REACH: state of art and base definitions Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS 2007 EU User group Napoli 31/05/07

2 WERCS EU User group 2007 – Erwin Annys REACH Registration Evaluation Authorisation and restriction of Chemical substances

3 WERCS EU User group 2007 – Erwin Annys Substance – preparation - article

4 WERCS EU User group 2007 – Erwin Annys REACH Registration Evaluation Authorisation Restriction Classification index Sharing data Info in supply chain Down stream use Responsibility industry Agency

5 WERCS EU User 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

6 WERCS EU User 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

7 WERCS EU User group 2007 – Erwin Annys What to register?

8 WERCS EU User group 2007 – Erwin Annys > 1 ton Registration >100 ton 01/06/07 01/12/10 01/06/13 01/06/18 01/06/08 01/12/08 >1000 ton CMR >1 ton N, R50-53 > 100 ton Pre-registration Non phase-in substances

9 WERCS EU User group 2007 – Erwin Annys Registration Technical dossier Chemical safety report > 10 ton/year

10 WERCS EU User 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

11 WERCS EU User 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

12 WERCS EU User 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

13 WERCS EU User 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

14 WERCS EU User group 2007 – Erwin Annys Restrictions General issues Safety net Takes over existing legislation (Directive 76/769/EEC)

15 WERCS EU User 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

16 WERCS EU User group 2007 – Erwin Annys