Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley

2 Cefic Research and Science INDUSTRY PRIORITIES Innovation Risk Assessment Reach (RIPs) Precaution Product / Health Health & Environment SCALE R&S MAIN ACTIVITIES SUSCHEM LRI Children’s Environment & Health Issue Management GLOBAL LINKS ICCA LRI Bio-Monitoring Project ICCA TAG Children’s Health Endocrine

3 L ong R ange I nitiative’s mission Identify and fill gaps in our understanding of the hazards posed by chemicals, to advance estimates of exposure and to improve the methods for assessing the associated risks Support informed risk management decisions Transparency to build trust

4 Drivers of the LRI programme Public demand that industry “know” its products Public impact of biomonitoring programmes The draft European union chemicals policy (REACH) Demands for human risk-related information Demands for ecological risk-related information Demands for knowledge of potential risks to children (SCALE) International public and governmental concerns over endocrine-active compounds Demands for Alternatives to animal testing

5 REACH Implementation Projects (RIPs) Industry Involvement RIP 3.2 Chemical Assessment Report Basis for Technical basis guidance RIP 3.3 Develop a general and cost-effective decision-making framework on information requirements based on Integrated Testing Strategy (ITS) Four endpoints: Aquatic toxicity; Degradation; Eye irritation; Reproduction Next step: Drafting technical guidance document (waiting for call from proposal from the European Commission)

6 EU 3Rs Partnership 3Rs: Develop Alternative Methods to Animals – Reduce Refine Replace the number of animals used. Important to reduce the number of animals for cost and ethical purpose for the implementation of REACH Partnership signed in November 2005 between the European Commission and Industry Partners (Colipa; Efpia; Cefic; Europabio; Crop Protection Association; IFAH; AISE)

7 Principles of the Partnership A voluntary bi-lateral relationship Flexible/pragmatic structure Commission to coordinate (provide “platform”) Stakeholders with secondary role, i.e. recipients of output, no steering role)

8 Research that makes a difference

9 Environment Suite – modelling the environmental fate of Chemicals in risk assessment Atmospheric: ADEPT Estuarine: GEMCO Soil: TERRACE Rivers: GREAT-ER II Used by UBA/DEFRA

10 Persistence & Bioaccumulation – Assessing the risks ACC-HUMAN is a dynamic bioaccumulation model predicting human tissue levels from concentrations in air, soil and water Dynamic effects through the food chain 2.Understanding Persistence The project has investigated persistence and bio- concentration of a diverse range of chemical types, including man-made and naturally-occurring ones, in the oceans and on land. 3.Relationships between Persistence and Bioaccumulation potential Predicting human exposures from bioaccumulation and magnification through the food chain

11 Improving Exposure Assessment Exposure is the more subjective part of risk assessment Creating relational databases for dispersed data on exposures to consumers, & workers, as regulatory tools to improve exposure estimates in risk assessment Risk= f [Hazard, Exposure]

12 Reducing Uncertainty in Exposure Estimates Consumer Exposures -IERIE : inventory of research on indoor pollutants -EXPOLIS : European urban exposure patterns (implemented within INDEX EU project on Indoor Air) -ExpoFacts : European Sourcebook of human exposures Occupational Health -HEROX – inventory of European workplace exposure to chemicals -EASE – understanding and reducing uncertainties within the current regulatory model -Improved basis for the assessment and management of risks arising from dermal exposures to chemicals Biomarkers of exposure -Background incidence on biomarkers of exposure to chemicals in UK – what is normal? How does it vary over time and between people?

13 Animal Alternatives 1.Funded Secondment to OECD for policy development for QSARs Access to EU/ECB/ECVAM network important to REACH 2.Existing LRI work to predict extended low dose exposures and skin permeation for Risk assessment 3.New portfolio from the Alternatives Issue Management Team Modelling approaches to skin irritation, mutagenicity/genotoxicicity and bioconcentration Use of fish cells/embryo’s as model test substrates

14 Conclusions Science contribution directly relevant to: -The applicability and science of Risk Assessment -Practical tools for RIPs Recommendation -Review processes to maximise advocacy impact of R&S work relevant to PS e.g. Use of QSAR’s in REACH

15 More information European Technology Platform for Sustainable Chemistry Long Range Initiative