produce submission (candidate list consultation) 104
Impacts of REACH Authorisation Final Report
eftec November 2017
xv
Table 620 Number of submissions received during the public consultation (Annex XIV) 105 Table 621 Number of submissions received (per substance level) ndash 2008-2016 105 Table 622 10 substances that received the most public consultation submissions 106 Table 623 Estimated time taken to produce response (Annex XIV consultation) 107 Table 624 Estimated time taken to produce response (AfA consultation) 110 Table 625 Types of compliance related costs incurred 115 Table 626 Costs for companies to familiarise themselves with the requirements under REACH
Authorisation 115 Table 627 Change in RampD innovation or investment spending (by use) 120 Table 628 Change in innovation investment and RampD spending 121 Table 629 Scale of change in innovation investment and RampD spending 121 Table 630 Industry consultees reporting relocation or closure in response to authorisation 124 Table 631 Estimated closure and relocation costs from selected applications for authorisation 125 Table 632 Reported mean application costs per use and applicant 2013-2016 (source ECHA) 127 Table 633 Reported mean notional total application costs per use and applicant by supply chain
position 2013-2016 (source ECHA) 128 Table 634 Reported mean notional total application costs per use and applicant by company size
2013-2016 (source ECHA) 128 Table 635 Reported mean notional total application costs per use by application route 2013-2016
(source ECHA) 129 Table 636 Reported notional total costs for applicants in the opinion-making phase (source ECHA)
130 Table 71 Instances of improved risk management activities 140 Table 72 Instances of risk management activities ndash Description of activities carried out (industry
survey) 140 Table 73 Improvements reported in the AfA per substance 143 Table 74 Improvements reported in the AfA TH Non-TH 144 Table 75 Change in the average concentrations of arsenic in the air in the environmental
monitoring station in Murano 2014-16 149 Table 81 Definition of an SME 156 Table 82 Number of AfArsquos by size of firm 158 Table 83 Type of applications SME survey respondents were involved in 160 Table 91 Seven hypotheses around the lsquoannouncement effectrsquo 169 Table 92 Evidence relative to the seven hypotheses around the lsquoannouncement effectrsquo 175 Table 101 Chromium Trioxide substance profile 178 Table 102 Chromium Trioxide REACH authorisation timeline 179 Table 103 Presence of RampD plans in Chromium Trioxide AfArsquos 188 Table 104 Sources used for estimation of exposure to CrVI 194 Table 105 Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at
different 8h-TWA concentrations of Cr(VI) for 40 years 194 Table 106 Historical measurement campaigns on Cr(VI) reported from various EU countries values
for inhalation 195 Table 107 Results from the Belgian inspection campaign 196 Table 108 Overview of occupational exposures results from the submitted AfAs for Chromium
Trioxide expressed as ranges 196 Table 109 Number of applicants and their size per substance 201 Table 111 Trichloroethylene substance profile 204 Table 112 Trichloroethylene REACH authorisation timeline 205 Table 113 Existing OELs for TCE inhalation (adapted from the GESTIS database) 215 Table 114 Comparison of OEL levels for TCE for different EU countries over time values for
inhalation 216
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xvi
Table 115 Historical measurement campaigns on TCE reported from various EU countries values
for inhalation 217 Table 116 Overview of occupational exposures results from the submitted AfAs for TCE expressed
as ranges 219 Table 121 Dibutyl Phthalate substance profile 222 Table 122 Dibutyl Phthalate REACH authorisation timeline 224 Table 123 Existing OELs for Dibutyl Phthalate for inhalation (adapted from the GESTIS database)
230 Table 124 Historical measurement campaign for DBP reported from EU countries inhalation 230 Table 125 Overview of occupational exposures results from the submitted AfAs for DBP expressed
as ranges 231 Table B01 REACH Authorisation intervention logic (non-exhaustive high-level list) 249 Table B02 Total number of activities excluded with justification 252 Table B03 Number of activities carried out along the authorisation process that are assessed in
this study 253 Table C01 The main stages in the authorisation process 263 Table E01 Authorisation application fees set in Commission Regulation (EC) No 3402008 332 Table E02 Authorisation application fees set in Regulation (EU) No 2542013 332 Table E03 Have any of your customers requested the removal of SVHCs from your products 350 Table E04 What has been the response of your firm to the placing of substances relevant to your
business in the Candidate List (Percentage of firms indicating) 352 Table G01 Stakeholders invited to take part in a MS CA questionnaire 389 Table G02 Stakeholders invited to take part in the NGO online survey 390 Table G03 Stakeholders invited to take part in the industry online survey 392
LIST OF FIGURES
Figure 21 Overview of method 5 Figure 41 Assessing changes in the market using different approaches 20 Figure 42 Changes in the supply of SVHCs and alternatives ndash Type of impact (industry survey) 25 Figure 43 Changes in competitiveness ndash Type of impact (industry survey) 27 Figure 44 Changes in quality price availability ndash Type of impact (industry survey) 31 Figure 45 Production value and import value of 12-dichloroethane (ethylene dichloride) 55 Figure 46 Export value of 12-dichloroethane (ethylene dichloride) 55 Figure 47 Production value and import value of methyloxirane (propylene oxide) 55 Figure 48 Export value of methyloxirane 55 Figure 49 Production value and import value of ldquoChromium manganese lead and copper oxides
and hydroxidesrdquo (PRODCOM code 20121200) 56 Figure 410 Export value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo
(PRODCOM code 20121200) 56 Figure 411 Production value and import value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic
trioxiderdquo (PRODCOM code 20111250) 57 Figure 412 Export value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM
code 20111250) 57 Figure 413 Production value and import value of ldquoChromates and dichromates peroxochromatesrdquo
(PRODCOM code 20135125) 58 Figure 414 Export value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code
20135125) 58 Figure 415 Production value and import value of ldquoTrichloroethylene tetrachloroethylene 59 Figure 416 Export value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo
(PRODCOM code 20141374) 59
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eftec November 2017
xvii
Figure 417 Production and import values as well as export value of ldquoCyclohexanone and
methylcyclohexanonesrdquo ldquoDiazo- azo- or azoxy-compoundsrdquo and ldquoOther esters of orthophthalic
acidrdquo 61 Figure 51 Instances of substitution - Number of years to achieve substitution (Industry survey) 70 Figure 52 Stage in the REACH authorisation process that triggered substitution activity 71 Figure 53 Substitution activities ndash Types of activities undertaken (industry survey) 74 Figure 54 Drivers of substitution activities (industry survey) 75 Figure 55 Barriers to substitution (industry survey) 76 Figure 61 Number of AfA public consultations and comments received 108 Figure 62 Types of REACH actors that have commented on an AfA 109 Figure 63 Number of comments received by substance 109 Figure 64 Main reasons for industry stakeholder to provide comments 111 Figure 65 Whether the industry organisation read published response to their comments 112 Figure 66 Main reasons for not providing comments 112 Figure 67 Whether respondents organisation incurred costs associated with compliance with
REACH authorisation process 114 Figure 68 Cost to update registration dossier following granting of an authorisation 116 Figure 69 One off investment costs to implement alternative (substance or process) to an SVHC 118 Figure 610 Annual net operating costs to use the alternative (substance or process) to an SVHC 118 Figure 611 Annual spending on substitution activities 119 Figure 612 What authorisation stage triggered these risk management activities 130 Figure 613 Estimated one-off cost of risk management activities 131 Figure 81 Number of applicants (2013-16) by applicant size 159 Figure 82 Top 3 challenges faced by SMEs associated with the authorisation process 160 Figure 83 Top 3 challenges faced by SMEs associated with AfAs 161 Figure 84 Who SMEs used to support them 161 Figure 85 SMEs views on the REACH authorisation guidance and other information on the ECHA
website 162 Figure 91 Whether REACH authorisation has led to internal policy concerning managingknowing
what substances are used within respondents organisations including (possible) SVHCs 171 Figure 92 Authorisation stage that triggered decision to substitute from an SVHC 172 Figure 93 Authorisation stage that triggered substitution related activities 172 Figure 94 Authorisation stage that triggered further risk management activities 173 Figure 101 Chromium Trioxide imports to EU 2000-2016 181 Figure 102 Chromium Trioxide exports to outside EU 2000-2016 181 Figure 103 Supply chain for Chromium Trioxide 182 Figure 104 Chromium Trioxide ndash Market share by use 185 Figure 105 Evolution of the exposure to CrVI 197 Figure 111 Production export import volumes TCEPER 2003-2016 207 Figure 112 Uses of TCE sold into EU markets 1996 and 2003 208 Figure 113 Trichloroethylene ndash Production consumption exports imports in EU 2012-2016 209 Figure 114 Trichloroethylene ndash Production consumption in EU 2017-2022 210 Figure 115 Tetrachloroethylene ndash Production consumption exports imports in EU 2012-2016 213 Figure 116 Tetrachloroethylene ndash Production consumption in EU 2017-2022 214 Figure 117 Excess risk for carcinogenic effects-Working lifetime exposure 218 Figure 121 DBP production volumes 225 Figure 122 DBP use distribution (1998 2007) 226 Figure 123 Percentage of phthalate sales in EU compared to total plasticisers 229 Figure C01 The processes in authorisation and contributory processes 261 Figure C02 Timeline of key events in the authorisation process (2007-2016) 265 Figure E01 EU chemicals sales 315 Figure E02 Share of member states in EU chemical sales 316
Impacts of REACH Authorisation Final Report
eftec November 2017
xviii
Figure E03 EU chemicals sales by destination 316 Figure E04 Extra-EU imports amp exports and trade balance 317 Figure E05 EU export market share 318 Figure E06 EU chemicals production 319 Figure E07 EU regulatory cost 320 Figure E08 Capital spending 321 Figure E09 Research amp Development (RampD) Spending 322 Figure E010 Distribution of costs related to application for authorisation (micro companies) 331 Figure E011 Share of REACH REFIT respondents thinking that authorisation application fees are
too high 333 Figure E012 Legislation cost (as annual share of turnover 2004-2014) by size of firms 347
Impacts of REACH Authorisation Final Report
eftec November 2017
xix
LIST OF ABBREVIATIONS
AC Adequate Control
ACEA European Automobile Manufacturersrsquo Association
ADCA CC-azodi(formamide)
AfA Application for Authorisation
AfAs Applications for Authorisation
Al-RCF Aluminosilicate Refractory Ceramic Fibres
AoA Analysis of Alternatives
API Active Pharmaceutical Ingredient
BBP Benzylbutyl Phthalate
CAS Chemical Abstracts Service
CBA Cost Benefit Analysis
CCH Compliance Check
CEFIC The European Chemical Industry Council
CIRCABC Communication and Information Resource Centre for Administrations Businesses
and Citizens
CLH Harmonised Classification and Labelling
CLP Classification Labelling and Packaging
CMR Carcinogenic mutagenic or toxic to reproduction
CO2 Carbon Dioxide
COM European Commission
CoRAP Community rolling action plan
CrIII Trivalent chromium
CrVI Hexavalent chromium
CSR Chemical Safety Report
CVP Chemical Vapour Deposition
DBP Dibutyl Phthalate
DEFRA Department for Environment Food and Rural Affairs
DEHP Bis(2-ethylhexyl)phthalate
DIBP Diisobutyl Phthalate
DIDP Diisodecyl Phthalate
DINCH Di-(isononyl)-cyclohexan-12-dicarbooxylate
DINP Di-isononyl Phthalate
DMF NN-dimethylformamide
DNEL Derived No Effect Level
DOTE 2-ethylhexyl-10-ethyl-44-dioctyl-7-oxo-8-oxa-35-dithia-4-stannatetradecanoate
DPHP Bis(2-propylheptyl) Phthalate
DU Downstream User
DUs Downstream Users
EBFRIP European Brominated Flame Retardant Industry Panel
EC European Commission
ECMA European Federation of Catalyst Manufacturers
ECHA European Chemicals Agency
ECPI European Council for Plasticisers and Intermediates
ED Endocrine Disruption
EDC 12-Dichloroethane
EEA European Economic Area
Impacts of REACH Authorisation Final Report
eftec November 2017
xx
EEB European Environmental Bureau
EED Electro- electrodialysis
EEN Enterprise Europe Network
EPS Expanded Polystyrene
eSDS extended Safety Data Sheet
ESR Existing Substances Regulation
ESR RAR Existing Substances Regulation Risk Assessment Report
ESTAL European Association of Alumina Platers
ETP Tin-plated Steel
ETS Emissions Trading Scheme
EU European Union
EUMEPS Association for European Manufacturers of Expanded Polystyrene
FGK Fachverband Galvanisierte Kunststoffe eV
FR EPS Flame Retarded Expanded Polystyrene
FTE Full Time Equivalent
GOS Gross Operating Surplus
HBCDD Hexabromocyclododecane
HCFCs Hydrochlorofluorocarbons
HFCs Hydrofluorocarbons
HFEs Hydrofluoroethers
HH Human Health
HIPS High Impact Polystyrene
HMW High Molecular Weight
HSS High Speed Steel
HVOF High Velocity Thermal Process
IPA Institut fuer Praevention und Arbeitsmedizin der Deutschen Gesetzlichen
Unfallversicherung
IPCS International Programme on Chemical Safety
ITT Invitation to Tender
LAD Latest Application Date
LCD Liquid-Crystal Display
LOW Low Molecular Weight
MDA 44rsquo- Diaminodiphenylmethane
MHHPA Hexahydromethylphthalic Anhydride
MI Manufacturer Importer
MIs Manufacturers Importers
MA Maleic Anhydride
MEC Methylene Chloride
MOCA 22-dichloro-44-methylenedianiline
MOTE 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-
oxa-35-dithia-4-stannatetradecanoate
MS Member State
MS CA Member State Competent Authority
MS CAs Member State Competent Authorities
MSC Member State Committee
MSC-WG Member State Committee ndash Working Group
MSs Member States
NEAs National Enforcement Authorities
NeRSAP Network of REACH SEA and Analysis of Alternatives Practitioners
Impacts of REACH Authorisation Final Report
eftec November 2017
xxi
NGO Non-Governmental Organisation
NGOs Non-Governmental Organisations
NiB Nickel Boron
NiP Nickel-phosphor
NMP 1-methyl-2-pyrrolidone
Non-TH Non-threshold
OC Operational Conditions
OECD Organisation for Economic Co-operation and Development
OEL Occupational Exposure Limit
OSOR one substance one registration
PACT Public Activities Coordination Tool
PBT Persistent Bioaccumulative Toxic
PC Public Consultation
PCBs Printed Circuit Boards
pFR Polymeric flame retardant
PER Tetrachloroethylene
PNEC Predicted No Effect Concentration
POPAA Plating on Plastics for Automotive Applications
POPs Persistent organic pollutants
PPORD product and process orientated research and development
PRODCOM PRODCOM is abbreviated from the French Production Communautaire
PS Polystyrene
PSIS Pre-Submission Information Session
PVC Polyvinyl Chloride
PVD Physical Vapor Deposition
QC Quality Control
(Q)SARs (Quantitative) Structure-Activity Relationships
RAC Risk Assessment Committee
RAR Risk Assessment Report
RCFs Refractory Ceramic Fibres
RCOM Response to Comments document
RampD Research amp Development
REACH A European Union regulation concerning the Registration Evaluation Authorisation
amp Restriction of CHemicals
RER Rapid Evidence Review
RMM Risk Management Measure
RMMs Risk Management Measures
RMO Risk Management Option
RMOA Risk Management Option Analysis
RMOAs Risk Management Option Analyses
RoHS Restriction of the Use of Certain Hazardous Substances
RRS Risk Reduction Strategy
SCFs Supercritical Fluids
SCOEL Scientific Committee on Occupational Exposure Limits
SDS Safety Data Sheet
SDSC SUBSPORT Screening Criteria
SEA Socio Economic Analysis
SEAC Socio Economic Analysis Committee
SEAs Socio Economic Analyses
Impacts of REACH Authorisation Final Report
eftec November 2017
xxii
SEv Substance Evaluation
SHVC Substance of Very High Concern
SiC Standard Industrial Classification
SIEF Substance Information Exchange Forum
SME Small and Medium-sized Enterprise
SMEs Small and Medium-sized Enterprises
SVHC Substance of Very High Concern
SVHCs Substances of Very High Concern
TCE Trichloroethylene
TH Threshold
TiN Titanium Nitride
tpa Tonnes per annum
US EPA United States Environmental Protection Agency
UTC Unintentional Trace Contamination
vPvB very Persistent very Bioaccumulative
WC Tungsten Carbide
WCCo Cobalt-tungsten Carbide
WFD EQS Water Framework Directive Environmental Quality Standards
WHO World Health Organization
WP Working procedures
WSSD World Summit on Sustainable Development
WTO World Trade Organisation
XPS Extruded Polystyrene
Zr-RCF Zirconia Aluminosilicate Refractory Ceramic Fibres
Impacts of REACH Authorisation Final Report
eftec November 2017 1
1 INTRODUCTION
11 Context and rationale of this study
The REACH Regulation entered into force on the 1st June 2007 It was adopted to improve the
protection of human health and the environment from the risks that can be posed by chemicals and
the free circulation of chemicals in the internal market while enhancing the competitiveness and
innovation of the EU chemicals industry It also promotes alternative methods for the hazard
assessment of substances in order to reduce the number of tests on animals3
The REACH Regulation includes the obligation for a review every five years to monitor progress in
the achievement of its objectives The first review was carried out in 20124 and the second REACH
Review due in 2017 is being carried out in parallel with the fitness check on the most relevant
chemicals legislation excluding REACH This study will feed into the REACH 2017 review by
providing evidence on the impacts of REACH authorisation (ie one specific regulatory procedure of
REACH)
The first review of REACH concluded that ldquoREACH functions well and delivers on all objectives that
at present can be assessed Some needs for adjustments have been identified but balanced
against the interest of ensuring legislative stability and predictability the Commission will not
propose any changes to the enacting terms of REACH Within the current framework however
there is a need to reduce the impact of REACH on SMEsrdquo4 The findings also note that ldquothere are
many other opportunities for further improvement of the functioning of REACH by optimizing the
implementation at all levelsrdquo4
This project is the first comprehensive attempt to obtain evidence on the overall impacts of the
REACH authorisation procedure Some evidence exists within ECHA on the costs of applications and
evidence of risk reduction as part of applications for authorisation ECHA is also currently carrying
out a meta-analysis of the benefits and costs of authorisation applications However less is known
about the other costs and benefits associated with the authorisation process on different actors and
on instances where companies have substituted a substance of very high concern (SHVC) thereby
avoiding the need to apply for authorisation Such impacts include amongst others the
administrative burden to public authorities and third parties costs (and benefits) to industry (and
EU society) from complying with REACH authorisation and costs and benefits associated with
substitution and improved risk management
The project is seeking to fill such information gaps and substantiate and quantify the currently
available qualitative information on the costs benefits and other impacts of authorisation It
focusses on the areas where until now it has been more difficult to collect reliable information
namely the substitution objective of authorisation As stated in the Invitation to Tender (ITT) while
data on costs and burden may be easier to gather some of the benefits and other impacts may only
materialise much later and even if identified they are usually difficult to quantify Capturing and
quantifying them fully at this point in time would therefore not be possible However this study
makes a serious effort to include the information on benefits in a qualitative manner and quantify
what is possible
3 httpsechaeuropaeuregulationsreachunderstanding-reach 4 httpeceuropaeuenvironmentchemicalsreachreview_2012_enhtm
Impacts of REACH Authorisation Final Report
eftec November 2017 2
12 Project objectives
The main objective of the project is to evaluate the performance of REACH authorisation by
providing evidence on whether it is working as intended and achieving its objectives This final
report encompasses all the findings of this study and sets out results based on the five areas the
study sought particular information on (i) cost of authorisation (ii) benefits of authorisation (iii)
changes in the market structure (iv) substitution and (v) affordability of authorisation for SMEs
Through data collected to meet this main objective and through existing amp ongoing studies it
should also be possible to (i) provide evidence on the functioning of the current implementation of
the SVHC 2020 Roadmap (which commenced in February 20135) and in particular the risk
management option analysis (RMOA)6 and (ii) to evaluate the adequacy of current guidance for
stakeholders to facilitate the preparation of Applicants for Authorisations (AfAs) and where
possible evidence on ongoing initiatives to streamline and simplify the authorisation procedure
This extends the coverage of the authorisation process to collect information (since 2013) on the
RMOA process which is voluntary (ie not part of the processes as defined in the legislation)
Within the context of this study this means collecting information on for example the costs to
public authorities to develop RMOAs and the benefits of this process (eg whether it facilitates
substitution for those substances where authorisation is recommended)
ECHA together with Member States and the Commission has started to review some elements of
the SVHC Roadmap implementation and this will continue next year with the objective to report on
the overall review in the annual report of the SVHC Roadmap to be published in 2018
To date there has been a reasonable number of applications for authorisation through the entire
authorisation process (ie with final decisions made by the Commission) and a large number of
opinions A larger number of substances have been introduced in the process from the RMOA to
the registry of intentions the candidate list and the ECHA recommendation for inclusion on Annex
XIV With this experience now should be a good time to critically look back on the REACH
authorisation process to identify instances where companies have substituted substances instead of
submitting an AfA and to assess the current RMOA process In doing so this project is seeking to
address the following gaps
1 What effects authorisation has and what impacts these have on different stakeholders
(including public authorities and different size of firms using the substance of concern or an
alternative) and along the supply chain
2 Where along the authorisation process these stakeholders are more affected (eg from
Screening of substances and RMOAs inclusion of substances in the Candidate List all the
way through to reviewing AfAs following their review periods)
3 What the overall costs and benefits of authorisation have been both as the substance goes
through the authorisation process and as a result of authorisation decisions For example
5 Substance of Very High Concern 2020 Roadmap httpsechaeuropaeuaddressing-chemicals-of-
concernsubstances-of-potential-concernpact-substance-
rev1988del50colsynonymDynamicField_3413typeascpre1view 6 Roadmap for SVHC identification and implementation of REACH Risk Management measures from now to
2020 (called the SVHC Roadmap) ndash Available at
httpsechaeuropaeudocuments1016219126370svhc_roadmap_2015_enpdf
Impacts of REACH Authorisation Final Report
eftec November 2017 3
has authorisation lead to reduced overall risks Has it led to reduced competitiveness
relative to non-EU companies
4 How efficient the current process is and whether there is scope for reducing administrative
and regulatory steps whilst preserving the intended aims of REACH authorisation
13 Structure of this report
The remainder of this report is structured as follows
Section 2 Methodology
Section 3 Authorisation process 2007-2016
Section 4 Changes in the EU market for SVHCs (and their alternatives)
Section 5 Instances of substitution
Section 6 Costs of the authorisation process
Section 7 Benefits from the authorisation process
Section 8 Affordability of authorisation for SMEs
Section 9 Tier 2 case study Evidence of the lsquoannouncement effectrsquo
Section 10 Tier 1 case study substance 1 Chromium Trioxide
Section 11 Tier 1 case study substance 2 Trichloroethylene
Section 12 Tier 1 case study substance 3 Dibutyl Phthalate (DBP)
Section 13 Summary and conclusions
There are also a series of Annexes that provide supporting information like stakeholders
contacted details of the online surveys and an annex containing confidential information (which
wonrsquot be available in the public version of the final report)
131 Logic for the sequencing of impacts (Sections 4-9)
Given that many of the impacts are linked interdependent it would only be possible to assess
certain impacts after others have been identified and quantified This introduces a hierarchy of
what data needed to be collected first
The first step was to understand how the market for a particular substance has changed over time
This is done through identifying how the following have changed
The number of suppliers of the substance (Manufacturers or Importers (MIs))
The volumes manufactured in the EU imports into the EU and exports outside of the EU
The uses of the substance
The focus was on collecting information on (i) the market situation before the substance entered
the authorisation process (ii) during the authorisation process and (iii) the current situation
Changes in the market situation between these periods would help us understand the scope of
certain impacts like
1 Any possible substitution of the substance ndash eg comparing the uses before REACH
authorisation and currentknown uses of the substance and
2 Any possible instances of relocation and closure ndash eg closure of MIs within the EU
location of end-use markets (eg through changes in volumes of importsexports)
Impacts of REACH Authorisation Final Report
eftec November 2017 4
The second step was to understand the drivers for these changes (eg market forces fashion
technological development regulation and so forth) and when these changes occurred (eg
whether there was already a declining trend in the use of the substance before it was subject to
the REACH authorisation process)
The third step is to find out further information on possible alternatives and how the markets for
these alternatives have changed This would help us understand to what extent changes in the
market for SVHCs have been displaced by alternatives or simply a case of relocation of activities
outside of the EU The latter being an undesirable societal outcome
This would then help us estimate what changes can be attributed to the REACH authorisation
process and to estimate the costs and benefits of these changes
The report therefore sets out the information gathered in the order following this logic process
Section 4 Changes in the EU market for SVHCs (and their alternatives)
Section 5 Instances of substitution
Section 6 Costs of the authorisation process
Section 7 Benefits from the authorisation process
Section 8 Affordability of authorisation for SMEs
Section 9 Evidence of the lsquoannouncement effectrsquo
These individual chapters are used to explain the way the impacts are assessed and the Tier 1 case
studies that follow (in Sections 10-12) build on this framework by going into detail on these impacts
for three specific substances
Before the detailed findings Section 3 sets out some supporting context and data about the
authorisation process This information also helps assess the lsquoeffectivenessrsquo of the REACH
authorisation process relative to defined targets like having all known SVHCs on the candidate list
by 2020
132 Use of case studies
Case studies are used throughout this report to provide where possible more in-depth insights on
the five impact areas of the study (i) costs of authorisation (ii) benefits of authorisation (iii)
changes in the market structure (iv) substitution and (v) affordability of authorisation for SME
The case studies build upon existing studies and relevant information already in submitted
applications
The Tier 1 case studies (presented in Sections 10-12) are on three specific substances (Chromium
Trioxide Trichloroethylene and Dibutyl Phthalate) Within each Tier 1 case study the above five
main impact areas are covered
The Tier 2 case studies contribute to the study by collecting data on specific aspects (eg on
substitution risk management and evidence of the announcement effect) The analysis here is not
limited to any particular substance
Impacts of REACH Authorisation Final Report
eftec November 2017 5
2 METHOD OVERVIEW
This section sets out the project activities carried out Further details on the method can be found
in Annex B
This project follows the EC Better Regulation Guidelines7 and Toolbox8 in order to assess the
ldquoImpacts of REACH authorisationrdquo The evaluation needs to be evidence-based robust and able to
withstand public scrutiny since this study could be heavily referred to in the future by a wide range
of stakeholders (eg industry associations NGOs Member State Authorities the European
Commission and ECHA) as well as potentially informing future decision making on the REACH
authorisation process
211 Overview
As illustrated in Figure 21 the project was broken down into four main tasks Within each task
there were a number of sub-tasks reflecting activities that need to be undertaken in order to
successfully complete these tasks
Figure 21 Overview of method
212 Task 1 Structuring Phase
In Task 1 of this study a framework for carrying out the work the scope of the work as well as
deciding on the Tier 1 and Tier 2 case studies were agreed (see Annex B for further details) A
rapid evidence review (RER) was carried out examining a number of studies that have been carried
out concerning REACH (with a few studies specifically on REACH Authorisation) This enabled us to
7 httpeceuropaeusmart-regulationguidelinestoc_guide_enhtm 8 httpeceuropaeusmart-regulationguidelinestoc_tool_enhtm
Impacts of REACH Authorisation Final Report
eftec November 2017 6
prioritise quantitative and monetary data gaps for this study This RER was further built on as the
project developed with the results of the literature review set out in Annex E
213 Task 2 Data collection
The main steps carried out within Task 2 were
1 Mapping activities carried out along the authorisation process ndash We mapped out 150
activities carried out by different actors along the authorisation process and their impacts
(See Annex D) This enabled us to focus on those impacts worth considering further in this
study (and is feasible to do so) what information was needed who holds it and how best to
get access to it
2 Developing a consultation plan ndash We set out a plan for contacting stakeholders that may
have information useful for this study and what types of information we were targeting
from each type of stakeholder (eg what we expect to be able to get from consulting with
NGOs and industry respectively)
3 Initial stakeholder engagement ndash We spent a significant amount of time contacting over 200
stakeholders (NGOs industry associations and sector groups) that may have been impacted
by REACH authorisation and a number of relevant downstream users of whose interest in
taking part in an online survey we were aware
Various members of the project team also presented at various REACH related events
spoke to industry sector groups and NGOs (in person or over the phone) to raise the
awareness of the project and encourage stakeholders to take part in the forthcoming
survey Stakeholders were targeted to those that may have been impacted by REACH
authorisation and who can provide data required rather than contacting as many
stakeholders as possible ndash in particular any companies that had substituted from an SVHC
(or were in the process of doing so) where prioritised as this was a particular data gap that
needed to be addressed in this study Therefore some of the results of this study (eg
proportion of companies that have substituted away from an SVHC) may have been very
different if the survey was simply an open link (via a public consultation) with no prior
contact with stakeholders
This task was supported by ECHA who informed by email those stakeholders that had
commented to a public consultation on a submitted application and to applicants ECHA
also included a call for information on substitution as part of their newsletter The EC and
ECHA also both provided contacts of companies that have substituted from an SVHC (and
therefore avoided the need to submit an application for authorisation)9
The main goals were to (i) produce a list of stakeholders that have confirmed their interest
in taking part in the survey and (ii) to give these stakeholders advance notice of the survey
and what information is being requested so that they can plan ahead A list of
stakeholders contacted is set out in Annex G
9 Some companies have also substituted from an SVHC after the submission of an AfA (eg downstream users
who notified ECHA of their use and later ceased use of the SVHC)
Impacts of REACH Authorisation Final Report
eftec November 2017 7
4 Developing consultation toolsndash We issued four different questionnaires (the questionnaires
and key statistics can be found in Annex F)
a An industry online survey ndash This was originally intended to be designed and
administered using the EUSurvey tool which is the ECrsquos official survey management
tool10 However due to the need to try to collect very specific data and where
possible quantitative and monetary data the questionnaire was too complex for
the EUSurvey tool to handle (in terms of both the style and number of questions)
Instead the survey was issued via Survey Monkey The scripts were commented on
by some steering group members and changes made to address their comments
b A Non-Government Organisation (NGO) online survey ndash A similar but shorter survey
which focused on instances of substitution was developed for NGOs
c A questionnaire to Member State Competent Authorities (MS CAs) - A Word-based
questionnaire was developed to gather data from MS CAs which focused on
administrative costs they incur along the whole authorisation process Again this
was commented on by some steering group members and changes made to address
their comments
d A questionnaire to the European Commission (EC) ndash A Word-based questionnaire
similar to the one for MS CAs was developed to gather data from the EC which
focused on administrative costs they incur along the whole authorisation process
The EC have indicated they cannot fill in most aspects of the questionnaire but it
will be used as a template for what they can provide
Data was provided by ECHA on the costs they incur along the authorisation process as well
as costs associated with the Risk Assessment Committee (RAC) Socio Economic Analysis
Committee (SEAC) and Member State Committee (MSC) ECHA did not require a
questionnaire from the project team instead a call was held to discuss data needs
5 Launching online surveys ndash We sent personalised emails to stakeholders who had already
agreed to take part in the survey to inform them the survey was ready and to check their
inboxes for a separate email via Survey Monkey containing their personal link to the survey
They were able to save the link and return to the survey so as not to be required to
complete it in one go
Personalised links were also sent to the interested members of trade sector associations
through engagement in their supply chains Other stakeholders completed the open link
(whereby the survey needs to be completed in one go)
Those stakeholders who did not confirm whether they will take part were sent an email to
inform them that the survey is available and were asked to email back if they wanted to
take part
Further rounds of reminders were sent out to encourage further uptake of the online survey
and the survey was eventually closed at the end of June
10 httpseceuropaeueusurveyhomewelcomerunner
Impacts of REACH Authorisation Final Report
eftec November 2017 8
6 Data collection from other sources ndash We also collected production import and export data
from Eurostat for PRODCOM11 codes market reports and data from ECHA Further details
are set out in Section 47
7 Collating survey responses ndash We thanked all respondents to the survey for completing the
survey If they agreed to follow up questions a holding response was sent to mention the
possibility that we may query any unexpected answers and seek further evidence for
responses that would seem to be highly relevant
8 Data collection for the Tier 1 case studies ndash We collected data for the three Tier 1 case
study substances namely Chromium Trioxide Trichloroethylene and Dibutyl Phthalate
We contacted many companies connected with these substances (current and former MIs
of the substance downstream users and relevant sectortrade associations) We also
collected relevant data from existing studies and Eurostat We also explored what market
information was available from market report providers Further details are set out in
Sections 10-12
9 Further follow up with survey respondents ndash We respected the wish of the stakeholders for
their input to be anonymous However some respondents indicated they were willing to be
a case study whereby we could go into more detail than is possible through the survey on a
particular issue (eg about their substitution) These respondents were prioritised for
interviews following closure of the survey
10 Targeted interviews ndash We conducted ~50 interviews with stakeholders Depending on the
role of the stakeholder interviewed different topics were discussed including details of
any substitution away from SVHCs or any ongoing substitution activities and the impacts
incurred due to REACH authorisation (both costs and benefits)
11 Data validation of survey responses ndash We checked the completeness and accuracy of data
(eg identifying any outliers) provided by respondents This check was a critical step prior
to the detailed data analysis in Task 3
Table 21 summarises the number of stakeholders contacted for the different methods of obtaining
information and the number that responded
Table 21 Approaches to collecting new information
Data collection method Statistics
No Contacted No Respondents
NGO survey 30 4 (+2 partial responses)
Industry survey 240 63 (+21 partial responses)
ECHA teleconferences and emails 3 webinars and 20-30 emails (different types of data or
contacts provided)
MS CA Questionnaire 20 16
EC Questionnaire (DG GROW and DG
ENV only) 1 1
Industry interviews 64 49
11 Prodcom provides statistics on the production of manufactured goods Further details can be found here
httpeceuropaeueurostatwebprodcom
Impacts of REACH Authorisation Final Report
eftec November 2017 9
214 Tasks 3 and 4 Data analysis and reporting
Upon completion of Task 2 the data gathered was used to assess the impacts of REACH
authorisation (both the process and resulting outcomes) The headline results were presented to
the steering group at a webinar at the end of June 2017 A draft final report was submitted and
discussed with the Steering group in September 2017 with comments received from DG GROW DG
ENV and ECHA in October 2017 The final report was finalised in November 2017
Impacts of REACH Authorisation Final Report
eftec November 2017 10
3 AUTHORISATION PROCESS 2007-2016
There is a long process preceding the inclusion of a substance into Annex XIV with several options
for stakeholders to provide information The process consists of (1) the official legislative steps as
set out described in the REACH regulation and (2) the voluntary steps that were introduced with
the goal to improve among others planning and predictability12
The official steps set out in the REACH regulation start from the Annex XV dossiers for SVHC
identification until the inclusion into Annex XIV and all the steps in between such as two public
consultations and a recommendation for inclusion into Annex XIV Once a substance is included into
Annex XIV industry has to either substitute before the sunset date or has to file an application for
authorisation to request authorisation for continued use for a well-justified amount of time
The voluntary steps that were introduced to improve the functioning of the process are described in
the SVHC Roadmap to 2020 Implementation Plan 9 December 201313 which defines priority criteria
until 2020 and describes the processes of Screening and Risk Management Option Analysis (RMOA)
In this study we analyse the impact of the authorisation process from 2007 when REACH came into
force until the end of 2016
Annex C provides an overview of the process highlighting the main stages and the aims and
objectives of the authorisation process from the perspective of the formal process (ie leading to
applications for authorisation) The aims are explained in terms of an lsquointervention logicrsquo which
links the objectives to actions and outcomes (as illustrated in Figure C01) Later sections
summarise some statistics collected on the main stages in authorisation that help to quantify the
levels of activity in these stages (for example the number of RMOAs processed and what stage they
are at the inclusion of substances on the Candidate list and Annex XIV and the number of AfAs
made)
31 Screening of substances and Risk Management Option Assessment (RMOA)
A study reviewing the operation of REACH14 reported a perceived lack of transparency in the
identification and selection of SVHCs as well as a need for understanding which substances would
be identified to give a higher level of certainty to prepare for authorisation applications or
substitution activities etc On the regulatory side the need was identified for consistency in the
approach for identification of SVHCs and connection to the most appropriate regulatory measures
for control of risks
The 2020 SVHC Roadmap built on the political commitment to have all relevant currently known
SVHCs included in the candidate list by 2020 There was a consequent need to analyse the
12 Roadmap on Substances of Very High Concern Council of the European Union do 586713 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT 13
httpsechaeuropaeudocuments1016219126370svhc_roadmap_implementation_plan_enpdf66ba723a-
d2e4-4d1a-ae89-a78c4db4d621 14 Technical Assistance to Prepare the Commission Report on the Operation of REACH
0703072010584820SERD3 March 2012 - prepared for European Commission DG Environment by Risk amp
Policy Analysts Limited
Impacts of REACH Authorisation Final Report
eftec November 2017 11
information on a large number of substances not only to determine the relevance of known
potential SVHCs but also to identify new potential SVHCs from the processes of REACH registration
(phase-in stages completed in 2018) and evaluation The roadmap implementation plan describes
two distinct but related processes (1) the Screening process and (2) the RMOA process The
purpose of the Screening process is to identify and prioritise substances of potential concern for
further regulatory action Those substances of potential concern are those where the impact on
human health and the environment are expected to be the greatest Priority is given to substances
that have the highest exposure potential combined with their potentially hazardous properties for
example substances that are carcinogenic mutagenic and toxic to reproduction (CMR) persistent
bioaccumulative and toxicvery persistent very bioaccumulative (PBTvPvB) or endocrine
disruptors and therefore potential SVHCs Once the concern is confirmed the substance is normally
taken forward to RMOA by authorities The purpose of the RMOA is to help authorities decide
whether further regulatory risk management activities are required for a substance and if so to
identify the most appropriate instrument to address a concern Thus in view of the authorisation
process the roadmap sets out the RMOA process as central to the decision making on the inclusion
of SVHCs on the Candidate List The processes of Screening and RMOA as set out by ECHA are
described in Box C1 (see Annex C) In addition ECHA sets up the Public Activities Coordination
Tool (PACT) that provides information (published on the ECHA website) on substances that are or
have been subject to informal assessment (of their potential PBT vPvB or ED properties) andor
RMOA
Table 31 summarises the progress on Screening and RMOA to date (data collected from ECHA
statistics for this study) Of the 110 substances that have been assessed under Screening andor
RMOA 48 (44) have been found to have no concern of these 30 on the basis that they were not
PBTvPvB or ED and 18 on the basis that no further regulatory risk management was needed Seven
substances were found to be of concern due to endocrine disruption (ED) or PBTvPvB properties
and 55 substances (50 of the completed assessments) required further regulatory action to control
the risks Of these 16 were sensitizers 4 were PBT 12 were CMR and one was ED (lsquootherrsquo was also
reported in the scope and some substances were multiple categories eg CMR and PBT)
Table 31 Progress on hazard assessment and RMOA development (as of Dec 2016)
Stage
Outcome text
Number of substances
per outcome Per stage
In progress
Under development 130 229
Substance evaluation under development 99
On hold
On hold 14
25
Potential ED (but further assessment is
postponed) 1
Potential PBTvPvB but further
assessment is postponed 10
Complete - no
concern
According to authorityrsquos assessment not
ED 4
48 According to authorityrsquos assessment not
PBTvPvB 26
No need to initiate further regulatory risk
management action at this time 18
Complete ndash
concern
According to authorityrsquos assessment ED in
accordance with WHOIPCS definition 6
7 According to authorityrsquos assessment PBT
or vPvB 1
Impacts of REACH Authorisation Final Report
eftec November 2017 12
Stage
Outcome text
Number of substances
per outcome Per stage
Complete - action
requested
Appropriate to initiate regulatory risk
management action 55 55
Totals 364 364
Source ECHA
32 Inclusion of substances in the Candidate List
The inclusion of a substance on the Candidate List designates that substance as a substance of very
high concern (SVHC) Therefore this is the first official list that indicates a substance fulfils at
least one of the Article 57 criteria and that it may be selected for listing on Annex XIV From the
implementation of the 2020 Roadmap for SVHC substances proposed to be included on the
Candidate list should be those for which the RMOA outcome indicated that the most appropriate
option to address the concerns from the use of that substance is Authorisation An exception to
this being SVHC identification of substances with PBTvPvB properties or Art 57(f) hazard properties
without harmonised criteria in Annex I of CLP (eg endocrine disruptors) In these cases the
Candidate List can also be used as an official recognition of these hazard properties when further
regulatory action (eg restriction) under REACH is deemed to be needed15 As set out in Annex C
(and illustrated in Figure C01) the selection of SVHC substances is done initially by Member
States or ECHA upon request of EC making an Annex XV dossier to demonstrate that the substance
meets the Article 57 criteria
The Commissions aim to have 136 substances on the Candidate List by the end of 2012 was
achieved and the 2020 Roadmap objective is to have all currently known SVHCs on the Candidate
List by 2020 As mentioned in the REACH 2012 review4 that objective has the merit of stimulating
an increased activity of Member States in relation to the submission of proposals for SVHC
identification The Candidate List currently (as of Jan 2017) contains 173 substances16
Table 32 below summarises the candidate list (as of Jan 2017) in terms of reason for inclusion It
can be seen from the table that the majority of substances (82) placed on the Candidate List are
due to concerns for human health hazard ie they are CMR (Carcinogenic Mutagenic or toxic to
Reproduction) or of equivalent concern In contrast substances for which there are only concerns
for the environment (ie PBTvPvB or equivalent concern) make up 12 of the substances with a
similar proportion for substances for which there are both environmental and health concerns The
total number of substances which are included because of health concerns (including with both
health and environmental) is 153 (=142+11) and the total number for which there are
environmental concerns (including both environmental and health) is 32 (=21+11)
15 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT 16 There is a discrepancy of 1 between the candidate list as shown on the ECHA web site and the download of
the substances (this is assumed to be due to substance grouping)
Impacts of REACH Authorisation Final Report
eftec November 2017 13
Table 32 Candidate list of substances (SVHC) by reason for inclusion (as of Jan 2017)
Category EnvHH or both Reason for inclusion (Article 57) Number of substances
Environment Total 21
PBT 3
PBTvPvB 4
vPvB 8
Equivalent concern (Env) 6
Human Health Total 140
Carc 39
Carc and Equivalent concern (HH) 3
Muta 2
Carcmuta 6
Carcrepro 11
Repro 69
CMR 4
Equivalent concern (HH) 3
CMR and Equivalent concern (HH) 3
Human Health and environment Total 11
PBTRepro 4
CarcPBTvPvB 2
CarcmutaPBTvPvB 2
Equivalent concern (Env)Repro 1
CMR and PBT 1
Total 173
Note
- There is a discrepancy in the total of 1 between the candidate list as shown on the ECHA web site
and the download of the substances (this is assumed to be due to substance grouping)
In terms of progress towards the 2020 Roadmap objective it is difficult to judge because the data
for 1 to 100 tonnes per annum phase-in substances is not yet available from registration and
because the process is somewhat dependent on the activities of Member State CAs coming forward
with proposals for SVHCs in the form of Annex XV dossiers In addition whilst CMR and to some
extent equivalent concern to CMR (eg such as sensitisers) can be identified through classification
(CLP) environmental concerns in terms of meeting the specific criteria for PBTvPvB can only be
assessed against the criteria in Annex XIII of REACH
33 Prioritisation and inclusion of substances in the Authorisation List
The prioritisation of substances for Annex XIV is normally based on (1) the inherent properties of
the substance (2) the high volume and (3) the use (wide-dispersive) Before sending its
recommendation to the European Commission ECHA launches a public consultation which lasts for
3 months in particular on uses which should be exempt from the authorisation requirement17
According to REACH Art 58(3) ldquopriority shall normally be given to substances with (a) PBT or
vPvB properties or (b) wide dispersive use or (c) high volumesrdquo on which basis ECHA developed
17 REACH article 58(4)
Impacts of REACH Authorisation Final Report
eftec November 2017 14
the prioritisation approach18 The draft recommendation amongst other includes the following
information
Substance identity and its intrinsic properties of very high concern
lsquoSunset Datersquo from which the placing on the market and the use of a substance is
prohibited unless an authorisation is granted or the use is exempt from authorisation
The latest application date by which applications must be received if the applicant wishes
to have certainty on continued use of the substance after the sunset date but when a
decision has not been adopted yet
Review periods for certain uses if relevant and
Uses exempted from the authorisation requirement if any
The Member State Committee of ECHA prepares its opinion on the draft recommendation taking
into account the received comments The Committeersquos opinion and the comments received during
the public consultation are used by ECHA to finalise its recommendation The recommendation is
submitted to the EC The EC has the discretion to decide (or not) upon inclusion of the substances
in the Authorisation List ndash this is done as a Regulation amending Annex XIV of REACH
Table 33 sets out the number of substances on the Authorisation list (Annex XIV) according to their
inherent property Note that inherent property is just one aspect considered in the prioritisation
assessment which in addition to the Art 58(3) takes also further considerations into account eg
potential interchangeability among substances in (some of) their uses
Table 33 Authorisation list substances (Annex XIV) by SVHC type (as of 13th June 2017)
Category EnvHH or both Reason for inclusion (Article 57) Number of substances
Environment
PBT 1
vPvB 1
Endocrine disrupting 2
Human Health
Carcinogenic 14
Carcinogenic Mutagenic 2
Carcinogenic toxic to Reproduction 3
Toxic to Reproduction 14
CMR 4
Environment and Heath Carcinogenic PBT vPvB 2
Total 43
34 Applications for Authorisation (AfA)
The AfA stage involves the compilation and submission of the AfA itself by industry The process
continues with the assessment by the authorities (ECHA RAC and SEAC) as well as inputs from third
parties (alternatives during the public consultation) In addition the Risk Assessment Committee
(RAC) may have specific activities prior to submission of the AfA (for example this includes the
18 ECHA (2014) Prioritisation of substances of very high concern (SVHCs) for inclusion in the
Authorisation List (Annex XIV)
Impacts of REACH Authorisation Final Report
eftec November 2017 15
defining of no effect levels (reference DNELs or PNECs) and the derivation of dose response curves
(eg for calculation of the risk from exposure to non-threshold substances)
Table 34 was taken from ECHArsquos website on (Nov 2016)19 It should be noted that in Table 34 the
figures in red text are not exactly as shown on the ECHA web site This is because applications for
these substances (namely chromium trioxide and sodium dichromate) had applications after
December 2016 (this study is considering applications up to and including December 2016)
By the end of December 2016 there were 111 applications for authorisation Contained within
these applications there have been 185 uses applied for (each application may have more than one
use (eg consultation numbers 0013-01 and 0013-02 denotes two uses associated with application
0013) By the end of 2016 the progress made on these applications could be broken down into the
stages presented in Table 35
Table 34 Number of Applications for Authorisation (AfA) (as of Dec 2016)
Substance Number
of received applications
Number of applicants
Number of uses
Bis(2-ethylhexyl) phthalate (DEHP) 5 7 10
Dibutyl phthalate (DBP) 2 2 4
Bis(2-ethylhexyl) phthalate (DEHP) and Dibutyl phthalate (DBP)
1 1 3
Lead sulfochromate yellow (CI Pigment Yellow 34) and Lead chromate molybdate sulphate red (CI Pigment Red 104)
1 1 12
Hexabromocyclododecane (HBCDDD) 1 13 2
Diarsenic trioxide 4 4 5
Trichloroethylene 13 15 19
Lead chromate 1 1 1
Chromium trioxide 25 57 41
Sodium dichromate 17 23 23
Chromium trioxide Sodium dichromate and Potassium dichromate
1 6 7
Sodium chromate 2 4 3
12-Dichloroethane (EDC) 15 17 19
Potassium dichromate 4 4 7
Ammonium dichromate 3 5 4
Dichromium tris(chromate) 1 2 2
Chromium trioxide Dichromium tris(chromate) 1 2 5
Strontium chromate 1 10 2
Potassium hydroxyoctaoxodizincatedichromate 1 5 2
Diglyme 8 8 9
19 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationapplications-for-
authorisationreceived-applications
Impacts of REACH Authorisation Final Report
eftec November 2017 16
Substance Number
of received applications
Number of applicants
Number of uses
Arsenic acid 1 1 1
Chromic acid 1 1 1
Formaldehyde oligomeric reaction products with aniline (technical MDA)
1 1 2
22-dichloro-44-methylenedianiline (MOCA) 1 1 1
Total 111 191 185
Source ECHA website
Table 35 Status of decisions of AfArsquos submitted (Dec 2016)
AfA status No of uses applied for (end Dec 16)
Opinion development 63
Opinions adopted 86
Commission decided 34
Application withdrawn 2
Total 185
The review period applied for by applicants is listed in Table 36 (the review periods recommended
by SEACRAC and granted by EC are also listed)
Table 36 Review periods applied for (Dec 2016)
Review period (years)
No of use applications - end Dec 2016
Applied for by applicants
Granted recommended
lt4 3 4
4 15 25
5-6 1 0
7 23 47
8-11 7 2
12 77 44
gt12 26 0
unclear or confidential 33 NA
decision not yet made NA 63
Total 185 185
A comparison of applied-for versus recommended andor granted review period is made in Table
37 for AfA upto the end of December 2016 Table 37 shows data for the total number of
applications at that time (185) A total 63 AfA were undergoing opinion development (by ECHA
Committees) The ECHA Committees have made its recommendation on applicants review periods
for a total of 81 AfAs of these 37 (46) were recommended to be granted the review period
requested and 34 (42) were not Note that for a number of applications it was not clear in the
AfA what length of review period was being requested (or this was confidential) this accounted for
Impacts of REACH Authorisation Final Report
eftec November 2017 17
10 AfA (12) As of the end December 2016 some 34 AfAs had been granted by the Commission of
these 6 (18) were granted the requested review period and 11 (32) were not There were 17
(50) in which the requested review period in the AfA was unclear or was confidential
Not shown specifically in Table 37 (but included in the data set summarised in the table) there
were 14 AfA for which it was not clear from the application what length of review period was
requested but for which the Commission decision granted a shorter review period than the ECHA
recommendation These were
two AfA for DEHP where 7 years was recommended and 4 years was granted
six AfA for lead sulfochromate yellow for which four AfA were recommended 12 years and
granted 7 years and two AfA were recommended 7 years and granted 4 years and
six AfA for lead chromate molybdate sulphate red for which four AfA were recommended
for 12 years and granted 7 years and two AfA were recommended 7 years and granted 4
years
The Table 37 does not differentiate between AfA from upstream (manufacturers) and downstream
(user) actors
Table 37 Were applicants given the review period they advocated for (Dec 2016)
Were applicants recommended or granted the review period (RP)
applied for
No of use applications
(up to end Dec 16)
No
Application is currently undergoing opinion development 63
Application is pending decision 5
Application has been withdrawn 2
Recommendation to grant the RP applied for
Yes 37 46
No 34 42
unclear or confidential 10 12
Total 81 100
Granted RP applied for
Yes 6 18
No 11 32
unclear or confidential 17 50
Total 34 100
Total 185
The number of applications for substances by Article 57 criteria is presented in Table 38
Impacts of REACH Authorisation Final Report
eftec November 2017 18
Table 38 Number of uses applied for defined by Article 57 criteria (Dec 2016)
SVHC identification criteria No of uses applied for
(end Dec 2016)
Toxic for reproduction (Article 57c) 26
Carcinogenic (Article 57a) 55
Carcinogenic (Article 57a) Toxic for reproduction (Article 57c)
13
Carcinogenic (Article 57a) Mutagenic (Article 57b)
48
Carcinogenic (Article 57a) Mutagenic (Article 57b) Toxic for reproduction (Article 57c)
41
PBT (Article 57 d) 2
Total 185
35 Review of Authorisation following their review period
In order that the authorisation holder benefits from continued use after the review period the
authorisation holder must submit a review report at least 18 months before the end of the review
period Should the authorisation holder not do this the authorisation for his uses would cease at
the end of the review period and further use would not be permitted unless and until a new
authorisation is granted for that use The review report must update the elements of the original
application including any aspects on which the authorisation decision requires further information
such as monitoring arrangements to reduce limitations and uncertainties in the risk assessment The
review report must also include an update of the AoA including information about any relevant
research and development activity possible new alternatives and progress made towards
substitution with safer alternatives
No authorisation holder has yet been through the review process However ECHA has received the
first review reports and for some authorisations the expiry of the review period is approaching If
the use of the SVHCs is still necessary then this should be documented in the review report
Impacts of REACH Authorisation Final Report
eftec November 2017 19
4 CHANGES IN THE EU MARKET FOR SVHCs (AND THEIR
ALTERNATIVES)
41 Introduction
Collating evidence on how the EU markets for SVHCs and potential (or proven) alternatives have
changed since the introduction of REACH authorisation is one of the five focus areas for this study
The indicators of change are (i) the number of companies manufacturing importing and using a
substance (concentration effects) (ii) number of uses of a substance and (iii) the size of the
market (volumes) The analysis is not limited to substances that have been through the whole
authorisation process For example possible market changes for substances currently on the
Candidate List are also assessed
Evidence on the drivers of such changes is also needed so that we can determine which changes can
be attributed to the REACH authorisation process To do this overall trends in the EU chemical
sector and any noticeable differences in trends for SVHCs and their (potential) alternatives need to
be identified It would then be possible to infer if authorisation leads to a concentration effect
(eg reduction of competition) development of markets for alternatives and macroeconomic
impacts (like changes in employment)
It is important to note that one of the goals of REACH (authorisation) is to promote the progressive
replacement of SVHCs where feasible Therefore over time one might expect to see a decline in
the volumes of SVHCs used in the EU over time as some companies substitute away from the use of
an SVHC as well as an increase in sales of alternatives There are of course a number of factors
why this might not necessarily be the case yet as (i) some uses are not subject to (affected by)
authorisation (eg exempted uses and intermediates) (ii) substitution away from an SVHC can take
time and it might still be too early to observe changes in the EU market due to REACH authorisation
(iii) for some companiesuses alternatives being tested may continue to prove to be unsuitable
despite continued efforts to find an alternative andor (iv) increased demandsales from the
continued use of the SVHC after the sunset date for those uses where authorisation has been
granted (for a given review period)
The section is split into seven sub-sections
Section 42 - EU Chemicals sector summarises changes in the EU chemicals sector since
2000 to understand the overall trend in the sector Supporting details are set out in Annex
E
Section 43 ndash Literature review summaries what existing studies indicate about changes in
the market for SVHCs and (possible) alternatives due to REACH authorisation Supporting
details are set out in Annex E
Section 44 ndash Survey responses summarises information provided by respondents to the
industry survey on any observed changes in their respective markets due to REACH
authorisation This does not focus on any particular substance on or off the authorisation
list and hence offers a different perspective to the Tier 2 case studies
Sections 45 ndash 46 Tier 2 case studies present changes in the market for a selection of
substances as ldquomini case studiesrdquo They make use of existing information and further
Impacts of REACH Authorisation Final Report
eftec November 2017 20
consultation with affected companiessector groups to investigate any links between the
changes in the market for these substances (and their uses) and REACH authorisation These
case studies start to build up a picture of changes in the market for specific SVHCs where
there is better data available (which may not be as readily available for all SVHCs)
Section 47 ndash Findings using other statistic sources summarises market changes that can be
observed using available statistical datasets including data held by ECHA and Eurostat
The data collection process to assess changes in the market makes use of several different types of
information The literature review presents an overview of what is known already The Tier 2 case
studies focus on individual substances The survey responses provide a glimpse of stakeholder
views The statistical analysis from Eurostat provides an overview of those SVHCs where there is a
good match between the substance and the product classification coding used Collectively these
different approaches start to build up a bigger picture of the changes in the EU market as depicted
in Figure 41
Figure 41 Assessing changes in the market using different approaches
42 EU chemicals sector general trends and drivers of change
This section presents the main findings of a literature review on the overall trends in the EU
chemicals sector20 in terms of (i) sales value (ii) imports (iii) exports (iv) the number of
companies and (v) spending on RampD and investment Data on the overall chemicals sector includes
both Substances of Very High Concern (SVHCs) and those not identified as SVHCs By comparing
changes in the market of the SVHC (eg sales volume) to the overall trend in the market for all
chemicals this allows for inferences to be made on whether the overall change in the EU market
for SVHCs might be due to REACH authorisation or follows the same trends observed in the overall
20 It is acknowledged that the manufacturing sector is also be affected by the REACH authorisation process as
it also uses SVHCs An analysis of the effects of the REACH authorisation process on this wider sector was not
possible for this study due to a lack of comprehensive EU level data over time
Impacts of REACH Authorisation Final Report
eftec November 2017 21
EU chemicals market There are of course a number of other factors (other than REACH
authorisation) that could influence market changes in SVHCs (eg price consumer preferences and
availability of alternatives) This requires a more detailed assessment of the market which is only
possible on a substance by substance This is done through the two Tier 2 studies carried out (see
Section 45 and 46)
The insights in this section are mainly based on the information provided by The European Chemical
Industry Council (see CEFIC 2014 CEFIC 2016a CEFIC 2016b) While other sources were examined
as part of the literature review the review revealed that the analysis in these other sources also
relied on the same data provided by CEFIC Therefore the CEFIC data was used as the main source
for this section
The complete literature review can be found in Annex E2 For the aforementioned purpose the
following findings of the literature review are of particular relevance
The EU share of the global chemical market has declined significantly from 323 in 1995 to
147 in 2015
While the change in annual EU chemical sales revenue has largely mirrored changes in the
global market between 1995 and 2002 the trends are divergent since 2012 According to
CEFIC data (See Annex E2) EU chemicals sales values have declined while global chemical
sales values (outside the EU) have increased since 2012 Whether this trend continued for
2016 ndash 2017 remains to be seen as there is no CEFIC data available yet
The majority of EU production (764 on average between 2005 and 2015) is sold and used
within its 28 Member States The export market therefore plays only a limited role in
determining the overall performance of the EU chemicals market
The slight decline in EU chemical sales values observed since 2012 is mainly caused by a
decline in domestic (home) sales in the Member States producing the chemicals and
specifically sales within Germany France Italy the United Kingdom the Netherlands
Spain and Belgium which together account for 84 of EU chemicals sales
The trade balance of the EU chemicals industry is positive between 2005 and 2015 which
indicates that in terms of sales value the EU exports more chemicals than it imports In
2013 imports started to increase (according to sales values) which may partly explain the
decline in home sales mentioned above
Several sources point to a decline of EU competitiveness based on export data in the short
(ie since 2013) and long term (ie since 2003)
The EU chemicals sector has experienced an unusual period of stagnation between 2012 and
2015 following a period of continuous long-term growth between 2003 and the beginning of
the global financial crisis in 2008
In addition to the exchange rate RampD intensity and energy prices ndash which are identified as
the three main drivers of competitiveness by an Oxford Economics study conducted for
CEFIC (ie CEFIC 2014) - regulatory costs can be a relevant driver of competitiveness if
businesses recover increased regulatory costs through higher prices for customers
Impacts of REACH Authorisation Final Report
eftec November 2017 22
43 Summary of literature review
To create a basis for the assessment of new results produced by this study previous literature has
been reviewed to identify and consolidate existing knowledge about the effect of REACH
authorisation on the market of SHVCs Existing literature consulted as part of this review provides
mainly anecdotal information on how key factors influencing the performance of the SVHC market
such as changes in investment and RampD decisions ndash factors closely related to innovation ndash as well as
the EUrsquos competitiveness are affected by REACH
This sub-section summarises the key findings of the aforementioned literature review and will
thereby constitute the basis for an assessment of whether the results from the present study are
aligned with findings from earlier studies as well as an assessment of the reasons behind potential
differences
The complete literature review can be found in Annex E3 The main findings of this literature
review are as follows
With respect to innovation according to a stakeholder consultation conducted as part of
the EC (2015) report21 authorisation does have an impact on innovation as investors require
regulatory certainty about the use of substances that are essential to their investment and
innovation plans Other sources point to the potential of the REACH authorisation process
to drive innovation by encouraging and pushing companies to engage in substitution
activities Overall the existing literature provides no clear assessment of whether the
REACH authorisation process affects the market for SVHC positively or negatively Both
effects are therefore possible
With respect to long-term investment in the EU the reviewed literature provides some
anecdotal examples that the REACH authorisation process could delay or divert investment
to areas outside of the EU due to a lack of predictability surrounding REACH Examples
(noted in Annex E3) concerning the nanomaterial and pharmaceutical sectors illustrate the
potential of REACH to create an environment inducing companies to implement new
projects involving large investments in countries outside of the EU and are not subject to
REACH
In terms of competitiveness a minor negative impact is possible due to EU manufacturers
being at a competitive disadvantage compared to manufacturers producing outside the EU
as the requirements of authorisation do not apply to non-EU producers of imported articles
This argument is supported in some respect by quantitative evidence on the effect of
REACH on imports and exports ndash the comparison of which is a good indicator of
competitiveness The EC (2015) industry survey revealed that the majority of respondents
experienced no changes in imports and exports as a result of REACH while the impact on
MIrsquos has tended to be negative
The literature review also points to the potential of the authorisation process to influence
the SVHC market negatively through internal demand factors In fact a business survey
conducted as part of the EC (2015) reveals that 39 of all survey respondents answering the
question whether their customers requested the removal of SVHCs from their products
21 European Commission (EC) (2015) Monitoring the Impacts of REACH on Innovation Competitiveness and
SMEs Luxembourg Publications Office of the European Union
Impacts of REACH Authorisation Final Report
eftec November 2017 23
(n=242) and even 70 of article suppliers received such requests This indicates that the
authorisation process might harm the market of SVHCs by decreasing the acceptance of
products containing SVHC among customers
In addition the EC (2015) report points to the potential for REACH authorisation to cause a
downsizing (ie reduction of the number of active companies) of the market for SVHCs due
to increasing the probability of market withdrawals and relocation The extent of this
downsizing effect is not clear as it is questionable if relocation of a use is an economically
feasible option for SMEs that make up the majority (95) of the chemical industry
44 Survey responses
This section presents survey findings regarding changes in the EU markets for (possible) SVHCs and
the respective alternative substancestechnologies caused by the authorisation process It is based
on online survey responses given by industry stakeholders The analysis relies on data provided by
46 respondents
441 Changes in the supply of SVHCs and alternatives
Fifty-seven percent of respondents (26 out of 46) to the industry survey stated that the REACH
authorisation process had led to an impact on their organisationsrsquo production or supply of (possible)
SVHCs andor their alternatives These respondents provided 30 examples of such impacts For
each example respondents provided
The (possible) SVHC or alternative that was impacted
The usefunction of the substance
The marketproduct that was affected
The type and direction of changesimpacts and
Whether any of these changes can be attributed to factors other than the REACH authorisation
process
Table 41 lists the substances (and specific uses) for which respondents reported a change in
production or supply The table also shows the number of examples given for each substance
Chromium trioxide is the substance with the highest number of reported examples of changes in
production or supply (ie 13 examples) This is followed by lead chromate with three examples In
terms of uses plating is the use with the highest number of examples Three of 30 examples refer
to this use
Table 41 Changes in the supply of (possible) SVHCs and alternatives (industry survey)
No Substance CAS number
Number of
examples
provided
Affected use(s)
1 12-dichloroethane 107-06-2 2 Pharmaceuticals
Solvent
2 2-[4-(244-trimethylpentan-2-
yl)phenoxy]ethanol 9002-93-1 2
Biotechnology
Cell lysis during
manufacturing of
vaccines and
cleaning of
Impacts of REACH Authorisation Final Report
eftec November 2017 24
No Substance CAS number
Number of
examples
provided
Affected use(s)
manufacturing
equipment
3 4-(1133-Tetramethylbutyl)phenol
ethoxylated 923-960-0 1 Surfactant
4 44-methylenebis[2-chloroaniline] 101-14-4 1 Curing agent
5 Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7 1 Plasticiser
6 Chromium trioxide 1333-82-0 13
Anti-corrosive
Catalyst
Decorative function
Electroplating
Etching and plating
Metalacid reaction
inhibitor
Passivation
Plating
Production of hard
chromium
Surface coating
7 Formaldehyde oligomeric reaction
products with aniline 25214-70-4 1
Polymerisation
agent
8 Lead chromate 7758-97-6 3
Pigments
Pyrotechnic
mixtures
9 Lead monoxide 1317-36-8
7439-92-1 1 Glass production
10
NN-dimethylacetamide NN-
dimethylformamide 1-methyl-2-
pyrrolidone
127-19-5 68-
12-2 872-50-4 1
Solvent
11 Sodium dichromate 7789-12-0
10588-01-9 2
Passivation
Sensitiser
12 Not stated Not stated 2 Surface treatment
Not stated
Total 30
Notes The 30 examples were provided by 26 respondents
For 80 of the examples respondents indicated that the downstream user market of the SVHCs
were the markets affected most by the authorisation process The market of SVHCs themselves
were reported lsquoaffectedrsquo in 10 of examples This is not surprising since most survey respondents
were downstream users of an SVHC rather than MIs of the SVHC
To get an idea of the type of change that their organisation had experienced respondents were
asked to indicate whether they had experienced any of the following changes
Decrease in price of (possible) SVHC
Increase in price of (possible) SVHC
Conditions imposed on safe handling of the substance
Increase in number of suppliers of alternatives to the substance
Impacts of REACH Authorisation Final Report
eftec November 2017 25
Decline in number of suppliers of the substance
Figure 42 reports the number of cases (out of 30) in which respondents stated that their
organisation experienced the changes
Figure 42 Changes in the supply of SVHCs and alternatives ndash Type of impact (industry survey)
Notes This figure is based on 30 examples provided by 26 respondents
For nearly 70 of the examples respondents attributed the reported changes to the REACH
authorisation process rather than any other possible factor For those examples in which changes
were partially attributed to other factors the most common factor was an internal
strategydecision by the organisation to progressively substitute SVHCs especially when this can be
done cost-effectively
442 Closure and relocation of organisations
Despite seeking to find companies that may have closed production and or relocated outside of the
EU only three respondents provided information about the closure andor relocation of their
organisations in the industry survey This might indicate (although difficult to conclude with
certainty) that such instances of closure andor relocation to outside of the EU due to REACH
authorisation are rare despite the reported risks of such responses within existing literature
However given this small sample it is not possible to carry out a detailed or representative
analysis of the impacts of authorisation on closure or relocation of organisations using the survey
responses as a basis The costs of closure and relocation are discussed in Section 610 using a
different data source than the online survey
443 Changes in competitiveness
Forty-one percent of respondents (19 out of 46) to the industry survey stated that the REACH
authorisation process had led to an impact on their organisationsrsquo competitiveness (ie ability to
sell products) relative to their competitors in the EU and outside For each example respondents
provided examples providing information on
The (possible) SVHC that was impacted
Impacts of REACH Authorisation Final Report
eftec November 2017 26
The usefunction of the substance
The marketproduct that was affected
The type and direction of changesimpacts and
Whether any of these changes are attributable to factors other than the REACH authorisation
process
Table 42 lists the substances (and a broad description of the use) for which respondents reported a
change in competitiveness The table also shows the number of examples given for each substance
Chromium trioxide is the substance with the highest number of reported examples of changes in
competitiveness (ie 10 examples) In terms of uses plating is the use with the highest number of
examples Five of 21 examples refer to this use
Table 42 Changes in competitiveness - (possible) SVHCs (industry survey)
No Substance CAS number
Number of
examples
provided
Affected use(s)
1 44-methylenebis[2-chloroaniline] 101-14-4 1 Curing agent
2 Chromium III 16065-83-1 1 Decorative function
3 Chromium trioxide 1333-82-0 10
Catalyst
Cold rolling for steel aluminium copper
Etching and plating
Passivation
Plating Surface coating Surface treatment
4 Chromium VI Chromium ion (Cr6+)
Hexavalent chromium 18540-29-9 2 Plating
5 Lead chromate 7758-97-6 1 Pigments
6 Lead monoxide 1317-36-8
7439-92-1 1
Additive to increase
refractive index
7
Orange lead Lead chromate CC-
azodi(formamide) (ADCA) Lead
246-trinitro-m-phenylene dioxide
1314-41-6
7758-97-6
123-77-3
15245-44-0
1 Pyrotechnic
mixtures
8 Sodium dichromate 10588-01-9
7789-12-0 2
Passivation
Sensitiser
9 Not stated Not stated 2 Not stated
Total 21
Notes The examples were provided by 19 respondents
For 86 of the examples respondents indicated that the downstream user markets for the uses of
SVHCs were most affected by the authorisation process (as opposed to markets for the sales of the
SVHCs themselves or their alternative substancestechnologies) This is not surprising since most
survey respondents were downstream users of an SVHC rather than MIrsquos of the SVHC
To get an idea of the type of change that their organisation had experienced respondents were
asked to indicate whether they had experienced any of the following changes
Impacts of REACH Authorisation Final Report
eftec November 2017 27
More difficult to sell to their non-EU customers
Easier to sell to their non-EU customers
More difficult to sell to their EU customers
Easier to sell to their EU customers
The results (n=21) are presented in Figure 43 For over 75 of the examples respondents
attributed the reported changes to the REACH authorisation process rather than any other possible
factor
Figure 43 Changes in competitiveness ndash Type of impact (industry survey)
Notes This figure is based on 21 examples provided by 19 respondents
444 Changes in spending on innovationinvestment opportunities andor RampD
Seventy-six percent of respondents (35 out of 46) reported that the authorisation process had
impacted their organisationsrsquo spending on innovationinvestment opportunities andor RampD The
analysis of these responses is presented later in the assessment of the innovationinvestment and
RampD costs reported in Section 69
445 Changes in employment
Only fifteen percent of respondents (7 out of 46) to the industry survey stated that the REACH
authorisation process had led to an impact on the number of people that their organisation
employs Given the limited number of responses indicating a change in employment the results
presented in this sub-section should be interpreted with caution and that overall REACH may not
have had a significant impact on employment (to date)
Respondents provided eight examples of this impact For each example respondents provided
details on
The (possible) SVHC that was impacted
The usefunction of the substance
The marketproduct that was affected
The direction and magnitude of changesimpacts and
Impacts of REACH Authorisation Final Report
eftec November 2017 28
Whether any of these changes are attributable to other factors than the REACH authorisation
process
Table 43 lists the substances (and related uses) for which respondents reported a change in
employment The table also shows the number of examples given for each substance
Table 43 Changes in employment (industry survey)
no Substance CAS
number
Number of
examples
provided
Affected use(s)
1 12-dichloroethane 107-06-2 1 Pharmaceuticals
2 Chromium trioxide 1333-82-0 2 Plating
Not stated
3
Chromium trioxide Sodium
dichromate Potassium dichromate
Dichromium tris(chromate)
1333-82-0
7789-12-0
10588-01-9
7778-50-9
24613-89-6
1 Anti-corrosive and
surface treatment
4 Chromium VI Chromium ion (Cr6+)
Hexavalent chromium 18540-29-9 2
Decorative function
Plastic etching
5 Not stated Not stated 2 Not stated
Total 8
Notes The examples were provided by 7 respondents
For all the examples provided respondents indicated that the downstream user markets for the
uses of SVHCs were the ones most affected by the authorisation process (as opposed to markets for
the SVHCs themselves or their alternative substancestechnologies)
Respondents were asked to indicate the changes that their organisations experienced in relation to
the number of people they employ (Table 44) Most of the affected respondents (63) reported an
increase in employment by 1-9 workers in their organisations For five out of eight examples
respondents attributed the reported changes in employment to the REACH authorisation process
The finding should be used with caution As set out earlier most respondents indicated no impact
of REACH authorisation on the number of people they are employing
Table 44 Changes in employment ndash Type of impact (industry survey)
(based on 8 examples)
Decrease
gt1000 workers -
100 - 1001 workers -
10 - 99 workers 25
1 - 9 workers -
Increase
1 - 9 workers 63
10 - 99 workers 13
100 - 1001 workers -
gt1000 workers -
Total 100
Notes This table is based on 8 examples provided by 7 respondents
Impacts of REACH Authorisation Final Report
eftec November 2017 29
446 Changes in sales revenue
Only twenty-two percent of respondents (10 out of 46) to the industry survey stated that the REACH
authorisation process had led to an impact on their organisationsrsquo sales revenue Overall this would
suggest that REACH may not have had a significant impact on sales revenue (at least to date) The
results presented in this sub-section should therefore be interpreted with caution since they only
refer to a minority of respondents
Respondents provided 10 examples of this impact For each example respondents provided
The product sold
The market application of the product
The direction and magnitude of changesimpacts and
Whether any of these changes are attributable to other factors than the REACH authorisation
process
Table 45 lists the sold products for which respondents reported a change in sales revenue in
conjunction with the reported market applications of these products The table also shows the
number of examples given for each product
Table 45 Changes in sales revenue (industry survey)
No Product sold
Number of
examples
provided
Market application(s)
1 Ammunition 1 Military sector
2 Chrome plated metal components 1 Automotive sector
3 Chrome plated parts 1 Automotive sector
4 Chrome plating of customer rolls 1 Cold rolling industry
5 Chromium trioxide (CAS no 1333-82-0) 2
Dehydrogenation
catalyst
Not stated
6 Lead monoxide (CAS no 1317-36-8 7439-92-1) 1 Glass production
7 Metal liner 1 PVD-chrome
8 Not stated 2 Aerospace sector
Printers
Total 10
Notes The examples were provided by 10 respondents
Respondents were asked to indicate the changes that their organisations experienced in relation to
their sales revenue (
Table 46) Most respondents (90) reported a decrease in their sales revenue by 11 to 19 For all
examples respondents attributed the reported changes in sales revenue entirely to the REACH
authorisation process The finding should be used with caution As set out earlier most
respondents indicated no impact of REACH authorisation on sales revenue
Impacts of REACH Authorisation Final Report
eftec November 2017 30
Table 46 Changes in sales revenue ndash Type of impact (industry survey)
( based on 10 examples)
Decrease
gt20 -
11 - 19 90
1 - 10 10
Increase
1 - 10 -
11 - 19 -
gt20 -
Dont know
-
Total 100
Notes This table is based on 10 examples provided by 10 respondents
447 Changes in quality price or availability of organisationsrsquo products
Only twenty-four percent of respondents (11 out of 46) to the industry survey stated that the
REACH authorisation process had led to an impact on the quality price or availability of their
organisationsrsquo products Overall this would suggest that REACH authorisation may not have had a
significant impact on product quality price or availability (at least to date) The results presented
in this sub-section should therefore be interpreted with caution since they only refer to a minority
of respondents
These respondents provided 13 examples of these impacts For each example respondents
provided
The (possible) SVHC that was impacted
The usefunction of the substance
The marketproduct that was affected
The type and direction of changesimpacts and
Whether any of these changes are attributable to other factors than the REACH authorisation
process
Table 47 lists the substances (and uses of that substance) for which respondents reported a change
in quality price or availability The table also shows the number of examples given for each
substance With 5 examples chromium trioxide is the substance with the highest number of
reported examples In terms of uses plating is the use with the highest number of examples
Three of 13 examples refer to this use
Table 47 Changes in quality price availability (industry survey)
No Substance CAS number
Number of
examples
provided
Affected use(s)
1 Chromates Not stated 2 Anti-corrosive
Surface treatment
2 Chromium trioxide 1333-82-0 5
Decorative function
Metalacid reaction inhibitor
Passivation
Impacts of REACH Authorisation Final Report
eftec November 2017 31
No Substance CAS number
Number of
examples
provided
Affected use(s)
Plating
3 Chromium VI Chromium ion (Cr6+)
Hexavalent chromium 18540-29-9 1 Plating
4 Lead chromate 7758-97-6 2 Pigments
Pyrotechnic mixtures
5 Sodium dichromate 10588-01-9 2 Passivation
Sealant
6 Strontium chromate 7789-06-2 1 Primers and
coating
Total 13
Notes The examples were provided by 11 respondents
For all the examples provided respondents indicated that the downstream user markets for the
uses of SVHCs were the ones most affected by the authorisation process (as opposed to markets for
the SVHCs themselves or their alternative substancestechnologies) This is not surprising since
most survey respondents were downstream users of an SVHC rather than MIrsquos of the SVHC
To get more specific information on the type of change that their organisation had experienced
respondents were asked to indicate whether they had experienced any of the following changes
Change in availability of final (end-use) product
Change in price of final (end-use) product
Change in quality of final (end-use) product
Figure 44 reports the number of cases (out of 13) in which respondents stated that their
organisation experienced the respective change Respondents were asked about both positive and
negative changes but no respondent reported a positive improvement in the above listed areas
Most respondents stated that the increase in price was a result of increased production or
compliance costs (for complying with the authorisation process) The reduction in product quality
was said to be due to the substituting to alternatives that did not adequately replace the functions
provided by using the SVHC in the final products
Impacts of REACH Authorisation Final Report
eftec November 2017 32
Figure 44 Changes in quality price availability ndash Type of impact (industry survey)
Notes This figure is based on 13 examples provided by 11 respondents
For eighty-five percent of the examples respondents attributed the reported changes to the REACH
authorisation process
45 Tier 2 case study Diarsenic trioxide and arsenic acid
451 Rationale for considering these substances
Arsenic acid and diarsenic trioxide were identified as case study substances due to the very small
number of applications for authorisation submitted for them (four applications for diarsenic
trioxide one application for arsenic acid) This raises the question of whether the use of these
substances has always been this limited historically or whether use has fallen over time (or some
other scenario) If use is seen to have fallen over time the questions then are first how the
markets for these substances (and their substitutes) have changed over the course of this fall and
second to what extent the authorisation requirement for these substances might have contributed
to the falls and the associated market changes
A principal use for both substances is in the manufacture of speciality glass The MSC opinion on the
prioritisation of arsenic acid stated that the substance could act as a substitute for diarsenic
trioxide and presented this as a justification for prioritisation For these reasons the substances
have been grouped together for this case study
Note that diarsenic pentaoxide was prioritised for inclusion in Annex XIV at the same time as
diarsenic trioxide because of its potential to act as a substitute for the latter substance in glass
manufacture However at the time of prioritisation there was no registration dossier for diarsenic
pentaoxide and comments from industry indicated that there was no manufacture in or import into
the EU There were also no applications for authorisation to use this substance after its sunset
date Therefore diarsenic pentaoxide is not considered further in this case study
452 Substance profiles
Impacts of REACH Authorisation Final Report
eftec November 2017 33
A profile of the substances are summarised below in Table 48
Table 48 Substance profiles
Diarsenic trioxide Arsenic acid
EC nos 215-481-4 231-901-9
CAS nos 1327-53-3 7778-39-4
SVHC Classification Carcinogenic (Article 57a) Carcinogenic (Article 57a)
Exempted uses - -
Existing restrictions REACH Annex XVII entries 19 and 28 REACH Annex XVII entries 19 and
28
Entry 19 of Annex XVII of REACH is a restriction on arsenic compounds It restricts the use of arsenic
compounds in industrial water treatment marine anti-fouling paints and for the preservation of
wood (although derogations are made for certain wood preservation uses) Entry 28 relates to
carcinogens more generally and restricts the use of such substances in substances and preparations
placed on the market for sale to the general public
453 REACH Authorisation timeline
The REACH authorisation timelines for the two substances are given in Table 49 A date for the
inclusion of diarsenic trioxide in the Registry of Intentions has not been found The time frames for
the two substances are similar with around seven years between the Annex XV dossier for diarsenic
trioxide being submitted and its subsequent Sunset Date and six years for the same process for
arsenic acid The one-year difference between the two is due to the faster time it took for arsenic
acid to be prioritised onto Annex XIV following its entry onto the Candidate List
Table 49 REACH authorisation timelines
Diarsenic trioxide Arsenic acid
Registry of Intentions Not known 30042008
Annex XV dossier 26062008 29082011
MSC opinion on SVHC identification 01102008 24112011
Candidate List 28102008 19122011
Annex XIV recommendation 17102010 13122012
Annex XIV 21052012 22082014
Latest Application Date 21112013 22022016
Sunset Date 21052015 22082017
454 Market prior to REACH authorisation
Diarsenic trioxide
The initial Annex XIV background document produced by ECHA in 2010 presented information on
uses and volumes collected for ECHA by the consultancy RPA in 2009 However much of this
Impacts of REACH Authorisation Final Report
eftec November 2017 34
information was judged inaccurate by the Arsenic Consortium in their response to the associated
public consultation The background document was subsequently updated and drew heavily on the
Consortiumrsquos contribution Unfortunately the Diarsenic Trioxide Consortium declined to contribute
new information to this study This section is therefore based primarily on the final ECHA Annex XIV
background document
Table 410 presents information provided to ECHA by the Arsenic Consortium on the production and
use of diarsenic trioxide in the EU over the period 2008-2010 Figures might not balance due to
inaccuracies and uncertainties
Table 410 Diarsenic trioxide in the EU 2008-2010
tonnes pa Uses tonnes pa
Manufacture 1500 Production of ultra-pure arsenic metal 30-40
Manufacture of impure form 320 Chemicals 60
Import 500-600 Zinc production 500-600
Glass 100-150
CCA wood preservative (export) 70-100
Diarsenic trioxide export 1100-1200
Waste 200
Net placed on the market 2320-2420 Total use 2060-2250
Most diarsenic trioxide is produced as a by-product of copper (and to a lesser extent lead) smelting
and refining Therefore manufacture of diarsenic trioxide depends largely on the production
volume of these metals and the arsenic impurity levels in the ores The volume placed on the
market further depends on consumer demand ndash when demand is low a higher proportion of
diarsenic trioxide is disposed of as hazardous waste whereas when demand is higher (particularly
in eg the zinc sector) both manufacture and imports can increase Only two producers of
diarsenic trioxide were identified for the 2011 background document
The primary use (around 550 tonnes per annum) of diarsenic trioxide in the EU can be seen to be in
the manufacture of zinc metal by electrolysis This use was claimed as intermediate by the Arsenic
Consortium and is identified as an intermediate use in the registration dossier However this claim
was contested by ECHA in the background document on the grounds that diarsenic trioxide used in
zinc manufacture acts as a purificationprecipitation agent This case has since been reviewed by
the ECHA Board of Appeal that concluded that the case needs to be remitted to the Agency for re-
evaluation (although the Board of Appeal has not found ECHArsquos conclusion as to the substancersquos
intermediate status in zinc manufacture to be necessarily incorrect) According to the Nordenhamer
Zinkhuumltte GmbHrsquos application for authorisation diarsenic trioxide has a dual role in zinc
manufacture in the purification of zinc sulphate solution but also in so doing producing a copper
concentrate which is then sold on to a chemicals producer
Impacts of REACH Authorisation Final Report
eftec November 2017 35
The second major use of diarsenic trioxide (c125 tonnes per year) was in glass manufacture as a
decolouring agent for glass and enamels and as a refining and oxidising agent in the manufacture
of special glass and lead crystal According to the JRC (2009)22 special glass products cover a wide
range including lighting glass (tubes and bulbs) optical glass laboratory and technical glassware
borosilicate and ceramic glasses (cookware and high temperature domestic applications) and glass
for the electronics industry (LCD panels) The Arsenic Consortium comment also identified artisanal
glass manufacture (eg in Murano Italy) where diarsenic trioxide might be used for particular
reasons This was said to account for around 8 tonnes per year As with zinc manufacture the
Consortium claimed the use in glass to be intermediate a claim which was similarly contested by
ECHA on the grounds that the substance was judged not to be used in the synthesis of glass itself
but as a processing agent for modifying the properties of the glass and specifically as a
decolourising opacifying and fining agent However it is understood that since the publication of
the ECHA background document industry has clarified that certain special glass applications as in
the manufacture of ceramic glass used for cooker hobs and stove door windows involve the use of
arsenic compounds as a lsquonetwork formerrsquo which does class as an intermediate use the use as a
fining agent in the manufacture of artistic glass is still considered non-intermediate however
The use of diarsenic trioxide in copper-chromium-arsenic wood preservatives was in 2011 said to be
much reduced in the EU compared with previously due to the introduction of the restriction
described in Section 452 and only for export It was expected that manufacture would cease
before the first ECHA registration deadline of 2010 In any case this use falls under the Biocides
Directive and hence is exempt from the REACH authorisation requirement The other uses identified
in Table 410 are not discussed in the ECHA background document Use in pharmaceuticals
identified in the Annex XV dossier had reportedly ceased in the EU by 2010 although internet
searches in July 2017 reveal suppliers of arsenic trioxide as a treatment for leukaemia and other
cancers23 Other uses referred to in the same dossier related according to the Arsenic Consortium
to uses of arsenic metal not diarsenic trioxide
A use of diarsenic trioxide not identified (separately) in the ECHA background document was the
use as a processing aid to activate the absorption and desorption of carbon dioxide by potassium
carbonate from synthesis gas which was used for the production of ammonia by Yara France
Additionally the arsenic serves as a corrosion inhibitor in this process In Yararsquos application for
authorisation (see below) the carbon dioxide removal unit was described as containing 40 tonnes
of diarsenic trioxide and potassium carbonate requiring the addition of approximately five tonnes
of diarsenic trioxide per year to compensate for the conversion of diarsenic trioxide to diarsenic
pentaoxide which is regularly extracted from the system by filtration
A further use of diarsenic trioxide which has been the subject of an application for authorisation
but not identified (separately) in the ECHA background document is in the production of etched
circuits These are used in smartcards in a range of applications such as SIMs payment cards ID
cards medical sensors RFID chips data storage cartridges and so on This is a very minor use in
volume terms (15-30kg per year) and might well not have been current at the time the document
was compiled (2010)
From Table 410 it can also be seen that imports exports and waste also accounted for significant
volumes over the 2008-2010 period As already mentioned volumes going to waste can depend on
production volumes and demand particularly from the zinc sector and from export markets
22 Joint Research Centre (2009) Best Available Techniques (BAT) Reference Document for the Manufacture of
Glass 23 httpwwwtevaukcomhcptrisenox
Impacts of REACH Authorisation Final Report
eftec November 2017 36
According to the ECHA database import notifications were received only from Switzerland over the
period 2006-2017 primarily to Germany and France but also to Sweden Belgium and the
Netherlands 24 import notifications in total are listed in the ECHA database over this period
Notifications of exports over the period 2004-2017 number 83 over the 2004-2010 period
exclusively from Spain and Germany (25 entries with two from Bulgaria and one from France) to a
variety of countries including the United States Brazil Switzerland and India Volumes are not
reported in these notifications However the greater number of export notifications compared with
import notifications (11 over 2006-2010) could be consistent with the higher export volume
reported in Table 410 compared with the import volume
Arsenic acid
Information on the use of arsenic acid prior to authorisation is provided in the Annex XV dossier
which Norway prepared to establish the substance as a SVHC and in the background document (and
associated public consultation comments) prepared by ECHA in support of the substancersquos
prioritisation for inclusion in Annex XIV Unfortunately the Arsenic Acid Consortium declined to
contribute new information for this project so these documents are the source of information on
pre-authorisation uses of arsenic acid
According to the Annex XV dossier arsenic acid can be manufactured using a variety of different
processes a typical one involving the reaction of arsenic trioxide with nitric acid in the presence of
a catalyst The Annex XV dossier reported that there had been manufacture of arsenic acid in the
EU in 2010 but that this had stopped by 2011 According to the Annex XIV background document
the registration dossier was updated to indicate manufacture below 100 tonnes in 2012 Total
volume was in the 100-1000 tonnes band
The Annex XV dossier cites the US Minerals Yearbook in stating that 89 tonnes of arsenic acid were
reported to have been imported into the US from France in 2008 with a figure of zero in 2009 In
2007 five tonnes were reported as being imported from Germany and six tonnes from France in
2006 No imports from the EU are reported in the Yearbook after 2008 None of these exports is
listed in the ECHA export notifications database
The Annex XV dossier concluded based on data reported in registration dossiers that a decreasing
trend in the total manufactured and imported volume could be assumed although information on
the trend over a more extended time period was deemed to be unavailable
Three uses of arsenic acid were considered current at the time the dossier was compiled
Ceramic glass manufacture
Copper foil production for use in printed circuit boards (PCBs) and
In a preparation as an analytical standard for test and measuring instruments
The use of arsenic acid in glass manufacture was described in the ECHA dossiers as a fining agent in
the manufacture of speciality glass for removing bubbles from the glass melt The addition of
arsenic acid releases oxygen late in the fining process which makes the bubbles more easily
absorbed by the melt This use was said to account for 97 of the total volume of use of arsenic
acid Comments to the public consultation on the prioritisation of arsenic acid indicated that the
volume used in copper foil production (the only other significant use ndash see below) was around 10
tonnes per year which might put the volume used in ceramic glass manufacturer at around 300
tonnes The definition as a process agent lead ECHA to conclude at the time that this use was not
intermediate as was claimed by industry However the function of arsenic as a lsquonetwork formerrsquo
was described by Glass Alliance Europe (2012) as follows
Impacts of REACH Authorisation Final Report
eftec November 2017 37
ldquoArsenic acid [hellip] used in the production (synthesis) of glass [hellip] reacts with other raw materials
(substances) at high temperature to produce the new substance glass During this process the
oxides from the raw materials form a new random network where different elements are linked
together by oxygen bridges Arsenic acid is completely consumed during this chemical reaction and
no longer contained as such in the final substance glass [hellip] The physico-chemical properties of the
new substance glass (chemical resistance mechanical resistance transmittance colour inertness
etc) are a function of the composition and the network formed A different composition leads to a
different glass (chemicalmolecular) structure and consequently different physico-chemical
properties of the final product [hellip] The presence of arsenic ions in the network structure confers
unique properties to the glass such as a specific redox state clarity colour transmittance absence
of bubbles lack of inclusion etchellip which are critical to the function of glassrdquo24
As discussed in the previous section the use of arsenic compounds as a network or matrix former in
the ceramic glass sector is now accepted as an intermediate use Therefore no applications for
authorisation for this use would be expected
The use of arsenic acid in copper foil production for PCBs is described in the ECHA dossiers only in
confidential annexes In the public consultation a copper foil producer indicated that two
companies used arsenic acid in the EU for this use amounting to around 10 tonnes The application
for authorisation submitted by Copper Foil Luxembourg describes their use as being to encourage
the deposition of copper and to prevent the release of hydrogen when the surface area of the
copper foil is being increased by the deposition of additional copper onto the surface of the foil
Thus increasing the surface area involves deposition (lsquogerminationrsquo) and growth (lsquonodularisationrsquo)
of copper crystals onto the surface of the copper foil This process involves using the electrolysis
bath below the current diffusion limit by reducing the bath temperature the copper concentration
and the level of agitation However doing this risks the process giving off hydrogen instead of
depositing copper Arsenic acid helps to prevent this by increasing the cathodic overpotential of the
hydrogen
Finally comments to the public consultation revealed the use of arsenic acid in a preparation as an
analytical standard for test and measuring instruments for laboratory use This use was reported to
account for minute amounts (grammes) of consumption per year and ECHA indicated in its
response to public consultation comments that this use could be regarded as exempt from
authorisation under the scientific research and development provisions of REACH Article 56(3)
455 Applications for authorisation
Diarsenic trioxide
The applications for authorisation which were submitted for the use of diarsenic trioxide are
presented in Table 411 There were four applicants for five uses Two of these applications relate
to use in zinc for a total volume of around 840 tonnes per year ndash higher than the volume reported
by the Consortium for the ECHA background document There were two further applications for
use in gold electroplating and in the production of ammonia All authorisations have been granted
The authorisation was granted to Linxens with a review period of seven years The review period
argumentation for this application is not available from the public non-confidential version The EC
decision on this application states that lsquowork towards potential implementation of an alternative
in a period of not less than 3 to 5 years is ongoingrsquo suggesting that the applicant is working
24 Glass Alliance Europe (2012) Position Paper of the European Glass Industries on the Proposed Inclusion of
Arsenic Acid on Annex XIV
Impacts of REACH Authorisation Final Report
eftec November 2017 38
towards substitution of diarsenic trioxide with an alternative for this use Authorisation was also
granted to Yara with a (requested) review period of 22 months which was designed to allow the
applicant to continue use during the implementation of a substitute process Note that there were
no applications for use in the glass industry
Table 411 Granted authorisation for uses of diarsenic trioxide
Applicant Use Use description Volume
(tpa) Status
Review
period Substitution
Boliden 1 Purification of metal impurities in
zinc electrowinning process 700
COM
decided 12 N
Nordenhamer 1 Production of copper concentrate
in zinc electrowinning process 140
COM
decided 12 N
Linxens
1 Formulation into a mixture COM
decided 7
2 Processing aid in gold
electroplating 0005
COM
decided 7
Yara France 1 Processing aid in the production
of ammonia 5
COM
decided 22 mths Y
Arsenic acid
As shown in Table 412 there has only been a single application submitted for the use of around
three tonnes per annum in the treatment of copper foil for the manufacture of printed circuit
boards (PCBs) The Committee opinions have been adopted but the decision has not yet been made
by the Commission The opinions recommend a review period of seven years with the condition
that use volumes decline over time to reflect the outline substitution plan of the applicant
However the applicant had stated that it expected to need to use arsenic acid until 2030 as this
was how long it would take users with stricter requirements to accept circuits made with an arsenic
alternative Note again that as with diarsenic trioxide there were no applications from users in
the glass sector
Table 412 Applications for authorisation for the use of arsenic acid
Applicant Use Use description Volume
(tpa) Status
Review
period Substitution
Circuit Foil
Luxembourg 1
Treatment of copper foil for
the manufacture of printed
circuit boards (PCBs)
3 Opinions
adopted 7 Y
456 Changes in the market for the substance and alternatives during the authorisation process
Diarsenic trioxide
At the time of the compilation of the Annex XIV background document around 2400 tonnes of
diarsenic trioxide were estimated to be produced in or imported into the EU with around 200
tonnes going to waste Zinc production was the biggest industrial use of this volume (550 tonnes)
with glass production chemicals and arsenic production estimated to constitute around 250 tonnes
Around 1300 tonnes were estimated to be exported (leaving a discrepancy of between 70 and 360
tonnes) Thus it can be seen (in Table 410) that although zinc production represented the biggest
Impacts of REACH Authorisation Final Report
eftec November 2017 39
industrial use of diarsenic trioxide in the EU the import-export volumes were even more
significant Two producers were identified in the EU in the 2011 ECHA background document It is
not known how many suppliers of imported material there were at this time
According to information provided by Eurometaux for this study there are currently four large
copper manufacturers in the EU (in Germany Poland Spain and Sweden) each of which is a
potential or actual supplier of diarsenic trioxide As indicated in Table 411 the use of a little
under 850 tonnes of diarsenic trioxide has been authorised almost all in zinc manufacture Use of
five tonnes per year was authorised to Yara France in the production of ammonia with a review
period of 22 months only This was designed as a bridging application to facilitate the substitution
to a process based on an alternative substance (See Section 54 for more information) This review
period has now expired and Yara did not submit a review report Yara has confirmed in
communications for this project that its ammonia operations were shut down in March 2017 (before
the end of its review period) and the modified vanadium-based plant started up in August 2017
The only other granted authorisation is for less than 1 tonne per year with a review period of seven
years
Use in the production of artistic glass was not authorised and hence might be assumed to have
largely ceased As reported by ECHA (2017)25 use of arsenic trioxide in the artistic glass sector of
Murano Italy has been widely substituted following efforts by local authorities to advise users of
the authorisation requirement (See Section 54 for more information) During enforcement action
after the sunset date nine site inspections found that all but one firm had substituted to other
substances and local air pollution monitoring found that arsenic concentration had fallen by 98
between 2014 and 2016 indicating widespread substitution ECHA (2017) reports information from
the local chamber of commerce and the Italian workersrsquo insurance institute (INAIL) which indicated
that 300 companies were operating in the field of glass manufacturing in the Venice area where
Murano is located This information was combined with data obtained from the major local
distributor of diarsenic trioxide which showed that in 2013 around 24 companies in that area were
using around 5 tonnes of the substance (compared with 8 tonnes given by the Arsenic Consortium in
the public consultation submission Although this suggests that use in the Murano area has largely
(and possibly entirely) ceased it is not clear whether unauthorised use might be continuing in the
artistic glass sectors in other countries or what has happened to the 92-142 tonnes of use
identified by the Arsenic Consortium as occurring in the special glass sector Use in glass production
is still (as of September 2017) listed in the registration dossier as an intermediate use (and does not
distinguish between use for network formation and use for other reasons)
Volumes associated with imports and exports of diarsenic trioxide are not available but the ECHA
PIC database lists the number of exports and imports and the countries involved as shown in Table
413 Thus the number of imports has remained approximately the same over the 2006-2017
period with a slight peak in 2015 (No data are provided for 2004 or 2005) All of these imports
have come from Switzerland Export notifications were approximately stable over the period 2004-
2013 but since then have appeared to increase quite markedly This would be consistent with a
reduction in domestic use around the time of the latest application date (end 2013) even though
overall use volumes might not necessarily appear to have fallen particularly when Table 410 and
Table 411 are compared Eurometaux have also communicated intelligence for this study to the
effect that disposal of diarsenic trioxide to waste might also have increased since authorisation
ostensibly due to a reduction in EU demand for the substance EU copper producers were contacted
for this study in an attempt to explore these issues although only one responded The view
25 ECHA (2017) Artistic glass manufacturers in Murano Italy substituted arsenic trioxide to safer alternatives
air concentrations of arsenic reduced by 98 in two years Helsinki ECHA
Impacts of REACH Authorisation Final Report
eftec November 2017 40
expressed was that the market for diarsenic trioxide had been declining for some years already
which was largely ascribed to restrictions on the use of arsenic in wood preservation products
authorisation had not according to this producer strengthened these existing trends significantly
However it should be noted that historically use volumes of diarsenic trioxide have been
dominated by a relatively small number of uses so significant impacts of authorisation on individual
use types (eg in artistic glass manufacture) could still occur without causing significant
supplydemand impacts at the market level
Table 413 Import and export notifications for diarsenic trioxide 2004-2017
Year Exports Imports
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
1
2
4
2
5
5
6
2
1
4
20
6
12
13
nd
nd
2
2
3
2
2
2
2
0
1
6
1
1
Regarding the possible impact of authorisation on the market for alternatives the principle uses of
diarsenic trioxide are in zinc manufacture and the production of special glass The former is subject
to long-term authorisation The latter has not been authorised but it is not clear to what extent
this reflects substitution or (claimed) intermediate use Certainly the artistic glass sub-sector has
seen significant substitution activity at least in the Murano area of Italy with switches suggested
to a range of alternative substances The ECHA case study document on Murano reported that out
of 104 companies operating in the field of artistic glass in a 2015 survey 18 indicated that they
used diarsenic trioxide until 2014 but had substituted to antimony trioxide cerium dioxide lithium
oxide andor blast furnace slag The ECHA estimate of the total volume of diarsenic trioxide used in
Murano before this substitution was around 5 tonnes which is small compared with the
manufacturedimported volumes of these substances listed on the ECHA website26 Other uses of
diarsenic trioxide are even more minor in volume Therefore significant authorisation-related
changes in the market for alternatives to diarsenic trioxide are not to be expected However
specific information on changes in markets for alternatives to diarsenic trioxide has not been found
in this study
Arsenic acid
26 The Substance Information section of the ECHA website gives the following manufactureimport volumes
10000+ tonnes (antimony trioxide) 1000+ tonnes (cerium dioxide) No registration is listed for dilithium
oxide Blast furnace slag is exempt from registration as a UVCB substance (httpwwweuroslagcomstatus-
of-slagreach) The industry association Euroslag gives volumes for blast furnace slag of more than 20 million
tonnes per annum
Impacts of REACH Authorisation Final Report
eftec November 2017 41
The Annex XV dossier and Annex XIV prioritisation background document identified speciality
ceramic glass for use in high-temperature applications as by far the biggest (97) user of arsenic
acid at that time Use in copper foil manufacture was the only other material use described and
had been identified in public consultation comments as accounting for around 10 tonnes per year If
this represents around 3 of total consumption this would put ceramic glass use at around 300
tonnes per year at this time
The documents also indicated that manufacture in the EU had ceased around 2010-11 but
lsquoreappearedrsquo around 2012 when the registration dossier was updated Discussions with Circuit Foil
Luxembourg for this project support cessation around this time when it was claimed that
manufacture had ceased at this point because the manufacturer deemed the costs of registration
andor authorisation too high to be justified by the value of the market This had obliged Circuit
Foil Luxembourg to submit its own registration dossier (at considerable cost) to enable it to import
arsenic acid into the EU
The public consultation on the proposal to prioritise arsenic acid for inclusion in Annex XIV had
identified two firms using arsenic acid in the production of copper foil for PCBs Circuit Foil
Luxembourg have reported to this study that the second firm closed its facility in Europe in 2014
although it was not clear whether this was for REACH-related reasons Google searches reveal at
least one additional manufacturer of PCB copper foil in Europe27 but it has not been possible to
contact this manufacturer to ascertain the nature of its production process
As described above the vast majority (97) of the arsenic acid used in the EU in 2011 was in the
manufacture of ceramic glass which is classed as an intermediate use It is reasonable to expect
therefore that pressures to substitute this use have not been significant although no evidence is
available to support this
Moreover Copper Foil Luxembourg in discussions for this study stated that the availability of
arsenic acid in Europe has reduced around the time of the first REACH registration when
manufacture in Europe had ceased This would provide an encouragement to users to substitute or
find alternative supplies However as already discussed the ECHA prioritisation background
document states that the registration dossier had been updated in 2012 and manufacture below 100
tonnes indicated Manufacture is listed in the current registration dossier Contact was made with
this manufacturer (listed in the registration) but unfortunately they did not provide information
for this study
As also already mentioned the Circuit Foil Luxembourg application for authorisation indicated that
a (confidential) alternative to arsenic acid had been identified and introduced gradually for five
years already by the time the application was submitted Gradual introduction was envisaged to
continue with the final most stringent applications finally being substituted by 2030 at the latest
This substitution process might be expected to be expedited if the RACSEAC recommendation of a
seven-year review period (instead of the 12 requested by the applicant) is accepted in the final
authorisation decision Given the confidential status of this application it is not possible to assess
how Circuit Foil Luxembourgrsquos substitution activities might affect the markets for the substances it
intends to substitute towards
27 httpwwwgoettledeenproducted-folie-von-5-400C2B5m-mit-und-ohne-treatment-
batteriefolien_2015-08-13_10-38-12_2016-07-15_09-10-06
Impacts of REACH Authorisation Final Report
eftec November 2017 42
As with diarsenic trioxide by far the biggest use of arsenic acid (in the production of ceramic glass
for high-temperature applications) is an intermediate use and hence outside of the scope of
authorisation The remaining uses are extremely minor Hence significant authorisation-related
changes in the market for alternatives to arsenic acid are not expected
457 Summary conclusions on the impact of authorisation on these and related markets
The markets for arsenic acid and diarsenic trioxide are complex and inter-related In fact one of
the justifications for prioritising arsenic acid given in the Member State Committee opinion on the
fourth Annex XIV prioritisation was so as to prevent substitution of uses of diarsenic trioxide
straight to arsenic acid Assessing changes in these markets is complicated by the fact that major
uses have been claimed intermediate by industry and disputed by ECHA Unfortunately both the
Diarsenic Trioxide Consortium and the Arsenic Acid Consortium declined to contribute information
to this study and it has proved difficult to identify individual companies willing to provide
comment
What seems apparent from the information which has been collected is that authorisation has had
impacts on the markets for both diarsenic trioxide and arsenic acid In the former case
authorisation has incentivised substitution in the artistic glass sector as well as by two
authorisation holders in the ammonia and electronics sectors Use in zinc manufacture does not
appear to have been affected but there is evidence that overall use in the EU might have fallen
relative to production given the increase in export notifications and the reported increase in
disposal to waste
Regarding arsenic acid there does appear to have been some disruption to the supply of the
substance with the registration dossier being updated to reflect cessation and recommencement of
manufacturing in the EU One user reported having to submit its own registration dossier to be able
to import because its previous EU supplier had decided to exit the market It is possible also that
some disruption has been caused by the disputed status of arsenic acid use in ceramic glass
manufacture as intermediate No authorisations for this use were received
46 Tier 2 case study HBCDD
The substance hexabromocyclododecane was selected for a second-tier case study for a number of
reasons
The substance had a relatively high number of applicants (13 the fourth highest of all
applications made to date covering many of the downstream users for the EPS use)
although a low number of applications (one) and uses (two)
A technically and economically feasible alternative was found but it was not available in
sufficient quantity to all applicants The sufficient supply of the alternative was secured by
other companies for their uses (that did not apply for authorisation)
HBCDD is to date the only PBTvPvB substance having gone through the application for
authorisation step of the process
461 Substance profile
A profile of the substance is summarised below in Table 414
Impacts of REACH Authorisation Final Report
eftec November 2017 43
Table 414 HBCDD substance profile
HBCDD
Substance name Hexachlorocyclododecane (and all major
diastereoisomers identified)
EC nos 221-695-9
247-148-4
CAS nos
25637-99-4
3194-55-6
134237-50-6
134237-51-7
134237-52-8
Stage in authorisation process On Authorisation List
Sunset date past Yes
SVHC Classification - Intrinsic
property(ies) referred to in Article 57
PBT (Article 57 d)
Exempted (categories of) uses None
Existing restrictions No
462 REACH Authorisation timeline
The REACH authorisation timelines for the substance is given in Table 415
Table 415 HBCDD REACH authorisation timeline
Date
Annex XV dossier 30062008
Date of inclusion (Candidate list) 28102008
Annex XIV recommendation 01062009
Annex XIV 17022011
Latest application date 21022014
Sunset Date 21082015
463 Market prior to REACH authorisation
HBCDD was assessed under the pre-REACH Existing Substances Regulation (ESR) programme and a
Risk Assessment Report (RAR) was finalised in 2008 The rapporteur was Sweden (done by the
chemicals regulator KemI) A risk reduction strategy (RRS) was prepared in 2007 (prior to the
official finalisation of the RAR) Based on the risks identified in the RAR the RRS recommended
limitations on uses (ie in textiles high impact polystyrene (HIPS) expanded polystyrene (EPS) and
extruded polystyrene (XPS) with exemptions for certain uses of HBCDD in EPS and XPS) In
addition the RRS recommended
The compulsory marking of exempted uses of HBCDD in EPS and XPS products and
classification of used material and products containing HBCDD as hazardous waste under
the Hazardous Waste Directive
Impacts of REACH Authorisation Final Report
eftec November 2017 44
Inclusion of HBCDD as a priority hazardous substance in Annex X of the Water Framework
Directive and
Development of a proposal for the inclusion of HBCDD in the Stockholm Convention on
POPs
Sweden prepared an Annex XV dossier proposing the substance as SVHC the Member State
Committee adopted a support document identifying the substance as SVHC (PBT) in 2008) The
substance was recommended by ECHA for inclusion in Annex XIV (ECHA prioritisation report January
2009) and was afterwards included in Annex XIV by the Commission (2011)
According to the ECHA background document (200928) HBCDD was manufactured at only one site in
the EU with an annual production volume assumed to be 6000 tonnesyear in 2005 Between 2000
and 2004 about 1000 tonnesyear of HBCDD were micronised in a grinding process occurring at a
very limited number of sites mainly for use in the textile industry It was considered likely that the
production of micronised HBCDD had reduced and was estimated to be about 210 tonnesyear
Again according to the ECHA 2009 background document at that time (pre-REACH) the total
volume of HBCDD used in the EU had been increasing over the years and was estimated to be about
11580 tonnesyear in 2006 It was believed that net imports of HBCDD had increased from less
than 4000 tonnes per year to close to 6000 tonnesyear between 2003 and 2007 The quantities of
HBCDD exported as such or in preparations as well as import in preparations were unclear No
reliable quantities of importexport of HBCDD in articles were available However it was
considered that HBCDD was likely to be imported in considerable amounts particularly in packaging
materials textiles and electricalelectronic equipment The volumes are summarised in Table 416
below
Table 416 Summary of volumes of HBCDD (excludes imports in articles) ndash 2006 data
Use Volume tonnes per year
Manufacture asymp 6000
Micronising1 1000
Net import (substance and preparations) asymp 6000
Net import (in articles) No data
Total use volume (2006) asymp 12000
1 The tonnage of HBCDD used in micronising is already included in the tonnage of the substance manufactured
Source ECHA 2009
HBCDD was reported solely as an additive flame retardant in the following main product types (data
for 2007 IOM 200829)
Expanded Polystyrene (EPS)
Extruded Polystyrene (XPS)
28 ECHA (2009) Prioritisation and Annex XIV Background Information 14 January 2009 29 IOM (2008) Data on Manufacture Import Export Uses and Releases of HBCDDD as well as Information on
Potential Alternatives to its Use Framework contract ECHA20082 (specific contract
ECHA200802SR4ECA226)
Impacts of REACH Authorisation Final Report
eftec November 2017 45
High Impact Polystyrene (HIPS)
Polymer dispersion for textiles
In all products HBCDD is uniformly incorporated as an integral encapsulated component within the
polymer matrix However it is not bound to the matrix or transformed (IOM 2008)
The main uses for EPS are insulation panelsboards in the construction sector and automobile
cushions for children Minor uses are packaging material and props for exhibitions films or similar
(IOM 2008) The use of EPS was reported as increasing from 3452 tonnesyear (2002) to 5301
tonnes per year in 2006 (IOM 2008)
XPS is mainly used in lsquocold bridgersquo insulation sandwich panels and different other uses in
construction materials (cavity insulation floors walls roofs etc) As with EPS XPS use had also
increased in the years 2002 to 2006 (3954 tonesyear to 5859 tonnes year from 2002 to 2006
respectively IOM 2008)
Although the use of EPS and XPS was expected to reduce slightly in the second decade of the
millennium because of the downturn in house-building affecting much of Europe in the longer
term industry predicted an increased use of insulation products as a response to increasing cost of
energy and awareness of climate change (IOM 2008)
The use of HBCDD into HIPS was mainly for video and stereo equipment distribution boxes for
electrical lines in the construction sector and refrigerator lining (IOM 2008) Different sources
estimate the HBCDD content of flame-retardant HIPS between 1-7 (ww) and the EU Risk
Assessment Report (cited in IOM 2008) assumed as a realistic worst case that HIPS contains 7
HBCDD The use volume has not changed in the last few years in Europe and is estimated as 210
tonnesyear (IOM 2008)
Micronised HBCDD is used in textile applications must comply with British and German DIN flame
retardant standards (IOM 2008) mainly for upholstered furniture and seating in transportation
draperies bed mattress ticking interior and automobile textiles A likely HBCDD concentration in
the final product was estimated to be 10-15 (IOM 2008) After a substantial reduction of this use
during the last few years it was estimated that only about 210 tonnes year were used in textile
coating (IOM 2008)
Table 417 provides an overview of the different uses of HBCDD The overall volume used (years
20062007) estimated on the statements of IOM (2008) was 11580 tonnesyear
Table 417 Summary table of the different uses of HBCDD EU (20067)
Use Volume tonnesyear No of sites
Expanded Polystyrene (EPS) 5301 21
Extruded Polystyrene (XPS) 5859 28
High Impact Polystyrene (HIPS) 210 3
Textile coating 210 16
Total 11580 47
464 Applications for authorisation
Impacts of REACH Authorisation Final Report
eftec November 2017 46
There was a single application for two uses in EPS (compounding and conversion (ie making
articles)ndash in the same application with the same applicants) Companies producing XPS have
substituted before the sunset date and did not have to apply because enough of the polymeric
flame retardant (a brominated polymer) was available to them after the sunset date No application
for authorisation was submitted for the other uses Based on 20067 data EPS and XPS represented
96 of the volume use for HBCDD
465 Changes in the market for the substance during the authorisation process
The changes in market structure for HBCDD were dominated by the availability of the alternative to
HBCDD for both EPS and XPS The alternative which is for both (EPS and XPS) a brominated
polymer referred to as pFR was manufactured by the same firms that supplied HBCDD to the EU
market
The pFR alternative was known to be a higher cost product (ie it costs more for unit volume than
HBCDDD and more mass of pFR per mass of EPS is required to achieve the same function) ndash as
evidenced in the HBCDD authorisation application The AfA SEA indicated that an important
consideration was the effectiveness of the pFR alternative when compared to HBCDD on a weight
basis To meet fire safety requirements for EPS and XPS it was estimated that compared to
HBCDDD 13 times the amount of pFR was required for EPS and 11 times the amount is required for
XPS
Data presented in the AfA for HBCDD (SEA) indicate the demand for HBCDD in terms of the EU split
between ESP and XPS uses in 2007 (Table 418) and the global demand in 2011 (Table 419)
Table 418 Demand for HBCDD in the EU (2007)30
Volume produced
in 2007 (kilo
tonnes)
Amount used in
construction
applications ()
Amount
that is FR
()
Average
HBCDD
content ()
Total HBCDD
consumed (t)
EPS 1461 78 77 07 6138
XPS 313 94 98 225 6488
Total - - - - 12625
Table 419 Global demand for HBCDD (2011)
Region Total HBCDD (tonnes) Relative share of demand ()
Japan 2480 7
Americas 2480 7
Europe 14483 44
China 12090 37
Korea 1550 5
Total 33595 100
Notes
30 Table from non-confidential version of SEA from AfA for HBCDDD (EPS use)
Impacts of REACH Authorisation Final Report
eftec November 2017 47
1 Source Chemtura (2013) presentation for non-EU demand for HBCDD
2 EU estimate based on CMAI (2009) study data and growth rate of 4pa for EPS and 3pa
for XPS
The ECHA (2009) data show that EU demand for HBCDD had increased on average by 10 per year
over the period 2002 to 2007 In the AfA the applicants used confidential data (provided by the
application consortium members) which showed an increased demand for HBCDD for use in EPS
continued by ~12 per year over the period 2007-2011 Furthermore they estimated that the
demand for both final products (XPS and EPS) would increase even post-2020 due to the need to
meet energy policy (eg European Energy Performance of Buildings Directive that mandates energy
performance certification for new existing and renovated buildings to make buildings more energy
efficient)
At least one EPS producer that did not submit an AfA31 expressed a strong view that the AfA for EPS
use of HBCDD was not needed because there waswould be sufficient pFR available for all EU
users The adoption of the pFR in light of the successful AfA (granted to a consortium of EPS
manufacturers) placed these companies (that had already completely switched to the pFR) at a
competitive disadvantage because of the greater mass of pFR required to fire proof EPS (weight for
weight) the pFR is more expensive and there were significant costs to introduction of the pFR (eg
different dosing equipment (pFR is pellet HBCDD typically a powder)) trails and product
qualifications with customers The successful applicants however in theory could carry on using
HBCDD for two years (granted review period)
Substitution with the polymeric alternative for HBCDD
The Dow Chemical Company owns the patent to a block copolymer of polystyrene and brominated
polybutadiene known as the polymeric flame retardant or lsquopFRrsquo and granted licences to three
producers of HBCDD (namely Chemtura Albemarle and ICL IP) The pFR was initially designed as a
replacement for HBCDD in XPS use but can also be used for making EPS (albeit more pFR is needed
relative to HBCDD to achieve the fire-retardant requirements) At the time of the AfA
manufacturers were committed to making the polymeric alternative but there were uncertainties
about the number of production sites that would be fully operational by the sunset date if global
demand for EPS and XPS use was to be met For any pFR supply available XPS manufacturers and
some FR EPS producers that were not part of the consortium are understood to have secured
contracts for the initial supplies of the pFR that were available
As mentioned on the EUMEPS website32 the authorisation (granted on 8 January 2016 to a
consortium of companies) allowed the consortium member companies to use HBCDD in the
production of flame retarded EPS (FR EPS) and their customers to use FR EPS articles for building
applications up to 21 August 2017
According to a representative of the EPS consortium the authorisation was meant to serve as an
lsquoinsurancersquo in case of insufficient availability of alternatives However well in advance of the
original sunset date of 21 August 2015 the consortium started producing flame retarded EPS with
HBCDD-free formulations From end November 2016 the European EPS market was largely supplied
with HBCDD free EPS The companies that were granted the Authorisation started subsequently
announcing their withdrawal from the authorisation for use of HBCDD at the end of November 2016
31 Apparent from the public consultation on the AfA and from consultation done for this present project 32 httpseumepsorgnewssupply-of-eps-in-europe-is-now-HBCDD-free
Impacts of REACH Authorisation Final Report
eftec November 2017 48
Overall on the market the lsquopFRrsquo is not the only possible flame retardant alternative as indicated
in the AfA for HBCDD use for EPS There were also possible monomeric alternatives However those
alternatives had not been tested and trialled by the consortium members companies Therefore it
was not known if they could be viable alternatives either technically or long-term environmentally
It is possible however that some companies in the EU have used and are using flame retardants
other than the pFR or HBCDD for EPS Although the pFR is more expensive both because a greater
weight per weight of EPS is required and because the price per unit volume of pFR is higher (than
HBCDD) a more major factor in the profitability for EPS is the ability to pass on downstream
variations in the price of styrene monomer on a monthly basis (styrene base price)
Recycling
The authorisation process (in complementarity with the parallel activities under the Stockholm
Convention on POPs dealing also with waste containing POPs) affected the market for recycled
plastics since it changed the status of the products (for which authorisation for use of HBCDD in
their manufactureproduction was being sought) with regard to waste and recycling This impact
of recycling is considered by the Commission to be not related to Authorisation under REACH and is
therefore not assessed further in this report
466 Benefits from use of the substitute (pFR)
Consultation for this project with one major supplier of EPS indicated that no changes in worker
exposure were noted (HBCDD is a Cat 2 reproductive toxin) in the switch from HBCDD to pFR This is
because the same controls are essentially in place workers were as protected from dust exposure
then as they are now
There are environmental benefits from use of pFR The costs for environment controls are reduced
since the very low concentration of the WFD EQS for HBCDD leads to the need for very stringent
controls on releases to the environment (via waste water and sewage treatment works) However
the benefits to the environment from the switch to the pFR from HBCDD have not been quantified
467 Summary conclusions on the impact of authorisation on these and related markets
Based on the available information the main market impact of the switch to the alternative for EPS
has been the higher price of the alternative for use in EPS It appears (from limited information)
that benefits in terms of a greater level of safety (lower exposure andor less need for risk
management measures) in the work place has not be realised since similar controls were in place
for dust protection However environmental benefits are envisaged since use of the pFR removes
the need for very stringent controls on waste water and reduce concentration in the (aquatic)
environment that were needed for HBCDD These benefits have not been quantified
47 Findings using other statistical sources
This section uses publicly available EU statistics to identify changes in the EU chemicals market
thereby allowing for inferences about the effect of REACH authorisation on the market
Impacts of REACH Authorisation Final Report
eftec November 2017 49
471 Data sources used
The information within this sub-section is based on (i) PRODCOM33 data about production imports
and exports provided by Eurostat and (ii) REACH registration data and data about ceased
manufacturing and importing of substances provided by ECHA
472 Manufacture import export and use of SVHCs
Ceased manufacturing and importing of SVHCs
As of November 2016 ECHA identified 103 registrants who have ceased manufacturing or importing
a substance which has been identified as SVHC Table 420 classifies these 103 cases by type of
registrant and whether the respective SVHC is on the Candidate or Authorisation List
Table 420 Number of registrants ceasing manufacturing of SVHCs
Registrant type On Candidate List On Authorisation List Total
Lead dossiers 6 4 10
Member dossiers 59 25 84
Not specified 4 5 9
Total number of dossiers ldquoceased
manufacturing or importingrdquo 69 34 103
Source ECHA - Data status 02112016
Table 421 shows the change in registration status for substances included on the authorisation list
The data shows that even after a substance is placed on the Authorisation List a significant number
of registrations remains In part this is due to the continued use of the substance for intermediate
uses which are not subject to authorisation Some of the ceased manufacturing is also potentially
related to joining two lead dossiers and in some cases due to a revocation decision by ECHA
Table 421 Change of registration status for substances on the Authorisation List
Substance on Authorisation List Remaining active
registrations Ceased manufacturing
Trichloroethylene 5 1
Diisobutyl phthalate (DIBP) 7 3
Dibutyl phthalate (DBP) 8 3
22-dichloro-44-methylenedianiline (MOCA) 5 1
44rsquo- Diaminodiphenylmethane (MDA) 10 3
12-dichloroethane (EDC) 36 6
Bis(2-ethylhexyl) phthalate (DEHP) 17 7
Diarsenic trioxide 6 1
33 PRODCOM provides statistics on the production of manufactured goods The term comes from the French
PRODuction COMmunautaire (Community Production) for mining quarrying and manufacturing sections B
and C of the Statistical Classification of Economy Activity in the European Union (NACE 2) Further details can
be found here httpeceuropaeueurostatwebprodcom
Impacts of REACH Authorisation Final Report
eftec November 2017 50
Substance on Authorisation List Remaining active
registrations Ceased manufacturing
Chromium trioxide 26 2
Lead sulfochromate yellow 7 1
Ammonium dichromate 1 1
Sodium dichromate 17 2
Lead chromate molybdate sulfate red 7 1
Hexabromocyclododecane 6 2
TOTAL 158 34
Source ECHA Data status 02112016
The information in Table 421 reflects the status at the time of carrying out the analysis The
status of registrants changes over time and there is further evidence provided by ECHA that shows
more active registrants ceasing manufactureimport of an SVHC following the sunset date For
instance for the substance TCEP there is currently no active registrant whereas there had been 2
before the sunset date The document from ECHA focused on registered SVHCs for which the sunset
date had past The conclusion was that for 8 out of 11 SVHCs there was a reduction in the number
of active (not ceased) registrants between the latest application date and April 2017 The average
decline amongst those 8 was 32
Removal of certain uses from registrations during Annex XIV prioritisation rounds
REACH registrations are the main source of information for ECHAs priority assessment for
recommending substances from the Candidate List for inclusion in Annex XIV In this context ECHA
reminds registrants to update their registration dossiers with any new relevant information in
particular on uses and volumes
Table 422 below provides examples of substances for which registrants had removed from their
dossiers certain identified uses during a round of ECHArsquos prioritisation This may have happened in
the time during which the public consultation on a draft Annex XIV recommendation is held as a
reaction to the use overview information published by ECHA for a substance included in the draft
recommendation It may also have happened in the time until the next prioritisation round as a
reaction to the use overview summary published by ECHA in its prioritisation table for a substance
which had not been included in the current draft recommendation Typically the updates are
focused on professional or consumer uses the incentive being to decrease the priority of the
substance for inclusion in Annex XIV (occurrence of wide-dispersive uses in the EU increases the
priority score of a substance)
The examples were identified by checking published prioritisation documents for the past rounds of
Annex XIV recommendations Depending on the case for a given substance either all or the
majority or several registrants have removed the respective uses
Removal of a use previously identified in the dossiers of registrants means that their customers
cannot any more perform this use unless they submit have submitted a Downstream User report
(Art 38 of REACH) to ECHA In the absence of Downstream reports for the respective use and
Impacts of REACH Authorisation Final Report
eftec November 2017 51
provided that industry actors respect their REACH obligations34 removal from registrations may be
interpreted either as cease of use or as further assurance about not occurrence of use in the EU
The latter corresponds to the case where a use had been originally included in registration dossiers
only due to uncertainties about whether it still takes place downstream or not or due to a mistake
by the registrant in terms of the reported life cycle stage accuracy of use description
It should be kept in mind that the analysis performed in this report is limited to lsquousersquo data
Potential changes in the tonnage manufacturedimported or allocated to specific uses may of
course have occurred but they are out of the scope of this report
Table 422Examples of substances with removals of certain uses from registrations during Annex XIV prioritisation rounds
Substance (EC) Statements from published ECHA documentation
regarding AXIV priority assessment
Hydrazine (206-114-9) ldquoThe substance is reported as only used at industrial
site (Indication that the substance can be used by
professional workers has been removed in the updated
versions of the registration dossiers)rdquo
N-methylacetamide (201-182-6) ldquoAll other uses except the use as intermediate have
been removedrdquo
Cadmium (231-152-8) ldquoThe lead registrant and most of the members have
updated their dossier in 20142015 They have removed
the professional uses from their dossier and indicated
that professional (and consumer) uses are advised
against There is a
small minority of registrants (representing a low total
tonnage) who updated their dossier but did not remove
the professional uses and still report
professional use in cadmium based brazing products
cadmium-based soldering products and PVDcoating)
However these members refer to the lead registrants
CSR which no longer supports these usesrdquo
ldquoDossier updates were received in 2015-2016
Professional uses of cadmium based brazing
products and cadmium-based soldering products have
been removed from the majority of
the registrations The lead registrants CSR no longer
supports these uses The professional
use of brazing products if still happening in the EU is
expected to be limited to applications
derogated from the existing restriction under Annex
XVII (derogations apply to brazing
fillers used in defence and aerospace applications and
to brazing fillers used for safety reasons) No restriction
appears to apply to the use of cadmium based soldering
products and PVDcoating Considering the above it is
assumed that there is no professional use of
34 Information in eSDS supplied by registrants is kept consistent with registration Downstream Users
check and comply with eSDS received etc
Impacts of REACH Authorisation Final Report
eftec November 2017 52
Substance (EC) Statements from published ECHA documentation
regarding AXIV priority assessment
cadmium in the EU (ie PROF not considered for
WDU)rdquo
Cadmium oxide (215-146-2) ldquoThe lead registrant and most of the member
registrants have recently updated their registrations
They have inter alia removed professional and
consumer uses from their registrations There are some
members who have not yet updated their registrations
and the professional and consumer uses remain in
their dossiers (eg use of CdO-containing polymers for
tube amp sheet articles) However these members refer
to the lead registrantrsquos CSR which no longer supports
these usesrdquo
Cadmium chloride (233-296-7) ldquoAccording to recently updated registration
information cadmium chloride is no longer
manufactured andor imported into the EU
However the registration status of the substance is still
active and uses in the scope of authorisation are still
registered
Therefore some uses of the substance may remain in
the EUrdquo
Lead monoxide (lead oxide) (215-267-
0)
ldquoThe lead registrant and most of the member
registrants have updated their registrations during the
spring of 2014 and they have removed the consumer
use of artistsrsquo paints containing orange lead from their
dossiers and CSR
Furthermore the International Lead Association has
informed that the use in artistsrsquo paints is an obsolete
use and the lead registrant has asked the member
registrants to update their dossiers There are some
members who have not yet updated their registrations
and the use remains in their dossiers However these
members refer to the lead registrantrsquos CSR which no
longer supports the userdquo
Orange lead (lead tetroxide) (215-
235-6)
ldquoThe lead registrant and most of the member
registrants have updated their registrations during the
spring of 2014 and they have removed the consumer
use of artistsrsquo paints containing orange lead from their
dossiers and CSR
Furthermore the International Lead Association has
informed that the use in artistsrsquo paints is an obsolete
use and the lead registrant has asked the member
registrants to update their dossiers There are some
members who have not yet updated their registrations
and the use remains in their dossiers However these
members refer to the lead registrantrsquos CSR which no
longer supports the userdquo
Source ECHA (Aug 2017)
Production import and export of SVHCs
Impacts of REACH Authorisation Final Report
eftec November 2017 53
To identify changes in the EU chemicals market and a potential role of REACH authorisation
therein PRODCOM data was used to analyse trends in the production value as well as import and
export values of SVHCs Whilst PRODCOM data can be used as an indicator of market changes it is
important to be aware of the caveat that PRODCOM data is not broken down by uses of the
substance The total volumes used imported and exported therefore include uses (eg
intermediate use) that are exempt from authorisation and can continue to be used even after the
sunset date (if the SVHC is placed on Annex XIV)
The analysis was conducted by matching the 39 substances on the Authorisation List as well as 154
substances on the Candidate List with a PRODCOM code The substances were then classified into
five categories (ie 1 to 5) based on the quality of the match between the Candidate or
Authorisation List substance and the best-matching PRODCOM code The criteria used for the
classification are detailed in Table 423 in conjunction with an example for each category
Category 1 is the ideal category for the analysis of changes in production import and export of
SVHCs and the role of REACH authorisation in causing these changes Information about substances
in this category enables the most meaningful analysis of how changes in production import and
export coincide with key dates of the REACH authorisation process (ie date of placing the
substance on the candidate list and last application date) As there are only two SVHCs (12-
dichloroethane and methyloxirane) in Category 1 the nine PRODCOM codes in Category 2 relating
to 20 substances (ie 16 substances on the Authorisation and four on the Candidate List) have also
been considered for the analysis However since the PRODCOM data for some of the substances on
the Candidate List was incomplete the subsequent analysis is based solely on substances on the
Authorisation List for which complete datasets were available A list of these substances and the
relevant PRODCOM codes is provided in Table 424
Table 423 Classification of Candidate and Authorisation List substances based on quality of PRODCOM match
Cate
gory
Cri
teri
on
Example
Num
ber
of
PR
OD
CO
M c
odes
Num
ber
of
SV
HC
s
Subst
ance
PR
OD
CO
M
code
PR
OD
CO
M
desc
ripti
on
1 Exact match Single
substance in category
12-dichloroethane
(EDC) 20141353
12-Dichloroethane (ethylene dichloride)
2 2
2
Substance fits within category ldquoNarrowrdquo range of substances
within category
Hydrazine 20132580 Hydrazine and
hydroxylamine and their inorganic salts
9 20
3
Substance fits within category Larger
range of substances within category (Meaningful data
may be extracted)
Lead titanium trioxide
20121150 Titanium oxides 17 44
Impacts of REACH Authorisation Final Report
eftec November 2017 54
Cate
gory
Cri
teri
on
Example
Num
ber
of
PR
OD
CO
M c
odes
Num
ber
of
SV
HC
s
Subst
ance
PR
OD
CO
M
code
PR
OD
CO
M
desc
ripti
on
4
Substance fits within category However
the range of substances within
this category is too broad for meaningful
data to be extracted
Arsenic acid 20132460
Oxides of boron boric acids
inorganic acids (excluding hydrogen
fluoride)
35 83
5 Poor or no fit to a
category
24-dinitrotoluene
(24-DNT) 20141470
Derivatives of hydrocarbons
containing only nitro or only nitroso
groups
18 44
Table 424 Authorisation List substances (with complete datasets) in Category 2
Substance PRODCOM code
Name CAS No Description Code
Chromium trioxide
1333-82-0
Chromium manganese lead and copper oxides and hydroxides
20121200
Diarsenic trioxide
1327-53-3
Sulphur trioxide (sulphuric anhydride) diarsenic trioxide
20111250
Dichromium tris(chromate)
24613-89-6
Chromates and dichromates peroxochromates
20135125
Lead chromate
7758-97-6
Lead sulfochromate yellow
1344-37-2
Pentazinc chromate octahydroxide
49663-84-5
Potassium chromate 7789-00-6
Potassium dichromate
7778-50-9
Potassium hydroxyoctaoxodizincate- dichromate
11103-86-9
Sodium chromate
7775-11-3
Sodium dichromate
10588-01-9 7789-12-0
Impacts of REACH Authorisation Final Report
eftec November 2017 55
Substance PRODCOM code
Name CAS No Description Code
Strontium chromate
7789-06-2
Trichloroethylene
79-01-6
Trichloroethylene tetrachloroethylene (perchloroethylene)
20141374
12-dichloroethane is one of the SVHCs included in Category 1 Its date of inclusion on the
Candidate List and final application date are 19 December 2011 and 22 May 2016 respectively As
shown in Figure 45 the production value of this SVHC has mainly been in the range of euro250 to euro325
million between 2006 and 2015 The import value is very small compared to the production value
while the export value shown in Figure 46 is a reasonable share of the total production value This
indicates that the EU market relies on internal production and that the majority of production is
used in Europe
Figure 45 Production value and import value of 12-dichloroethane (ethylene dichloride)
Figure 46 Export value of 12-dichloroethane (ethylene dichloride)
Note LAD stands for last application date
In general the trend in production values of 12-dichloroethane is in line with the overall trend in
the EU chemicals market which has seen a continued increase of sales between 2005 and 2008 that
was interrupted in 2009 when sales values decreased significantly as a result of the global financial
crisis After a period of recovery and reaching pre-recession levels in 2011 the EU chemicals
industry has seen a small decline of sales since 2012 which is broadly in line with what can be
observed for the production value of 12-dichloroethane
Therefore data does not provide any indication of an effect of placing 12-dichloroethane on the
Candidate List This is not unsurprising as according to the background document35 published by
ECHA in November 2012 99 of the total volume of 12-dichloroethane is used as in intermediate
for the manufacturing of vinyl chloride monomers (VCM) and therefore exempt from authorisation
The second SVHC for which an exactly matching PRODCOM code could be found is methyloxirane
(propylene oxide) This substance has been placed on the Candidate List on 19 December 2012
Production values for methyloxirane (propylene oxide) range between euro1000 and euro2000 million
while import and export values are very small in comparison as shown in Figure 47 and Figure 48
The vast majority of methyloxirane produced in the EU is thus used internally
35 Available here httpsechaeuropaeudocuments1016238c352db-d89e-472f-9539-4fec08c6ca34
Impacts of REACH Authorisation Final Report
eftec November 2017 56
Figure 47 Production value and import value of methyloxirane (propylene oxide)
Figure 48 Export value of methyloxirane (propylene oxide)
The changes in the production value are generally in line with the trend observed in the EU
chemicals market This is also the case for the decline of the production value between 2012 and
2015 While the starting point of this decline coincides with the year in which methyloxirane was
placed on the Candidate List the inclusion in the Candidate List most likely plays a negligible role
in causing this decrease in production values The reason for this is that only a small proportion of
the total volume of methyloxirane seems to be affected by the authorisation requirement
According to the table presenting the results of ECHArsquos most recent priority assessment of
Candidate List substances only 1-10 tonnesyear out of a total volume of gt1000000 tonnesyear
are subject to authorisation36 There is consequently little indication for an effect of the
authorisation process on the market of methyloxirane
The next SVHC that has been analysed is chromium trioxide (CAS No 1333-82-0) This substance
was matched to the PRODCOM category titled ldquoChromium manganese lead and copper oxides and
hydroxidesrdquo and classified as belonging to Category 2
As shown in Figure 49 the production value for this category has ranged between euro200 and euro700
million between 2006 and 2015while import and export values were relatively stable over this time
period (as depicted in Figure 410) the share of imports relative to the total amount of chromium
trioxide available in the EU has increased since 2010
36 More information on the results of the priority assessment of Candidate List substances can be found here
(httpsechaeuropaeudocuments1016213640prioritisation_results_CL_substances_march_2017_enpdf3
91ae908-23f4-550d-94c9-090b922e50ec)
Impacts of REACH Authorisation Final Report
eftec November 2017 57
Figure 49 Production value and import value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo (PRODCOM code 20121200)
Figure 410 Export value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo (PRODCOM code 20121200)
Note LAD stands for last application date
The changes in production value are generally in line with those observed in the overall EU
chemicals market except for the fact that production values have to date not reached pre-
recession levels and that they do not follow an upward trend until 2012 but only 2010 There might
thus be a noticeable effect on the market resulting from placing chromium trioxide on the
Candidate List on 15 December 2010 This is investigated further in Section 10 which assesses
chromium trioxide in detail The effect of the final application date (ie 21 March 2016) cannot be
analysed currently due to no data being available for the period after 2015
The PRODCOM category titled ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo was used
to analyse the potential effects of subjecting diarsenic trioxide (CAS No 1327-53-3) to the REACH
authorisation process The process started on 28 October 2008 when diarsenic trioxide was placed
on the Candidate List The final date for application was 21 November 2013
The production value of diarsenic trioxide is very small (ranging from euro3 to euro55 million considered
together with sulphur trioxide) compared to that of the other analysed substances As depicted in
Figure 411 and Figure 412 imports and exports show very little fluctuations in terms of nominal
value and the majority of diarsenic trioxide produced in the EU is also used there Despite import
and export values being stable the production value has varied over time
Figure 411 Production value and import value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM code 20111250)
Figure 412 Export value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM code 20111250)
Note LAD stands for last application date
The changes observed after 2008 (when diarsenic trioxide was placed on the Candidate List) are not
in line with the trends observed for the EU chemicals market for the period from 2012 to 2015 The
Impacts of REACH Authorisation Final Report
eftec November 2017 58
production value of Sulphur trioxide (sulphuric anhydride) diarsenic trioxide increased from 2013
onwards while EU chemicals sales declined Thus data does not provide any indication of a
noticeable market effect of including diarsenic trioxide in the Candidate List Similarly the final
authorisation date has had no discernible effect on the market
The PRODCOM category ldquoChromates and dichromates peroxochromatesrdquo has been matched to
10 SVHCs The dates on which theses substances have been included in the Candidate List and the
final application dates are shown in Table 425 Apart from sodium dichromate which was put on
the Candidate List in 2008 all substances were included in the cCandidate List in 2010 or 2011
Lead chromate and lead sulfochromate yellow are the only substances for which the final
application data lies prior to 2016
Table 425 Substances matched to ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)
Substance Date of inclusion (Candidate list)
Final application date Name CAS No
Dichromium tris(chromate)
24613-89-6
19122011
22072017
Lead chromate
7758-97-6
13012010 21112013
Lead sulfochromate yellow
1344-37-2 13012010 21112013
Pentazinc chromate octahydroxide
49663-84-5
19122011
22072017
Potassium chromate
7789-00-6
18062010
21032016
Potassium dichromate
7778-50-9
18062010
21032016
Potassium hydroxyoctaoxodizincatedichr
omate
11103-86-9
19122011
22072017
Sodium chromate
7775-11-3
18062010
21032016
Sodium dichromate
10588-01-9 7789-12-0
28102008
21032016
Strontium chromate
7789-06-2
20062011
22072017
As shown in Figure 413 the EU has been reliant on imports with respect to chromates dichromates
and peroxochromates since 2006 In general the production value of chromates dichromates and
peroxochromates has declined significantly since 2011 while the import and export values have
seen little variation between 2006 and 2015
Impacts of REACH Authorisation Final Report
eftec November 2017 59
Figure 413 Production value and import value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)
Figure 414 Export value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)
Note LAD stands for last application date
Changes in the sum of production and import values for chromates dichromates and
peroxochromates (ie the amount available in the EU) are mostly in line with developments in the
overall EU chemicals market The only significant difference is that the EU chemicals market has
experienced growing sales values between 2009 and 2012 before starting a decline while the sum
of production and import values has started to decline in 2011 The significant drop observable in
2011 which is mainly accounted for by a significantly lower production value provides an
indication for a potential effect of placing several SVHCs on the candidate list in 2010 and 2011
The final application dates of lead chromate and lead sulfochromate yellow have no noticeable
effect on the market
Trichloroethylene (CAS No 79-01-6) was put on the Candidate List on 18 June 2010 and
companies were asked to apply for authorisation by 21 October 2014 According to the background
document37 for trichloroethylene developed by ECHA in the context of the third recommendation
for the inclusion of substances in Annex XIV the volume of trichloroethylene that is subject to
authorisation is above 10000 tonnesyear while the total volume lies between 50000 and 100000
tonnesyear The data provided for the PRODCOM category called ldquoTrichloroethylene
tetrachloroethylene (perchloroethylene)rdquo indicates that the production value declined significantly
from around euro110 million in 2006 to less than euro40 million in 2015 as shown in Figure 415
Figure 415 Production value and import value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo (PRODCOM code 20141374)
Figure 416 Export value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo (PRODCOM code 20141374)
Note LAD stands for last application date
37 Available here httpsechaeuropaeudocuments101629cedf499-8e10-4aef-b51d-82199a37dce5
Impacts of REACH Authorisation Final Report
eftec November 2017 60
The data presented in Figure 415 and Figure 416 also suggests that since 2010 the majority of
trichloroethylene and tetrachloroethylene produced in the EU is being exported rather than used in
the EU This is an indication for a potential effect of placing trichloroethylene (CAS No 79-01-6)
on the Candidate List However no conclusions can be drawn using this PRODCOM data as
tetrachloroethylene (perchloroethylene) is an alternative to the use of trichloroethylene
Therefore it is better to use different market data as can be seen later in a more detailed
assessment within Section 11
Conclusion
Based on the data analysis possible with publicly available PRODCOM data it is not possible to infer
what the effects of the authorisation process are This is because PRODCOM in most cases
(concerning SVHCs) merges SVHCs with other substances (similar in chemistry terms) together for
confidentiality reasons so substances cannot be assessed in isolation Where it has been possible to
assess a single substance using PRODCOM data these substances (volume wise) are mostly used as
intermediates and as it is not possible to isolate PRODCOM data to uses that are only subject to
authorisation Data is also only available until 2015 so overall PRODCOM has not been useful for
this project Further work could be done in the future using the confidential version of the
PRODCOM but this was not made available to the project team for this project
473 Manufacture import export and use of alternative substances
PRODCOM data was also used to analyse the potential effects of REACH authorisation on the
production import and export value of substances which were named as an alternative to an SVHC
by online industry survey respondents
Similar to the PRODCOM analysis of SVHCs (in Section 472) the analysis was based on matching
the mentioned alternative substances to a PRODCOM code where possible and classifying them
into one of five categories based on the quality of the match Table 426 presents the criteria used
for classification as well as the number of substances placed in each category and the number of
unique PRODCOM codes these refer to
Table 426 Classification of alternative substances based on the quality of the PRODCOM match
Category Criteria Number of
PRODCOM codes Number of substances
1 Exact match
Single substance in category 0 0
2 Substance fits within category ldquoNarrowrdquo range
of substances within category 2 2
3 Substance fits within category Larger range of substances within category (Meaningful data
may be extracted) 2 2
4 Substance fits within category However the range of substances within this category is too
broad for meaningful data to be extracted 5 6
5 Poor or no fit to a category 2 3
Impacts of REACH Authorisation Final Report
eftec November 2017 61
Only the four substances classified into Category 2 or 3 are deemed suitable for inclusion in the
analysis of changes in production import and export values as they can provide meaningful data for
this purpose For these categories the alternative substances and the PRODCOM categories they
have been matched to are listed in Table 427
Table 427 Assigned PRODCOM categories
It was necessary to exclude PRODCOM code 20141374 from the analysis as this code is identified as
being a match for an SVHC and included in the analysis of trends in production import and export
values of SVHCs in Section 472 Because of the simultaneous relevance of this PRODCOM category
for both SVHCs and alternatives a potential effect of REACH authorisation on the production
export and import value of the relevant alternative substance would not be discernible from the
data even if it existed
Figure 417 shows the trends in production and import values for Cyclohexanone and
methylcyclohexanones (PRODCOM code 20146233) Diazo- azo- or azoxy-compounds (PRODCOM
code 20144420) and Other esters of orthophthalic acid (PRODCOM code 20143420) in the left
column and the corresponding export values in the right column
Category
Alternative substance
Best-matching PRODCOM category
PRODCOM code
PRODCOM description
2 2-methylcyclohexanone 20146233
Cyclohexanone and methylcyclohexanones
Tetrachloroethylene (perchloroethylene)
20141374 Trichloroethylene tetrachloroethylene
(perchloroethylene)
3
4-(phenylamino)benzenediazonium hydrogen sulfate formaldehyde
(11) (Diazo)
20144420 Diazo- azo- or azoxy-compounds
Di-isononyl phthalate (DINP) 20143420 Other esters of orthophthalic acid
Impacts of REACH Authorisation Final Report
eftec November 2017 62
Figure 417 Production and import values as well as export value of ldquoCyclohexanone and methylcyclohexanonesrdquo ldquoDiazo- azo- or azoxy-compoundsrdquo and ldquoOther esters of orthophthalic acidrdquo
As Figure 417 shows PRODCOM data for these substances indicates no marked increase in the use
of alternatives (that were noted as a substitution for an SVHC) in the EU in the analysed time
period Based on the data analysis possible with publicly available PRODCOM data it is not possible
to infer what the effects of the authorisation process are on markets for identified alternative
substances to a previous use of an SVHC This is because PRODCOM in most cases combines
substances (similar in chemistry terms) together for confidentiality reasons so substances cannot be
assessed in isolation Data is also only available until 2015 so overall PRODCOM has not been
useful for this project Further work could be done in the future using the confidential version of
the PRODCOM but this was not made available to the project team for this project
Impacts of REACH Authorisation Final Report
eftec November 2017 63
48 Summary of observed market changes
According to CEFIC statistics the value of sales of the EU chemicals sector generally increased over
the period 1995-2012 with a significant dip in 2008 coinciding with the global financial crash Since
then the value of sales has declined slightly As a share of the global chemicals market however
EU sales declined over this period slowly until 2004 and more quickly since then Since 2008
exports have increased as a share of total sales in the EU chemicals sector but remain a minor (28)
proportion of the total
The best publicly available data on changes in substance volumes and sales values in the EU over
time was from Eurostat (PRODCOM) which showed that EU sales of SVHCs have generally followed
the same market trend as the overall EU chemicals market However limitations in the data means
it is not possible to assess as one might expect whether REACH Authorisation has led to a
reduction in EU sales of SVHCs and an increase in sales of alternative substances in line with the
goal of REACH to progressively replace SVHCs with suitable alternative substances or technologies
PRODCOM data were only available to 2015 and for some SVHCs most of the volume was used as
intermediate uses38 (which are exempt from Authorisation) For instance of Annex XIV substances
only 12-dichloroethane is in a PRODCOM category of its own but 99 of the use of this substance is
as an intermediate
There are a number of other factors why there has not been an apparent reduction in the market
for SVHCs Firstly substitution away from an SVHC can take time and it might still be too early to
observe changes in the EU market due to REACH Authorisation Secondly for some companiesuses
alternatives being tested may continue to prove to be unsuitable despite continued efforts to find
an alternative Finally for those uses where Authorisation has been granted (for a given review
period) there could be increased demandsales from the continued use of the SVHC after the
sunset date Overall this means that PRODCOM data are not suitable to observe any market
changes due to REACH Authorisation for only those uses of SVHCs that are subject to Authorisation
What is possible to note is that using REACH registration data as of November 2016 ECHA had
identified 103 registrants who have ceased manufacturing or importing a SVHC 69 of which
occurred to substances on the Candidate List (the remainder to Annex XIV substances)
One of the aims of the online survey for this study was to collect information on whether REACH
Authorisation is having a market impact (eg changes in sales prices demand and
competitiveness) Whilst the results can only provide a partial view of the EU market the
responses provide some interesting insights on the types and scale of impacts for individual
companies (rather than for the whole EU economy)
Most respondents (57) to the online industry survey indicated that they experienced lsquosignificantrsquo
market related impacts due to Authorisation for downstream user markets that use SVHCs but that
REACH Authorisation has not had a lsquosignificantrsquo impact yet on the market for known alternative
substances for SVHCs or alternative products made without an SVHC The main impacts were (i) a
reduction in the number of suppliers of SVHCs (ii) reduced availability of the SVHC for their use
(iii) an increase in the price of the SVHC and (iv) conditions being imposed on safe handling and
use of an SVHC Whilst respondents were only asked to indicate impacts due to REACH
Authorisation some of these impacts could also be due to requirements under REACH Registration
rather than solely due to Authorisation
38 REACH Article 3(15) Intermediate means a substance that is manufactured for and consumed in or used for
chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)
Impacts of REACH Authorisation Final Report
eftec November 2017 64
The online survey found limited cases of where companies have ceased production andor relocated
outside the EU This is in contrast to the existing literature which reports such risks However
given that all Authorisation applications to date have been granted (or recommended to be
granted) closures andor relocations due to REACH Authorisation are likely to be rare Just under
half of survey respondents did find that selling products made with SVHCs to EU companies was
ldquomore difficultrdquo but overall most respondents said REACH Authorisation had not had a significant
net impact on sales revenue (to date) The online survey also found evidence that REACH
Authorisation has led to an increase in RampD spending on finding an alternative to an SVHC but this
increase often diverts funds from other investment opportunities (eg in production capacity and
developing new markets) More detail on such market trends can be found in Section 4 of the main
report
Finally lsquominirsquo case studies were undertaken of diarsenic trioxide and arsenic acid and HBCDD The
market picture for the first two substances is complicated by the fact that significant proportions
of total use have been identified as intermediate by industry but not by ECHA Some disruption to
supply was reported in the arsenic acid market but the view expressed about diarsenic trioxide
was that the market was already on a downward trend due to earlier restrictions The HBCDD case
described a large-scale switch to an alternative with an authorisation to provide temporary
support to one use while supply capacity of the alternative increased It highlights the importance
of applying for a lsquobridgingrsquo Authorisation (eg 2 years) until it is possible for all users of HBCDD to
fully substitute to the identified alternative
Impacts of REACH Authorisation Final Report
eftec November 2017 65
5 INSTANCES OF SUBSTITUTION
51 Introduction
Substitution ie the progressive replacement of SVHCs with suitable alternative substances and
techniques is a key objective of Title VII of REACH In this context substitution does not simply
mean replacing one substance for another but in-line with the objective of Title VII it is to replace
the SVHC whether that is with another substance or a technique Whilst information about
substitution is revealed through applicants for authorisation (AfAs) where applicants request
continued use of an SVHC the authorisation process does not require companies to inform ECHA (or
any other regulatory authority) that they have substituted and no longer use an SVHC
A number of substances that have been identified as SVHCs within REACH also have had other
regulatory and policy pressures on them which will have influenced the activities of users of these
substances to identify and implement alternatives For example CMR are substances that are
classified under the CLP Regulation as carcinogens mutagens and reproductive toxins (CMR) and
are prohibited for use by consumers in mixtures via a restriction in Annex XVII Directive
200437EC (lsquocarcinogens or mutagens at workrsquo) sets out an obligation to replace carcinogenic and
mutagenic substances in the workplace and prevent exposure (if replacement is not possible the
employer shall use closed technological systems) Other more substance-specific legislation has
also brought pressure to replace specific substances for example under the POPs legislation (eg
HBCDD) by banning or severely restricting use and other use-specific legislation such as restricting
the use of hazardous substances in electrical and electronic equipment lsquoRoHSrsquo - Directive
200295EC (eg hexavalent chromium and polybrominated biphenyls)
As is apparent from AfAs submitted to date the replacement of a SVHC substance is a complex
process and is highly dependent on the technical requirements of the process in which the
substance is being used Nevertheless there has been a considerable amount of research on the
general principles of substitution from methodologies for assessing alternatives to analysis of
specific substance types and identification of substances with similar functional properties but less
hazardous profiles (eg solvents that have the desired solvation properties but that do not meet
the Article 57 criteria for SVHC)
In this context a number of research programmes that promote substitution by for example
provision of databases case studies and shared experiences have been reviewed The detail of this
review is in Annex E4 which is summarised in Section 52
Key sources of information are the Tier 1 and 2 case studies which look in more depth at the
impacts of authorisation for specific substances In addition the results from the stakeholder
questionnaires and follow-up interviews have yielded insights into substitution Where substitution
has occurred the data gathered has allowed an attempted assessment of the effects of substitution
including assessing whether substitution has led to an overall reduction in risk (or hazard profile)
and what impacts (both positive and negative) the use of the alternative has had on demand
production costs their competitiveness product prices worker satisfactionconditions ability to
invest in RampD and profitability of the company Further detail is set out in Sections 54 and 55
below The Tier 1 case studies are set out in Sections 10 11 and 12
Impacts of REACH Authorisation Final Report
eftec November 2017 66
52 Summary of literature review
A number of publicly available tools are available (via the internet) to support in substitution
activities The bullet points below indicate the tools and information sources that were reviewed
and a concise summary given more detailed explanations are given in literature review Annex E
(E4) While case studies resources and methodologies are very useful and allow a systematic
process to be followed the substitution of a SVHC will normally be a complex process In all but the
simplest cases it appears that considerable product testing is required as is the adaptation of
production equipment and processes
SUBSPORT (EU based) - httpwwwsubsporteu a free-of-charge multilingual platform
for information exchange on alternative substances and technologies as well as tools and
guidance for substance evaluation and substitution management
Lowell Center for Sustainable Production (USA based) -
httpswwwumleduResearchLowell-CenterChemicals-Materials-ProductsAlternatives-
AssessmentAlternativesAssessmentaspx - process for identifying comparing and selecting
safer alternatives to chemicals of concern (including those in materials processes or
technologies) on the basis of their hazards performance and economic viability It is
intended to support decision making for scientific market or regulatory reasons
National Academy of Sciences (USA based) - A Framework to Guide Selection of Chemical
Alternatives httpswwwnapeduread18872chapter1 - on line book covering and
reviewing a wide aspect of replacement of chemicals
OECD (international) summarises a number of guide and programme on the assessment of
chemical alternatives httpwwwoecdsaatoolboxorgHomeAAGuides - Includes reports
and programmes (including the Lowell Center and SUBSPORT)
Royal Society of Chemistry (UK) ldquoChemical Alternatives Assessmentsrdquo ndash Book (not free
access)
US EPA (US-based) - Design for the Environment Alternatives Assessments -
httpswwwepagovsaferchoicedesign-environment-alternatives-assessments - Web-
based tool with key steps to conducting an alternatives assessment and case studies
BizNGO (US-based) The Commons Principles for Alternatives Assessment -
httpswwwbizngoorgalternatives-assessmentcommons-principles-alt-assessment -
Web based principles and tools for alternatives assessment
In some cases tools were developed to select alternatives for specific products and uses An
example of such a tool is ldquoCleantoolrdquo CLEANTOOL (httpwwwcleantoolorghome-3das-
projektlang=en) started in 2001 as a European Innovation Project with the goal to create a
database of best practice for the cleaning of metal surfaces The tools support the selection of the
best cleaning alternative based on very specific properties of the use such as the parts to clean and
the dirt to be removed This tool illustrates that substitution is often a matter of details about
specific use in order to be successful
The more detailed documentation of the literature review that can be found in Annex E4 indicates
in more detail some of the resources that are publicly available to assist with substitution
However although the methodologies cited are detailed and present frameworks for planning
Impacts of REACH Authorisation Final Report
eftec November 2017 67
substitution programmes these do not make the technical process of substitution substantially
easier or remove the specific barriers to substitution (which are technical and economic and linked
to specific uses) Specific uses require further considerations and the apparent technical feasibility
of an alternative does not guarantee that it is economically feasible leads to an overall reduction
in risks and is available in sufficient supply
53 Survey responses
This section summarises survey findings regarding instances of substitution due to the REACH
authorisation process The analysis relies on data provided by 83 respondents
531 Evidence of substitution from SVHCs
Forty-three percent of respondents reported that their organisation had substituted (possible)
SVHCs (Table 51) Most of them (approximately 77) substituted due to the REACH authorisation
process while approximately 23 say they substituted as a result of other drivers A further 29 of
survey respondents reported that they had undertaken activities to investigate the possibility of
substitution
Table 51 Whether respondents substituted a (possible) SVHC (industry survey)
(n = 83)
Yes partly due to the REACH authorisation process 33
Yes but not due to the REACH authorisation process 10
No but we are aware of substitution in our supply chain 2
No but we are investigating possibilities to substitute 29
No 27
Total 100
Those respondents that reported that they had substituted a (possible) SVHC (ie 37 respondents)
provided 61 examples of substitution For each example respondents provided
The (possible) SVHC that was substituted
The usefunction of the substance
The alternatives that the substance was replaced by and
The number of years required to substitute illustrated in
Figure 51
Table 52 lists the (possible) SVHCs for which respondents provided examples of substitution in
conjunction with the related uses and alternatives mentioned by the respondents The table also
shows the number of examples given for each substance Chromium trioxide is the substance with
the highest number of reported examples of substitution (ie 7 examples) This is followed by 12-
dichloroethane and the category lsquoChromium VI Chromium ion (Cr6+) Hexavalent chromiumrsquo for
which five and four examples were provided respectively In terms of uses the use as solvent and
plating applications are the uses with the highest number of reported examples (ie seven and four
examples of substitution respectively) In most cases substitution took place in the form of
switching to alternative substances In fact only eight out of 61 examples reported a switch to an
alternative technology
Impacts of REACH Authorisation Final Report
eftec November 2017 68
Table 52 Instances of substitution ndash (Possible) SVHCs uses and alternatives (industry survey)
No Substance CAS number
Number of
examples
provided
Use of (possible) SVHC Alternative
1 12-dichloroethane 107-06-2 5 Softener for PVC
Solvent
Swelling agent
2-methylcyclohexanone
4-methylpentan-2-one
Alternative technology
Not stated
2 1-methyl-2-pyrrolidone 872-50-4 1 Solvent Not stated
3 2-(2H-benzotriazol-2-yl)-46-
ditertpentylphenol (UV-328) 25973-55-1 1 Stabiliser Bumetrizole
4
2-ethylhexyl 10-ethyl-44-
dioctyl-7-oxo-8-oxa-35-dithia-4-
stannatetradecanoate (DOTE)
15571-58-1 1 Stabiliser
2-ethylhexyl 10-ethyl-4-[[2-[(2-
ethylhexyl)oxy]-2-oxoethyl]thio]-4-
octyl-7-oxo-8-oxa-35-dithia-4-
stannatetradecanoate
5
4-(1133-
Tetramethylbutyl)phenol
ethoxylated
923-960-0 1 Surfactant Not stated
6 4-Nonylphenol branched and
linear na 1
Costabilizer for
plasticized PVC Triisotridecyl phosphite
7 Aluminosilicate Refractory
Ceramic Fibres (RCF) na 2
Insulation material
Protective heat insulating layer
Glass oxide chemicals
Not stated
8 Bis(2-ethylhexyl) phthalate
(DEHP) 117-81-7 2 Plasticiser
Di-isononyl phthalate (DINP)
Not stated
9 Bis(2-methoxyethyl) ether
(Diglyme) 111-96-6 1 Solvent Dimethyl sulfoxide
10 Bis(pentabromophenyl) ether 1163-19-5 1 Flame retardant Phosphinic acid PP-diethyl-
aluminium salt (31)
11 Boric acid 11113-50-1 2 Buffer substance
Plating Not stated
12 CC-azodi(formamide) (ADCA) 123-77-3 1 Smoke ammunition and
illuminating ammunition Alternative technology
Impacts of REACH Authorisation Final Report
eftec November 2017 69
No Substance CAS number
Number of
examples
provided
Use of (possible) SVHC Alternative
13 Cadmium 7440-43-9 3
Manufacture of solder
Plating
Protection of aerospace hardware
Alternative technology
Not stated
14 Chromic acid 7738-94-5
13530-68-2 1 Etching of copper
Disodium peroxodisulphate (Sodium
persulfate)
15 Chromium trioxide 1333-82-0 7
Anodising process
Anti-corrosive
Catalyst
Chrome plating
Electro-plating
Pre-treatment at colour-coating line
Not stated
2-ethylhexanoic acid chromium salt
Alternative technology
Sulphuric acid
Titanium
Not stated
16 Chromium VI Chromium ion
(Cr6+) Hexavalent chromium 18540-29-9 4
Chromate conversion coating
Decorative function
Plating
Chromium III
Not stated
17 Dibutyl phthalate (DBP) 84-74-2 1 Plasticiser Not stated
18 Hexabromocyclododecane
(HBCD) 25637-99-4 3
Flame retardant
Not stated
13 Butadienestyrene copolymers
Polymeric flame retardant
Not stated
19 Lead 7439-92-1 1 Manufacture of solder Alternative technology
20 Lead chromate 7758-97-6 2 Pigments Polymeric flame retardant
Not stated
21 Lead sulfochromate yellow 1344-37-2 1 Pigments Various lead-free pigments
22 Perboric acid sodium salt
10332-33-9
11138-47-9
12040-72-1
37244-98-7
1
Bleachbleach precursor
in consumer laundry
tablets and powder
Disodium carbonate compound with
hydrogen peroxide (23) (Sodium
percarbonate)
Impacts of REACH Authorisation Final Report
eftec November 2017 70
No Substance CAS number
Number of
examples
provided
Use of (possible) SVHC Alternative
23 Potassium dichromate 7778-50-9 1 Plating Not stated
24 Sodium chromate 7775-11-3 3
Descaling
Passivation of metals
Sensitiser in light-sensitive lacquer
4-(phenylamino)benzenediazonium hydrogen sulfate formaldehyde (11) (Diazo)
Alternative technology
Chromium oxide
25 Sodium dichromate 10588-01-9
7789-12-0 3
Passivation
Softener
Nitric acid
Not stated
26 Trichloroethylene 79-01-6 2 Degreasing parts in
manufacture
Solvent
Alternative technology
Tetrachloroethylene (perchloroethylene)
27 Trilead Dioxide Phosphonate 12141-20-7 1 Acid scavenger as part of stabilizer
Triisotridecyl phosphite
28 Not stated - 8
Passivation
Plastisiser
Solvent
Not stated
2-methoxy-1-methylethyl acetate
Not stated
Total 61
Notes The examples were provided by 37 respondents
Impacts of REACH Authorisation Final Report
eftec November 2017 71
Figure 51 presents the survey results with respect to the time that it took to substitute the
(possible) SVHC The quantitative results presented in the pie chart have been derived by excluding
the answer categories lsquoUnknownrsquo and lsquoNot statedrsquo (which together contain 12 examples) from the
analysis The figure is therefore based on 49 examples Most respondents stated that it took their
organisations between 1 and 4 years (53) or 5 and 10 years (27) to achieve substitution
Figure 51 Instances of substitution - Number of years to achieve substitution (Industry survey)
Notes The figure is based on 49 of 61 examples (excluding the cases for which respondents said lsquounknownrsquo or
did not provide an answer
Respondents who substituted possible (SVHCs) due to the REACH authorisation process (the first row
in Table 51) were asked about the stage of the authorisation process which triggeredconfirmed
the decision to substitute (see Q19 in Annex F5) The quantitative results presented below have
been derived by excluding the answer categories lsquoNot surersquo and lsquoNot applicablersquo from the analysis
(which account for 67 of all answers given to question Q19) As shown by Figure 52 most
respondents reported that their organisations had substituted after the screening and RMOA stage
and before the AfA stage whereby
29 of respondents stated that their organisations substituted when substances were
included in the Candidate List
23 when substances were recommended for inclusion in the Authorisation List and
25 when substances were included in the Authorisation List
Impacts of REACH Authorisation Final Report
eftec November 2017 72
Figure 52 Stage in the REACH authorisation process that triggered substitution activity
532 Evidence of activities to investigate substitution
Fifty-three percent of respondents (44 out of 83) reported that their organisation had undertaken
activities to investigate the possibility of substituting (possible) SVHCs These respondents provided
71 examples of such activities For each example respondents provided
The (possible) SVHC for which the possibility of substitution is investigated
The usefunction of this substance and
The substitution activities being carried out
Table 53 lists the substances for which respondents reported that they are investigating the
possibility to substitute in conjunction with the related uses reported by the respondents The table
also shows the number of examples provided for each substance Note that some of the
respondents that indicated they have substituted a use of an SVHC (previous section) may also still
be using the SVHC (ie for different uses) or are still using a different SVHC that they are also
seeking to substitute away from Therefore the total number of respondents that have substituted
(n=37) andor those actively seeking to substitute (n=44) should not be added together
As with examples of full substitution in the preceding section chromium trioxide is the substance
with the highest number of reported examples of investigations of substitution (ie 17 examples)
This is followed by the category lsquoChromium VI Chromium ion (Cr6+) Hexavalent chromiumrsquo with
five examples and boric acid and 1-methyl-2-pyrrolidone (NMP) with four examples each In terms
of uses the use as solvent (nine examples) anti-corrosive agent (eight examples) and plating
applications (five examples) are the uses with the highest numbers of reported examples
Table 53 Substitution activities - (Possible) SVHCs and uses (industry survey)
No Substance CAS
number
Number of
examples
provided
Use of (possible) SVHC
1 12-dichloroethane 107-06-2 1 Solvent
2 1-methyl-2-pyrrolidone
(NMP) 872-50-4 4 Solvent
3
2-(2-[4-(1133-
Tetramethylbutyl)phenoxy]
ethoxy)ethanol
9036-19-5 1 Emulsifier
Impacts of REACH Authorisation Final Report
eftec November 2017 73
No Substance CAS
number
Number of
examples
provided
Use of (possible) SVHC
4
2-[4-(244-
trimethylpentan-2-
yl)phenoxy]ethanol
9002-93-1 1
Cell lysis during manufacturing
of vaccines and cleaning of
manufacturing equipment
5 44-isopropylidenediphenol
(bisphenol A) 80-05-7 2
Used in epoxy resins
Not stated
6 44-methylenebis[2-
chloroaniline] 101-14-4 1 Curing agent
7 Aluminosilicate Refractory
Ceramic Fibres (RCF) na 1 Insulation
8 Aprotic polar solvents on
the Candidate List na 1 Solvent
9 Bis(2-ethylhexyl) phthalate
(DEHP) 117-81-7 1 Component in glue
10 Boric acid 11113-50-1 4 Buffering agent
Micronutrient in biological fermentation processes
11 Cadmium 7440-43-9 1 Protection of aerospace hardware
12 Chromates na 1 Anti-corrosive
13 Chromic acid 7738-94-5
13530-68-2 1 Decorative function
14 Chromium trioxide 1333-82-0 17
Anti-corrosive
Catalyst
Conditioning and electroplating
Decorative function
Passivation
Plating
Reaction inhibitor
Surface treatment
Wear resistance
Not stated
15
Chromium VI Chromium
ion (Cr6+) Hexavalent
chromium
18540-29-9 5
Anti-corrosive
Decorative function
Plastic etching
Plating
Not stated
16 Cobalt dichloride 7646-79-9
7791-13-1 1
Micronutrient in biological fermentation processes
17 Cobalt salts - 1 Anti-corrosive
18 Disodium tetraborate
anhydrous
1303-96-4
1330-43-4
12179-04-3
2
Brazing flux
Used in smelting to increase fluidity
19 Hexabromocyclododecane
(HBCD) 25637-99-4 1 Flame retardant
20 Hexahydromethylphthalic
anhydride 25550-51-0 2 Hardener
21 Hydrazine 302-01-2
7803-57-8 2 Reduction agent
Impacts of REACH Authorisation Final Report
eftec November 2017 74
No Substance CAS
number
Number of
examples
provided
Use of (possible) SVHC
22 Lead 246-trinitro-m-
phenylene dioxide 15245-44-0 1 Used in pyrotechnic mixtures
23 Lead chromate 7758-97-6 1 Used in pyrotechnic mixtures
24 Lead monoxide 1317-36-8
7439-92-1 1 Additive to increase refractive
index
25 Lead oxide 1335-25-7 2 Component of a glass paste
Solvent
26 Lead titanium zirconium
oxide 12626-81-2 1 Manufacture of electronic
components
27 NN-dimethylacetamide 127-19-5 1 Solvent
28 NN-dimethylformamide 68-12-2 1 Solvent
29 Nickel sulphate 7786-81-4 2 Anti-corrosive
30 Nonylphenol 25154-52-3 1 Component in glue
31 Nonylphenol ethoxylates 9016-45-9 2 Emulsifier
Used in epoxy resins
32 Orange lead 1314-41-6 1 Used in pyrotechnic mixtures
33 Sodium dichromate 7789-12-0
10588-01-9 3
Additive for suppressing parasitic reactions and oxygen evolution pH buffering and cathode corrosion protection
Passivation
Process chemical
34 Not stated Not stated 3 Coatings
Not stated
Total 71
Notes The examples were provided by 44 respondents
Figure 53 shows that for most examples of substitution activities respondents reported that their
organisation had undertaken RampD activities to investigate substitution (55 of all examples)
Among those engaging in RampD activities a few reported that they are testing alternative
technologies or using alternative substances to continue to make the same product In 11 of
reported cases the organisations are currently in the process of product testing and requalification
of the products that will be made with alternative substance andor technology In a further 20 of
cases respondents were in the final stages of substituting a (possible) SVHC but had not completed
the process yet
Impacts of REACH Authorisation Final Report
eftec November 2017 75
Figure 53 Substitution activities ndash Types of activities undertaken (industry survey)
Notes This figure refers to 71 examples
Respondents who indicated that they were investigating the possibilities to substitute SVHCs were
asked about the stage of the REACH authorisation process which triggeredconfirmed these
activities (see Q60 in Annex F5) The quantitative results presented below have been derived by
excluding the answer categories lsquoNot surersquo and lsquoNot applicablersquo from the analysis (which account
for approximately 75 of all answers given to question Q60)
43 of respondents stated that the decision to investigate substitution originated when the
substances were included in the Candidate List39
27 when substances were recommended for inclusion on the Authorisation List and
11 when substances were subject to applications for authorisation
533 Drivers for substitution
This section presents information about the drivers for substitution based on the results of two
questions from the online industry survey
Respondents who indicated that they had substituted SVHCs or had been investigating substitution
through preparatory activities were asked to choose the three main reasons motivating them to
substitute a (possible) SVHC andor engage in activities investigating the possibility of substitution
out of a given list (Q62 in Annex F5) Figure 54 reports the number of respondents (out of 61) that
chose the respective reason as one of their top three reasons The figure shows that the top two
reasons for substitution activities selected by respondents are both related to the REACH
authorisation process (one option was the REACH authorisation process the other related to the
need to assess the suitability of possible alternatives as part of an AfA) The third most selected
factor for respondents whose organisations substituted was the REACH regulation in general (ie
not limited to the authorisation process) For respondents who did not (necessarily) substitute due
39 This is consistent with anecdotal evidence from the REACH 2012 report reported in Section 432 that ldquothe
placing on the Candidate List can lead in some cases to the launch of initiatives to develop new substances
or to the reformulation of existing substancesrdquo
Impacts of REACH Authorisation Final Report
eftec November 2017 76
to the authorisation process the fourth most selected factor was due to new opportunities in the
market using an alternative
Overall 33 of respondents indicated lsquoother reasonsrsquo as one of their top three reasons to substitute
or investigate substitution Some of the reasons mentioned were (i) business continuity (as the
company would then not have to worry about applying for authorisation) (ii) company internal
policies to phase out SVHCs (iii) internal company policies regarding the safety of workers and (iv)
requests by customers to transition to safer alternatives
Figure 54 Drivers of substitution activities (industry survey)
Note This figure shows the number of respondents (out of 61) that chose the respective reason as one of their top three
reasons for substituting or engaging in activities investigating the possibility to substitute
The respondents that did not engage in any substitution activities were asked to choose their three
main reasons for not carrying out any substitution activities out of a given list (Q64 in Annex F5)
Figure 55 reports the number of respondents (out of 21) that chose the respective reason as one of
their top three reasons The figure shows that the top reason that prevented respondents from
substituting SVHCs was the lack of technically feasible alternatives to deliver similar end-user
requirements This was followed by the lack of lsquonewrsquo alternatives worth investigating and financial
constraints and losing a competitive position in the market compared to those who continue to use
the SVHC
Approximately 24 of respondents chose lsquoother reasonsrsquo as one of their top reasons The reasons
they provided are (amongst others) that the substitution process was covered by the RampD program
of their partner (not them) and another noted that the identified alternative substance was
deemed equally hazardous for human health andor the environment A further reason mentioned
by one respondent is that the organisation applied for authorisation as a precautionary measure as
the organisation considers its use as an intermediate while ECHA did not
Impacts of REACH Authorisation Final Report
eftec November 2017 77
Figure 55 Barriers to substitution (industry survey)
Note This figure shows the number of respondents (out of 21) that chose the respective reason as one of their top three
reasons for not carrying out any substitution activities
54 Tier 2 Case studies
The tier 2 case studies provide further insights to the process of substitution as well as indicate the
drivers for those substitutions happening outside of the AfA process
During this study in addition to the online survey 49 interviews were conducted with various
stakeholders One of the focal points of these interviews was the lsquosubstitution strategyrsquo of the
stakeholders Twenty-seven of the companies interviewed were downstream users andor
applicants (both those that submitted an AfA or were covered by an AfA made by their supplier)
Three interviewees were suppliers of alternative substances or technologies NGOs were also
interviewed and provided their view on the barriers to substitution Nine industry associations were
interviewed who provided a wider view on the substitution issues of their members
NGOs expressed their concern that the authorisation process by itself could be a barrier to
substitution for companies that are granted authorisation their incentive to use alternative
technology will be low which slows down the introduction of new technologies Although this could
be correct in some cases (assuming that the timelines for introduction of alternatives in the AfA
AoA are exaggerated) interviews with other stakeholders showed that in several cases substitution
took place despite there being a case for applying for authorisation instead (see case studies 1 and
3 in this section)
Substitution can occur in the context of an application for authorisation or in absence of an
application for authorisation The first type of substitution (ie within the AfA process) can be
found within the substitution plans where the adequate control route is possible or within the
development plans (or something referred to as RampD plans) mentioned in the context of an applied
for use scenario under the SEA route These plans are discussed in the next section As such these
plans do not automatically lead to substitution as in most cases the feasibility needs to be
demonstrated (ie both lab testing and then pilot testing as well as end-usercustomer
testingapproval) but they provide some insight into how companies are considering substitution
The latter type of substitutions (ie in the absence of an AfA) are actual cases where SVHCs have
been substituted so no AfA was necessary These instances are difficult to find (ie in the public
Impacts of REACH Authorisation Final Report
eftec November 2017 78
domain) as they remain largely undocumented and are sometimes confidential Examples of both
types of substitutions are provided in this section
From the interviews it is clear that while the decision to substitute is case-specific it is driven by
some common considerations Overall the number of well documented cases of early substitutions
(that could be found) is limited Several companies indicated that a lot of substitution had been
done in the past but they were not able to provide much detail in the limited time context of the
interviews (for example because people change in the company and it is difficult to find details of
historical cases of substitution ndash However given many of these instances are prior to REACH
authorisation they are not relevant to document as part of this study)
Overall concerns that suggest that authorisation itself is a disincentive to substitution (because it
allows time-limited continued use rather than imposing blanket bans and forcing substitution)
would seem to be not well founded since the AoA forces the justification of continued use inter
alia on the basis of having done an assessment of possible alternatives and justifying why they are
not suitable
Further details of nine examples (cases) of substitution are presented below
Case 1 Use of a hexavalent chromium (CrVI) containing catalyst in a catalytic waste gas
treatment installation
This case relates to a production site of a large company active in life sciences The company
operates a large specialty chemicals manufacturing site Waste gases from the various production
installations were collected and used to be treated by a waste gas installation using a CrVI based
catalyst to destroy the hazardous substances present in the waste gas The installation was
essentially a closed-process installation with no operational exposure of workers during the use of
the substance Very limited exposure was only possible during loading and unloading of the catalyst
(an activity that did not happen every day)
When the CrVI based substance present in the catalyst was listed on Annex XIV the supplier of the
catalyst announced that the catalyst would no longer be supplied after the sunset date As a result
of this the company (a downstream user) using the catalyst started a programme to find a solution
for the problem that future supply of the catalyst would no longer be available from their supplier
Alternative catalysts were evaluated but failed technically because of the complex nature of the
waste gas stream A solution was found in an alternative technology called lsquoregenerative thermal
oxidizerrsquo Using this technology waste gases are burned with energy recovery (heat) This
technology provides the same level of emissions reduction of the hazardous substances in the waste
gas as the previous technology that used the CrVI based catalyst The investment cost for this new
installation was about euro11 million The new installation has a marginally lower operating cost of
euro100k per year The company did not consider or realise the option to import the catalyst directly
and to apply for authorisation themselves even though this solution would probably have been
cheaper
Because of the criticality of the waste gas treatment in the operation of a key production
installation relocation of the waste gas treatment or to stop processing the waste gas treatment
were both not a viable option As a result the high net cost of the replacement of the existing
installation was deemed necessary
In this example the main drivers for the substitution were
The identification and availability of a technically feasible alternative technology
Impacts of REACH Authorisation Final Report
eftec November 2017 79
Avoidance of using an Annex XIV substance and
Absence of another solution given their supplier ceasing supply of the catalyst (based on an
SVHC)
Case 2 Use of hexavalent chromium (CrVI) based acids for the plating of aluminium profiles
The authorisation requirement for CrVI containing substances such as chromium trioxide has proven
to be complex Several AfAs were made including large consortium driven applications small group
applications and individual downstream user applications However during several interviews it
was clear that several companies had substituted the use of substances such as chromium trioxide
prior to the sunset date and did not needhave to rely on an authorisation
An interesting case is the use of CrVI based substances as anti-corrosion coating for aluminium
profiles in the construction sector This industry is represented in the EU by ESTAL ESTAL
communicated to its members that authorisation for their use of CrVI would be difficult because of
the existence of alternatives The existing alternatives were known to be technically inferior to the
CrVI based solutions but it was presumed that this would not be sufficient to prove that an
authorisation should be granted
Based on this information a manufacturer of window frames assessed their specific situation and
decided not to apply for authorisation and decided to search and develop alternative technologies
for the anti-corrosion treatment of the aluminium profiles This decision was made knowing that an
upstream application was being prepared which could cover their use and would be a cheaper
option Because there has been no final decision yet on this upstream application and the
application was not made by this company it cannot be concluded if this is an instance of a
lsquoregrettable substitutionrsquo or not
In general this industry tends to be conservative regarding the replacement of anti-corrosion
technology Because without a proper anti-corrosion treatment parts of a window frame can
corrode causing blistering of the final lacquer coating Premature corrosion of window frames can
lead to significant customer complaints including consequential damage
A first type of alternative technology consisted of a Cr-free application of a very thin coating The
exact composition of the coating is confidential including to the aluminium plater This technology
was implemented based on a known technology but significantly improved by in-house
development The technology provides only a very thin and mechanically not very resistant anti-
corrosion layer Storage of the parts between the application of the anti corrosion layer and the
application of the final coating potentially can damage the thin anti corrosion layer Any damage of
this layer leads to a premature failure of the final product As a consequence the coated parts
cannot be stored between the anti-corrosion layer and the final coating Changes to the production
facilities and production procedures were required to accommodate this A second disadvantage of
this technology is its dependence on the quality of the base material as it is known that impurities
in the base material (specifically traces of iron) strongly affect the end result Because of the high
level of recycling of aluminium the possibility for iron contamination is high As a result the
company had to issue more stringent specifications for its raw material resulting in a slight price
increase (lt5) However this specification excluded sourcing the aluminium from the recycling
stream The processing cost for the alternative process is roughly the same as for the original CrVI
based process
To implement the alternative significant investments were required including for the on-line
process control Compared to the CrVI based process this alternative process is less robust and is
more sensitive to small variations in process conditions
Impacts of REACH Authorisation Final Report
eftec November 2017 80
A second alternative implemented by this company is a totally different process called lsquopre-
anodisationrsquo or lsquoanodicrsquo oxidation This technology allows an even higher corrosion protection
compared to the CrVI coating but has doubled the operating cost This technology is very robust
and tolerates iron impurities in the raw material The total investment made by this company to
implement both alternatives was euro3-4 million
Having implemented the two types of technology the manufacturer has mixed feelings On the one
hand substitution was more or less standard for this kind of application (aluminium coating in
construction sector) but there is still an AfA pending which would allow certain competitors to
avoid the investment It would be worth investigating in the future customer experiences with the
alternative technology
In this case the drivers for the substitution were
Based on a ESTAL communication that authorisation would not be possible
Availability of a known alternative technology with short development time
Control over raw material specifications and
Business model which allows absorption of the additional cost
Case 3 Use of an SVHC in the high-tech life science sector
This case concerns two companies considering relocation of their business to outside of the EU as a
direct consequence of the authorisation process The two companies use different SVHCs that were
at the time of the interviews in different phases of the authorisation process40 namely 12 DCE
(12-dichloroethane) and octyl phenol ethoxylate
Octyl phenol ethoxylate is a frequently used substance in the life science sector For instance in
this case it is used in the manufacturing of in vitro diagnostics kits Several manufacturers have
asked for clarification whether this use of octyl phenol ethoxylate would be exempt for
authorisation on the basis of the SRampD use of these kits This has been requested from the
authorities but they were unable to provide clear responses immediately As a result this company
immediately started to evaluate alternatives The volume of this substance required in this use is
small (less than 500 kg per year) The amount of octyl phenol ethoxylate present in the diagnostic
kits the end product is even smaller Nevertheless the exemption does not apply for their
particular case this company would have to look for an alternative or be required to apply for
authorisation The search for an alternative to the use of octyl phenol ethoxylate would in this case
require extensive scientific and development work (meaning there is no suitable alternative
available yet)
The 12 DCE is used in a high tech genetic engineering related technology The manufactured
product uses 12 DCE as solvent in volumes even smaller than the previous example (ie lt20 kg
year) The company with headquarters outside of the EU sees the authorisation process as a
complex process with no assured outcome The use conditions of the 12 DCE are cleanroom and lab
type of conditions with a very limited number of people involved and highly controlled conditions of
use Also in this case a search for alternatives would require extensive scientific and development
work (meaning there is no suitable alternative available yet)
40 More recently Otylphenol ethoxylate has been listed in Annex XIV
Impacts of REACH Authorisation Final Report
eftec November 2017 81
For both cases there are two common elements a lack of alternatives and regulatory certainty In
general these types of industry have a small physical size and can relatively easily (at least
compared to a large chemical site) be relocated
In one of the two cases it was decided not to apply for authorisation and to relocate this part of
the production (to outside the EU) In the other case the relocation option was being evaluated but
a decision was still pending at the time of interview In any case a project for a ldquocomplex and
costlyrdquo application for authorisation was not considered although for both cases the case for
authorisation would seem to be strong
For these two cases the main drivers for relocation are
Legal uncertainty
Lack of a technical alternative and
Realistic to relocate whole production outside of the EU
From consultation for this project it is known that the application and granting of patents in the
pharmaceutical industry for innovator based companies (ie companies that produce new products
under patent) is a critical factor The granting of a 25-year patent allows innovator companies to
make profit on products that no-one else can produce Therefore the optimisation of the patent
relies on applying for patent as late as possible in the product development process The
manufacturing process is included in the patent and changes to the process would require a new
patent to be applied for In the cycle of product development the closer the product gets to the
market the more investment is made (clinical trials are very expensive) Therefore unless SVHC
replacement can be made at an early stage in product development or review periods can be long
enough to cover the patent period an option will be to push production out of the EU to other
facilities (however if production facilities outside the EU do not already exist but they do in the
EU then the cost of development of those facilities can be prohibitively expensive)
Case 4 Regulatory burden as decision element
To illustrate that substitution of a substance is a result of many factors a case of a company
active in life sciences using an octyl phenol ethoxylate for two different purposes (uses) is
summarised here For both uses the required volume of the substance is low the use conditions are
very highly controlled and no suitable alternative is available at present However for one use
the substance is in direct contact with the final product and in the other use of octyl phenol
ethoxylate it is not The regulatory burden linked to substitution is different for the two different
uses because in one case there is a need to re-apply for marketing authorisation in the other case
not This was crucial in the decision-making process of the company to attempt to find a substitute
for one use (ie the one with the lowest regulatory burden) and to apply for authorisation for the
other use In fact even if a technically suitable alternative would be available it would be
impossible to obtain the regulatory approval before the sunset date required as a result of the
process change to continue to put the product on the market
Although as far as emissions are concerned the cost of the substitution most probably outweighs
the benefits of the non-use scenario in both cases only in one case the company decided to apply
for authorisation In the other case substitution was preferred even at a cost significantly higher
than the cost for an application for authorisation The reason for this mentioned by the company
was to avoid the perceived administrative and resource burden of the authorisation process and
the high likelihood to find an alternative before the sunset date
Impacts of REACH Authorisation Final Report
eftec November 2017 82
In this case the drivers for substitution were
Their ability to find and implement a suitable alternative prior to the sunset date and
Avoiding the authorisation process
Case 5 GreenCoat using an alternative technology for CrVI surface coating
The company GreenCoat uses an alternative technology to surface treat articles which does not
use Cr(VI) The technique is based on PVD (Powder Vapour Deposition) The company did not
develop the technology but has purchased it As such the company has the same role as a contract
plater using CrVI has today in the supply chain So far the company has invested about euro10 million
in this technology The company focuses on developing projects within the automotive industry for
the surface treatment of parts as this sector represents for them by far the biggest potential
market Developing this market opportunity takes about 9-12 months including process optimisation
and testing as the process needs to be repeated for each automotive part and for each car
manufacturer
An important step for further development of this market was the development of a specification
for PVD coated parts for the automotive industry This specification replaces a previous
specification for CrVI based surface treatment which was used to evaluate PVD coating Experience
has shown that in certain cases PVD coating has a clear advantage over CrVI based coatings This
advantage is related to a wider variety of base materials which can be used for PVD coating This
can for instance result in a cost saving - if cheaper base materials are used - or design
improvements - if high performance materials are used - allowing more complex designs
According to GreenCoat their technology could also be implemented in the sanitary industry
Although GreenCoat supplies their products to this market since 2013 the collaboration with the
sanitary industry seems today more difficult GreenCoat recognises that PVD coating is not a full
alternative for all CrVI based coatings but claims that for certain applications it is a real
alternative
Because of the lengthily process of introducing new PVD coated parts (for instance in the
automotive sector) the required build-up of capacity and the current price difference GreenCoat
expects that both technologies ndash CrVI based and PVD coatings - will coexist for the next 12 to 15
years This is an example where the authorisation process in principle can create new market
opportunity for new technologies in well established markets (where substitution may not have
happened without regulatory scrutiny on CrVI) However for comparison the companyrsquos turnover
is euro10 million whilst the total business volume for the automotive sector for surface coating is euro 1
billion (meaning they can only provide for a small part of the current market) However because of
the technical advantages and the expected cost reductions the company sees the replacement of
CrVI coating with PVD coating as a typical case of competing technologies The fact that
authorisation was applied for chromium VI coating does not affect the development of the business
significantly
In this case the drivers for the emergence of a CrVI alternative technology are
REACH authorisation
Technical feasibility of the alternative resulting in specific technical Specifications and
Certain technical advantages from using this alternative technology
Impacts of REACH Authorisation Final Report
eftec November 2017 83
Case 6 Yara
Yara France used diarsenic trioxide as a processing aid to activate the absorption and desorption of
carbon dioxide by potassium carbonate from synthesis gas which is used for the production of
ammonia at its site in Le Havre France The diarsenic trioxide additionally served as a corrosion
inhibitor in the process Diarsenic trioxide was previously used as it was effective in the process of
carbon dioxide stripping energy efficient clean and compatible with the comparatively low
pressures at which the Yara Le Havre site operates The Le Havre Yara operation is a 247 continual
process which held 40 tonnes of diarsenic trioxide circulating in a closed system Per year around
five tonnes were added to the system as the process is in principle catalytic but as with all such
reactions not 100 efficient
In response to diarsenic trioxide being made subject to authorisation Yara France explored
alternative physical and chemical solvents A water-based process was said to have the advantage
of being a simple process using a solvent which is not reactive with other trace constituents and
which does not introduce nitrogenous vapours into the gas stream However the carbon dioxide
partial pressure at the Le Havre installation is sufficiently low that the amount of solution required
to absorb the same amount of carbon dioxide is twice that required with chemical solvents making
the physical solvent solution incompatible with the Yara Le Havre process Using water would also
increase hydrogen contamination while other physical solvents would require the introduction of
an additional drying unit
Yara also considered switching to a process based on an amine chemical solvent This was
considered technically and economically challenging since it would require significant changes to
the existing installation costing euro20m over seven years or longer However using the existing
process but two alternative substances as activators and vanadium pentaoxide as a corrosion
inhibitor was found to have several advantages over the current diarsenic trioxide-based process
and other alternatives These included lower energy requirements lower corrosion inhibitor use
cleaner and smoother production and lower health and safety requirements
However switching to the vanadium pentaoxide-based alternative was estimated to take until the
end of March 2017 22 months after the sunset date for diarsenic trioxide The only viable solution
to this transition in case the company were not submitting an application would be complete
closure of the plant by the sunset date Yara therefore submitted an application for authorisation
to continue their use of diarsenic trioxide for 22 months after the sunset date including planning
necessary for substitution to a vanadium pentaoxide alternative
The discussion within their application concerning the time required to substitute makes it clear
that the substitution of diarsenic trioxide had already been considered early in the REACH process
(and possibly before) as part of an overall evaluation of the future of the plant A switch to an
amine-based process had originally been considered most cost-effective but further analysis in
2013 revealed that such a switch would be far costlier and technically complicated than originally
thought It was then that the vanadium pentaoxide option was evaluated and ultimately approved
The costs of implementing the switch were implied to be around euro4m (one fifth of the costs of
implementing the amine alternative) but a full net present value including energy efficiency and
other savings was not provided in the authorisation application
Contacts were made with Yara but it was not possible to discuss this substitution further with them
Impacts of REACH Authorisation Final Report
eftec November 2017 84
Case 7 Fine Chemicals company
The company in this case has a large portfolio of products that they manufacture in different
countries The regulatory constraints are managed and the use of very hazardous substances in
manufactured substances or used raw materials is tracked proactively Because of this proactive
process this company was in the past able to substitute several chemicals in a timely manner
Three examples were provided
In the first example the RampD to replace the substance started when the substance appeared on the
Candidate List The main reason for going ahead with the substitution rather than applying for
authorisation was that the AfA process was considered as an uncontrollable risk as there was no
guarantee of continued use for the foreseeable future This was because the substance is a PBT and
it was unclear to this company how a justification for continued used could be developed (given
there is no widely accepted way of valuing the risks associated with the use of a PBT substance)
Although the substance is still not on Annex XIV the use of the substance has been discontinued
and substituted by a structurally similar substance which does not meet the PBT criteria
The second example concerned a substance not on the Candidate List but recognised as a PBT and
on the CoRAP list for several other properties such as being an ED The substance was used as
additive to polymers The replacement of this substance only took six months A key driver here
was the fact that a technical alternative was available and the outcome of a possible authorisation
application was uncertain
The last example related to the use of Nonyl phenol in an imported mixture The total use volume
was fairly low (2 tpa) Although an alternative was known their customer did not want to pay for
the additional cost for the use of the alternative However the company did not want to be
associated with the sale of this SVHC and as a result authorisation was not considered and the
marketing of the substance was stopped
The common driver for substitution in these cases are mainly the proactive management of the
Chemical substance inventory in order to identify in a timely manner the possible options for
substitution and start-up research for alternatives at an early stage
Case 8 replacement of TCE by PER
In this case a company active in the aviation sector was using TCE as a metal degreasing solvent
Because of the low level of technology used for exposure control it was clear that authorisation
would not have been possible for the use An alternative provided by a solvent supplier proved to
be very expensive and a cheaper solution was sought
The alternative found was tetrachloroethylene (PER)41 This choice was made after the conclusion
of substance evaluation for PER stating that there was no need for further regulatory follow-up
Because of the low boiling point of PER new equipment was developed in collaboration with a
supplier The investment cost for the new equipment is estimated to euro1 million However because
of the lower emissions the solvent use is lower hence a lower operational cost was achieved (from
41 It is worth noting that several TCE AfA applicants viewed PER as not being a suitable alternative given it has
health and environment concerns (albeit less toxic than TCE) which could mean PER being subjected to further
regulatory scrutiny in the future However that is not to say other previous uses of TCE that did not apply for
authorisation may also have switched to PER (see Chapter 11)
Impacts of REACH Authorisation Final Report
eftec November 2017 85
euro60kyear to euro2kyear) This solution was evaluated positively to the extent that other degreasing
solvents used (kerosene) will also be replaced by the use of PER
The key drivers for this substitution are
availability of a technically suitable alternative and
Reduction of operational costs
Case 9 Substitution of diarsenic trioxide in artistic glass-making in Murano Italy
As reported in Section 45 the use of diarsenic trioxide in the production of artistic glass was
claimed intermediate by industry but assessed as a processing agent (ie non-intermediate) by
ECHA No application for authorisation was received for this use from the artistic glass sector ECHA
(2017) subsequently produced a report on the use and substitution of diarsenic trioxide in the
artistic glass sector of the Murano area of Italy and this section cites this report42
Raw materials used in glass manufacture include silica sands sodium and potassium carbonate and
others Other substances may be added to glass during manufacturing as matrix builders melting
agents stabilisers refining agents and colourants Diarsenic trioxide is used in glass manufacturing
as refining agent added mostly to remove bubbles The substance was included in Annex XIV of
REACH with latest application date 21 November 2013 and the sunset date 21 May 2015
In early 2015 local authorities began checking how authorisation obligations for diarsenic trioxide
were being handled by Murano glassmakers The glassmakersrsquo position was that their use of
diarsenic trioxide was exempt from authorisation on the grounds of being an intermediate Local
authorities supported by the Ministry of Health (Italian Competent Authority for REACH and CLP)
and ECHA concluded that the use of diarsenic trioxide as a refining agent in the manufacture of
Murano glass could not be considered intermediate and enforcement inspectors advised
glassmakers that their use of the substance after the sunset date should cease because neither EU
manufacturers nor glassmakers (downstream users of the substance) had applied before the latest
application date for authorisation to continue In September 2015 the REACH authority of the
Veneto region (having jurisdiction over Murano) decided to create a working group to monitor the
use of diarsenic trioxide in Murano glass manufacture The group was made up of members of the
Italian CA the regional environmental agency and the local control authority on REACH The action
plan of the working group included
An information campaign for local glassmakers about the ban to use of diarsenic trioxide in
glass production and
A control and inspection plan aimed to check if diarsenic trioxide was still being used after
the sunset date and to monitor levels of diarsenic trioxide in the environment
The working group began by gathering information on companies involved in glass manufacture in
the area Information from the chamber of commerce and the worker insurance institute indicated
that there were about 300 companies operating in the sector in the Veneto region This information
was integrated with data obtained from the major local distributor of diarsenic trioxide showing
that in 2013 about 24 companies in that area were using in total around 5 tonnes of diarsenic
trioxide per year
42 ECHA (2017) Artistic glass manufacturers in Murano Italy substituted arsenic trioxide to safer alternatives
air concentrations of arsenic reduced by 98 in two years Helsinki ECHA
Impacts of REACH Authorisation Final Report
eftec November 2017 86
An information sheet on the regulatory status of diarsenic trioxide and a questionnaire were
prepared and sent to all these companies by the working group Responses to the questionnaire
showed that 104 companies operate in the field of artistic glass 18 of which indicated that they
had used diarsenic trioxide until 2014 but had since switched to antimony trioxide cerium oxide
lithium oxide andor blast furnace slag Use of these substances implied a change in the process
conditions and substances were used individually or in combination
Nine workplace inspections were undertaken by local enforcement authority between December
2015 and May 2016 One artistic glass manufacturer was found to be using diarsenic trioxide in
breach of REACH ie without an authorisation for its use Other inspected companies had replaced
diarsenic trioxide with other substances instead of applying for authorisation
The Veneto environmental protection agency monitored the level of arsenic in air in the Murano
area over the periods June-November 2014 SeptemberndashNovember 2015 and JulyndashDecember 2016
The data from the environmental monitoring stations (located in the neighbourhood of the primary
school of Murano) showed a significant decrease in arsenic levels (see Table 54) Concentrations
were found to have dropped from over 200 ngm3 to 4 ngm3 being in 2016 below the annual limit
of 6 ngm3 for arsenic which is the target value of the EU as agreed in Directive 2004107EC on
arsenic cadmium mercury nickel and polycyclic aromatic hydrocarbons in ambient air and
implemented by Italian Legislative Decree 155201043
Table 54 Average air concentrations of arsenic at the Murano environmental monitoring station 2014-16
Reference period Average arsenic concentration (ngm3)
June-November 2014
September-November 2015
JulyndashSeptember 2016
OctoberndashDecember 2016
2347
110
5
39
No information on the costs of switching to these alternative substances is available
55 Applicants ndash Future possibilities to substitute
In this section some cases are documented where applicants indicate future substitutions in the
public versions of their application for authorisation These developments are documented in the
AfA as RampD plans Table 55 shows to what extent these plans are included in AfAs
Table 55 RampD plans included in AfAs
Plan to substitute away from the SVHC No of Uses (AoAs) (All
substances)
Plan included 62
Plan referred to 34
No clear plan 71
Formulation uses (no plan expectednecessary) 19
Total 186
Table 55 shows for all AfAs considered (total of 111 up to end December 2016) whether the AoA
indicated a plan for how to make the non-suitable alternative suitable (ie an lsquoRampD planrsquo since a
43 Legislative Decree No 155 of 13082010 ndash conversion into Italian legislative system of Directive 200850EC
concerning air quality in Europe httpwwwcameraitparlamleggideleghe10155dlhtm
Impacts of REACH Authorisation Final Report
eftec November 2017 87
lsquosubstitution planrsquo is only relevant for AfA for SVHC in the adequate control route) Where a plan
was lsquoincludedrsquo that was where there was a clear indication and time line showing how a possible
alternatives would be identified and the steps that would be needed to introduce that including
time and actions for product acceptance by customers Where a plan was lsquoreferred torsquo this was a
less definite plan but that there was an indication of time and steps (actions) needed to justify the
review period applied for For lsquono clear planningrsquo this was where the public version of the AfA did
not indicate a plan and action and timings were not at all clear in the AfA
The quality of information within AfAs presented to date is variable (although no opinions
recommended not to grant authorisation) and as noted in Table 55 it is reported that 34 of AfA
presented a clear RampD plan 18 referred to a plan and 38 presented no clear plan at all Some of
this information may have been provided by the applicant confidentially as part of the AfA or
submitted post submission of the AfA (eg in responses to a RACSEAC question) but based on
publicly available data this suggests that even in an AfA (where there is an obvious need to
specifically consider the adoption of alternatives) overall there is not enough clear documentation
of how alternatives could be made suitable and available
In the following examples some of these plans are summarised and the key success factors or
drivers to develop such plans are indicated
Case 1 Use of TCE in a cloth dye process
The company uses trichloroethylene (TCE) in the manufacturing of a dyed textile The specific dye
process requires a wax which has to be removed from the cloth during the process For this
purpose a solvent with specific properties is required Several solvents were tested but except
PER which was considered at that point in time nearly as hazardous (the decision of the CoRAP was
not available at the time of submission of the dossier) none provided a technical solution The
company however identified a different solvent technology as a potential alternative for the use
of TCE This technology using so called switchable solvents has as only alternative the potential to
provide cost savings by eliminating the solvent evaporation step which is required by other
solvents However the technology of switchable solvents is a relatively new technology For the
development of the alternative the company has set up a joint development plan with a Canadian
research institute familiar with this technology
Although the alternative is not technically ready because of the authorisation the company has the
opportunity to develop a new technology to substitute the use of TCE while avoiding the use of
another hazardous substance (PER) with the potential outlook of a cost saving in the production
process
In this case the drivers for the substitution were
Cost saving potential of the new technology and
Ambition to produce SVHC free
Case 2 Grohe
The application for continued use of chromium trioxide by Grohe consisted of two uses chrome
plating and etching of plastic material prior to chrome plating Grohe elected to differentiate both
uses and filed two different uses Apparently the main driver for this decision is the difference in
substitution potential for both uses While for the etching a possible alternative seemed to have
been identified for the surface coating an alternative seemed to be further away This difference
in possible substitution was also the main argument for a difference in review period
Impacts of REACH Authorisation Final Report
eftec November 2017 88
56 Summary of instances of substitution
A deliberate attempt was made to target stakeholders who may have been impacted by REACH
Authorisation and those that may have substituted a SVHC Whilst the AfA process provides a good
indication of companies and uses that require continued use of a SVHC priority to this study little
was known about the instances of substitution In this respect the online survey for this study has
been very successful with 43 of respondents indicating they have substituted a use of a SVHC (and
therefore avoided the need to apply for Authorisation) These respondents (n=83) provided 61
examples of substitution of SVHCs
There were also 44 respondents providing 71 examples of no substitution yet but actively seeking
to substitute and investment in substitution related activities In some instances some companies
have been successful at substituting the use of one SVHC but are still trying to phase out use of
another SVHC Whilst the specific targeting of respondents may have led to a higher percentage of
respondents who have substituted (43) the survey at least provides evidence that substitution of
SVHCs is occurring Based on survey responses REACH Authorisation seems to be a major (but not
the only) driver for substitution
The survey data suggest that in 53 of the cases substitution took between one and four years In
27 of cases it took 5 to 10 years 12 took longer (11 to 20 years) 2 took over 20 years and 6
are finalising their substitution activities but do not know exactly when this will be fully
completed
The present study found that the Authorisation process leads to substitution where it is technically
feasible even if in some cases the cost of applying for Authorisation could have been cheaper
This report sets out several drivers for these substitutions with numerous case study examples
Authorisation might not necessarily be the only motive as some of the substances that have been
through the entire Authorisation process have previously been regulated by other parts of REACH
and related legislation (such as harmonised classification amp labelling and evaluation) as well as
being subject to other regulation prior to REACH and therefore in some instances substitution
related activities have been ongoing for many decades
Where substitution was technically feasible drivers most commonly cited by companies include
their desire to avoid the lsquostigmarsquo of using SVHCs costs of regulation and uncertainty associated
with having to apply for Authorisation (and whether it is granted) Companiesrsquo internal policy to
avoid using a SVHC is also given as a reason Taking the initiative to substitute allowed these
companies to agree long-term contracts with customers and not delay investment plans (eg new
production capacity or new types of products) Interviews done for this study suggested that these
plans and contracts could otherwise have been postponed pending the outcome of the application
or companies could have even moved their part of production using SVHCs to outside the EU
Impacts of REACH Authorisation Final Report
eftec November 2017 89
6 COSTS OF THE AUTHORISATION PROCESS
61 Introduction
The cost of the authorisation process is the third of the five focus areas assessed The cost analysis
seeks to set out (i) at what stage in the authorisation process are these costs incurred (building on
from the analysis in Section 3) (ii) who incurs these costs (and if they differ along the supply chain
ndash eg upstream application vs downstream user applications) (iii) how they compare with what was
anticipated (eg if there are any unintended costs) and (iv) to understand how costs are changing
over time (eg whether the total cost of drafting RMOAs is increasing due to the numbers carried
out but the time required per RMOA is falling)
The section contains the following sub-sections covering the costs included in this analysis
Section 62 Literature review ndash summaries what the key findings were from existing
studies
Section 63 Costs to Member State Competent Authorities (MS CAs) ndash sets out the costs
incurred by MS CAs along the authorisation process
Section 64 Costs to the European Chemicals Agency (ECHA) ndash sets out the costs incurred by
ECHA along the authorisation process
Section 65 Costs to the European Commission (EC) ndash sets out the costs incurred by the EC
along the authorisation process
Section 66 Costs to third parties ndash sets out the costs incurred by third parties (like NGOs)
along the authorisation process
Section 67 Compliance costs - sets out the compliance costs incurred by
manufacturersimporters (MIs) and downstream users (DUs) from continued use of an SVHC
along the authorisation process
Section 68 Costs of substitution - sets out details on the costs of substitution from an
SVHC due to the authorisation process
Section 69 Costs of RampD innovation and investment ndash sets outs details on the costs of
RampD innovation and investment encouraged by the authorisation process
Section 610 Costs of closure and relocation - sets out details on the costs of closing sites
in the EU and relocation of production outside of the EU due to the authorisation process
Section 611 Costs to apply for authorisation ndash sets out details of the costs to applicants
who requested continued use of an SVHC beyond the sunset date of the substance
Section 612 Costs to improve risk management - sets out details of the costs to improve
risk management from continued use of an SVHC due to the REACH authorisation process amp
Section 613 Summary of costs ndash sets out a summary of all the costs assessed
Impacts of REACH Authorisation Final Report
eftec November 2017 90
62 Summary of literature review
To create a basis for the assessment of new results produced by this study existing literature was
reviewed to identify and consolidate existing knowledge about the costs related to the
authorisation process The consulted literature includes regulation documents EC study reports a
Finnish study commissioned by ECHA as well as reports and position papers submitted during the
public consultation of the 2017 REACH Evaluation
This sub-section summarises the key findings of the literature review The complete literature
review (with supporting evidence) can be found in Annex E5 The following findings of the
literature review are of particular relevance
Based on a survey among authorisation applicants in 2013 and 2014 ECHA estimated the
average cost per applicantuse to be approximately euro230000 (EC 2015) As the average
cost per applicantuse was lower for applicants submitting AfAs in the last quarter of this
period it is expected that average costs will decline in the long run due to increasing
experience with the process
Several studies indicate that the application fees paid to ECHA make up a small share of the
total authorisation cost (at most 15) to the applicant Costs incurred to fulfilthe
information obligations set by public authorities and the preparations of application
dossiers are more significant The analysis of alternatives and the preparation of the socio-
economic analysis are shown to be the parts of the authorisation application that are the
biggest cost drivers
Despite the low share of application fees in terms of total costs the need to minimise the
regulatory cost burden for SMEs has been recognised by the EU through further lowering the
reduced application fees for such companies with the implementation of Regulation (EU) No
2542013
The public consultation to inform the 2017 REACH Evaluation reveals that almost 90 of
respondents think that the authorisation fees are too high As expected this percentage is
especially high (ie gt 90) for industry associations and businesses A considerable share of
stakeholders from the public and research sector (42 and 50 respectively) shares this
view
Submissions to the public consultation that informs the REACH REFIT indicate that costs
incurred as part of substitution activities ndash the alternative way of fulfilling the Annex XIV
requirement ndash amount to significant sums that might even be higher than direct REACH
authorisation application costs
Substitution can be linked to significant follow-up costs for the company itself authorities
or end-users of the products in certain industries Examples were provided by position
papers from stakeholders in the medical technology industry and defence sector In the
defence sector for example military authorities need to requalify products affected by
substitution and related products (eg tanks and aircrafts) that may need to be adapted to
the product directly affected by the substitution activities (eg ammunition) to ensure
compatibility
Besides industry actors EU- and Member State level institutions also incur considerable
costs during the authorisation process due to their administrative and management duties
Impacts of REACH Authorisation Final Report
eftec November 2017 91
Even state-level institutions not directly involved in these tasks such as Ministries of
Defence might face higher costs due to the need to finance more RampD activities
The public consultation conducted to inform the REACH Evaluation 2017 revealed that the
general opinion about the proportionality of costs and benefits of authorisation is the most
negative out of all analysed REACH chapters (ie registration information in the supply
chain such as extended Safety Data Sheets evaluation of dossier evaluation of substance
authorisations restriction and requirements for substances in articles)
63 Costs to Member State Competent Authorities (MSCAs)
The costs to MSCAs are largely driven by the time spent on the following activities
The screening and risk management option analysis (RMOA) stage
Inclusion of substances on the Candidate List
The Member State Committee (MSC) ECHA Scientific Committees (RAC and SEAC) and
REACH Committee
Compliance and enforcement of REACH authorisation and
Policy costs
A questionnaire was sent out to MS CAs44 requesting information on most of these activities and
responses were received from 16 CAs The findings are summarised in this section Some of these
costs have also been estimated as part of ECHArsquos time recording system (see Section 64 for more
information) This system in addition covers the activities of the RAC and SEAC whose costs are
largely paid for by MS CAs so these ECHA-estimated costs are also covered in this section ECHA
pays for the time of Committee members who undertake lsquorapporteurrsquo duties on authorisation
opinions although this might only partially cover the full cost of the membersrsquo time These costs
are included under ECHA costs
Table 61 presents responses to the question on average cost of staff employed on authorisation
activities (For this question what constitutes lsquoauthorisation activitiesrsquo was not specified) The
mean lsquoaverage costrsquo value was euro401 per day with mean upper and lower bounds of euro306 and euro412
These values appear reasonably close but they disguise significant variation across CAs ndash the lowest
lsquolow valuersquo reported was euro20 per day whereas the highest lsquohigh valuersquo was over euro1000 per day
Table 61 Average staff cost per day (euro) for time spent carrying out authorisation activities
Low Average High
Mean 306 401 412
n 10 14 9
Table 62 presents the results of the question asking CAs how much staff time they spend on
undertaking RMOAs Screening and RMOA activities were described in the questionnaire as follows
ldquoThe term lsquoscreeningrsquo covers the identification and investigation of substance (and dossier)
specific information to make a preliminary assessment on whether that substance (or
dossier) should be handled via a particular REACH or CLP process The first stage is the IT
mass screening phase which is predominately carried out by ECHA The second stage is the
httpsechaeuropaeuinformation-on-chemicalscl-inventory-database-disclidetails103892 44 The EC contacted MS CAs and those willing to take part were sent the survey
Impacts of REACH Authorisation Final Report
eftec November 2017 92
manual screening phase which is a targeted substance or dossier specific assessment of the
information provided in the registration dossier(s) in relation to the search criteria applied
As the vast majority of substances that are screened (either in mass screening or manual
screening) do not go down the authorisation route the screening phase is not being
assessed in this questionnaire
An RMOA is a voluntary step where an analysis is carried out (by ECHA upon request by the
Commission or a Member State Competent Authority (MSCA)) on a substance-by-substance
level to conclude if additional regulatory risk management should be proposed to manage
the risks to human health or the environment as well as which risk management option to
use Although there are several Risk Management Options that could be proposed (other
than Authorisation) we are interested in understanding the time taken (on average) to carry
out an RMOArdquo
The mean of the estimates of the lsquoaveragersquo was 41 days with a mean lsquolow estimatersquo of 20 days and
a mean lsquohigh estimatersquo of 70 days Again these figures mask individual extremes ndash for instance a
lsquolowrsquo of two days and a lsquohighrsquo of 175 days (the latter figure representing over six months of full-
time employment) The first set of estimates in Table 62 of the cost of undertaking a RMOA are
the means of responses from CAs who answered questions on both the staff cost and the days per
RMOA questions since not all respondents answered both questions This is why the number of
respondents (n) is different for the lsquoaverage daysrsquo responses and the lsquoown costsrsquo responses in Table
62 The second set is obtained by taking the simple means in Table 61 and Table 62 recognising
that the sample of CAs responding to each question is different Average costs obtained are around
euro13k-164k ranging from euro35k to almost euro29k Respondents generally reported that the time spent
on RMOAs is increasing over time due to greater average complexity of case substances (eg PBTs
compared with CMRs)
Table 62 Time for and cost (euro) of carrying out a RMOA per substance
Average days
Total cost per RMOA
Based on own costs Based on sample costs Low Average High Low Average High Low Average High
Mean 20 41 70 3484 12988 25112 6120 16441 28840
n 10 13 9 7 11 6 na na na
ECHA publishes data from the Public Activities Coordination Tool (PACT) which lists the substances
for which a RMOA or an informal hazard assessment for PBTvPvB (persistent bioaccumulative and
toxicvery persistent and very bioaccumulative) properties or endocrine disruptor properties is
either under development or has been completed since the implementation of the SVHC Roadmap
commenced in February 2013 The PACT currently (August 2017) lists 374 activities - 178 are
described as RMOAs of which 168 were or are being undertaken by MS CAs The assignment of
these activities to REACH authorisation is not clear-cut since some RMOAs conclude that a
restriction (or another instrument) is appropriate some have been put on hold some are still
ongoing and some are listed as having a finalisation date which precedes their inclusion on the
PACT list Seventeen RMOAs have been included in the PACT list since September 2014 which have
already concluded (four of them in 2017) that a substance should receive a SVHC follow-up This
might suggest RMOA numbers in single figures per year ultimately associated with authorisation
although clearly this will tend to be an underestimate Based on the sample-based average cost in
Table 62 this might suggest a rough cost of around euro100k per year45
45 17 RMOAs over the period September 2014-2017 or just over five per year at euro16400 each gives euro92000
per year
Impacts of REACH Authorisation Final Report
eftec November 2017 93
Table 63 presents information on the time spent on and costs of the Annex XV process for
identifying SVHCs The activities covered include dossier preparation responding to public
consultation comments (lsquoRCOMrsquo) revision of the dossier and commenting on dossiers prepared by
other CAs and by ECHA As might be expected dossier preparation itself is the most time-
consuming activity taking a mean average of 36 days per dossier (average low estimate 22 days
average high estimate 57 days) The total cost of the Annex XV dossier process for SVHC
identification is estimated at around euro19k-euro20k (own costs or sample costs) with a mean low of euro7k
(own costs) and a mean high of euro34k (sample costs) In commentary most CAs did not feel that the
Annex XV process is becoming more burdensome over time even though several did state that they
had little direct experience of dossier preparation
Table 63 Time for and costs (euro) of the Annex XV dossier process for SVHC identification
Average days Total cost per dossier
Based on own costs Based on sample costs
Low Average High Low Average High Low Average High
Preparation 22 36 57 6435 13869 20967 6757 14537 23336
RCOM 3 6 11 408 2134 3204 985 2347 4671
Revision 2 5 11 253 2094 1745 747 2060 4415
Commenting 1 2 5 259 665 2277 313 890 2061
Total 28 49 84 7354 18762 28193 8802 19835 34482
ECHA publishes data on the Registry of Intentions to submit SVHC Annex XV dossiers CAs submitted
nine such dossiers in mid-2015 or early 2016 and eight in mid-2016 or early 2017 Assuming that
these all took approximately one year to compile and an average total cost of around euro20k gives a
total annual cost of around euro160k This does not include dossiers for which an intention was lodged
but withdrawn
Table 64 presents information on the time spent on and the costs of authorisation-related Member
State Committee activities In the questionnaire this was defined as average time spent by MSC
member (and advisors) on preparing and attending for a single Member State Committee meeting
specifically for authorisation activities Time in this case is measured in hours per meeting The
responses covered MSC meetings on SVHC identification Annex XIV activities (ie prioritisation)
and other authorisation activities (not specified in the questionnaire) Substance-related activities
seem to take longer on average than other authorisation-related activities with the former
requiring about 20 hours of time (range 8-45) and the latter 13 (range 7-20) This puts the
authorisation component of MSC meetings at costing from around euro600 to over euro5k with an average
of around euro25k-euro3k This is per CA so each actual meeting will cost around 30-times that
(depending on attendance) or around euro50k-euro100k With six meetings per year the total annual
cost for CAs is around euro300k-euro600k46 This does not include the costs of attendance by ECHA the EC
or stakeholders In comments most CAs stated that MSC activities can vary significantly depending
on the number and complexity of the cases being considered as well as the role the CA is taking in
the meeting
46 An alternative approach to costing MS CA time spent on candidate listing and prioritisation based on ECHArsquos
time-recording system gives a cost of around euro330k (see the discussion at Tables 69-12)
Impacts of REACH Authorisation Final Report
eftec November 2017 94
Table 64 Time for and costs (euro) of Member State Committee activities on authorisation (per Member State)
Average hours Total cost
Based on own costs Based on sample costs
Low Average High Low Average High Low Average High
SVHC ID 10 21 37 202 1189 1580 412 1125 2047
Annex XIV 8 18 45 222 800 1335 323 987 2451
Authorisation 7 13 20 232 558 800 272 684 1071
Total 25 52 102 656 2546 3715 1007 2795 5569
Table 65 covers the time spent on an authorisation-related meetings of the REACH Committee
both preparation and attendance Total hours per meeting are estimated at 34 on average with a
range of 17-61 This results in mean costs of less than euro2k with a range of euro05k (own costs) up to
euro33k (sample costs) With approximately 10 meetings per year this puts average annual costs at
around euro20k for each CA or around euro600k in total per year In commentary respondents were of
the general opinion that average REACH Committee costs were increasing due to an increase in the
number and complexity of authorisation application cases which were being considered
Table 65 Time for and costs (euro) of REACH Committee activities on authorisation
Average hours Total cost
Based on own costs Based on sample costs
Low Average High Low Average High Low Average High
Preparation 14 28 50 442 1201 2153 589 1521 2720
Meetings 3 6 11 110 270 445 111 323 586
Total 17 34 61 552 1471 2198 700 1844 3306
Table 66 covers time spent by ECHA Scientific Committee members on reviewing and commenting
on authorisation applications for which they are not acting as rapporteurs outside of plenary
meetings Responses were given in terms of hours per application On average CAs report spending
longer on SEAC opinions than RAC opinions giving a mean average cost of euro600-900 for SEAC
compared with around euro375 for RAC However one explanation for this could be that RAC members
have a heavier workload and therefore are more constrained in terms of how much time they can
spend on each case ndash this is supported by comments made by CAs in their questionnaires
Alternatively it could mean that more RAC activity is undertaken in plenary rather than outside
compared with SEAC Around 28 applications (50 uses) per year have been submitted to ECHA since
2013 implying a total non-plenary cost of around euro28-euro50k per MS CA per year depending on
whether AfA case is interpreted as an application or use applied for With 28 MS CAs in the EU and
three in the EEA this gives a total cost to MS CAs of around euro870k-euro15m
Impacts of REACH Authorisation Final Report
eftec November 2017 95
Table 66 Time for and costs (euro) of ECHA Scientific Committee (RAC and SEAC) non-plenary activities on authorisation applications per MS CA per AfA case
Average hours Total cost
Based on own costs Based on sample costs
Low Average High Low Average High Low Average High
RAC 4 7 15 216 389 761 160 361 849
SEAC 5 12 21 272 854 814 197 623 1129
Total 9 19 36 488 1243 1375 357 984 1978
RAC and SEAC time spent in plenary was not covered in the MS CA questionnaire but was instead
estimated via the ECHA time-recording system (see Section 64) Preliminary results indicate that
the Committees spend approximately 18 days on opinion-making per use giving a cost of around
euro7200 With around 50 uses per year this gives a total annual cost of euro360000 Costs of RAC and
SEAC rapporteurs are treated as costs to ECHA and are covered in Section 64
On the subject of monitoring and enforcement CAs gave a variety of responses which are not easily
presented in tabular form Some CAs reported having no data Some responded that they did not
undertake any enforcement relating to REACH authorisation Interestingly some of these explained
this by saying that no company had yet been granted an authorisation in their country so there was
no need for enforcement even though it is the use of an Annex XIV substance without an
authorisation which is the key enforcement issue not compliance with a granted authorisation
(although this is still an issue clearly) Others estimated their time spent at around 10-20 days
Two reported spending around 70 days and over 100 days on enforcement in relation to around 25-
35 investigations Although patchy these responses do indicate that CAs are not expending very
significant effort on enforcing Annex XIV and granted authorisations
Finally CAs were asked questions designed to estimate how much time they spend on REACH
authorisation policy issues When asked to estimate the percentage of REACH staff time spent on
REACH authorisation policy issues responses ranged between zero and 20 with an average of just
under 10 CAs reported an average of just under 6 FTEs employed on REACH authorisation This
implies that policy aspects account for around 55 of one FTE At an average daily cost of euro401
this implies a cost of staff time spent on policy issues of around euro50k per year per CA
In summary questionnaire responses suggest that MS CAs might spend around
euro100k per year on undertaking RMOAs
euro160k per year on compiling Annex XV dossiers
euro300k-euro600k per year on MSC meetings
euro600k per year on REACH Committee meetings
euro870k- euro15m per year on RACSEAC non-plenary activities
euro360k per year on RACSEAC plenary activities and
euro15m per year (euro50k per CA) on lsquopolicy issuesrsquo broadly defined
This gives a total of around euro373m-euro486m per year (~euro43million per year on average) This figure
excludes enforcement activities for which insufficient data were supplied to permit costing
Impacts of REACH Authorisation Final Report
eftec November 2017 96
64 Costs to the European Chemicals Agency (ECHA)
ECHA has established a time management information system to record the time that staff spent on
different activities Using information from this system and expert judgement where necessary
ECHA has estimated time spent on the following authorisation-related activities
Risk Management Options Analysis (RMOA)
o Time spent preparing an RMOA
Annex XV dossier preparation and SVHC identification (candidate-listing)
o Time spent on Annex XV dossier preparation responding to comments from the
public consultation and preparing support documents
o Management of the Annex XV dossier evaluation process
o Member State and stakeholder analysis and commenting during the public
consultation
o Any additional time spent on Annex XV dossiers by the Member State Committee
(MSC) secretariat and members
Annex XIV recommendation
o Time spent on Annex XIV recommendation separately for ECHA and for MSC
members total (including rapporteurs and working groups)
Applications for authorisation
o Time spent on managing the applications process within ECHA
o Time spent by RAC and SEAC rapporteurs on evaluating applications
o Time spent on discussions related to applications for authorisation in RAC and SEAC
plenaries
Costs reported by ECHA were expressed in terms of days A representative cost per day for ECHA
staff time of around euro750 (including a 25 overhead)47 Time recorded by ECHA but paid for by
other agencies is not counted here
ECHA also spends time on additional activities such as providing guidance and training to applicants
(and others) developing policy in relation to aspects of the application process and
communicating to stakeholders through conferences webpages and so on ECHA also commissions
research and consultancy as part of for instance establishing Risk Assessment Committee (RAC)
dose-response functions for non-threshold substances It is assumed that these costs have not been
accounted for directly and hence appear (partly) in the 25 overhead charge
641 SVHC identification and prioritisation
ECHA has provided a description of its efforts to estimate the costs of its activities associated with
SVHC identification and prioritisation for authorisation This covers screening RMOA SVHC
identification and SVHC prioritisation
Screening
Common screening aims to make use of the full REACHCLP database and available external data to
support efficient implementation of all REACHCLP processes48 Hence the vast majority of
substances that are screened (either in mass screening or manual screening) do not go down the
47 John Wickham ECHA pers corr 11 April 2017 48 httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernscreening
Impacts of REACH Authorisation Final Report
eftec November 2017 97
authorisation route Therefore ECHA does not consider it meaningful to relate time and cost spent
on screening to the authorisation process
RMOA
Similarly only approximately one third of substances for which an RMOA is carried out go directly
to the authorisation route In addition most of the ECHA time spent on RMOA relates to more
generic tasks including co-ordination of Member States activities in RMOA developing approaches
supporting MSCAs and ensuring transparency and is not substance specific
Time spent on preparation of a RMOA ranges between 2-12 weeks full time equivalent (rough
estimate) with the average time spent by MSECHA being closer to the lower end of this range
This includes equivalent level of concern analysis for potential Article 57f substances where
relevant
Table 67 sets out the number of days spent by ECHA on RMOA activities and the cumulative
number of substances for which RMOA work is ongoing or concluded by ECHA or MSs in the last
three years These days are translated into cost estimates by applying the euro750 per day figure If
(as stated above) around one third of these costs are directly authorisation-related this puts
annual costs to ECHA at around euro40k-euro65k
Table 67 ECHA time and cost (euro) spent on and number of substance RMOAs 2014-2016
2014 2015 2016
Time spent (days) 236 171 264
Total cost (euro000s) 177 128 198
Cumulative number of substance RMOAs at end of year
Under development 74 89 92
Concluded 24 50 67
Total 98 139 159
The PACT started in September 2014 hence all RMOA PACT inclusions dated 2014 include all RMOA
intentions received between the start of the SVHC Roadmap (Feb 2013) and that date
At euro750 per day
Annex XV dossier preparation and SVHC Identification
Hazard identification is the primary purpose of the SVHC Annex XV dossier and in that sense
identification of substance properties (CMREDPBT etc) is an integral part of the process
However COM has advised that CLH (Harmonised Classification and Labelling) processes (which
relate primarily to identification of CMR hazards) are not in scope when calculating administrative
costs which would suggest that hazard identification activities for non-CMR properties should also
be out of scope ECHA has therefore considered two scenarios for a typical dossier
Time spent on CMR dossiers (not including CLH activities) and
Time spent on dossiers which relate to identification of other non-CLH hazards eg
PBTvPvBArt 57f dossiers
For the second category of substances time spent on dossiersubstance evaluation activities is not
included as this relates to a different regulatory process In addition time spent on the work of the
EDPBT Expert Groups is not included as these groups primarily support substance evaluation
activities
Impacts of REACH Authorisation Final Report
eftec November 2017 98
It should be noted that the time spent on Annex XV dossier preparation particularly for PBTvPvB
amp Art 57(f) dossiers is here only very roughly estimated by ECHA These estimates with associated
costs are presented in Table 68 It can be seen that the estimated time taken for PBTvPvBArt
57(f) dossier activities is significantly higher than for CMR dossiers as therefore are the costs Total
costs for a CMR dossier come to around euro20k whereas for a PBTvPvBArt 57(f) dossier costs are
more like euro100k ECHA also estimates that it spends an average of 80 days on court cases related to
PBTvPvB amp Art 57(f) dossiers
Table 68 ECHA estimates of mean (min max) days and cost (euro) spent on Annex XV dossier preparation
Task CMR PBTvPvB amp Art 57(f)
Days Cost (euro000) Days Cost (euro000)
Annex XV dossier preparation RCOM
Updating Annex XV dossier and preparing
Support Document (MSECHA)
11 825 70
(30 125)
525
(225 9375)
ECHA dossier management (including
substance ID and accordance check PC
activities)
11 825 35
(25 45)
2625
(1875 3375)
MS and stakeholder analysis and commenting
during PC (typically 20 commenters per
dossier 2 hours each)
5
(3 15)
375
(225 1125)
30
(15 45)
225
(1125 3375)
At euro750 per day
Table 69 reports estimates of additional time and cost spent by the MSC secretariat and the MSC
members on candidate listing activities MSC costs are valued at the euro401 per day figure used in the
previous section It can be seen that costs increase depending on whether the substance can go
straight to the Candidate List or needs to be referred to the MSC The upper estimates for
PBTvPvB amp Art 57(f) substances include opinion formation where MSC agreement is not reached
Table 69 Time and cost spent on candidate listing (days euro000 per substance)
CMR PBTvPvB and Art 57f
Secretariat MSC Cost
(euro000) Secretariat MSC
Cost
(euro000)
Direct to Candidate List 1-2 2-3 155-270 1-2 2-3 155-27
Referred to MSC and
addressed in WP 2-4 3-4 27-46 10-20 10-20 115-23
Referred to MSC and
addressed in plenary 4-6 4-5 46-65 20-50 20-50 23-575
In order to put some context on these figures Error Not a valid bookmark self-reference sets
out the number of SVHC dossiers dealt with per year broken down according to proposed hazard
property49 Assuming CMR dossiers cost around euro20k to administer and go straight to the Candidate
List the cost over the last three years is approximately euro200k Assuming other dossiers cost
approximately euro100k to administer go to the MSC and are 5050 addressed in plenary or working
procedures (WP) gives a cost over the last three years of euro309m The total annual cost is therefore
approximately euro11m but this is very much a ball-park figure About euro101m of this figure is cost to
ECHA with the remainder (euro83k) a cost to MS CAs
49 Note that where a substance has been proposed for SVHC identification due to both CMR and PBTvPvBArt
57(f) properties to avoid double-counting it has not been counted in the table as CMR
Impacts of REACH Authorisation Final Report
eftec November 2017 99
Table 610 SVHC dossiers by hazard property per year
2014 2015 2016
CMR 5 3 1
PBT vPvB 2 4 2
Art 57(f) 7 2 7
Total 14 9 10
Annex XIV Recommendation
Estimations of time spent on this activity are only very roughly possible in particular for MSC
members and the MSC Working Groups In addition recommendation cycles are not running per
calendar year whereas time spent is estimated per year The number of substances assessed for
priority and the number of substances in a recommendation are given as a rough indicator of
workload (see Table 611) However it needs to be remembered that there is no 11 relationship
between the number of substances and the workload eg having 11 substances in the 7th draft
recommendation compared to 22 in the 6th draft recommendation does not mean the workload in
the 7th recommendation was only half of that in the 6th recommendation
Table 611 Recent Annex XIV recommendations
5th Recommendation 6th Recommendation 7th Recommendation
Date draft June 2013 September 2014 November 2015
Date final February 2014 July 2015 November 2016
No of Substances
assessed 20 101 97
No of Substances in
draft 6 22 11
No of Substances in
final 5 15 9
Previous priority assessment approach used
Table 612 presents ECHArsquos estimates of ECHA and MSC time and cost spent on prioritisation
exercises based on the ECHA time recording system and qualitative judgement Time costs for MSC
members is based on the euro401 per day figure presented in Table 61 This suggests a total cost in
2016 of around euro05m euro0425m of which is ECHA costs
Table 612 Time and cost spent on Annex XIV prioritisation days per year
2014 2015 2016
Days Cost (euro000) Days Cost (euro000) Days Cost (euro000)
ECHA 621 46575 702 5265 566 4245
MSC members No data No data No data No data 173 694
642 Authorisation application opinion-making
ECHA has provided the first outputs of their time-recording system relating to opinion-making and
these are presented in Table 613 This indicates that on average ECHA spent just under 67 days
on opinion-making per use The estimate of time spent by the Committees is given by the average
Impacts of REACH Authorisation Final Report
eftec November 2017 100
time the Committees spend in plenary meetings to discuss each use multiplied by the average
number of Committee members in each meeting The time of rapporteurs and Committee members
is valued according to the average value in Table 61 This suggests a total direct cost (excluding
membersrsquo non-plenary time) of around euro37k per use over the period 2014-2016 of which just under
euro22k is ECHA time directly Rapporteursrsquo time is compensated for (although not necessarily to 100
of the cost) via payments made for each opinion The cost related to Committeesrsquo plenary time
listed in Table 613 have already been covered in section 63 For the purposes of this report it will
be assumed that costs to ECHA for each opinion are equal to around euro30k Assuming a rough
average of 50 opinions per year gives a figure for costs to ECHA of around euro15m annually
Table 613 ECHA estimates of time and cost (euro000) spent on opinion-making per- use 2014-2016
2014 2015 2016 2014-2016
days uses AfAs days uses AfAs days uses AfAs days cost
Secretariat 23 33 10 42 23 16 28 63 41 29 2175
Rapporteurs 14 33 10 26 23 16 24 39 26 20 8
Committees
(covered in
Section 63)
18 72
Mean total 676 37
Based on timesheets received by 31032017
643 Authorisation application fees received
ECHA receives fees from applicants for authorisation according to factors such as the number of
uses applied for the number of exposure scenarios and the size of the applicant firm or
organisation These fees are designed to cover at least part of the costs of ECHArsquos activities
relating to authorisation Authorisation fee income received by ECHA is published in the ECHA
financial accounts and is presented in Table 614 The yearly fee totals relate to the year in which
invoices were issued whereas the opinion-making stage of the application process commences only
after the invoice has been paid Thus there is no simple link between the fees received in Table
614 and the opinions and costs generated in Table 613
Table 614 Total authorisation application fees received by ECHA 2013-2016
Year Fees received (euro)
2013 587633
2014 1682281
2015 728239
2016 6074483
Total 9072636
Over the period 2013-2016 applications were received for 178 uses This implies a mean
application fee per use of just under euro51000
Impacts of REACH Authorisation Final Report
eftec November 2017 101
644 Summary
The proceeding discussion suggests that ECHA incurs costs of around euro50k per year on authorisation-
related RMOAs around euro1m on Annex XV and candidate listing and around euro0425m on Annex XIV
prioritisation Costs of opinion-making are difficult to estimate given the significant variation in the
number of cases considered per year but a figure of around euro15m per year on opinion-making
might be reasonable This suggests costs to ECHA of around euro3m per year This is quite close to the
average application fees per year received over the 2013-2016 period (around euro225m)
65 Costs to the European Commission (EC)
This section sets out the main costs incurred by the EC to manage the authorisation process Based
on initial communications with the EC as noted from the literature review the administrative costs
to the EC are expected to be much smaller compared to those incurred by ECHA and Member State
Competent Authorities
A questionnaire was sent to the EC requesting information about the time spent on activities
concerning
RMOA stage
Inclusion of substances on the candidate list
The REACH committee
Decision on applications for authorisation (AfA)
Post decisions on an AfA and
Policy costs
The responses are summarised in Table 615 for the year 2016 The average annual cost per full-
time equivalent (FTE) is set equal to euro138k the value used in EC impact assessments to value EC
staff time The breakdown of total resource across different activities is considered valid for the
last two years as this is when process of authorisation application opinions commenced Policy
development includes interpretation of for instance court case judgements
Table 615 Estimates of DG ENV and DG GROW time spent on authorisation activities 2016
DG ENV DG GROW Total
Total FTEs
22
6
82
Total cost (euro000)
3036
828
11316
RMOA and SVHC Roadmap 10 3036 20 1656 17 19596
ECHA recommendations and Annex XIV amendments 10 3036 10 828 10 11316
Authorisation decisions 50 1518 50 414 50 5658
Policy development 30 9108 20 1656 23 25668
Thus it can be seen that just over euro11m in staff costs was spent on authorisation about three
quarters of this by DG GROW (DG ENV has recently expanded its authorisation staff to three FTEs)
Both DGs spend around half of their time on authorisation decisions
66 Costs to third parties for responding to public consultations
As set out in Section 3 third parties have three formal opportunities to comment at specific times
during public consultations as a substance moves through the authorisation process
Impacts of REACH Authorisation Final Report
eftec November 2017 102
1 Inclusion on the Candidate List
2 Inclusion on the authorisation list (Annex XIV) and
3 Submission of applications for authorisation
Details on each of these public consultations are discussed below in terms of available information
on the number of responses received by ECHA from third parties and the estimated time spent they
spent producing these responses
661 Public consultation on the inclusion of a substance to the Candidate List
During the public consultation for the inclusion of a substance to the Candidate List ECHA is
seeking information concerning the ldquoidentity of the substance and intrinsic properties relevant for
the identification (unless identification is based on harmonised classification and labelling and
cannot be challenged in this context) Additionally information on uses exposure potential and
alternativesrdquo50 These public consultations occur twice a year (for 45 days in March-April and
September-October)
As set out in Table 616 from 2008 until 2016 ECHA has received 3591 submissions during public
consultation in relation to 194 substances being proposed for inclusion on the candidate list Once
on the Candidate List these substances will be Substances of Very High Concern (SVHCs) and could
be subject to authorisation in the future if included on Annex XIV (authorisation list)
Table 616 Number of submissions received during the public consultation
Type of respondent
2008 2009 2010 2011 2012 2013 2014 2015 2016 Total
Academic institution
4 7 4 3
7 25 1
Company 35 45 210 130 239 47 30 20 23 779 22
EU or National or Local governmental Organisation
27 76 64 50 10 4
231 6
Individual 27 34 136 16 66 4 6 1 2 292 8
Industry or trade association
27 46 164 128 141 33 27 11 111 688 19
Member State CA
33 44 77 146 230 75 66 40 44 755 21
NGO 52 70 55 88 256 42 62 27 36 688 19
Other 6 3 10 4 4 7
1 35 1
Trade union
18 28 35 9 2 6
98 3
Total 211 325 738 593 981 221 193 105 224 3591 -
Notes
1 Underlying data provided by ECHA on 25052017
2 The type of respondent has been simplified so the number of submissions presented in the table may
not match the underlying raw data
The main actors that responded to public consultation were (i) companies (ii) Member State
Competent Authorities (MS CAs) (iii) Non-Governmental Organisation (NGOs) and (iv) industry or
50 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationpublic-consultation-in-the-
authorisation-process
Impacts of REACH Authorisation Final Report
eftec November 2017 103
trade associations Since the costs to MS CAs were already covered in the Section 63 the
remainder of this section focuses on the costs to industry stakeholders (companies + tradeindustry
associations) and NGOs to provide comments during the public consultation for substances for
inclusion on the candidate list
As shown in Table 617 the number of submissions received by ECHA between 2008 and 2016 varied
significantly at substance level On average the number of responses received is around 13-18
responses
Table 617 Number of submissions received (per substance level) ndash 2008-2016
Candidate List Minimum Average
Maximum Median mean
Number of public consultation
submissions received per substance 1 13 18 245
The ten substances that received the most submissions are shown in Table 618 These ten
substances account for 24 of the total number of submissions A further 33 substances would have
to be added to the list to make 50 of total submissions
Table 618 10 substances that received the most public consultation submissions
Substance name Number of public
consultation submissions
Proportion of total submissions (2008-2016)
Boric acid 245 7
44rsquo-isopropylidenediphenol (bisphenol A) 123 3
Chromium trioxide 93 3
Disodium tetraborate anhydrous 79 2
Diazene-12-dicarboxamide (CC-azodi(formamide)) 72 2
NN-dimethylformamide dimethyl formamide 65 2
Lead oxide (lead monoxide) 58 2
Lead tetroxide (orange lead) 46 1
Lead styphnate 41 1
Tetraboron disodium heptaoxide hydrate 41 1
TOTAL 863 24
In the NGO and industry surveys questions were asked around the average time spent providing
comments to the three public consultations covering REACH authorisation The overall numbers of
industry survey respondents were reasonably good (22) to derive indicative ranges for time spent
There were however a limited number of NGO responses (4) Based on NGO interviews most NGOs
rely on either CHEMSEC EEB or Client Earth to comment on REACH authorisation as they do not
have the resources available These respondents indicated they spend between 1-8 hours providing
a response at candidate listing stage but this does vary depending on the substance
Respondents to the industry survey were asked to describe the activities carried out as well as their
estimates for average cost and time spent The types of activities reported by respondents are
listed below (some similar responses were omitted)
Impacts of REACH Authorisation Final Report
eftec November 2017 104
ldquoTaking part in meetings within the sector getting informed about the REACH process
preparing comments organizing internal meetings with different parts of the business
talking to customers to encourage them also to commentrdquo
ldquoGathering evidence and time required to prepare responserdquo
ldquoCompiling of data from member companies preparing and validating comments with
experts from member companiesrdquo
ldquoPreparing comments sometimes achieving consensus with other industry participants
(when answering via industry association)rdquo
ldquoCollecting evidences from suppliers quantity purchased emission quantification in air
and water and waste worker exposure data collection consolidation of relevant products
sold consolidation of quality checks and time spent for new product qualification after
SVHC substitutionrdquo
ldquoCollect data and arguments to feed into industry association commentsrdquo
ldquoWorking together with associations so we can divide this in cost for associations and
company costsrdquo
ldquoAssessment of the prioritisation arguments and evidence given by official documents
evaluation of base studies (if available) gathering information comparing different facts
available interviewing experts of different knowledge sectors gathering market details
gathering risk data (if available) evaluation of datas representatively and timelinessrdquo
ldquoPerforming an impact assessment of the proposed substance on our business operations
We have thousands of specifications covering processes for millions of parts Once we
know what specifications are affected we determine whether we have relevant exposure
information (we typically do not) If there is an opportunity to provide socioeconomic
data we may do so Although SEA data is not typically sought at this stage we believe
this can be relevant information that should be taken into account when ECHA makes risk
management decisionsrdquo
Table 619 categorises the screened responses into bands for time taken to respond What can be
observed from looking at their description of activities carried out and time estimates the data
suggests that the low estimate of time often relates to responses from a single company often for
collecting information and forming a response The upper estimate of time often relates to when
industry or trade association level responses requires collating responses from individual members
or when companies and or industry (consortiatrade association) provide more detailed information
such on the intrinsic properties hazard exposure data on the substance
Impacts of REACH Authorisation Final Report
eftec November 2017 105
Table 619 Estimated time taken to produce submission (candidate list consultation)
Time taken to produce response Frequency
1 day (or less) 0
1-5 days 5
6-10 days 3
11-40 days 4
40+ days 0 Notes
Source screened online survey data (ie some only provided cost estimates but not days)
Some responses were deliberately excluded as it was clear they included costs beyond those related
to producing a submission to the public consultation
Whilst it is possible to produce indicative estimates of the total costs over the period 2008-2016
using the low and high estimates of the costs of time spent by third parties (via survey responses)
with the total number of responses which results in a too wide estimate (euro2 million to euro73 million
over the period 2008-2016) which was not deemed to be credible given the survey sample size and
that individual low and high costs represent very different types of activities carried out In reality
ECHA will have received a variety of responses some of which would have taken a long time to
prepare and others only a short quick response As some submissions prepared at sectortrade
association levels are also re-sent by individual members (with some further details in some cases)
these companies donrsquot incur the same cost to prepare their submission (or reflected within the
costs to prepare the sector response)
662 Public consultation on the inclusion of an SVHC on to Annex XIV (authorisation list)
During the public consultation for the inclusion of an SVHC into the authorisation list ECHA is
seeking ldquoconfirmation on uses and volumes used Views on the transitional arrangements and
possible exemptionsrdquo51 The public consultation normally occurs once a year and lasts for 90 days
As set out in Table 620 between 2009 and 2016 ECHA has received 3088 responses during the
public consultation in relation to 87 substances being proposed for inclusion on the authorisation
list Once on the authorisation list these substances would be subject to authorisation with a
sunset date by which time uses subject to authorisation must cease in the EU unless an
authorisation has been granted or the applicant is pending a final decision of their AfA (which was
submitted prior to the latest application date)
51 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationpublic-consultation-in-the-
authorisation-process
Impacts of REACH Authorisation Final Report
eftec November 2017 106
Table 620 Number of submissions received during the public consultation (Annex XIV)
Type of respondent 2009 2010 2011 2012 2013 2014 2015 2016 Total
Academic institution 2 4 2 8 0
Company 91 8 1040 98 218 230 42 4 1731 56
EU or National or Local governmental Organisation
56 11 2 27 96 3
Individual 20 60 8 29 32 2 151 5
Industry or trade association
57 5 184 38 113 177 70 644 21
Member State CA 105 29 44 28 15 40 13 2 276 9
NGO 36 16 31 20 6 5 6 120 4
Other 4 1 16 2 3 8 5 39 1
Trade union 1 4 10 7 1 23 1
Total 371 60 1394 204 395 520 136 8 3088 -
Notes
1 Underlying data provided by ECHA on 25052017
2 The type of respondent has been simplified so the number of responses presented in the table may
not match underlying raw data
3 The PC for the 8th recommendation was from 2 March 2017 until 2 June 2017 so these 8 comments
were submitted in May 2017 whilst the PC for the 8th rec is still running At the close of the publc
consultation a total of 82 comments were received 3 individuals 55 company 23 Industry
association 1 MS)
The main actors that responded to public consultation were (i) companies and (ii) industry or trade
associations The remainder of this section focuses on the costs to industry stakeholders (companies
+ tradeindustry associations) to provide comments during the public consultation for substances
for inclusion on the authorisation list
As shown in Table 621 the number of submissions received by ECHA between 2009 and 2016 varied
significantly at substance level On average the number of responses received per substance is
around 16-35
Table 621 Number of submissions received (per substance level) ndash 2008-2016
Candidate List Minimum Average
Maximum Median mean
Number of public consultation
submissions received per substance 1 16 35 493
The ten substances that received the most submissions are shown in Table 622 These ten
substances account for 53 of the total number of submissions By adding a further eight substances
to that list would account for 80 of total submissions
Impacts of REACH Authorisation Final Report
eftec November 2017 107
Table 622 10 substances that received the most public consultation submissions
Substance name Number of public
consultation submissions
Proportion of total submissions (2009-2016)
Chromium trioxide 493 16
Chromic acid Oligomers of chromic acid and
dichromic acid dichromic acid 263 9
Boric acid 159 5
Sodium dichromate 116 4
Aluminosilicate Refractory Ceramic Fibres (Al-RCF) 115 4
Potassium dichromate 108 4
Zirconia Aluminosilicate Refractory Ceramic Fibres
(Zr-RCF) 99 3
NN-dimethylformamide (DMF) 94 3
Cobalt dichloride 87 3
Cobalt(II) sulphate 87 3
TOTAL 1621 53
In the NGO and industry surveys questions were asked around the average time spent providing
comments to the three public consultations covering REACH authorisation Based on NGO
interviews most NGOs rely on either CHEMSEC EEB or Client Earth to comment on REACH
authorisation as they do not have the resources available Available data from the NGO survey
suggests on the whole these NGOs do not devote as much time (~2 hours per submission) on the
Annex XIV public consultation as compared to candidate listing or on AfAs (see next sub-section)
The overall numbers of industry survey respondents were reasonably good (23) to derive indicative
ranges for time spent
Respondents to the industry survey were asked to describe the activities carried out alongside their
average cost and time spent estimate The types of activities reported by respondents are listed
below (some similar responses were omitted)
ldquoEvidence gathering and comment preparationrdquo
ldquoGathering information on the REACH process talking to customers in order to encourage
them to comment prepare commentsrdquo
ldquoData gathering coordination and approvalrdquo
ldquoGathering general data on [sector] exposure of workers and consumers use of
[substance] for [sector] short review of alternativesrdquo
ldquoReview of ECHA documents Assessment of SVHC used internally and by suppliers drafting
comments reviewing comments etcrdquo
ldquoWe have responded on our own as well as part of an industry group Activities are similar
to those of an SVHC listing proposal We perform an impact assessment and determine if
we have any relevant data that can be providedrdquo
Impacts of REACH Authorisation Final Report
eftec November 2017 108
ldquoPreparing comments joining efforts with other industry participantsrdquo
ldquoCollect data and arguments to feed into industry association commentsrdquo
ldquoPreparing comments discussion in associations gathering information from customersrdquo
ldquo[substance] several meetings with associations exchange of information develop a huge
amount of documentsrdquo
ldquoAssessment of the prioritisation arguments and evidence given by official documents
gathering information comparing different facts available interviewing experts of
different knowledge sectors gathering market details gathering risk data (if available)
evaluation of datas representatively and timeliness gathering detailed information on all
different uses including state of the art of facilities comparing practical experiences of
uses assigning data to different uses reading and interpreting authorisations dossiersrdquo
Table 623 categorises the screened responses into bands for time taken to response Data on the
description of activities carried out and time estimates suggests that the low estimate of time
often relates to responses from a single company often for collecting information and forming a
response The upper estimate of time often relates to when industry or trade association level
responses require collating responses from individual members or when companies and or industry
(consortiatrade association) provide more detailed information such as volume and uses
information and justifications for exemptions
Table 623 Estimated time taken to produce response (Annex XIV consultation)
Time taken to produce response Frequency
1 day (or less) 1
1-5 days 7
6-10 days 2
11-40 days 5
40+ days 1 Notes
Source screened online survey data (ie some only provided cost estimates but not days)
Some responses were deliberately excluded as it was clear they included costs beyond those related
to producing a response to the public consultation
The number of submissions andor time spent by industry preparing a proposal for exemptions
might be reduced by clarifications concerning when an exemption might be granted and what
supporting evidence is required for better informed decisions Further supporting information has
been made available by ECHA in March (2017) which may reduce this going forward (see
footnote52) This kind of supporting information was available in 2014 and is updated with every
recommendation round
52 ECHA(2017) - ECHArsquos general responses on issues commonly raised in public consultations on draft
recommendations - Available at
httpsechaeuropaeudocuments1016213640recom_general_responses_doc_enpdf44e192e5-ac72-4458-
b4f5-c016754a1d4c
Impacts of REACH Authorisation Final Report
eftec November 2017 109
Whilst it as possible to produce indicative estimates of the total costs over the period 2009-2016
(eg using low and high estimates or average time spent) with the total number of responses the
resulting estimates (euro02million to euro100million over the period 2009-2016) were not deemed to be
credible given the small sample and given individual low and high costs represent very different
types of activities carried out In reality ECHA will have received a variety of responses some of
which would have taken a long time to prepare and others not As some submissions prepared at
sectortrade association levels are also re-sent by individual members (with some further details in
some cases) these companies donrsquot incur the same cost to prepare their submission (or are
reflected within the costs to prepare the sector response) According to ECHA in the last years a
lot of effort has been made by industry and their associations (in close cooperation with ECHA) to
prepare and submit consolidated comments This has reduced the total number of comments but
at the same time has generally improved their quality ie ECHA get fewer submissions compared
to previous years but a higher number of those submissions are well prepared and raise important
issues with respective justifications (such comments are likely to taker longer time to prepare)
663 Public consultation on the applications for authorisations
An application for authorisation will be subject to a public consultation that fits within a public
consultation window that occurs quarterly for eight weeks (starting in mid-February mid-May mid-
August and mid-November) The number of substances included in a public consultation will vary
with some windows being busier than others As shown in Figure 61 since the first application in
2013 to the end of 2016 ECHA has conducted 180 such public consultations and received 1128
responses from various stakeholders For each AfA ECHA is seeking information on ldquoAlternative
substances or technologies to the use(s) applied for risks technical feasibility and costs of
alternativesrdquo53
Figure 61 Number of AfA public consultations and comments received
Source ECHA (10082017)
53 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationpublic-consultation-in-the-
authorisation-process
0
50
100
150
200
250
300
350
400
450
0
5
10
15
20
25
30
35
40
45
50
Co
mm
en
ts
Co
nsu
ltat
ion
s
No of consultations No of comments
Impacts of REACH Authorisation Final Report
eftec November 2017 110
As set out in Figure 62 the majority of comments have been from industry Downstream Users
(DUs) Manufacturers Importers (MIs) and industrytrade associations A large number of
comments have also been received from NGOs
Figure 62 Types of REACH actors that have commented on an AfA
Source ECHA (10082017)
As shown in Figure 63 the substance that received the most comments was Chromium trioxide
This would suggest that despite the formal intention of the public consultation to seek to gather
information about alternatives a number of responses especially in relation to upstream
applications seem to have come from their downstream supply chains providing further
information they deem relevant for RAC and SEAC and the EC in order for them to make their
opinions and decisions respectively on the outcome of the authorisation application(s)
Figure 63 Number of comments received by substance
Source ECHA (10082017)
Downstream User33
Importer8Industry or
trade association
17
Manufacturer14
MSCA2
NGO14
Individual3
Trade unionlt1
Other 8
2
11
41
6
152
232
12
115
19
9
31
6
9
449
5
2
1
1
11
13
4
0 50 100 150 200 250 300 350 400 450 500
Lead chromate
Trichloroethylene
HBCDD
Diarsenic trioxide
Lead chromate molybdate sulphate red
Lead sulfochromate yellow
Dibutyl phthalate (DBP)
Bis(2-ethylhexyl) phthalate (DEHP)
Potassium dichromate
Potassium hydroxyoctaoxodizincatedichromate
Sodium dichromate
Sodium chromate
Strontium chromate
Chromium trioxide
Chromic acid
Ammonium dichromate
EDC
Arsenic acid
Dichromium tris(chromate)
22-dichloro-44-methylenedianiline (MOCA)
Bis(2-methoxyethyl) ether
Impacts of REACH Authorisation Final Report
eftec November 2017 111
In the NGO and industry surveys questions were asked around the average time spent providing
comments to the three public consultations covering REACH authorisation Based on NGO
interviews most NGOs rely on either CHEMSEC EEB or Client Earth to comment on REACH
authorisation as they do not have the resources to comment on each AfA Responses from these
NGOs suggest that they can spend between a few hours to 3 days commenting on the AfA depending
on the specific use quality of the application itself and availability of information on alternatives
The overall numbers of industry survey respondents were at a first glance reasonably good (16) to
derive indicative ranges for time spent Respondents to the industry survey were firstly asked to
describe the activities carried out alongside their average cost and time spent estimate Based on
these it was clear that some respondents had misinterpreted this as time taken to gather
information during lsquoinformalrsquo consultations that applicantsconsortia may have done to preparing
for authorisation The data from these responses were therefore excluded
The types of activities reported by the screened listed on respondents (7) are listed below (some
similar responses were omitted)
ldquoRespond to a response provided by an NGO during the public consultationrdquo
ldquoPrepare comments based on the AfA documents based on supporting evidence gatheredrdquo
ldquoData mining and then commenting timerdquo
ldquoResponse as part of an industry group We gathered information and fed it to the industry
group for aggregation along with input from other industry group members Our
comments have typically been high level and supportive of information within upstream
applicationsrdquo
ldquoIn the public consultation process alternatives had been suggested ndash Time was required to
provide information to explain why those suggested were not technically feasiblerdquo
Table 624 categorises the screened responses into bands for time taken to response Data on the
description of activities carried out and time estimates suggests that the low estimate of time
often relates to responses from a single company for collecting information and forming a response
The upper estimate of time often relates to when industry or trade association level responses
requires collating responses from individual members or when applicants and or industry
(consortiatrade association) provide specific information on the unsuitability of an alternative
Table 624 Estimated time taken to produce response (AfA consultation)
Time taken to produce response Frequency
1 day (or less) 1
1-5 days 2
6-10 days 1
11-40 days 3
40+ days 1 Notes
Source screened online survey data (ie some only provided cost estimates but not days)
Some responses were deliberately excluded as it was clear they included costs beyond those related
to producing a response to the public consultation
Impacts of REACH Authorisation Final Report
eftec November 2017 112
Whilst it is possible to produce indicative estimates of the total costs over the period 2013-2016
(eg using low and high estimates or average time spent) with the total number of responses the
resulting estimates were not deemed to be credible given the small sample and that individual low
and high costs represent very different types of activities carried out This reflects reality in that
ECHA will have received a variety of responses some of which would have taken a long time to
prepare and others not
664 Why stakeholders may or may not have provided a response during the public consultation
As part of the industry and NGO surveys respondents were asked for their motives for why they
responded or did not respond during the public consultation As noted earlier most NGOs do not
respond to public consultation as they rely on CHEMSEC EEB or Client Earth to comment on REACH
authorisation as they do not have the resources available The NGOs that do provide submissions
during the public consultations indicated in their responses the most common reasons for
commenting (from a list given to them) being their disagreement with the resultsfindings
presented followed by highlighting that there was critical information missing that needed to be
taken into consideration
As set out in Figure 64 the reasons why an industry stakeholder submitted a response were very
varied with some supporting and others disagreeing with the findings being shared This is because
the response is dependent on the actual public consultation Most industry stakeholders commented
because of disagreement with submissions made by regulators noting that critical information was
missing in their submissions for a substance to be included on the Candidate List and Annex XIV
respectively Comments submitted concerning AfAs on the other hand were mostly supportive as
they often came from downstream users who were being covered by an lsquoupstreamrsquo application
There were however some comments during the public consultation where some respondents
disagreed with applicants providing their information on the suitability of possible alternatives
from their perspective
Figure 64 Main reasons for industry stakeholder to provide comments
15
13
14
11
12
10
0 2 4 6 8 10 12 14 16
There was critical information missing
There were inaccuracies in informationpresented
We disagreed with the resultsfindingspresented
We agreedsupported the resultsfindingspresented
We were seeking an exemption for a specificusesector
Other (please specify)
Impacts of REACH Authorisation Final Report
eftec November 2017 113
There was more consistency in responses when respondents were asked about if they had read the
response to their submission Over 80 of respondents indicated they had read the response to
their comments with around half unsatisfied with the response given The main reason for this
was that they felt the public consultation was somewhat of a lsquoformalityrsquo and despite time and
effort to provide information or argumentation it was demotivating to get the answer such as
Thank you for your comment andor only reference to paragraphs or articles in the regulation at
the inclusion of substances onto the candidate list
Figure 65 Whether the industry organisation read published response to their comments
Whilst there is again a varied response for why stakeholders did not respond during public
consultations as set out in Figure 66 some of the key reasons were due to a lack of resources
expertise or that the information already available was sufficient or that they did not have
additional information to add
Figure 66 Main reasons for not providing comments
26
44
12
6
12Yes and I was satisfiedwith the response
Yes but I was not satisfiedwith the response
Yes but I canrsquot remember donrsquot have a particular opinion on the response
No
8
11
4
2
9
3
4
1
1
5
2
8
0 2 4 6 8 10 12
We believed the information provided was sufficient
We do not have enough staff to be able to respond
Substances and alternatives to date have not been relevantfor our organisation
We were not aware of opportunities to comment
We did not have further informationevidence to provide
We did not think commenting would influence the decision
The consultation process was too complex
The information requested was too limited (eg informationon alternatives for consultation on AfAs)
There is not enough time available to prepare comments
We did not have the technical expertise required to evaluatethe information provided
We did not know that for most of the public consultations responses to comments are later published at ECHArsquos website
Other (please specify)
Impacts of REACH Authorisation Final Report
eftec November 2017 114
Industry stakeholders who did not respond during public consultations were asked what could be
done to encourage further participation Some of the responses are shown below
ldquoWe as a medium-sized company are not in a position to participate in a public
consultation The associations that represent us complain about the complexity of the
process and the unfavourable chronological sequence In particular the association is of
the opinion that the consideration of the alternatives only happens too late during the
public consultationrdquo
ldquoIt must be possible to read answers in our mother tongue Acceptance and cooperation
would have been significantly higher if these prerequisites had been created The
navigation is too complex and you have to be a freak to work through itrdquo
ldquoIt is not clear enough communicated what the aim of the process isrdquo Some information is
not taken into consideration and this then leads to resentment and perceptions that ECHA
ldquodoes not carerdquo
ldquoMore time would be helpful for trade associations to assemble responses especially over
the summer monthsrdquo
ldquoResponses given by ECHA via RCOMs are not conclusive and provide vague (as opposed to
specific) reasons why exemptions were rejected the COM did not even bother to respond
directly to those of us who made a response during the better regulation public
consultation in SeptOct 2016 in summary specific and conclusive responses from
ECHACOM during public consultations can help during any future public consultationsrdquo
ldquoAlthough we understand the rationale behind the format proposed for input to the public
consultation we would like to highlight the importance of input from users along the
chain which may not be specifically technical about other alternatives but is nevertheless
important to support or question the content of the documents submitted in the AfA This
should be taken into account by enabling other formats of input to be submittedrdquo
ldquoAs such the consultation processes are quite transparent However the timelines can be
challengingrdquo
ldquoThe public consultation is the first public step to gather information about other
technologies that may have potential to become an alternative in the REACh context
(economically and technically feasible for the applicant) This is far too late This
collection should be performed before putting a substance on Annex XIV (eg by RMOA) In
some cases this would make the authorisation process obsolete at all in some cases this
would open the way to focus all efforts (by applicant authorities associations and public)
to the main questions and issues Instead the applicant has to deal with all possible
topics may they be serious or may they be out-of-date already and all third-parties as
well ECHA and potential applicants (possibly represented by their specific associations)
should identify the main approaches to risk reduction and alternatives available in
advance They should identify together the main issues that may be of concern The
current brute-force approach of discussing any possible use and any proposed parallel
technology without prioritising end in a lack of overview comparability assessment of
outcome and side-effects (eg risk-risk-trade-offs) EU-Commission and ECHA together
with case-specific stakeholder authorities should identify in advance the major issues that
may have a real measurable impact Only then should be part of a possible authorisation
Impacts of REACH Authorisation Final Report
eftec November 2017 115
procedure Actually too many issues are discussed late in the process giving no opportunity
of rational adjustmentrdquo
ldquoMany AfAs on chromium trioxide are concerning basically the same issue Why ask for all
these individual AfAs per applicationrdquo
Some of these issues are not new and were the basis for introducing the RMOA process The clear
message of requesting and using information on alternatives as early as possible (ie the RMOA
stage) is worth reiterating though However according to communications with ECHA (4th October
2017) from their experience sometimes companies can be hesitant to provide information on
alternatives during public consultations as this may have an impact on their relationships with
other companies along the supply chain
Some of the issues could at least be addressed by giving stakeholders more time (especially when
consultations occur in the summer holidays or during Christmas) and more justification given for
actions taken by regulators in light of all the information submitted
Based on an interview with an NGO they stated that ldquoalthough they have knowledge that
production of certain products can be done without the SVHC lack the technical details required
during the public consultation As a result the input of the NGOs is ignored by SEAC Same goes for
downstream users who use an alternative but not produce this alternative They also have the
knowledge and experience that alternatives are available (and commercial) but do not have the
technical details of the alternative (and do not want to ldquospeak for their supplierrdquo to that extentrdquo
67 Compliance costs
As illustrated in Figure 67 the majority of respondents (71) to the online survey indicated they
incurred some costs associated with compliance with REACH authorisation The type of compliance
incurred depends on the position in the supply chain (eg MIs have different requirements
compared to DUs)
Figure 67 Whether respondents organisation incurred costs associated with compliance with REACH authorisation process
Sample size 63
71
14
8
6
Yes
No
Dont know
Not applicable
Impacts of REACH Authorisation Final Report
eftec November 2017 116
Respondents were asked to select the types of compliance related costs they incurred due to
REACH authorisation As set out in Table 625 most respondents indicated they incurred some
costs to familiarise themselves with what they needed to do The remainder of the costs are
dependent on what type of actor they are (eg it would be the responsibility of a MI to produce
and maintain an extended safety data sheet)
Table 625 Types of compliance related costs incurred
Types of compliance costs
No respondents who incurred
costs
Proportion () of respondents that
indicated this specific compliance
related cost
Updating and maintaining an eSDS 23 51
Providing information to allow safe use of an article 10 22
Updating a registration dossier following AfAs 8 18
Notifying DUs of an authorised use 8 18
Complying with reporting obligations in authorisation decision and preparing review report
9 20
Familiarisation with REACH authorisation requirements 40 89
TOTAL 45 -
671 Familiarisation with REACH authorisation
Familiarisation with REACH authorisation requirement was the most commonly incurred cost All
the respondents who provided estimates for the number of days and costs incurred were collated
Whilst the estimates were within the same orders of magnitude rather than present a single
estimate the costs shown in Table 626 are differentiated between those that are SMEs and non-
SMEs as well as those involved in submitting an AfA vs those companies that have not been involved
in submitting an AfA as this helps to explain the variation in time spent
Table 626 Costs for companies to familiarise themselves with the requirements under REACH Authorisation
Familiarisation costs SME Non-SME Involved in
AfA
Not involved in
AfA
Average time (days spent per company) 46 74 76 53
Average cost (euro per company) euro 18300 euro 32700 euro 32900 euro 22000
Table notes
Sample size = 40 of which 34 respondents provided quantitative data
Two quantitative responses were excluded as they included time spent on preparing AfA
Costs were rounded to the nearest hundred euros
The results unsurprisingly show that SMEs do not spend the same amount of time familiarising
themselves with REACH authorisation as larger companies and that those companies submitting an
AfA invest more time familiarising themselves with the requirements under REACH authorisation
The averages are shown but the estimates at company level do vary as some companies have more
staff involved in regulatory compliance than others different staff costs and many respondents
noted that they may incur further costs due to keeping on top of any policy changes
Impacts of REACH Authorisation Final Report
eftec November 2017 117
672 Costs associated with information on safe use of SVHCs
It is not surprising that only a sub-set of respondents (14) indicated that they incurred some costs
associated with producing an extended Safety Data Sheet (eSDS) The majority (~90) indicated
the cost at up to euro50000 with an even spread between those indicating the cost at euro500-1000
1001-10000 and euro10000-euro50000 Only one respondent indicated a cost above euro50000 (in fact
gteuro200000 which related to biotechnology)
A smaller subset of respondents (9) noted that they incurred a cost to update an eSDS for example
reflecting on further information received from downstream users on their use of the SVHC Two
thirds of respondents indicated the costs of updating an eSDS at between euro500-50000 with the
most common estimate being euro1000-euro10000 A third of respondents indicated the cost at
gteuro100000 (these related to biotechnology aerospace and laundry detergent applications)
Once a substance is on the Candidate List it triggers obligations for article producers and importers
to notify to ECHA and for suppliers of articles to inform recipients on the presence of SVHCs in the
articles following the provisions of Articles 7(2) and 33 of REACH These requirements might not be
easy to meet especially for complex articles (see [Title 4 of REACH] for more details) A subset of
respondents (10) provided costs associated with providing information to allow safe use of an
article Half the respondents indicated the cost to be between euro100000 and euro200000 One
respondent suggested the cost was gteuro200k whilst four respondents indicated the cost at between
euro1-10000
673 Costs following the granting of an authorisation
If an authorisation is granted it requires the registration dossier to be updated (eg if there is
better information on exposure and safe use) Only a subset of respondents (8) estimated the costs
of this update As shown in Figure 68 nearly two-thirds reported costs between euro1000 and
euro50000 A further 25 of respondents reported costs between euro50000 and euro200000 while 13 of
respondents reported costs of more than euro200000
Figure 68 Cost to update registration dossier following granting of an authorisation
Sample size 8
Impacts of REACH Authorisation Final Report
eftec November 2017 118
If a downstream user uses a substance that is on the Authorisation List (Annex XIV) based on an
authorisation granted to an applicant high up in their supply chain they have to notify (for free)
their use to ECHA54
Based on just (screened) responses received from downstream users who have to submit a
notification the estimated cost was euro1001 and euro10000 For a single DU to notify ECHA believe it
should only take a few minutes DUs need to follow the link provided eg by the authorisation
holder or at ECHAs website create an account in REACH-IT select your useauthorisation number
from the pick-list and if they wish provide voluntary info on quantity and number of staff for the
use However what may be costly is the obligation in some cases due to the authorisation
decision to report on exposure andor alternatives For practical reasons ECHA have added a
functionality for attaching a file for this purpose at the notification tool The costs could therefore
in part relate to collecting new exposure data costs
The final cost of compliance estimated was the cost incurred by applicants who had reporting
obligations as part of their authorisation decision and for preparing the review report The
majority (gt75) of respondents (9) indicated the cost at between euro1000 and euro50000 (a broadly
even spread between euro1001-euro10000 and euro10001-euro50000) A minority of respondents (lt25)
however reported costs of gteuro200000 These were from applicants related to the pharmaceutical or
aerospace sector The high costs may relate to the costs of preparing a review report where a
short review period was granted costs costs of RMMs stated to be implemented in the post
submission of the AfA andor costs of any monitoring requirements
68 Costs of substitution
This sub-section focuses on the costs associated with substituting SVHCs with alternative substances
andor technologies It is based on the findings presented in Section 5 regarding instances of
substitution and efforts to substitute
681 Costs to switch from an SVHC to an alternative
Most respondents have indicated one-off substitution cost at less than euro1 million (see Figure 69)
and that the net change in operating costs at lteuro100000 per year Unfortunately the cost ranges
included in the survey were too broad to be able to derive precise point estimates of average costs
across the whole sample but if it is assumed that companiesrsquo costs were equal to the lower limit of
their cost range the mean cost per company would be euro15m for one-off costs and euro738k per year
for operating costs even though the majority of companies would be assigned zero additional costs
following this approach This is because of the very high one-off and operating cost increases
incurred by a relatively small number of companiesrespondents
This could mean that where substitution has been financially possible it has been the preferred
strategy compared with applying for authorisation This would then imply that the (intentionally)
material costs of the authorisation process ((i) fees (ii) administrative burden (complexity) and
(iii) costs to prepare for authorisation (iv) costs related to the uncertainty of the outcome of the
authorisation process (v) compliance costs after granting the authorisation (eg improved RMM and
monitoring costs)) are driving substitution because it is a cheaper option compared with a company
applying for authorisation
54 See httpsechaeuropaeusupportdossier-submission-toolsreach-itdownstream-user-authorised-use
Impacts of REACH Authorisation Final Report
eftec November 2017 119
Even though the range of substitution costs for most respondents overlaps with the average
estimated cost of submitting an authorisation application (around euro220k Section 611) it should be
remembered that the authorisation cost covers an extended period of time and assuming a
lsquostandardrsquo review period of seven years means the annual cost of authorisation is below euro40k on
average This is low enough that if firms reporting choosing substitution rather than authorisation
were doing so for financial reasons (rather than lsquoriskrsquo or other non-financial ones) it would be
reasonable to expect more respondents to report substitutions having zero net cost or even
beneficial impacts on profitability overall However as described only a single respondent
reported a substitution of zero net cost and none reported a beneficial one substitution case
studies considered in Chapter 5 also suggested substitutions have generally been cost-increasing
rather than cost-saving This suggests that other non-financial factors are indeed also contributing
to the decision to substitute However for reasons discussed firm conclusions on this topic are not
possible
Figure 69 One off investment costs to implement alternative (substance or process) to an SVHC
Figure 610 Annual net operating costs to use the alternative (substance or process) to an SVHC
The possibility is confirmed however by observing overall survey responses one reason for citing
substitution is due to an internal policydesire to not use an SVHC Another reason is the avoided
time required (and to a lesser extent the cost) for preparing for an application The limited
78
9
13
0 0
lteuro1million
euro1-euro10 million
euro11-euro50 million
euro51-100 million
gteuro100 million
61
28
56
0 0
lteuro100 000 per year
euro100 000 - euro1 million per year
euro1-euro10 million per year
euro11-euro50 million per year
euro50-euro100 million per year
gteuro100 million per year
Impacts of REACH Authorisation Final Report
eftec November 2017 120
possibility of getting a normallong review period if there were alternatives on the market was also
noted An alternative could be preferred even if its cost is much higher than the cost of applying
for authorisation since using an alternative avoids uncertainty and does not limit the businessesrsquo
ability to commit to long term contracts with customers
One of the survey respondents noted that the applicant (their supplier) was not applying for
authorisation for their specific use given the small volume This meant the user was lsquoforcedrsquo to
substitute to an alternative on the market even though the use of this alternative would result in an
inferior product The switch to the alternative was nevertheless a less risky option as the user
believed they would not get a favourable authorisation decision
682 Cost to undertake substitution activities
As mentioned in Section 5 around one in three respondents to the industry survey said they had not
substituted SVHCs but were investigating opportunities to substitute In total 43 respondents were
able to estimate the annual costs spent on substitution related activities (that were set out in
Section 5) As shown in Figure 611 the amount spent per year by respondents is varied but
around half the respondents noted costs between euro10-100k per year
Figure 611 Annual spending on substitution activities
Examining the data further the following observations can be made
The respondents who were also SMEs noted they spent on substitution between euro1kyear
and euro100kyear There were no SME respondents who noted annual investment in
substitution above euro100kyear
Whether the respondent was involved in an AfA or not had no significant relationship to
how much was spent on finding an alternative This would imply the average amount spent
on looking for an alternative is not linked to how far the substance is along the
authorisation process (but that it could be subject to authorisation at some point in the
future) This is supported by the analysis shown in Section 5 whereby 43 of substitution
activities were triggered by placing the substance on the Candidate List in comparison to 7
of substitution activities being driving by applications for authorisation
5
16
28
23
18
55
0
lteuro1 000 per year
euro1 001 - euro10 000 per year
euro10 001 - euro50 000 per year
euro50 001 - euro100 000 per year
euro100 001 - euro1 million per year
euro1-euro10 million per year
euro10 - euro100 million per year
gteuro100 million per year
Impacts of REACH Authorisation Final Report
eftec November 2017 121
The type of use of the SVHC or sector the respondent is from did not seem to have a
relationship with how much was spent on finding an alternative
The findings from the survey regarding the benefits of substitution are covered in Section 76
69 Costs of RampD innovation and investment
According the industry online survey more 80 of respondents (3546) indicated that authorisation
has had an impact on their annual RampD innovation investment spending These relate to the
following substances (in alphabetical order)
12-dichloroethane (EDC)
44-Methylene bis(2-chloroaniline)
Boric acid
Chromium trioxide
DEHP
Hydrazine
Lead chromate
Lead chromate lead styphnate orange lead
methylhexahydrophthalic anhydride
NMP
Not stated
octylphenol ethoxylates
Perboric acid sodium salt
Refractory Ceramic Fibres (RCFs)
sodium chromate
Sodium dichromate
Further details on the specific uses of these substances are listed in Table 627 The list above and
in the Table are organised in alphabetical order to preserve the confidentiality of individual
responses
Table 627 Change in RampD innovation or investment spending (by use)
List of uses (alphabetical order)
Additive for suppressing parasitic reactions and oxygen evolution pH buffering and cathode corrosion protection
Bleachbleach precursor
Buffer substance
Cell lysis during manufacturing of vaccines
Coatings and sealants
Conditioning of the plastics in the pre-treatment and for the final plating
Curing agent of polyurethane
Decorative plating
Electroplating of injected plastic parts
Etching and plating plastic parts
Galvanic surface coating
Hardener for epoxy resin
Ingredient used in surface treatment processes to deliver a barrier film
Insulation material
Impacts of REACH Authorisation Final Report
eftec November 2017 122
List of uses (alphabetical order)
Manufacturing of pharma active ingredient
Metal Acid reaction inhibitor
Passivation of tin plating
Pigment
PLASTIC ETCHING (POP)
Plasticizers in tape
Plating of steel bars
Precursor for ClO2 generation
Pre-treatment of plastics
Solvent
Solvent used in the manufacture of APIs
Use as a reduction agent
Used as a Viral inactivation in API manufacturing processes
Various pyrotechnic mixtures
Respondents were asked for each use whether there was an increase or decrease in spending as
well as the option to not state a response As set out in Table 628 most respondents indicated
both an increase in innovation and investment and RampD spending as a result of the REACH
authorisation process
Table 628 Change in innovation investment and RampD spending
Change in annual spending
Number of respondents
Increase Decrease Didnrsquot state
Innovation and investment spending 26 (67) 7 (18) 6 (15)
RampD spending 28 (72) 5 (13) 6 (15)
Those respondents that indicated a change in spending were then asked to estimate (from a given
list) the scale of the change in annual spending (see Table 629) The results give more insight into
the scale of these changes reported increases in spending are generally lower than reported
decreases Therefore it is possible that the net impact of authorisation could be a decrease in
spending but it is not possible to say either way given the sample size
Table 629 Scale of change in innovation investment and RampD spending
Annual spending change
No respondent reporting a change in innovation investment spending
No respondent reporting a change in RampD spending
Increase Decrease Increase Decrease
lteuro1k 1 - 1 -
euro1k-10k 2 - 2 -
euro10k-euro50k 4 1 5 1
euro50k-100k 2 - 3 -
euro100k-1 million 3 4 7 1
euro1million-10million 3 - - -
euro10million-100million - 1 - 1
gteuro100million - - - 1
TOTAL 15 6 18 4
71 29 82 18
Impacts of REACH Authorisation Final Report
eftec November 2017 123
When asked if there were other factors that may have been responsible for these changes in
spending most respondents said there was not (59) whilst some said yes (23) and others did not
know (18) The main other driver for changes in spending was existing internal policies to try to
substitute away from the substance
Some of the qualitative justification respondents provided for their monetary estimates also reveal
some interesting insights
Several respondents noted that they would accelerate spending on RampD and investment to
substitute away from the SVHC However this would be funded by a decrease in spending
on developing new markets and products Some money needs to be spent doing intensive
testing of possible alternatives including laboratory testing pilot testing and spending on
raw materials and staff
Several respondents noted that many investments are based on long term planning that
pre-dates when the authorisation process starts Authorisation may not stop these plans
but would put into question if the production occurs in the EU if the continued use of the
substance is essential for the new productsmarket
One respondent noted that as ldquoeasyrdquo (eg drop in replacements) solutions have not been
identified the efforts have turned into long term projects that have required steady
funding The priority focus has been on ldquobig hitterrdquo processes where they believe they can
get the most reduction in the use of the substance and employee exposure for the budget
available With the onset of REACH the overall budget for RampD must now include REACH
compliance This has necessitated the redirection of some researchers to non-RampD activities
in support of REACH This includes supporting development and review of AoA documents
and attention spent on smallspecialty use cases
One respondent noted a diversion of investment from their EU sites to their sites outside
the EU They nevertheless expected to increase spending within the EU to find an
alternative in order to continue operations at their existing EU sites
Several respondents noted a halt in investment until the outcome of the authorisation is
known One respondent noted invest was being diverted to Switzerland where the
continued use of chromium trioxide is secured for the next 20 years
610 Costs of closure and relocation
Costs covered in this section are those incurred by firms which have no suitable alternatives to an
Annex XIV substance but which do not apply for authorisation to continue their use Instead they
choose to comply with the requirement to cease their use in the EEA by the sunset date by closing
their operations entirely or relocating them to another country outside of the EEA
Closurerelocation has been the lsquonon-usersquo scenario in the majority of applications for authorisation
submitted and publicly available end of 2016 It is reasonable to expect firms which choose to close
or relocate to face the same types of costs as those which have them only as non-use scenarios in
their applications for authorisation ndash even though it is not reasonable to assume the same
magnitude of costs faced by these two groups as explained below This means that descriptions of
non-use scenarios contained in applications for authorisation are useful for characterising the costs
of closure and relocation as a response to authorisation Examples of these costs can be
summarised as follows
Impacts of REACH Authorisation Final Report
eftec November 2017 124
Demolition site closure and remediation ndash Some costs might be offset by revenues from
plant and land sales
Redundancy costs and temporary unemployment ndash Note that redundancy payments
themselves are transfers from employers to employees so do not count as social costs
Unemployment insurance payments are excluded for similar reasons Temporary
unemployment can have costs in terms of lost output job search and deskilling (scarring)
which can be (partly) offset by increases in leisure time availability
Site acquisition buildings plant project management and recruitment and training at the
new site ndash Some costs might be offset if the company already owns suitable spare capacity
andor can transfer assets and employees (at a cost) from the old site to the new site
Temporary profit losses as a result of reductions in output during relocation or until the end
of the natural life of the assets In principle such profit losses (and other costs) can be
experienced both up and down the firmrsquos supply chain and
Outsourcing transport and inventory costs ndash Firms might need to outsource production to
maintain output during relocation projects as well as face additional transportation and
inventory costs in shipping output back to EU markets Some of these costs might be offset
by reduced costs elsewhere (eg production cost savings from closure and lower transport
costs for markets nearer the new site)
Note that impacts on the competitors of firms which close andor relocate are generally not
included explicitly in the cost assessment This is because they are captured implicitly by the
assumption of a finite length of time of impacts ndash and hence costs ndash of the closurerelocation after
which it is assumed that the level of output and profit returns to pre-closure-relocation levels If
competitors increase their output in response to an increase in demand following the closure of the
firm in question this can usually only happen with an increase in spending on capacity and
production which tends to take time What is important with closure and relocation is that they
will generally involve the premature obsolescence (and hence loss) of valuable productive capital
and the incurrence of additional investment in productive capital which would not have been
necessary otherwise Whether these are incurred by the lsquoauthorisation firmrsquo or its competitors is a
distributional question There might be some temporary increase in profit for competitors if they
are able to increase their prices in response to the increase in demand from customers of the firm
which closes but any such benefit is in reality a transfer away from customers and will be
associated with a loss in consumer surplus ie a net loss from the societal perspective Only if
competitors have excess capacity available and can supply a product of equivalent quality and price
can we assume that there will be no net societal loss ndash and in general we will not be able to
assume that is the case
The non-use scenarios included in applications for authorisation are hypothetical since they are
only proposed to apply in the event that the authorisation application is rejected and no
application has been rejected yet In addition the estimated costs of these hypothetical
closurerelocation non-use scenarios can be expected to differ from the costs of
closuresrelocations which actually do occur because clearly firms which apply for authorisation
consider the expected costs of authorisation to be lower than the expected costs of
closurerelocation Firms which choose to closerelocate on the other hand clearly expect the
opposite situation ndash that the costs of authorisation (including an assessment of the probability that
authorisation will be granted) will be greater than the costs of closurerelocation The costs of
compiling and submitting the application itself are relatively predictable (see Section 611) even
Impacts of REACH Authorisation Final Report
eftec November 2017 125
though there could be (potentially significant) additional costs in any specific case where a firm
must reduce its exposures and otherwise improve its risk management measures The costs of
closurerelocation estimated for non-use scenarios are generally relatively high (eg euromillions) but
could in principle be lower in specific cases for instance where the relevant operations are a small
part of a larger site (so the site itself will not need closure) employ few workers and there is
already a suitable alternative site operational Finally discussions with industry suggest that firms
often seem to place a significant risk premium on the authorisation route associated with the
(perceived) uncertainty over the initial authorisation decision and with the continued cost and
(perceived) uncertainty from the need to reapply for authorisation at the end of the review period
This premium could be the explanation if a firm chooses to close andor relocate its operations
even when the (financial) costs of authorisation would appear to be lower
Nevertheless in general it is reasonable to expect firms which apply for authorisation to be facing
different cost magnitudes from those which choose to close andor relocate This is why the
estimated costs of closurerelocation non-use scenarios presented in applications for authorisation
are not expected to be good indicators of the costs of closures and relocations actually
implemented by firms as a means of complying with the need to cease use of a substance by its
sunset date This in turn means that estimates of these costs can only be obtained from firms which
actually have closed or relocated which first requires these firms to be identified
In the consultation with industry only three respondents reported that their companies had
undertaken closures or relocations as a means of complying with the requirement to cease the use
of a SVHC by its sunset date and none of these respondents was willing to provide comprehensive
information on these activities including on costs One respondent who reported a closure was
actually predicting what they thought would happen in the event they were unable to continue
their use of their SVHC Anonymised details of these three respondents and responses are provided
in Table 630
Table 630 Industry consultees reporting relocation or closure in response to authorisation
No Substance Use and sector Relocationclosure Notes
1 Sodium
dichromate
Sensitiser used in
engraving of printing
screens
Relocation No reported impact on
employment
2 Chromium
trioxide
Corrosion inhibitor used in
aerospace
Diverted
investment
3 Confidential Surface treatment of
aluminium and steel Relocation Impact on employment
4 octyl phenol
ethoxylates Life sciences Relocation Case 3 chapter 53
5 Nonyl phenol Fine chemicals Closure Case 7 chapter 53
Respondent 1 reported using sodium dichromate as a sensitiser in the engraving of printing screens
This use had been relocated out of the EU No impact on employment was reported suggesting that
this could be a relatively minor use A further use of sodium dichromate as a sensitiser was
reported to have been substituted with a diazo compound No explanation was given as to why the
engraving use had been relocated instead of authorisation being sought However if it were a
minor use this could imply a relatively low cost of relocation compared with authorisation REACH
authorisation was seen as the only reason why this relocation had occurred
Respondent 2 reported using chromium trioxide for its corrosion resistance in the aerospace sector
This respondentrsquos use of chromium trioxide was continuing in the EU under a granted authorisation
Impacts of REACH Authorisation Final Report
eftec November 2017 126
However the company had recently switched an investment in chromium trioxide-based plating
which was planned for an EU country to a country outside of the EU The reason given for this was
the length of the review period of the authorisation which it was said was too short for the
investment planning required for this new project
Respondent 3 reported that the use of a confidential SVHC in the surface treatment of aluminium
and steel had ceased in the EU with impacts on jobs but no further details were provided (It is
not clear whether this relates to the respondentrsquos own use or anotherrsquos) It also reported having
relocated two production plants outside of the EU but no further details were provided
The case of respondent 4 is described in case 3 in Chapter 54
Because of the lack of information provided by these respondents a brief review was undertaken of
a small number of public applications for authorisation which had closure or relocation as their non-
use scenario Table 631 summarises these applications It reports the name of the applicant the
substance and use applied for the nature of the non-use scenario an assessment of cost and the
time over which it was estimated and any pertinent notes Because many applications do not
include financial figures in their public versions the cost figures given in Table 631 are those
reported in the associated SEAC opinion and are therefore subject to confidentiality ranges
Table 631 Estimated closure and relocation costs from selected applications for authorisation
Applicant SVHC Use NUS SEAC cost Time Notes
Parker Hannifin
TCE Process solvent for the manufacturing of modules containing hollow fibre gas separation membranes
R euro75-150m NPV
18 95 profit
Laboratoires Expanscience
EDC Process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients
C gteuro100m 12 Lost profit
Rimex Metals (UK)
Chromium trioxide
Oxidising and hardening agent in the manufacture of coloured stainless steel
C lteuro100m pa 10 Lost profit (99 customers)
Circuit Foil Luxembourg
Arsenic acid
Treatment of copper foil used in the manufacture of Printed Circuit Board
R euro300-400m 7-12 Lost profit
Topocrom Chromium trioxide
Functional chrome plating for the establishment of adjustable hemispherical surface structures
C euro5m 15 Lost profit unemployment
Veco
Ammonium dichromate
Photosensitive component in a photolithographic lacquer system
R euro10-17m 7 Lost profit unemployment relocation costs
Eli Lilly EDC Reaction medium and a solvating agent in the manufacture of an API
R euro6-20m 14 Decommissioning outsourcing (profit loss excluded)
Notes Substances ndash TCE trichloroethylene EDC ethylene dichloride Non-use scenario ndash C closure R relocation
This selection is in no way representative and is provided just to give a sense of possible
magnitudes of costs included in authorisation applications It can be seen that a few applications
have relatively low (euro5m-euro20m) costs whereas others have costs estimated to run into several
hundred million euros Closure and relocation costs themselves tend to represent a relatively small
proportion of these totals which tend to be dominated by losses in profit (from the destruction of
the capital stock or relocation of the capital stock outside of the EU) These costs are orders of
magnitude higher than the costs of applying for authorisation (Section 611) which would explain
(partly) why these companies choose to apply for authorisation rather than to relocate or close As
Impacts of REACH Authorisation Final Report
eftec November 2017 127
already discussed we expect the costs of closure and relocation to be significantly different
(higher) for applicants for authorisation than for companies which actually close or relocate
However if the costs in Table 631 are representative of the costs companies face from closure or
relocation it would go some way to explaining why so few examples of closurerelocation have
been reported in the consultation
611 Costs to apply for authorisation
Costs covered in this section are those incurred by applicants in compiling and submitting
applications for authorisation and then engaging with the application process post-submission
Costs to other parties engaged in this process are covered in other sections
Since the authorisation application process started in 2013 ECHA has used an applicant survey to
collect information on the costs to applicants of preparing and submitting an application This
survey collects information on the lsquodirect costsrsquo of the application and the amount of lsquointernal
staff timersquo expended lsquoDirect costsrsquo are defined as follows
Preparation of assessment reports
Handling of the application process (overhead project management legal advice etc)
Consortium fees
Expenses (travel hotel and meeting rooms etc) and
Application fees (payable to ECHA)
ECHA has provided these figures in terms of the mean per applicant per use applied for These have
been calculated by taking the simple average of each respondentrsquos estimated mean cost per use
That is for each respondent the total reported cost of their application is divided by the number
of uses they applied for to give a cost per use for each respondent and then the average of these
figures across all respondents is calculated Thus the simple averages reported do not take account
of the characteristics of the respondent or the application Although it is not clear what weighting
if any should be given to the figures from different respondents the fact that those reported here
are unweighted should be born in mind
A breakdown of these figures by size of applicant position in the supply chain and authorisation
route was also provided by ECHA To aid comparison the estimates of direct costs and internal
staff time expended have been converted into a total mean application cost per use using a
notional euro75000 per year total (including overhead) wage cost for internal staff
Application fees paid to ECHA are included in the application cost figures in the survey but reflect
costs incurred by ECHA in processing the application and hence have been included in the section
on costs to ECHA It has not been possible to identify the actual fees paid by individual respondents
to the ECHA survey so fees have been estimated in terms of the average per use for each class of
applicant covered in Tables 69 to 612
Table 632 presents application cost information reported by all survey respondents over the period
2013-2016 Direct costs and fees are reported in euros and internal staff time in person-months
Means reported in the final row of the table are averages of each yearrsquos figures weighted by the
number of respondents in that year It can be seen that on the basis of responses from 57
applicants covering 101 uses over four years the mean direct costs per use were just over
euro100000 and the mean number of internal staff months expended per use was just under 10 The
average fee paid was just under euro40000 per use (This compares with the figure derived in Section
643 of euro51000) Reported costs were clearly highest in the first year of applications (when the
Impacts of REACH Authorisation Final Report
eftec November 2017 128
survey response rate was also highest) but since then there has been no clear trend Given the
variation in application types substances etc and the low response rate in some years it is not
possible from these data to say whether application costs have changed over this period
Table 632 Reported mean application costs per use and applicant 2013-2016 (source ECHA)
Direct costs
exc fees
(eurok)
Fees
(eurok)
Internal
staff time
(months)
Notional
total cost Respondents Uses
Total
applicants
Response
rate
2013 19693 3656 1621 33480 8 25 14 57
2014 8043 4033 47 15014 14 23 30 47
2015 7916 3702 1051 18187 14 23 70 20
2016 9617 3929 1072 20246 21 30 82 26
10227 3860 996 20312 57 101 196 29
including co-applicants
ECHA has provided a breakdown of these figures by size of applicant position in the supply chain
and authorisation route To aid comparison the estimates of direct costs and internal staff time
expended have been converted into a total mean application cost per use using a notional euro75000
per year total (including overhead) wage cost for internal staff Thus the total mean application
cost per use across all respondents to the ECHA survey is just over euro200000 (Table 632) This can
be compared against the broken-down figures in the following tables Tables showing a greater
level of disaggregation are provided in the confidential annex
Table 633 presents reported mean notional total application costs per use broken down by the
position in the supply chain of the applicant It can be seen that over 2013-2016 the majority of
applicants (146 out of 196) have been downstream users with a survey response rate of around 13
for this group The next largest category is importers but only 3 out of 20 importers have
responded to the ECHA survey
It does appear generally that applications submitted by manufacturers (euro273000) and importers
(euro262000) have tended to be more expensive per use than those submitted by downstream users
(euro159000) with those submitted by only representatives (euro88000) being cheapest of all Fees
appear comparable across groups except for only representatives who have paid lower fees per
use perhaps reflecting economies in application costs However as can be seen from the more
detailed annual figures presented in the confidential annex there is sufficient variation in these
figures to make firm conclusions impossible In addition numbers in different categories are small
enough by year that as with the overall figures reliable time trends cannot be drawn on the basis
of these data
Impacts of REACH Authorisation Final Report
eftec November 2017 129
Table 633 Reported mean notional total application costs per use and applicant by supply chain position 2013-2016 (source ECHA)
M I OR DU MI IDU
IC F TC n(N) IC F TC n(N) IC F TC n(N) IC F TC n(N) IC F TC n(N) N IC F TC n(N)
273 37 310 3(10) 262 40 302 3(20) 88 17 105 3(10) 159 41 196 46(146) 145 34 179 2 2 - - - 0(7)
Key
M = manufacturers I = importers OR = only representatives DU = downstream users MI = manufacturer-importers IDU = importer-downstream users
IC = internal notional cost F = application fee TC = total notional cost
n = number of survey respondents in category
N = total number of applicants in category
Table 634 Reported mean notional total application costs per use and applicant by company size 2013-2016 (source ECHA)
Large Medium Small Micro
IC F TC n N IC F TC n N IC F TC n N IC F TC n N
179 42 221 48 151 119 38 156 3 18 95 16 112 4 17 32 5 37 2 10
Key
IC = internal notional cost F = application fee TC = total notional cost
n = number of survey respondents in category
N = total number of applicants in category
Impacts of REACH Authorisation Final Report
eftec 130 November 2017
However one aspect which is worth drawing attention to is the fact that the costs per user rather
than per use are likely to vary significantly across applications by supply chain position
Downstream user applications seem to be cheaper than manufacturersrsquoimportersrsquo but only cover
the bottom of the supply chain ndash essentially a single user Manufacturersrsquo and importersrsquo
applications cover the whole supply chain and hence potentially at least all users (for a given
use) The cost per user therefore is likely to be significantly lower for upstream than for
downstream applications
Table 634 presents reported mean notional total application costs per use by company size The
first thing to note is that the vast majority of applications have been from large companies (151
applicants out of 196) Large companies make up an even bigger proportion of survey respondents
(48 out of 57) Due to the very low number of respondents from non-large companies it is not
considered possible to draw conclusions about application costs for different-sized companies
Table 635 Reported mean notional total application costs per use by application route 2013-2016 (source ECHA)
Adequate control Socio-economic Analysis
Notional
internal cost Fee
Notional
total cost n(N)
Notional
internal cost Fee
Notional
total cost n(N)
272 40 311 8(18) 147 38 185 49(178)
n = number of survey respondents in category
N = total number of applicants in category
Table 635 presents reported mean notional application costs per use by the route of application
ie lsquoadequate controlrsquo or lsquosocio-economic analysisrsquo The vast majority of applications (178 out of
196) and respondents (49 out of 57) followed the SEA route and hence drawing conclusions on the
relative costs between application routes is difficult It should also be remembered that although a
SEA is not required for applications under adequate control ECHA does advise all applicants to
compile one as a fall-back if adequate control is not demonstrated and to provide support for
other aspects of the application (eg the requested review period) However one aspect which is
worth drawing attention to is the fact that the costs per user rather than per use are likely to
vary significantly across applications by supply chain position Downstream user applications seem
to be cheaper than manufacturersrsquoimportersrsquo but only cover the bottom of the supply chain ndash
essentially a single user Manufacturersrsquo and importersrsquo applications cover the whole supply chain
and hence potentially at least all users (for a given use) The cost per user therefore is likely to
be significantly lower for upstream than for downstream applications
Table 635 suggests that applications under adequate control have not generally been cheaper
than those under the SEA route However the sample size is small and these applications might
also have included a SEA anyway so drawing conclusions is difficult
As already noted these cost estimates apply to pre-submission activities only ECHA has recently
started undertaking a survey of applicantsrsquo post-submission activities These are specified in the
survey to include
Responding to requests for additional information by RAC and SEAC
Responding to public consultation comments
Participating in the trialogue meeting with RAC and SEAC rapporteurs (if one is held) and
Providing comments on the draft opinions
Impacts of REACH Authorisation Final Report
eftec 131 November 2017
The first results of this survey have been provided by ECHA and are presented in Table 636 Direct
costs are reported in euros and internal staff time in person-days Using the same notional euro75000
figure for a full-cost FTE these figures are translated into a notional total cost for applicants
during the opinion-making phase The mean notional total cost reported by applicants was just
under euro17000
Table 636 Reported notional total costs for applicants in the opinion-making phase (source ECHA)
Direct costs
(consultants fees) euro
Internal staff
time
(person days)
Notional total cost Number of
respondents Number of uses
euro13670 8 euro16526 29 49
This implies that the total (notional) cost of applying for authorisation has averaged around
euro180000 per use over the period 2013-2016 with an additional euro40000 paid to ECHA in application
fees Application fees have not apparently changed significantly over time although the number of
applications has increased markedly
612 Costs to improve risk management
This sub-section focuses on the costs associated with improving risk management of SVHCs Further
details of the uses where improved risk management took place as well as details of the measures
are set out later in Section 73 (benefits of improved risk management)
In total (n=57) 40 of industry survey respondents indicated that they had improved risk
management of SVHCs as a result of the authorisation process As set out in Figure 612 most
stages in the authorisation may trigger improved risk management This suggests that companies do
not wait until the substance is placed on the authorisation list before carrying out further risk
management
Figure 612 What authorisation stage triggered these risk management activities
However it is not surprisingly that most respondents noted the applications for authorisation stage
as a key driver for improving risk management as it is legal requirement (art 6010) for applicants
to show minimisation of emissions as part of their application Whilst there is pressure to make sure
exposure and emissions are as low as possible there are examples with TCE (as publicised in AfA
opinions) where the RAC have recommended to SEAC to grant shorter review periods when there
15
27
815
35
0Screening of substance and Risk ManagementOption Analysis (RMOA)
Inclusion of substance in Candidate List
Recommendation for inclusion of substance inAuthorisation List (Annex XIV)
Inclusion of substances in Annex XIV
Applications for authorisation (AfA)
Post-authorisation decisions (eg after sunsetdate of Annex XIV substance)
Impacts of REACH Authorisation Final Report
eftec 132 November 2017
was not sufficient evidence of minimisation of emissions as well as imposing additional conditions
to improve RMMs andor monitoring requirements This is despite the evidence that a longer review
period was justified from an SEA perspective
Respondents were asked to indicate the one-off cost incurred by their organisation in implementing
these risk management activities of which a subset (n=22) were able to quantify these one-off
costs As shown in Figure 613 around half of respondents indicated the costs to around (euro10k-
100k) even though a third of respondents spent over euro100k Assuming that each company spent a
figure equal to the bottom limit of its cost range this would put the average spend per company at
just under euro140k With 200 applicants for authorisation over four years this might suggest an
annual one-off cost of around euro7m This figure is extremely uncertain however given the small
sample number of respondents
Figure 613 Estimated one-off cost of risk management activities
Examining the data further the following observations were found in the data
The respondents who were also SMEs noted they spent between euro1k and euro100k There
were no SME respondents who noted risk management investment above euro100k The risk
management investments above euro100k have therefore been carried out by non-SMEs
Whether the respondent was involved in an AfA55 or not had no significant relationship to
the average spend on improving risk management
However what could be observed (but cannot be generalised given the smaller sample size)
from the data was that the higher risk management investment seemed to be linked to the
earlier stages in the authorisation process This could be explained because
o There is more time for companies to plan for such improvements at RMOA and
candidate listing stage as well as fewer constraints on resources (financial and
human) whereby companies do not need to also prepare for an application for
authorisation There is also an incentive for companies to improve their RMMs as it
may affect their prioritisation to Annex XIV and reduce uncertainties concerning the
outcome of evaluations made by authorities on the applications for authorisation
55 This includes both applicants and downstream users covered by the application
9
14
41
27
9
0
euro0-euro10 000
euro10 001 - euro50 000
euro50 001 - euro100 000
euro100 001 - euro1 million
euro1-euro10 million
gt euro10 million
Impacts of REACH Authorisation Final Report
eftec 133 November 2017
o There could be pressure at sectorconsortia level to drive down exposure in the
supply chain once a substance is on the candidate list so that regulators prioritise
other SVHCs for authorisation
o Applicants have already invested to reduce exposureemissions earlier in the
process so there are fewer options available at AfA stage
The effectiveness of these measures are set out later in Section 73 which sets out survey results on
the benefits of improved risk management on human health and the environment
613 Summary of costs
This chapter has covered a wide variety of different types of cost associated with the authorisation
process including administrative costs of running and engaging with the process costs of improving
risk management measures costs of substitution and costs of closure and relocation
Administrative costs of running the authorisation process incurred by ECHA MS CAs and the EC
appear to amount to around euro84million per year (euro43m for MS CAs euro3m for ECHA and euro11m for
the EC) Application costs (excluding fees) might be estimated at a similar ballpark figure of
euro9million per year (50 uses per year at euro180k per use (Table 631)) although subject to significant
variation given the variation in the annual number of applications Costs of additional risk
management measures associated with these applications are difficult to estimate given the nature
of responses to the survey but might add another euro7million per year (50 applicants at euro140k per
applicant Section 612) This figure is extremely uncertain however given the small sample size
of respondents Costs to stakeholders associated with providing comments and so on are not
estimated here due to the very small number of survey responses received
The total costs of risk management measures introduced because of authorisation are difficult to
estimate but might add another euro7million per year assuming that all applicants implement them
(50 applicants at euro140k per applicant see Section 612) This figure is extremely uncertain
however given the small sample number of respondents
The total costs of compliance by companies affected by REACH Authorisation RampD activity
substitution and relocation are impossible to calculate because the total number of firms that
might have engaged in these activities is unknown This also explains why extrapolation of the
costing results to the EU-level is not feasible Section 67 of the main report suggests the costs of
compliance are likely to run into thousands (possibly tens of thousands) of euros per company
which could make them significant at an aggregate level
Substitution costs are uncertain due to the design of the survey used in the study with a large
proportion of respondents (78) reporting one-off substitution costs in the euro0-euro1m range However
for reasons discussed in Section 681 despite it being cheaper for these companies (at least in the
short term) to apply for authorisation these firms have chosen to substitute away from an SVHC
instead In addition it would take only a relatively small minority of firms to experience very high
costs of substitution to raise the average cost (eg euro15m one-off costs and euro768k operating costs
per year based on proportions reported in the survey) Only one respondent reported a substitution
which had no net costs and none reported cost savings
Authorisation requires that there are no suitable alternatives available to the applicant ndash defined
operationally by ECHA as (amongst other things) not entailing an increase in overall costs All but
one of the examples identified would entail an increase in overall costs and hence the applicant
Impacts of REACH Authorisation Final Report
eftec 134 November 2017
may have been able to demonstrate they were not suitable ndash meaning that the firms in question
would in principle be eligible for authorisation Despite this they have elected to substitute
suggesting they have placed a premium on regulatory certainty and other factors associated with
avoiding the Authorisation process altogether
It is not possible to provide a reliable estimate of the total costs to third parties associated with
providing comments during the three public consultation stages in the Authorisation process ie
relating to (i) inclusion of a substance on the candidate list (ii) the recommendation of substances
to Annex XIV and (iii) an application for Authorisation The average time spent per submission
varies from up to 1 day to 40 days depending on the type of public consultation and stakeholder
For example tradesector associations can spend a lot of time preparing responses compared to
individual companies and NGOs Due to the small number of responses received to the survey on
this topic and variability in the estimates provided it is too speculative to derive a total cost
Costs of authorisation
Costs to EU public authorities ~euro84million per year
Costs to EU applicants ~euro9million per year
Costs of additional RMMs associated
with these applications
~euro7million per year
Costs of substitution Not possible to estimate the total costs without knowing how
many firms in the EU have substituted One off costs
estimated at lteuro1million per company (mean ~euro15million per
company) and euro768k annual operating costs per company
Costs of compliance Not possible to estimate the total costs without knowing how
many firms are affected The costs of compliance are likely
to run into thousands (possibly tens of thousands) of euros
per company which could make them significant at an
aggregate level
Costs to third parties Not possible to estimate a total cost due to limited
responses The average time spent per submission varies
from up to 1 day to 40 days depending on the type of public
consultation and stakeholder
Impacts of REACH Authorisation Final Report
eftec 135 November 2017
7 BENEFITS FROM THE AUTHORISATION PROCESS
71 Introduction
Assessing the benefits from the REACH authorisation process is the fourth of the five focus areas
assessed The key benefits are expected to be the reduction in risks to human health and
environment as a result of the reduced use of a substance and through the improvement of
operational conditions (OCs) andor risk reduction measures (RMMs)
In theory reduced use (due to substitution) is associated with elimination or reduction of exposures
and releases which were occurring during the use but also of exposures and releases due to
preceding and subsequent stages (eg manufacture unless export will replace the ceased use in
the EEA article service life waste stage) In practice the applications so far have seen very few
cases where the substance is still present in the article The impact on the manufacturing stage was
also limited as in several cases the majority of the manufacturing was for intermediate use
Furthermore substitution does not only eliminate the risks from scenarios of reasonably
foreseeable use but also from occasional accidents or micro-accidents involving the use (or even
eg road transfer) of the substituted SVHC To what extent the substitues consist of an actual
reduction of risks is mostly untested For example the impact on risk of the use of a solvent with
SVHC properties with a high ignition temperature (non-ATEX regulated) versus the use of a non-
SVHC solvent with a lower ignition point is difficult to make
lsquoInternalisationrsquo of SVHC risks into firmsrsquo decision making could benefit them in several ways First
substitution of an SVHC could reduce production costs due to the reduced need for control
measures There could also be a lsquohousekeepingrsquo effect whereby actions the firms adopt to reduce
their SVHC use and emissions could increase overall production efficiency and hence reduce costs
Better risk and exposure management processes could also be implemented even if continued use is
allowed andor substitution is not possible
There are two approaches to estimating these benefits and linking them or a proportion of them
to the requirements of the REACH authorisation The first is to use the lsquono REACH authorisationrsquo
baseline This involves estimating what would have happened to use of SVHCs exposures and the
populations at risk of these exposures (eg workers local residents etc) without REACH
authorisation and compared them to what happened with it The difference is the net benefit (or
indeed cost) of the authorisation The challenge here is that the lsquono REACH authorisationrsquo baseline
is usually not known The second approach is to compare use exposure and population before and
after the REACH authorisation (at a firm or market level) The challenge here is that there are
usually many factors that lead to changes in the same period making it at best very difficult to
apportion the benefits to REACH authorisation (or indeed any other single factor)
This is not a challenge faced by this study alone Indeed there is a developing literature on what
the benefits could be and what indicators could be used to measure them For example Okopol
undertook a review of many early studies56 However as with costs studies have generally not
focused on authorisation specifically and have been undertaken prior to the authorisation process
achieving full implementation The Okopol review also states that studies have not generally
distinguished clearly between the true benefits related to improved societal outcomes and those
that relate to intermediate outcomes or distributional changes For instance lsquobetter conditions for
56 httpeceuropaeuenvironmentchemicalsreachpdfbackgroundreach_benefit_studiespdf
Impacts of REACH Authorisation Final Report
eftec 136 November 2017
innovationrsquo which is mentioned as a benefit of REACH authorisation simply reflects a change in
the relative cost of using SVHCs versus using non-SVHCs and it can come about due to any ensuing
innovation not only REACH authorisation
A total different approach on evaluating the benefits of authorisation would be by comparing the
benefits if different risk management options were adopted This approach has not been followed
in this report This is evaluated in a Risk Management Option Analysis In such an analysis the
properties and the effects of each option are evaluated in a specific case to select the best RMO
which best manages the concern related to the use of a SVHC For instance what in one case is a
benefit of authorisation could consist of a disadvantage in another RMO A detailed analysis of
these choices is outside the scope of this report which focus on the actual impact of the
authorisation process not on the relative impact compared with other RMOs In that sense a
benefit for the authorities of Authorisation is that there is an additional regulatory tool available to
manage the risks associated with the use of a substance
EC (2016) reported the development of a system of indicators for the calculation of the benefits of
chemicals legislation57 and differentiates between Output Result and Impact indicators
Output indicators relate to the activities of regulators to implement the legislation (eg
number of substances with harmonised classifications) This type of indicator is of less
relevance for this project because the number of classifications that are harmonised (CLH)
does not in itself lead to any benefit to health or the environment ndash it just means that the
classifications are now agreed upon However CLH hazard warnings and labels can lead to
differences in the way the substances are handled and used that could bring about a
benefit (this would be a lsquoresults basedrsquo indicator)
Result based indicators for the benefit of authorisation are reduced use of a substance
exposure of workers and emissions to environment However even these indicators are
difficult to populate with data to assess what proportion of these reductions are due to the
authorisation process per se
Impact based indicators relate to the net effect on humans or environment such as the
occurrence of occupational diseases or the diversity of fauna and flora Because of the
multiple factors that influence the effects like the occurrence of diseases it is deemed not
possible to use this kind of impact indicators to estimate the benefit of authorisation
Therefore other albeit proxy indicators are needed to measure the benefits of authorisation For
example one indicator could be the comparison of the change in the market share of all chemicals
versus SVHCs (see Section 4) However some substances such as TCE are also marketed for uses
which are not subject to authorisation which makes it more difficult to interpret that data
Therefore such proxy indicators are also not conclusive and difficult to apportion to authorisation
with certainty
Several Member States maintain databases to collect worker exposure data for carcinogens These
databases should allow a detailed assessment of the evolution of the workers exposure over time
Within the context of this report access was requested to the databases of the Belgian German
French and Italian authorities None was able to provide detailed data The Belgian authorities
shared a recent dataset on exposure data for CrVI but no historical values Extensive discussions
57 Study on the Calculation of the Benefits of Chemicals Legislation on Human Health and the Environment
Development of a System of Indicators April 2016 prepared by RPA DHI for DG Env
Impacts of REACH Authorisation Final Report
eftec 137 November 2017
were held with the responsible authorities of the German MEGA database which contains historical
data for more than 10 years However it was not possible to share more than what is already
available in public literature which comprises reports issued on a regular basis by these
authorities In the absence of large historical datasets on worker exposure the benefits from the
authorisation process on worker exposure can only be inferred from the reported (measured) data
in AfA and through the interviews and online surveys done for this present project
This section presents the information on the benefits of authorisation that was possible to compile
from literature review the responses to the on-line survey and some specific case studies both for
worker exposure and for environmental emissions Where possible the following aspects are
covered (i) at what stage in the authorisation process benefits occur (building on the analysis in
Section 3) (ii) what changes along the supply chain result in benefits (iii) who benefits (iv) how
the benefits realised compare to what was expected (eg if there are any unexpected benefits)
and (v) how benefits are changing over time
The section contains the following sub-sections covering the benefits included in this analysis
Section 72 Literature review ndash summaries the key findings from existing studies
Section 73 Survey responses ndash overviews the responses from the survey
Section 74 Human health benefits from improvement risk management
Section 75 Environmental benefits from improvement risk management
Section 76 Benefits of substitution
Section 77 Benefits to alternative suppliers
Section 78 Benefits of better information
Section 79 Other benefits and
Section 710 Summary of benefits
72 Summary of literature review
The review of existing literature focused on the major and influential sources in this area A more
detailed review can be found in Annex E6 The summary here pulls together key messages in terms
of the impacts of authorisation
The majority of the reports reviewed analysed the impacts of REACH and other associated
legislation rather than the process of REACH authorisation In fact only one of the reports
specifically targeted authorisation
In common with this study a number of the studies had made use of consultation with stakeholders
to compile information In general there is little reporting of quantitative benefits however there
were indications that substitution had improved worker safety as well as lsquosofterrsquo benefits such as
improved brand reputation and worker satisfaction (eg Tickner J and M Jacobs 2016) Positive
reports are made of the authorisation process triggering activity on searching for alternatives to
SVHC even though such reports are anecdotal and at a single Member State level (eg Backes D
2017) The encouragement of substitution and widening of the market for alternatives is also
reported (Lietzman et al 2017) Another study specific to a Member State (Finland) and
authorisation indicated that energy consumption labour productivity and chemical portfolio as
examples of benefits Only one benefit described as lsquoclearrsquo by the authors was identified in the
form of micro-sized companies improving their communication networks with each other (Harrikari
and Montonen 2017)
Impacts of REACH Authorisation Final Report
eftec 138 November 2017
Other reports focused on case studies with specific substances ndash the case of substitution of arsenic
oxide in Murano glass was documented by ECHA and shared with us Clear decreases in exposure
levels were documented as a result of substitution which suggests benefits to health exposure
However the size of this benefit was not reported in terms of the number of workers or specific
health benefits Occupational health campaigns such as that documented in Belgium on hexavalent
chromium compounds provided no specific commentary on the benefits of control measures or
impacts of the authorisation even though that study was reported to illustrate that the REACH
authorisation process is a significant lsquoleverrsquo when it comes to the substitution process
Studies associated with the review of REACH and REFIT gave some indications of environmental
benefits ndash for example the EC (2016) Study on the Calculation of the Benefits of Chemicals
Legislation on Human Health and the Environment cited reduction in environmental contamination
of HBCDD PFOSPFOA and DEHP even though the benefits were not quantified
More general commentary of reduction in risk and business benefits is reported in Reihlen and
Luumlskow (2007) whilst other studies such as Hennig (2016) pulled together data on overall health
impacts from AfAs done on carcinogenic substances (cumulative monetised risks (cancer burden on
workers and the general population were estimated to have an upper bound of euro74 million per
year)
The DG Environment (2013)58 indicated boarder benefits of REACH authorisation in the context of
the development of the EU progress under a system of indicator in this case indicator
6 lsquoSubstitution and Phase Outrsquo
73 Survey responses
This section sets out the findings regarding the benefits of the authorisation process based on the
online survey responses by industry stakeholders The analysis of the benefits of substitution and
the benefits of risk management activities relies on 83 respondents and 68 respondents
respectively and include also partially completed surveys The exact number of relevant answers
can be different depending if the respondent provided information on that specific sub topic
731 Benefits of substitution
The benefits of substitution presented in this section reflect the views of those respondents who
provided examples of substitution carried out due to the REACH authorisation process The benefits
to organisations who substituted due to other reasons are not attributable to REACH authorisation
and therefore not reported here
Increased sales due to substitution
Although 68 respondents were involved in substitution activities only twenty-nine respondents
reported that their organisations had substituted SVHCs due to REACH authorisation or that they
knew of examples of substitution in their supply chain because of REACH Of these organisations
31 stated they did not know whether substitution to alternative substances andor technologies
had an effect on the volume or revenue from the sale of their products (see Q34 in Annex F5)
58 DG Environment (2013) Goal and an Assessment of the EU Efforts to meet the World Summit of Sustainable
Development (WSSD) Commitment
Impacts of REACH Authorisation Final Report
eftec 139 November 2017
Only six respondents (21) stated that volumes and revenue had changed as follows
All six reported a decrease in the volume of products with alternative substances andor
technologies with an equal proportion of respondents indicating a reduction in volume by
1 - 10 11 - 20 and more than 20 (see Q36 in Annex F5)
Most reported a decrease in the revenue from products with alternative substances andor
technologies (see Q37 in Annex C5) following from the reduction in volume mentioned
above Most indicated that the decrease was between 1 and 10 (a third of respondents)
or more than 20 (another third of respondents) Seventeen percent of respondents
indicated that they had not seen a change in revenue from products manufactured with
alternative substances andor technologies
It is to be noted that in total 11 respondents (including the six mentioned above) replied to Q34
that the substitutions had led to changes in the sales or revenue volume Of these 11 two clearly
indicated an increase in sales and revenue as result of the substitution However the appreciation
of these respondents is that these substitutions were made outside of the REACH context The one
respondent was a supplier of a CrVI alternative and the other respondent had an alternative flame
retardant Based on this result it seems that the substitutions that have a positive business case are
implemented earlier than the other cases
Increased employment due to substitution
Most respondents (72) whose organisations substituted SVHCs due to REACH authorisation or who
provided examples of substitution in their supply chain stated that this had not lead to changes in
the number of people employed in their organisations Only 14 (4 respondents) stated that
substitution had led to changes in the number of people employed (see Q38 in Annex F5) Most of
these reported an increase by 1 - 10 workers (see Q39 in Annex F5)
Reduction in worker exposure to SVHCs due to substitution
Around half of the respondents (14 respondents) stated that substitution in the context of REACH
had led to a reduction in the number of workers exposed to SVHC (see Q40 in Annex F5) Most
stated that substitution had led to 21 ndash 50 workers with less or no exposure to SVHCs (see Q41 in
Annex F5) This was followed by nearly 20 of respondents who stated that less than 5 workers or 6
- 10 workers had less or no exposure to SVHCs as a result of substitution
On top of these 14 6 respondents reported to have reduced workers exposure to an SVHC through a
substitution not related to REACH
Reduction in emissions of SVHCs due to substitution
Around 45 of the respondents (n=13) stated that a substitution as a result of REACH had led to a
reduction in emissions of SVHCs to the environment (see Q42 in Annex F5)
Wastewater (see Q43 in Annex F5) Most respondents (75) indicated a decrease in emissions
to wastewater by up to 01 tonnes per year as a result of substituting SVHCs with alternatives
substances andor technologies
Air (see Q44) Most respondents (71) indicated a decrease in emissions to the atmosphere by
up to 01 tonnes per year as a result of substitution
Impacts of REACH Authorisation Final Report
eftec 140 November 2017
Waste (see Q45) Most respondents (60) indicated that substitution had led to a reduction in
waste generated from SVHCs sent for appropriate disposaltreatment of up to 01 tonnes per
year Some 27 indicated a decrease between 02 ndash 1 tonne per year
On top of the 13 respondents 5 respondents reported that a substitution of an SVHC but not
related to REACH had resulted in a reduction of the emissions
Respondents were also asked whether substitution had led to a reduction in the volume of SVHCs in
the finished products (see Q46 in Annex F5) Over half of the 17 respondents (59) stated that the
volume of SVHCs in finished products had decreased When asked for clarification most of these
respondents indicated that they had either substituted or reduced the volume of SVHCs in their
finished products Note that these responses relate to cases of substitution which occurred before
the application stage of the authorisation process (eg inclusion on the Candidate List or the
Authorisation List)
732 Evidence of improved risk management activities
Sixty-three respondents indicated (Q68) that their organisations use (possible) SVHCs Of these
respondents 23 respondents (ie 37) indicated that their organisations had improved the handling
and operational conditions of the (possible) SVHCs as a result of the REACH authorisation process
(Q69) They provided 25 examples in terms of
The (possible) SVHCs that these risk management activities relate to
The usesfunctions of these (possible) SVHCs and
The risk management activities carried out in relation to the uses of these substances
Additionally 34 respondents replied that they did not improve the use conditions as a result of the
REACH authorisation process It is not clear which part of this group did not improve the conditions
at all and which part improved conditions outside the context of the REACH authorisation From the
targeted interviews with one of the respondents it is clear that at least some of them did improve
the use conditions outside the context of the REACH authorisation process
Table 71 lists the substances for which respondents reported improved handling and operational
conditions through the implementation of risk management activities as a result of the REACH
authorisation process The table also shows the number of examples given for each substance as
well as the reported uses With nine examples chromium trioxide is the (possible) SVHC with the
highest number of reported examples Table 72 lists the risk management activities reported by
survey respondents in conjunction with the number of examples referring to each risk management
activity
Impacts of REACH Authorisation Final Report
eftec 141 November 2017
Table 71 Instances of improved risk management activities
No (Possible) SVHC CAS
number
Number of
examples
provided
Use(s)
1 12-dichloroethane 107-06-2 3 Solvent
Solvent in manufacture of active pharmaceutical ingredient
2 Acetone 67-64-1 1 Not stated
3 Bis(2-ethylhexyl)
phthalate (DEHP) 117-81-7 2
Bonding ingredient
Rocket propulsion
4 Boric acid 11113-50-1 2 Buffer substance
Decorative function
5 Cadmium 7440-43-9 1 Corrosion inhibitor and anti-scaling
6 Chloroplatinates Not stated 1 Refining and producing catalysts
7 Chromic acid 7738-94-5
13530-68-2 1 Decorative function
8 Chromium trioxide 1333-82-0 9
Corrosion inhibitor and wear resistance
Decorative function
Plastic plating
Plating
Printing
Reaction inhibitor
Surface treatment
9 Chromium VI 18540-29-9 1 Steel plating
10 Dibutyl phthalate
(DBP) 84-74-2 1 Rocket propulsion
11 Methylenedianiline
oligomers 25214-70-4 1 Polymerization agent
12 Sodium dichromate 10588-01-9
7789-12-0 1 Process chemical
13 Not stated - 1 Hardener
Total 25
Notes The examples were provided by 23 respondents
Table 72 Instances of risk management activities ndash Description of activities carried out (industry survey)
No Substance Number of examples
provided
1 Automating production process(es) to minimise worker exposure 1
2 Confinement of production process(es) to minimise exposure
reduced use of SVHC to limit their prevalence in final products 1
3 Employee training and examination 1
4 Exposure controls and new procedures 1
5 Improved information to workers continuous monitoring of
exposure 1
6 Improved ventilation and closed production systems 1
7 Improvements to containment and monitoring measures 1
Impacts of REACH Authorisation Final Report
eftec 142 November 2017
No Substance Number of examples
provided
8 Personal protective equipment 1
9 Personal protective equipment improved monitoring 1
10 Protection against inhalation training workers development of
safety documents 1
11 Use of alternative substances to modify the production process 1
12 Not stated 14
Total 25
Notes The examples were provided by 23 respondents
Respondents who provided examples of risk management activities were asked about the stage of
the authorisation process which triggered these activities (see Q80 in Annex F5) Most stated that
the decision to implement further risk management activities originated at the application for
authorisation stage followed by the inclusion of substances in the Candidate List (35 and 27
respectively) The recommendation for including substances on the Authorisation List (which is
distinct from their actual subsequent inclusion) triggered the smallest number of risk management
activities (8) It is important to note that the percentage values presented in this paragraph have
been derived by excluding the lsquoNot surersquo and lsquoNot applicablersquo responses from the analysis These
categories account for approximately 78 of all answers given to question Q80
733 Benefits of risk management activities
Reduction in worker exposure to SVHCs due to risk management activities
Eighty-three percent of the respondents who provided examples of risk management activities
stated that these activities had led to a reduction in worker exposure to (possible) SVHCs Most
stated that the activities had led to 6-10 or 11ndash20 workers with less exposure (33 and 30
respectively) This was followed by nearly 20 of respondents stating that 21 ndash 50 workers had less
exposure to SVHCs as a result of risk management activities
Reduction in emissions of SVHCs to the environment due to risk management activities
When asked whether risk management activities had led to a reduction in emissions of SVHCs to the
environment
22 of respondents indicated a decrease in emissions to wastewater with all respondents
stating that emissions fell by up to 01 tonnes per year
39 of respondents indicated a decrease in emissions to air with most stating that emissions
fell by up to 01 tonnes per year and
30 of respondents indicated a decrease in waste generated from SVHCs sent for appropriate
disposaltreatment Most stated the decrease was by of 6 ndash 20 tonnes per year
Only three respondents (13) stated that implementing risk management activities had led to a
reduction in the volume of SVHCs required in the production process Further respondents stated
that activities had led to a reduction in the volume of SVHCs in finished products Given the small
Impacts of REACH Authorisation Final Report
eftec 143 November 2017
sample sizes quantitative results for this decrease are not representative and therefore not
presented here
Risk management activities post-submission of applications for authorisation
Sixty-five percent of the respondents (41 out of 63) stated they had submitted an application for
authorisation (AfA) or had been covered by an application by an upstream actor Of these 32 (13
respondents) stated that their AfA included specific risk management activities to be implemented
post-submission or that they had carried out further activities following submission Around 1 in 4
respondents (27) stated that these activities had led to reductions in workplace exposure and
emissions to the environment
Twelve respondents indicated that RAC had included conditions within their opinions in relation to
risk management measures and five of these respondents stated that complying with these
conditions had led to a reduction in workplace exposure andor emissions to the environment
74 Human health benefits from improvement of risk management
The results of the online survey showed (section 731) that the most pronounced benefit of
substitution is the reduction in worker exposure and emissions of SVHCs to the environment
Estimate the human health benefits of this requires knowing the exposure levels and the number of
workers exposed before and after substitution The benefits should also be estimated as net of the
health risks of the alternative substance For instance the use of TCE as a solvent has been
reduced through substitution However according to a distributer of solvents the alternative
solvent frequently used is tetrachloroethylene (PER) which is classified as Carcinogen 2 and aquatic
chronic 2 More details on the substitution of TCE is provided in Section 11
Several cases were identified where the authorisation process resulted in improvements in risk
management measures that lead to reductions in worker exposure According to the online survey
(see Q80 annex F5) these improvements are either prior to an application for authorisation or
realised in the course of an application or improvement plans announced in the AfA Some of the
improvements were made as early as during the RMOA phase which could explain why some
respondents see these improvements as not related to the authorisation process (Q69) There are
also the improvements imposed by the authorisation decision itself (eg based on a RAC opinion)
Overall in about 35 of the public versions of the applications for authorisation improvements in
exposure andor emissions were either recently implemented or were planned for the future Table
73 reported the improvements are listed per substance for the chrome related dossiers which are
the majority of the AfA in the scope of the evaluation 32 of the AfAs mentioned recent
improvements or improvement plans For the organic substances in about 40 of the AfAs an
improvement was either announced or recently done These findings are in line with the results
obtained via the online survey Based on the responses received 23 out of 63 respondents (37)
have provided information on risk management improvements due to REACH authorisation (See
Section 732) This indicates that the fact that a substance is subject to authorisation invites
companies to revisit their exposure values but only in a minority of the cases leads to improved
RMM reported in the applications for authorisation The data in the AfA does not enable estimation
of to what extent the emissions and exposure were reduced
Impacts of REACH Authorisation Final Report
eftec 144 November 2017
Table 73 Improvements reported in the AfA per substance
Substance No evidence of improvement
plan in AfA ( of applications)
Evidence of improvement plan
in AfA ( of applications)
Acids from Cr trioxide 100 0
Ammonium dichromate 100 0
Arsenic acid 0 100
Chromic acids 50 50
Chromium trioxide 76 24
DBP 67 33
DEHP 100 0
Diarsenic trioxide 80 20
Diglyme 44 56
EDC 42 58
HBCDD 0 100
Lead chromate 0 100
Mixture of Cr VI 100 0
Pigment yellow 100 0
Pigment Yellow 34 100 0
Potassium dichromate 75 25
Sodium chromate 0 100
Sodium dichromate 19 81
Strontium chromate 100 0
Technical MDA 0 100
Trichloroethylene 63 37
Grand Total 65 35
ECHA reported that the numbers in Table 73 could be an underestimate Based on their
experiences the majority of applications already show improved OC and RMM as a result of
monitoring and reassessment in the preparation of the application (either through improvement in
specific RMMs during the preparation of the application or through the implementation of plans to
reduce overall exposure to SVHC) Also nearly all downstream applications indicate new (2013-
2015) campaigns to measure exposure or intensification of existing monitoring programmes This
information is not publicly available but ECHA may know of this through the Committeesrsquo QampAs and
trialogues
The meta-analysis by ECHA on the applications for authorisation shows that in 72 of the cases
improvements and or additional RMMOC are requested Thus in the majority of the cases an
application for authorisation can be expected to lead spontaneously or via the opinion of RAC to
improvements in RMM and OCs However in the survey only in 27 of the cases the applicant
expected that complying with these conditions would lead to a reduction in workplace exposure
andor emissions to the environmentA possible follow-up could be to check the effects of such
improvements on exposure after the implementation of the RMMOC for example through
enforcement campaigns and data presented in the review reports (for companies that decide to re-
apply)
During the interviews very little detailed information could be collected on exposure improvement
plans even though several companies indicated that they improved the conditions as a direct result
Impacts of REACH Authorisation Final Report
eftec 145 November 2017
of the authorisation process Also most companies stated in general terms that they pursue
continuous improvement in these matters
More than 80 of the companies interviewed who were involved in a AfA of a Cr(VI) based
substance indicated that they saw no possibility to further reduction in the exposures because a
lot of improvements were already implemented in the past The driver of these improvements was
not REACH authorisation but compliance with the national exposure limits (OELsWELs etc) There
is not enough information available to judge if this result from the interviews is in line with the
result represented in Table 71 where 9 of the 25 instances of improved RMM were attributed to
Chromium trioxide use In any case from the interviews it was clear that the users of Chromium
trioxide had a history of improvements To what extent these improvements are sufficient or these
are related to REACH authorisation is difficult to tell
This is in clear contrast with the observation of ECHA that in the majority of the cases the OCs and
RMMs were improved as a result of an AfA The difference may be related to the fact that ECHA in
their communication mostly speak with the applicants while most of the interviews on Cr(VI) uses
were with DUs
A recent report (2017) on benefits from authorisation was published in Finland59 In this report 14
Finnish companies (mostly in electroplating business using Cr(VI) compounds) involved in the
authorisation process were interviewed The overall conclusion of the report is that there is no
consistent improvement of worker safety for all involved companies Only in one case a change in
RMMs were reported as a direct result of the AfA
One company interviewed was not yet applying for authorisation but worked with substances
(metals) which could end up on Annex XIV They indicated that they have recently agreed on a euro5
million improvement plan for emission and exposure reduction The main driver for them was the
current legislation (local OELs) Although exposure values on average were below the limits peak
values did exist and should be addressed by the new investments
The difference in threshold (TH) non-threshold (Non-TH) has a direct impact on the analysis of
the use conditions as reported in the CSR For threshold substances there are significantly fewer
improvement plans in the AfAs (28) while for non-threshold substances more than 41 of the AfAs
contain some form of improvement plan
Table 74 Improvements reported in the AfA TH Non-TH
No evidence of improvement
plan in AfA ( of applications)
Evidence of improvement plan
in AfA ( of applications)
All 65 35
Threshold (TH) 73 28
Non- Threshold (Non-TH) 59 41
For the cases where AfAs were filed the improvement in human health can be estimated by
comparing the historical exposure levels with the exposure documented in the CSR of the AfA Key
in this analysis is the availability of historical exposure data Several Member States have such data
but it was not possible to obtain it for this project In the case studies on chromium trioxide and
TCE an attempt is made to estimate the improvement based on the publicly available information
59 How the REACH authorisation process affects and benefits companies A Harrikari amp R Montonen 2017
Impacts of REACH Authorisation Final Report
eftec 146 November 2017
In the next section examples of improvements directly related to the applications for authorisation
are documented In all of the cases the improvements during the application phase were an
extension of on-going improvement plans This confirms the results from interviews where almost
all respondents confirmed that over the years significant investments have been made to reduce
the emissions of and exposure to SVHCs
In theory human health benefits can be due to closure or relocation of the economic activity
involving an SVHC or substitution of an SVHC or through implementation of improved RMM and OCs
In practice it was not possible to estimate the benefits to human health due to closure or
relocation The few cases of relocations that are documented in this report have a very low
exposure and are probably not representative
Case 1 Use of TCE in the manufacturing of dyed cloth
In this process TCE is used by Vlisco to remove a wax from cloth and to remove the wax from the
waste water For the continued use of the substance the company filed an AfA The AfA reported
significant improvements over the past years in the enclosure of the installations where TCE is
used These improvements reduced both the workersrsquo exposure and the emissions to the
environment The application provides an extensive overview of the technical and procedural
improvements over the years and the resulting significant reduction of the emission of TCE Due to
local legislation the applicant reported that it was not possible to use the historical worker bio
monitoring data due to protection of personal data This campaign revealed that the emission of
TCE could lead to exposure of workers in the same area even though they are not directly involved
in the TCE using activity New engineering measures were defined Some of these measures could
not be implemented before the latest application date but would be implemented before the
sunset date
Case 2 Use of TCE in the manufacturing of high performance polymer membranes
Parker is a company located in the Netherlands and uses TCE in the manufacturing of polymer
membranes The company applied for authorisation for the continued use of TCE The company
already had an extensive program in place for the minimisation of the emissions and worker
exposure However in the context of the application for authorisation the company had a new
campaign of worker exposure monitoring This monitoring program was based on analysis of
activities of the workers as would be reported in the AfA (contributing scenarios) The campaign
confirmed the low exposure of workers except for one location where the exposure was still low
but could be further minimized This would improve the far field exposure of several workers in the
surroundings An engineering measure was defined and budgeted but could not be installed prior to
the latest application date hence the assessment was made on the current installation This
assessment showed a very low exposure but in this case the monitoring programme and
engineering creativity will allow a further reduction in the exposure
Case 3 Use of chromium trioxide in electroplating by a large company at several locations
A large company operating several electroplating installations applied for authorisation for the
continued use of Chromium Trioxide Monitoring programmes already existed but the methodology
and the sample locations were not aligned between the different sites which made comparing the
results difficult In the context of the AfA a new monitoring program was designed to align
measurement methods However even in a controlled setup it was not possible to achieve exactly
the same detection limit for the different sites The methods of available local suppliers could not
be aligned Within the context of the AfA working with local suppliers instead of a central
analytical lab was chosen as a more sustainable solution for the future
Impacts of REACH Authorisation Final Report
eftec 147 November 2017
Despite the differences in detection limits it was possible to compare the performance of the
different sites Although the risk reduction measures were different in different sites the exposure
and emissions were comparable In this case the AfA did not lead to reductions in the exposure or
emissions but created a relationship between the sites to continue to exchange best practices
Case 4 Use of EDC as solvent in polymer production
A polymer producing company uses EDC as solvent in the manufacturing of the polymer The
process is a closed system and the solvent is separated from the manufactured polymer and is
recycled Over time the company had reduced the solvent losses significantly by monitoring the
inventory of the solvent carefully However this methodology has its limits to detect small losses
In the context of the application for authorisation a worker exposure monitoring program was set
up and a survey of the process was done by an external expert to evaluate the minimisation of
emissions as required for an AfA As a result of both measures hot spots for worker exposure were
identified and additional engineering measures were installed to reduce the emissions In the
future the company will implement a leak detection and repair (LDAR) programme to minimise the
fugitive emissions The production site is fairly small and use of external experts allowed the
company to achieve a significantly lower level of worker exposure and emissions
Case 5 Use of EDC in the manufacturing of an active pharmaceutical ingredient
A producer of Active Pharmaceutical Ingredients (APIs) used EDC as a solvent in the manufacturing
of two APIs As can be expected in a pharmaceutical environment the exposure to any substance
during the manufacturing of the API is very low Very high levels of confinement are achieved to
prevent exposure of workers to the APIs In the context of an AfA a monitoring program was set up
and a survey was conducted to evaluate the minimisation of the emissions The monitoring
programme confirmed the low level of exposure during the API manufacturing but both the
monitoring programme and the survey indicated that the unloading of the EDC from barrels resulted
in the highest exposure level New engineering measures were defined and implemented before the
filing of the application
The cases summarised above show that the application for authorisation has proven to be a driver
for the review of exposure and emissions situation of the SVHC The contribution of external
experts has proven in several cases to be crucial in the review and renewal of existing loss and
exposure reduction programs Exact magnitudes of reductions are very difficult to obtain Often the
reductions are small because most companies already have reduction programmes in place
eliminating the largest losses A longer evaluation period is required to quantify the effect of these
additional measures and to accurately measure the reduction
More cases on benefits by the authorisation process on the exposure to Annex XIV substances are
provided in the TIER 1 case studies (Chapters 1011 and12)
75 Environmental benefits from improvement of risk management
As noted in Chapter 3 (and elsewhere in this report) the only SVHC to have gone through the
authorisation process for environmental hazards (ie subject to and AfA for which a final decision
has been made) is hexabromocyclododecane (HBCDD) According to REACH Title VII (Article 60 (2))
the AfA should consider the risks for which the SVHC has been placed on the Authorisation List (ie
under which parts of Article 57) In this section we consider the benefits to the environment only
the benefit to the general public is not considered For HBCDD the PBT risk was considered in the
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eftec 148 November 2017
AfA But the applicants argued that no further assessment of risks to human health (ie workers
and professionals) was required since adequate controls on category 2 reproductive toxicant
substances were already demonstrated in the CSR The RAC commented that human health risks
should be considered but did not require the applicants to reassess In the end the argumentation
in the AfA for HBCDD was focussed very much on the non-availability of the alternative to the
applicants rather than a comparison of the risks The RAC stated that they could not conclude on
environmental risk Therefore a real test of whether environmental risk can be quantified in order
to compare to overall benefits has not been made It remains for other PBT and vPvB AfA to show
this
It should be noted that it is the obligation of all registrants to make a PBT assessment of their
substances against the criteria in Annex XIII of REACH If they conclude that the substance is PBT or
vPvB then since adequate control cannot be demonstrated for the environment release to the
environment must be controlled to levels that are as low as possible (ldquomeasures which minimise
exposures and emissions to humans and the environmentrdquo60) regardless of whether the substance is
actually listed on the Candidate List
Quantified benefits for the environment from additional controls (ie risk management measures)
are difficult to identify however as reported in the literature (see Section 72) there is qualitative
and anecdotal evidence that additional environmental controls promoted by the authorisation
process have led to environmental benefits AfA that have focused on risk to human health for
workers but that also have environmental releases shows evidence that controls have been at
least optimised to reduce exposure to the environment In the AfAs for trichloroethylene (TCE) for
example the applicants considered the exposure of the general public (sometimes referred to as
lsquoman via the environmentrsquo in risk assessment terminology) such that the impacts on both workers
directly exposed to the SVHC in the workplace and general public (exposed thought the
environment) were considered In addition to hazard to human health (for which the substance was
placed on the candidate list) TCE has an environmental hazard classification (H412 Harmful to
aquatic life with long lasting effects) and was one of the very few substances for which a Predicted
No Effect Concentration (PNEC) was derived for air in the (pre-REACH) substances regulation (EC
Council Regulation (EEC) No 79393) Therefore in the AfA assessments the applicants assessed
concentrations against the PNECair and determined adequate control based on this It is noted that
during the ESR process a risk reduction strategy for environmental risk of TCE concluded that risk to
the environment should be controlled through measures that control releases to atmosphere (such
as the lsquoSolvents Emissions Directiversquo 199913EC) and legalisation controlling emissions from
certain processes (formerly IPPC (Directive 20081EC) now IED (Directive 201075EU))
The actual effect on the environment of the authorisation process was investigated through the on-
line survey For instance it was shown (Q42) that in 45 of the substitution cases the emissions to
environment were reduced Also in 39 of the cases (Q84) additional risk management measures
have resulted in reduced emissions to the environment This shows that although the large
majority of the substances present on the authorisation list are selected for human hazard there is
still a benefit of the environment in terms of reduded emissions To what extent this reduction also
resulted in a reduced risk for the environment is untested In case the emissions prior to the
authorisation process were adequately controlled the reductions of the emissions due to
authorisation would not have contributed to a reduction of risk 60 REACH Annex 1 Paragraph 65 ldquoFor substances satisfying the PBT and vPvB criteria the manufacturer or
importer shall use the information as obtained in Section 5 Step 2 when implementing on its site and
recommending for downstream users risk management measures which minimise exposures and emissions to
humans and the environment throughout the lifecycle of the substance that results from manufacture or
identified usesrdquo
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eftec 149 November 2017
76 Benefits of substitution
Evidence of benefits due to substitution triggered by the authorisation process was collected via
the on-line survey targeted interviews and via leads provided by the European Commission and
ECHA The following potential benefits due to substitution were investigated through the online
survey which received twenty-nine responses on this topic (as shown in Section 731)
Increased sales
Increased employment
Reduction in worker exposure to SVHCs and
Reduction in emissions of SVHCs
It seems that there were no net benefits in terms of volume of sales or revenue There were some
very small indications of net changes (increase) in employment
The main benefits from substitution appear to come from reductions in exposure emissions or
waste In addition respondents reported better handling operations for SVHCs as well as risk
management measures leading to reductions in worker exposure to SVHCs Whilst the survey
sought responses on who had taken action to control risks and indicated the range of volumes to
which such actions apply no specific evidence was gathered that allowed a quantification of the
benefits of substitution The evidence gathered is qualitative but suggests improvements in
exposure control for workers and decreases in releases to the environment This is substantiated by
a review of the literature (Section 72) and the example shown below
Case 1 Substitution of As2O3 in the production of Murano Glass
Artistic glass makers in Murano have used arsenic trioxide (As2O3) widely as a refining agent for
centuries The Commissionrsquos decision to include it to the Authorisation List (Annex XIV of REACH)
in 2011 forced local glass manufacturers to decide on whether to apply for authorisation or
substitute to other substances or techniques After getting the clarity that the use of As2O3 was not
an intermediate Murano glass manufacturers decided to opt for substitution based on research
carried out by the Stazione Sperimentale del Vetro in 2010
The substitution of As2O3 by Antimony Trioxide Cerium Oxide Lithium Oxide and blast furnace slag
resulted in a significant reduction in the concentration of arsenic in air from over 200 ngm3 in 2014
to about 4 ngm3 in 2016 This is below the annual limit of 6 ngm3 of arsenic which is the target
value of the EU as agreed in Directive 2004107EC on arsenic cadmium mercury nickel and
polycyclic aromatic hydrocarbons in ambient air and implemented by the Legislative Decree
155201061 in Italy (see Table 75)
61 Legislative Decree No 155 of 13082010 ndash conversion into Italian legislative system of Directive 200850EC
concerning air quality in Europe httpwwwcameraitparlamleggideleghe10155dlhtm
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eftec 150 November 2017
Table 75 Change in the average concentrations of arsenic in the air in the environmental monitoring station in Murano 2014-16
Source Reports of Veneto environmental authority of 2014-15
Information from the Chamber of Commerce and the worker insurance institute (INAIL) indicated
that there were about 300 companies operating in glass manufacturing in the area of Venice (where
Murano is located) This information has been integrated with data obtained from the major local
distributor of As2O3 showing that in 2013 about 24 companies in that area were using As2O3 in
quantities between 5 kg and 5 tonnes per year Site inspections made in 2016 corroborated that
As2O3 was no longer used by any of the inspected companies apart from one
77 Benefits from closure and relocation
The benefits towards reduced worker exposure and emissions to the environment in the EEA are
obvious in the case of closure or relocation of the use of the substance But these have to be seen
in light of the emissions and exposure in the receiving location and in comparison to the cost of
relocation changes to profitability and loss of knowhow from the EEA
Closure and relocation of a use and related activities mean that exposure to and emissions of the
affected Annex XIV substances cease in the EEA The net benefits for the society would require
taking into account the loss of revenue employment etc In the context of this report lsquoclosurersquo
refers to the case when the use activity andor the complete business of which use is a part is
stopped For instance a company could decide to discontinue the manufacturing of a certain
product which specifically uses the Annex XIV substance if their other products cannot be
substitute In case of relocation the use is discontinued in the EEA but is moved to outside of the
EEA In the case of a relocation of a use a company can split a manufacturing process and relocate
a specific use This comes typically at an additional logistics cost and increased complexity of the
manufacturing When this burden is too high a full relocation of all production process can be
decided This study has not identified any cases of such full relocation
An analysis of 158 authorisation files publicly available at the end of 2016 found that 58 of them
(37) indicated relocation as an option for the non-use scenario It was not analysed if this reported
relocation would mean only a relocation of a specific use or if this would result in relocation of
additional processes or in the extreme would lead to the relocation of the complete company
During the interviews and the online survey two cases were reported where the use of the
substance had ceased as a direct result of the authorisation process (see Table 622 in Section 610
and case 3 in Section 54) In both cases the volume of the Annex XIV substance was very small and
it was used in well controlled conditions As such the benefit for the EEA from this relocation would
be as far as exposure is concerned small Again in both cases the companies had the intention to
relocate a part of the business and import the final products In one case the final product did not
contain the Annex XIV substance and in the other case contained the Annex XIV substance but at a
concentration less than 01 This means that in the latter case the relocation only resulted in the
reduction of exposure and emissions during the manufacturing phase
Reference period Average content of arsenic (ngm3)
June-November 2014 2347
September-November 2015 110
JulyndashSeptember 2016 5
OctoberndashDecember 2016 39
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eftec 151 November 2017
Another downstream user of a SVHC on the Annex XIV active in the aviation industry indicated in
an interview that an investment in an expansion of a production site using that SVHC had stopped
because of the authorisation process According to this downstream user the authorisation process
made things more complex to operate in the EEA Although he expected that a closure or relocation
decision would seldom be made solely on the basis of regulation the REACH authorisation process
was seen as a factor which supported such a decision In the same line the AmCham position
paper62 reports two cases where investments (life science and aerospace) were not made in the EEA
as a direct result of the uncertainty created by the authorisation process While these cases are
strictly not cases of relocation they indicate the impact of the authorisation process on business
decisions
From this we can conclude that relocation is considered by industry as an option in response to
authorisation requirements The costs associated with this were discussed in Section 610 which
also explained that respondents interviewees were very reluctant to provide much detail on the
relocation cases Therefore this report cannot be conclusive about to what extend the relocation
or closure actually occurs and results in reduced the worker exposure and emissions
As mentioned above the net benefits to the EEA from a closure or relocation can be assessed by
comparing the benefits due to a reduction of worker exposure or environmental emission to other
impacts such as the one-time relocation costs loss of employment loss of profit increased logistic
costs etc Such a comparison is done during the evaluation of an authorisation dossier So far no
authorisation has been refused Therefore without a detailed analysis of the individual cases it
can be concluded that in the cases where an application was filed with a relocation as non-use
scenario the benefits of reduced exposure or emission were deemed to be less than the costs to
society
However Section 610 already indicated that the costs for closure or relocation as reported in the
AfA are probably not a good indication of the costs related to actual cases of closure and
relocation In the same way the direct benefits from relocation or closure as reported in the non-
use scenarios are also not a good indicator of the benefits in the actual cases of closure or
relocation
The interviews and the online survey show that companies often take decisions on alternatives
(including in a limited number of cases closure and relocation) without filing for authorisation
Those decisions are taken on the basis of criteria set by the companies themselves Individual
companies will not consider larger societal impacts in case of a decision to relocate For instance
it might be a justifiable decision for a company to relocate a high-tech manufacturing process to
avoid the hassle of the authorisation process while relocation could cost the wider society loss of
knowhow
In addition other interviews showed that in some cases companies take decisions on authorisation
which are not economically justified from their own perspective (see case 3 in Section 53) In that
case the company decided to relocate the business outside the EEA when (objectively assessed)
reduction in emissions and exposure will be negligible but loss of profit and technology will be
measurable The driver for the relocation was the perceived uncertainty of the outcome of the
authorisation process
62 AmCham EU (2016) A private sector view on REACH and competitiveness - 2017 REFIT evaluation key to
addressing outstanding obstacles Position Paper for REACH REFIT Evaluation November 2016
Impacts of REACH Authorisation Final Report
eftec 152 November 2017
In terms of the worker exposure or emissions beyond the EEA relocation could lead to benefits in
exposure and emission reduction only if the RMM at the new locations are better than those in the
EEA In the context of this report this aspect was not studied But in general one could assume
that the RMM in place in the EEA are better than the average RMM in the rest of the world meaning
that on average a relocation outside the EEA can be expected to result in an increase in exposure
or emissions Counter examples exist For instance in the DBP application of Huntsman it was
reported that the RMM in the European site was improved after comparing it with the US site At
the same time this example indicates that when a company has an alternative site outside of the
EEA with better RMM it could still be cheaper to upgrade the EEA site than relocate During an
interview with a plater using chromium trioxide the company mentioned that if they were to
relocate to China they would still operate in line with the technology they currently use in Europe
In conclusion while at the EEA level a closure or relocation results in an obvious and direct benefit
in terms of reducing exposure andor emissions in the EEA on a global scale it is unlikely that
relocation would result in any benefits Few examples of relocation were identified in the course of
the project but the reason why these companies considered relocation was generic not specific to
their case and could be applicable for others However insufficient details were available to have a
quantitative assessment of the total benefits of closure or relocation on the EEA
78 Benefits to alternative suppliers
It has been shown that the authorisation process leads in many cases to the use of alternative
substances or technologies
The DUs responding to the online survey confirmed this and indicated that the REACH authorisation
process has in the majority (59) of the cases been a driver for substitution This means that
REACH authorisation is indirectly a driver for the development of the business for the suppliers of
alternatives This is further confirmed in interviews with suppliers of alternatives such as
GreenCoat and another supplier of a similar technology
In Section 5 more details are provided how the markets as a result of authorisation change Two
additional examples are provided here
An interview with a distributor of solvents indicated that for Trichloroethylene the market was
largely taken over by perchloroethylene (see for instance case 8 in Section 54) Details of this are
reported in Section 11
A totally different type of benefit for the supplier of alternatives is found in the HBCDD case
HBCDD has been regulated by REACH but also by the POPs regulation For the use of HBCDD as
flame retardant in EPS an alternative has been developed called pFR (polymeric flame retardant)
and taken into production However it was clear that at the sunset date there would be
insufficient amount of pFR available on the market Without authorisation several EEA based EPS
manufacturers were at risk to have to stop production because of lack of flame retardant In the
AfA the applicants showed that this interruption of business could lead to a permanent loss of EPS
capacity in the EEA By granting the authorisation not only they were able to introduce the
alternative as it became sufficiently available on the market but also protected the market for the
suppliers of the alternative by safeguarding the demand for the flame retardant Thus by taking
the availability of the alternative over time into account the authorisation supported the
introduction of the alternative
Both for trichloroethylene and HBCDD the supplier of the alternative substances was also the
supplier for the Annex XIV substance Nevertheless the position of the supplier was totally
Impacts of REACH Authorisation Final Report
eftec 153 November 2017
different in the two cases In the case of TCE the manufacturer of TCE took the initiative to apply
for authorisation for a large part of its market The manufacturer of HBCDD did not apply for
authorisation but left this initiative to the DU of the substance
In the case of Chromium trioxide the situation is again quite different For this substance the
alternative is either a totally different technology not using chrome or adapting an existing
technology using CrIII which is not on Annex XIV However the majority of the CrIII supply into the
EEA is by the company that imports the CrVI containing compounds In the case of CrVI the
initiative for an AfA was also taken up the supply chain by the importers of the CrVI compounds
Also in this case the authorisation allows the supplier of the alternative substance CrIII to delay
the introduction of alternatives until the technology is available without disruption of the market as
could be the case without authorisation
The suppliers of alternatives clearly benefit from the authorisation process The authorisation
process not only creates a market for alternatives but also allows time for the introduction of
alternatives so that it can align with the availability of alternatives Otherwise if the authorisation
is pushed or if the manufacturers or users decide to close or relocate outside the EEA this would
destroy the market opportunities for the alternative substances and technologies
79 Benefits of better information
The study found no evidence through its surveys and literature review that would allow
quantification of benefits from better information It is clear however that the authorisation
process has prompted a number of sources of information on SVHCs themselves and methods for
and instances (eg case studies) of substitution (see Section 52) Indeed the transparency of the
authorisation process is welcomed by some stakeholders (particularly NGOs) such that increased
knowledge of hazards regulatory action (such as authorisation and restrictions) are more widely
understood
Information on the specific control of risks is less widely available because it is rather specific to
the uses for which SVHC are being used Although AfA are publicly available specific parts dealing
with exposure control may be considered confidential by the applicants so may not necessarily be
in the public domain
It is the obligation of suppliers to communicate control of substances in the supply chain (in the
form of extended safety data sheets) for SVHC subject to authorisation These will include details
of control measures to be applied that were considered by RAC in their assessment of the AfA
However this is not specifically prompted by the authorisation process
For the authorities a benefit from authorisation is the availability of structured information on
remaining uses of SVHCs and via the Art 66 notifications of the sites were the substances are
used While this information does not lead directly to reduced exposure or emission this
information can be used for targeted actions to further support substitution and control of exposure
and emissions and for enforcement The monitoring requests will help to develop a database of
exposure and emissions that could be used to check improvements The extent of such benefits
cannot be assessed now and they will become more evident when more authorisations have been
granted
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710 Other benefits
A Finnish study on the benefits from the authorisation process could not identify many structural
benefits for 14 Finnish companies involved in applications for authorisation One benefit however
was clear the authorisation process has led to better networking among companies This has
resulted at least in one case of sharing best practices on exposure reduction measures
One of the expected side effects of authorisation at the outset was improved innovation to find
substitutes to the use of SVHCs During the various interviews several cases were reported Two
cases are reported here where the innovation was clearly related to the authorisation process
Case 1 Dyed cloth manufacturer
The application for authorisation by Vlisco for the continued use of trichloroethylene contains an
ambitious research plan for the development of a new technology using switchable solvents to
remove a resin during the manufacturing of dyed cloth This novel technology was developed in
Canada In this sense the authorisation process was the direct cause for an innovation and a
transfer of knowledge into the EEA
Case 2 Chemicals management as starting point for innovation
The authorisation process has resulted in several companies setting-up new or additional chemicals
management programs to track the use of hazardous chemicals in their processes or supply chain
The ELV Directive had already led to the development of extensive chemicals tracking programs in
the automotive industry This tracking system focuses on certain chemicals present in car
components The REACH authorisation process requires the companies to go further and track the
use of chemicals in manufacturing processes if these chemicals are present in the end product A
world scale fine chemicals manufacturing company reported during an interview that they have an
extensive chemicals management system in place which flags if any substance they use appear in
the Candidate List It was reported that in several cases this has led to an early replacement of the
substance In all of these cases this was only possible after an RampD phase In this sense the
authorisation process has resulted in several companies having a better view on the use of
hazardous substances and having initiated RampD activities
711 Summary of benefits
Several approaches were used to obtain data to assess the benefits associated with the
Authorisation process The most tangible benefits due to REACH authorisation are the reduction of
worker exposure to SVHCs and reduced emissions of SVHCs into the environment (eg air
wastewater and waste) This is either due to (i) improvements in RMMs where SVHCs are still be
used (ii) substitution away from an SVHC (eg to using an alternative substance or technology) or
(iii) avoided exposure and emissions within the EU due to closing andor relocating EU production
sites that previously used in SVHCs within the EU
There is evidence from the online survey interviews and evidence presented within AfAs to date
that REACH authorisation is resulting in an improvement in RMMs at all stages in the authorisation
process For example the survey results show that most improvements in RMMs occurred at early
stages in the REACH process perhaps so that the SVHC was not prioritised for inclusion on Annex
XIV as well as strengthening companiesrsquo cases for a possible future application Many applicants
that have submitted an AfA have also indicated that they have improved RMMs andor have planned
Impacts of REACH Authorisation Final Report
eftec 155 November 2017
investment in place in order to demonstrate minimisation of emissions Examples of some of the
types of RMMs identified by respondents are noted in Table 72 (within Section 73)
Where RAC were not certain that minimisation of emissions was demonstrated in some cases
conditions were imposed on the applicant as part of granting the application (as well as potentially
recommending a shorter review period than might have been possible had there been fewer
uncertainties concerning minimisation of emissions) Survey responses have suggested that at least
some cases that they have improved their RMMs further (or are putting further measures in place)
which have led to (or they hope it will lead to) further improvements in reducing exposure to
workers and releases of emissions of SVHCs to the environment However most indicated that it
was too soon to be able to provide quantitative data on this benefit
The survey results indicate that the levels of exposure reductions and emissions reductions of
SVHCs achieved by both applicants and those that substituted (ie did not need to apply for
authorisation) seemed to be relatively small (see Section 73) This is not necessarily surprising
since companies should have been reducing their exposure over many yearsdecades While
qualitatively it can be shown that REACH authorisation is having a positive effect due to lack of
detailed data it is currently not possible to quantify these benefits
Despite being 10 years into the REACH process this study suggests it is still too early to be able to
quantify the benefits of REACH authorisation To quantify the benefits historical data on the
number of workers exposed and the exposure level over time would be required Some of this data
does exist as at Member State (MS) level as some Member States have confidential databases (for
their MS) containing historical values for worker exposure which the study team were unable to
obtain In the future should applicants reapply for authorisation (ie review report) the monitoring
data which is set as a requirement in some of the authorisation decisions could provide some
additional data to assist in assessing the scale of reductions being achieved over time
The authorisation process creates opportunities for alternative products In some cases the
alternative is provided by the same company as the Annex XIV substance in other cases different
companies or technologies emerge Granting an authorisation however takes account of the time
needed to develop alternative substances and technological in order to allow the applicant(s) both
the users of the Annex XIV substance and the suppliers of the alternatives to adjust to in market
demand (and other factors like product requalification)
Whilst there will have been an overall increase in sales of alternatives (substances andor final
products not made with an SVHC) for those companies that have already adopted an alternative
prior to REACH these survey respondents did not attribute any increased sales they achieved to
REACH Authorisation Most respondents who substituted to an alternative due to REACH
authorisation indicated (at least in the short term) either a net loss in sales revenue or no net
change (relative to sales revenue when previously using an SVHC) Further details on these are set
out within Section 7 (eg case study examples)
Specific benefits of closure andor relocation were also investigated Data from existing AfAs show
that the benefits in terms of reduced exposure or emissions as a result of relocation are far less
compared to the costs of the relocation Case studies on the other hand have shown that companies
have decided to relocate at a cost higher than the cost for an AfA and most probably higher than
the monetized benefit of reduced exposure Uncertainty about the authorisation process is
mentioned as a driver for this
Impacts of REACH Authorisation Final Report
eftec 156 November 2017
Few other less tangible benefits were also identified The two main ones are improved
communication within the supply chain and encouraging further development of existing
technologies and in some cases innovation
Benefits of authorisation
Human Health benefits Clear evidence of improved RMM and reduced exposure
Benefits of substitution Mainly reduction in exposure and emissions
Benefits from closure and relocation Few case of relocation or closure identified
Benefits to alternative suppliers Authorisation process helps to create a market for
alternatives in a controlled way
Benefits of better information Improved transparency and communication with
authorities
Other benefits Communication between applicants leading to exchange
in experience Driver for innovation
Collection of structured information on the use of SVHC
Impacts of REACH Authorisation Final Report
eftec 157 November 2017
8 AFFORDABILITY OF AUTHORISATION FOR SMEs
81 Introduction
The affordability of the authorisation process to Small and Medium Sized Enterprises (SMEs) is the
fifth and final focus area assessed It made sense to assess this area following the analysis of
changes in the market the level of substitution away from SVHCs and the costs associated with the
authorisation process
SMEs are defined in the EU recommendation 2003361 Following that definition and as set out
Table 81 the main factors determining whether an enterprise is an SME are (i) staff headcount and
either (ii) turnover or (iii) balance sheet total
Table 81 Definition of an SME
Company category Staff headcount Turnover Balance sheet total
Medium-sized lt 250 le euro 50 m le euro 43 m
Small lt 50 le euro 10 m le euro 10 m
Micro lt 10 le euro 2 m le euro 2 m
Source What is an SME (EC 2017)
According to the EC (DG GROW)63 SMEs represent 99 of all businesses in the EU The EC CCA study
(EC 2015) states the proportion of SMEs is stable among all subsectors of the EU chemical industry
between 96 and 98 of chemical companies are SMEs
The Chapter is split into six sub-sections
Section 82 Summary of literature review ndash sets out what the key findings were from
existing studies ndash The detailed review is set out in Annex E7
Section 83 Applicants from SMEs ndash summarises how many applications have so far been
received from SMEs compared to large firms
Section 84 Survey responses - summarises information provided by SME respondents to the
industry survey This does not focus on any particular substance(s) on the authorisation list
Section 85 Tier 2 Case studies - presents impacts on SMEs using specific companies as
ldquomini case studiesrdquo using survey responses existing information and further consultation
with affected companiessector groups to try to explain role REACH authorisation has had
on them These case studies build up a picture of challenges faced by SMEs
Section 86 Affordability ndash concludes on the affordability of the authorisation process for
SMEs taking into account the experience of SMEs that submitted applications on their own
or as members of existing authorisation consortia It also sets out to what extent the
63 What is an SME (EC 2017)- Available at httpeceuropaeugrowthsmesbusiness-friendly-
environmentsme-definition_en
Impacts of REACH Authorisation Final Report
eftec 158 November 2017
recommendations from the REACH 2012 review have been implemented and their
effectiveness
Section 87 ndash concludes the Chapter with a summary
82 Summary of literature review
Existing literature has been reviewed to put the new results about the impacts on SMEs produced by
this study in the context of research to date This literature includes regulation documents EC
study reports studies commissioned by ECHA (ie Harrikari and Montonen 2017 Tickner and
Jacobs 2016) a journal paper written by Philipp Hennig from the German Federal Institute for
Occupational Safety and Health as well as reports and position papers submitted during the public
consultation of the REACH REFIT Evaluation 2017
The complete literature review can be found in Annex E7 The key findings of the literature
review are
Studies commissioned by the EU and ECHA as well as position papers submitted during the
REACH REFIT Evaluation 2017 suggest that affordability of applying for authorisation or
substitution to avoid an application is a bigger problem for SMEs than larger firms
The above finding is in line with the results of a cumulative cost assessment for the EU
chemical industry (EC 2016) revealing that the financial impact of chemicals legislation in
general differs based on company size While total chemical legislation costs as a
percentage of annual turnover is low (lt1) for SMEs it is more than twice as high for SMEs
as for large firms
The regulatory burden that REACH authorisation places on SMEs is recognised by the EU
which tries to minimise it by lowering the existing reduced application fees through
Regulation (EC) No 3402208
With respect to affordability the authorisation application fees seem to be less significant
than administrative costs of preparing an application dossier The dossier preparation is
particularly costly when external expertise is required which is more likely for SMEs
according to several sources
Affordability of authorisation is further worsened for SMEs by the difficulty to finance some
of the additional costs through an increase in product prices In fact studies on the
experience of Austrian and Finnish companies reveal that companies find it difficult to
recover additional costs through price increases due to low acceptance of such increases
among customers and the expectation that doing so would lead to a loss of customers
For SMEs the affordability of internal REACH-related activities is a bigger issue than the
availability of qualified persons to deal with these activities
REACH authorisation is expected to affect SMEs more strongly economically by drawing
away resources from other potentially revenue-raising activities such as innovation and
RampD
Impacts of REACH Authorisation Final Report
eftec 159 November 2017
Differences with respect to the impact of REACH on business performance ndash a factor
influencing the evaluation of the affordability of authorisation in the long term - were
revealed by the EC (2015) study titled Monitoring the Impacts of REACH on Innovation
Competitiveness and SMEs According to that study the loss of international
competitiveness is a less significant issue for SMEs than large firms A higher percentage of
SMEs than large firms (47 compared to 32) even reported a positive effect on their
competitiveness Regarding trade inside the EU the effect on SMEsrsquo business performance
seems to be more negative as a higher percentage of small and micro firms (17 and 50
respectively) compared to large firms (63) reports a decrease of intra-EU exports
83 Applications to date from SMEs
Table 82 provides a high-level summary of data provided by ECHA on the number of applicants
received by size of firm during the period 2013-2016
Table 82 Number of AfArsquos by size of firm
Size of firm Total (2013-2016) Share (nearest )
Micro 9 5
Small 15 8
Medium 11 6
Large 160 82
Total 195 100
Source ECHA (updated data 10082017) In total for the period 2013-2016 around 18 of applications64 have been from SMEs As shown in
Figure 81 the highest number of SME applicants was in 2016 related to one of the several
Chromium compounds that were subject to authorisation The highest proportion of SMEs relative
to the total number of applicants was in 2015 where 35 of applicants were SMEs
64 An application is received in terms of Article 64(1) of REACH when ECHA has received the application fee
SMEs pay a reduced fee to ECHA compared to large firms
Impacts of REACH Authorisation Final Report
eftec 160 November 2017
Figure 81 Number of applicants (2013-16) by applicant size
Data source ECHA (updated data 10082017)
Despite the EU chemicals sector being dominated by SMEs the majority of SMEs have relied on the
upstream supply chain (eg MIs of the substance) to submit applications for authorisation that
cover their use of the substance This is not surprising as it was envisaged during the time of
developing the authorisation guidance documents that most applications would be made by MIs of
the substance rather than downstream users in the supply chain However there are unintended
(and somewhat unforeseen) consequences associated with upstream applications whereby uses are
defined too broad suffer from less precise data on exposure and information on the suitability of
alternatives which tend to result in shorter review periods This adversely affects all actors
involved in the supply chain ndash both large firms and SMEs which are set out in more detail in the
remainder of this section Whilst the analysis below better reflects the consequences and impacts
associated with upstream applicants it is relevant to cover in the SME section given that SMEs rely
on upstream actors covering their use within their application
84 Survey responses
In total 20 SMEs responded to our survey accounting for 32 of all survey respondents Most SMEs
were involved in an lsquoupstreamrsquo application by their supplier or someone even higher up the supply
chain (eg MI of the SVHC) meaning that SMEs did not submit the application themselves It is
reasonable to assume that those that answered lsquodonrsquot knowrsquo are SMEs that did not submit an
application themselves but supported an applicant (eg financially andor with data) higher up in
the supply chain
10
33
20
132
0
20
40
60
80
100
120
140
2013 2014 2015 2016
Number of applicants (2013-16) by applicant size
Micro
Small
Medium
Large
Impacts of REACH Authorisation Final Report
eftec 161 November 2017
Table 83 Type of applications SME survey respondents were involved in
Type of application that SME survey respondents were involved in Number
Joint or individual upstream application (or application by an actor up in my supply chain covering my use)
7
Joint application (group of actors came together) 4
Individual application (I applied for my own use only) 3
Donrsquot know 8
Total 22
Note There are 20 respondents but 22 responses because an SME was involved in more than one type of application
Respondents were asked to identify their main challenges associated with the authorisation process
(they could select up to three) As shown in Figure 82 the most common responses were
Understanding what was required how they were affected
Internal staff time required for preparing an AfA and
Finding a possible alternative to the SVHC in question
The data would suggest the main challenges faced by SMEs were knowledge based followed by
resource constraints and finally financial constraints Further details to support these responses
were gathered as part of follow up interviews with the results set out in Section 85
Figure 82 Top 3 challenges faced by SMEs associated with the authorisation process
Note ldquoOtherrdquo was excluded as respondents who selected this option did not clarify what this challenge was
SME respondents were also asked to identify their main challenges associated with the applying for
authorisation (again they could select up to three) As shown in Figure 83 the most common
responses were
Resources required for preparing applicationmy organisationrsquos inputs
Understanding what data is required and
Collecting the necessary data
Impacts of REACH Authorisation Final Report
eftec 162 November 2017
Figure 83 Top 3 challenges faced by SMEs associated with AfAs
Note ldquoOtherrdquo was excluded as the respondent indicated they were responding on behalf of several SMEs
The data would suggest the main challenges faced by SMEs were again concerning knowledge and
resources rather than financial constraints Further details to support these responses were
gathered as part of the follow up interviews with the results set out in Section 85
SMEs were asked about where they got support from during the AfA process As set out in Figure
84 SMEs relied mostly on consultants who knew about REACH authorisation from their MI or
tradesector association
Figure 84 Who SMEs used to support them
Respondents were specifically asked to comment on how helpful REACH authorisation guidance and
other information on the ECHA website were There was quite a mixed response with nearly a third
of respondents indicating they did not use any of the information nearly a third indicating it was
either very helpful or helpful (combined total) and a fifth of respondents finding it not helpful and
a fifth with no opinion either way Further details to support these responses were gathered as part
of follow up interviews with the results set out in Section 85
Impacts of REACH Authorisation Final Report
eftec 163 November 2017
Figure 85 SMEs views on the REACH authorisation guidance and other information on the ECHA website
85 Tier 2 Case studies
In total five survey respondents who were SMEs and involved in an application for authorisation
indicated they were willing to be contacted further In the follow up four companies remained
engaged and two telephone interviews were carried out and two written responses were received
To use their limited time in the most efficient way the questions focused on areas of particular
interest as identified by the project steering group
What were the consequences on their business as a result of the main challenges they faced
applying for authorisation and with the authorisation process
If there was any supportguidanceinformation that ECHA could provide that they would
have found helpful and might have saved them some time costs and
Their views on the ECHA website and authorisation related guidance
There were two types of responses between the four respondents all of whom were involved in an
upstream application ie they did not submit the application themselves which was submitted by
their supplier or someone even higher up the supply chain (eg MI of the SVHC) Those that were
more active65 or knowledgeable about REACH authorisation were able to give more feedback whilst
those less active knowledgeable were able to give limited feedback beyond what they had
already set out in the online survey It is important to present both sets of responses rather than
aggregating all their responses as they also reflect well on the differences in responses from micro
sized firms compared to small and medium sized firms
Those SMEs less familiaractive with REACH authorisation
65 By active we refer to attendance to meetings with sectortrade association concerning REACH attendance
at Authorisation application REACHAfA Consortia meetings or any ECHAEC webinars conferences meetings
concerning REACH authorisation
0
1
2
3
4
5
6
7
Very helpful Helpful No opinion eitherway
Not helpful Very unhelpful I did not use any ofthis information
Fre
quency
Impacts of REACH Authorisation Final Report
eftec 164 November 2017
They opted to rely on their suppliers (further up in the supply chain) to submit the
authorisation application as they felt carrying out their own application was too
complicated and expensive As small companies applying for authorisation themselves
would have meant forgoing too many activities and this would have had a detrimental
impact on profits They gave support to the applicant by assisting the collection of
necessary information This alone was costly and time consuming from their perspective
and was paid from profits rather than through charging higher prices Due to the
international competition in the market it was not possible to raise prices for their
customers so they had to forgo some profits
Because they did not apply for authorisation themselves they did not make any use of the
guidance or material on the ECHA website
One respondent described the authorisation process as a ldquojourneyrdquo with a certain amount
of ldquolearning by doingrdquo with questions like should we do an authorisation on our own or
should we join a consortium and what are the advantage disadvantage of such a choice
One respondents felt that the main way the EC and ECHA could help would be to reduce the
time taken to examine applications and make final decisions quicker They often ldquofelt in
the darkrdquo when customers ask about REACH authorisation and if they can continue to
provide them with their products
Another respondent noted that reducing the complexity of the process would help They
suggested that perhaps an exact listing of requirements step by step and in detail how to
fulfil the need for documentation and a dedicated tool to fill up all these steps would help
For environmental purposes in the Netherlands they noted something similar called
ldquoeMJV66rdquo might be a good example for how this could work
Those SMEs more familiaractive with REACH authorisation
As SMEs applying for authorisation themselves would have meant forgoing too many
activities and this would have had a detrimental impact on profits They gave support to
the applicant by assisting in the collection of necessary information
One respondent was involved at consortium level meetings and noted it took a lot of time
and effort to get the lsquoinfrastructurersquo right to talk and share and develop the AfA within a
joint consortium application ndash Most SMEs donrsquot have this time This alone was costly and
time consuming from their perspective and was paid through profits rather than charging
higher prices Neither gave an exact estimate on how much they spent but said it was a 5-
digit number (so between euro10-99k)
One respondent noted that understanding what is required and the resources to provide it
can be complicated because many documents are in English That and the technical nature
of what data is required makes it impossible for their company to answer questions quickly
The process of answering the questions is very time-consuming as they first needed to
translate the documents from English to German before preparing an answer in German
which is subsequently translated in English
66 eMJV electronic environmental reporting httpwwwe-mjvnl
Impacts of REACH Authorisation Final Report
eftec 165 November 2017
One respondent noted it would be useful to know what similar firms have provided in terms
of information so that the same things are not mentioned repeatedly He said that this
would also help in terms of knowing what information is relevant However they
recognised that with consortium level questionnaires the applicants are trying to gather as
much information from as many companies as possible so this level of data sharing is not
feasible (also from a confidentiality perspective)
The main problem with authorisation is that they donrsquot have enough capacity in terms of
staff availability to deal with it Both respondents noted that they donrsquot have a specific
resource (staff member) dedicated to REACH and therefore it is hard to coordinate
responses to data requests or understand what is required Collecting data requires
communicating with a number of people and cannot be assigned to one person
Nevertheless the work needed to be done if they wanted to continue to compete in the
market
One respondent noted that for an SME the provision of socio-economic information can be
challenging and at times they felt overwhelmed by the task This is because they donrsquot
have the ability to do it and donrsquot even lsquohave a cluersquo about where to start
One respondent noted they are involved in their third AfA (as they use several SVHCs) for
two of which they have been part of a consortium and for the last one they are the single
applicant They noted the additional time required to do their own application but felt this
was the best way forward from their experience to date as they felt they were punished
being part of a consortium application due to the short review periods granted and as such
it felt like a never-ending application process From their experience the bigger the
consortium the harder the AfA ndash the smaller the consortia the tighter the exposure
scenarios and the fewer uncertainties
They noted it is a very stressful process and despite going through the process for a third
time there are lsquoa lot of sleepless nightsrsquo worrying about what would happen if they donrsquot
get authorisation They also noted that deadlines set by RAC and SEAC for answering their
questions post submission are particularly unfair on SMEs given the limitations on resources
and partially because data requests often come during holiday periods They cannot stop
people going on holiday as they donrsquot know sufficiently in advance when comments will
come and therefore this can compromise what information can be provided to respond to
RAC and SEAC questions It would also help to know which questions were essential to
respond to which ones were nice to know and if they could signpost to the AfA itself
where they felt they had already answered this point
Both respondents noted a sense of perceived unfairness that big companies who have the
financial capacity and necessary staff to work on their own AfAs got long review periods
(eg 12 years) while upstream applications only got an authorisation for four years For
them that means that those with the fewest resources have to provide the highest input as
they need to deal with an AfA repeatedly (with shorter intervals) They acknowledged that
one reason for this situation is certainly that bigger companies can produce more
convincing dossiers with stronger arguments as they can allocate more time and resources
to it One respondent mentioned that his company just does not have the ability and
capacity to produce a dossier that is as convincing
ECHA in their communications do explain the advantages and disadvantages of individual
applications vs upstream applications keeping in mind that there is not one solution that
works best for every usecompany However one respondent was also unhappy because
Impacts of REACH Authorisation Final Report
eftec 166 November 2017
they perceived that they received contradicting information They said industry actors were
first advised to apply in big groups if possible The information they got was that the bigger
the group the better (as it would avoid multiple applicants for the same use) They pointed
out that in contrast to this advice they are now being told that it might be better to apply
in smaller groups as this increases the chances for a longer authorisation period
Both respondents noted that the authorisation process is problematic as it creates lots of
business uncertainty as they are unable to predict how long they will be permitted to use
the substance This is an issue when it results in not being able to give contractual
commitments to their customers
o One respondent said that for Chromium Trioxide the sunset date has passed but
they have not received their confirmation about an authorisation yet They get
many phone calls and emails from worried clients asking them what will happen
and they are unable to give them any information about the future as no one knows
what will happen The only thing they can tell them is that they assume that they
will get an authorisation for four years (based on the RACSEAC opinion) but that
this is far from certain Thus the situation makes them and their clients feel very
insecure and worried and creates fears about the continued existence of their
companies
o The other respondent noted that SMEs further down the supply chain donrsquot get
access to information coming from ECHA committees so they feel they are lsquoleft in
the darkrsquo for months and months whilst they have customers asking if they can
continue to supply them with products This is despite the fact that ECHA inform
stakeholders of new published material through the ECHA Weekly which anyone
can sign up to67
With regards to the ECHA website and related documentation one respondent noted that
they found it difficult to know where to go on the site for the information and often had to
use search engine providers to find information on the ECHA website instead They also
mentioned that a problem is that they dont get notified when new information has been
published This means that they need to check the website manually to keep track of
changes or new information which is not practically feasible
The other respondent indicated that guidance documents are far too long citing the
downstream user guidance at 132 pages They said it is difficult to say what kind of
guidance they would find useful as there is no substitute for experience gained from going
through the process It might therefore be useful to collect information from those who
have been through the process and to see what can be learned from their experiences
rather than more guidance This has already been addressed by ECHA in their 2016 lsquohow to
apply for authorisationrsquo guide68
67 ECHA Weekly httpsechaeuropaeusubscribe 68 This issue has been looked at by ECHA as part of their lsquoHow to apply for authorisationrsquo guide which was
based on the experiences gained by applicants ECHA the Commission and other stakeholders over the first
couple of years of the AfA process The purpose of this guide was to be practical rather than theoretical and
ECHA undertook a lot of consultations with various stakeholders (both before and during the drafting stage) to
ensure that they covered the most important experiences gained It includes short explanations practical
examples and links to where further information can be found if needed See
httpsechaeuropaeudocuments1016213637apply_for_authorisation_enpdfbd1c2842-4c90-7a1a-3e48-
f5eaf3954676
Impacts of REACH Authorisation Final Report
eftec 167 November 2017
The biggest challenge they faced was the supply chain complexity ndash How can guidance help
here For very long and complex supply chains products can get used six times (by
different downstream users) before they end up with the final end-user The respondents
often donrsquot know more than one company down along the supply chain end user so it is
hard to get data further downstream They noted that end-users might not have a good
understanding of REACH and its hard to get data from customers stress the importance of
having this information to give to ECHA
One respondent noted that a clear and easy document highlighting the main steps would be
helpful They are very active within their association and therefore relatively well
informed but has experienced that many competitors act based on what they hear along
the supply chain
We made other attempts to get feedback from SME applicants but we encountered similar
problems as noted by other EC studies that it has been difficult to obtain information directly from
SMEs
86 Affordability analysis
The assessment builds on the affordability of the authorisation process for SMEs taking into
account the experience noted above from SMEs that submitted applications on their own or as
members of existing authorisation consortia
This sub-section examines the extent to which the recommendations from the REACH 2012 review
have been implemented and their effectiveness The REACH 2012 recommended revising the Fee
Regulation to lower the costs for SMEs This has been implemented and whilst affected SMEs will
have welcomed the change survey responses (and existing literature) do not highlight the fee paid
to ECHA associated with an AfA as being the main affordability issue for SMEs
The interviews with SMEs and SME survey responses show that resource and knowledge constraints
are bigger challenges than the fees paid to ECHA for applications A reduction in fees does not
change the requirements in terms of what SMEs need to submit as part of their AfA SME applicants
are expected to submit the same types of document and level of detail required (to make their
case) as a large firm who have more financial and human resources available They are also given
the same amount of time to respond to RAC and SEAC comments and planning for lsquotrialoguesrsquo
As shown in Chapter 6 the authorisation process does present financial challenges that are not
necessarily linked to the fee for submitting an application Chapter 6 shows that SMEs do not have
the same financial capacity to invest in RampD innovation investigating alternativessubstitution
activities and improved risk management SMEs who decide to submit their own application
therefore have to sacrifice new investments andor divert both staff and budgets away from RampD
and innovation or new marketproduct development in order to prepare their applicant
Due to the resource commitment and financial implications on the business many SMEs have relied
on actors higher up in the supply chain to apply for authorisation instead They weigh up the
reduced resource commitment and financial implications of an upstream application against the
higher costs and resources required to submit their own application which may be more successful
in getting a longer review period They have noted upstream applications to be a lsquonecessary evilrsquo as
from their experiences consortia applications have generally been granted shorter review periods
compared to single applicant company applications They do recognise this is because single
Impacts of REACH Authorisation Final Report
eftec 168 November 2017
applicants can provide much more information specific to their company and operations which are
not possible with a jointconsortia level application
The interviews with SMEs specifically highlighted that responding both to RAC and SEAC questions
are particularly challenging given the short time period available to respond For example the
companies cannot stop staff going on holiday as these requests (in their cases) came during times
when people are away (eg summer vacations and the Christmas period in December)
Interviewees felt they were unfairly punished as they didnrsquot have sufficient time or the right person
to respond and this jeopardises the quality of the response they could give (eg directly to ECHA or
through their upstream applicant)
It would have been helpful if the Committees were to give more time for SMEs or at least separate
questions that are lsquoessentialrsquo for the Committee decision making and those that are lsquonice to know
more aboutrsquo so that limited resources could be focused on providing responses to the former
group
Part of the issue may be the difficulties for the upstream applicants to filter information provided
by ECHA further down the supply chain to those affected ECHA does try to facilitate applicantsrsquo
planning by sending them the indicative timelines for RACSEAC questions trialogue etc after
submission (See Annex 1 in the How to apply for authorisation guide) For every application there
is an lsquoAuthorisation team managerrsquo running the process within ECHA After submission the
applicant is sent the team managerrsquos contact details (and the team manager also tends to contact
the applicants directly) For any questions the applicant has about the process eg in terms of
the timing of the key steps or regarding the reasons for specific questions they can contact the
team manager directly as this person is also the contact person for the rapporteurs of the case and
therefore is usually well informed about why the rapporteurs ask the questions they ask
There was a perception that the numbers of questions asked (especially by RAC) on the CSR
(specifically the exposure scenario) were not proportionate to the scale of the problem They felt
they were not in line with what they expected based on the ECHA guidance and templates and
therefore if the lsquogoal postsrsquo had moved this should be reflected in available guidance templates
and information on the ECHA website This is important since it is better (from both a financial and
resource perspective) to provide the necessary information in the application
The REACH 2012 review also recommended ldquoECHA and industry should develop more user-focused
guidance with special attention to SMEs The review identified a specific problem in relation to
the vast amount of guidance developed to support the implementation of REACHrdquo This was further
confirmed through survey responses and industry interviews that guidance documents are too long
and shorter documents (available in all EU languages) would better assist SMEs Whilst ECHA have
recently updated some of the support documents associated with authorisation this is not support
specifically designed for SMEs69
ECHA industry Member States and NGOs have come together noticeably through the Network of
REACH SEA and Analysis of Alternatives practitioners (NeRSAP)70 to advance and review concepts
methods and experiences for Socio-economic Analysis (SEA) and Analysis of Alternatives (AoA) on
EU-wide or national chemicals management implementation Whilst there still remains insufficient
representation from industry in NeRSAP it could be a forum through which further practical
That said keeping SMEs specifically in mind ECHA made an effort to present the advice in a clear and
concise way with plenty of examples from real applications 70 httpsechaeuropaeusupportsocio-economic-analysis-in-reachnetwork-of-reach-sea-and-analysis-of-
alternatives-practitioners
Impacts of REACH Authorisation Final Report
eftec 169 November 2017
information guidance is generated on how the authorisation process could be made more
affordable for SMEs
87 SME summary
The EU chemicals industry is mainly made up of SMEs (see Section 42) However only 35 (18) of
195 applicants between 2013 and 2017 were from SMEs The surveys identified (and the interviews
provide supporting details) that the main factors for this were the resource and knowledge
challenges presented by the authorisation process
SMEs have typically relied on their MIs trade associations or their consultants for support on the
AfA process There were mixed views on available information on the ECHA website and relevant
guidance Whilst it is not disputed that relevant information is there respondents often referred
to difficulties with finding the information they need and the length and complexity of the
guidance documents especially since the SMEs donrsquot have dedicated personnel who deal with
REACH
Financial constraints are an important factor for SMEs both due to their limited ability to invest up-
front in substitution activities and to meet the costs associated with applying for authorisation The
fee charged by ECHA is a cost item but it is insignificant compared to the financial costs of
preparing an application finding and implementing a suitable alternative and the impacts on the
forgone activities (eg RampD and innovation) as a result of diverting time and budget to apply for
authorisation Due to these factors SMEs have typically relied on their upstream suppliers to apply
for authorisation (and therefore they are covered by their suppliers)
As noted in the survey findings in Section 4 the indirect impact of this is that SMEs become reliant
on these suppliers (eg limits who they can buy the SVHC from) and many of them expect or have
already had to pay for this lsquoupstreamrsquo authorisation through higher prices which they cannot pass
through onto their customers
The main issue with lsquoupstreamrsquo authorisation applications for SMEs however has been that they
tended to result in shorter review periods and that it took time for information on the application
to filter down the supply chain This creates further business uncertainty both for the SMEs and
their customers with regards to the long-term supply of their products
Impacts of REACH Authorisation Final Report
eftec 170 November 2017
9 EVIDENCE OF THE lsquoANNOUNCEMENT EFFECTrsquo
91 Introduction
Evidence of the lsquoannouncement effectrsquo represents the last of the Tier 2 study areas A study by
Oumlkopol GmbH (2007) for the European Commission developed seven hypotheses around the
lsquoannouncement effectrsquo ie once a substance was added to the Candidate List As set out in Table
91 the report suggests there was some supporting results for some of the hypotheses one was
disproved and the rest had mixed results
Table 91 Seven hypotheses around the lsquoannouncement effectrsquo
No Hypothesis Results
1 Increasing awareness of risks and further risk management Supporting
2 Companies will look at the candidate list and consider it in their product
development Supporting
3 Industry will try to demonstrate adequate control of identified threshold
SVHC during registration Disproved
4 Importers producers and professional recipients of articles will prefer
articles without SVHC Supporting
5 Innovative alternatives not using identified SVHC will be promoted Mixed
6 The candidate list provides a harmonised tool for prioritisation of substances Mixed
7 With the candidate list the actors in the supply chains get time to identify
optimum solutions Mixed
Source Oumlkopol GmbH (2007) Case study on ldquoAnnouncement effectrdquo in the market related to the Candidate List of
substances subject to authorisation
This section sets out further information on the lsquoannouncement effectrsquo using the results of the
online survey case studies and further literature review carried out since the Oumlkopol study In
particular it seeks to identify if effects like early substitution improvement of exposure conditions
and market disturbance were lsquotriggeredrsquo by key announcements like candidate listing authorisation
listing and the sunset date
The section is split into four sub-sections
Section 92 Literature review ndash sets out what the key findings are from existing studies
Section 93 Analysis testing the announcement effect - uses available statistics to see if
there is an observable effect that can be explained by key REACH authorisation
announcements (eg sunset dates)
Section 94 Case studies - presents evidence around the lsquoannouncement effectrsquo for specific
companies as ldquomini case studiesrdquo They make use of survey responses existing information
Impacts of REACH Authorisation Final Report
eftec 171 November 2017
and further consultation with affected companiessector groups to try to explain the role of
REACH authorisation
Section 95 ndash concludes the Chapter with a summary
92 Summary of literature review
In order to create a basis for the assessment of new results produced by this study a literature
review has been conducted to identify and consolidate existing knowledge about the announcement
effect The consulted literature includes regulation documents the report prepared by Heitmann
and Reihlen (2007) as part of the Oumlkopol study several EC study reports a Finnish study
commissioned by ECHA (ie Harrikari and Montonen 2017) as well as reports and position papers
submitted during the public consultation of the REACH REFIT Evaluation 2017
The complete literature review can be found in Annex E8 The key findings of the literature
review are as follows
Heitmann and Reihlenrsquos analysis of past reaction patterns of industry actors to comparable
legal approaches reveals that the extent of the announcement effect of the Candidate List
is likely to depend on market pressure exerted by downstream users article producers and
retailers as well as the ldquoimaginary pressurerdquo of the Candidate List
o According to Heitmann and Reihlen (2007) the market pressure exerted by
downstream users tends to be higher for companies producing or selling consumer
products (eg household articles and cosmetics) and companies with brand names as
they are more susceptible to NGO campaigns calling for the disuse of hazardous
substances
o With respect to ldquoimaginary pressurerdquo Heitmann and Reihlen (2007) point out that the
expert consultation revealed that this is likely to depend on the number of the
substances placed on the Candidate List as it will influence the perception about
whether the authorisation requirement is perceived as an imminent situation
EC (2015) report titled Monitoring the Impacts of REACH on Innovation Competitiveness
and SMEs provides numerical evidence for market pressure in the authorisation context It
indicates that an open-ended business survey with companies from all 28 EU Member States
as well as EEA and non-EU countries revealed that 388 of all respondents answering the
question (n=242) received requests from their customers to remove SVHCs from the
products as a reaction to the candidate listing
EC (2015) also provides anecdotal and numerical evidence for an announcement effect
o In terms of anecdotal evidence it stresses that according to the interviews conducted
as part of the EC (2015) study substitution attempts are often only based on the legal
status of the substance (ie that it is listed on the Candidate List) Information about
potentially negative implications of this announcement effect can be found in Annex
E8
o In terms of numerical evidence the open-ended on-line business survey reveals that
i 246 of SMEs and 419 of large firms launched reformulation initiatives in
response to the Candidate List
Impacts of REACH Authorisation Final Report
eftec 172 November 2017
ii 189 of SMEs and 368 of large firms requested substitution of substances as
a result of the substance being placed on the Candidate List
iii Out of the respondents (n=278) providing an answer to the question what their
response to the placing of substances relevant to the firm on the Candidate
List was only 187 indicated that they took no special action
According to the numerical evidence provided by the EC (2015) study the announcement
effect thus seems to be stronger in the case of large firms than SMEs Further anecdotal
evidence for the existence of an announcement effect comes from reports and position
papers submitted during the public consultation of the REACH REFIT Evaluation 2017 The
position paper by the European Environmental Bureau71 even provides evidence for an
announcement effect on companies that are located in countries that are not subject to
REACH by referring to the Swiss company Hoffmann-La Roche This company committed to
phase out SVHCs wherever possible within a decade of their addition to the Candidate
List The main reason for this is the risk of supply chain discontinuity in the future
93 Analysis testing the announcement effect
The online survey generated data on the announcement effect that could act as supporting
evidence to validate much of the key findings from existing literature The survey results (see
Figure 91) show that REACH authorisation is triggering internal policies to learn more about and
better manage the use of SVHCs
Figure 91 Whether REACH authorisation has led to internal policy concerning managingknowing what substances are used within respondents organisations including (possible) SVHCs
Source Online survey Q5 (n=83)
71 European Environmental Bureau (na) EEB Comments to the REACH REFIT public consultation Position
Paper for REACH REFIT Evaluation
Yes47
Yes but not due to REACH
authorisation
36
No13
No but we are considering
having a policy
4
Impacts of REACH Authorisation Final Report
eftec 173 November 2017
As set out in Figure 92 the early stages of the authorisation process do trigger substitution away
from the use of SVHCs About 66 of survey respondents indicated they had already begun
substitution away from an SVHC before it was placed on the Authorisation List
Figure 92 Authorisation stage that triggered decision to substitute from an SVHC
Source Online survey Q19 (n=44)
This would suggest that where substitution is possible the REACH authorisation process (in
particular the inclusion on the Candidate List) triggers substitution The results reported in Section
6 show that substitution costs can be higher than the costs of applying for authorisation which may
support the view that companies are switching away from SHVCs for other reasons such as avoided
stigma associated with SVHCs as well as avoiding future regulatory costs and being able to give
customers certainty of supply (as they are not faced with the perspective of a sunset date on use or
that their continued use is reliant on the outcome of an AfA decision)
Where available alternatives are not evident the survey responses (see Figure 93) also give a good
indication that the announcing the inclusion of an SVHC in the Candidate List triggers further
substitution related activities (See Section 53 for more details)
Figure 93 Authorisation stage that triggered substitution related activities
Source Online survey Q60 (n=56)
As set out in Figure 94 most stages in the authorisation may trigger improved risk management
This suggests that companies do not wait until the substance is placed on the Authorisation List
before carrying out further risk management However it is not surprising that most respondents
noted the application for authorisation stage as a key driver for improving risk management as it is
14
29
23
25
9
0Screening of substance and Risk Management OptionAnalysis (RMOA)
Inclusion of substance in Candidate List
Recommendation for inclusion of substance inAuthorisation List (Annex XIV)
Inclusion of substances in Annex XIV
Applications for authorisation (AfA)
Post-authorisation decisions (eg after sunset date ofAnnex XIV substance)
9
43
27
7
11
3Screening of substance and Risk Management OptionAnalysis (RMOA)
Inclusion of substance in Candidate List
Recommendation for inclusion of substance inAuthorisation List (Annex XIV)
Inclusion of substances in Annex XIV
Applications for authorisation (AfA)
Post-authorisation decisions (eg after sunset date ofAnnex XIV substance)
Impacts of REACH Authorisation Final Report
eftec 174 November 2017
a legal requirement (Article 6010) for applicants to show minimisation of emissions as part of their
application There is therefore pressure to make sure exposure and emissions are as low as possible
even though there are numerous examples from RAC comments of AfAs to suggest that applicants
are not presenting sufficient evidence of minimisation of emissions
Figure 94 Authorisation stage that triggered further risk management activities
Source Online survey Q80 (n=26)
The PRODCOM data shown in Section 47 also provides mixed results on observed changes in the
market although there is potentially an indication that candidate listing may have resulted in a
decline in the production and use of these SVHCs This is however difficult to be conclusive about
given limitations with the data and difficulties of getting reliable market data to confirm the
observed trends
94 Case studies
A large number of stakeholders (both companies and trade associations) were contacted to improve
the understanding of which activities are triggered by various announcements such as candidate
listing and recommendations for inclusion on Annex XIV Whilst initial contacts seemed promising
and stakeholders understood the overall value of providing information not all stakeholders wanted
to share their specific information given the risk that it would raise awareness of their substances
to regulators and this in turn may lead to further regulatory scrutiny
Only in a few cases were some stakeholders willing to provide information that was already in the
public domain given the information is not necessarily widely read (eg public consultation
response to ECHA) These are briefly discussed below
Case 1 - Space sector
The European space sector is likely to be affected by authorisation as more and more substances
they use fall within the authorisation process The sector has been affected and contributed to the
Cr(VI) applications for several uses (eg corrosion protection and inhibitors) However the focus is
15
27
815
35
0Screening of substance and Risk ManagementOption Analysis (RMOA)
Inclusion of substance in Candidate List
Recommendation for inclusion of substance inAuthorisation List (Annex XIV)
Inclusion of substances in Annex XIV
Applications for authorisation (AfA)
Post-authorisation decisions (eg after sunsetdate of Annex XIV substance)
Impacts of REACH Authorisation Final Report
eftec 175 November 2017
on activities being carried out for substances on the Candidate List A position paper72 was prepared
and sent to ECHA and the EC proposing an exemption73 for propellant-related use of hydrazine
from REACH authorisation The substance was included on the Candidate List on 20 June 2011 and
could be prioritised for Inclusion in Annex XIV of REACH in the future The paper sets out details
for an exemption providing information on the importance of continued use of hydrazine for the
space sector
Reference is made to a hydrazine REACH Authorisation Task Force of the European Space Industry
The task force work has triggered a number of activities (eg in relation to looking at substitution)
and generated availableknown information about alternatives that may otherwise not have been
produced if hydrazine was not placed on the Candidate List
This example highlights that candidate listing can stimulate action on RampD substitution where
possible information on alternatives and information on the importance of these uses of such
substances Based on the initial engagement with a number of other stakeholders and the public
consultation submission statistics shown in Section 66 coordinated efforts to gather information
(and to apply for exemptions) is very common especially for sectors and trade associations that are
already well engaged with the REACH authorisation process74
Case 2 ndash Automotive sector
A Tier 2 supplier of the automotive sector expects that a SVHC listing of his substance would have a
detrimental effect on the competitive position of the product The downstream user of the
substance produces articles which still contain the substance and are built directly into the cars
The automotive sector has a comprehensive system to track the use of hazardous substances in
their supply chain
The expectation of the supplier of the substance reflects the attitude the automotive sector has
regarding the use of substances The supplier of the substance expects that even well before the
substance is listed but based on the hazard properties the pressure on substitution by the article
manufacture will be very high
While the listing or announcement effect in the automotive sector is supported by uniform data
collection tools other companies also map their supply chain and try to identify when hazardous
substances are used However this is mostly company specific and only seldom has a scope beyond
the direct supply (Tier one)
Case 3 ndash Company level ndash Evaluation on the use of hazardous substances
One company reports on its website the use of a management system which evaluates the use of
hazardous substances and does this in advance of possible legislation
72 httpwwweurospaceorgposition-paper-on-reach-and-hydrazine-in-the-space-sectoraspx 73 Stakeholders have an opportunity to comment during the public consultation within three months of
publication under Article 58(4) when a substance is being proposed for inclusion on Annex XIV lsquoInterested
partiesrsquo are invited in particular to comment on ldquouses which should be exempt from the authorisation
requirementrdquo 74 For example (and there are many others) the International Lead Association (ILA) provided evidence for
proposed use specific exemptions for four lead compounds currently on the 7th draft recommendation on
priority substances for inclusion in REACH Annex XIV httpsila-reachorgwp-
contentuploads201605Briefing-Note-REACH-Article-582-v2pdf
Impacts of REACH Authorisation Final Report
eftec 176 November 2017
ldquoOur company-wide priority substance process takes a systematic approach to the identification
review and management of hazardous substances that we use in our products and chemical
processes Taking this proactive approach promotes the use of safer and sustainable products and
means we often take action to manage harmful substances in advance of legislation future-
proofing our products against changes in regulations
The process identifies hazardous substances for review by scoring them on the basis of their
human and environmental hazards and where societal concern exists over their use Substances
with higher scores are designated as priority substances and are subject to review by our experts
Where a safer and effective alternative exists (which is economically feasible) priority substances
are substituted with less hazardous materials In cases where substitution is not possible a full
risk assessment is carried out on the substance using state-of-the-art techniques from the EU
REACH regulations
Only when use of a priority substance can be managed safely can it be used in [name omitted]
products and processesrdquo
Other companies have similar systems which they announce on their websites For instance a
different company has an open ldquobanned substancesrdquo list which they set up using an in-house
developed tool
ldquoOur Product Stewardship group monitors developments in both regulation and public perception
for all relevant hazardous chemicals that either fulfil or are suspected to fulfil SVHC criteria
The substances are ranked by their risk using a tailor-made toolrdquo
Despite these policies in certain cases these companies still find it impossible to substitute the
use of the substance and have either initiated an authorisation or are using substances for which
and authorisation has been applied for
95 Summary of the announcement effect
Table 92 summarises the findings from this study using the seven hypotheses around the
lsquoannouncement effectrsquo presented earlier in Table 91 Overall the findings from this study align
well to existing literature concerning the announcement effect (but some hypotheses are outside of
the scope of this study and therefore were not assessed)
Table 92 Evidence relative to the seven hypotheses around the lsquoannouncement effectrsquo
No Hypothesis
Results
Oumlkopol GmbH
(2007) This study
1 Increasing awareness of risks and further risk
management Supporting
2 Companies will look at the candidate list and consider it
in their product development Supporting
3 Industry will try to demonstrate adequate control of
identified threshold SVHC during registration Disproved
Not assessed
in this study
4 Importers producers and professional recipients of
articles will prefer articles without SVHC Supporting
Not assessed
in this study
Impacts of REACH Authorisation Final Report
eftec 177 November 2017
No Hypothesis
Results
Oumlkopol GmbH
(2007) This study
5 Innovative alternatives not using identified SVHC will be
promoted Mixed
6 The candidate list provides a harmonised tool for
prioritisation of substances Mixed
Not assessed
in this study
7 With the candidate list the actors in the supply chains
get time to identify optimum solutions Mixed
The survey results interviews and Tier 1 amp 2 case studies both show that companies have sought
to improve risk management as a result of announcement made along the whole authorisation
process All stages in the authorisation process lead to further RMM investment ndash most occurred at
candidate listing (43 followed by 27 at recommendation to authorisation list) For example
companies may have improved RMM at earlier stages within the authorisation process so as to delay
being prioritised for inclusion on Annex XIV and even once on Annex XIV applicants have sought in
their applications to demonstrate that further RMMs have been introduced or are being planned so
as to demonstrate minimisation of emissions within their AfA
The survey data shows that authorisation process lead many companies (~46) to set up an
internal policy to managingknowing about use of SVHCs (~36 already had one) The case
studies above also examples where a lot of effort is spent on seeking exemptions and there
is a stigmadesire to switch once a substance becomes an SVHC Around 66 of respondents
had also already substituted a use of an SVHC before the substance was on the
authorisation list showing that classifying a substance as an SVHC and placing on the
substance on the candidate list does trigger and drive substitution It also shows in many
cases that substitution was possible prior the sunset date and therefore these companies
avoided the need for authorisation
Impacts of REACH Authorisation Final Report
eftec 178 November 2017
10 TIER 1 CASE STUDY SUBSTANCE 1 CHROMIUM TRIOXIDE
101 Introduction
Tier 1 case studies are an attempt to assess the impacts associated with REACH authorisation
through detailed analysis on a few specific substances This chapter sets out the evidence found
for the substance of Chromium Trioxide
As noted earlier in Table 622 Chromium Trioxide received the most responses (493) during the
public consultation compared to any other substance to date when it was proposed to be included
on the authorisation list75 A more detailed breakdown of the reasons for commenting is described
in Section 104 Chromium Trioxide also received the most comments (compared to other
substances) during the public consultation for applicants for authorisation with 449 (~40 of total
number of comments received to date) The large number of comments also means that a large
number of businesses are affected and the use of the substance in industry is extensive These were
the reasons for choosing Chromium Trioxide as a case study Further reasons for this choice are set
out in Section 103
A study on the impact of authorisation for chrome VI by the Dutch consultancy Panteia (2016)76
estimates that close to 730000 employees in around 42200 businesses in the EU are directly or
indirectly affected by the application for authorisation of Chromium Trioxide
Information for this Tier 1 case study has been gathered on market volumes as well as the online
survey results and follow-up interviews Of the 66 online survey responses about 50 originated
from applicants downstream users providers of alternatives NGOs or associations dealing with
Chromium Trioxide (34 survey participants) 29 of the 34 respondents were applicants or
downstream users
In addition to the survey data follow up interviews with stakeholders for Chromium Trioxide were
held (12 in total)
NGOs (1)
Associations (1)
Applicants (3)
Suppliers of alternatives (1)
Previous Downstream Users who did not apply for authorisation (6)
The objective was to collect as much information as possible for a more in-depth review of the
main impacts experienced by the businesses applying for authorisation and other stakeholders like
providers of alternatives and NGOs
75 Due to the grouping of the comments in different categories some of the comments could be counted double
as they would fit several categories 76 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo
Impacts of REACH Authorisation Final Report
eftec 179 November 2017
102 Substance profile
Table 101 Chromium Trioxide substance profile
Name Chromium Trioxide
EC no 215-607-8
CAS no 1333-82-0
Stage in Authorisation Process On Authorisation List
SVHC Classification - Intrinsic
property(ies) referred to
in Article 57
Carcinogenic (Art 57a)
Mutagenic (Art 57b)
Exempted (categories of) uses none
Existing restrictions No Annex XVII restrictions
Restricted by RoHS
Stage in Authorisation Process On Authorisation list
The production of Chromium Trioxide starts with chromium ore (FeCr2O4) which has historically
been mined in Russia Philippines Southern Africa and Finland In 2016 29 million tonnes of ore
were mined77 The majority of the ore (95) is metallurgical grade and used for stainless steel
alloyed steels and non-ferrous steel78 This use is outside the scope of the authorisation of
hexavalent chromium compounds
Only 078 million tons or 27 of the globally produced chrome ore is chemical grade79 The first
step to transform the chromite ore to Chromium Trioxide is the extraction of the chromium as
sodium chromate (Na2CrO4) The vast majority of the sodium chromate is converted to sodium
dichromate (Na2Cr2O7) In 2010 the global production of sodium dichromate was estimated at
700000 tonnes which is split into the following downstream products ndash basic chrome sulphates
(33) chromic acids (33) chrome trioxides (29) and other products (5)80 Chromium Trioxide is
made by the reaction of sodium dichromate with sulfuric acid The reaction can be carried out with
solid sodium dichromate or with solutions or suspensions Both methods are in use industrially
Chromium can exist either as elemental chromium alone or combined with other metals or
chemically bound to other substances In the latter case the chromium can be either trivalent
Cr(III) or hexavalent (Cr(VI) The toxicological hazard of chrome predominantly exists for the
substances containing Cr(VI) as Cr(III) does not have a classification which complies with Art 57
criteria for SVHC Also the requirement for authorisation is only for Cr(VI) containing substances
such as Chromium Trioxide
Based on studies that show its genotoxic potential the Risk Assessment Committee (RAC) concluded
that Chromium Trioxide (EC no 215-607-8 CAS no 1333-82-0) should be considered as a non-
threshold substance with respect to risk characterisation for carcinogenic effect of hexavalent
chromium81
77 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 78 No exact data is available what volumes are used within EEA however 70 of the global chromite
production is consumed domestically in ferro-chrome production in the country of origin 79 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 80 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 81 Reference to the studies examined are included in the RAC document RAC27201306 Rev 1 Final
Impacts of REACH Authorisation Final Report
eftec 180 November 2017
103 Case study rationale
Chromium Trioxide fulfils all the key criteria set for the selection of a Tier 1 case study substance
Latest application date has passed so that the impacts of the whole authorisation process
should be possible to assess ndash for Chromium Trioxide this was 21 March 2016
There are a large number of applications and applicants which increases the opportunities
for getting data ndash for Chromium Trioxide there were 20 applications for 54 applicants
There are a large number of uses applied for ndash 37 different uses
There are diverse and complementary impact aspects ndash widespread use in the EU by
numerous SMEs with widespread applications82
There is little accurate data available on the number of companies impacted by the authorisation
of Chromium Trioxide A study on the impact of authorisation for chrome VI by the Dutch
consultancy Panteia (2016) estimates that close to 730000 employees in around 42200 businesses
in the EU are directly or indirectly affected by this application for authorisation83
The available data from ECHA shows that for the continued use of Chromium Trioxide most of the
applications for authorisation were from SMEs This is supported by a number of consortia applying
for authorisation (nine applications out of submitted 20 were by consortia) Although this criterion
was not used explicitly this selection meant that this aspect (affordability for SME) could be
explored within this Tier 1 case study
104 REACH Authorisation timeline
The REACH authorisation timelines for the substance is given in Table 102
Table 102 Chromium Trioxide REACH authorisation timeline
Key REACH authorisation timeline Date
Inclusion to Candidate list 15122010
Inclusion to Annex XIV 20122011
Latest Application Date (LAD) 21032016
Sunset date 21092017
In accordance with Article 57(a) and (b) Chromium Trioxide was identified as a Substance of Very
High Concern (SVHC) It is classified as carcinogen category 1A and mutagen category 1B The
reasoning behind the decision to prioritise and include Chromium Trioxide on Annex XIV was that it
is supplied for uses in high volumes and for many sites Therefore significant workplace exposure
may occur in a number of sites
Chromium Trioxide was included on the Candidate List on 15 December 2010 for possible
authorisation in the future During the period for commenting 173 comments were submitted by
82 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo 83 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo
Impacts of REACH Authorisation Final Report
eftec 181 November 2017
industry (123) associationstrade unionsMember State authorities (42) and NGOs (8)84 Half the
submitted statements related to general comments (85) and the other half to the use exposure
alternatives and risks (74) A large majority of the comments (almost 75) were submitted from
France Prior to this inclusion no RMOA was carried out (as the RMOA process had not been
established at this stage) In 2012 Eurometaux indicated in an article in Chemical Watch that
ldquoWorker exposure would have been best covered he says by developing and implementing
other more focused risk management tools like an EU-wide occupational exposure limit
(OEL) for chromium VI and chromium III and updated pollution prevention guidance on
best available techniques (BAT) for sites producing or using itrdquo85
On 20 December 2011 the substance was included to Annex XIV This meant that the use of
Chromium Trioxide would require authorisation after the sunset date of 21 September 2017 with a
latest application date on 21 March 2016
During the period for commenting for the inclusion of Chromium Trioxide to Annex XIV 1229
comments were submitted by industry (1084) industry associations Member States trade unions
academic institutions (139) and NGOs (6) The majority of the comments related to general
comments on the recommendation to include the substance in Annex XIV (489) followed by the uses
that should be exempted from authorisation (389) and transitional arrangements (218)
By end of 2016 28 applications by 52 applicants for the uses of Chromium Trioxide after sunset
date were submitted In addition one application was made jointly with sodium dichromate and
one application was made jointly with dichromium tris(chromate)
105 Market prior to REACH authorisation
The risk assessment report86 for Chromium Trioxide was finalised in 2005 The rapporteur was the
United Kingdom The same report mentions three producers of hexavalent chromium compounds
even though it is not stated where these are located In 2006 the last manufacturer of Chromium
Trioxide ceased production of the substance in the EU (Elementis Chromium in the UK) Since 2006
all of Chromium Trioxide used in the EU is imported (see Figure 101)
The EU is a net importer of Chromium Trioxide Less than 10 of the volume imported is exported
outside the EU from formulators within EU The export volume comes from formulators that sell
their products to customers outside the EU (see Figure 102)
For the last five years the import volume has been relatively stable at around 12000 tons per year
In principle this is also the volume covered by the scope of the submitted AfAs for Chromium
Trioxide The import market is split between 7-10 key players The number of formulators using
Chromium Trioxide in the EU is estimated to be about 20 companies87
84 Due to the grouping of the comments in different categories some of the comments could be counted more
than once as they would fit several categories 85 httpschemicalwatchcom12927chrome-platers-put-their-case-for-chromium-trioxide-authorisations 86 European Chemicals Bureau ndash Risk Assessment Report Chromium Trioxide Sodium Chromate Sodium
Dichromate Ammoniul Dichromate and Potassium Dichromate 2005 87 (ref LANXESS presentation 20121001 ECHA Helsinki)
Impacts of REACH Authorisation Final Report
eftec 182 November 2017
Figure 101 Chromium Trioxide imports to EU 2000-2016
Figure 102 Chromium Trioxide exports to outside EU 2000-2016
Impacts of REACH Authorisation Final Report
eftec 183 November 2017
1051 Supply chain structure
In the context of the authorisation of Chromium Trioxide it is important to elaborate briefly on the
structure of the supply chain for the surface treatment industry in the EU All six interviewed
applicants and downstream users stated their frustration that in their experience their own
particular position in the supply chain was not taken into consideration sufficiently during the
authorisation process This refers mainly to their ability to alter the process to use alternative
substances without explicit approval from their customers (which means the products still matching
the customerrsquo specifications)
As mentioned above there is no manufacturer of Chromium Trioxide left in the EU Imports are
entering the EU mostly through importers with manufacturing facilities outside the EU LANXESS
estimates that there are approximately 10 key importers for the substance88 Most of the Chromium
Trioxide is then supplied to formulators that use it in specific formulations to be used by their end
users (Figure 103)
Figure 103 Supply chain for Chromium Trioxide89
The supply chain differs here from that of other industries A substantial number of companies can
be identified amongst the downstream users which are contract manufacturers (contract platers)
using Chromium Trioxide containing substances or mixtures Contract manufacturers tend to be
SMEs and manufacture products to the specifications of their customers in a variety of industries
(eg aerospace automotive construction furniture machinery sanitary ware consumer products
and packaging) As a consequence the contract manufacturers cannot change the process unless
approved by their customers and unless the different process still ensures that the same
specifications defined by their customers are met
88Lanxess Deutschland GmbH Dr Martin Kleban 10012012 Presentation ldquoChromium Trioxide Authorisation
Consortium CTACrdquo 89Lanxess Deutschland GmbH Dr Martin Kleban 10012012 Presentation ldquoChromium Trioxide Authorisation
Consortium CTAC
Impacts of REACH Authorisation Final Report
eftec 184 November 2017
The contract manufacturers are in fact dependent on their customers being able to change to an
alternative process If the customers do not see any advantage to do so ndash main reason often being
to reduce costs ndash the contract manufacturers cannot change the process A key feature of the
contract manufacturers is also that they have no or limited capacities for research and
development for example for a new process
Manufacturers that develop produce (surface treat) and sell their own products are different to
contract manufacturer They define their own specifications and have therefore the advantage to
make their own decisions about which process to use for their products
Although there is no detailed information on the structure of the plating industry across the EU and
hence the supply chain available it can be estimated based on the report published by the Dutch
consultancy Panteia that many companies in the EU are affected by the authorisation of Chromium
Trioxide90 The majority of these are estimated to be SMEs
Some contract manufacturers also use the opportunity to organise themselves into networks and
join efforts to carry out RampD into alternatives One particular example is the Fachverband
Galvanisierte Kunststoffe eV (FGK) in Germany which was established by 13 that also submitted
two applications for the authorisation for Chromium Trioxide
In total at the end of the supply chain the surface plating downstream users are covering millions of
articles that use chrome plated or passivated parts Also for the customers it is almost impossible
to identify which components are treated with Chromium Trioxide in the production process as it
is not part of the component or end product Therefore customers complain about the complexity
to identify relevant components that would need to undergo a different process to phase out
Chromium Trioxide ldquoThe search has to be carried out by responsible component
developersbuyerssuppliers within a complex supply chain with 1500 to 4500 suppliers per
OEMrdquo91
1052 Uses
Chromium Trioxide is used in various applications where metal finishing (surface treatment) is by
far the biggest use The Annex XV report from 201092 estimates the quantitative apportionment of
Chromium Trioxide in industrial chemical substances and mixtures is 75 in metal treatment
formulations 15 in wood protection formulations and 10 in other uses This means that the risk
associated with a significant part of the uses can be managed via authorisation
The same report mentions the following main uses for Chromium Trioxide
Metal finishing (for electroplating eg hard chrome plating decorative or bright-chrome
plating conversion coatings eg passivation of zinc aluminum cadmium and brass
pickling [CrO3 solution]) and
Manufacture of wood preservation products (biocidal agent (not relevant for REACH93)
90 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo 91 Verband der Automobilindustrie Dr Wolfgang Marquardt 11122014 Zulassung unter REACH und die
Herausforderungen aus Sicht desVerbands der Automobilindustrie eV (VDA) 92 ANNEX XV report ldquoProposal for identification of a substance as a CMR Cat 1 or 2 PBT vPvB or a substance of
an equivalent level of concernrdquo August 2010 93 At the 21th Competent Authorities meeting in 2006 it was decided that biocidal products containing
chromium had to be removed from the market by 1 September 2006
Impacts of REACH Authorisation Final Report
eftec 185 November 2017
fixing agent in waterborne wood preservatives)
The report refers also to ancillaryother uses like
Catalyst manufacture
Chromium dioxide manufacture
Pigment manufacture
Manufacture of paints varnishes and inks putty (anticorrosive dye)
Oxidant in organic chemistry
Electronic component manufacturing (characterization of silicon wafers)
Production of polyethylene and other plastics (catalyst)
Metallurgy of nonferrous metals (elaboration of chromium metal)
Manufacture of soap detergents and cleaning agents
Manufacture of other organic basic chemicals
Inorganic hardening agent layer of photosensitive galantine
Manufacture of jewelry (production of synthetic sapphire)
Additionally there are some uses in research and development for the hardening of microscopic
preparation or as oxidizers (Jones reagent Sarret reagent)
There are currently 23 active registrations Two registrations are inactive The total use based on
the tonnage band is according to the ECHA website in the range of 10000-100000 tonnes per
year The actual import of the substance is in the range of 12000 to 16000 tonnes per year (see
Figure 101)
The uses identified in the registration dossier and falling under authorisation are
Formulation of preparations used eg in metal finishing or as catalysts
Manufacture of other chromium substances
Manufacture of Chromium Trioxide (as substance and in catalysts)
Manufacture of preparations used in metal finishing and non-metal surface treatment
Catalyst production
Manufacture of Chromium Trioxide as a catalyst precursor
Catalyst use
Metal treatmentfinishing
The use of Chromium Trioxide as fixing agent for the manufacture of wood preservation products is
not specifically registered According to the lead registrant for Chromium Trioxide during the
preparation for registration dossier this use was no longer in demand as alternatives were available
on the market Therefore the lead registrant decided not to register the use in the registration
dossier for Chromium Trioxide
106 Changes in the market for the substance during the authorisation process
The available information shows that during the authorisation process (since inclusion of the
substance on Annex XIV) no substantial changes in market volumes could be identified relating to
the authorisation of Chromium Trioxide Since 2011 the import volume for Chromium Trioxide
remained stable around a yearly import volume of approximately 12000 tonnes
The split of the various applications in 2016 was similar to the one in 2010 (see Figure 104)
Impacts of REACH Authorisation Final Report
eftec 186 November 2017
Figure 104 Chromium Trioxide ndash Market share by use
At the end of 2011 Chromium Trioxide was included in Annex XIV One of the key players (an
importer with manufacturing capacities outside EU) took the lead to form a consortium for a joint
upstream application This approach was supported by ECHA who feared otherwise a very high
number of applications for authorisation The key player was also the lead registrant for the
substance
To facilitate a systematic and efficient dossier preparation this consortium concluded to include
the following uses in the application for authorisation
Formulation of mixtures
Functional chrome plating
Functional chrome plating with decorative character
Surface treatment (except passivation of tin-plated steel (ETP)) for applications in various
industry sectors namely architectural automotive metal manufacturing and finishing and
general engineering (unrelated to functional chrome plating or functional chrome plating
with decorative character)
Surface treatment for applications in the aeronautics and aerospace industries unrelated
to functional chrome plating or functional chrome plating with decorative character
Passivation of tin-plated steel (ETP)
Of all submitted applications for authorisation for Chromium Trioxide more than 80 could be
allocated to the above listed use categories Besides the joint application lead several other
applications were made by individual or groups of downstream users
An analysis of changes in registration data through the authorisation milestones concluded for
Chromium Trioxide that some of the registered uses do not seem to be covered by any applications
for authorisation so far (eg impregnating agent for carbon filter media or catalyst manufacturing)
For the latter example this discrepancy could be explained by an early position taken by ECMA
(European Federation of Catalyst Manufacturers) that catalysts are in some cases transported
Impacts of REACH Authorisation Final Report
eftec 187 November 2017
isolated intermediates94 and hence exempt from authorisation or because these catalysts are not
manufactured in the EU
The online survey results indicate that nearly half of the businesses participating in the survey and
using Chromium Trioxide experienced changes in the market structure in some form (13 of 29) The
biggest impact that the majority of the companies (seven) stated was that it led to an increase in
prices for Chromium Trioxide while the number of suppliers of products containing Chromium
Trioxide decreased Three out of 34 survey participants stated that their organisation was impacted
by a closure within the EU or a relocation to outside EU as a result of REACH authorisation process
A follow up interview with these three asked for the reason of the relocation that and one stated
ldquosome of our customers do not want to source certain components from the EU because of concerns
about the uncertainties caused by REACH authorisationrdquo
During the follow-up interviews the decline in the amount of possible suppliers was seen as
especially critical by four respondents The next critical issue was the fear that the upstream
application would make them dependant on their supplier Companies also expected that
consolidation of suppliers would eventually lead to higher prices One downstream user working in
the hard chrome plating sector said
ldquoA lot of money has been invested into the authorisations Only suppliers with
authorisation remain and they will push their cost into the supply chainrdquo
Only one out of 29 survey respondents felt that the authorisation has led to an increase in the
number of alternatives suppliers
107 Substitution
One objective of REACH is to eliminate the use of SVHC over time which can only be achieved if
alternative substances processes or products are developed The search for alternatives to replace
Chromium Trioxide has been on-going for decades with substantial amounts of money and
resources already invested (both by industry and via projects sponsored by various authorities) to
find alternatives to avoid using hexavalent chromium in their various applications
A detailed overview of the best available techniques for the surface treatment of metals and
plastics has been published by European Commission in 200695 This document comprehensively
describes the various alternatives that were available and the state of the art in technology in the
surface treatment at the time
Some alternative substances and processes are available today an important question is whether
these alternatives are also technically and economically suitable The question whether there are
suitable alternatives has been the basis for intensive discussions during the authorisation process
Applicants insist that there is no suitable alternative currently available for chrome trioxide
especially for the functional metal plating use Providers of alternatives and NGOs claim the
opposite
94 REACH and Catalysts (Fresh and Spent) A position paper by the European Catalyst Manufacturers Association
(ECMA) September 2008 Annex 1 added November 2008 Amended (Annex 1 amp consideration of intermediates
without SCC) November 2009 Amended (Waste Framework Directive amp Annex 1 EINECSCAS for MoS2 added)
May 2012 95 European Commission 2006 ldquoReference Document on Best Available Techniques for the Surface Treatment
for Metals and Plasticsrdquo (under the Council Directive 9661EC on Integrated Pollution Prevention and Control)
Impacts of REACH Authorisation Final Report
eftec 188 November 2017
To allow a more neutral assessment of the different positions the feasibility of substitution of
Chromium Trioxide is assessed from different perspectives
Applicants
Non-applicants
Non-industrial stakeholders
Providers of alternatives
1071 Applicantsrsquo perspective
The particularity of the supply chain of the users of Chromium Trioxide has been described in
Section 105 The fact that Chromium Trioxide has a key function in a high number of very different
manufacturing processes ranging from car parts sanitary equipment military equipment space
and aviation building materials and others adds a level of complexity to looking for alternatives
Each of these sectors has its own dynamics and specific technical requirements
The challenge to develop alternatives arises from the numerous varying specifications that must be
met for the millions of articles that use chrome plated or passivated parts Therefore it is not
sufficient to develop an alternative process but the alternative process must be sufficiently
technically mature and economically feasible to cover a wide range of the required specifications
of the final articles While currently one process seems to be capable to cover a wide range of
specifications there are indications that several alternatives are required to cover the wide range
of applications of the chrome plated parts (eg see case on alternatives for alumina plating in the
window frame industry) Moreover several of these parts are used in a safety context andor in a
highly regulated industry such as aviation and hence require specific product qualification testing
For example it is estimated that more than 10000 chrome plated parts with different
specifications are in use per car manufacturer96 (eg for interior exterior specific parts injector
valve piston rod safety belt lock and so forth) Each of these parts is introduced only after
testing Any significant process change in the plating of these parts would require a specific re-
qualification
In addition some alternatives like Boric Acid or Cobalt compounds are expected to face in future
the same authorisation requirement as Chromium Trioxide therefore adding to uncertainty about
whether investments for the development of the alternatives should be carried out A presentation
for the German automotive industry in 2014 stated that the industry has to face the possibility that
approximately 100 potential alternatives will have to be further researched and tested97
As part of the application for authorisation applicants may have submitted an RampD plan to setting
out details of efforts to substitute away from Chromium Trioxide A screening of the public versions
of the applications for authorisation for available RampD plans shows that compared to the average
percentage of applications containing RampD for other substances the share of applications for
Chromium Trioxide is higher at 43 (Table 103) The actual percentage of improvement plans may
be higher as further information could also be provided as part of the committees (RAC and SEAC)
QampA and the trialogues
96 European Automobile Manufacturers Association Presentation by Dr Wolfgang Marquardt (BMW)
27032014 Authorisation for Chromium Trioxide ndash Automotive Industry Challenges 97 Verband der Automobilindustrie Presentation by Dr Wolfgang Marquardt 11122014 Zulassung unter
REACH und die Herausforderungen aus Sicht desVerbands der Automobilindustrie eV (VDA)
Impacts of REACH Authorisation Final Report
eftec 189 November 2017
Table 103 Presence of RampD plans in Chromium Trioxide AfArsquos
All Subst of AfAs
Chromium Trioxide AfAs
No
RampD plan included 62 (34) 16 43
RampD plan referred to 34 (18) 7 19
No clear RampD plan 89 (48) 14 38
Total 184 37 100
Applicants also indicated that in some cases the use of an alternative solution would face
competition from imported articles from outside of the EEA still using the Chromium Trioxide (cfr
Grohe AfA)
Looking at the results from the online survey from the applicants andor downstream users three
out of a 29 (Chromium Trioxide only) reported a successful substitution yet two of those three
companies still applied for authorisation Seventeen out of 29 companies indicated that they were
busy with substitution activities The remaining nine respondents stated that they were not
investigating any substitution alternatives
Although not representative further interviews with stakeholders showed additional cases in which
companies also decided to take a parallel route and apply for authorisation while at the same time
carrying out substitution (see Section 54)
A leading high-tech company stated that the drive for substitution was due to safety reasons ndash they
did not want to expose their workers to Chromium Trioxide any longer After reviewing and testing
possible alternatives they switched to a more effective tin-based passivation As process owners
the high-tech company could make the decision to shift to an alternative more easily than a
contract manufacturer ndash as mentioned above
A leading company in the field of pharmaceuticals used Chromium Trioxide as a catalyst in waste
gas burner As their supplier decided to discontinue the supply the company was effectively
ldquoforcedrdquo to invest in an alternative Tests with alternative catalysts failed leading to the
development of a different technology While the new technology operates with slightly lower costs
(close to euro01 million) it required an overall investment of about euro10 million
The interviews with stakeholders clearly showed that there is a link between substitution and
competitiveness In those cases where the products made were in markets under severe price
competition customers (further down the supply chain) would only support substitution effort if it
led to a reduction in the cost of the product providing them a tangible benefit
1072 Non-applicantsrsquo perspective
Non-applicants are companies that previously used Chromium Trioxide but have since discontinued
their use (for that specific use) by either implementing an alternative substance or a different
process before the sunset date Therefore these companies did not have to apply for authorisation
The cases of early substitution are limited and less well documented
During the interviews companies which used to use Chromium Trioxide but have discontinued this
use without applying for authorisation were also identified
Impacts of REACH Authorisation Final Report
eftec 190 November 2017
A manufacturer of alumina window and door frames stated in one of the interviews that after
receiving input from their sector organisation ESTAL98 they decided not to apply for authorisation
due to the estimated low chance of obtaining an authorisation As a result in 2014 the company
started to develop two alternative technologies that would enable them to produce and coat
alumina frames without chrome VI After investing between euro3 to 4 million in new equipment they
managed to switch to chrome VI free production but with considerable limitations One of the new
alternative technologies doubled operating costs the other technology is less robust and requires
tighter process control with better quality base material A key driver for successful substitution in
this case was the fact that this manufacturer controlled the full manufacturing process including
the choice of the raw materials
Another route to identifying early substitution cases is the analysis of the registered uses compared
to the filed applications for authorisation It is expected that a registered use will after the
inclusion of Chromium Trioxide to Annex XIV lead also to an application for authorisation The
examples of uses registered but without an application for authorisation have already been
described in Section 106
1073 Non-industrial stakeholdersrsquo perspective
Non-industrial stakeholders such as NGOs are indicating that there are several possibilities for
substitution of Chromium Trioxide They believe that the authorisation process itself could act as
an obstacle to substitution From their perspective they claim that companies that are granted
authorisation will have less incentive to look for an alternative to Chromium Trioxide Additionally
NGOs claim that the authorisation process does not provide sufficient clarity about why applicants
are not using the alternatives that are available on the market and what efforts the applicants are
undertaking to phase out the substance Client Earth a NGO stated that
ldquoIn relation to applications for authorisation participation can be increased by setting
criteria that need to be fulfilled for an alternative to be considered suitable At the
moment the SEAC has no such criteria and there is no evidence the SEAC would be able to
positively assess the suitability of an alternativerdquo
In the online survey the participating NGOs mentioned several tools that businesses looking for a
substitution of Chromium Trioxide could use
An example of a useful tool is the substitution support portal (SUBSPORT) developed by the
Koordinationsstelle Hamburg IFE An overview paper available on the SUBSPORT website99
describes a range of alternatives for the use of Chromium Trioxide In addition the report
also lists potential alternatives which should be rejected as they would pose a high risk to
the environment or human health (ldquoregrettable substitutesrdquo) For that SUBSPORT uses its
own database containing substances that are not accepted for substitution due to their
hazards (SDSC) Alternatives for Chromium Trioxide that would pass the screening test can
also be found on their website
98 ESTAL ndash European Association of Alumina Platers (Italy excluded) with around 400 member mainly SMEs 99
httpwwwsubsporteucasestoriessearch=chromium+trioxideampsektor=0ampFunction=0ampprozess=0ampcslimit=15amp
methodology_check=onamptype=case_studiesx413-en
Impacts of REACH Authorisation Final Report
eftec 191 November 2017
Another NGO ChemSec is offering a web-based platform ldquoChemSec marketplacerdquo100 via
which buyers and sellers of alternatives to hazardous chemicals can interact It offers
producers of safer alternatives a window to display their ldquogreenrdquo alternatives to
downstream user companies looking to substitute hazardous chemicals in their products or
processes
ChemSec also stated that the OECD Substitution and Alternatives Assessment Toolbox
(SAAT)101 could prove very helpful the tool is an approach for evaluating a chemical
material process product andor technology for attribute analysis within a chemical
substitutionalternatives assessment
In their application for authorisation the leading consortium CTAC provides a detailed and long
(possibly not exhaustive) list of the possible alternatives for substitution of Chromium Trioxide eg
for the use of hard chrome plating such as
Electroless plating
Nickel and Nickel alloy electroplating
Case hardening Carburizing carbonitriding cyaniding nitriding borodizing
Chemical vapour deposition (CVP)
Nanocristalling Cobalt Phosphorus alloy coating
High velocity thermal process (HVOF)
Trivalent chrome plating
Physical vapour deposition 5PVD)
Plasma spraying
General laser and weld coating technology
Stainless steel and high-speed steel (HSS)
Thermal spray coating
During the follow up interviews one NGO stated with reference to substitution that during the AfA
process SEAC does not seem to take the comments from providers of alternatives into
consideration This would lead to reluctance on the alternative providersrsquo part to participate in the
trialogue due to ldquobad experiencerdquo The NGO however also recognised that the setup of providing
alternatives during the public consultation was not ideal for collaboration between providers of
alternatives and applicants Both the consequence of a possible alternative (refused application)
and the limited time for the applicant to reply (14 days) were regarded as a reason why this process
was not as successful as it could be
1074 Providers of alternativesrsquo perspective
Authorisation applicants have to assess what alternatives for their use of Chromium Trioxide exist
in the context of the analysis of alternatives (AoA) and argue their feasibility against four criteria
(technical and economic feasibility availability and overall reduction of risk) In the AoA
applicants therefore should describe alternatives known to them
Additional providers of alternatives were identified during the public consultation rounds for
Chromium Trioxide In the context of this project interviews were held with some providers of
alternatives who clearly indicated that there is an increased interest in their product For instance
100 httpsmarketplacechemsecorg 101 httpwwwoecdsaatoolboxorg
Impacts of REACH Authorisation Final Report
eftec 192 November 2017
a supplier of PVD coating technology reported that several projects were on-going with car
manufactures to introduce PVD coated parts The same provider reported that a major obstacle for
the introduction of this new technology was the existing specifications based on chrome plating
For some car manufacturers he was able to develop bespoke specifications for PVD coated
particles The supplier expects now that this specification is developed the introduction of more
parts will be easier The supplier confirmed that an authorisation for chrome VI based plating is
required as there is at present insufficient capacity for PVD plating available Significant capacity
building is still required and he expects that the two technologies will co-exist for a while even
though he is confident that in the end a switch to the alternative process will be possible
In some cases clear collaboration between suppliers of alternatives and applicants is reported in
the AfA For instance in the Grohe application for the use of Chromium Trioxide for the etching of
plastic parts prior to chrome plating Grohe reports details of an on-going development program
with a supplier of alternative technologies In these cases the provider obviously did not come
forward during the public consultation phase
An interviewed provider of alternatives that had developed a patented new alternative cylinder
technology stated that he encountered quite some resistance from potential customers when he
introduced and promoted his new technology for the printing and flexible packing industry Due to
the fact that companies assumed they would be successful with their application for authorisation
for Chromium Trioxide it appeared that the trigger for an alternative based on purely health
improvements would not be strong enough Only when he was able to provide (after more testing)
additional value in the form of lower operating costs and longer durability of the cylinders he
experienced substantially more interest from industry
The Belgian authorities carried out an inspection campaign in 2015 on chemical agents in the sector
of surface treatment and coating of metals with focus on hexavalent chromium listed under REACH
Annex XIV In this campaign 83 companies were visited and inspected In the course of the
inspection companies were also questioned about specific impacts of REACH and the authorisation
obligation The report on this campaign comes to the conclusion that ldquothe authorisation procedure
under REACH drives substitution much more efficientlythan OSHrdquo ndash ldquotrigger to substituterdquo102
108 Changes in the market for alternatives
No publicly (or commercially) available information was identified that could help to evaluate
relevant changes in the markets for alternatives While providers of alternatives stated that they
experienced an increasing interest in their products and processes there is little or no hard data to
assess the impact for the market of alternatives So far the volume of alternatives supplied is still
minimal NGOs which were interviewed for this project expressed their concern regarding the
impact of granting authorisation on the development of the market for alternatives They fear that
granting of authorisation will prevent alternatives to enter the market It appears however that
despite authorisation providers of alternatives are confident that they will be able to penetrate
the market over time
102 The Federal Public Service Employment Labour and Social Dialogue and the Belgian REACH Competent
Authority 2016 Results of Inspection Campaign for Chemical Agents in the metal surface treatment sector
Impacts of REACH Authorisation Final Report
eftec 193 November 2017
109 Evidence of improved risk management
The reduction of the occupational and environmental exposure to the SVHC is one of the key
objectives of REACH To what extend this has happened or will happen for the Chromium Trioxide
applications is investigated in this section using two approaches Firstly the number additional risk
management measures that were implemented or announced as a result of the authorisation
process is investigated Secondly historical exposure data is compared with exposure data from the
AfA The information for both approaches was collected from literature the on-line survey the
public available AfA files and targeted interviews with stakeholders involved in the authorisation
process for chromium trioxide
Additional risk management measures
In 24 of the public versions of the AfAs dossiers for Chromium Trioxide improvements in RMM
were mentioned This is similar to all AfA (35 mentioning improved RMM in the context of the
public dossier) Four out of 37 Chromium Trioxide dossiers reviewed had clear indications of
improvements of RMM In seven other applications general statements regarding improvements of
RMM were identified
Several of the AfA for chromium trioxide are upstream applications In these applications there is
no mention of improved RMM as a result of the authorisation process This can be the direct result
of the fact that these are upstream applications which typically contain less detail on specific use
conditions
The availability of new measured exposure data as a result of the AfA was mentioned as an
example of improvement
ldquodue to authorisation businesses have been generating new data on exposure levels
(occupational or environmental) which helped them identify areas for further
improvementsrdquo
In a survey carried out in the context of a workshop on chromates authorisation application103 one
third of the respondents stated that the authorisation process led to improvements in risk
management which is in line with the findings based on the AfAs The workshop participants
claimed that the authorisation process would lead to improvements by focussing activities but most
of the improvements in exposure and emission were achieved prior to the REACH authorisation
process
The data from the analysis of the applications for authorisation on improvements is also supported
by the survey results The survey results indicate that (nine out of 29 31) were able to improve
their risk management activities as a consequence of the authorisation For all these companies
the measures have led to a reduction or elimination of the occupational exposure to their workers
For seven of these companies less than 20 employees were affected by the measures Five
companies stated a reduction of emissions to air and wastewater though without providing
detailed information about how much In four of the companies the improved risk measures also
led to a reduction either in the waste or in the consumption of the SVHC
103 ldquoChromates Authorisation Application workshoprdquo 2829062017 organised by Eurometaux
Impacts of REACH Authorisation Final Report
eftec 194 November 2017
Asked for the key trigger to improve the handling and operational conditions for using Chromium
Trioxide the companies stated equally the inclusion to the Candidate List the inclusion to Annex
XIV and the application for authorisation as the starting points for their measures
Although In the interviews stakeholders did not provide additional input on possible improvement
for risk management measures other than generic statements some qualitative comments were
collected
One interviewed downstream user mentioned that there was not much expectation that the
authorisation would lead to benefits in reducing exposure as most of the work (on exposure
reduction) had already been done
This is in contrast with three other interviewed stakeholders stating that despite continuous
improvements over the last 10 years the event of the application of authorisation led to a renewed
view on the processes to identify possible improvements But since they believed that the levels of
exposure were already under control the willingness to invest in additional improvements was
limited
All evidence shows that improvements in risk management measures were implemented in the
context of the authorisation process Although the level of improvements is probably different for
the different users of chromium trioxide This could be the direct result of the fact that some up
stream applications refer to local OEL with which companies have to comply but do not argue
minimisation based on the technology which is employed
Exposure measurements
Several Member States manage databases which contain measured exposure data For Chromium
Trioxide substantial information is available because hexavalent chromium has been under the
close attention of authorities for at least two decades due to the known substance hazards
Unfortunately of the relevant bodies few were able to supply any information (Belgium Germany)
France and Italy did not respond to the request to supply data but published data could be used
Publicly available studies on the development of occupational exposure levels have been analysed
to extract trends in the improvement efforts covering almost the past two decades (Belgium
France Italy Germany)
Historically several measurement campaigns have been carried out by different Member States
authorities to assess the level of occupational exposure (see Table 107) Unfortunately the setup
and the reporting of these data vary across Member States This makes it difficult to compare the
values and to compare them with the values mentioned in the AfAs Nevertheless these values can
be used as reference points to highlight the trend in the reduction of occupational exposure levels
over the years when compared to the values in the Afas
The sources listed in Table 104 were used and cover several CrVI compounds in addition to
chromium trioxide
Impacts of REACH Authorisation Final Report
eftec 195 November 2017
Table 104 Sources used for estimation of exposure to CrVI
Country Publication Period
Italy Hexavalent Chromium Compounds in the Workplace
Assessing the Extent and Magnitude of
Occupational Exposure in Italy
1996-2009
Germany MEGA-auswertungen zur Erstellung von REACH-Expositionsszenarien
fuumlr Chrom(VI)-Verbindungen (2000-2009) in Deutschland
2000-2009
Galvanotechnik und Eloxieren
Empfehlungen Gefaumlhrdungsermittlung der Unfallversicherungstraumlger
(EGU) nach der Gefahrstoffverordnung (DGUVI 213-716)
2001-2011
France Occupational Exposure to Chrome VI Compounds in French Companies
Results of a National Campaign to Measure Exposure (2010ndash2013)
2010-2013
Belgium Resultaten Inspectiecampagne Chemische Agentia in de sector van de
oppervlaktebehandeling van metalen
2015
For the interpretation of the exposure levels it is useful to use the reference dose response curve
published by ECHA104 In Table 105 the values are provided for workers exposure
Table 105 Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at different 8h-TWA concentrations of Cr(VI) for 40 years
Ambient Cr(VI) exposure concentration (μgm3)
Excess lung cancer risk in the general population (x10-3)
25 100
125 50
10 40
5 20
25 10
1 4
05 2
025 1
01 04
001 004 Background cumulative lifetime risk of dying from lung cancer between ages 0 and 74 in EU males is 481000 (Globocan
2008)
Additionally a new proposal by the EU Commission on carcinogens and mutagens at work105
foresees a proposed limit for Chromium Trioxide of 10 microgm3 for the first five years after the date
of transposition of the Directive and a limit of 5 microgm3 after then will apply
In Table 106 values are provided from German and French measurement campaigns From this it
can be noticed that the French and more recent results provide a lower value compared to the
German values (eg Chrome plating max = 171 microgm3 while P90 value for Germany 13 microgm3)
104 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of
Hexavalent Chromium (RAC27201306 Rev1) 105 Proposal for a Directive of the European Parliament and of the Council amending Directive 200437EC on
the protection of workers from the risks related to exposure to carcinogens or mutagens at work
Impacts of REACH Authorisation Final Report
eftec 196 November 2017
Table 106 Historical measurement campaigns on Cr(VI) reported from various EU countries values for inhalation
EU-
country Trade sector Application Samples Sites
Values
microgm3
Referenc
e
Range (1)
France
Metal fabrication
Hard chrome plating
Chrome plating
Aeronautics painting
Hot metal spraying (HVOFarc
plasma spray)
99
97
90
77
8
99
lt002 - 97
lt003 ndash 23
lt002 ndash 171
lt002 ndash 896
182 ndash 15
90 value (2)
Germany
Metal construction
Equipment manufacturing
Manufacturing transport
equipment
Electroplating
Engine and vehicle
construction in generall
Machine building
Metal working in general
Surface treatment and
hardening
Application of liquid coatings
160
123
99
1174
83
272
774
100
71
79
55
31
379
33
120
398
40
15
28
50
132
13
326
208
11
14
283
Note
(1) Measurement campaign carried out by seven CARSAT chemistry laboratories CRAMIF laboratory and
INRS over the 2010 ndash 2013 period106 incl 99 companies involved in various activity sectors
(2) Measurements carried out in Germany in the period 2000 to 2009 measurements taken from
companies in the machine building and metal working sector (measurements from 1218 companies)
107
The slightly more recent data from the DGUVI 213-716 nuances by providing more detail on the
Galvanik use mentioned in the Table 106 Depending on the process step the Cr exposure value
(P95) varies between 25 microgm3 (hardchrome) to 67 microgm3 The value for the loading and unloading
positions is the same as in Table 106 13 microgm3
Belgian authorities that audited 83 companies that used Chromium Trioxide at the end of 2015
supply the most recent data
106 Vincent Gillet Goutet Guichard and others 2014 Occupational Exposure to Chrome VI Compounds in
French Companies Results of a National Campaign to Measure Exposure (2010-2013) 107 IFA Institut fuer Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung February 2012 MEGA-
Auswertungen zur Erstellung von REACH-Expositionsszenarien fuer Chrom(VI)-Verbindungen (2000 bis 2009) in
Deutschland
Impacts of REACH Authorisation Final Report
eftec 197 November 2017
Table 107 Results from the Belgian inspection campaign108
Type of sample lt 1 microgm3 1 - 10 microgm3 gt 10 microgm3
Personal sample 45 50 5
Stationary Sample 43 52 5
Total 44 51 5
(1) Results of inspection campaign for chemical agents in the metal surface treatment sector inspection
in 83 companies in 2015
This Belgian data does not allow a like for like comparison as it neither differentiates the uses
accurately nor it takes the available technology into consideration However the campaign
provides a high-level view on the exposure to CrVI
Recently ECHA estimated the impact of the authorisation on the exposure to CrVI in a meta-
analysis109 This analysis started from the data of the French publication and compared these
results with the exposure values reported in the AfAs on chrome compounds According to ECHA in
the AfAs used in that analysis a maximum exposure level of 2 microgm3 was imposed Assuming that
the French data is representative for the EU and an estimated number of workers in sectors using
CrVI the number of avoided cancer case was calculated In case of an exposure level of 2 microgm3
post authorisation the number of avoided lung cancer cases amounts 82 per year in case 15 of
the CrVI workers were actually exposed to CrVI The value of 15 of the workforce exposed is a
rough estimate but for instance for the AfA for Grohe about 11 of the total workforce was
potentially exposed to Cr(VI)
This value could be even optimistic in the sense that the French data estimates more than 60 of
the exposure below 1 microgm3 while the data collected by the Belgian authorities indicates that in
2015 only 45 of the samples were below 1 microgm3
Additionally the value of 2 microgm3 is in several cases an overestimate In practice several
applicants estimate the exposure value lower An overview generated from the publicly available
AfAs documents (for Chromium Trioxide) delivered the following exposure results (see Table 108)
Table 108 Overview of occupational exposures results from the submitted AfAs for Chromium Trioxide expressed as ranges
Inhalation
Measured data Modelled data
Range in microgm3 Range in microgm3
lt1 1-10 10-50 lt1 1-10 10-50
15 7 1 15 17 1
This means that the number of avoided cancer cases as a result of the authorisation CrVI as
estimated by ECHA could be underestimated For instance if the real exposure level after
authorisation would be closer to 1 microgm3 the number of avoided cancer cases would be closer to
11 per year (same assumption of 15 of the CrVI workers exposed)
108 The Federal Public Service Employment Labour and Social Dialogue and the Belgian REACH Competent
Authority 2016 Results of Inspection Campaign for Chemical Agents in the metal surface treatment sector 109 Socio-economic impacts of REACH authorisations mdashA meta-analysis of the first 100 applications for
authorisation (September 2017)
Impacts of REACH Authorisation Final Report
eftec 198 November 2017
These values can be compared with the values reported by the Italian authorities indicating that
over the period 1996-2009 the average exposure level to CrVI was still more than 30 microgm3
However this report differentiates between the CrVI compounds For chromium trioxide the
reported P95 exposure level is below 2 microgm3 In the publication the authors show that over the
period 1997-2008 there is a statistically non-relevant decreasing trend in the exposure values (see
Figure 105)
In any case different publications show that some caution needs to be taken when using overall
data The difference between the exposure depending on the task or the substance used can be
very significant In that sense the estimation of the number of avoided cancer cases can only be a
rough estimate A better estimate would for instance require a more exact number of people
exposed at a certain level
Figure 105 Evolution of the exposure to CrVI110
There seems at first sight a discrepancy between the improvement in exposure as a result of the
authorisation process based on the measured values and the results of the interviews While the
interviewed stakeholders were generally sceptical and claimed that the majority of the
improvements were done independent of authorisation comparing the recent actual exposure data
110 Alberto Scarselli Alessandra Binazzi Davide Di Marzio Alessandro Marinaccio amp Sergio Iavicoli (2012) Hexavalent Chromium Compounds in the Workplace Assessing the Extent and Magnitude of Occupational Exposure in Italy Journal of Occupational and Environmental Hygiene 96 398-407 DOI 101080154596242012682216
Impacts of REACH Authorisation Final Report
eftec 199 November 2017
shows that still a reduction of the number of cancer cases can be expected after the
implementation of authorisations
Despite the frustration about the burden of the application process one SME owner we interviewed
expressed the hope that ldquoone of the visible benefits due to authorisation will be the consolidation
amongst the small contract platers The lsquoblack sheeprsquo of the trade will eventually be forced either
to improve their working conditions or they will disappearrdquo
1010 Competition and competitiveness
It is difficult to assess the impact of the authorisation process on competition and competitiveness
due to limited research available The time to the sunset date (2192017) is too short to
experience any visible effects in market volumes It is expected that in time the impact will be
better supported by data
A Finnish study looking at impact and benefits of the REACH authorisation covering 14 Finnish
companies working with hexavalent chromium came to the conclusion that ldquouncertainty about the
scope of the process itself (authorisation process) caused confusion for all enterprisesrdquo111 A
similar statement did also recur in almost three quarters of the interviewed applicants and
downstream users for Chromium Trioxide Uncertainty and unpredictability about the outcome of
the authorisation process would substantially weaken the competitive position of their businesses
During a breakfast briefing in the European Parliament on the topic of EU 2020 and Industrial
Competitiveness SMEs in the Surface Engineering Sector in 2014 Mr Dave Elliott President of the
Committee for Surface Treatment which represents around 20000 SMEs in total stated in
reference to REACH that
ldquoThe surface engineering industries are suffering from mounting environmental legislation
that always assumes the worst-case scenario This threatens the very survival of many
surface engineering companies reduces their global competitiveness and poses the risk
that industrial value chains relocate part of the productions processes outside the EUrdquo
Later in this briefing it was also concluded that SMEs require stability predictability confidence
and better regulation ndash where better regulation means reducing the administrative burden and
simplifying REACH112
The responses to the online survey indicate that 11 out of 29 businesses experienced a negative
impact of the authorisation on their competitiveness Except for one business all respondents
stated authorisation made it more difficult to sell products to EU customers The uncertainty about
the success of the applications for authorisation led to customers shifting their orders to Non-EU
competitors For measure of balance it has to be noted that a shift to Non-EU customers would
face a different set of challenges such as ensuring the required quality standards flow of knowhow
and the unknown future development of regulatory process in Non-EU countries (like China and
Turkey) Customers would pick up information that Chromium Trioxide would be banned after
sunset date via medianews or associations ndash this required some businesses to invest efforts into
111 ldquoHow the REACH authorisation process affects and benefits companiesrdquo 2017 Atte Harrikari amp Riku
Montonen Aalto UniversityECHA 112 Paul Ruebig MEP Austria EU 2020 and Industrial Competitiveness SMEs in the Surface Engineering
Sector13th November 2014
Impacts of REACH Authorisation Final Report
eftec 200 November 2017
informing customers about REACH Another negative impact on the competitiveness was the
increase in cost due to the applications for authorisation The additional cost burden would provide
an advantage to competitors outside EU
A particular case was mentioned in the defence industry As a consequence of REACH authorisation
applicants experienced that their customers would ask for products free of substances from the
Candidate List stating that they would not want to continue the uses of these hazardous
substances While this may represent an ultimate goal it would be difficult if not impossible to
implement in the short term
The follow up interviews with stakeholders confirmed the statement that businesses felt their
competitive position weaken due to the authorisation process More detailed impacts on the
competitive position was possible to clarify during the interviews The typical impacts mentioned in
the interviews were
Weakening of competitiveness due to reallocation of RampD to support substitution efforts
(and away from other innovative development work)
The fear of losing or the actual loss of orders as customers would shift to non-EU
competitors
The additional cost burden associated with the authorisation in a market operating with
tight profit margins and thus allowing no or only exceptional price increases
Almost all of the interviewed companiesdownstream users stated that the uncertainty about the
outcome of the application for authorisation and the possible threat of a short review period would
lead to discussions with customers who would demand (long term) planning security As that
security could not be provided customers started shifting the orders to suppliers outside EU One
interviewed company stated an estimated loss of turnover of around euro30 million for the last three
years due to orders being shifted to outside EU Another interviewee stated that their production
facilities in Germany lost new development projects and the subsequent orders went to a Swiss
production facility due to the fact that the local legislative framework there provided longer term
clarity for the use of Chromium Trioxide (20 years) which determined the customerrsquos decision to
shift to Switzerland In Switzerland chrome plating companies will have to comply with a new
threshold limit value of 1 microgm3 (from previously 5 microgm3)113
A typical small contract plating business stated that they had lost orders from customers outside
the EU but for now were able to compensate these orders with orders from other customers In the
past however customers would develop new products in cooperation with them that would allow
the business future orders for five to seven years and therefore represent the business base At the
time of the interview the downstream user expressed the concern that no development order was
in the pipeline due to the uncertainty of the authorisation and the short review period that had
been proposed by RAC and SEAC Admittedly this statement was only by one contract plater
However the way in which it is losing customers could be applicable for more small businesses
This is in contrast to the optimism expressed by the Dutch association of coating shops that stated
at the end of 2016 that all of its member companies had the best year of their history and that
demand for its services was soaring
While one of the objectives of REACH is to improve competitiveness it appears that in the case of
Chromium Trioxide many businesses experienced the opposite As discussed under the topic of
substitution mainly smaller companies felt that authorities (especially the assessment committees)
113 ldquoSchweizer Galvano-Briefrdquo Ausgabe Mai 2017 p52
Impacts of REACH Authorisation Final Report
eftec 201 November 2017
do not understand their industrial environment114 Especially the so-called contract platers ndash
traditionally SMEs with limited or no influence on the product specifications set by their customers
- experienced that their particular situation was not appreciated
While the key message on the impact of the authorisation on the competitiveness is clearly that
companies from the survey and the interviews feel disadvantaged some stakeholders particularly in
the interviews also stated positive effects Consolidation of the plating business was stated as one
advantage that some interviewed stakeholder identified Those companies that would (or could)
not adopt either by switching to alternative technologies or by improving their exposure conditions
would inevitably disappear over time One small contract plater mentioned that ldquoI think that we
will especially in the running up to the re-application of authorisation see some companies simply
disappearingrdquo
Providers of alternatives also judged a positive effect of the authorisation on their competitiveness
As a result of the uncertainty the authorisation process generated amongst the customersrsquo
research would be accelerated and more resources allocated However they also indicated that
their role in the process of authorisation proved to be difficult To comment as a supplier of
alternative technologies during public consultation was considered by one interviewee ldquocommercial
suiciderdquo meaning that supplier of alternative technologies would not want to confront applicants
and therefore potential future customers during the public consultation
1011 RampD innovation and investment
Due to its hazardous characteristics the replacement of hexavalent chromium received substantial
attention even before the introduction of REACH Several EU-funded projects were commissioned
about replacement of Cr(VI) or reduction of the use of Cr(VI) such as CRAFT (1999) ndash See Annex H
In addition in several Member States research programmes have been carried out with the
objective of developing suitable alternatives for the use of Chromium Trioxide eg in France The
impact of this funded research has been to enable new technologies to be supported during their
development to help them reach the market
From the survey results of the 27 respondents referring to Chromium Trioxide two thirds (17)
responded that the authorisation did have an impact on their organisationsrsquo spending on innovation
or investment opportunities andor RampD The large majority (13 out of 17) indicated that they
increased their spending on RampD efforts while three stated a reduction in RampD spending
In contrast the majority of the interviewed stakeholders (six) referred to not having increased the
RampD budgets but to have it deprioritised In the process of the preparation of an application for
authorisation the available RampD resources would be shifted away from innovation projects to
support authorisation and the search for an alternative substance or process
A leading supplier to the defence industry stated that due to the authorisation process overall RampD
budget could not be increased but was in fact redirected from required new technology
development to finding an alternative for Chromium Trioxide The required military qualification
for products produced with an alternative would be costly and time consuming ndash on top of that the
supplier had to expect that their products would not list high on the priority list for the military
114 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits
companies Aalto Aalto University
Impacts of REACH Authorisation Final Report
eftec 202 November 2017
qualification for their customers As a consequence the supplier felt that resources were wasted
and instead of developing innovative new products their non-EU competitors would benefit from
not having to apply for authorisation
Another discrepancy in the result from the online survey and the interviews was the attitude
towards investments andor innovations In the online survey 13 of the 17 respondents stated that
due to authorisation they had increased the volume for innovation and investment opportunities
During the interviews the opposite was stated In five of the interviews the stakeholder confirmed
investment freezes in the EU locations as a consequence of authorisation Due to the uncertainty
about the outcome of the authorisation process new investment projects in the EU have been put
on hold or directly shifted to suppliers outside the EU In two instances even replacement
investments were limited to the minimum pending the outcome of the application for
authorisation
1012 Experience of SMEs
For Chromium Trioxide applications for authorisation have been filed for different sized companies
(Table 109) For some small and medium enterprises the fact that continued use of Chromium
Trioxide would need authorisation came as a surprise
Table 109 Number of applicants and their size per substance
Substance Large Medium Small Micro
Chromium trioxide 42 2 9 8
Chromium trioxide Dichromium tris(chromate) 2 2
Chromium trioxide Potassium
dichromate Sodium dichromate 5 1
Total 49 3 9 10
Data provided by ECHA (03112016)
However this provides only a limited view on the impact of the inclusion of Chromium Trioxide on
Annex XIV on SMEs Ninety eight percent of the surface plating industry of more than 1000 chrome
plating shops in the EU are thought to be SMEs
As expected the majority of the SMEs sought the umbrella of a consortium to apply for
authorisation In total of the 27 applications for authorisation for Chromium Trioxide submitted
nine have been prepared by consortia The big consortia were able to join large numbers of
businesses CTAC mentions approximately 150 members and HAPOCVecco indicates more than 170
members Key reasons for SMEs joining consortia were (i) the reduction in cost for an application
and (ii) the avoided time and expertise required to prepare for an application
The case of German HAPOCVecco is of interest To cope with the application challenges seven
SMEs established an association (Vecco) to support the authorisation activities The intention of this
association is also to cooperate beyond the authorisation by joining forces on RampD providing
consulting work sharing best practices and enforcing standards amongst member companies in the
form of audits and reporting As an association could not submit an application for authorisation a
company (HAPOC) was founded that would act as importerformulatordistributor for the member
companies of the Vecco association According to the Vecco website the association had more than
170 members in 2015
Impacts of REACH Authorisation Final Report
eftec 203 November 2017
In a recent study in Finland on the benefits of authorisation115 14 Finnish applicants for
authorisation have been interviewed Half of these companies were SMEs or micro companies
Several of these companies applied for authorisation for Chromium Trioxide Although the main
purpose of the study was related to benefits also the SME aspect was investigated
Eleven of the 14 Finnish companies interviewed by the study used Chromium Trioxide and stated
that the first issue the businesses associate the authorisation with is the additional cost burden
This was also confirmed by the statistics that except for one company all were organised in some
form of consortia to address the application for authorisation This joining of forces led over time
also to improved networking As a result one company ldquoadopted the idea of using a foaming agent
in their process baths from better performing companies and improved their process safetyrdquo116 The
report also states that a majority of the micro-sized companies got into contact with partner
companies in other EU countries like Sweden UK or Germany
The OY Kromatec application for the use of Chromium Trioxide for functional plating is the result of
collaboration between seven Nordic plating companies (CRAN) According to the SEA of the AfA
these companies are all small or micro sized companies Although the total profit of turnover for
the companies is not provided in the AfA it is mentioned that the discontinuation of the use of
Cr(VI) would result in a cost of euro79 million over the total applied for review period of 12 years
based on 46 jobs lost Based on the details of the volume of Cr(VI) used it seems that the group
consists of six companies fairly similar in size and one larger company (annual volume of Cr(VI) used
is 10 tons per year for one site and between 1-5 tons per year for the 6 others)
This application is next to other applications which include the use ldquofunctional platingrdquo For
instance the application ndeg 32 with LANXESS as the lead applicant Provided that the applicants in
the OY Kromatec application can be supplied by one of these applicants the Kromatec application
can be seen as redundant An own application however would also provide the independence to
choose suppliers themselves rather than depending on the supply via suppliers from the consortium
(CTAC) Nevertheless and probably with the knowledge of the existing other application the
Nordic SMEs still elected to submit their own application Both the LANXESS application and the
Kromatec application applied for a review period of 12 years and for both applications the
recommended review period is seven years (no final decision yet) For the other applications there
was no recommendation yet available In any case the application of Kromatec showed that groups
of even micro companies can apply for authorisation
1013 Summary of Tier 1 case study
Looking at all influencing factors for the case of Chromium Trioxide three main consequences could
be identified
Benefits in the form of exposure reduction
The substitution challenge
Impacts on the competitiveness of applicants
115 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits
companies Aalto Aalto University 116 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits
companies Aalto Aalto University
Impacts of REACH Authorisation Final Report
eftec 204 November 2017
At the time of writing of the report the sunset date was not passed and hence it was not possible
to have actual exposure and emission data post authorisation It was only possible to a very limited
extent to estimate the benefit with regards to exposure and emissions prior to the sunset data
Measured and reported exposure data in the AfAs and announced additional RMM lead to the
expectation that a further reduction of exposure will be possible after the sunset date The exact
value of this improvement is hard to estimate but based on the interviews the interviewed
stakeholders stated that the majority of their exposure reduction was done before authorisation for
Chromium Trioxide was considered It is a common statement by industry that a lot has been done
before authorisation was considered nevertheless if one compares the exposure level
recommended by RAC (r2 ugmsup3) improvements could still be achieved by authorisation It is
expected that after the authorisation decisions have been fully implemented and enforced the
benefits of reduced exposure will be recognised
From a hazard perspective hexavalent chromium poses a severe hazard to humans For the
majority of the uses the authorisation process can be used to manage the risks However the
widespread use of Chromium Trioxide particularly in surface plating means that the authorisation of
this substance affects a large number of businesses of which a number have reported a
considerable negative economic impact for the business in this sector
The online survey responses and the interviews carried out within this study support the position
that especially contract manufacturers are facing difficulties This is because they are not the
owners of the process and hence cannot independently change to an alternative as customers shift
their orders to non-EU suppliers rather than support the development of an alternative technology
or move directly to platers that have invested into alternative technology This means that as a
consequence of the authorisation a consolidation in the surface treatment industry can be
expected over the next few years This will result in companies that will adopt and perhaps be even
strengthened by authorisation and others that will likely cease in the process There is no hard data
currently available to support this conclusion as sunset date is still in the future and the final
decision by the EU commission is still pending but there is a general consensus in the industry that
this will be the future
While not originally in the scope of the case study it is worth mentioning that Chromium Trioxide
shows clearly the challenge for upstream applications As upstream applications cover potentially a
broad range of uses they also face uncertainties on for example exposure levels The advantage
of an upstream application is a commercial one ndash the cost spread over large number of companies is
lower but this comes at the price of a shorter review period While industry regards this as a
ldquopunishmentrdquo one could argue that the cost per review year might be fairly acceptable The lesson
learned from Chromium Trioxide is that data specific applications with a clear use tend to receive
recommendations for longer review periods This may come at the price of an increase in the
number of applications and most probably also higher application costs for smaller businesses that
decide to apply by their own rather than being covered by an upstream application However
longer review periods deliver security for investments and customers Without the planning for
stability customers are shifting orders to outside EU according to the interviewed stakeholders
mainly to China but also to Turkey
Impacts of REACH Authorisation Final Report
eftec 205 November 2017
11 TIER 1 CASE STUDY SUBSTANCE 2 TRICHLOROETHYLENE
111 Introduction
Due to concerns about its toxicity the use of trichloroethylene (TCE) has been banned in the food
and pharmaceutical industries in much of the world since the 1970s At the end of the 1990s and
the beginning of 2000 companies made substantial efforts in reducing the consumption of the
substance as a solvent also driven by the Volatile Emissions Directive which forced companies to
reduce emissions considerably to comply with the legislation
One of the key reasons for the recommendation of this substance registered in volumes up to 1
million tonnes for inclusion in Annex XIV was that ECHA concluded that the volumes allocated to
the uses in the scope of authorisation were very high and at least some of the described uses would
potentially create significant exposure of industrial workers and professionals and hence could be
considered wide-dispersive However with the biggest use allocated as intermediate the volumes
for which authorisation is sought are considerably lower at a range of close to 20000 tonnes for all
the uses except for ldquopackagingrdquo which is in the range of 10000 to 100000 tonnes
There were six responses to the online survey from applicants downstream users or NGOs dealing
with TCE and only four of these responded to questions with reference to TCE Of the four
respondents three were downstream users and one an NGO This is much less than those for
Chromium Trioxide
For the follow up interviews four stakeholders for TCE were contacted
NGO (1)
Associations (0)
Applicants (1)
Downstream users (0)
Users non-applicants (2)
112 Substance profile
Table 111 Trichloroethylene substance profile
Name Trichloroethylene
EC no 201-167-4
CAS no 79-01-6
Stage in Authorisation Process On Authorisation List
SVHC Classification - Intrinsic
property(ies) referred to in Article 57
Carcinogenic (Article 57a)
Exempted (categories of) uses None
Existing restrictions No Annex XVII restrictions
Trichloroethylene is a chlorinated hydrocarbon Most TCE is produced from ethylene Ethylene is
chlorinated over a ferric chloride catalyst to produce 12-dichloroethane (ClCH2CH2Cl) When
heated to around 400degC with additional chlorine 12-dichloroethane is converted to
trichloroethylene (C2HCl3)
Impacts of REACH Authorisation Final Report
eftec 206 November 2017
This reaction can be catalyzed by a variety of substances (a most commonly used catalyst is a
mixture of potassium chloride and aluminum chloride) This reaction produces tetrachloroethylene
as a byproduct Depending on the amount of chlorine fed to the reaction tetrachloroethylene (or
perchloroethylene in the following referred to as PER) can even be the major product Typically
TCE and PER are collected together and then separated by distillation In Europe an alternative
process is in place which starts from PER and uses catalytic hydrogenation117
Based on studies that show its carcinogenic potential it was concluded that TCE (EC no 201-167-4
CAS no 79-01-6) should be considered as a non-threshold substance
113 Case study rationale
TCE fulfils most of the key criteria set for the selection of a Tier 1 case study substance
Latest application date has passed so that we should be able to assess the impacts of the
whole authorisation process ndash for TCE this was 21 April 2014
There is a high number of applications and applicants which increases the opportunities for
getting data ndash for TCE there were 13 applications for 14 applicants
There is a high number of uses applied for ndash 19 uses and
The impacts are diverse and complementary ndash high volumes allocated to the uses and
widespread use in EU in numerous businesses (especially for the metal degreasing and
surface cleaning use) with widespread applications
There is little information available to quantify accurately the number of companies potentially
affected A report from 2011 estimated that up to 141000 companies engaged in the lsquotreatment
and coating of metalsrsquo employing around 11 million employees could be affected EU wide118 While
the Eurostat data cannot differentiate whether all these companies are using TCE this number can
still be ndash as a worst case - assumed as TCE has been regarded as an effective and widely used
solvent for the cleaning of metals
114 REACH Authorisation timeline
The REACH authorisation timelines for the substance is given in Table 112
Table 112 Trichloroethylene REACH authorisation timeline
Key REACH authorisation timeline Date
Date of inclusion to Candidate list 18062010
Date of inclusion to Annex XIV 20122011
Latest application date 21042014
Sunset date 21042016
117 European Chlorinated Solvent Association ndash Trichloroethylen Legislation Markets Use 2010 118 Institute of Occupational Medicine Research Project P9373 (2011) - Health socio-economic and
environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks
related to exposure to carcinogens and mutagens at work ndash Trichloroethylene Data from Eurostat 2006
Impacts of REACH Authorisation Final Report
eftec 207 November 2017
According to Article 57(a) TCE was identified as a substance of very high concern It is classified as
carcinogen category 1A ECHA concluded that the volumes of TCE allocated to the uses in the scope
of authorisations were very high and at least some of the described uses would bear the potential
for significant exposures of industrial workers and professional and could hence be considered wide
dispersive
TCE was included on the Candidate List for authorisation on 18 June 2010 During the period for
commenting 38 comments were submitted by industry (6) and industry associationstrade
unionsMember States authorities (32) The majority related to general comments (17) followed by
specific comments on use exposure alternatives and risks (12)119
On 20 December 2011 the substance was included in Annex XIV This meant that the use of TCE
would require authorisation after the sunset date of 21 April 2016 with a latest application date of
21 April 2014
During the period for commenting for the inclusion of TCE to Annex XIV 95 comments were
submitted by industry (65) industry associationstrade unionsMember States authorities (23) and
NGOs (7) The majority related to comments on uses that should be exempted from authorisation
(36) and general comments on the recommendation to include the substance in Annex XIV (34)
By end of 2016 13 applications by 14 applicants for 19 uses of TCE after sunset date were
submitted
115 Market prior to REACH authorisation
Trichloroethylene was assessed in the context of a risk assessment report finalised in 2004 with the
UK as the rapporteur120 The report refers to four producers of TCE in the EU and in the Defra risk
reduction strategy report from 2005 three producers of TCE in the EU are mentioned One French
producer ceased the production of trichloroethylene in 2006
Since 1996 the sales volumes of TCE in the EU have steadily declined from levels of 100000 tons
per year to around 38000 in 2003 The key reasons for the decrease were related to the continuous
substitution of TCE by alternative substances or technologies
Use of closed systems The introduction of closed loop safety containers (ldquosafetainersrdquo)
led to an elimination of emissions during filling and
The process improvements by converting to closed systems in surface cleaning led to a
minimisation of solvent emissions and a reduction of solvent consumption by improved
recycling and re-use
The main driver for industry to make efforts to improve emissions respectively substitute
trichloroethylene as a process solvent were to comply with the Solvent Emissions Directive
(introduced in its first version in 1999121) and in anticipation of REACH sometimes even in the form
119 Due to the grouping of the comments in different categories some of the comments could be counted
double as they would fit several categories 120 European Union Risk Assessment Report Trichloroethylene European Chemicals Bureau 2004 121 The purpose of the Solvent Emissions Directive is to prevent or reduce the direct and indirect effects of
emissions of volatile organic compounds into the environment mainly into air and the potential risks to
human health by providing measures and procedures to be implemented for certain activities (description by
Department for Environment Food and Rural Affairs)
Impacts of REACH Authorisation Final Report
eftec 208 November 2017
of voluntary industry commitments The risk assessment report of 2004 stated that the Directive
caused a significant reduction in use and emissions of TCE in metal cleaning due to requirements to
phase out the substance where feasible and to impose limits upon emissions to atmosphere by the
use of closed systems The Defra report of 2005 expected that ldquodue to the use of closed systems
respectively substitution to other solvents the trichloroethylene consumption into solvent
applications would drop by an additional 60 compared to the 2006 consumptionrdquo122 The same
report states that in 2007 the TCE use as a solvent accounted for in the EU was 25 of the EU
production The rest would be used as intermediates ndash this is a substantial change as in 1996 TCE
was used up approximately 63 as solvent and intermediate use was 37 of the EU TCE production
(see Figure 111 and 112)
Figure 111 Production export import volumes TCEPER 2003-2016
Note The numbers in this figure represent the combined figures for TCE and PER
122 Defra - Risk Reduction Strategy and Analysis of Advantages and Drawbacks for Trichloroethylene Entec UK
2005
Impacts of REACH Authorisation Final Report
eftec 209 November 2017
Figure 112 Uses of TCE sold into EU markets 1996 and 2003
According to the Annex XV report of 2010123 the majority of the TCE volume produced today is used
as a chemical intermediate (estimated at 80) which is out of scope of the authorisation under
REACH The same report mentions that the remaining volume is allocated to the following main
uses
Industrial solvent for metal cleaning and degreasing and
Solvent used in certain adhesives
The Annex XV report refers also to miscellaneous uses as solvent like
In the metal processing
For asphalt testing
For wool scouring
For high-tech ceramic goods production
As process solvent
As heat transfer fluid
TRI has long been replaced in dry cleaning machines with tetrachloroethylene (PER) due to the
milder solver action Additionally it is mentioned that some consumer products could still contain
trichloroethylene such as corrective liquids (for typing machines) paint removers adhesives stain
removers and liquids for carpet cleaning but only at concentrations of 01
There are currently five registrations active The total use is in the range of 100000 to 1 million
tons per year based on the tonnage bands presented on the ECHA website The actual import of the
substance is as shown in the Table 115 has been on average for the past five years in the range of
just below 6000 tons per year
123 ANNEX XV report ndash Proposal for identification of a substance as a CMR cat 1 or 2 PBT vPvB or a substance
of an equivalent level of concern submitted by France 2010
Impacts of REACH Authorisation Final Report
eftec 210 November 2017
The uses identified in the registration dossier and falling under authorisation are
Industrial use as heat transfer fluid
Industrial use as process chemical
Industrial use as process chemical (closed systems)
Industrial use as process chemical (semi-closed systems)
Industrial use as process chemical (enclosed systems)
Industrial use in surface cleaning (enclosed systems)
Industrial use in surface cleaning (closed systems)
Industrial use as intermediate
Distribution and (re)packing
Industrial use of adhesive
Industrial use in adhesives
Industrial use in textile scouring
116 Changes in the market for the substance during the authorisation process
The Annex XV report states that due to rationalisation and consolidation the number of European
producers of TCE declined from more than 10 in 1984 to two producers in 2009124 After one of the
manufacturer ceased production of TCE in 2016 after a merger with a competitor only one
manufacturer remains today (in Romania) The available information shows that the decline of the
production and consumption of TCE has further declined after 2006 Figure 113 shows the trend
between 2012 and 2016
Figure 113 Trichloroethylene ndash Production consumption exports imports in EU 2012-2016
124 ANNEX XV report ndash Proposal for identification of a substance as a CMR cat 1 or 2 PBT vPvB or a substance
of an equivalent level of concern submitted by France 2010
Impacts of REACH Authorisation Final Report
eftec 211 November 2017
At the end of 2011 TCE was included in Annex XIV One of the key players Dow Chemicals
(manufacturer of the substance) took the lead to submit an upstream application for authorisation
for five uses Of all submitted applications for authorisation for trichloroethylene (15 in total) more
than 90 could be allocated to the use as solvent either for surface cleaning metal degreasing or
as processextraction solvent
An analysis of changes in the registration data through the authorisation milestones125 concluded for
TCE that at least one of the registered uses (use as heat transfer fluid reported by four registrants)
does not seem to be covered by any applications for authorisation When checking whether any of
the uses which were applied for regarded uses not registered before (or not reported according on
Article 38 of REACH) the same report concludes that ldquoall uses applied for appear to fall under the
generic scope of the registered uses the names of which were however not specified further after
sunset date The comparison relies solely on the use names and therefore is not conclusiverdquo In
total for TCE there is one registrant less today compared to pre-authorisation period
Based on market research information (Figure 114) the production and consumption of TCE in the
EU will further decrease to an estimated level of 23500 tonnes per year by 2022
Figure 114 Trichloroethylene ndash Production consumption in EU 2017-2022
At the time of generation of the market research report there were still two producers of TCE in
the EU The data forecast for the production of TCE in the EU as described in Figure 114 is
therefore considerably lower as the maximum capacity of the remaining producer is around 12000
tonnes per year However the consumption levels in the graph are still regarded as accurate as
the difference in production volume will likely be compensated by an increase in imports of TCE
In one of the interviews held for this study a stakeholder expressed his concern that the market for
TCE was ldquorapidly decreasingrdquo His expectation was that TCE consumption would be ldquostable for the
125 ECHA Changes in the registration data through authorisation milestones TCE DBP CrO3 Status as of 10th
April 2017 p12
Impacts of REACH Authorisation Final Report
eftec 212 November 2017
market as intermediate but the availability of alternatives would further reduce the demand for
TCE as a solvent for the metal degreasing industryrdquo A forecast for the metal cleaning equipment
industry in the EU126 however predicts a steady growth for the metal cleaning industry with an
estimated annual growth of 62 between 2016 and 2024
117 Substitution
The substantial decline in the production and consumption of TCE over the last two decades means
that alternatives have been available for a long time and companies have been actively seeking to
substitute or change the process even before REACH One of the main legal drivers for this was the
Solvent Emission Directive Despite the substitution efforts for more than 10 years and the
availability of quite a number of alternatives especially in the area of metal cleaning and surface
degreasing some critical applications still remain where the use of TCE is essential for the process
andor the quality of the goods produced127
There are numerous alternatives to TCE in its use as a solvent for metal cleaning and degreasing
Those substances closest to be as drop-in substances are chlorinated solvents ndash tetrachloroethylene
(PER) and methylene chloride (MEC) Dow Chemicals refers to additional alternatives and processes
such as128
Aqueous cleaning The process uses detergent-water or an alkaline chemical solution which
is a very popular alternative but not always as effective at removing grease and oils
Aqueous cleaning is quite successful with steel parts less efficient with aluminium parts
and even less so for mixed metals
Semi-aqueous or emulsion cleaning Parts are exposed to a non-chlorinated solvent that
incorporates a surfactant The surfactant ensures that remove residual solvents and
residual oils from the parts carrying them into aqueous phase
Non-chlorinated solvents Acetone n-methylpyrrolidone (NMP) or terpenes can often
provide good cleaning However these are mainly limited to cold cleaning applications due
to their characteristics as flammable or combustible substances In addition new
engineered solvents have been developed such as volatile methyl siloxanes oxygenated
solvents (glycol ethers and dibasic esters) the hydrochlorofluorocarbons (HCFCs)
hydrofluorocarbons (HFCs) hydrofluoroethers (HFEs) and n-propyl bromide The
disadvantages of the alternatives are the usual lower performance and considerably higher
cost (12 to 15 times the cost of a traditional chlorinated solvent)
Supercritical fluids (SCFs) Particularly supercritical carbon dioxide (CO2) does have good
cleaning properties with little environmental impact Since the substances reach their
supercritical phase only when compressed and heated beyond their critical pressure and
temperature the process requires costly equipment with safety features
Other options There are additional cleaning processes available as plasma cleaning laser
cleaning thermal vacuum cleaning and mechanical cleaning
126 Transparency Market Research ndash Metal Cleaning Equipment Market Analysis 2016 127 ECSA European Chlorinated Solvents Association ndash Trichloroethylene Legislation Markets and Use 2010 128 Dox Clorinated Solvents ndash Newsletter Volume 3 Alternatives to chlorinated solvents
Impacts of REACH Authorisation Final Report
eftec 213 November 2017
An online research delivered several available tools that businesses looking for alternatives for a
substitution of TCE could use
The substitution portal SUBSPORT (as described under Section 1073) The portal also
describes 14 case studies in which TCE has been successfully substituted for different
applications
Cleantool is an online best practice database dedicated to alternatives for best options for
cleaning of metal surfaces129 The database has been developed between 2001 and 2004 by
five partners with the Kooperationsstelle Hamburg IFE in the lead supported by funds from
EU research programme
A similar database has been developed for users by the Technical University of Dortmund
called ldquoBauteilereinigungrdquo130 available in German The database was mainly developed for
users from automotive industry and allows selection of both alternative substances and
alternative processes depending on the size and type of parts that need to be cleaned
An analysis of the submitted applications shows that in eight cases the alternative mentioned in the
analysis of alternatives refers to PER as an at least technically feasible alternative This confirms
the view of Defra (2005)131 that ldquoperchloroethylene is reported to be the most technically feasible
substitute for trichloroethylene in the majority of the cases even though this will depend upon the
particular applicationrdquo
Looking at the results from the online survey from the applicants andor downstream users two out
of six companies had substituted TCE successfully Half of the respondents (three) mentioned that
they were not investigating any substitution two indicated successful substitution with one
company confirming to carry out substitution activities
An example of early substitution was followed up during the interviews A supplier to the defence
industry stated that substitution of TCE started as early as in the 1990s with switching to
alternative processes (aqueous cleaning) for applications where the qualitative result would allow
it Even before TCE was identified as a substance of very high concern (SVHC) in 2010 the company
decided to substitute the substance and not follow the route of an application for authorisation
Main reason for this was the doubt that an application would be successful due to relatively old
technology used in the processes cleaning with the substance PER was considered as a suitable
alternative but first rejected on the grounds of its hazard profile in addition PER was under
substance evaluation from a Member State authority (Latvia in 2014) As the evaluation concluded
that PER was not a SVHC and no further measures were required it was reconsidered as an
alternative As a consequence a new installation for vapour degreasing has been developed and
implemented based on PER that consumes and emits considerably less solvent This installation was
implemented just before sunset date for trichloroethylene
129 wwwcleantoolorg 130 ldquoBauteilreinigungrdquo means ldquocomponent parts cleaning - wwwbauteilereinigungde 131 Defra ndash ldquoRisk Reduction Strategy and Analysis of Advantages and Drawbacks for Tryichloroethylenerdquo 2005
Entec UK Ltd
Impacts of REACH Authorisation Final Report
eftec 214 November 2017
118 Changes in the market for alternatives
Depending on the application and use there are alternatives for TCE Very little publicly (or
commercially) available information was identified that could help to evaluate relevant changes in
the markets for alternatives
Tetrachloroethylene (PER) has been regarded by the supplier of TCE as a technically suitable
alternative to TCE From its hazard characteristics (suspected for causing cancer) it was expected
that PER would follow a similar route as TCE and require authorisation is some years But as
mentioned above the result of the Latvian substance evaluation in 2014 ensured suppliers of PERrsquos
long term stability
The available information shows (see Figure 115) that the EU is a net exporter of PER with
negligible import volumes On average in the last five years 150000 tons of PER were produced in
the EU per year compared to an average import volume of less than 300 tons
After the decision of the substance evaluation in 2014 the consumption of PER peaked towards the
sunset date in 2016 This is in line with a peak in the production volumes in 2016 compared to the
last five years
Figure 115 Tetrachloroethylene ndash Production consumption exports imports in EU 2012-2016
In a market report for tetrachloroethylene132 (Figure 116) the forecast for the next five years
indicates that the production level for PER will continue to decrease while consumption will remain
around a level similar to the average of the last five years This could mean that despite PER being
a technically feasible alternative for the substitution of TCE it is either disregarded due to its
132 BAC reports Trichloroethylene Tetrachloroethylene (Perchloroethylene) ndash European Union Market Outlook
2017 and or Forest till 2022 2017
Impacts of REACH Authorisation Final Report
eftec 215 November 2017
hazard profile or only substituted in cases where exposure is well-controlled and minimised (eg
closed systems)
Figure 116 Tetrachloroethylene ndash Production consumption in EU 2017-2022
119 Evidence of improved risk management
Also for TCE the improvements in risk management are documented in this case study by means of
the evolution of the exposure values and the implemented RMM
Additional risk management measures
As part of the public versions of the AfAs for TCE 27 of the dossiers mention improvements in
RMM This is slightly lower in comparison to all AfA submitted (35 mentioning improved RMM in the
context of the dossier) However as mentioned above according to ECHA most applicants refer to
improved RMM during the application process (PSIS RAC questions) even though data is not
available Furthermore again as mentioned above it seems to be more difficult for upstream
applications to document the improvements in RMM in detail
Nevertheless for two TCE applications applicants clearly mention additional RMMs which were
implemented as a result of the authorisation process (eg Vlisco Parker) In the Vlisco application
more than 20 emissions reduction was announced as a result of process modifications that were
planned to be implemented before the sunset date These improvements were identified on the
basis of mass balances exposure measurements and field audits Another key element in that
dossier was that it also described and documented previous (historical) efforts in minimising
exposure In the Parker case it was also possible to reduce the emissions in the workplace
significantly by process modifications Because of this Parker will be able to double its capacity
without increasing the use of solvent exposure or emission In practice even after such capacity
expansion the exposure will be 20 lower compared to today
Impacts of REACH Authorisation Final Report
eftec 216 November 2017
Akzo identified in their application for authorisation for the continued use of TCE several
opportunities for improvements using close follow up of the solvent consumption in combination
with field audits and exposure measurements These findings resulted in the change of certain parts
of the installation and the introduction of new maintenance programs
None of the survey respondents replied to the questions on improved risk management activities In
the interviews with stakeholders no reference or comments were made with regards to
improvements in exposure reductions implemented or planned
Exposure values
A basic approach to assess the exposure to TCE at the workplace is by evaluation of the imposed
limit values While the limit values are not indicators of the actual exposure values it can be
assumed that lowering the limit value will lower the average exposure value
TCE is considered as a non-threshold carcinogen without any DNEL value There are however still
local occupational exposure limits with which companies have to comply The existing OEL values
across Europe show a considerable variance between a minimum level of 33 mgm3 for workers
inhalation in Austria and a maximum level of 550 mgm3 in the UK (Table 113)
In 2009 SCOEL proposed new occupational exposure limit for TCE of 10 ppm 547 mgm3 (8-hour
TWA) and 30 ppm 164 mgm3 (short-term exposure limit 15 min)133
Table 113 Existing OELs for TCE inhalation (adapted from the GESTIS database134)
EU-country
Limit value ndash
Eight hours TWA
Limit value ndash
Short term
mgm3 mgm3
Austria 33 132
Belgium 55 137
Bulgaria 135
Croatia 550 820
Cyprus 535
Czech Republic 250 750
Denmark 55 110
Finland 50
France 405 1080
Germany 60
Hungary 540
Ireland 1375
Italy 54 140
Latvia 10
Lithuania 50 134
Malta 55 1375
Poland 50 100
133 Recommendation from the Scientific Committee on Occupational Exposure Limitsfor Trichloroethylene
2009 SCOELSUM142 134 Commission staff working document Impact Assessment - Accompanying the document Proposal for a
Directive of the European Parliament and of the Council amending Directive 200437EC on the protection of
workers from the risks related to exposure to carcinogens or mutagens at work (2017)
Impacts of REACH Authorisation Final Report
eftec 217 November 2017
EU-country
Limit value ndash
Eight hours TWA
Limit value ndash
Short term
mgm3 mgm3
Romania 100 150
Spain 55
Sweden 50 140
Slovakia 275
Slovenia 270 1080
United Kingdom 550 820
A comparison of the development of the occupational exposure limits over time shows that
considerable improvements can be expected to have been achieved by adjusting the OELs over time
to lower levels (Table 114)
Table 114 Comparison of OEL levels for TCE for different EU countries over time values for inhalation
EU-country
2010135 2017136
Limit value ndash Eight hours Limit value ndash Eight hours
ppm mgm3 ppm mgm3
Austria 50 270 06 33
Belgium 50 269 10 55
Denmark 30 160 10 55
Finland 30 160 10 50
France 75 405 75 405
Ireland 100 535 10
Sweden 10 50 10 50
United Kingdom 100 550 100 550
Historically several measurement campaigns have been carried out by different Member States
authorities to assess the level of occupational exposure (see Table 115) While these results are
not representative and should not be compared like-for-like they serve as reference point and can
be compared with the values as reported in the AfA The following sources were used
Country Reference Period
France INRS Raymond VINCENT (2009) Donneacutees COLCHIC dexposition professionnelle agrave divers agents chimiques pour la peacuteriode 2002-2008 Butylglycol et aceacutetate de butylglycol Toluegravene Dichloromeacutethane Perchloroeacutethylegravene Trichloroeacutethylegravene Styregravene Acrylamide As reported in the Annex XV report for trichloro ethylene France 2010
2002-2008
Germany BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz Hauptverband der gewerblichen Berufsgenossenschaften
1990-1994
135 Annex XV Report Proposal for Identification of a Substance as CMR cat 1 or 2 PBT vPvB or a substance of
an equivalent level of concern France 2010 136 GESTIS 2017 httplimitvalueifadguvde
Impacts of REACH Authorisation Final Report
eftec 218 November 2017
Table 115 Historical measurement campaigns on TCE reported from various EU countries values for inhalation
EU-
country Trade sector Application values companies
90 value
(mgm3)
Refere
nce
France
Manufacture metal products
except machinery and
equipment
215
152 sites
236
(1)
Printing and reproduction 91 194
Manufacture of rubber
products and plastics 85 191
Manufacture computer
electronic and optical
components
38 89
Manufacture of electrical
equipment 23 1
Chemical industry 14 859
Other sectors 274 215
Germany
Loading and distillation in
chemicals industry
- without LEV
- with LEV
31
10
19
16
8
9
71
32
82
(2)
Surface coating Adhesive
bonding laminating lining
stopping
- with LEV
-without LEV
144
74
66
78
44
41
215
185
232
Surface cleaning manually 14 7 304
Surface cleaning
installations
- without LEV
- with LEV
188
23
159
90
18
74
241
282
239
Notes (1) Colchic study 2002-2008137 and (2) BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz
Hauptverband der gewerblichen Berufsgenossenschaften
For the applications for authorisation RAC has published a reference dose response curve138
137 Annex XV Report Proposal for Identification of a Substance as CMR cat 1 or 2 PBT vPvB or a substance of
an equivalent level of concern France 2010 138 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene (RAC28201407 rev 2)
Impacts of REACH Authorisation Final Report
eftec 219 November 2017
Figure 117 Excess risk for carcinogenic effects-Working lifetime exposure139
It is to be noted that in BEkGS910140 the risk level of 4x10-4 6 ppm (32 mgm3) is considered an
ldquoacceptable riskrdquo until 2013 2018 latest even though it is not considered to be a formal reference
value for an AfA After that date 4x10-5 is considered as an acceptable risk level which corresponds
to 06 ppm (32 mgm3)
An analysis of the submitted AfAs shows that in 11 of the 13 applications actual measurements
were available with some supported by modelled data The ranges shown in Table 116 refer to the
highest exposure value found per application in different scenarios for workers which means the
data represents the worst-case exposure information both because the highest value is reported
and there is no correction for duration of the contributing scenario
139 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene (RAC28201407 rev 2) 140
httpswwwgooglebeurlsa=tamprct=jampq=ampesrc=sampsource=webampcd=4ampved=0ahUKEwjkvtOuy4TXAhWOaFAKHe
wdBr4QFgg7MAMampurl=https3A2F2Fwwwbauade2FDE2FAngebote2FRechtstexte-und-Technische-
Regeln2FRegelwerk2FTRGS2Fpdf2F9102F910-
trichlorethenpdf3F__blob3DpublicationFileampusg=AOvVaw1QS_qPaFsmMdl7_lRgcVB1
Impacts of REACH Authorisation Final Report
eftec 220 November 2017
Table 116 Overview of occupational exposures results from the submitted AfAs for TCE expressed as ranges
Inhalation Dermal
Measured data Modelled data Measured data(1) Modelled data
Range in mgm3 Range in mgm3 Range in mgkgday Range in mgkgday
lt1 1-10 10-50 lt1 1-10 10-50 lt01 01 - 1 1 - 5 lt01 01 - 1 1 - 5
2 6 3 1 7 8 1 12 5
Note (1) No measured data for dermal exposure was identified in the submitted AfAs
Although the historical numbers cannot be compared directly with the numbers in the AfA it is
clear that after the implementation of the exposure scenarios of the AfA the exposure level will be
significantly reduced compared to the historical exposure While historically only 4 sectors had an
exposure level below 50 mgm3 (8 hrs average) (Table 115) as a result of the authorisation
process all sectors will have a maximal exposure level below 50 mgm3 (Table 116) meaning that
the actual 8 hrs average exposure level will be even lower
The COLCHIC data reported in the Annex XV background document shows that 25 of the measured
data (8 hrs average) is above 50 mgm3 (10 ppm) The average exposure level is 749 mgm3 (139
ppm) and a 90 percentile of 168 mgm3 (311 ppm) The raw data is missing to estimate the number
of avoided cancer cases However if the average exposure to TCE would be historically about 749
mgm3 the reduction to an exposure of 34 mgm3 (6 ppm risk = 4 10-4) represents for an estimated
population exposed to TCE in the EU of 200000141 workers 1137 avoided cancer cases
In conclusion both when looking at historical exposure data and when interpreting the AfA it is
clear that during the authorisation process the exposure level of TCE has decreased Although it is
difficult to prove that these reductions are a direct result of the authorisation in at least three AfA
and based on the observations of ECHA this seems to be the case
1110 Competition and competitiveness
The impact of the authorisation process on competition and competitiveness for TCE is difficult due
to limited research available on that topic As in the case of Chromium Trioxide it is expected that
a large number of the surface cleaning companies in the EU are SMEs and are providing surface
cleaning as contract manufacturers even though no statistical data is available
Of the four online survey respondents referring to TCE none referred to any impacts authorisation
had on their competitive position
In one of the follow up interviews one stakeholder mentioned that the impact of authorisation on
their companyrsquos competitive position was not ldquoon their horizonrdquo He stated that ldquoin the metal
degreasing industry the main consolidation already happened 10 years ago We have been in the
business of looking at alternatives for TCE for 20 years so this has become part of our business
and authorisation did not impact that in any wayrdquo
In another interview the stakeholder referred to the problem of uncertainty about the process
The uncertainty about the outcome of the application for authorisation led to a decision to
141 Extrapolation based on Risk of Cancer Among Workers Exposed to Trichloroethylene Analysis of Three
Nordic Cohort Studies
Impacts of REACH Authorisation Final Report
eftec 221 November 2017
substitute TCE prior to the sunset date ldquoWe would rather accept the cost of an alternative process
than face the risk of possibly not being granted authorisationrdquo
1111 RampD innovation and investment
Due to its hazardous characteristics the replacement of TCE was already in the focus before the
introduction of REACH even though a search on the internet deliver only a few specifically TCE-
related projects funded by EU Most of the funded projects have been targeted at the
bioremediation of soil contaminated with TCE (andor other chlorinated solvents)
From the survey results of the four respondents referring to TCE none responded to the question
whether the authorisation did have an impact on their organisationrsquos spending on innovation or
investment opportunities andor RampD
The interviews with stakeholders did not provided any additional information on this topic In the
one case where the company substituted TCE with PER prior to the sunset date the stakeholder
mentioned that the pay back for investments would be compensated by the reduction in
operational costs (less maintenance better recycling and re-use of the solvent less consumption of
the solvent)
1112 Experience of SMEs
It is estimated that the market for metal degreasing is dominated by SMEs who would provide the
service of degreasing as contract manufacturers However no data could be found to indicate the
structure of SMEs in the surface cleaning industry
Further information on the experience of SMEs in the authorisation process for TCE could not be
obtained from the online survey or the interviews with stakeholders
In one of the interviews a stakeholder mentioned that as a consequence of the authorisation for
TCE the company even considered to insource the service of metal degreasingsurface cleaning
He stated ldquoit is strange to think that 20 years ago we outsourced this activity and were thinking
now about integrating it again to have direct control of the operating conditions and the exposure
situation but the question was whether these small companies would be able to do what was
required to get an authorisation And there we were doubtfulrdquo
1113 Summary of Tier 1 case study
Looking at all influencing factors for the case of TCE two main consequences could be identified
Benefits in the form of exposure reduction and Impacts on the competitiveness of applicants
TCE is a SVHC and the risk profile has been known for decades Therefore a lot of work prior to
REACH has gone into improving occupational exposure also driven by other legislation (eg Solvents
Emission Directive) Closed systems and better re-cycling loops recommended by the European
Commission in 2008 have led to fewer emissions and consequently also lower consumption of TCE
For instance Dow Chemicals had already their Safetainer packaging system for TCE introduced
Impacts of REACH Authorisation Final Report
eftec 222 November 2017
years before the authorisation process In a JRC report142 a 25 reduction of solvent use was
reported in 2006 as a result of the introduction of the Safetainer
There are various substitutes for TCE and substitution has been taking place since the 1990s The
authorisation is today covering basically uses for which no alternative is yet available The
authorisation dossiers also show that in the case of TCE at least one third is continuing to invest
into research to find a suitable alternative in the coming years
At the time of writing of this report it was not possible to have actual exposure and emission data
post authorisation Measured and reported exposure data in the AfAs and announced additional
RMM lead to the expectation that a further reduction of exposure will be possible following the
sunset date The exact value of this improvement is hard to estimate The survey responses and the
interviews confirmed the statement that the majority of the benefits in the form of exposure
reduction were achieved before REACH
As in the case of Chromium Trioxide it seems evident that uncertainty from the legislative position
is a key driver for the companiesrsquo decisions with regards to authorisation The fact that even
today 15 months after the sunset date there is no final decision on some TCE AfA is creating a
huge delay increasing the uncertainty for the applicants In one way or the other this is influencing
decisions
A surprising element is that despite expected similarities in the market structure (supply chain)
between the surface cleaning and the surface plating industries there were less intensive
discussions on the role of the contract manufacturers using TCE It appears that in the case of TCE
downstream users have long been exposed to the question of alternatives and substitution despite
the estimated small size of the businesses Also the question of relocation as a form of substitution
of TCE was not mentioned at all This could also support the statement that most of the impacts
have happened prior to REACH and businesses have long adapted to the framework
142 Chemical product services in the European Union (January 2006)
(httpswwwgooglebeurlsa=tamprct=jampq=ampesrc=sampsource=webampcd=8ampved=0ahUKEwimpfm73oTXAhWCaFAKH
RPjDX8QFghfMAcampurl=ftp3A2F2Fftpjrces2Fpub2FEURdoc2Feur22213enpdfampusg=AOvVaw20-
2NiGi1nXDl9H7uYB6aH
Impacts of REACH Authorisation Final Report
eftec 223 November 2017
12 TIER 1 CASE STUDY SUBSTANCE 3 DIBUTYL PHTHALATE
(DBP)
121 Introduction
Phthalates like Dibutyl Phthalate (in the following referred to as DBP) are the most commonly used
plasticizers in the world accounting for more than 80 of worldwide plasticizer production143 The
different phthalates provide flexibility to PVC as well as to other products and can be found in
almost anything including toys automobiles food packaging cleaning materials cosmetics
building materials medical devices clothing and household furnishings
One of the key reasons for the recommendation for inclusion for Annex XIV was that ECHA
concluded from the available information that DBP is supplied for uses and applications that must
be considered as wide dispersive in high volumes The registration dossier refers to the registered
volume tonnage for DBP in the range of 1000 to 10000 tons per year
As DBP only covers a narrow market there were only few responses in the online survey with
regards to that substance ndash of the 66 online survey responses five originated from applicants
downstream users or NGOs dealing with the substance (two were applicants or downstream users
two were usersnon-applicants one was an NGO) For the follow up interviews four stakeholders
for DBP were contacted
NGO (1)
Associations (0)
Applicantsdownstream users (3)
Users non-applicants (0)
122 Substance profile
Table 121 Dibutyl Phthalate substance profile
Name Dibutyl Phthalate
EC no 201-557-4
CAS no 84-74-2
93952-11-5
Stage in Authorisation Process On Authorisation List
SVHC Classification - Intrinsic
property(ies) referred to in Article 57
Toxic for reproduction (Article 57c)
Exempted (categories of) uses
Uses in the immediate packaging of medicinal
products covered under Regulation (EC) No 7262004
Directive 200182EC andor Directive 20183EC
Existing restrictions No Annex XVII restrictions
In 2016 another proposal was submitted to restrict four phthalates (DEHP BBP DBP DIBP) on articles containing the four phthalates for (i) indoor use and (ii) outdoor use if in contact with
143 wwwplasticizerorg
Impacts of REACH Authorisation Final Report
eftec 224 November 2017
human skin or mucous membrane144 This proposal is still waiting for the final decision by the EU Commission Dibutyl Phthalate (DBP) does not occur naturally in the environment145 It is produced by the
reaction of phthalic anhydride with n-butanol in the presence of concentrated sulphuric acid as a
catalyst Excess alcohol is recovered and recycled and the di-n-butyl phthalate is purified by
vacuum distillation andor activated charcoal146
In the decision for the inclusion in Annex XIV it was concluded that due to available information it
seems possible to determine a toxicological threshold in accordance with Section 64 of Annex I
Therefore applicants intending to apply for authorisation for DBP would be able to demonstrate
adequate control of the exposure to this substance
123 Case study rationale
DBP fulfils only two of the key criteria set for the selection of a Tier 1 case study substance
Latest application date has passed so that we should be able to assess the impacts of the
whole authorisation process ndash for DBP this was 21 August 2013
There is a high number of applications and applicants which increases the opportunities for
getting data ndash for DBP there were three applications for three applicants
There is a high number of used applied for ndash for DBP there were six uses and
There is diversity and complementarity of impact aspects ndash high volumes allocated to the
uses and widespread use in EU in numerous businesses with widespread applications
There is little information available to quantify the number of companies potentially affected A
background document for the recommendation for the inclusion of DBP in Annex XIV estimated that
50 to 100 companies EU wide could be affected147 It is also assumed that a large number of
companies (gt1000) is involved in further processing and formulation of DBP in the supply chain ldquoas
downstream users and users of preparations and articles containing DBP represent several different
industry sectorsrdquo148
144 ECHA Danish Environmental Protection Agency Annex XV Proposal for a Restriction for four Phthalates
5DEHP BBP DBP DIBP) 2016 145 EU Commission Scientific Committee on Occupational Exposure Limits SCOELREC143 Di-n-butyl phthalate
Recommendation from the SCOEL 2016 146 Chemical Substance Bureau The Netherlands 2003 Dibutyl Phthalate Risk Assessment 147 ECHA 2009 Background document for dibutyl phthalate (DBP) - Document developed in the context of
ECHArsquos first Recommendation for the inclusion of substances in Annex XIV 148 ECHA 2009 Dibutyl Phthalate - Prioritisation and Annex XIV background information