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Consultation Document - Octamethylcyclotetrasiloxane(D4)

4. Existing Risk Management Actions

4.1 Information Gathering Activities

Canada

In May and June 2010, a voluntary questionnaire was sent to certain facilities that reported using or releasing D4 and D5 under the Challenge.  The purpose of this questionnaire was to help Environment Canada gain a better knowledge of practices used in the industry.  The questionnaire is included in Annex 2.

United States

On March 17, 2010, the US Environmental Protection Agency announced that it is preparing an action plan for siloxanes. The action plan is expected to summarize uses, substitutes, human health hazards, environmental hazards, fate and exposure characterization, domestic and international regulatory reviews, and next steps with regards to siloxanes.

4.2 Risk Management Activities

Canada

Pest Control Products Act - D4 is currently classified as a List 2 formulant. List 2 formulants are considered potentially toxic, based on structural similarity to List 1 formulants (defined as having significant concern with respect to their potential adverse effects on health and the environment) or on data suggestive of toxicity. Formulants may be reassessed when new information is received (PMRA 2007).

Transportation of Dangerous Goods Regulations - D4 is a Class 3 substance (Flammable liquid). These regulations establish safety requirements for the transportation of dangerous goods, including means of containment, training, emergency response assistance plans, and accidental release and imminent accidental release report requirements (EC & HC 2009).

Europe

As of May 26, 2010, the chemical priority database of the Swedish Chemicals Inspectorate (PRIO 2006) identifies D4 as a priority risk-reduction substance because it meets the criteria for “Environmentally hazardous, potential long term effects.”

The European Commission Health Working Group agreed that D4 should be classified as a Repr Cat 3, R62, R53 (IHCP 2004). A substance classified as R53 “may cause long-term adverse effects in the aquatic environment.” A substance classified as R62 indicates a “possible risk of impaired fertility”. The Reproduction Category 3 signifies the chemical produces or increases the incidence of non-heritable effects in progeny and/or impairment in reproductive functions or capacity (HSE 2010).

Council Directive 2003/15/EEC states that a “substance classified in category 3 may be used in cosmetics if the substance has been evaluated by the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) and found acceptable for use in cosmetic products.”

No conclusion has been made by the SCCNFP to date on D4. However, industry has submitted data indicating products do not use more than 1% D4 (SCCP 2005).