Two organisms added to Domestic Substances List

Summary#

Order 2026-112-09-01 Amending the Domestic Substances List adds two living organisms to the Domestic Substances List under the Canadian Environmental Protection Act, 1999. The change means those organisms are no longer subject to the pre‑market notification rules in the New Substances Notification Regulations (Organisms); the order came into force on July 22, 2026 and was published in the Canada Gazette on August 12, 2026.

What it does#

• Adds these two living organisms to Part 5 of the Domestic Substances List:
  • KAN-004 consortium containing human gastrointestinal bacteria
  • Recombinant, non-replicating adeno-associated virus serotype 8 (AAV8) vector encoding human miniaturized dystrophin protein, microdystrophin (RGX-202)
• Records that the Minister of the Environment and the Minister of Health reviewed information about these organisms and concluded the criteria for adding them to the list were met.
• Removes the requirement for the persons who provided the information to follow the notification steps in the New Substances Notification Regulations (Organisms) for these specific organisms.
• The order is administrative — it does not create new rules or endorse the substances.

Who's affected#

• The companies or people who manufactured or imported these organisms into Canada and who supplied the required information to the government.
• Biotech and life‑sciences firms, research labs, contract‑manufacturers, and health companies working with AAV‑based gene therapies or human gut microbiome products.
• Regulators and service providers who help firms with new‑substance notifications.
• If it’s unclear whether a particular product or strain is the same as one listed here, affected parties should check with Environment Canada; the Gazette item lists the exact organism names.

Why it matters#

• Being on the Domestic Substances List means these particular organisms are no longer subject to the special pre‑market notification process for new organisms, which can remove a regulatory step for businesses that work with them.
• This can make it easier for authorized manufacturers and importers to continue or expand work involving these organisms in Canada.
• The order is not a safety endorsement and does not remove other legal or regulatory obligations (for example, health, safety, transport, or clinical trial rules still apply).
• The government statement says the assessed information did not indicate these organisms were suspected of being toxic or becoming toxic.