European Commission REACH European Chemicals Policy Experts Tour

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

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

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

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

European Commission, DG Environment Unit C. 3: Chemicals REACH One System q Single, coherent system for new/existing chemicals q Elements: Ø Ø Ø 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 q Focus on: Ø high volumes Ø greatest concern. A Tiered Approach

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

European Commission, DG Environment Unit C. 3: Chemicals Registration (1) Ensure industry adequately manages the risk from its substances q Method: Ø Ø 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. q Substances produced/imported > 1 tonne/year Ø Information requirements increase according to tonnage Ø > 100 tonnes/year: testing proposals Ø Reduced requirements - Intermediates q Deadlines for phase in substances No formal acceptance necessary - industry retain responsibility

European Commission, DG Environment Unit C. 3: Chemicals Registration (2): Deadlines A Phased Approach 1 - 10 t >1000 t + CMR Yr 0 100 - 1000 t Yr 0 +3 Yr 0 + 6 10 - 100 t Yr 0 + 11

European Commission, DG Environment Unit C. 3: Chemicals Data sharing Avoidance of unnecessary animal testing + save costs q Non-phase-in substances (= new): Ø potential registrant checks if already registered Ø CA responds: previous registration older than 10 years: give data previous registration less than 10 years: enable contact with previous registrant q Phase-in substances (= existing): Ø potential registrants (before deadline) submit lists of available data Ø all potential registrants = a ‘SIEF’ (Substance Info Exchange Forum) Ø 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; Ø Sharing mandatory, if company refuse => sanctions (but testing allowed).

European Commission, DG Environment Unit C. 3: Chemicals Evaluation Confidence that industry is meeting obligations Prevent unnecessary testing q Dossier evaluation: Competent authorities review certain registrations Ø check testing proposals CAs assess test proposals (allocation criterion) CAs prepare draft decisions requiring tests Decision Ø check compliance with registration requirements q 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 q Development of ‘central entity’. q Feasibility study - Agency advantages: Ø better long term continuity Ø financial (fees, staff) Ø consistent with Governance WP (role of COM) q Structure: Ø Ø Ø Committees - RA, SE, MS Forum for exchange of info on enforcement Secretariat Management Board Executive Director

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

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

European Commission, DG Environment Unit C. 3: Chemicals Substances in articles q Producers/importers of articles have obligation to register substances in them if: Ø substance present > 1 tonne per article type/year; and Ø intended to be released under normal use; and Ø substance has not already been registered for that use q Producers/importers notify substances in articles if: Ø Ø Ø 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 q Inventory: Ø managed by Agency Ø contains C and L info for all marketed substances: no tonnage limit q industry co-operate to resolve differences in C&L q EU harmonisation: Ø CMRs Ø respiratory sensitisers

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

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

European Commission, DG Environment Unit C. 3: Chemicals Costs q Impact Assessment: Ø Direct costs: € 2 billion(range € 1. 6 - 2. 9 billion). less than 0. 1 % of yearly turnover 11 years Ø Agency: one off cost € 0. 4 billion Ø Indirect costs (downstream users): € 2. 8 - 3. 6 billion q 60 % of direct costs from testing Ø An indication of the amount of information industry has about its chemicals? The knowledge gap REACH is designed to fill

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

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

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

European Commission, DG Environment Unit C. 3: Chemicals Timing q End Oct 2003: Adoption of proposals by Commission and start of codecision procedure q Nov 2003: Submission proposal to EP and Council Decision making in EP and Council: 2003 -2006?

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