Part IIOrderPublished: November 22, 2023

Organisms added to Domestic Substances List

Order 2023-112-10-01 Amending the Domestic Substances List: SOR/2023-234

Order 2023-112-10-01 adds five living organisms to the Domestic Substances List under the Canadian Environmental Protection Act, 1999, so they are no longer treated as “new substances” under the New Substances Notification Regulations (Organisms). The additions include cattle descended from a cloned Bos taurus (Breed: Holstein) and four genetically modified Pristella maxillaris founder lines expressing orange, red, green or purple fluorescent proteins. The order took effect on 2023-11-08 and is administrative in nature, not imposing new controls.

Published
November 22, 2023
Department
Unavailable
Section
Order 2023-112-10-01 Amending the Domestic Substances List
Comment deadline
Unavailable
Effective date
November 8, 2023
Publication part
Part II

Summary

Summary#

Order 2023-112-10-01 Amending the Domestic Substances List adds several living organisms to Canada’s inventory of substances under the Canadian Environmental Protection Act, 1999. The change means these specific organisms are now listed on the Domestic Substances List and are no longer treated as “new substances” for the purposes of Canada’s new-substance notification rules. The order took effect on November 8, 2023.

What it does#

  • Adds 5 living organisms to the Domestic Substances List:
    • Cattle descended from a cloned Bos taurus (Breed: Holstein) — added to Part 5 (listed with an N flag).
    • Four genetically modified Pristella maxillaris entries (founder lines expressing fluorescent proteins) — added to Part 7 with the identifiers 19681-9, 19682-0, 19683-1, and 19684-2 (each listed with an N flag).
  • Because they are now on the Domestic Substances List, these organisms are no longer subject to the New Substances Notification Regulations (Organisms).
  • The order is administrative: it does not add new controls or safety rules for these organisms.

Who's affected#

  • Companies or institutions that import, breed, or manufacture these specific organisms in Canada.
  • Research labs, aquaculture facilities, and animal-breeding operations that work with these listed organisms.
  • Regulators and people who handle environmental or health reviews of biological imports.
  • The general public is unlikely to notice immediate changes; the listing mainly affects regulatory paperwork for businesses and researchers.

Why it matters#

  • Being listed on the Domestic Substances List removes the requirement for new-substance notification under CEPA for these organisms. That can make it easier for the businesses and researchers who work with them to bring them into or use them in Canada.
  • The order does not mean the government endorses these organisms, nor does it remove other legal obligations: other federal, provincial, or municipal laws (for example animal health, food safety, or environmental release rules) may still apply.
  • The change is administrative and intended to reflect that these organisms have already been manufactured in or imported into Canada and assessed as required under CEPA.

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances ListNew Substances Notification Regulations (Organisms)Pristella maxillarisBos taurus (Holstein)genetically modified organismsEnvironment and Climate Change CanadaHealth Canadafluorescent proteinOPM-0RPM-0GPM-0PPM-0

Source: Canada Gazette

Official source