1 December2013

6

3 First substance evaluation decisions to be finalised

After unanimous agreement of the Mem-ber State Committee in November, ECHA will finalise the first batch of decisions for seven substances. They will be pub-lished on ECHA's website in 2014.

6 ENES 5: Focus on mixtures ENES5 meeting participants learnt that around 15 different approaches are cur-rently being developed to to compile safe use information for mixtures. The aim now is to further refine these methods down to two to three generic ones that can be used by the majority of formulators.

9 Member States agree on the practical actions of the SVHC Roadmap 2020

The implementation plan for the ‘Roadmap on substances of very high concern for 2020’ was endorsed by the Member State competent authorities in their meeting at the end of November.

14 Ensure technical equivalence before apply-ing for an EU or national authorisation for a biocidal productDoes your biocidal product contain an active substance which comes from an alternative source that differs from the reference source of the approved active substance? If so, you need to ask ECHA to assess whether your active substance is technically equivalent to the one already approved .

This is our last newsletter of 2013 and a good opportunity to reflect on the year's work and to look towards 2014. It is also the one-year anniversary of our online Newsletter format, which you appreciate very much according to our news reader-ship survey. You can read more about the results of the survey on the last page of the issue.

This year has been marked by the second REACH registration deadline in May and the entry into operation of the new Biocidal Products Regulation in September.

The second deadline brought us another step towards the safe use of chemicals in Europe. Nearly 3 000 substances were registered by May, which brings us to nearly 7 500 substances registered under REACH since 2008. Over the years, we have received almost 38 000 registration dossiers.

Three months into the entry into operation of the new biocides regulation, ECHA has received over 1 300 biocidal submissions. Most of the applications are related to renewals of national authorisations and more than 1 000 applications have already been forwarded to the responsible evaluating competent authority. The first public consultation on a biocidal active substance was launched at the end of November. There is a lot of information published on biocides on our website. You can find data from 49 approved biocidal active substances and a lot of authorised biocidal products under the Biocidal Products Directive. Most of the web pages are now also available in all EU languages.

Taking stock: second peak conquered

annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu

05 DECEMBER 2013

2

In this issue: 3 First substance evaluation decisions to be finalised4 Conclusion documents published on four evaluation cases5 ECHA Scientific column: Evaluation of grouping and read-across6 ENES5: Focus on mixtures9 Member States agree on the practical actions of the SVHC Roadmap 202012 Smaller companies share their experiences on REACH registration14 Ensure technical equivalence before applying for an EU or national authorisation for a biocidal product 16 How to find information about chemicals on ECHA’s website18 Are you importing or exporting hazardous chemicals?20 Lost in translation? Go to ECHA-term22 Brazil interested in learning from ECHA’s experiences24 Wanted: practical examples from industry

To subscribe to the ECHA news alerts and newsletter, register at: http://echa.europa.eu/subscribeDisclaimer: The views presented in the Newsletter do not necessarily represent the official position of the European Chemicals Agency. All the links are up to date at the time of publication.

ISSN: 1831-4953

Editor-in-chief: Lindsay Jackson Editor: Hanna-Kaisa Torkkeli

European Chemicals AgencyAnnankatu 18, P.O. Box 400,FI-00121 Helsinki FinlandTel. +358 9 6861 80Fax +358 9 6861 8210

http://newsletter.echa.europa.euechanewsletter@echa.europa.eu

“This year has been marked by the

second REACH registration

deadline in May and the entry into

operation of the new Biocidal Products

Regulation in September. ”

Executive DirectorGeert Dancet

© ECHA

We also received the first application for authorisation this year. The public consultation on the application, which concerned the use of DEHP in aero engine fan blades, was launched in September. We have asked the rappoteurs to deliver the draft opinions from the ECHA Committees for Risk Assessment and Socio-economic Analysis by mid-December.

In addition, the first decisions on substance evaluation cases have recently been agreed by the Member State Committee. You can read more about the decisions on page 3.

Year 2014 – preparing for the future peaks

Year 2014 will be the first year of our multi-annual strategy, which is built around the Agency’s four long-term strategic goals: improving the quality of information on chemicals; making best use of that information for risk manage-ment and control; addressing scientific challenges; and working efficiently and effectively on the old as well as new tasks coming from the Biocidal Products and PIC Regulations.

Although, there are no major legislative deadlines in 2014, it will be a challeng-ing year in a different way. Our focus will be less on meeting measurable targets and more on completing the necessary quality and efficiency foundations, which will pave the way for final REACH registration deadline in 2018, the po-litical targets on the safe use of chemicals in 2020, and a smooth authorisation process for substances of very high concern and biocidal substances and prod-ucts. The Agency will also draw practical conclusions from the Commission's REACH review and its follow up actions.

Reflecting on these targets, it’s good to keep in mind that many of them can only be achieved through intense cooperation with the Member States, the Eu-ropean Commission and ECHA’s Accredited Stakeholder Organisations. I hope we can make this cooperation more effective in the coming years.

With these words, I wish you a very Merry Christmas and every success in 2014.

3

Member States have prepared proposals for first decisions on substance evaluation. Sub-stance evaluation decisions, if prepared and endorsed, always request more information on the substance from the registrants. After unanimous agreement of the Member State Committee in November, ECHA will finalise the first batch of decisions for seven substances. They will be published on ECHA’s website in 2014.

This is the outcome of the first round of substance evaluations by the Member States, which started in 2012. The first community rolling action plan (CoRAP) was published for 2012-2014 and has since then been updated annually. Authorities in 17 Member States have evaluated altogether 36 substances in 2012; many of these decisions will be finalised in 2014. The decisions and evaluation reports will be available on ECHA's website.

The substances are chosen for evaluation because of potential risks to human health or environment. In the decisions, the registrants may be asked for additional information for example on any eco-toxicological or toxicological hazard or exposure. The requests for more information may include a test or data beyond the REACH standard information requirements.

WHAT HAPPENS AFTER THE DECISION?

Registrants have had the possibility to comment draft decisions before the final decision is taken. After the final decision, registrants need to update their registration dossiers within the deadline set. The respon-sible Member State will examine the new information and if, on the basis of this information, there is

still concern of risk related to the substance, the Member State may draft another decision within 12 months.

The Member State will consider whether and how to use the infor-mation obtained for EU-wide risk management measures, such as restriction, authorisation or harmo-nised classification and labelling.

The conclusion can also be that the risks of the substance are now ad-equately controlled. ECHA informs the registrants, the Commission and other Member States about the conclusions.

125 SUBSTANCES TO BE EVALUATED IN 2014-16

This year, 21 Member States are evaluating 47 substances. The draft plan for 2014-16 contains 125 substances. After consultation of the Member States Committee in February 2014, ECHA aims to adopt and publish the final CoRAP update 2014-16 in March 2014. On average, 50 substances are planned

TEXTBYTIIU BRÄUTIGAM

to be evaluated each year. The plan has been prepared in close coop-eration with the Member States, taking into account the agreed risk-based criteria for the selection of substances. The Member States have also proposed substances based on national priorities.

ECHA informs the stakeholders of the progress made by publishing this draft list of substances and encourages registrants to coordi-nate their actions and to have early interactions with the evaluating Member States.

Further information:

First MSC agreements on sub-stance evaluation, Press release 14 November 2013http://echa.europa.eu/view-article/-/jour-nal_content/title/first-msc-agreements-on-substance-evaluation

Draft update of substance evalua-tion planning for 2014-2016, News alert 4 November 2013http://echa.europa.eu/view-article/-/journal_content/title/draft-update-of-substance-evaluation-planning-for-2014-2016

First substance evaluation decisions to be finalised

Table on substances for which decisions are to be finalised. Once the decisions have been published, they can be accessed online through the CoRAP table by clicking on ‘Details’.

Substance Evaluating MS

Indication why the substancewas originally chosen for evaluation

4’4- isopropylidenediphenol(Bisphenol A)

GermanySuspected endocrine disruptor; Expo-sure/wide dispersive use, consumer use, high aggregated tonnage

Isoheptane Latvia Environment/suspected PBT; Expo-sure/wide dispersive use, high tonnage

A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-meth-ylpyran-4-ol

SpainHuman health/CMR; Exposure/wide dispersive use, consumer use, high aggregated tonnage; Risk characterisa-tion ratio close to 1 (human health)

Carbon tetrachloride FranceHuman health/CMR; Exposure/high exposure for workers, high aggregated tonnage

Imidazole UK Human health/CMR; Exposure/wide dispersive use, high tonnage

N,N'-bis(1,4-dimethylpentyl)-p-phenylene-diamine

Belgium Environment/suspected PBT; Expo-sure/high aggregated tonnage

Oligomerisation and alkylation reac-tion products of 2-phenylpropene and phenol (previously registered as Phenol, methylstyrenated)

DenmarkEnvironment/suspected PBT; Sus-pected endocrine disruptor; Exposure/wide dispersive use, high tonnage

4

news from echa

TEXTBYTIIU BRÄUTIGAM

Conclusion documents published on four evaluation cases

© FOTOLIA

Four substance evaluation cases, namely ethylene oxide, tributyl phosphate, m-tolylidene diisocy-anate and toluene, were concluded earlier in 2013.

In these cases, the evaluating Mem-ber States decided not to ask for any further information and hence no draft decision was prepared. The evaluating Member States have instead finalised their assessment and drawn conclusions about the suspected risks.

This information is available in the conclusion documents, which are published on ECHA’s website.

The conclusion document sum-marises the evaluating Member State’s view on the potential need for risk management. However, this conclusion alone is not starting any new regulatory process and is not

binding to the Member States or the Commission. The registrants, Member State competent authori-ties and the Commission are invited to take note of the conclusions drawn by the four Member States, and to consider if further actions for ensuring the safe use of the substances is necessary. Moreo-ver, where the report recommends further action, ECHA expects the reporting Member State to take the initiative.

Further information:

First four conclusion documents on substance evaluation published on ECHA website, News alert 26 November 2013http://echa.europa.eu/view-article/-/jour-nal_content/title/first-four-conclusion-documents-on-substance-evaluation-published-on-echa-website

DID YOU KNOW?

Member States are in charge of conducting substance evalua-tions.

After evaluating, they make a proposal to request further information from registrants of the substance if the available in-formation does not fully address potential risks.

ECHA coordinates and supports the work of Member States. After consulting the registrants and all Member States, ECHA takes the final decision on the substance. In the case of non-unanimous agreement among the Member States, the Commission takes the final decision.

For follow up regulatory risk management measures, separate actions have to be initiated and the registrants will have the right to be heard on the measures.

In the four substance evaluation cases, concluded in 2013, the evaluating Member States decided not to ask for any further information from the registrants. The evaluating Member States have instead finalised their assessment and drawn conclusions about the suspected risks.

5

ECHA Scientific column | Karel De Raat

Evaluation of grouping and read-across The REACH Regulation gives registrants the possibil-ity to use means other than standard methods to meet the standard information requirements for a registered substance. One such approach is to predict the proper-ties of a substance by grouping and read-across. These alternatives to the use of standard test methods – referred to as adapta-tions of the standard testing regime in Annex XI of the REACH Regulation – are often used by registrants to meet information requirements that may bring great costs and result in more testing on animals, for example when registering chemically similar groups of substances.

The core of every grouping and read-across is a scientifically credible explanation as to why a data gap for a substance can be filled by these methods. This explanation is com-monly referred to as a read-across hypothesis, cat-egory justification or category rationale. If subject to an evaluation by ECHA, a judgement on the acceptance or rejection of grouping or read-across, and whether or not a registrant has demonstrated compliance, ulti-mately depends on the adequacy of this explanation. Authorities must be confident that the hazards of the registered substance are not underestimated and that a meaningful use of the result in the context of REACH is possible, for example for risk assessment purposes. In other words, it has to be demonstrated that the result of the alternative method is as reliable as the result of the standard method or test that it replaces.

The evaluation of grouping and read-across in ECHA focuses on the quality of the explanation provided by the registrant. A scientifically-sound explanation is an absolute prerequisite for the acceptance of grouping and read-across. If it is not there, the registrant has not demonstrated how the information requirement will be met. Therefore, further evaluation of the intended ap-proach is hampered. It is the registrants’ responsibility to make the appropriate arguments, not ECHA’s.

When there is an explanation, ECHA’s evaluation subse-quently addresses its compliance with the REACH re-quirements. In practice, an evaluator will also consider the completeness, the clarity of its formulation, as well as the presence, presentation and validity of supporting data. Then a decision is taken on scientific credibility and adequacy in the context of REACH.

Registrants often make a testing proposal for a certain substance that is not the registered substance and use the information from the testing to adapt the information requirements of the registered substance. When this approach is followed, read-across is based

on information yet to be obtained by the proposed test. If ECHA concludes that the possibility for read-across is not adequately demonstrated, it must reject the intended approach of the registrant. Similarly, if during a compli-ance check of a registration the judge-ment of ECHA is that the possibility to apply grouping and read-across is not adequately demonstrated, the Agency may identify that there is a data gap and issue a decision requesting for the missing information to be provided. It

is therefore important that registrants include adequate explanations as to why read-across is justified in their dossiers.

It is not possible to develop detailed and fully compre-hensive criteria that cover the evaluation of all group-ing and read-across cases. In principle, many different explanations can be made depending on, among many other things, the nature of the registered substance and its analogues, the availability of information, and the information requirements under consideration. Different and varying (scientific) disciplines may be involved. Last but not least, experts may have different opinions on the scientific aspects of the explanation. In particular, when it comes to the final decision on scien-tific credibility and adequacy in the context of REACH, expert judgement plays an important role.

ECHA’s experience shows that despite the available guidance, registrants still have difficulties in present-ing their grouping and read-across cases in the context of the REACH information requirements. Often, seem-ingly promising cases fail in the first instance due to their incomplete or inadequate presentation.

To share best practice, illustrative examples based on ECHA’s experience of evaluating real world examples, will be published on ECHA’s website. These examples emphasise the crucial role of a high quality explana-tion and supporting data. The first example has already been published at: http://echa.europa.eu/support/grouping-of-substances-and-read-across

Karel De RaatSenior scientific officerECHA's Evaluation Unit

6

stakeholders

© ECHA

The safe use of mixtures was the main topic of the fifth meeting of the Exchange Network on Ex-posure Scenarios (ENES) held in Brussels at the end of No-vember. The meeting learnt that around 15 different approaches are currently being developed by different industry sectors to gather safe use information for mixtures based on informa-tion generated under REACH. The aim now is to further refine these methods down to two to three generic ones that can be used by the majority of formula-tors.

“Industry set an objective for our next meeting (ENES6) to come up with a limited number of methods. This means that in six months we would take a big step forward in connecting the safety of mix-tures to the REACH processes for mixtures’ safety. That would be a quite an achievement,” says ECHA’s Andrew Murray.

Industry has worked on the mixture issue intensively since the May ENES meeting. It set up a taskforce that conducted a survey on all the different ways in which mixture formulators are putting together pieces of information from the substance safety data sheets and picking out the essential parts for communicating the safe use of their particular mixture downstream.

“At ENES4 we were aware of about three different methods. Now, after this survey, industry pre-sented an overview of around 15 different methods; whether they were company led or sector led, as well as what the main features, outputs and potential stumbling blocks that need to be resolved are. Fortunately, there were some very common standard features to all of

them. Refining the methods down to two or three would benefit a big community of mixture formulators by providing consistency to the approaches, harmonisation of in-formation structure and confidence in the outcomes,” says Dr Murray.

Industry’s challenges for generating safe use information for mixtures were already presented in the October issue of the ECHA News-letter: http://newsletter.echa.europa.eu/home/-/newsletter/entry/5_13_challeng-es-for-generating-safe-use-information-for-mixtures

REPORTING BACK ON THE CSR/ES ROADMAP

ENES5 dedicated a session on the activities of the Chemical safety report/Exposure scenario Road-map, published in July.

One main area of work during the autumn has been the short titles for exposure scenarios, which help to create a table of content for the extended safety data sheet and thereby help downstream users to quickly identify which informa-tion is relevant to their uses. ”In principle, the guidelines for short titles were accepted by the ENES participants but we still want more

ENES5: Focus on mixtures

companies to test them with their substances in order to gain more confidence that the information generated is useful for those who actually receive the extended safety data sheet. I hope that by ENES6 we will have workable solu-tions,” Andrew Murray explains.

The second implementation plan for the roadmap, looking through 2014, was also discussed. Alto-gether, 18 of the roadmap's 21 actions are expected to start or to be on-going in 2014. For more information, see http://echa.europa.eu/en/csr-es-roadmap.

“Our aim is to publish the second draft implementation plan in early 2014. This plan will set the tasks for the rest of the year, to which the core organisations are committed to and to which we also hope to at-tract more contributors.”

TWO-YEAR PROJECT ON EXPOSURE SCENARIO COMMUNICATION

During the meeting, the European Chemical Industry Council (Cefic) presented its plans to develop the exposure scenario communication (ESCom) package over the next two

TEXTBY HANNA-KAISA TORKKELI

The meeting participants learnt that around 15 different approaches are currently being developed by different industry sectors to compile safe use information for mixtures based on information generated under REACH.

© CEFIC, 2013

7

stakeholders

© ECHA

years. The ESCom package consists of the phrase catalogue which will be constantly updated, and the ES-Com XML standard which is used to exchange information on exposure scenarios.

The catalogue of agreed phrases is used to describe the uses of a substance and the conditions of use in an exposure scenario. Having a harmonised catalogue of phrases allows these phrases to be trans-lated for safety data sheets.

“Industry and the IT-providers, supported by ECHA, have signed a memorandum of understanding governing the development of the phrase catalogue. In practice, this agreement will allow the use and exchange of ESCom phrases in any software the companies are using without a fee,” Dr Murray points out.

Industry and the IT providers have also agreed on the structure and working procedures that will be implemented. For example, stake-holders can propose phrases to be included in the catalogue by submitting their proposals online. The phrases are then reviewed by a working group made up of Cefic, ECHA, the Downstream Users of Chemicals Coordination Group (DUCC), the Federation of German Industries (BDI) and IT providers.

Currently, the development of the ESCom package is a two-year com-

mitment between industry, ECHA and the IT providers. “Ultimately, the expectation is that the project will continue. We will evaluate the outcomes in 2015 with a view to prolonging the project to support the 2018 registrants,” Dr Murray highlights.

PROGRESS ON SCEDS

Following up on ENES4, industry and competent authorities have made good progress on the specific consumer exposure determinants (SCEDs), which are harmonised sets of data that the registrants can use to better estimate the exposure of consumers to a substance.

“We are convinced that the SCED concept will deliver more consis-tent and more realistic consumer exposure estimates, once broadly implemented across the differ-ent sectors producing consumer products,” Dr Murray mentions of the benefits.

As the Member State competent authorities monitor and enforce the legislation and check how the registrants have carried out their assessment, they have an interest in developing SCEDs. “The authori-ties want to see transparency in terms of the data set, where it comes from and what the justifica-tions are."

The work on SCEDs will continue. Currently, the group of leading oil companies, Concawe, and DUCC are updating their SCEDs template and guidance on how to complete the document.

ECHA, on the other hand, is de-veloping a solution to make the import of SCED data possible in the Agency’s assessment tool for regis-trants - Chesar. “One aspect of this work relies heavily on downstream users, particularly on formulators, to provide data to registrants who can be quite far from consumer products, so that they can carry out their consumer exposure assess-ment. This is another illustration of why it is important to get the communication working both up and down the supply chain,” Dr Murray concludes.

The next meeting of ENES will be held in spring 2014.

Further information:

Programme, summaries and pres-entationshttp://echa.europa.eu/view-article/-/journal_content/title/fifth-meeting-of-the-echa-stakeholder-exchange-network-on-exposure-scenarios-enes-5-

What is ENES? http://echa.europa.eu/about-us/ex-change-network-on-exposure-scenarios

CSR/ES Roadmaphttp://echa.europa.eu/csr-es-roadmap

Mixtures, the CSR/ES Roadmap, exposure scenario communication and specific consumer exposure determinants were on the agenda of ENES5. The next meeting, ENES6, will be held in spring 2014.

© CEFIC, 2013

8

stakeholders

FROM OUR STAKEHOLDERS:

Erwin Annys, European Chemical Industy Council, Cefic

"ENES 5 showed that industry has been making a lot of efforts to progress on many issues that are covered by the very ambitious CSR/ES Roadmap.

Although, in six months, significant developments have been made on different issues, a lot of work still remains ahead. I dare to compare it with the Fellowhip of the Ring in the Lord of the Rings, where dif-ferent partners, in this case, ECHA, the national authorities, industry,

the Commission, NGO’s and trade unions can discuss their approaches to progress, in order to achieve the ultimate goal - good quality of the chemical safety report and hence safe use of chemicals.

In my view, ENES is very special in the sense that in a non-confronta-tional way for all players to really contribute to finding solutions for real world problems that we are all confronted with. REACH is the result of a reflection on how

the previous legislations could be improved. Many concepts were theoretical, but the ENES communi-ty is trying to materialise them in a practical way. The journey is indeed long, but worthwhile continuing if we want to improve.

There is, however, one major chal-lenge not covered so far: how can the ENES community of 100 people reach the rest of the industrial world?"

Marten Kops, Dutch Detergents Association, NVZ

“Whereas registrants are progress-ing collectively towards the most appropriate methods and tools to comply with communication obliga-tions of REACH, since ENES1, many downstream user companies and sectors are still finding their way.

As a representative from the downstream user detergents sector and presenter of a generic expo-sure scenario approach, I attended the fifth meeting of ENES, which covered the subject of exposure

scenarios for mixtures. The meeting resulted in very fruitful discussions on this topic.

Sharing experiences on different generic exposure scenario ap-proaches has proven to be especial-ly important for ensuring as much standardisation as possible, and to learn from each other’s strengths.

I am very much looking forward to the actions towards ENES6: pro-gression with the CSR/ES Roadmap

activities and thereby working towards optimising and simplifying communication on the safe use of substances and mixtures through-out the supply chain.

Having followed the previous ENES meetings from a distance with interest, for me, ENES has proven to be an ideal forum for discuss-ing the way forward for everything surrounding exposure scenarios, involving many stakeholders.”

Jouni Räisänen, Finnish Safety and Chemicals Agency, Tukes

“The establishment of ENES was a very successful action from ECHA and the European chemicals industry.

ENES is an excellent forum for exchanging views as well as iden-tifying and promoting workable solutions in chemical risk control measures in the supply chain.

From a Member State authority point of view, I have found ENES cooperation to be extremely useful and beneficial.

It is very inspiring to have an inside view of the 'other side of the fence'.

I was very happy to notice that the ENES meetings are moving in a more practical and problem-solving direction.

I look forward to the ENES6 meet-ing and the work with the CSA/ES Roadmap implementation.”

9

interview

of very high concern already includes 144 substances.

The roadmap actions aim to continue and build up on what has already been done. It focuses on specific groups of substances that will be looked at in more detail by the authorities. These are CMRs, PBTs and vPvBs, endocrine disruptors, sensitisers, and petroleum and coal stream substances.

A lot of work which is crucial for the implementation of the roadmap is already ongoing. “For example, we have together with Member States gone through our databases to identify substances that have a harmonised classification as a CMR and are regis-tered for non-intermediate uses and added those to the Candidate List. We have also done systematic screenings on respiratory sensitisers, which have been registered and have a harmonised classification and labelling. For these two groups, the roadmap implementa-tion plan foresees as a new activity to identify new candidates that are likely to have similar properties and see whether harmonised classification and labelling should be proposed for these substances,” Ms Karhu says.

On PBTs and vPvBs, ECHA and the Member States have continued the work started under the previous legis-lation and included those substances that fulfil the SVHC criteria in the Candidate List. In addition, the data-bases have been screened for potential PBTs. “In most cases, available infor-mation on potential PBTs, even though compliant with REACH, is not enough to determine whether the criteria are met. If so, we need to ask for more information. This takes time.”

As with potential PBTs, it will also take time before many new endocrine disrupting chemicals are added to the Candidate List. “We have done screen-ings on endocrine disrupters and added first of them to the Candidate List, but

Member States agree on the practical actions of the SVHC Roadmap 2020

substance expert groups. If we go through the expert groups, we then need to continue with the formal SVHC identification process,” Ms Karhu explains.

When there is a sufficient under-standing of the intrinsic properties of a chemical, either based on the registration data or after genera-tion of additional information, the most appropriate risk management option should be selected to address the concern. “We have the possibil-ity to use authorisation or restric-tion under REACH or other legal instruments in the EU. We may also conclude that there is no need for further regulatory actions in addition to what is already in place. This is the approach we have been develop-ing in co-operation with Member States and the Commission and will continue to develop and apply under the roadmap.” Ms Karhu says and continues, “Coordination of authori-ties’ activities during the screening and risk management option analysis will hopefully bring efficiency gains as we can ensure that we are not duplicating work or leaving gaps between our processes.”

FOCUSING ON FIVE SUBSTANCE GROUPS

The work on identifying substances of very high concern has been on-going since the beginning of REACH and the Candidate List of substances

The implementation plan for the ‘Roadmap on substances of very high concern for 2020’ was endorsed by the Member State competent authorities in their meeting at the end of November.

“This is an important step towards reaching the policy goal of having all the relevant substances of very high concern on the Candidate List by 2020. We now have agreed lines on how we, Member States and the European Commission will work to-gether to identify those substances that are relevant under the roadmap and should therefore be further processed in the coming years,” says Elina Karhu, Head of ECHA’s Risk Management Identification Unit.

The aim of the implementation plan is to enhance common understanding on how authorities screen sub-stances, generate further informa-tion where necessary, and channel substance to the most efficient regulatory processes. “A common approach is necessary to make the implementation predictable,” says Ms Karhu.

A common screening approach will be used to identify substances for further scrutiny. The result of the screening might be that there is no further action required or that the data in the registration is enough for authorities to act upon. “How-ever, we expect that in many cases, we need further information on the substance. For this, we can use the REACH evaluation processes: substance evaluation or compli-ance check. Then, we also need to do a proper assessment to find out whether this information confirms that the substance indeed meets the relevant criteria or not. For this we can use either the formal pro-cess of harmonised classification and labelling, when the criteria is in the CLP Regulation, or our informal

INTERVIEW BY HANNA-KAISA TORKKELI

© ECHA

Elina Karhu, Head of Risk Management Identification.

10

interview

in many cases we need more test data and therefore it is important to do the ground work first.”

The petroleum and coal stream substances have not been screened under REACH so far. “Some of these may be CMRs or PBTs. There is a need for systematic work on these substances and we have decided that under the roadmap we will start looking into, in particular, those pe-troleum and coal stream substances that have non-fuel uses,” Elina Karhu points out.

REGISTRATION DATA IS KEY

The screening and risk management option approaches rely heavily on the data available in registration dossiers and CLP notifications.

Therefore, the quality of data is very important. “It is the responsibility of the registrant to make sure that the registration data is up-to-date and accurate. For instance, if we do not have sufficient understanding of how a substance is used, we need to take a conservative approach when estimating the potential for expo-sure and how wide dispersive uses are. It is beneficial for registrants to proactively give information, for example, on uses, exposure and risk management measures. This helps us to make informed decisions,” Ms Karhu stresses and reminds that registration data can act as evidence that there is no need for further regulatory action.

Another important aspect is that when the information is provided in the registration dossier, the authori-ties have an obligation to use it. “We of course welcome information through our various public consulta-tions and use that in our decision-making as well. This applies in par-ticular to information which cannot be included in the registration data, such as information on alternatives and socio-economic aspects related to the use of the substances. How-ever, third parties providing infor-mation and comments during public consultations should pay attention to what information is asked for and

DID YOU KNOW?

In March 2010, Vice-President Tajani and Commissioner Potočnik an-nounced their long-term policy objective to have "all relevant currently known SVHCs included in the Candidate List by 2020". The ‘Roadmap on Substances of Very High Concern for 2020’, adopted by the Commission in 2012, sets the framework for achieving this policy objective.

The Roadmap focuses on presenting a credible process to ensure that the 2020 objective is achieved by defining methodologies, setting clear deliverables, planning and sharing responsibilities.

Collaboration of all actors (European Commission, ECHA and the Mem-ber States) is needed to make the implementation a success.

No numerical goal for substances to be included in the Candidate List has been set as how many or which substances will be identified as relevant SVHCs cannot be pre-judged.

can be used in that specific phase of the regulatory process,” Ms Karhu points out.

In addition, industry and NGOs can contribute to the work of the expert groups. “There are also representa-tives from industry and NGOs in the PBT and endocrine disrupters’ expert groups,” Ms Karhu adds.

INCREASING TRANSPARENCY AND PREDICTABILITY

One of the cornerstones of the roadmap is open and transparent communication. This is necessary to help stakeholders, such as industry, NGOs and the general public, to understand the objectives and scope of the roadmap.

ECHA will publish the implementa-tion plan online in mid-December together with a new web section that focuses solely on the roadmap actions. “The web section will explain how we aim to find new SVHCs, what we do in screening, in the assess-ment phases and in risk management option analysis. There will also be basic information on the different substance groups,” Elina Karhu says.

Later, substance-specific informa-tion will also be made available. This substance-specific communication will increase the predictability of how substances with certain hazard,

fate or use profiles will be dealt with by the authorities.

“The communication around the road-map will allow stakeholders to be bet-ter prepared and to make longer term, proactive planning. It provides them with earlier information about the substances the authorities are look-ing into, which risk management route they may be directed to and what the estimated timelines are. The roadmap informs about the plans before the formal regulatory processes, such as identification of SVHCs, kicks in.”

CMR: Carcinogenic, mutagenic and reprotoxic chemicalsPBT: Persistent bioaccumulative toxic chemicalvPvB: Very persistent and very bioaccumulative chemicalSensitisers: Chemicals that cause allergic reaction in normal tissue after exposureEndocrine disrupters: Chemicals that at certain doses, can interfere with the endocrine (or hormone system) in mammals. These disruptions can cause cancerous tumours, birth defects, and other devel-opmental disorders.Petroleum and coal stream substances: Chemicals used to transform crude petroleum or coal into intermediate and end products, such as fuels (e.g. gasoline, diesel, and kerosene), finished non-fuel products (e.g. solvents, greases, and asphalt) and feedstock for the petrochemical industry.

Further information:

Roadmap on Substances of Very High Concern for 2020http://register.consilium.europa.eu/pdf/en/13/st05/st05867.en13.pdf

Authorisation under REACHhttp://echa.europa.eu/addressing-chemicals-of-concern/authorisation

11

interview

Screening the REACH and CLP databases for substances of potential concern

Is there enough information to substantiate the concern?

Analyse risk management options

No

Document in risk management

option analysis

RestrictionAuthorisationList

Candidate List

No action Other legislation

Generate further information

Yes

Assess the information(supported by the expert

groups, where needed)

Harmonised classificationand labelling

High-level overview of the SVHC Roadmap implementation.

12

stakeholders

AWARENESS RAISING: INDUSTRY ASSOCIATIONS AND ECHA E-NEWS THE KEY SOURCES

The majority of the SME respond-ents said that they became aware of REACH and their obligations from their industry or trade as-sociation (44%), whereas 36% said that they became aware through a publication or media.

In terms of keeping themselves updated about their REACH obliga-tions, 74% indicated that they follow ECHA’s e-News.

MEMBER REGISTRANTS: COSTS TO ACCESS THE DATA UNREASONABLE

The respondents were asked spe-cific questions about the function-ing of the registration process. The questions concerned the substance information exchange forums (SIEFs) and joint submissions; data sharing; cost sharing; submissions tools and follow-up after registra-tion. Below is a summary of the results by each of the respondent groups:

Lead registrants (16 respondents):

69% indicated that the com-munication was at least somewhat frequent and helpful in the SIEFs; 69% indicated that they had used the services of a consultant for the main content of the IUCLID file work; All were at least somewhat satisfied with the support offered by the consultant; Provided for the participants of the joint submission:• only the data set: 32%• chemical safety report: 27%• data set, chemical safety re-

port and support to establish the IUCLID file: 23%

• data set, the chemical safety report, support to establish the IUCLID file and advice on the post-submission follow-up: 18%

56% invoiced their costs by ton-nage band.

TEXT BY HANNA-KAISA TORKKELI

First time small and medium sized enterprise (SME) reg-istrants had a say about their experiences in registering their chemicals under REACH through a survey ECHA con-ducted in October. The high-lights of the results are summa-rised below. More information about the conclusions and follow-up actions will be pre-sented at the REACH SME workshop on 10 December 2013 in Brussels.

Member registrants (109 respondents):

73% felt that the communica-tion helped to establish friendly working relationships within the SIEFs, 71% said that the commu-nication had built trust, 62% said the communication within the SIEFs had enabled best practice to be shared; 61% indicated that the com-munication had failed to continue post-submission; 22% created the main data set content themselves, 38% used a consultant and 40% said that the content had come from the lead registrant; 97% were at least somewhat satisfied with the consultants’ sup-port; Only 16% claimed that they had difficulties in sharing data. The most commonly occurring difficul-ties were receiving information from the lead registrant and cost of data; 89% received access to data in good time;

Smaller companies share their experiences on REACH registration

© FOTOLIAMost of the SME member registrants said that they received access to data in good time but felt that they had to pay for studies that were not part of their information requirements.

13

stakeholders

© FOTOLIA

The ‘Survey of 2013 SME registrants’ was conducted from 30 September until 18 October 2013.

Addressed first-time SME registrants (lead registrants, members and individual registrants).

The survey was sent to 705 registrants who successfully registered their substances for the 2013 REACH registration deadline.

Responses were received from 143 people.

The questions concerned the registrants' awareness, the registration process - functioning of SIEFs, joint submissions, data sharing, cost sharing and submisssion tools - support given by ECHA, the national helpdesks or other actors and SME self-classification.

BACKGROUND

62% said that they had to pay for access to data and/or contrib-ute to the costs of studies that were not part of their information requirements; 61% felt that the Letter of Ac-cess costs were disproportionate and unreasonable.

Individual registrations (17 respondents):

47% indicated that they had been aware of other companies who had registered their substance or were intending to do so; Reasons for registering individually included:• cost;• was not seen as necessary;• difficulties in dealing with

consortiums. 88% used a consultant for con-structing the main content of the data set of the IUCLID file work; 93% said they were at least somewhat satisfied with the con-sultants’ support.

IT TOOLS: ONLY SOME MAJOR DIFFICULTIES

Most SME registrants did not face major difficulties with the use of IUCLID 5 or REACH-IT tools: 66% said that they faced no difficulty in using IUCLID, and 82% indi-cated that they had smooth use of REACH-IT.

However, one third indicated that the invoice sent through REACH-IT was difficult to understand.

In terms of using Chesar, 66% had no major difficulties.

When asked about preparing safety data sheets, 57% said that they prepared these themselves and the remaining 43% told that they outsourced this process. 18% of those who prepared the safety data sheets themselves, used Chesar.

FOLLOW-UP MECHANISMS IN PLACE IN MORE THAN HALF CASES

66% of the respondents said that they had foreseen a mechanism for updating their registrations.

Of those, 28% indicated that they will get this service from the consultant; 19% said that such a mechanism is in place in the compa-ny; and 19% said that the follow-up is included in the SIEF agreement.

ECHA TO FOCUS ON PRACTICAL EXAMPLES

The majority of SMEs that respond-ed to the survey (40%) would like ECHA to concentrate on providing more practical examples in the future. Improving the Guidance documents was also seen as an important support for SMEs (30%).

14

Does your biocidal product con-tain an active substance which comes from an alternative source that differs from the reference source of the approved ac-tive substance? An alternative source means that the manufac-turing process, the manufactur-ing location or the manufacturer of the active substance is differ-ent.

If this is the case, you need to ask ECHA to assess whether your active substance is technically equivalent to the one already approved before you can submit an application for biocidal product authorisation.

Below are the steps that you need to take to get the technical equivalence of your active substance assessed.

Collect information for your dossier

1. Information requirements

When you start to compile your dos-sier, keep in mind that the infor-mation requirements differ if you choose to apply for Tier I or Tier II technical equivalence assessment.

Tier I assessment focuses on the substance identity and the impurity profile. In addition to these require-ments, for Tier II toxicological and ecotoxicological data are also evalu-ated. Paragraph 3.3 in the Guidance on applications for technical equiva-lence lists the information require-ments of the technical equivalence application and guides you to further reading. http://echa.europa.eu/guidance-docu-ments/guidance-on-biocides-legislation

2. Application type determines the fee

The fee for your application will be based on the type of your application and varies therefore from

€5 000 to €40 000. Annex III of the BPR Fee Regulation gives a de-tailed explanation of the different fees related to technical equiva-lence assessment.

Create a IUCLID 5 dossier

1. Include all information in the IUCLID 5 dataset

Now that you know what infor-mation needs to be submitted to ECHA, prepare your IUCLID 5 dossier. Check section 2.5 of the Biocides Submission Manual 3b: Active substances Part B, Techni-cal equivalence to find detailed instructions on how to include all required information in your IUCLID 5 dataset.

Before finalising the dossier crea-tion, remember that if your appli-cation is for Tier II assessment, you also need to attach a self-as-sessment of technical equivalence in section 13 of your IUCLID 5 dossier. The template for the self-assessment is available in Annex I of the Guidance on applications for technical equivalence.

To be able to submit your applica-tion to ECHA, create a “BPR active substance application” dossier in IUCLID 5 and export it to your computer.

Remember that each dossier can only refer to one alternative source. If you need to get several alternative sources assessed, for example if you obtain your active substance from more than one different source with a different manufacturing process, you need to submit separate applications for each alternative source of the active substance.

If the reference active substance is not yet approved as part of the

review programme, the chemical simi-larity of the active substances must be confirmed.

ECHA is currently developing a pro-cess for this and you can soon read more about it on ECHA’s website.

2. Further reading on dossier creation

If you need more instructions on how to create and build a IUCLID 5 dossier, read the following support docu-ments:• BPR dossier creation/IUCLID

Quick Guide, available on the IUCLID website. http://iuclid.eu/index.php?fuseaction=home.documentation#bprmanual

• Biocides Submission Manual 1: Using IUCLID for biocide ap-plications, available on ECHA’s website. http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-sub-mission-manuals

Submit and follow-up your application using R4BP 3

1. Prepare the supporting document

The supporting document includes in-formation about the reference active substance, its product-type and the type of assessment that you request from ECHA (Tier I or Tier II).

Download the template Application for assessment of technical equiva-lence from ECHA’s website and fill in all required information.

2. Use R4BP 3 to submit your application

Remember to upload your IUCLID 5 file and the supporting document to your application. The submission wiz-ard in R4BP 3 will guide you through the submission.

Ensure technical equivalence before applying for an EU or national authorisation for a biocidal product

TEXT BY PÄIVI JOKINIEMI

biocides

1

2

3

15

biocides

Infograph. Steps that you need to take to get the technical equivalence of your active substance assessed.

• If you are not familiar with R4BP 3 yet, have a look at the Biocides Submission Manual 2: Using R4BP 3 for biocide applications first to get useful information of the basic func-tions of the software. http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals

• If you have used R4BP 3 before, you will find advice on how to submit a dossier for technical equivalence assessment in the Biocides Submission Manual 3b: Active substances Part B, Technical equivalence. http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals

3. Remember to follow up your application in R4BP 3

All important information related to your application will be commu-nicated to you through R4BP 3.

Therefore, it is essential to keep checking your account after you have submitted your application.

• To complete your application you need to pay the invoice that you receive through R4BP 3. More information related to invoicing and R4PB 3 can be found in the Biocides Submis-sion Manual 5: Invoicing in R4BP 3 http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals.

• If ECHA needs additional information from you when assessing your application, this request will be sent to you through R4BP 3.

• Once the assessment of the ap-plication is completed, you will have an opportunity to com-ment on the outcome of the assessment. The assessment will be completed within 90 days from the payment of the application fee and the final decision will be sent to you us-ing R4BP 3.

DID YOU KNOW?

The obligation to assess the technical equivalence of your active sub-stance before applying for a product authorisation is based on the Com-mission Delegated Regulation (EU) No 837/2013 that is amending Annex III of the Biocidal Products Regulation.

It states that the biocidal product may be authorised even if one or more of the active substances contained therein has been manufactured in a different location or according to a different process, including from different starting materials, as long as it can be ensured that those active substances do not have significantly more hazardous properties than the one that has been evaluated for the purpose of approval.

The technical equivalence assessment can only be made for already ap-proved substances. If your alternative source for an active substance is still under review, you will soon have the possibility to apply for the new chemical similarity service, which ECHA plans to launch in early 2014.

USEFUL LINKS

Assessment of technical equiva-lence http://echa.europa.eu/support/dossier-submission-tools/r4bp/assessment-of-technical-equivalence

All guidance on biocides legislation http://echa.europa.eu/guidance-docu-ments/guidance-on-biocides-legislation

All biocides submission manualshttp://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submis-sion-manuals

IUCLID 5 support documentshttp://iuclid.eu/index.php?fuseaction=home.documentation

ECHA’s YouTube channel with video tutorialshttp://www.youtube.com/user/EUchemicals

All supporting document templates for biocides http://echa.europa.eu/support/dossier-submission-tools/r4bp/supporting-documents BPR Fee Regulationhttp://echa.europa.eu/regulations/biocid-al-products-regulation/legislation

start

end

Collect information for your dossier

1) Check the information requirements2) Application type determines the fee

Create IUCLID 5.5 dossier1) BPR active substance application dossier

Submit and follow-up your application in R4BP 3

1) Prepare supporting document2) Submit application using R4BP 33) Follow-up in R4BP 3

For Tier II assessment - add self assessment in section 13

16

downstream users

Downstream users

How to find information about chemicals on ECHA’s websiteTEXT BYMONIQUE PIILLET

ECHA held a webinar in September 2013 giving an overview of how to find information about chemicals on ECHA’s website. Tips were also given to support downstream users to know when they need to take action and on how they can use the information to comply with their obligations. More than 300 indus-try professionals from 24 EU and non-EU countries joined the open, free-of-charge webinar.

During the event, participants asked many interesting questions. We now share some of them with you. The questions and answers related to certain topics have been merged to increase clarity.

Q: Is the information of all reg-istered substances open to the public or are there some restric-tions (like legal or supplier's restrictions)?

A: All of the non-confidential infor-mation on registered substances is made public by ECHA in accord-ance with Article 119 of REACH, which specifies which information is always to be published, and which can be claimed confidential.

Q: Can the information published be used for purposes other than REACH? How can I contact the data owner, who is not identified on ECHA's website?

A: The data from dossiers is published on ECHA’s website for general information purposes.

Any other use of the information without obtaining the permission from the owners might violate their rights.

To contact the data owner, you need to send your question through the ECHA Helpdesk contact form for the specific data you need: http://echa.europa.eu/contact/helpdesk-con-tact-form.

Once you have permission from the data owner, you can use the data.

Q: Why is the harmonised classifi-cation sometimes different from the registered or notified classifi-cation?

A: Differences between harmo-nised and registered or notified classifications can have different origins.

A substance which is subject to har-monised classification and labelling (Part 3 of Annex VI to CLP) must be classified in accordance with that entry. In addition, the manufacturer or importer should self-classify the substance for those hazard classes where no harmonised classification is available. For example, a sub-stance may have a harmonised clas-sification for acute oral toxicity,

but not for acute dermal toxicity. This means that the manufacturer or importer would have to use the available harmonised classification and then explore, using the infor-mation available, whether the clas-sification criteria for acute dermal toxicity are fulfilled, and classify accordingly.

The resulting classification and labelling should be introduced in the notification the manufacturer or importer submits to the Classifi-cation and Labelling Inventory.

Self-classification can depend on the data each supplier has access to or on the impurities present in the substance. Therefore, differ-ences in self-classification can have a firm basis.

For substances with a minimum harmonised classification (clas-sification marked with an asterisk in Annex VI to CLP), notifiers must also classify them in a more severe hazard category if they have infor-mation showing that this is more appropriate. Again, the result of this classification will depend on the data the notifier has access to and may give rise to different clas-sifications.

Up-to-date information on registration, harmonised classification as well as authorisation and the re-striction status of substances is important to downstream users for both economic and safety reasons. Do you know how to find this information on ECHA’s website?

17

downstream users

UPCOMING WEBINARS

12 February 2014 How to bring your registration dossier in compliance with REACH – Tips and hints (part 5)This webinar provides feedback to registrants on how to submit information on chemicals in the technical dossier to ECHA in compliance with REACH.

Q1/2014How to ensure the safe use of nanomaterials under REACH, part 3: Exposure and risk assessment

Q4/2014How to bring your registration dossier in compliance with REACH – Tips and hints (part 6)

Further information: http://echa.europa.eu/support/training-material/webinars

Q: Which classification must I use if I have two suppliers who have different classifications in their safety data sheets and there is no harmonised one?

A: Downstream users may use the classification from one of their suppliers or otherwise they must self-classify the substance and notify ECHA.

We recommend that you contact your suppliers to clarify and agree on a classification, if possible. There could be justified reasons, such as impurities, that explain the difference.

If no agreement can be reached we recommend taking a cautious approach and using the more severe classification.

Q: What is the Registry of Inten-tions (RoI)?

A: Member States or ECHA (on request of the Commission) can initiate for a substance:• identification of substances of

very high concern; or• restriction.

In addition, Member States or manufacturers, importers or down-stream users may submit proposals for harmonised classification and labelling.

Intentions to initiate these pro-cesses are notified to ECHA and can be found on ECHA’s website in the RoI.

The aim of the public Registry of Intentions is to inform interested parties of authorities’ planned ac-tivities well in advance of the actual submission of the dossiers.

This helps them to prepare in time for the commenting and for the possible future regulatory require-ments.

Q: Are there fixed dates for updat-ing the list of harmonised classifi-cation and labelling, Classification and Labelling Inventory, Candidate List, Authorisation List (Annex XIV) and the List of Restrictions (Annex XVII) or must they be moni-tored continuously?

A: The list of harmonised clas-sification and labelling and the Authorisation List of REACH are updated about once a year and the List of Restrictions whenever a new restriction has been agreed and published. The Candidate List is updated twice a year, in June and in December.

The Classification and Labelling Inventory is updated about once a month.

***

These are only a few of the ques-tions that were raised during the webinar. If you wish to find out more about the event, check out the recording and presentations at: http://echa.europa.eu/view-article/-/jour-nal_content/title/webinar-downstream-users-navigating-echas-website-for-infor-mation-on-chemical-substances

The webinar received a very positive feedback with 93% of the respondents being satisfied or very satisfied with the overall effective-ness of the webinar.

Further information :

Questions and answershttp://echa.europa.eu/support/qas-support/qas

Downstream usershttp://echa.europa.eu/regulations/reach/downstream-users

National helpdesks providing sup-porthttp://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks

ECHA Helpdesk contact formhttp://echa.europa.eu/contact/helpdesk-contact-form

Registry of Intentionshttp://echa.europa.eu/addressing-chemi-cals-of-concern/registry-of-intentions

18

news from echa

“The use of chemicals regulated under PIC is by definition either banned or severely restricted in the EU, but are under certain derogations still manufactured and exported all over the world,” says Chiara Macchi from ECHA’s Registration Directorate.

The regulation applies to two lists of chemicals that can be found in Annexes I and V. Annex V includes the chemicals, which are subject to an export ban. “These chemicals can only be exported in quantities below 10kg and exclusively for research and analysis purposes,” Ms Macchi says, and continues, “What we mostly work with are the chemicals in Annex I. This list is updated on average once or twice a year.”

The Annex I chemicals are hazard-ous industrial chemicals, biocides or pesticides. “It currently contains 162 entries, including 26 group entries, such as ‘cadmium and its compounds’. When the groups are expanded, the list covers 977 different chemicals al-together. All of these are subject to an export notification - meaning that the receiving country must be informed about the details of the export before it can take place,” Ms Macchi explains. The export notification is valid for one calendar year and does not oblige the exporter to export. “The notification is a theoretical document – it’s about expected exports. In reality, some of these exports may never take place. In the subsequent calendar year, export-

ers have a legal obligation to report on the actual exports that have taken place.”

NOTIFICATION TO THE NATIONAL AUTHORITIES

The notification of the export is done by the exporter 35 days before export to the designated national authority of the Member State in which the company is es-tablished. National authorities then have to do a compliance check and send the notification to ECHA, who forwards the notification to the national authority in the receiving country.

“For the more hazardous chemi-cals, the export notification is not enough and the national authori-ties in the exporting country have to ask for explicit consent from the receiving country before the export can take place. If the receiv-ing country does not give consent, the export cannot take place. The extension of the explicit consent requirement to a larger number of chemicals is one of the additions of the PIC regulation in comparison to the Rotterdam convention,” Ms Macchi points out.

Nailing down the timelines that the different actors have to perform their tasks under PIC, is one of the changes introduced by the recast. “The old regulation has different deadlines for first time exports and exports that have previously taken place. This was an unnecessary

INTERVIEW BY HANNA-KAISA TORKKELI

The Prior Informed Consent (PIC) Regulation regulates the import and export of hazardous chemicals between the EU and third coun-tries, and implements the global Rotterdam Convention within the European Union. The recast of PIC will enter into operation on 1 March 2014 and, at the same time, ECHA will take over the opera-tional responsibility from the Joint Research Centre of the European Commission. complication. Now, there is one set of

deadlines irrespectively: the exporter has to notify no later than 35 days before export, the national author-ity has to process the notification no later than 25 days, and ECHA has to send the notification to the importing country no later than 15 days before the expected date of export.”

The notifications are currently done through an IT application called EDEXIM. “ECHA will begin operations by using EDEXIM in March. In parallel, we are also developing a new IT appli-cation, ePIC, that will be easier to use and have more automated steps which should streamline the work. This tool will be launched in September 2014,” Ms Macchi highlights.

UPDATED GUIDANCE AND IT MANUALS COMING

The PIC recast adapts the regulation to the Classification, Labelling and Packaging (CLP) Regulation and shifts the operational responsibility from the European Commission to ECHA. “These are the main reasons for the recast. Other changes are the new timelines, as already mentioned, and the fact that the REACH Enforcement Forum will have a role in coordinating enforcement under PIC,” Ms Macchi says.

In autumn 2014, the Agency will pub-lish an updated PIC guidance, which also highlights those legal provisions that are new and provides guidelines on how to implement them. IT manu-als for both industry and designated

Are you importing or exporting hazardous chemicals?

Heidi Pihol, Istvan Mak, Chiara Macchi and Raluca Pica are part of the team working on PIC at ECHA.

© ECHA

19

Are you importing or exporting hazardous chemicals? national authorities on the use of ePIC are also under preparation.

“In addition, we will publish and keep regulatory information on the Annex I chemicals up-to-date on our website. We will also provide statistics on export notifications.”

ECHA has a legal obligation to report on the exact exports that have taken place. “We will assist the national authorities in col-lecting this information from the exporters and importers and will make a non-confidential version of the report available online,” Chiara Macchi explains.

PROMOTING INFORMED EXPORTS AND RAISING AWARENESS

The aim of the Rotterdam Con-vention – and PIC in the EU – is to protect the health of consumers and workers as well as the environ-ment against potentially harmful impacts from certain hazardous chemicals and pesticides. It also contributes to environmentally sound use of these chemicals by promoting shared responsibili-ties and cooperative efforts in the international market.

According to Ms Macchi, the PIC Regulation is all about facilitat-ing informed exports of hazard-ous chemicals. In many cases, as already mentioned, exports cannot take place without the consent from the responsible authorities in the importing country.

“With PIC, in certain cases we have no legal basis for preventing an export from taking place if all condi-tions have been fulfilled. However, what we still do is alert the national authorities in the receiving country that a particular import is going to take place. Among other things, we provide the name of the importing company and their contact details.The national authorities of the im-porting countries are therefore more aware of the substances that compa-nies are trading in their territory and can also alert customs on an upcom-ing import if needs be,” she says.

Prior Informed Consent Regulation.

Regulates import and export of hazardous chemicals from the EU.

Implements at EU level the Rotterdam Convention, but has some additional provisions.

Deals with chemicals that are by definition either banned or severely restricted in the EU.

What is PIC?

List of chemicals in Annex I.

Two high level categories: - Industrial use (professional and public) - Pesticides (plant protection products, biocides)

List of chemicals in Annex V (subject to an export ban).

What does PIC apply to?

Currently, 977 chemicals all subject to an export notification: export cannot take place before the receiving country has been notified.

Is divided into three parts.

What is in Annex I?

PART 1 chemicalsSubject to an export notification

161 entries covering 136 substances and 26 groups

PART 2 chemicalsSubject to an export notification AND and explicit consent from the importing country.

79 entries, e.g. nicotine

PART 3 chemicalsSubject to an export notification AND the rules of the Rotterdam Convention.

Chemicals formally listed in the Rotterdam Convention

43 entries, e.g. ethylene oxide

New regulation is adapted to the CLP Regulation.

Operational responsibility shifts from the European Commission to ECHA.

Fixed timelines for different actors.

REACH Enforcement Forum to coordinate enforcement.

What changes with the recast?

35 days before export is due to take place: Exporters must notify the designated national authority in which they are established.

25 days: Designated national authorities have to finalise the compliance check and send the notification to ECHA.

15 days: ECHA sends the notification to the national authority in the receiving country.

What are the timelines?

What are the main differences between the Rotterdam Convention and PIC?

Rotterdam Convention

International convention. Exchange of information only between countries that have ratified.

Lists a limited number of chemicals (43) many of which are no longer actively traded.

Chemicals are associated with a specific use, which restricts the number of exports falling under the rules of the Convention.

PIC

Exports from the EU are notified to all countries in the world regardless of whether the country has ratified the Convention.

Expands the list of chemicals subject to regulatory obligations to include substances that are traded on a daily basis.

Focuses on the exported chemical, not on its intended use.

Infograph on the PIC Regulation.

With each export notification, ECHA provides the receiving country with a regulatory information package that includes the safety data sheets in the local language, information as to why these chemicals are not in use in the EU anymore and, if available, names of safer alterna-tives. “We are not just asking ‘do you agree to this export – yes or no’. The receiving country has a choice and can make an informed decision,” Ms Macchi emphasises, and continues,

“A lot happens to the side of PIC activities. The EU plays an impor-tant role in awareness-raising with third countries about the chemicals exported, replying to their questions, organising workshops and assisting underdeveloped countries to im-prove their controls and risk assess-ment. We assist in building working relations that may even lead to joint projects on chemical safety.”

20

news from echa

“The aim is to help industry to comply with the legal requirements, support the national authorities in their work and to improve the quality of translated material,” says Nerija Jukniute, ECHA’s translation coordinator.

The tool, launched in 2009, is de-signed specifically to the needs of ECHA’s stakeholders. “We wanted to go beyond the basic legal terms. The database has, for example, all the CLP pictograms and the hazard and precautionary statements that can be used when creating the safety data sheets in the national language,” Ms Jukniute says. All terms or selected lists can also be exported to an Excel file in one or many languages.

MULTIPLE SEARCH OPTIONS

Searches on the database can be done by a term, EC or CAS numbers, GHS (Globally Harmonised System) codes or by hazard and precaution-ary statements. “Or then you can browse the terms in an alphabetical order,” Ms Jukniute mentions.

As a result, the tool not only shows the translation, definition and the possible acronym used, but also a reference to the legal text or other documentation where the term occurs. In this way, the database guides its users to more in-depth information.

“To be able to get an explanation of the meaning of the term can be of benefit for example to those users who are not yet familiar with all concepts of the different legislation. Small and medium sized enterprises just getting to know

REACH, CLP or biocides could well find ECHA-term helpful.”

There is a possibility to comment each existing entry by clicking the feedback button. “If you think a term is inaccurate in your language, we encourage you to inform us. We will then reanalyse these terms and potentially revise the term,” Ms Jukniute points out. Feedback on the whole database can be sent by clicking Contact us on the bottom of the web page.

AROUND 3 200 MONTHLY VISITS

The biggest user group of the tool is industry, according to the user survey conducted in 2012. Next come translators and member state authorities. “We have around 3 200 online visits per month and 300 search queries every day. Most active users come from Germany, Luxembourg, Finland and France,” Ms Jukniute mentions. There is no registration needed to use the data-base and it is free of charge.

MORE TERMS COMING

Around 100 terms are added to the database every year. The proposals for additions are done by ECHA’s scientific units and sent for transla-tion in the Translation Centre for

the Bodies of the European Union (CdT). “We are currently working on identifying new biocides terms. In the beginning of 2014, we will add 50 more terms to the database,” Nerija Jukniute concludes.

USER PERSPECTIVE: “HELPS IN GETTING TO KNOW THE TERMINOLOGY”

Lina Dunauskiene from the Lithu-anian Environmental Protection Agency has been involved in developing ECHA-term from the beginning. She thinks the user-friendliness of the search is very good compared to other similar products, but would appreciate more terms included. “We used the database very much when we were validating the Lithuanian transla-tions of the technical guidance documents for REACH. It was very useful to have the exact terms available as they are in the regula-tion,” she says.

Beata Volujevič from the Lithu-anian REACH and CLP Helpdesk has reviewed all the Lithuanian terms in the database. “I’ve used it now for two years. Sometimes, I use it in replying to industry enquiries: I go to the English version of the regula-tion because it is clearer to me and simply translate the response in Lithuanian. For that, ECHA-term is my place to go to,” she says.

Both Ms Dunauskiene and Ms Volujevič say that in their work-place of 15 staff, ECHA-term is used regularly. “We use it in our daily work. As for other stakehold-ers, small companies and people just starting to work with the legislation could really benefit from what the database has to offer. It can help you get familiar with the terminology,” Ms Dunauskiene says. Ms Volujevič agrees and adds, ”The search results point you to the specific Articles of the regulation,

Lost in translation? Go to ECHA-termThe ECHA-term database has 1 200 terms related to REACH, CLP and the biocides regulation in 23 languages. Users can look for terminology used in the legislation in their own language and even learn what the terms mean.

INTERVIEWS BY HANNA-KAISA TORKKELI

Nerija Jukniute from ECHA says that on average 100 terms are added to ECHA-term every year.

© ECHA

21

news from echa

Beata Volujevič and Lina Dunauskiene think that small companies and people only just starting to work with the legislation could really benefit from what the database has to offer.

The database is a source of reliable, coherent and up-to-date multilingual terminology in the chemicals field.

No registration, anyone can use it.

Free of charge.

It has terminology from• REACH Regulation• CLP Regulation (terms, hazard and precautionary state-

ments)• Biocidal Products Regulation• ECHA Guidance documents (terms and descriptors)• CLP hazard pictograms• Substances of very high concern

ECHA-TERMwhere the term appears. This is one way of getting more information about a certain topic.”

The main advantage of ECHA-term is getting unified terminology for all translations, according to Ms Dunauskiene. “The database certainly improves the coherency of translations and gives meaning to different terms. Therefore, it is very important to get more terms in.”

Further information:

ECHA-termhttp://echa.cdt.europa.eu/

ECHA-term leaflet: Overview of the REACH and CLP terminology database that supports you in 23 EU languages andECHA-term Quick Guide: All you need to know to use ECHA-termhttp://echa.cdt.europa.eu/doc.jsp

© ECHA

22

stakeholders / international

© ECHA

Brazil interested in learning from ECHA’s experiences TEXT BY PETTERI MÄKELÄ

Brazil is among the largest global economies and chemical industries in the world. In 2012, Brazil was the eighth most important trade partner to the European Union and chemicals were among the top trade categories. Knowing the different aspects of chemical legislation in Europe is therefore vital for the Brazilian authorities and industry.

In spring this year, two delegations from Brazil visited ECHA to learn about the Classification, Labelling and Packaging (CLP) Regulation, the Globally Harmonised System (GHS) and the REACH Regulation.

Rogerio de Oliveira Corrêa of the Brazilian National Institute of Me-trology, Quality and Technology and Cayssa Peres Marcondes of the Ministry of Environment spoke to ECHA Newsletter about the major challenges for chemicals manage-ment in Brazil.

“The main challenge is that Brazil has not yet established a regula-tory instrument for chemicals management at federal level. We have legislation that covers some applications and specific uses, such as pesticides, disinfectants, food additives and cosmetics, but the assessment and control of a wide range of substances, mainly the chemicals used for industrial purposes, are not covered by any national regulation,” says Ms Mar-condes.

Mr Corrêa points out that there are challenges both for industry and

the government. “Industry likes to work in an environment that allows flexibility and therefore companies are concerned about the detailed nature of GHS that is planned to be carried out for substances by 2015 and mixtures by 2023. On the other hand, government bodies are wor-ried about the additional work that the change to the new legislation will generate,” he says.

Both Ms Marcondes and Mr Corrêa feel that the implementation of GHS is important for Brazil.

Firstly, it gives companies a modern system for the classification and labelling of chemicals – currently there is no classification and label-ling legislation in Brazil – that will help in the importing and exporting of goods. Secondly, it will protect human health by improving the com-munication of safety information to workers and consumers.

Delegation from the National Institute of Metrology, Quality and Technology. From the left: Rogerio de Oliveira Corrêa, Luciene Bot-tentuit, Lopez Balottin, José Mauro Granjeiro and Eduardo Trajano Gadret.

Delegation from the Ministry of Environment. From the left: Karina Cham, Cayssa Peres Marcondes and Marília Passos Torres. ECHA's Rafal Brykowski on the right.

23

stakeholders / international

The Globally Harmonised System of classification and labelling of chemicals provides a basis for uniform physical, environmental, health and safety information on hazardous chemicals on a global level through the harmonisation of the classification criteria, labelling rules and guid-ance on the preparation of safety data sheets. The GHS is developed and maintained by the United Nations.

In Brazil, the GHS should apply for substances by 2015 and for mixtures by 2023.

In the EU, the CLP Regulation that introduced GHS in the EU legislation has been applied since 2009. The deadline for substance classification was 1 December 2010 and for mixtures, it is 1 June 2015. Old pictograms can still be seen on the market in parallel with the new ones until 1 June 2017.

CLP Regulation on ECHA’s website:http:// echa.europa.eu/regulations/clp

United Nations Economic Commission for Europehttp://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

DID YOU KNOW?

Independent since 1822

201 million inhabitants

Main industries: textiles, shoes, chemicals, cement, lumber, iron ore, tin, steel, aicraft, motor vehicles and parts, other machinery and equipment

Has one of the world’s largest chemical industries

Brazilian chemicals industry segments:

Industrial chemicals Pharmaceuticals Fertilisers Perfumes and cosmetics Soaps and detergents Crop protection Paints and varnishes Fibres

Source: The World Factbookhttps://www.cia.gov/library/publications/the-world-factbook/

BRAZIL IN A NUTSHELL

The visits to ECHA provided the Brazilians with a wealth of infor-mation on the status of CLP and REACH implementation in Europe.

“We now understand better indus-try’s concerns in relation to the legislation,” Mr Corrêa says, and continues, “This knowledge will help us to assist Brazilian companies that want to enter the European market.”

“The European experience on chemicals management is valuable when designing a system for Brazil. We will keep these lessons in mind when we select relevant elements for the Brazilian chemicals manage-ment,” Ms Marcondes concludes.

24

The ECHA Newsletter readers want to read stories about communication in the supply chain, authorisation and restriction of chemicals, and classification and labelling.

Over 60% of the respondents to our recent news read-ership survey indicate that they want the Newsletter to have more stories for downstream users (66%), on authorisation and restriction (64%), and classification and labelling (62%). Practical examples from industry (85%) and best practice, top tips from ECHA (79%) were the most popular story types – mentioned by almost 1 000 respondents.

“We have increased the content related to downstream users of chemicals and will continue to do so in the future. We will also encourage industry to present their own best practice through the Newsletter. In 2014, we will be writing more about the developments concern-ing the roadmap for substances of very high concern, substitution and the upcoming CLP classification deadline for mixtures in 2015. The challenges for small and medium-sized enterprises concerning chemicals and the biocides legislation will also get more coverage,” says Lindsay Jackson, Head of Unit for ECHA’s Commu-nications.

78% of you were either very satisfied or satisfied with the online format, launched in December 2012. “This is an encouraging result. However, many people still like the PDF version, which is also readily available. We plan to keep it this way,” Ms Jackson points out.

E-NEWS TO PROVIDE EASIER ACCESS TO CHEMICAL LISTS AND NEW CONSULTATIONS

The weekly e-News is well appreciated by our readers. Over 85% of the respondents either agree or strongly agree that the e-News content is reliable and that it is an efficient way of getting news from ECHA. Nearly 80% also think that the e-News is clear and up-to-date and that it helps them to better understand what ECHA is doing.

The respondents’ feedback concerning suggestions for improvement is categorised under the following:• Providing translations; easier format and layout;

clarity of language• Easier access to new additions on chemical lists

(e.g. Registry of Intentions, Candidate List) and new consultations; timely information about chemicals of concern.

Wanted: practical examples from industry“We will certainly pay attention the language we use in the e-News and are working on a simpler template that will be easier to read on mobile and tablet devices. As for translations, our main focus is the website: to keep that up-to-date in 23 languages,” Ms Jackson says, and contin-ues, “We will also try to find a better way to communicate the new substance additions to the chemical lists in the e-News and inform our subscribers in timely manner about the Candidate List updates.”

THE FOLLOWING Q&A will bring clarity on some of the comments provided through the survey.

Q: I like the PDF version of the ECHA Newsletter. Is that still available?

A: Yes, the PDF is still there for each issue. You can access it from the left hand side column, under the issue content listing. There is a PDF icon and the link says ‘Print this issue as PDF’.

Q: I would like to see the new consultations in the e-News. How do I know when a new consultation is launched?

A: When a new consultation is launched, we lift it in the e-News as one of the main news items. The on-going consultations are listed at the bottom of the e-News. All consultations are also added to the homepage of the ECHA website when launched under the heading Public Consultations, which now also indicate the start date.

Q: If I cannot access the e-News from my email, where can I find it?

A: All the e-News are also available online in the e-News archive: http://echa.europa.eu/news-and-events/e-news-archive.

stakeholders

TEXT BY HANNA-KAISA TORKKELI

The annual news readership survey covered both the weekly e-News and the bi-monthly ECHA Newsletter. It was sent out as an email to subscribers on 19 September, and closed on 10 October 2013. Altogether, 1 305 re-sponses were received, which is over 1 000 more respondents than in 2012.

We would like to thank all respondents for their time and effort. You can send addition-al feedback at any time to: echanewsletter@echa.europa.eu.