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

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

Akzo-NobelBASFBoraxCibaClariantCognisColgate PalmoliveDalliDegussa-Huls Dow Corning Firmenich FMC Foret Henkel

HuntsmanMcBride Procter & GamblePetresaReckitt-BenckiserRhodiaRohm & HaasSASOLShell ChemicalsSolvayUnileverUniqemaWacker Chemie

AISECefic Sector GroupsCESIONVZVerband TegewaSDAJSDA

Partners in HERABlue = Downstream Users

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.

The scope of HERA risk assessments

Treatment, recycling & disposal

effluent

sludge

INGREDIENTS and BREAKDOWN PRODUCTS

INGREDIENTmanufacture formulation

PRODUCTPRODUCT

uselosses

HERA Process

1. Develop the methods: Sept 1999-, using 3 *substances;

2. Verify the methods: 2000-, using 13 more substances;

3. Cover all remaining **functions: 2002-, using 12 more;

4. 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 ………

Alkyl ether sulphatesAlkyl sulphateBoric acid / sodium borateFatty acid saltsFabric whitening agent-5Linear alkylbenzene

sulphonatePhosphonatesPolycyclic musks AHTNPolycyclic musks HHCBSodium carbonateSodium perborateSodium percarbonateTetra-acetyl-ethylene-

diamineSodium tripolyphosphateZeolite -A

11 22

HERA substances: (assessments in red published; approx 120 CAS numbers) Total ca. 250 CAS numbers.

Alkali silicatesAmine oxides Amylase CellulaseCitric acid / Salts Coco-amido propyl betainesDiethylenglycol n-butyletherEster quatsFabric whitening agent-1HydroxycitronellalHydrogen peroxideIsoeugenolIsopropyl Alcohol

Lipase MonoethanolaminePropylenglycol n- butyletherProteaseSodium sulphateSulphonates: xylene-, cumene-, toluene- TriethanolamineZeolites: -P and -X

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

EU volume (estimate excl. H2O)

Phase 3

Phase 2

Phase 1

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)

From the publication of the White Paper, we have constantlyseen that HERA represents

• a way forward for high tonnage chemicals with frequent human exposure and wide dispersion in the environment

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).

HERA’s aims, methods and principles are mostly in good agreement with those of the draft EU Policy

There is one important difference however:

Treatment, recycling & disposal

effluent

sludge

INGREDIENTS and BREAKDOWN PRODUCTS

PRODUCTuse

The special HERA target for communication (of safety based on risk assessments) is the general public, but the REACH Proposal hardly mentions such communication.

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.

Workshops

1. October, 2001 - debating our principles, methods and choice of substances;

2. July, 2002 - placing HERA in the context of the political debate on a new chemicals policy for Europe;

3. November, 2003 - first workshop on communication with the consumer;

4. November, 2004 - Talking about chemicals with consumers “Confidence through Communication?“

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

From the third WorkshopQuestions 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?

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?

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.

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:

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

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

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

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.