Two biotech organisms added to Domestic Substances List

Summary#

The government added two living organisms to the Domestic Substances List through Order 2021-112-12-01 Amending the Domestic Substances List. The order was registered on December 21, 2021 and published in the Canada Gazette on January 5, 2022; it came into force on the registration date. The order was signed by Steven Guilbeault, Minister of the Environment.

What it does#

• Adds these two living organisms to Part 5 of the Domestic Substances List:
  • Non-replicating recombinant adeno-associated virus containing AAV9 capsid and a codon-optimized expression cassette encoding OptiDysΔ3978 (mini-dystrophin) (PF-06939926)
  • Recombinant human mesenchymal stromal cells with a non-viral plasmid expressing the angiopoietin and acyloxyacyl hydrolase genes (GEM00220)
• Because they are now on the Domestic Substances List, these specific organisms are no longer subject to the New Substances Notification Regulations (Organisms) for new-substance notification.
• The change is administrative: it does not mean the government is endorsing the substances, and other laws or rules that apply to their use (for example, health or safety rules) still apply.

Who's affected#

• Companies or organizations that manufacture or import these exact biological products. (The order refers to the entities that previously submitted required information, but does not name them.)
• Researchers, clinics, or health developers working with these specific viral vectors or engineered cell products may notice fewer administrative steps related to new-substance notification.
• Regulators who track which substances are on the Domestic Substances List.

Why it matters#

• Being added to the Domestic Substances List removes the requirement for the specific notification process for new organisms under the New Substances rules. That can make it administratively easier for the firms that make or import these exact products to continue supplying or working with them in Canada.
• This is an administrative step, not a safety approval. Other regulatory requirements (for example for drugs, clinical trials, or biosafety) can still apply.