Coumarin 1 and PHMB flagged

Summary#

The Department of the Environment and the Department of Health published screening assessments that found the chemical known as coumarin 1 (CAS RN 91-44-1) and the antimicrobial PHMB may pose a risk to human health and could be recommended for addition to Schedule 1 of the Canadian Environmental Protection Act, 1999.
Health Canada also launched a public consultation on proposed fees for natural health products, open for 75 days, with fees planned to start on April 1, 2025.

What it does#

• For coumarin 1 (2H-1-benzopyran-2-one, 7-(diethylamino)-4-methyl-, CAS RN 91-44-1):
  • The screening assessment concluded it meets at least one test in section 64 of the Canadian Environmental Protection Act, 1999 (meaning a potential danger to human health).
  • The ministers propose to recommend adding the substance to Schedule 1 and released a proposed risk management approach for public comment (comment period 60 days after publication of that document).
• For the "Other Polymers Group" (four substances):
  • DGEBA-DA resin, soya alkyd resin, and polyurethane-33 were found NOT to meet the health-or-environment criteria and no further action is proposed now.
  • PHMB (polyaminopropyl biguanide; CAS RN 32289-58-0 and equivalent 27083-27-8) was found to meet the criteria in section 64. The ministers propose to recommend adding PHMB to Schedule 1 and released a proposed risk management approach for comment (comment period 60 days).
• On natural health products (NHPs):
  • Health Canada signaled intent to introduce fees to cover regulatory work under the Natural Health Products Regulations.
  • The proposal sets three fee types: site licence (SL) fees, right to sell (RTS) fees, and pre-market evaluation fees.
  • The fee proposal is open for public comment for 75 days (ending July 26, 2023) and, if finalized, fees are planned to take effect April 1, 2025. The proposal includes small-business mitigation measures.
• Other items in the Gazette include decisions and documents posted by Innovation, Science and Economic Development Canada about spectrum licensing (for example the 3900–3980 MHz band and some millimetre-wave bands).

Who's affected#

• Companies that make, import, formulate or sell:
  • cosmetics and personal-care items (temporary hair dyes, nail polish, makeup, sprays) that may contain coumarin 1 or PHMB;
  • cleaning products, carpet cleaners, and other consumer products listing these substances.
• Natural health product manufacturers, sellers, and small businesses that will face the proposed site licence, right to sell, or pre-market evaluation fees.
• Consumers, especially children and people who use specialty body makeup or sprayable products, since the assessments flagged potential exposure risks for some uses.
• Telecom and local wireless planners and businesses affected by spectrum licensing changes (document from Innovation, Science and Economic Development Canada).

Why it matters#

• If coumarin 1 or PHMB are added to Schedule 1, federal risk-management actions (for example limits, restrictions or bans) can be developed. That could change what products are allowed on store shelves, how products are formulated, or how they are labelled.
• Businesses that use these chemicals may need to reformulate products, change suppliers, or comply with new controls. That can affect costs and product availability.
• The proposed NHP fees would shift some regulatory costs from public funding to industry. That could raise operating costs for NHP firms and might affect small producers despite proposed mitigation measures.
• The public still has a chance to comment: the chemical risk-management approaches have 60‑day comment periods, and the NHP fees consultation runs for 75 days (ended July 26, 2023). Public input can influence final rules or fee designs.