SETAC Fourth World Congress, Portland OR: USA 14-18 November 2004 Governance and Law: Global Perspectives

1. SETAC Fourth World Congress, Portland OR: USA14-18 November 2004 Governance and Law: Global Perspectives • Human & Environmental Risk Assessment of Household Detergent Cleaning Products • Communicating risk assessment on household chemicals in the European Project HERA - lessons learned • John Solbé, Chair: HERA Operational Team

2. Human & Environmental Risk Assessment a joint European initiative of Cefic (European Chemical Industry Council): suppliers of the raw materials & A.I.S.E (International Soap, Detergent and Maintenance Products Association): formulators of products

3. Akzo-Nobel BASF Borax Ciba Clariant Cognis Colgate Palmolive Dalli Degussa-Huls Dow Corning Firmenich FMC Foret Henkel Huntsman McBride Procter & Gamble Petresa Reckitt-Benckiser Rhodia Rohm & Haas SASOL Shell Chemicals Solvay Unilever Uniqema Wacker Chemie AISE Cefic Sector Groups CESIO NVZ Verband Tegewa SDA JSDA Partners in HERA Blue = Downstream Users

4. The HERA Project delivers risk assessments… • - to a standard format: based on EU TGD* • - for an important group of chemicals: those in detergent cleaning products; • in a particular use scenario: household use; • - conforming to an agreed set of principles: • partnership, • open dialogue; • transparency; • no preconceived outcomes; • sound basis of knowledge; • avoidance of animal testing; • one common assessment, based on tiered risk evaluation. • *The European Union Technical Guidance Document on • Risk Assessment of new and existing chemicals.

5. INGREDIENT PRODUCT manufacture formulation losses INGREDIENTS and BREAKDOWN PRODUCTS effluent Treatment, recycling & disposal PRODUCT use sludge The scope of HERA risk assessments OUT OUT OUT OUT IN IN IN

6. HERA Process • Develop the methods: Sept 1999-, using 3 *substances; • Verify the methods: 2000-, using 13 more substances; • Cover all remaining **functions: 2002-, using 12 more; • Deepen understanding of all other significant substances in the chosen product range: 2004-. * ‘Substances’ can be one or many CAS numbers. ** ’Functions’ = eg surfactancy, fragrance, enzyme-action, bleaching, stabilisation, processing-aid, solvency ………

7. 1 Alkyl ether sulphates Alkyl sulphate Boric acid / sodium borate Fatty acid salts Fabric whitening agent-5 Linear alkylbenzene sulphonate Phosphonates Polycyclic musks AHTN Polycyclic musks HHCB Sodium carbonate Sodium perborate Sodium percarbonate Tetra-acetyl-ethylene-diamine Sodium tripolyphosphate Zeolite -A HERA substances: (assessments in red published; approx 120 CAS numbers) Total ca. 250 CAS numbers. 2 Alkali silicates Amine oxides Amylase Cellulase Citric acid / Salts Coco-amido propyl betaines Diethylenglycol n-butyletherEster quats Fabric whitening agent-1 Hydroxycitronellal Hydrogen peroxide Isoeugenol Isopropyl Alcohol Lipase Monoethanolamine Propylenglycol n- butylether Protease Sodium sulphate Sulphonates: xylene-, cumene-, toluene- Triethanolamine Zeolites: -P and -X

8. EU volume (estimate excl. H2O) Phase 3 Phase 2 Phase 1 In total, HERA will assess approximately 250 CAS* numbers and cover over 30 chemical ingredient families. These represent the great majority of ingredients used in household cleaning products in Europe. *Chemical Abstract Service

9. Eighteen months after HERA started work, the European Commission announced its White Paper on a new policy (the ‘REACH Process’) for managing the safe use of chemicals in Europe. REACH: Registration, Evaluation, Authorisation & Restriction of Chemicals White Paper (Feb 2001); Proposal (Oct 2003)

10. From the publication of the White Paper, we have constantly • seen that HERA represents • a way forward for high tonnage chemicals with frequent human exposure and wide dispersion in the environment

11. and that HERA demonstrates an example • of industry taking responsibility for safety; • (Industry responsible for (preliminary) risk assessment) • & • of information-sharing and collaboration between manufacturers and downstream-users • (Downstream users to be involved alongside chemical producers / importers: HERA offers a model to work the responsibilities along the chain).

12. HERA’s aims, methods and principles are mostly in good agreement with those of the draft EU Policy There is one important difference however:

13. IN PRODUCT use effluent sludge The special HERA targetforcommunication (of safety based on risk assessments) is the generalpublic, but the REACH Proposal hardly mentions such communication. INGREDIENTS and BREAKDOWN PRODUCTS Treatment, recycling & disposal IN IN

14. Some lessons learned Communication of an initiative like HERA (or indeed REACH) must be tailored to the various interested stakeholders using language that is appropriate and clear. All forms of communication may have value; HERA workshops have been found useful in bringing issues forward for debate.

15. Workshops • October, 2001 - debating our principles, methods and choice of substances; • July, 2002 - placing HERA in the context of the political debate on a new chemicals policy for Europe; • November, 2003 - first workshop on communication with the consumer; • November, 2004 - Talking about chemicals with consumers “Confidence through Communication?“

16. Workshops • November, 2003 - first workshop on communication with the consumer; • Supplier ⇒ Formulator ⇒ Consumer • November, 2004 - Talking about chemicals with consumers “Confidence through Communication?“ • Supplier ⇒ Formulator ⇒ Retailer ⇒Consumer

17. From the third Workshop Questions and answers were developed for a web-based information system. For example: What is Substance A and how does it work? In which products is Substance A used? Does Substance A pose a problem to my health? Can I get in contact with the Substance A? If yes, does this amount cause a problem or is it bad for my health? What about skin irritation and allergic effects?

18. From the third Workshop Does Substance A pose a problem to the environment? Does this ingredient come into the environment? Does Substance A have a negative impact on the environment? Can a trace of this ingredient enter our food chain? What is the overall conclusion? What about similar substances?

19. From the fourth Workshop Reiteration: Language to be ‘fit for purpose’. Remember the fundamental needs are those of the consumer. Other thoughts: “Keep it simple, stupid.” Acknowledge that retailers are driven by consumer perceptions and will (at least in the UK) do nothing to upset their customers, regardless of the scientific case.

20. From the fourth Workshop Find creative ways of talking to retailers and consumers. Education in risk perception and its links with science must start at school level. A more friendly (and fun) way to enter the Q/A area:

21. Consumers want to know how to use the products and whether they are safe for their family and for Planet Earth.

22. Consumers want answers about the products they buy, use and their safety.

23. Am I safe? Is my family safe? Is my environment safe?

24. HERA will continue in its present form, at least until it has completed the risk assessments on the main ingredients used in household cleaning products. It is hoped that this process will be completed before mid-2005. Already we are debating how best to use the experience gained to further help the Chemical Industry in Europe, for example in its approach to the requirements of REACH. Communication will continue to be high on the agenda. A REACH without appropriate communication to consumers is an incomplete process for assuring the safe use of chemicals.