1. REACH European Chemicals Policy Experts Tour USA, 20-28 October 2003 Robert Donkers, Delegation of the European Commission to the U.S.

2. The Current EU Chemicals Policy Problems • 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 Burden of the Past

3. Solution: A New EU Chemicals Policy Objectives • 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 Guiding Principles - substitution and precaution

4. 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 2001 - Mar 2002): • Technical consultation (Working Groups), Studies • Drafting stage (Mar 2002 - 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)

5. REACH One System • 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. A Tiered Approach

6. Information through the supply chain Improve risk management • 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

7. Registration (1) Ensure industry adequately manages the risk from its substances • 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

8. Registration (2): DeadlinesA Phased Approach 1 - 10 t 100 - 1000 t >1000 t + CMR 10 - 100t Yr 0 Yr 0 +3 Yr 0 + 6 Yr 0 + 11

9. Data sharing Avoidance of unnecessary animal testing + save costs • 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).

10. Evaluation Confidence that industry is meeting obligations Prevent unnecessary testing • 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

11. 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

12. Authorisation Control uses of very high concern substances • 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

13. Restrictions Safety net • 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)

14. 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

15. Who does what?

16. 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

17. 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

18. 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

19. Costs • Impact Assessment: • Direct costs: €2 billion(range €1.6 - 2.9 billion). • less than 0.1 % of yearly turnover over 11 years • Agency: one off cost €0.4 billion • Indirect costs (downstream users): €2.8 - 3.6 billion • 60 % of direct costs from testing • An indication of the amount of information industry has about its chemicals? • The knowledge gap REACH is designed to fill

20. 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

21. 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

22. 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. REACH = large-scale information collection, = large-scale testing.

23. 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: 2003-2006?

24. Conclusion - REACH will ensure: Benefits significantly outweigh costs • 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