1

European Stakeholders Workshop: Brussels, Oct 2001

Human & Environmental Risk Assessment

HERAin the global chemical management scene

Lothar Kistenbrügger & Véronique Scailteur Members of the HERA Management Team

2

European Stakeholders Workshop: Brussels, Oct 2001

Hazard vs. Risk

Hazard + Exposure = Risk RiskInformation Information 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

3

European Stakeholders Workshop: Brussels, Oct 2001

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:

4

European Stakeholders Workshop: Brussels, Oct 2001

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

5

European Stakeholders Workshop: Brussels, Oct 2001

Output = Risk Information *)• 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 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

6

European Stakeholders Workshop: Brussels, Oct 2001

Voluntary Industry Activities• OECD HPV Chemicals Programme• 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 priority chemicals programme

+ ACA risk perspective

+ Risk Assessment of selected chemicals

7

European Stakeholders Workshop: Brussels, Oct 2001

• OECD HPV Chemicals Programme• 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 priority chemicals programme

+ ACA risk perspective

+ Risk Assessment of selected chemicals

A New Challenge

The EU”White Paper on the Strategy for a future

Chemicals Policy”

8

European Stakeholders Workshop: Brussels, Oct 2001

European Milestones in Chemicals Management

9

European Stakeholders Workshop: Brussels, Oct 2001

Why HERA ?

• HERA Launch

Nov. 99

• Reviews of chemicalmanagement policyworldwide– 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

10

European Stakeholders Workshop: Brussels, Oct 2001

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

11

European Stakeholders Workshop: Brussels, Oct 2001

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 decision on chemicals with significant general public exposure and wide dispersion in the environment.

• Supplements international and regional programmes and initiatives that provide hazard information.