Human & Environmental Risk Assessment An introduction to HERA:

1. Human & Environmental Risk Assessment • An introduction to HERA: • an A.I.S.E and CEFIC initiative on focused risk assessment for household cleaning chemicals • John Solbé • Chair of the HERA Members Forum and Management Team HERA at XXXI CED jfs

2. The need • The EU comprehensive risk assessment programme on Priority List substances is delivering very slowly. • One danger for industry was the administratively convenient solution of chemicals management on the basis of hazard assessment only. • The White Paper “Strategy for a future Chemicals Policy” puts an onus on industry: • “Exposure estimates….should be obligatory for manufacturers and downstream users…” HERA anticipates this need. HERA at XXXI CED jfs

3. Problems • We have few publicly available risk assessments on detergent ingredients. • We need a process for collecting and reviewing the required data. • We need to identify significant gaps in hazard and exposure data. • The existing risk assessment procedures contain default values set at highly conservative levels. • We need streamlined but scientifically sound processes. • Public confidence in chemicals needs to be improved - transparency in our work will help HERA set out to address these problems. HERA at XXXI CED jfs

4. Outline • Hazard and risk • ‘Historical’ perspective, including industry work, risk assessment for new and existing chemicals, priority and working lists of chemicals • Origins of HERA • HERA partnerships, objectives, focus • HERA principles and programme • Relationships with other initiatives & the White Paper • Organisation of HERA HERA at XXXI CED jfs

5. Hazard and Risk • What is the ‘hazard’ of a substance? • Some, or all, of its intrinsicallyharmfulproperties, including • toxicity and ecotoxicity; • carcinogenicity, mutagenicity….; • flammability, corrosivity….; • irritancy, sensitisation potential etc etc Note that these aren’t necessarily included in HERA assessments. HERA at XXXI CED jfs

6. Hazard and Risk • What is the ‘hazard’ of a substance? …..and properties which are not in themselves harmful but may increase the hazard of other properties, including: • persistence; • bioaccumulation potential. HERA at XXXI CED jfs

7. Hazard and Risk • What is ‘hazard assessment’ used for? • Classification, eg under the Classification, Packaging & Labelling Directive 67/548/EEC. • Examples of classifications • very toxic to aquatic life; • carcinogenic; • toxic to honey bees; • irritant; • reproductive toxicant HERA at XXXI CED jfs

8. Hazard and Risk • What is ‘hazard assessment’ used for? • Identification of hazard by use of symbols and safety phrases • Some symbols, used with warning labels: • Such symbols guide users, and emergency services in the event of accidents. HERA at XXXI CED jfs

9. Hazard and Risk What is ‘risk’? Risk is an expression of the probability, the possibility or the likelihood that hazardous properties, combined with exposure, will cause harmful effects. Therefore risk assessment involves an estimate of probability or chance, based on the co-incidence of a hazard and some kind of exposure to that hazard. HERA at XXXI CED jfs

10. 1 in 2 million, per year in the NL 1 in 5,700, per year Hazard and Risk How is risk expressed? (a) pictorially, statistically HERA at XXXI CED jfs

11. Chance of exposure risk Severity of hazard Hazard and Risk How is risk expressed? (b) by risk diagrams HERA at XXXI CED jfs

12. Significant risk Safety margin (tolerable zone of higher-than- normal body temperature) Risk to health No significant risk 37C Hazard and Risk How is risk expressed? (c) by commonly understood reference points HERA at XXXI CED jfs

13. Comparing PEC and PNEC No significant risk Safety margin shows no significant risk. We can also describe this safety as a ‘margin of exposure’. concentration Predicted No-Effect Concentration Safety margin Predicted Environmental Concentration Hazard and Risk How is risk expressed? (d) by comparing PEC and PNEC, or Margins of Safety Situation (‘scenario’) A HERA at XXXI CED jfs

14. Predicted Environmental Concentration Significant risk Predicted No-Effect Concentration Hazard and Risk How is risk expressed? (d) Comparing PEC and PNEC Lack of safety margin shows that a significant risk exists in this prediction. Situation (‘scenario’) B HERA at XXXI CED jfs

15. Comparing PEC and PNEC Predicted Environmental Concentration No significant risk concentration Significant risk Note that PNEC does not change in these examples. Predicted No-Effect Concentration Safety margin Predicted Environmental Concentration Situation (‘scenario’) B Hazard and Risk How is risk expressed? (d) HERA at XXXI CED jfs

16. Comparing PEC and PNEC Predicted Environmental Concentration concentration Improve PEC by more realistic measurements / estimates ? Significant risk Improve PNEC by longer-term studies which require smaller application factors Predicted No-Effect Concentration Hazard and Risk What happens when a significant risk is predicted? HERA at XXXI CED jfs

17. Hazard and Risk separating the constituent parts Exposure concerns all these areas: Occupational, Consumer, Environmental HERA at XXXI CED jfs

18. Environmental exposure Human exposure • Examples of exposure • to skin • to eye • from diet • to terrestrial environment • to surface waters • to the atmosphere HERA at XXXI CED jfs

19. Hazard is intrinsic: it is independent of usage, environment, quantity marketed etc X HERA at XXXI CED jfs

20. Examples of other properties • solubility in water • bioaccumulation potential • persistence Other properties Classification for hazardous properties • Examples of hazard • dangerous to the environment • corrosive • highly flammable • irritant • harmful • toxic HERA at XXXI CED jfs

21. Other properties Classification for hazardous properties Environmental exposure Human exposure Putting together exposure and hazard to evaluate risk HERA at XXXI CED jfs

22. Other properties Classification for hazardous properties RISKS Environmental exposure Human exposure • Graded risks: white = negligible; black = severe; grey = intermediate • The thickness of the lines indicates the magnitude of the hazard or likelihood of exposure. HERA at XXXI CED jfs

23. Hazard assessment: 67/548/EEC Classification, packaging & labelling of Dangerous Substances Historical perspective of legislation involving hazard & risk assessment relevant to the detergents industry Detergents 73/404/EEC detergents 73/405/EEC anionics 82/242/EEC nonionics 82/243/EEC anionics 86/94/EEC detergents revision 60. . . .65. . . .70. . . .75. . . .80. . . .85. . . .90. . . .95. . . .00 Risk assessment: 93/67EEC (new subst) Reg 793/93 (existing subst) Risk assessment included in: 76/464/EEC(Dangerous Subst) General Chemicals HERA at XXXI CED jfs

24. Limelette I principles of environmental risk assessment Limelette II practical application of principles Historical perspective of work on hazard and risk assessment relevant to the detergents industry -  AIS/CESIO assembly of toxicity & biodegradation data for surfactants Limelette III assessment of LAS, AE, AES, soap in NL 89 90 91 92 93 94 95 96 97 98 99 00 01 HERA at XXXI CED jfs

25. AIS/CESIO in 1991 established ERASM - environmental risk assessment for surfactants management: GREAT-ER, Comité de Pilotage, Monitoring & Model Validation, Mesocosms, Untreated Discharge, Bioaccumulation, Terrestrial Risk Assessment, Environmental Analysis & Monitoring, Anaerobic Biodegradation Historical perspective of work on hazard and risk assessment relevant to the detergents industry -  89 90 91 92 93 94 95 96 97 98 99 00 01 HERA at XXXI CED jfs

26. ECETOC Technical Reports Biodegradation kinetics PECs from models Environmental hazard assessment Marine biodegradation Aquatic toxicity data evaluation Environmental exposure assessment Non-occupational exposure evaluation 89 90 91 92 93 94 95 96 97 98 99 00 01 Historical perspective of work on hazard and risk assessment relevant to the detergents industry - a HERA at XXXI CED jfs

27. Historical perspective of work on hazard and risk assessment relevant to the detergents industry - b ECETOC Technical Reports Monitoring & modelling for aquatic risk assessment QSARs in environmental fate & effect assessment Value of aquatic ecosystem studies Role of bioaccumulation in aquatic risk assessment 89 90 91 92 93 94 95 96 97 98 99 00 01 HERA at XXXI CED jfs

28. Historical perspective - Priority Lists for risk assessment of existing chemicals (number of substances in brackets) Fourth Priority List ( 30 ) Third Priority List ( 32 ) Second Priority List ( 36 ) Σ = 140 First Priority List ( 42 ) 89 90 91 92 93 94 95 96 97 98 99 00 01 HERA at XXXI CED jfs

29. Historical perspective of work on hazard and risk assessment relevant to the detergents industry - V: Origins of HERA A.I.S.E and CEFIC initiative on focused risk assessment CED XXXI Annual Meeting Phases 1A and 1B and drafting of methodology by Task Forces and Substance Teams; administrative & communication arrangements developed Founding meeting - September 89 90 91 92 93 94 95 96 97 98 99 00 01 HERA at XXXI CED jfs

30. HERA Some detail….. A European new joint initiative between: • A.I.S.E (International Soap, Detergent and Maintenance Products Association) and • CEFIC (European Chemical Industry Council), suppliers of the raw materials HERA at XXXI CED jfs

31. HERA Partnership • Producers and • Downstream users of chemicals in household cleaning products. HERA at XXXI CED jfs

32. HERA Objectives • To show with real examples that HERA risk assessment concepts can provide relevant safety information on ingredients used in detergent and cleaning products, to Authorities and to the public in a fast, effective and transparent way; • To contribute in a useful and practical way to the risk-based approach in EU chemicals legislation; • To serve as a pilot for possible application in other product sectors and /or geographical areas. HERA at XXXI CED jfs

33. HERA Risk Assessment Concept • Focus on ingredients of household detergents and cleaning products and identify • potential environmental effects • potential effects on human health • Focus on consumer phase • known and probable uses and discharges of detergent and cleaning products …..a form of focused, targeted risk assessment hazard exposure HERA at XXXI CED jfs

34. HERA F O C U S HERA at XXXI CED jfs

35. HERA Principles • Partnership chemicals/products manufacturers • Open dialogue with stakeholders • Transparency • Data • Procedures • Sound science at all steps • Risk (hazard & probable exposure) based priorities • Tiered approach • No preconception of outcome of risk assessment • Risk management to be considered where needed HERA at XXXI CED jfs

36. A B HERA Phased Work Programme Phase 1 • Develop methodology for HERA risk assessments • Objective: rapid & efficient, but still good, sound science • Work on example substances • Objective: establish feasibility with industry partners, Authorities and all interested parties Phase 2 Apply to a wider range of substances HERA at XXXI CED jfs

37. Phase 1 • Scientific and regulatory stakeholder input • 1A Establish methodology and write guidance manual, using three substances as examples: alkylsulphates surfactant family, an optical brightener, a zeolite • Additional stakeholder input • 1B Evaluate and refine methodology on another 15-20 substances, using Substance Teams • Broad stakeholder input HERA at XXXI CED jfs

38. Phase 2 • Use methodology on relevant A.I.S.E. Ingredients, again using Substance Teams (supported, as before, by advice from Task Forces). HERA at XXXI CED jfs

39. HERA’s relationship with other chemical initiatives • Voluntary initiative complementary to others • ICCA, ACA, EU Existing Chemicals current programme and USA HPV program HERA at XXXI CED jfs

40. HERA’s relationship with the EC White Paper: Strategy for a future Chemicals Policy, and other international chemical programmes • HERA looks compatible with the aspirations of such programmes, in terms of • industry taking responsibility, • focus (flexibility) driven by exposure, • information to downstream users, • grouping of substances, • international integration and • meeting the challenge of coping with existing substances. HERA at XXXI CED jfs

41. CEFIC AISE Producer Co’s & Sector Groups Formulator Companies HERA Members Forum Individual Substance Stakeholder Companies USA, Japan Associations HERA Administration HERA Sponsors HERA SteeringCommittee Communications Committee Management Team Secretariat Environmental ExpertsTask Force Human Health ExpertsTask Force SubstanceTeams HERA at XXXI CED jfs

42. HERA Substance Teams • multi-disciplinary • expert knowledge • one team per substance • advised by Task Force members when needed • assemble and approve hazard and exposure data-sets • prepare and approve draft risk assessment reports HERA at XXXI CED jfs

43. HERA Databases • data on substances • confidential in individual details • managed within AISE offices • record of decisions with justification • managed within AISE offices HERA at XXXI CED jfs

44. CEFIC AISE Producer Co’s & Sector Groups Formulator Companies HERA Members Forum Individual Substance Stakeholder Companies USA, Japan Associations HERAFurther presentations at CED XXXI HERA Sponsors HERA SteeringCommittee Communications Committee Management Team Secretariat Environmental ExpertsTask Force Human Health ExpertsTask Force SubstanceTeams HERA at XXXI CED jfs

45. HERASummary • We have focused our work on risk assessments for human health and the environment of the ingredients of household cleaning and detergent products. • We have developed a collaborative team structure with responsibilities assigned to experts in risk assessment and communication, and to production and formulation. International communication and co-ordination are integral to the team. HERA = Focused RAhc Σ Focused RA1-n = Comprehensive RA HERA at XXXI CED jfs

46. HERASummary • We have established a methodology using a small number of substances and have incorporated advances in risk assessment thinking to help create an efficient, science-based process. Some advances have already been taken up at EU authority level. • We have designated Substance Teams to use this process to complete assessments of the most important ingredients used in household cleaning and detergent products. HERA at XXXI CED jfs

47. HERA is on its way! • Thanks for listening. HERA at XXXI CED jfs