Bjorn Hansen Directorate General for Environment European Commission

1. DU obligations under REACH and how they can be metCopenhagen, Denmark3 March 2005 Bjorn Hansen Directorate General for Environment European Commission

2. Structure • REACH Objectives • REACH Basics • Current Situation (Information flow and competences) • Under REACH (Information flow and competences) • Conclussions

3. 1. REACH Objectives • Industry to take responsibility for their substances Show that risks are adequately controlled • Industry to carry the burden of proof • The tool for industry to do this is: • Chemical Safety Assessment • Recorded in a Chemical Safety Report • Communicated using the Safety Data Sheet

4. 2. REACH Basics • Industry is to apply and communicate sufficient operational conditions and RMMs to protect humans and the environment • CSR is to document that the operational conditions and RMMs are sufficient • CSR is to be based on clear and enforceable information requirements (Annex IV – VIII), with substance tailored derogations (incl. exposure based waiving) (Annex IX) What does this really mean?

5. 2. REACH Basics • Industry should have sufficient flexibility to do this, suiting business and costumer needs • Authorities only intervene (Restrictions) in those cases where industry can not take or is not taking its responsibility, i.e., there is a need for additional risk management beyond that already in place • Enforcement is key to the success What does this really mean?

6. 3. Current Situation Collect Information C&L M/I EU Legislation e.g. Dir. 67/548, IPPC National Legislation e.g. Permits, OELs SDS DU

7. 3. Current Situation Not sufficient information available Inconsistent C&L Safety Paradox: No info, no C&L, limited RRMs in SDS, little knowledge base for DUs to implement sufficient RMMs Not much knowledge of DU M/I SDS: Not always sufficient content Not always sufficient info DU

8. 3. Current Situation Collect Information Hazard Assessment C&L Risk based decisions M/I EU Legislation e.g. Dir. 98/24, IPPC National Legislation e.g. Permits, OELs SDS Read, evaluate, apply recommendations in SDS DU

9. 4. Under REACH Collect Information CSR (incl. C&L), SDS M/I EU Legislation e.g. Dir. 98/24, IPPC National Legislation e.g. Permits, OELs Information SDS + ES* Read, evaluate, apply ES annexed to SDS DU *ES = Exposure Scenario

10. 4. Under REACH • M/Is do RA (CSR) covering identified uses in the life cycle of the chemical • Enable DUs to decide if they prefer the M/Is to do the RA (CSR) or to do it themselves How does this work?

11. 4. Under REACH • Avoid double work : • What ever the M/I does, the DU should not need to repeat • Enable DUs to decide if they prefer the M/Is to do the RA (CSR) or to do it themselves Two fundamental assumptions: • Make it as simple as possible : • REACH Implementation Projects

12. 4. Under REACH Collect Information • Exposure Scenarios are Annexes because: • easier accessible • holistic package • supplier can tailor info • SDS does not include heading for consumer Does CSA Writes CSR M/I SDS + Exposure Scenarios • RMMs • Operational Conditions • C&L • PBT • PNECs • DNELs

13. 4. Under REACH SDS + Exposure Scenarios Yes No Let the use be known to the supplier DU Apply ES Am I inside ES? No Yes No Use Hazard Assessment DU Develop ES Do targeted CSA and CSR

14. 5. Conclusions • Industry takes responsibility • Clear requirements (enforceable, legal certainty) • flexible execution (business and costumer tailored) • Responsibilities in the supply chain are based on competences • M/Is know Hazard Assessment, C&L, Risk based decisions, .. • DUs know RMMs, operating conditions, processes • If you want to reduce uncertainties regarding REACH • Start communicating upstream NOW • Start communicating downstream NOW

15. Information Thank you! http://europa.eu.int/comm/environment/chemicals/index.htm http://europa.eu.int/comm/enterprise/chemicals/index.htm http://ecb.jrc.it/REACH and http://ecb.jrc.it/