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Understanding REACH: Implementing the Environmental Acquis

Learn about REACH - a system for chemical regulation focusing on human health, environment, and market competitiveness. Discover registration, evaluation, authorization, and restrictions, promoting sustainable development and transparency.

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Understanding REACH: Implementing the Environmental Acquis

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  1. 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 Training REACH AT THE EDGE OF THE SECOND READING Karel Bláha Department of Environmental Risks

  2. What is REACH ? • Introduction, current state of art • Workplan in 2006 SCOPE OF THE PRESENTATION

  3. 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) What is REACH? A Tiered Approach

  4. 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 OBJECTIVES OF REACH Substitution and precaution underpin system

  5. 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) REGISTRATION: GENERAL

  6. 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 CHEMICAL SAFETY ASSESSMENT

  7. 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) DATA SHARING

  8. EVALUATION: AGENCY DOSSIER EVALUATION SUBSTANCE EVALUATION Check test proposals Compliance Examine any information on a substance • Output: • Further information decisions • Info to other parts of REACH/other legislation

  9. 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) AUTHORISATION (1)

  10. 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) AUTHORISATION (2)

  11. MS or COM initiated (Annex XIV dossier) • Community wide concern • Agency Committees examine: • the risk, and • the socio-economic aspects involved • 3rd part comments • Consumer use CMR substances - fast track possible. • Commission - final decision through comitology • Carry-over of existing restrictions (76/769/EEC) RESTRICTIONS Safety net

  12. 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 Agency

  13. Pre-registration and phase-in Notification of SVHCs in SIA Agency start up Pre-registration • 1000+ tonnes • CMRs 1+ tonne • PBTs/vPvBs (R50-53) • 100+ tonnes 100-1000 tonnes 1-100 tonnes Non-phase-in substances [6 months] EIF 12 months 3 years 6 years 11 years 18 months

  14. Feb 2001White Paper published • May 2003Internet consultation launched: 6000+ comments received • Aug/Sep 2003Proposals substantially amended as result of comments • 29 Oct 2003Draft REACH regulation adopted by Commission • 20 Nov 2003Ad-hoc Working Party established REACH – brief history

  15. Council Conclusions Parliament’s Opinion Feb. 2001 1999 - Feb 2001 Stakeholder Consultation April –Nov. 2001 2 April 2001 Council Common Position 2005/6 Parliament’s 2nd Reading 2006 Parliament’s 1st Reading NOV 2005 Legislative Proposals October 2003 Final Legislative Acts New Chemical Policy in Force:2007? Proposal DG ENV DG ENT April 2003 EU Chemicals Policy Review Co-decision process & timing Interservice Process Commission Development of the White Paper Internet Consultation May-July 2003 White Paper Proposal DG ENV DG ENT September 2003 Opinion Commission Interservice Process Commission Conciliation Directly applicable in Member States

  16. REACH Voting Calendar

  17. 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. Council - AT Presidency 2006 • Council AHWP Meetings • 13-14FEB: Recitals Consolidated text of the Regulation document 15921/05 REV 1 (March 9, 2006) • 16MAY: Technical amendments • 27 JUNE: Common position adopted by the Council

  19. 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. Council - FI Presidency 2006 • Council AHWP Meetings • 3-4JULY: 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 !

  21. 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. European Commission Working Groupon 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 MAY Preparations for the Agency establishment

  23. European Parliament 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

  24. European Parliament • WHAT CAN HAPPEN on Nov 16 or Dec 14?? • EPapproves the Common Position – • proposal adopted • 2.EP approves the amendments to the Common Position – proposal goes back to the Council CONCILIATION STARTS (6 WEEKS)

  25. CONCILIATION • WHAT CAN HAPPEN within 6 weeks ?? • 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 COUNCILand EP

  26. END OF THE GAME • 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

  27. Thank you for your attention !karel_blaha@env.cz

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