SNAc for Bacillus P6T48; chlorocresol decision

Summary#

On May 22, 2021, the Government published Environment notices in the Canada Gazette that do three things: it issues Significant New Activity Notice No. 20598 for the bacterium Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48, it announces the final screening assessment for the chemical phenol, 4-chloro-3-methyl (chlorocresol) under the Canadian Environmental Protection Act, 1999, and it amends the Non‑domestic Substances List by removing four CAS numbers via Order 2021-87-06-02 Amending the Non‑domestic Substances List. The SNAc and the chlorocresol decision both create new regulatory steps for certain uses and may lead to further controls.

What it does#

• Significant New Activity Notice for the bacterium

  • Declares that any use of Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 outside a few narrow uses is a "significant new activity."
  • The allowed, non‑significant uses listed are:
    • in cleaning or degreasing products not applied to natural environments;
    • controlling odours in dumpsters and trash compactors; and
    • treating water in artificial aquatic environments (e.g., aquariums, ornamental ponds).
  • Exemptions include limited research uses, production in contained facilities, and sale/distribution for the allowed uses.
  • Anyone planning a significant new activity must submit a notification (SNAN) at least 120 days before starting and provide specified test data, including tests following Environment and Climate Change Canada guidance and OECD good‑laboratory‑practice standards. The government will assess the submission within 120 days.

• Final screening assessment for chlorocresol

  • Concludes that chlorocresol meets one or more criteria of section 64 of the Canadian Environmental Protection Act, 1999 (specifically a potential danger to human life or health).
  • A proposed risk management approach for chlorocresol is being released and is open for comment for 60 days.
  • The assessment notes low volumes reported in Canada (imports in 100 to 1 000 kg range in the survey year) but finds that exposure from some consumer uses (for example, certain body lotions) could be of concern, especially for infants.

• Amendment to the Non‑domestic Substances List

  • Order 2021-87-06-02 removes these CAS numbers from Part I of the Non‑domestic Substances List: 27289-84-5, 68512-17-4, 76326-99-3, 86013-04-9.
  • That Order takes effect when a companion Order changing the Domestic Substances List comes into force (no specific date given in the notice).

Who's affected#

• Companies and labs that use, import, manufacture, or sell the bacterium Bacillus amyloliquefaciens... strain P6T48 for new or expanded purposes (for example, in agriculture, aquaculture, wastewater treatment, bioremediation, or industrial applications).
• Researchers and product developers who work with that bacterium; some small‑scale research uses are exempt but others will need advance notification.
• Manufacturers, importers and sellers of products that contain chlorocresol, including some body moisturizers, licensed natural health products, pharmaceuticals, and certain concrete admixtures — they may face new restrictions or requirements if risk management is adopted.
• Firms handling the substances identified by the four CAS numbers may notice a change in their reporting or regulatory status because those entries were deleted from the Non‑domestic Substances List.

If it’s unclear whether a specific activity or product is affected, the notice says the information and definitions in the regulations should be used to determine applicability.

Why it matters#

• For businesses and researchers: the SNAc means extra lead time, testing and information requirements before using the bacterium in ways outside the listed low‑risk uses. That can add cost and delay to product development or deployment.
• For consumers and health professionals: the chlorocresol finding signals the government sees a potential health concern from some uses. A formal risk‑management process is starting, which could lead to limits or labelling changes for products that contain it.
• For environmental oversight: removing substances from one list and adjusting the Domestic/Non‑domestic Lists affects which regulatory pathway applies to a substance. This can change notification, assessment, and management duties for companies.
• If you are a business, researcher, or product-supplier affected by any of these items, you should look at the full notices and timelines on the Canada.ca Chemical Substances pages or contact Environment and Climate Change Canada for details.