Siloxane SNAc; 22 Organisms Proposed Removed; DEHP

Summary#

This Canada Gazette notice from the Department of the Environment covers three related items under the Canadian Environmental Protection Act, 1999. It (1) proposes removing 22 masked living organisms from the Domestic Substances List, (2) puts a binding Significant New Activity Notice No. 20490 in place for a specific siloxane polymer (Confidential Substance Identity Number 19494-2), and (3) announces the final screening assessment for a group of phthalates, finding DEHP meets the Act’s criteria for concern while 14 other phthalates do not.

What it does#

• Domestic Substances List (proposed deletion)

  • Proposes to delete 22 living organisms from Part 7 of the Domestic Substances List because they are judged not to meet the eligibility criteria.
  • Lists each organism only by a confidential accession number (for example, 18115-7, 18116-8, etc.).
  • Invites public comments for 60 days and offers a way for companies to ask the New Substances program to confirm whether a living organism they make or import is on the proposed list.

• Significant New Activity (SNAc) for the siloxane polymer (now in force)

  • The SNAc applies to siloxanes and silicones described as CSIN 19494-2. The government says certain new uses could make the substance “toxic” under the Act.
  • A “significant new activity” includes using the substance in the manufacture or sale of products that release or spray airborne particles of ≤ 10 micrometres in size when the substance is present at ≥ 1% by weight.
  • Distribution for sale thresholds trigger the notice when quantities exceed 10 kg per year for those sprayable products. A transitional threshold of 1,000 kg per year applied until December 10, 2021.
  • Anyone planning such a use must give the Minister 90 days advance notice and provide specified information, including certain inhalation toxicity test data consistent with OECD Test No. 412 or Test No. 413.

• Phthalates screening assessment and next steps

  • The screening assessed a group of phthalates. It concludes that 14 phthalates in the assessed grouping do not meet the criteria in section 64 of CEPA.
  • It concludes that DEHP does meet one or more of those criteria (environmental harm), and the ministers have released a proposed risk management approach for DEHP and will take comments for 60 days.
  • The ministers also say they may use information‑gathering tools to track commercial activity and exposures for 20 phthalate substances.

Who's affected#

• Companies that manufacture, import or use the 22 masked living organisms named by accession number. They may need to confirm whether their strains are on the proposed deletion list or respond during the comment period.
• Chemical manufacturers, formulators and product makers that use the siloxane polymer CSIN 19494-2, especially those who use it in aerosols or other products that create fine airborne particles (cosmetics, sprays, some consumer products).
• Laboratories and contract research organizations that would perform the required inhalation tests (OECD Test No. 412 or 413) and other studies specified in the SNAc.
• Companies that manufacture, import or sell products containing DEHP (a phthalate used as a plasticizer) and other phthalates in the grouping. They may face future regulatory controls, data requests, or market changes from the proposed risk management actions.
• Consumers and workers who may be exposed to aerosols, cosmetics or products that can spray respirable particles — the notices are focused on potential inhalation risks from such uses.

If it’s unclear whether a specific product or organism is covered, affected businesses are encouraged to contact the New Substances program or Environment and Climate Change Canada for confirmation.

Why it matters#

• Public safety and environment: The siloxane SNAc targets uses that can create tiny airborne particles. Those particles can reach the lungs, so the government is asking for more health data before such uses proceed. That protects workers and consumers from potential inhalation hazards.
• Business impact: Firms planning to introduce or expand uses covered by the SNAc must notify regulators 90 days in advance and supply sometimes costly test data. That can delay product launches or prompt reformulation.
• Regulatory signals on phthalates: The finding that DEHP meets CEPA criteria means the government intends to pursue steps to reduce environmental harm from that chemical. That can lead to restrictions, labelling changes, or other controls that affect suppliers of plastics, toys, building materials and other goods that use phthalates.
• Transparency for research and trade in microbes: Deleting organisms from the Domestic Substances List can change whether they are treated as “new” under the New Substances rules, affecting who must notify the government before import or manufacture. Manufacturers should check the confidential accession list if they think they make or import any of the numbered organisms.

If you want to comment or learn more: the notices describe how to submit comments and how industry can request confidentiality where appropriate.