1. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Twinning Project RO2004/IB/EN-09 Implementation and enforcement of the environmental acquis at national level and coordination of the other 8 regional twinning projects TrainingREACH AT THE EDGE OF THE SECOND READING Karel Bláha Department of Environmental Risks

2. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 SCOPE OF THE PRESENTATION  What is REACH ?  Introduction, current state of art  Workplan in 2006

3. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 A Tiered Approach What is REACH?  Single, coherent system for new (non phase-in) and existing (phase–in) chemicals  Elements: Registration of substances ≥ 1 tonne/yr (staggered deadlines) Evaluation of some substances by Member States Authorisation only for substances of very high concern Restrictions - the safety net Agency to manage system  Focus on priorities: high volumes (early deadline) greatest concern (CMRs early)

4. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 S ubstitution and precaution underpin system OBJECTIVES OF REACH  Sustainable Development  Protection of human health and the environment  Maintain/enhance innovation/competitiveness  Maintain the internal market  Increase transparency and consumer awareness  Integration with international efforts  Promotion of non-animal testing  Conformity to WTO obligations

5. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 REGISTRATION: GENERAL  Scope substances produced/imported ≥ 1 tonne/year Isolated intermediates: reduced requirements. Exemptions e.g. PPORD, polymers  Tasks of the registrant (manufacturer/importer only): obtain adequate information (inc (Q)SAR and existing data) perform CSR for substances > 10 tonnes/year (prove safety of uses) send information to Agency by deadline (and to clients)  Joint submission encouraged (OSOR)

6. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 CHEMICAL SAFETY ASSESSMENT  Scope: Substances subject to registration > 10 t/year Preparations:for substances above certain concentration limits,  No health consideration needed for: cosmetic end uses food contact material end uses  Process description in Annex I:  Physicochemical and human health hazard assessment  Environmental hazard assessment  PBT and vPvB assessment  Exposure scenario generation

7. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 DATA SHARING  Information > 10 years – freely available  At registration – registrants indicate if share non-animal data  Non-phase-in substances: Agency enables contact with previous, or potential, registrants – share costs Studies involving vertebrate animals not repeated  Phase-in substances: Potential registrants of substance: ‘SIEF’ (Substance Info Exchange Forum) Share data (inc new tests) and costs; Sharing mandatory (vertebrate animals)

8. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 EVALUATION: AGENCY DOSSIER EVALUATION SUBSTANCE EVALUATION Check test proposals Compliance Output: Further information decisions Info to other parts of REACH/other legislation Examine any information on a substance

9. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 AUTHORISATION (1) Which substances require authorisation?  Substances of very high concern: CMR PBT, vPvB, ‘serious and irreversible effects’: identified on basis of Dossier prepared by Agency or MS (agreement procedure)  Recommendation on priority substances Agency recommendation PBT/vPvB; wide dispersive uses; high volumes  Inclusion into Annex XIII: Commission decision (comitology) application date and sunset date (18 months later)

10. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 AUTHORISATION (2) How to obtain authorisation?  Application to Agency Broad info on uses applied for is published (comments)  Agency Committees deliver opinions Risk Assessment Committee Socio-economic Analysis Committee Sent to applicant for comments which are taken into account for final opinion  Commission decision (comitology)

11. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Safety net RESTRICTIONS  MS or COM initiated (Annex XIV dossier)  Community wide concern  Agency Committees examine: the risk, and the socio-economic aspects involved 3 rd part comments  Consumer use CMR substances - fast track possible.  Commission - final decision through comitology  Carry-over of existing restrictions (76/769/EEC)

12. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Agency Composed of: Executive Director Management Board (25 nominated by Council; 3 nominated by Commission; 3 non-voting members from stakeholders) Committee for risk assessment (authorisations and restrictions) Committee for socio-economic analysis (authorisations and restrictions) Member State Committee (evaluation, C&L and identification of SVHC) Forum (enforcement) Technical and scientific Secretariat (registration, C&L, Agency decisions, management of committees) Board of Appeal

13. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Pre-registration and phase-in EIF12 months Pre-registration 3 years6 years11 years 1000+ tonnes CMRs 1+ tonne PBTs/vPvBs (R50-53) 100+ tonnes Agency start up 100-1000 tonnes1-100 tonnes [6 months] 18 months Notification of SVHCs in SIA Non-phase-in substances

14. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 REACH – brief history  Feb 2001 White Paper published  May 2003 Internet consultation launched: 6000+ comments received  Aug/Sep 2003 Proposals substantially amended as result of comments  29 Oct 2003 Draft REACH regulation adopted by Commission  20 Nov 2003 Ad-hoc Working Party established

15. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 EU Chemicals Policy Review Co-decision process & timing New Chemical Policy in Force: 2007? Opinion Commission Final Legislative Acts Conciliation Development of the White Paper 1999 - Feb 2001 White Paper Feb. 2001 Stakeholder Consultation 2 April 2001 Council Common Position 2005/6 Parliament’s 1st Reading NOV 2005 Parliament’s 2nd Reading 2006 Directly applicable in Member States Council Conclusions Parliament’s Opinion April –Nov. 2001 Legislative Proposals October 2003 Proposal DG ENV DG ENT April 2003 Internet Consultation May-July 2003 Proposal DG ENV DG ENT September 2003 Interservice Process Commission Interservice Process Commission

16. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 REACH Voting Calendar AM tabled CommentsConsiderati on of AM VotesPlenary ENVI1185All AM available Evaluation done Sacconi 15 SEP 4 OCT14/17 NOV ITRE1301All AM available Evaluation done Ek 30 AUG13 SEP IMCO895All AM available Evaluation done Nassauer 5 SEP13 SEP

17. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Council meetings - 2005 11 OCT: Competitiveness Council – Policy Debate 17 OCT: Environment Council – Policy Debate 13 DEC: Competitiveness Council – Extraordinary Meeting Political agreement achieved

18. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Council AHWP Meetings   13-14 FEB: Recitals Consolidated text of the Regulation document 15921/05 REV 1 (March 9, 2006)   16 MAY: Technical amendments   27 JUNE: Common position adopted by the Council Council - AT Presidency 2006

19. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 COMMON POSITITION 7524/06 COMPET 72 ENV 189 CHIMIE 12 CODEC 252 OC 224 (June 27, 2006) Common position adopted by the Council with a view to adopting a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants} and a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals

20. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Council AHWP Meetings   3-4 JULY: Discussion of EP amendments WD 31/06 (March 9, 2006)   17-18 JULY: Discussion of EP amendments continues   4 AHWP meetings scheduled in September Adoption of the Regulation in the second reading by the end of 2006 Finish should finish ! Council - FI Presidency 2006

21. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 WD 31/06 Rev 1 (June 22, 2006) The groups of amendments: - Duty of care - Animal testing - The Agency and the involvement of the European Parliament therein - Communication of Information - SMEs - Other amendments

22. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 European Commission Working Group on the Practical Preparations on REACH 11 OCT: CWG/15/2005 – Preparation for the European Chemicals Agency 25 OCT: AHWP Meeting – Cion presents WD 255/05 2 NOV:CZ sends the Letter of Commitment to Cion 28 NOV: CWG Meeting (London) back-to-back with the CA meeting 13 MAR: subgroup for REACH enforcement established 22 MAYPreparations for the Agency establishment

23. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006

24. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 ENVI   June 21: first exchange of views on amendments   June 30: Draft Recommendation published (inet) by Mr. Sacconi (out of 230 amds., 49 retabled) and taken by Presidency in WD 31/06   Oct. 10: Voting PLENARY   Sept. 6: Common Position to be delivered to the Chair 3 (+ 1) months for 2nd reading !!!   Nov. 16 or   Dec. 14: Voting European Parliament

25. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 WHAT CAN HAPPEN on Nov 16 or Dec 14?? 1. 1.EP approves the Common Position – proposal adopted 2. EP approves the amendments to the Common Position – proposal goes back to the Council CONCILIATION STARTS (6 WEEKS) European Parliament

26. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 WHAT CAN HAPPEN within 6 weeks ?? 1. 1.COUNCIL can by qualified majority revert the EP amendments, provided that Cion agrees (if it is not the case, COUNCIL must be unanimous) 2. If the step 1 fails, a Conciliation Committe must prepare the COMPROMISED TEXT 3. COMPROMISED TEXT submitted to COUNCIL and EP CONCILIATION

27. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 WHAT CAN HAPPEN ?? EITHER COUNCIL (by qualified majority) and EP (by absolute majority) approves the compromised text PROPOSAL ADOPTED OR Either COUNCIL or EP disagree PROPOSAL REJECTED END OF THE GAME END OF THE GAME

28. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006

29. Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects Component 1 - Activity 1.3 training in EU co-ordination 20 July 2006 Thank you for your attention ! karel_blaha@env.cz