Human & Environmental Risk Assessment HERA in the global chemical management scene

1. Human & Environmental Risk Assessment • HERAin the global chemical management scene • Lothar Kistenbrügger & Véronique Scailteur • Members of the HERA Management Team European Stakeholders Workshop: Brussels, Oct 2001

2. Hazard vs. Risk Hazard + Exposure = Risk RiskInformationInformation Assessment Management intrinsic properties of substances including toxicological and ecotoxicological data production, use, misuse, use patterns, environmental distribution risk assessment based on hazard and exposure information; comparison predicted no effect level (concentration) with predicted exposure level (concentration) e.g., where applicable, use restrictions European Stakeholders Workshop: Brussels, Oct 2001

3. Risk AssessmentThe Context All along, individual companies have conducted risk assessments of existing chemicals. In addition there are various national, regional and international programmes and voluntary initiatives in respect of chemicals management in the broadest sense: European Stakeholders Workshop: Brussels, Oct 2001

4. Current Programmes and Initiatives • OECD HPV Chemicals Programme (“SIDS Programme”) • ICCA HPVC Initiative = Refocused OECD HPVC Programme • IPCS CICADs Programme • EHC Monographs Programme • EU Existing Chemicals Regulation 793/93 EEC & Risk Assessment Regulation 1488/94 • EU Notification of New Substances (Directives 67/548/EEC & 92/32/EEC) and Risk Assessment Directive 93/67/EEC • EU Biocidal Products Directive 98/8/EC • EU Safety Data Sheet Directive 1/155/EEC • EU Classification & Labelling Directive 67/548 EEC & 1999/45/EC • Global Harmonisation of Classification and Labelling • US HPV Chemicals Programme (“Challenge Programme”) • US VCCEP programme • Canadian priority chemicals programme European Stakeholders Workshop: Brussels, Oct 2001

5. Output = Risk Information *) • OECD HPV ChemicalsProgramme(“SIDS Programme”) • ICCA HPVC Initiative = Refocused OECD HPVC Programme • IPCS CICADs Programme • EHC Monographs Programme • EU Existing Chemicals Regulation 793/93 EEC & Risk Assessment Regulation 1488/94 • EU Notification of New Substances (Directives 67/548/EEC & 92/32/EEC) and Risk Assessment Directive 93/67/EEC • EU Biocidal Products Directive 98/8/EC • EU Safety Data Sheet Directive 91/155/EEC • EU Classification & Labelling Directive 67/548 EEC & 1999/45/EC • Global Harmonisation of Classification and Labelling • US HPV Chemicals Programme (“Challenge Programme”) • US VCCEP programme • Canadian priority chemicals programme *) Bold/Italic = risk European Stakeholders Workshop: Brussels, Oct 2001

6. Voluntary Industry Activities • OECD HPVChemicalsProgramme • ICCA HPVC Initiative = Refocused OECD HPVC Programme • IPCS CICADs Programme • EHC Monographs Programme • EU Existing Chemicals legislation • EU New Substances legislation • EU Biocidal Products Directive • EU Safety Data Sheet Directive • EU Classification & Labelling legislation Global Harmonisation of Classification and Labelling • US HPV Chemicals Programme (“Challenge Programme”) • US VCCEP programme • Canadian prioritychemicals programme + ACA risk perspective + Risk Assessment of selected chemicals European Stakeholders Workshop: Brussels, Oct 2001

7. A New Challenge • OECD HPVChemicalsProgramme • ICCA HPVC Initiative = Refocused OECD HPVC Programme • IPCS CICADs Programme • EHC Monographs Programme • EU Existing Chemicals legislation • EU New Substances legislation • EU Biocidal Products Directive • EU Safety Data Sheet Directive • EU Classification & Labelling legislation Global Harmonisation of Classification and Labelling • US HPV Chemicals Programme (“Challenge Programme”) • US VCCEP programme • Canadian prioritychemicals programme + ACA risk perspective + Risk Assessment of selected chemicals The EU”White Paper on the Strategy for a future Chemicals Policy” European Stakeholders Workshop: Brussels, Oct 2001

8. European Milestones in Chemicals Management European Stakeholders Workshop: Brussels, Oct 2001

9. Why HERA ? • HERA Launch Nov. 99 • Reviews of chemical management policy worldwide • US HPV • EU debate • ICCA HPV Initiative • Focus on consumer products • Phase I A Substances • Stakeholder Workshop Oct. 01 • Various programmes and initiatives • EU White paper European Stakeholders Workshop: Brussels, Oct 2001

10. AISE (Downstream users): • Concern about hazard data without use perspective: • To provide reassurance to the public and to the Authorities of SAFETY of household detergent and cleaning products • RISK ASSESSMENT IS KEY IN ADDITION TO HAZARD EVALUATION • Readiness to contribute in particular with consumer phase exposure information European Stakeholders Workshop: Brussels, Oct 2001

11. HERA on the Global Chemical Management Scene?And in the Spirit of the EU White Paper? • Concrete working model for doing cooperative risk assessment : • downstream users working together on exposure • partnership between producers and downstream users to provide risk assessments. • Provides a transparent basis for risk based management decisionon chemicals with significant general public exposure and wide dispersion in the environment. • Supplements international and regional programmes and initiatives that provide hazard information. European Stakeholders Workshop: Brussels, Oct 2001