1. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 1 FUTURE CHEMICALS POLICY and HERA Anne-Marie Rodeyns, A.I.S.E. Deputy Director 11 July 2002

2. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 2 CHEMICAL LEGISLATION Commission White Paper 02/01 Parliament Opinion 11/01 New Law 2004 Comm. WG’s 12/01 HERA 9/99 Kick off meeting 02/01 Present to Countries + Commission 03/01 Website 06/01 Methods + First RA 10/01 First Stakeholder Workshop 07/02 Second Stakeholder Workshop 09/02 Start of HERA Phase 2

3. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 3 HERAFUTURE EU CHEMICALS MANAGEMENT POLICY PRINCIPLES 1.Responsibility of industry to ensure safe use of chemicals. 2.Shared responsibility between producers and downstream users of chemicals. 3.Risk (hazard and exposure) assessment as basis of safety evaluation. 4.Risk management measures to control risk. 5.Transparency. 1.Partnership between producers and downstream users of chemicals in household detergent and cleaning products. 2.Targeted risk assessment : one common risk assessment per substance. 3.Risk management by companies where needed. 4.Open dialogue with stakeholders and transparency of results.

4. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 4 How can HERA and the IMPLEMENTATION of FUTURE EU CHEMICALS MANAGEMENT POLICY come together? 1.Promote data sharing whilst protecting legitimate confidentiality and maintaining European industry’s competitiveness. 2.Avoid too complex and inflexible system and promote integration of chemicals management programmes. 3.Ensure integration of downstream users all through the process and clarify producers/downstream users share of responsibilities. 4.Management should be based on risk rather than hazard.

5. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 5 IDEAS 1.Platform to facilitate formation of consortia (producers/users). 2.Organise pre-Registration phase to collect data. 3.Build on input from industry initiatives such as HERA.

6. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 6 MORE IDEAS 4.Prioritise substances submitted to authorisation process. 5.No "pre-imposed" management measures, if risk assessment shows safety in use. Authorisation should not be based on hazard. We need to move progressively from a hazard-based management system to a risk-based one.

7. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 7 HERA AS A PRACTICAL IMPLEMENTATION OF KEY ELEMENTS OF THE EU "STRATEGY FOR A FUTURE CHEMICALS POLICY" - Partnership between manufacturers and downstream users : HERA offers a model to work the responsibilities along the chain : budget, data contribution and sharing, legal aspects - Risk based approach : targeted risk assessment

8. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 8 HERA AS A PRACTICAL IMPLEMENTATION OF KEY ELEMENTS OF THE EU "STRATEGY FOR A FUTURE CHEMICALS POLICY" -Best use of all available information : physico-chemistry, available animal data, in-vitro, QSAR, human data, … -Thereby limiting animal testing to absolute minimum. -Grouping of substances.

9. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002 9 HERA A way to apply the proposed process of REACh (Registration, Evaluation & Authorisation of Chemicals) for chemicals with potentially high human and environmental exposure.