Permit to Manufacture Confidential Polymer

Summary#

The federal Environment Minister has allowed the manufacture or import of a specific industrial polymer — 2-propenoic acid, 2-methyl-,2-hydroxyethyl ester, polymer with hexadecyl 2-propenoate, octadecyl 2-propenoate and polyfluoroalkyl 2-methyl-2-propenoate (Confidential Substance Identity Number 19721-9) under the Canadian Environmental Protection Act, 1999. That permission comes with a set of conditions and record-keeping rules and took effect on May 23, 2024.

What it does#

• Allows the person who notified the government (the “notifier”) to manufacture or import the substance, but only if they follow the listed conditions.
• Requires the notifier to tell the Minister in writing at least 120 days before starting manufacture in Canada and to provide:
  • the expected annual quantity and the manufacturing facility address;
  • details about how the substance will be transported and stored, container types, likely environmental release points, releases to municipal wastewater, disposal methods, past and likely uses, and any factors that would limit environmental exposure;
  • information about the manufacturing process, including precursors, reaction stoichiometry, whether the process is batch or continuous, a process flow diagram, major steps, entry and release points, and ways to prevent environmental release;
  • a summary of all test data and other information the notifier has about hazards and exposure.
• If the substance is released during manufacture or in products, the notifier must immediately stop further release, limit its spread, and inform an enforcement officer as soon as reasonably possible.
• Before giving the substance to anyone else, the notifier must give that person written notice of these conditions and obtain written confirmation that they were informed.
• Record-keeping requirements:
  • keep records of uses; quantities manufactured, imported, purchased, distributed, sold and used; names and addresses of anyone who receives the substance; and the written confirmations from recipients;
  • update recipient-address records within 30 days of any change and create records within 30 days after the information becomes available;
  • store records in English or French at the notifier’s principal place of business in Canada (or their Canadian representative) and keep them for at least five years;
  • electronic records must be in a readable electronic format.

Who's affected#

• Primarily the notifier named in the Canada Gazette notice (the company or person who submitted information on March 26, 2024) and any other company that manufactures, imports, or receives this exact substance in Canada.
• Companies involved in transporting, storing, disposing of, or using products that contain this substance may also be affected, because they will need to follow the transfer and information rules.
• It is not clear from the notice whether other entities (for example, downstream product manufacturers who did not receive written confirmation) are directly regulated beyond the record and transfer rules.

Why it matters#

• The government suspects this substance may be harmful to the environment or health under the Canadian Environmental Protection Act, 1999, so it is allowing limited activity but with tight reporting and safety conditions.
• The rules force early sharing of manufacturing and exposure details. That helps regulators watch for risks before production begins.
• The record-keeping and immediate-response rules aim to reduce the chance of unreported environmental releases and make it easier to trace who handled the substance.
• For businesses, these conditions add compliance steps before starting manufacture or import, and for communities they mean more information and some safeguards if the substance is used locally.