Part IIOrderPublished: September 30, 2020

Advance Notice for Siloxane Polymer Use

Order 2020-87-12-01 Amending the Domestic Substances List: SOR/2020-203

The Order adds several chemicals to the Domestic Substances List and creates a Significant New Activity notification requirement for a specific siloxane/silicone polymer (CAS 756819-45-1). Companies must notify the Minister at least 90 days before using that polymer in sprayed consumer products or cosmetics at ≥0.1% by weight or if using more than 10 kg/year; the Order came into force on 2020-09-18.

Published
September 30, 2020
Department
Unavailable
Section
Order 2020-87-12-01 Amending the Domestic Substances List
Comment deadline
Unavailable
Effective date
September 18, 2020
Publication part
Part II

Summary

Summary#

This is Order 2020-87-12-01 Amending the Domestic Substances List under the Canadian Environmental Protection Act, 1999. It adds several chemical substances to the Domestic Substances List and creates a rule that companies must tell the government before using one specific polymer in certain sprayed consumer products or cosmetics. The Order came into force on September 18, 2020.

What it does#

  • Adds these substances to Part 1 of the Domestic Substances List: 3395-98-0, 35641-59-9, 1644387-94-9.
  • Adds one substance to Part 2 of the List with a “significant new activity” requirement: 756819-45-1 — a specific siloxane/silicone-based polymer. Under the new rule, a company must notify the government at least 90 days before starting any of these activities:
    • Making a product (consumer product or cosmetic) that contains the polymer at 0.1% by weight or more and that releases or sprays the substance in airborne particles smaller than 10 micrometres.
    • Using more than 10 kg of the polymer in a calendar year in such products where it is present at ≥ 0.1% by weight.
  • Exceptions: no advance notice is needed if the use is only for research and development, a site-limited intermediate, or for products made for export only.
  • Information required with a notification includes:
    • A description of the proposed activity and the expected annual quantity.
    • Particle-size data for what would be released or sprayed.
    • Test data from an inhalation toxicity study (either OECD Test No. 413 or Test No. 412) done according to good laboratory practice.
    • Other available health and environmental information, and contact details for the notifier.
  • The government has 90 days to assess the information it receives.
  • Adds several substances to Part 3 of the List (polymers and related compounds), including 19476-4, 19478-6, 19479-7, 19480-8, 19481-9.

Who's affected#

  • Manufacturers and importers of chemicals, especially anyone who makes or uses the polymer 756819-45-1.
  • Companies that make consumer products or cosmetics (as defined by the Food and Drugs Act) that spray or release fine airborne particles — for example, aerosols, pump sprays or similar products.
  • Testing laboratories that would perform the required inhalation studies.
  • It is unclear from the Order how many current products already contain this polymer or which brands will be affected.

Why it matters#

  • The rule is meant to give the government advance notice about uses that could increase inhalation exposure to this polymer. That lets officials review health and environmental risks before new uses start.
  • Businesses planning to use the polymer in sprayed products may need to do or commission inhalation testing, submit detailed data, change formulations, or delay launches while the government assesses the proposal.
  • For the public, this targets potential exposure from fine sprays and aerosols — products people might use at home or on their bodies.

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances List3395-98-035641-59-91644387-94-9756819-45-1siloxanes and silicones, di-Me, mono[3-[(2-methyl-1-oxo-2-propenyl)oxy]propyl] group-terminated, polymers with Bu methacrylate, 2-ethylhexyl acrylate and Me methacrylate19476-419478-619479-719480-819481-9Environment and Climate Change CanadaNew Substances Notification Regulations (Chemicals and Polymers)

Source: Canada Gazette

Official source