1. REACH: state of art and base definitions WERCS 2007 US User group Albany 27/06/2007 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

2. 2WERCS US Users group 2007 Erwin Annys REACH doesn’t come out of the blues New Substances Existing Substances 1965.......70.......75.......80.......85.......90.......95.......00.......03 Existing chemicals regulation Dir 67/548/EEC: Obligation to label dangerous substances Reg 793/93/EC: Risk Assessment existing substances Dir 79/831/EEC – 6th amendment Dir 92/32/EEC – 7th amendment Notification new substances List Existing Substances (before 1981) Safety Data Sheets White Paper Accepted commission

3. 3WERCS US Users group 2007 Erwin Annys Chronology Application de la nouvelle réglementation: 1 June 2007 Opinion Commission Processus internal Commission Discussion White book 1999 - Feb. 2001 Edition White book Feb. 2001 Consultation of Stakeholders 2 Avril 2001 Proposition DG Env. DG Entr. Begin 2003 1 st lecture Parliament Common Position of the Council Parlement 2de Lezing 2 nd reading Parliament 13 Dec 2006 Conclusions Council Ideas Parliament Avril – Nov. 2001 Proposal 29 Oct. 2003 Consultation Internet May 2003 17 Nov. 2005 13 Dec. 2005 12 June 2006 2 nd reading Council 18 Dec 2006

4. 4WERCS US Users group 2007 Erwin Annys REACH Registration Evaluation Authorisation and restriction of Chemical substances

5. 5WERCS US Users group 2007 Erwin Annys Substance – preparation - article

6. 6WERCS US Users group 2007 Erwin Annys REACH Registration Evaluation Authorisation Restriction Classification index Sharing data Info in supply chain Down stream use Responsibility industry Agency

7. 7WERCS US Users group 2007 Erwin Annys Registration Substances above 1 ton per year Not limited to bringing on the market Producing Importing Data in function of volume Timing in function of volume (and hazard) Sharing of data

8. 8WERCS US Users group 2007 Erwin Annys Registration No data, no market Inversement burden of proof-responsibility industry Substance and use Hence new communication in the supply chain Avoid testing on vertebrate animals

9. 9WERCS US Users group 2007 Erwin Annys What to register?

10. 10WERCS US Users group 2007 Erwin Annys > 1 ton Registration 0 1 2 3 4 5 6 7 8 9 10 11 >100 ton 01/06/07 01/12/10 01/06/13 01/06/18 01/06/0 8 01/12/0 8 >1000 ton CMR >1 ton N, R50-53 > 100 ton Pre-registration Non phase-in substances

11. 11WERCS US Users group 2007 Erwin Annys Registration Technical dossier Chemical safety report > 10 ton/year

12. 12WERCS US Users group 2007 Erwin Annys Evaluation Dossier evaluation Examination of testing proposals Agency examines proposal for testing, drafts decision and gives deadline Compliance check of registrations (min 5%) Information complies with requirements Adaptations of standard information requirements comply

13. 13WERCS US Users group 2007 Erwin Annys Evaluation Substance evaluation Criteria for substance evaluation Agency develops criteria for prioritising substances using a risk- based approach (hazard information, exposure and tonnage). Community rolling action plan Agency Inclusion in plan if grounds for considering risk –Structural ressemblance –Aggregated quantities of different suppliers Planning covers three year period

14. 14WERCS US Users group 2007 Erwin Annys Authorisation Substances of very high concern Carcinogenic cat 1 and 2 Mutagenic cat 1 and 2 Toxic for reproduction cat 1 and 2 Persistent, bioaccumulative and toxic (PBT) Very peristent and very bioaccumulative (vPvB) Endocrine disrupting substances, and substances of equivalent concern not fulfilling criteria of PBT and vPvB

15. 15WERCS US Users group 2007 Erwin Annys Authorisation MS or Agency makes Annex XV dossier Candidate list Inclusion in Annex XIV Application for authorisation Authorisatie granted or not Review of authorisations

16. 16WERCS US Users group 2007 Erwin Annys Restrictions General issues Safety net Takes over existing legislation (Directive 76/769/EEC)

17. 17WERCS US Users group 2007 Erwin Annys REACH: new communication A producer/importer Registers a substance For specific uses These uses are covered by the chemical safety assessment (if > 10 ton per year) If substance is dangerous exposure scenarios (ES) must be worked out These ES will be added to the extended safety data sheet

18. 18WERCS US Users group 2007 Erwin Annys