REACH Regulation Basic requirements 1
REACH Regulation Basic requirements
Semira Hajrlahović Mehić, LL.M., B. Sc.Tatjana Humar-Jurič, M.Sc.
REACH Regulation Basic requirements 2
Content Background/Objectives/Scope REACH Core elements ECHA Conclusions Good to know
REACH Regulation Basic requirements 3
Background
Negotiations Before and after proposal
of October 2003 13.12. 2005: political
agreement End 2006: European
Parliament and Council agreement
Regulation 1907/2006
Content of REACH A whole lot… Very complex… REACH replaces > 60
directives and regulations
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REACH Regulation
REGULATION (EC) No. 1907/2006 of the European Parliamenet and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
REACH Registration Evaluation Authorisation of CHemicals
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Some starting pointsDifferent chemical policies for: Existing Substances
100,106 substances; 99% of market volume; Risk assessments for ± 140; Focus on > 1,000 tpa
New Substances ca. 3,000 substances;
Notification from > 10 kg pa
Furthermore Many existing substances not risk
assessed
Call for reducing animal tests Differences not good for internal market
not good for man and the environment
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REACH in a bookshelf
I II III IV V VI
VII
VIII
II III IV V VI
VII
VIIIAnnexes:
Titles:
IX XI
XII
XIII
XIV XV
XV
I
IX X XI
XII
XIII
I
XIV XV
X
XV
II
Technical guidance……….
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Who are the players? Manufacturer (M) Importer (I) Downstream user (DU) Agency European Commission Member States
Policy level Execution level
Inspection / Enforcement Third parties
ECHA (Helsinki) Central role Facilitating Executive Partly paid through fees
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REACH “logic”
One single and coherent system for: New and existing substances Hazardous and non hazardous substances
Shift of responsibilities: public authorities industry
No data, no market
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REACH Objectives
Protection of the human health and the environment
Promotion of alternative methods Free circulation on the internal market Enhancing competitiveness and innovation
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REACH Core elements
Registration of substances ≥ 1 tonne/yr (staggered deadlines)
Information in the supply chain Evaluation of some substances by Member
States/ECHA Authorisation only for substances of very high
concern Restrictions - the safety net Agency (ECHA) to manage system
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REACH.Registration, Evaluation, Authorisation and restriction
of CHemicals
RestrictionsAuthorisationEvaluationRegistration
CMR & PBT & equivalent concern
Substances of concern
> 10 tonnes/yr
+ substances of concern
> 1 tonne/yr
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REACH Focus
Prioritieshigh volumes (as a proxy for potential risk)greatest concern (substances & uses
with highest risk)
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No data, no market
Article 5“ Subject to Articles 6, 7, 21 and 23,
substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required”
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Title II: Registration
Manufacturers/Importers Registration for substances ≥ 1 tonne per
year Chemical Safety Report (CSR) for all
substances ≥ 10 t per year
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Scope of the Regulation
REACH applies to the manufacturing, import, placing on the market and use of substances On their own, in preparations, in articles
Exemptions for certain: Substances Uses of substances
Reduced obligations R&D, polymers and intermediates
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Registration Aim
Manufacturers and importers obtain information on their substances
Use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle
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What is Registration
Submission of Dossier (Documentation) In case of absence of available
information, tests may be conducted Data sharing (in particular for vertebrate
tests) Substance Information Exchange Fora
(SIEFs)
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What is Registration
Registration Dossier = Documentation Technical Dossier:
starting at 1 tonnes per year IUCLID 5
Chemical Safety Report: starting at 10 tonnes per year
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Who has to register?
Manufacturers of substances and producers of articles with intended release:
Each legal entity must register separately May appoint Third Party Representative
Importers Non-EU manufacturer may appoint Only Representative
instead In such cases, Only Representatives is liable for
registration and importer is considered as downstream user
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Registration Exceptions
PPORD (notification still needed) for 5 years plus 5 or 10 (medicines) years
Pesticides (and co-formulants) Active ingredients of biocidal products Reduced registration for some (on-site and transported)
intermediates Joint submission of data (OSOR)
Mandatory sharing of data
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Reach time table
phase-in substances → pre-registration (finished 1.12.2008)
CMR cat. 1,2 > 1 t/y (1.12. 2010) R50-53 subst. > 100 t/y (1.12. 2010) EINECS subst. > 1000 t/y (1.12. 2010) EINECS subst. > 100 t/y (1.06. 2013) EINECS subst. > 1 t/y (1.06. 2018) Obligation to register →since 1. 06 2008. Prolongation only for pre-registered substances
.
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Reach time table
Non phase-in substances
1.06.2007 1.06.
2008
1.12.2008
30.11.2010
31.05.2013
31.05.2018
100-1000 tonnes
1-100 tonnes
RE
AC
H e
ntry
into
forc
e
> 1000 tonnesCMRs ( > 1 tonne)Very toxsic to aquatic organisms (R50/53) (> 100 tonnes)
Pre
-reg
istra
tion
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Substances in Articles (Article 7)
Substance intended to be released (regardless of hazard)
> 1 tonne / year per
Manufacturer / Importer (Not
registered for that use)
General obligation to Register
Substance of Very High Concern (CMRs, PBTs and vPvBs.)
Placed on candidate list for authorisation
Concentration of > 0.1 % weight-by-weight
Obligation to notify the Agency
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Title IIITitle III: : Data SharingData Sharing Pre-SIEFPre-SIEF formationformation
Industry pre-registersIndustry pre-registers ECHAECHA makes contact details available on restricted website makes contact details available on restricted website
SIEFSIEF FormationFormation Process led by industryProcess led by industry
Data sharingData sharing Process led by industryProcess led by industry
Joint submissionJoint submission Industry registersIndustry registers Data sent to evaluation (Data sent to evaluation (ECHECHA, MS)A, MS)
Both data sharing and joint submission are obligatory!Both data sharing and joint submission are obligatory!
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Joint submissionJoint submission ObligatoryObligatory joint submission joint submission::
information on the hazard properties of the substanceinformation on the hazard properties of the substance classification and labellingclassification and labelling
Voluntary Voluntary joint submissionjoint submission::
Chemical Safety Report (CSR) (for substances >10 t/a)Chemical Safety Report (CSR) (for substances >10 t/a)
Guidance on safe useGuidance on safe use
Individual Individual submissionsubmission:: Identity of manufacturer and substanceIdentity of manufacturer and substance
Identified usesIdentified uses Exposure information (for substances in 1-10t tonnage Exposure information (for substances in 1-10t tonnage
band)band)
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Title IV: Information in the supply chain
Supplier shall provide SDS to recipient, where:Substance is hazardous (1272/2008)Substance is PBT or vPvB
SDS shall contain relevant exposure scenario
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Title V: Downstream User Implement risk management measures communicated
to him via the Exposure Scenarios (SDS Annex) If he uses the chemical outside the conditions
described in the exposure scenario(s) Inform his supplier of this use to make it an
identified use Alternatively:
Conduct a safety assessment for his own use (and for his downstream uses if he is a supplier)
Implement ES from own safety assessment Report to the Agency
Communicate further down the supply chain if he is supplier
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Title VI: Evaluation
Objective To verify lack of adverse effects to human health and the
environment To prevent unnecessary use of animal tests
Two evaluations Dossier evaluation (including test proposals; initiated by registrant,
mandatory) Substance evaluation (initiated by Member State / Commission,
voluntarily)
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Title VI: Evaluation
Dossier Evaluation : ECHA Checking compliance of registration dossiers Checking of test proposals Priority to hazardous substances, CMR, resp.
sensitizers, PBT, vPvB Substance evaluation:
MSCA Checking whether there is a need for further
information on a substance
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Titles VII: Authorisation
To ensure good functioning of the internal market
While assuring that risks are properly controlled (substitution)
No placing on the market for substance on Annex XIV, unless it is authorised
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Titles VII: Authorisation
Only applies to Substances of Very High Concern, once included in Annex XIV: CMR (carcinogenic, mutagenic, toxic for reproduction) PBT/vPvB (persistent, bioaccumulative, toxic) substances of equivalent concern (endocrine disruptors,
others)
Identification of SVHC
Candidate list 15 substances is published http://
echa.europa.eu/chem_data/candidate_list_table_en.asp
)
Priority list for inclusion into Annex XIV
Inclusion in Annex XIV (comitology decision)
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SVHC:SVHC: Information RequirementsInformation Requirements Suppliers must provide sufficient information, Suppliers must provide sufficient information,
available to the supplier, to clients to allow the available to the supplier, to clients to allow the safe use of the article including, as a minimum, safe use of the article including, as a minimum, the name of that substance, if:the name of that substance, if:
They have been identified on the candidate listThey have been identified on the candidate list
The substance is present > 0.1% w/wThe substance is present > 0.1% w/w
On request by consumers, suppliers must provide the On request by consumers, suppliers must provide the consumers with the above information within 45 daysconsumers with the above information within 45 days
Obligation starts immediately afterObligation starts immediately after substance was put on substance was put on the candidate list!the candidate list!
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Title VIII:Restriction
Only minor changes compared to existing
system (Directive 76/769/EEC)
In addition to “marketing & use”, now also
manufacturing covered
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Annex XIV substances CMR, PBT, vPvB,
‘equivalent concern’
Authorisation(also on Annex XIV)
Restriction(Annex XVII)
Applicationby M, I, or DU for limited time
and scopeon basis of CSR,SEA may be used
Application by COM or Member State
on basis of CSR and SEA
Titles VII & VIII Authorisation and Restriction
Substances of Very High Concern
Formal procedure
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Title XI: Classification & Labelling Inventory
REACH does NOT include CRITERIA for C&L!!!
It refers to:
Substance Classification Directive 67/548/EEC
Preparation Classification Directive 1999/45/EC
These references are adapted CLP Reg. 1272/2008
But has links to C&L
Registration
Information in the supply chain
C&L Inventory – Title XI; moved to CLP Title V
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C’RA
EnforcementAuthorities
CompetentAuthorities
Member States
Forum
Agency
DGENT
DGENV
DGEMP
DG?? Management Board C’SEA
MS Committee
StandingCommittee
Nationalrepresentative
Experts
Secretariat
Manufacturers
Importers
Downstream users
IndustryCommission
Council Title X : ECHA
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ECHA ECHA today:
300 staffStarted to manage the
registration and evaluationFirst steps in authorisationGuidance / IT toolsHelpdesk(s)Committees + Forum establishedStakeholder involvement + consultations started
ECHA in future:Up to 450 staffWill have an important role
in authorisation and restriction
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Title XIV: Enforcement
Agency hosts Forum for coordinating activities There must be legal basis to sanction non-compliance Penalties must be effective, proportionate and
dissuasive A frequent report should be issued by each MS
Enforcement is national engagement, working on the basis of national legislation!
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REACH Annexes ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND
PREPARING CHEMICAL SAFETY REPORTS ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES
BETWEEN 1 AND 10 TONNES ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN
ACCORDANCE WITH ARTICLE 2(7)(a) ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN
ACCORDANCE WITH ARTICLE 2(7)(b) ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES
MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE
ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE
ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE
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REACH Annexes ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES
MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE
ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS ANNEX XVI SOCIO-ECONOMIC ANALYSIS ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE
MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES
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Conclusions
Players Shift in responsibility, while authorities keep some ECHA is important
Replacing animal tests
Good: reduce of costs and number of test animals
For major endpoint (# of test animals and costs) no
alternatives (yet)
Lots of validation and guidance needed
Sharing of test results (SIEF) does reduce # and $
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Conclusions Exposure scenarios Could potentially lead to thousands of exposure scenarios
per substance… Much more exposure assessors need to be involved
Evaluation Requires different mindset Resources for evaluation dependent on higher
management (within authorities, industry and Commission)
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Conclusions C&L Fast, transparent, open to the public Question how harmonisation between registrants will proceed Role enforcement?
Authorisation & Restriction Good procedures:
1st Annex XV 2nd Authorisation [Annex XIV] or Restriction [Annex XVII]
Authorisations Could become very complex Procedure could take a long time
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Conclusions
Enforcement / Inspection Success REACH depends on resources (quantity and
quality) at Enforcement
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Where to turn for help?
1. Check the legislation (available in all EU languages)
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML
2. Check the Guidance website http://guidance.echa.europa.eu
3. Check the Frequently Asked Questions on the ECHA website http://echa.europa.eu/reach/faq_en.asp
4. Talk to colleagues, business associations, industry helpdesks
5. Contact national helpdesk (addresses can be found on http://echa.europa.eu/reach/helpdesk/nationalhelp_en.asp )
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Further Information
http://echa.europa.eu
http://ec.europa.eu/enterprise/reach/index_en.htm
http://ec.europa.eu/comm/environment/chemicals/reach.htm
http://ecb.jrc.it/REACH/
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