Four Organisms Added to Domestic Substances List

Summary#

Order 2026-112-03-01 Amending the Domestic Substances List: SOR/2026-52 adds four living organisms to Canada’s inventory of substances. The order was registered on March 18, 2026 and published in the Canada Gazette on April 8, 2026; it came into force on registration.

What it does#

• Adds two named organisms to Part 5 of the Domestic Substances List:
  • Recombinant replication-incompetent adeno-associated viral vector serotype 9 expressing β-hexosaminidase genes (ssAAV9-CAG-HEXBP2AHEXA)
  • Unmodified UM171-expanded human hematopoietic stem cells
• Adds two masked-name organisms to Part 7 of the List (listed by confidential accession numbers and short descriptions):
  • 19815-3 N — Unmodified staphylococcal bacteriophage 1 for treating infections in humans
  • 19816-4 N — Unmodified staphylococcal bacteriophage 2 for treating infections in humans
• Because these organisms are now on the Domestic Substances List, they are no longer subject to the pre-market notification requirements under the New Substances Notification Regulations (Organisms).

Who's affected#

• Researchers, biotech developers and companies working with gene therapy vectors, stem-cell products, or bacteriophages.
• Hospitals, clinics and clinical-trial sponsors that might import or manufacture these specific organisms for research or treatment.
• Importers or manufacturers who previously had to file new-substance notifications for these exact organisms.
• The general public is indirectly affected if these organisms are used in health treatments; the order itself does not change other approval processes.

Why it matters#

• Adding these organisms to the List removes the specific pre-market notification hurdle under the new-substances rules. That can make it quicker and easier for the named products to be brought into Canada for research, development, or treatment.
• This is an administrative step, not a safety approval. The government says the substances were assessed and are not suspected of being toxic, but the order does not amount to an endorsement and does not replace other permits or approvals that may still be required under health or safety laws.