Human & Environmental Risk Assessment

1. Human & Environmental Risk Assessment • Human Health Risk Assessment under HERA: Challenges and Solutions • Christeine Lally • Co-Chair of the HERA Human Health Task Force

2. Human Health Task Force C. Poelloth, C. Arregui, J. Backmann – AISE Secretariat • G. Holland (Unilever) * • C. Lally (P&G) * • F. Bartnik (Henkel) • J. Boyd (Colgate) • G. Helmlinger (P&G) • S. Kirkwood (McBride) • ( * = co-chairs ) • W. Aulmann (Cognis) • O. Grundler (BASF) • S. Jacobi (Degussa) • R. Kreiling (Clariant) • M. Maier (ZEODET) • P. Martin (Rhodia) • H. Messinger (Cognis) • J.R. Plautz (Ciba) • G. Veenstra (Shell)

3. Human Health Task Force • The GOAL • propose a Methodology for a Human Health Risk Assessment (hazard + exposure) • test the Methodology with 3 initial chemicals – alkyl sulphates, a zeolite, an optical brightener (Phase IA) • seek peer consultation from scientific stakeholders • refine Methodology -“Framework Document” • deploy Methodology to Phase IB (15-20) and refine further (lessons learned!)

4. Human Health Task Force • The Process • focus on a tiered approach to both hazard and exposure assessment • focus on chemicals used primarily in AISE products – hazard profiles and potential exposure for humans • focus on consumer use of these products (i.e. not professional use or workplace exposure) • focus on intended use but also consider other foreseeable uses and accidental use • focus on endpoints of concern for the consumer from the exposures expected from AISE products

5. Human Health Conclusions • Specific for European Usage HERA Human Health Risk Assessment based on EU Technical Guidance Document for New and Existing substances

6. The HERA methodology follows a tiered approach: • Consider possible uses of chemicals in household detergent and cleaning products • Consider consumer activity during cleaning tasks - review also foreseeable other uses of products • Consider hazards which are relevant for known product uses and exposures (e.g. is dermal contact likely? could ingestion occur inadvertently?) • Consider also serious adverse effects (e.g. cancer, reproductive toxicity) and review relevance for consumer exposure through product use • Determine whether the consumer is at risk? (is the Margin of Exposure adequate for consumer safety?)

7. What do consumers do with products ? ?

8. USE & EXPOSURE • Identify • which product category (laundry compact, fabric conditioner, toilet cleaner….) • product concentration (% in product, range) • type of application (powder, tablet, spray, wipe….) and how is product used

9. Formulator companies asked to provide (in confidence): • Use levels of Phase 1A and 1B ingredients in their products • List of product categories where ingredients are currently used • Published or in-house data on consumer habits and practices for product categories (at least provide ‘recommended use’)

11. USE & EXPOSURE • HERA provides simple multiplicative mathematical models – based on exposure equations in EU TGD and in ECETOC Technical Reports • HERA uses real data (formulators) or, if unavailable, it uses ‘reasonable’ defaults • HERA uses a conservative ‘worst case’ scenario in first step (tiered approach) • HERA checks exposure estimate for ‘realism’ • HERA considers need for more refined exposure estimate

12. Consumer Exposure

13. + • HAZARD • Producer companies asked to: • collect available toxicology data on ingredient – IUCLID, SIDS, IPCS, in-house company data etc. • validate data based on current standards - but do not discard older data; consider human experience • consider toxicological endpoints most relevant for use - endpoints of interest largely driven by predicted exposure; identify no-effect-levels and possible data gaps And Formulator companies asked to provide: • product safety data where available and useful

14. Consumer “Hazard”

16. Is the consumer at risk…? • compare relevant hazard(s) with foreseeable exposure(s) for consumer • ratio of “no effect level” and “exposure”  MOS or “margin of safety” [NOAEL/Exposure = MOS]. • consider whether MOS is adequate to protect the consumer – follow guidance in Technical Reports from ECETOC and in EU TGD • how good is the answer ? (Uncertainty….)

17. Is the consumer at risk…? • If MOS is unacceptable…….. • review exposure estimates • review hazard dataset • consider product safety data • use human experience data • get more data…. (exposure, hazard…) • Expert judgement • Transparency in arguments & decisions !

18. Thank You ! • Gracias !