European Commission REACH European Chemicals Policy Experts Tour USA, October 2003 Robert Donkers, Delegation of the European Commission to the U.S.

European Commission, DG Environment Unit C.3: ChemicalsProblems Burden of the Past The Current EU Chemicals Policy  Existing substances can be used without testing  Burden of proof on public authorities  No efficient instrument to deal with problematic substances  Lack of incentives for innovation, in particular of less hazardous substitutes

European Commission, DG Environment Unit C.3: ChemicalsObjectives Guiding Principles - substitution and precaution Solution: A New EU Chemicals Policy  Sustainable Development  Protection of human health and the environment  Maintain/enhance innovation/competitiveness  Maintain the Internal Market  Increased transparency and consumer awareness  Integration with international efforts  Promotion of non-animal testing

European Commission, DG Environment Unit C.3: Chemicals Development of the new legislation: REACH  White Paper (Feb 2001)  Reactions: Council (Jun 2001) and Parliament (Oct 2001)  Reactions: stakeholders - very varied  Fact-finding (Sep Mar 2002):  Technical consultation (Working Groups), Studies  Drafting stage (Mar May 2003)  Internet Consultation (15 May 2003 to 10 July 2003)  6400 consultation responses  Review of replies & re-drafting (Jul - Aug 2003)  2nd inter-service consultation (Sept - Oct 2003)

European Commission, DG Environment Unit C.3: Chemicals One System A Tiered Approach REACH  Single, coherent system for new/existing chemicals  Elements:  Duty of Care for all manufacturers and importers  Registration of substances above 1 tonne  Evaluation by the Member States  Authorisation for substances of very high concern  Restrictions - the safety net  Agency to manage system  Focus on:  high volumes  greatest concern.

European Commission, DG Environment Unit C.3: Chemicals Information through the supply chain  What?  SDSs based on Chemical Safety Reports  Information on authorisations, restrictions, registration number etc.  Result?  more information on risks  downstream users brought into the system  dialogue up/down the supply chain- encouraged/stimulated Improve risk management

European Commission, DG Environment Unit C.3: Chemicals Ensure industry adequately manages the risk from its substances Registration (1)  Method:  manufacturer/importer obtains adequate data  > 10 tonnes/year: performs chemicals safety reports (inc RRM)  Electronic submission to authorities (enforcement, transparency)  Info in central, largely public, database.  Substances produced/imported > 1 tonne/year  Information requirements increase according to tonnage  > 100 tonnes/year: testing proposals  Reduced requirements - Intermediates  Deadlines for phase in substances No formal acceptance necessary - industry retain responsibility

European Commission, DG Environment Unit C.3: Chemicals Yr 0Yr 0 +3Yr 0 + 6Yr >1000 t + CMR t t t Registration (2): Deadlines A Phased Approach

European Commission, DG Environment Unit C.3: Chemicals Data sharing  Non-phase-in substances (= new):  potential registrant checks if already registered  CA responds:  previous registration older than 10 years: give data  previous registration less than 10 years: enable contact with previous registrant  Phase-in substances (= existing):  potential registrants (before deadline) submit lists of available data  all potential registrants = a ‘SIEF’ (Substance Info Exchange Forum)  internal communication in SIEF:  If a study is not available, participants agree who performs it;  If a study is available, participants agree on sharing cost and performing study;  Sharing mandatory, if company refuse => sanctions (but testing allowed). Avoidance of unnecessary animal testing + save costs

European Commission, DG Environment Unit C.3: Chemicals Confidence that industry is meeting obligations Prevent unnecessary testing Evaluation  Dossier evaluation: Competent authorities review certain registrations  check testing proposals  CAs assess test proposals (allocation criterion)  CAs prepare draft decisions requiring tests  Decision  check compliance with registration requirements  Substance evaluation  CAs look at any information on a substance (allocation criterion)  CAs may require further information on suspected hazardous properties  CAs prepare draft decisions (deadlines and agreement procedure)  Decision

European Commission, DG Environment Unit C.3: Chemicals Agency  Development of ‘central entity’.  Feasibility study - Agency advantages:  better long term continuity  financial (fees, staff)  consistent with Governance WP (role of COM)  Structure:  Committees - RA, SE, MS  Forum for exchange of info on enforcement  Secretariat  Management Board  Executive Director

European Commission, DG Environment Unit C.3: Chemicals Control uses of very high concern substances Authorisation  Substances (+ in preps + in articles)  Very high concern: CMR, PBT, vPvB, ‘equivalent concern’  Authorisation of use or several uses  may include a review period.  some uses or categories of use may be exempted  Prioritised (progressively authorised as resources allow)  Application date and sunset date  Applicant to show:  adequate control of risks, or  social and economic benefits outweigh the risks - substitution considered  Commission takes final decision via comitology:  Letter of access/downstream user access

European Commission, DG Environment Unit C.3: Chemicals Safety net Restrictions  Community wide concern  Agency Committees examine:  the risk and  the socio-economic aspects involved  Commission - final decision through comitology  Carry-over of existing restrictions (76/769/EEC)

European Commission, DG Environment Unit C.3: Chemicals Substances in articles  Producers/importers of articles have obligation to register substances in them if :  substance present > 1 tonne per article type/year; and  intended to be released under normal use; and  substance has not already been registered for that use  Producers/importers notify substances in articles if:  substance present > 1 tonne per article type/year; and  likely to be released under normal use; and  substance has not already been registered for that use, and  release may affect human health or the environment  Agency may request registration on basis of notification

European Commission, DG Environment Unit C.3: Chemicals Who does what?

European Commission, DG Environment Unit C.3: Chemicals C and L Inventory  Inventory:  managed by Agency  contains C and L info for all marketed substances:  no tonnage limit  industry co-operate to resolve differences in C&L  EU harmonisation:  CMRs  respiratory sensitisers

European Commission, DG Environment Unit C.3: Chemicals Downstream Users (DU)  Manufacturer/importer registration to cover all uses identified by downstream users  DU must  implement supplier’s RRM for identified uses  perform chemical safety assessments for unidentified uses  inform Agency of unidentified uses > 1 tonne  DU need to:  enter into dialogue with their suppliers  consider consortia building and/or cost sharing  DU may need to apply for authorisation

European Commission, DG Environment Unit C.3: Chemicals Stakeholder concerns raised  High costs  Increased animal testing  Impact on downstream users  Production moving outside the EU  EU industry disadvantaged internationally  Loss of marketed substances

European Commission, DG Environment Unit C.3: Chemicals The knowledge gap REACH is designed to fill Costs  Impact Assessment:  Direct costs: €2 billion(range € billion).  less than 0.1 % of yearly turnover over 11 years  Agency: one off cost €0.4 billion  Indirect costs (downstream users): € billion  60 % of direct costs from testing  An indication of the amount of information industry has about its chemicals?

European Commission, DG Environment Unit C.3: Chemicals Benefits (1)  For new and existing substances, equivalent:  levels of protection  competitive advantages  (Existing: hazardous v New: non-hazardous)  > 30,000 existing substances investigated  Acute (and long-term) toxicity  Improved innovation  more R&D flexibility  no significant loss of protection  Testing: 1-10 tonnes generally in-vitro

European Commission, DG Environment Unit C.3: Chemicals Benefits (2)  Occupational Health:  increase the effectiveness of existing law esp. for DU  Public health:  substantial benefits  Difficult to assess financially but total health benefits estimated €50 billion (over 30 yrs).  Environmental benefits hard to express in cash terms  reduced pollution of air, water, soil, reduced pressure on biodiversity. Conclusion: benefits significant

European Commission, DG Environment Unit C.3: Chemicals REACH = large-scale information collection, = large-scale testing. Limit animal testing  Information requirements - smart/targeted:  exposure often taken into account.  not always necessarily to do new testing (eg (Q)SAR).  Low volume chemicals (1-10 tonnes/year):  as far as possible no animal testing.  Higher volume chemicals:  testing only if existing information/validated alternative methods not sufficient.  Testing programmes - decided by the competent authorities  Data sharing compulsory; fair cost sharing.

European Commission, DG Environment Unit C.3: Chemicals Timing  End Oct 2003: Adoption of proposals by Commission and start of co- decision procedure  Nov 2003: Submission proposal to EP and Council Decision making in EP and Council: ?

European Commission, DG Environment Unit C.3: Chemicals Benefits significantly outweigh costs Conclusion - REACH will ensure:  High level of protection  Burden of proof on those creating risks  Improved knowledge  Improved innovation  Substitution of dangerous substances  particularly through authorisation  Better:  use of resources  reaction to emerging risks  information for downstream users  consumer confidence