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SETAC Fourth World Congress, Portland OR: USA 14-18 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

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

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Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

  • 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.


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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 ………


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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)


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

  • 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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

  • 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).


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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

There is one important difference however:


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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.


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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?“


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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?


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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?


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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.


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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:


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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


Setac fourth world congress portland or usa 14 18 november 2004 governance and law global perspectives

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.


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