1. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 2 C. Poelloth, C. Arregui, J. Backmann – AISE Secretariat Human Health Task Force 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. HERA at CED XXXI C.Lally 3   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!) Human Health Task Force

4. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 7 What do consumers do with products ? ?

8. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 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’)

10. HERA at CED XXXI C.Lally 10

11. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 12 EXPOSURE Identify where ingredient used Product category and form (e.g. gel, tablet…) Concentration range of ingredient in product Consumer Contact with product Use scenarios (recommended, foreseeable uses, accidents) Relevant exposure routes Indirect Exposures (via the Environment) Estimate Exposure using Simple Models Apply H&P data, defaults, models Use measured data where available Combine Exposure Estimates Use additive approach to give consumer ‘dose’ Include indirect exposure estimates from Environment TF Consumer Exposure

13. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 14 HAZARD Collect toxicological data on ingredient Validate the data required Criteria for reliability Identify critical endpoints of concern and data gaps Consider bridging data, QSAR and product safety data Summarise relevant data (robust summaries) focused on relevant exposures and endpoints Consumer “Hazard”

15. HERA at CED XXXI C.Lally 15 EXPOSURE Identify where ingredient used Product category and form (e.g. gel, tablet…) Concentration range of ingredient in product Consumer Contact with product Use scenarios (recommended, foreseeable uses, accidents) Relevant exposure routes Indirect Exposures (via the Environment) Estimate Exposure using Simple Models Apply H&P data, defaults, models Use measured data where available Combine Exposure Estimates Use additive approach to give consumer ‘dose’ Include indirect exposure estimates from Environment TF HAZARD Collect toxicological data on ingredient Validate the data required Criteria for reliability Identify critical endpoints of concern and data gaps Consider bridging data, QSAR and product safety data Summarise data (robust summaries) focused on relevant exposures and endpoints

16. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 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. HERA at CED XXXI C.Lally 18  Thank You !  Gracias !