Siloxane Allowed Under Conditions; Zuranolone Proposal

Summary#

• Ministerial Condition No. 22407 under the Canadian Environmental Protection Act, 1999 allows one identified company (the “notifier”) to manufacture or import a specific siloxane chemical (CAS RN 3086114-77-1) but only under strict conditions and record-keeping rules.
• Health Canada is proposing to add zuranolone to Schedule IV of the Controlled Drugs and Substances Act and is asking for public comments until April 18, 2026.

What it does#

• For the siloxane substance (full chemical name: siloxanes and silicones, di‑Me, Me 3‑(2‑oxiranylmethoxy)propyl, Me 3,3,3‑trifluoropropyl; CAS RN 3086114-77-1):
  • The named notifier may manufacture or import the substance, but only while following the listed conditions.
  • The notifier must immediately stop and limit any environmental release and notify emergency or enforcement contacts if a release occurs.
  • Before handing the substance to anyone else, the notifier must give them the written terms of the conditions and get written confirmation that they will follow them.
  • The notifier must keep records showing how the substance is used, quantities made/imported/sold, who received it, and the written confirmations. Records must be kept at the notifier’s Canadian principal place of business for at least five years, be available in English and/or French, and be created or updated within 30 days when new information arrives.
  • These ministerial conditions came into force on January 27, 2026.
• For zuranolone:
  • Health Canada proposes to list zuranolone in Schedule IV of the Controlled Drugs and Substances Act and to regulate it as a targeted substance.
  • If scheduled, activities like producing, selling, transporting, importing or exporting zuranolone would generally require a controlled‑substances licence and import/export permits for each shipment.
  • Research or clinical trials with zuranolone would need an exemption from Health Canada.
  • Zuranolone is already a prescription drug (sold as ZURZUVAE™), and it would remain prescription‑only; Health Canada plans a transitional period to ease changes to labelling and the supply chain.
  • The public comment period for this proposal is open until April 18, 2026.

Who's affected#

• For the siloxane condition:
  • The notifier named in the notice (the company that filed information on December 12, 2025) and any businesses that receive the chemical from that notifier.
  • Facilities that handle, store, ship, or dispose of this specific chemical may be asked for documentation or to follow the notifier’s conditions.
• For the zuranolone proposal:
  • People who prescribe or dispense ZURZUVAE™ (doctors, pharmacists) and the drug’s manufacturer and distributors.
  • Researchers and clinical trial sponsors working with zuranolone, who would need exemptions or licences.
  • Law enforcement and border agencies, because scheduling gives them more tools to act against illegal diversion or importation.
  • Patients prescribed zuranolone may notice administrative or labelling changes; the notice does not say access to the drug will be stopped.

Why it matters#

• The siloxane condition shows the government allowing limited manufacture/import while aiming to control environmental and downstream risks through quick‑response duties and multi‑year record‑keeping. That matters for nearby communities, waste handlers, and any businesses in the supply chain.
• Scheduling zuranolone responds to concerns about misuse and dependence (Health Canada compares its risks to some benzodiazepines). If added to Schedule IV, there will be more regulatory steps for companies and researchers, and stronger enforcement tools to prevent illegal diversion. Health Canada is seeking public feedback until April 18, 2026, so stakeholders can weigh in before any final regulatory change.