OCU400 added to Domestic Substances List

Summary#

Order 2025-112-07-01 Amending the Domestic Substances List adds one living organism to Canada’s inventory of existing substances. The organism added is Recombinant and non-replicative adeno-associated virus serotype 5 encoding a human NR2E3 gene (OCU400). The order was registered on August 29, 2025 and published in the Canada Gazette on September 10, 2025.

What it does#

• Adds the named organism to Part 5 of the Domestic Substances List.
• Records that the federal ministers reviewed the information about the organism under the Canadian Environmental Protection Act, 1999 and found the requirements for adding it to the list were met.
• As a result, the organism is no longer treated as a "new substance" under the New Substances Notification Regulations (Organisms).
• The order came into force on the date of registration (August 29, 2025).
• The order does not mean the government endorses the organism or removes any other legal or regulatory requirements that may apply.

Who's affected#

• Companies, research labs and contract manufacturers that make, import or work with the specific virus listed (for example, groups developing gene therapies or doing related lab work).
• The person or company that provided the original information to the government (the record shows it had already been manufactured or imported by that party).
• Regulators and reviewers who track what is and isn’t considered "new" under Canada’s chemical and organism notification rules.
• The broader public is unlikely to notice any immediate change unless they are involved with the specific product or activity.

Why it matters#

• Being on the Domestic Substances List means the organism is no longer subject to pre‑market notification rules for new organisms. That can reduce administrative steps for the party already using or importing it.
• It does not mean the organism is judged “safe” in every use or freed from other approvals (for example, health, clinical trial or other regulatory requirements may still apply).
• The change is mainly an administrative step that affects how future government notifications and assessments apply to this specific organism.