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FUTURE CHEMICALS POLICY and HERA Anne-Marie Rodeyns, A.I.S.E. Deputy Director 11 July 2002. HERA. 02/01 Present to Countries + Commission. 06/01 Methods + First RA. 10/01 First Stakeholder Workshop. 07/02 Second Stakeholder Workshop. 09/02 Start of HERA Phase 2. 9/99
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FUTURE CHEMICALS POLICY and HERA • Anne-Marie Rodeyns, • A.I.S.E. Deputy Director • 11 July 2002 HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
HERA 02/01 Present to Countries + Commission 06/01 Methods + First RA 10/01 First Stakeholder Workshop 07/02 Second Stakeholder Workshop 09/02 Start of HERA Phase 2 9/99 Kick off meeting 03/01 Website Commission White Paper 02/01 Parliament Opinion 11/01 Comm. WG’s 12/01 New Law 2004 CHEMICAL LEGISLATION HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
HERA FUTURE EU CHEMICALS MANAGEMENT POLICY PRINCIPLES • Partnership between producers and downstream users of chemicals in household detergent and cleaning products. • Targeted risk assessment : one common risk assessment per substance. • Risk management by companies where needed. • Open dialogue with stakeholders and transparency of results. • Responsibility of industry to ensure safe use of chemicals. • Shared responsibility between producers and downstream users of chemicals. • Risk (hazard and exposure) assessment as basis of safety evaluation. • Risk management measures to control risk. • Transparency. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
How can HERA and the IMPLEMENTATION of FUTURE EU CHEMICALS MANAGEMENT POLICY come together? • Promote data sharing whilst protecting legitimate confidentiality and maintaining European industry’s competitiveness. • Avoid too complex and inflexible system and promote integration of chemicals management programmes. • Ensure integration of downstream users all through the process and clarify producers/downstream users share of responsibilities. • Management should be based on risk rather than hazard. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
IDEAS • Platform to facilitate formation of consortia (producers/users). • Organise pre-Registration phase to collect data. • Build on input from industry initiatives such as HERA. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
MORE IDEAS 4. Prioritise substances submitted to authorisation process. • 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. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
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 HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
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. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002
HERA A way to apply the proposed process of REACh (Registration, Evaluation & Authorisation of Chemicals) for chemicals with potentially high human and environmental exposure. HERA STAKEHOLDERS WORKSHOP-11 JULY 2002