Part IIOrderPublished: July 7, 2021

Siloxane polymer added to Domestic List

Order 2021-87-02-01 Amending the Domestic Substances List: SOR/2021-156

Adds a polymer masked as CAN 19494-2 (a siloxane/silicone polymer) to the Domestic Substances List and retains Significant New Activity (SNAc) reporting for certain uses that could create inhalation exposure. Notification is required at least 90 days before proposed manufacture, import or use in consumer products or cosmetics that release or spray particles ≤10 µm at ≥1% concentration; transitional quantity thresholds apply (≥1,000 kg until 2021-12-10, then >10 kg per calendar year from 2021-12-11). Required information includes exposure details and inhalation toxicity study data consistent with OECD Test No. 412 or 413.

Published
July 7, 2021
Department
Unavailable
Section
Order 2021-87-02-01 Amending the Domestic Substances List
Comment deadline
Unavailable
Effective date
June 22, 2021
Publication part
Part II

Summary

Summary#

Order 2021-87-02-01 Amending the Domestic Substances List adds a single new polymer (masked as CAN 19494-2) to the Domestic Substances List under the Canadian Environmental Protection Act, 1999. It keeps rules that require companies to notify the government before starting certain uses of the substance that could release fine airborne particles.

What it does#

  • Adds the polymer masked as CAN 19494-2 (named in the order as “siloxanes and silicones, di‑Me, alkene Me, [(alkenedimethylsilyl)oxy]‑terminated, polymers with hydrogen‑terminated di‑Me siloxanes”) to the Domestic Substances List.
  • Keeps Significant New Activity (SNAc) reporting requirements for uses that may create inhalation exposure, specifically when the substance is present at ≥1% by weight in:
    • consumer products covered by the Canada Consumer Product Safety Act that release or spray particles ≤10 micrometres; or
    • cosmetics as defined in the Food and Drugs Act that release or spray particles ≤10 micrometres.
  • Sets quantity thresholds and timing:
    • Transitional period: use of ≥1,000 kg during the interim period up to December 10, 2021 required notification.
    • From December 11, 2021 the SNAc threshold is use of >10 kg in a calendar year for the listed product types.
  • Anyone proposing a covered “significant new activity” must notify the Minister at least 90 days before starting and provide information such as:
    • a description of the activity and the annual quantity expected;
    • exposure details and particle size distribution;
    • the function of the substance in the product;
    • existing toxicity and exposure data, including an inhalation toxicity study done to OECD guidelines (28‑day or 90‑day study) and any other relevant test data.
  • Exemptions: research and development uses, site‑limited intermediates, export‑only products, and certain regulated product categories are not subject to the SNAc notice requirement.

Who's affected#

  • Manufacturers, importers and formulators of consumer products and cosmetics that might contain this polymer at ≥1% by weight and that release or spray airborne particles ≤10 micrometres.
  • Companies planning to start new uses that would exceed the >10 kg per calendar year threshold (after December 11, 2021) must notify the government in advance.
  • Businesses doing only research, limited intermediate manufacturing, or exporting products only are generally not affected.
  • It is unclear from the order which specific brands or product lines use this polymer; affected firms will be those that have the substance in their formulations at the concentrations and product types described.

Why it matters#

  • The government kept the reporting rule because health experts flagged a potential risk if the substance is inhaled — the order notes possible adverse effects on the lungs. The notification requirement gives Health Canada and Environment Canada a chance to review new uses and require controls before widespread exposure occurs.
  • For businesses, adding the substance to the Domestic Substances List removes one set of new‑substance notification rules, but it does mean advance notice is still required for certain new product uses. That gives companies clearer rules to follow if they want to introduce the substance into sprayable consumer products or cosmetics.
  • For consumers, the rule aims to reduce the chance that a new use of this polymer would lead to uncontrolled inhalation exposure without prior government assessment.

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances ListSignificant New Activity (SNAc)Significant New Activity Notification (SNAN)siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanesCAN 19494-2Canada Consumer Product Safety ActFood and Drugs ActEnvironment and Climate Change CanadaHealth CanadaNew Substances Notification Regulations (Chemicals and Polymers)inhalation toxicityOECD Test No. 412OECD Test No. 413

Source: Canada Gazette

Official source