Adds two organisms to Domestic Substances List

Summary#

Order 2025-112-01-01 Amending the Domestic Substances List adds two living organisms to Canada’s inventory of substances. The order was registered on December 6, 2024 and therefore came into force on that date.

What it does#

• Adds these two living organisms to the Domestic Substances List:
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Thailand/8/2022 (H3N2)-like virus
  • Modified human T‑cells expressing a GPRC5D-directed chimeric antigen receptor (listed with the identifier 19745-3 N)
• Once added, those specific organisms are no longer subject to the New Substances Notification Regulations (Organisms), which govern pre‑import or pre‑manufacture notification and assessment for new organisms.
• The order is administrative: it takes effect on the day it was registered (December 6, 2024) and does not mean the government is endorsing the organisms or exempting them from other federal, provincial, or sectoral rules.

Who's affected#

• Companies, research groups or clinical developers that have already manufactured or imported these exact organisms into Canada.
• Organizations planning to import, manufacture or use these organisms (for example, vaccine researchers or developers of cell therapies) will notice the regulatory change.
• Regulators and public health or laboratory facilities that handle or oversee biological materials.
• If it is unclear whether a similar but different strain or cell product is covered, those parties should check the exact listing or contact regulators.

Why it matters#

• Being on the Domestic Substances List means these two organisms no longer require the specific pre‑notification process under the New Substances Notification Regulations (Organisms). That can make it faster or simpler for businesses and labs that deal with the listed organisms to operate in Canada.
• This is mainly an administrative change. It does not say the organisms are safe or unsafe, and other laws or safety requirements (for example, health, clinical trial, workplace biosafety or import controls) may still apply.
• If you work with or regulate biological materials, this change may affect how you plan imports, research or manufacturing involving these particular organisms.