16 Living Organisms Added to Domestic List

Summary#

Order 2026-112-05-01 Amending the Domestic Substances List (registered as SOR/2026-85) adds 16 living organisms to the Domestic Substances List under the Canadian Environmental Protection Act, 1999. The order was signed by Julie Dabrusin, registered on May 13, 2026, and published on June 3, 2026; it comes into force on the day it was registered.

What it does#

• Adds two organisms to Part 5 of the Domestic Substances List:
  • Adeno-associated virus 2 vector encoding human aquaporin 1 (rAAV2-hAQP1)
  • Carnobacterium divergens M35
• Adds fourteen entries to Part 7 (listed with their confidential accession numbers):
  • 19817-5 — Saccharomyces species YS223-F7
  • 19821-9 — Unmodified Pseudomonas bacteriophage 1 for treating infections in humans
  • 19822-0 — Unmodified Pseudomonas bacteriophage 2 for treating infections in humans
  • 19823-1 — Unmodified Morganella morganii bacteriophage 1 for treating infections in humans
  • 19824-2 — Phage QP-STA-003 targeting Staphylococcus aureus
  • 19825-3 — Phage QP-STA-005 targeting Staphylococcus aureus
  • 19826-4 — Phage QP-ECO-022 targeting Escherichia coli
  • 19827-5 — Pseudomonas species bacteriophage QP-PSA-006
  • 19828-6 — Pseudomonas species bacteriophage QP-PSA-007
  • 19829-7 — Pseudomonas species bacteriophage QP-PSA-009
  • 19830-8 — Phage QP-PSA-001 targeting Pseudomonas aeruginosa
  • 19831-9 — Phage QP-PSA-002 targeting Pseudomonas aeruginosa
  • 19832-0 — Phage QP-PSA-017 targeting Pseudomonas aeruginosa
  • 19833-1 — Phage QP-PSA-018 targeting Pseudomonas aeruginosa
• Practical regulatory effect:
  • Once a substance is added to the Domestic Substances List, it is no longer considered “new to Canada” for the purposes of the New Substances Notification Regulations (Organisms). That means these specific organisms are no longer subject to those pre-import or pre-manufacture notification requirements.

Who's affected#

• Companies, researchers, and labs that import, manufacture or develop the listed organisms in Canada. This likely includes:
  • biotech and pharmaceutical firms working with viral vectors or bacteriophages,
  • clinical developers of phage therapies,
  • industrial or food-related yeast users for the Saccharomyces entry,
  • research institutions handling these strains.
• Regulators and compliance officers who track whether a substance is subject to notification rules.
• It is not always clear which specific businesses are affected; the order lists the organisms and confidential accession numbers but does not name commercial sponsors.

Why it matters#

• For businesses and researchers, being on the Domestic Substances List generally removes the need for the specific new-substance notifications that apply to organisms. That can simplify bringing these particular organisms into use in Canada.
• The government reviewed the submitted information and decided these organisms meet the criteria to be added. The regulatory statement notes this does not imply government endorsement and that other laws may still apply.
• Officials also said adding these items does not create new regulatory costs and that the additions are not expected to lower environmental or human-health protection.