Viral vectors added to Domestic Substances List

Summary#

The government issued Order 2023-112-11-01 Amending the Domestic Substances List to add 2 living organisms to the Domestic Substances List. The order was registered on November 24, 2023 and published in the Canada Gazette on December 6, 2023. As a result, these organisms are no longer subject to pre‑market notification under the New Substances Notification Regulations (Organisms).

What it does#

• Adds 2 living organisms to Part 5 of the Domestic Substances List:
  • Recombinant and non-replicative adeno-associated virus serotype 8 (rAAV8), producing the aflibercept protein (NG101)
  • Recombinant replication-defective chimpanzee adenovirus ChAdOx1 expressing the glycoprotein E gene from the varicella-zoster virus (ChAdOx1‑VZV)
• Because those organisms are now listed, they are no longer subject to notification and assessment requirements under the New Substances Notification Regulations (Organisms).
• The order came into force on the day it was registered (November 24, 2023).

Who's affected#

• Biotech companies, research labs and manufacturers that make, import or work with these specific viral vectors or related products.
• Developers of gene therapies, biologics, vaccines or research tools that use these organisms.
• Regulators and consultants who advise on new‑substance notification and import requirements.
• If it is unclear whether a particular product or activity involves these organisms, businesses should check the exact names on the Domestic Substances List or contact the regulator.

Why it matters#

• Practically, listed organisms do not need a new‑substance notification under the New Substances rules, which can reduce administrative steps for businesses already manufacturing or importing them.
• This is an administrative change under the Canadian Environmental Protection Act, 1999 and is not a safety approval, endorsement, or exemption from any other federal, provincial or municipal laws (for example, health or biosafety rules still apply).
• The government says the change is intended to reflect substances that have already been introduced to Canada and does not create new regulatory costs.