Prevotella histicola ES894 N Listed

Summary#

This is an order — Order 2022-112-06-01 Amending the Domestic Substances List — that adds the living organism Prevotella histicola strain ES894 N to the Domestic Substances List. The order came into force on registration (July 26, 2022) and was published in the Canada Gazette on August 17, 2022.

What it does#

• Adds Prevotella histicola strain ES894 N to Part 5 of the Domestic Substances List.
• Because it is now on the list, the organism is no longer treated as a “new” substance under the federal notification rules — specifically the New Substances Notification Regulations (Organisms) — so the pre-notification/assessment requirements that apply to new organisms no longer apply to this strain.
• The government says it made the change after reviewing information from the person who manufactured or imported the organism and finding the criteria for addition were met.

Who's affected#

• Companies or people who make, import, sell or distribute Prevotella histicola strain ES894 N, including biotech suppliers and product manufacturers.
• Research, clinical, or diagnostic labs that use this strain.
• Regulators and anyone dealing with permitting or pre-market notification for new organisms will see one fewer item subject to those specific notification rules.

It is not clear from the order how many businesses or labs in Canada use this strain, so the practical reach may be small or large depending on current commercial or research use.

Why it matters#

• For businesses and researchers working with this strain, this removes a federal pre-notification step and can make it easier to import, manufacture, or use the organism in Canada.
• The change is administrative: it does not mean the federal government is endorsing the organism, and other laws or safety rules may still apply to activities that involve it.