Part IPublic NoticePublished: November 19, 2022

Notification for new SOPP cosmetic uses

Canada Gazette, Part I, Volume 156, Number 47: GOVERNMENT NOTICES

This notice (published 2022-11-19) announces the intent to amend the Domestic Substances List under CEPA so that Significant New Activity (SNAc) rules apply to sodium ortho-phenylphenate (SOPP, CAS RN 132-27-4). If adopted, manufacturers or importers would need to file a Significant New Activity Notification (SNAN) at least 90 days before using SOPP in leave-on cosmetics above 0.1% or importing more than 10 kg/year in such cosmetics; the public had 60 days to comment.

Published
November 19, 2022
Department
Unavailable
Section
DEPARTMENT OF THE ENVIRONMENT
Comment deadline
January 18, 2023
Effective date
Unavailable
Publication part
Part I

Summary

Summary#

This notice, published on November 19, 2022, says the government plans to change the Domestic Substances List under the Canadian Environmental Protection Act, 1999 so that new or different uses of the chemical sodium ortho-phenylphenate (SOPP) (CAS RN 132-27-4) would trigger a prior notification requirement. The screening assessment found SOPP does not currently meet the law’s test for taking immediate action, but the government wants to collect information before certain cosmetic uses begin. Public comments are invited for 60 days.

What it does#

  • Announces an intent to amend the Domestic Substances List so that the Significant New Activity (SNAc) rule (subsection 81(3) of the Act) applies to sodium ortho-phenylphenate (SOPP) (132-27-4).
  • Targets use of SOPP in cosmetics that stay on the skin (leave‑on products). Notification would be required when:
    • SOPP is present in a cosmetic at more than 0.1% by weight, or
    • SOPP is imported in cosmetics at more than 10 kg in a calendar year when the product concentration is over 0.1% by weight.
  • Exempts rinse‑off cosmetics, small‑quantity imports (≤ 10 kg per year), low‑concentration uses (≤ 0.1% by weight), research and development uses, site‑limited intermediates, and export‑only products.
  • Anyone proposing a covered new activity would have to submit a Significant New Activity Notification (SNAN) with detailed information — for example, the planned use, quantities, product description, likely sites, and available test data — at least 90 days before starting the activity.
  • The screening assessment concluded no immediate action under section 64 of CEPA is needed now, but the SNAc approach is being used to prevent unassessed uses from creating health concerns.

Who's affected#

  • Companies that make, import, formulate or sell cosmetics in Canada, especially those making leave‑on products (creams, lotions, etc.).
  • Importers of products that contain SOPP.
  • Suppliers, manufacturers and distributors of ingredients and finished cosmetic products.
  • Researchers and firms using SOPP only for research and development, site‑limited intermediates, or export‑only goods are excluded from the notification requirement.
  • The notice was prepared by the Department of the Environment and the Department of Health; these departments will assess any notifications.

Why it matters#

  • If you sell or plan to start using SOPP in leave‑on cosmetics above the thresholds, you will likely need to notify the government and wait for assessment. That can delay introducing a product or require more testing and data gathering.
  • The government reached this step because lab studies have shown health effects of concern (including an increased incidence of urinary bladder tumours in animal studies). Although current uses (for example in bar soap and some lubricants) were not judged to pose a human‑health or environmental risk now, new ways of using the chemical could change exposure.
  • The SNAc rule is a preventive tool. It forces companies to give regulators information before novel or higher‑exposure uses start, so potential risks can be checked early.

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances ListDSLSignificant New ActivitySNAcSignificant New Activity NotificationSNANsodium ortho-phenylphenateSOPPCAS RN 132-27-4Environment and Climate Change CanadaHealth Canadacosmeticsleave-on cosmetics

Source: Canada Gazette

Official source