Nine organisms added to Domestic Substances List

Summary#

This is Order 2024-112-01-01 Amending the Domestic Substances List. It adds 9 living organisms to Canada’s Domestic Substances List and was registered on January 18, 2024. Practically, those organisms are no longer treated as “new” under the New Substances Notification Regulations (Organisms).

What it does#

• Adds the following 9 living organisms to Part 5 of the Domestic Substances List:
  • Bacillus licheniformis strain MDG 10-01 N
  • Bacillus licheniformis strain MDG 10-06 N
  • Bacillus subtilis strain MDG 10-39 N
  • Bacillus velezensis strain MDG 10-19 N
  • Bacillus velezensis strain MDG 10-22 N
  • Bacillus velezensis strain MDG B0-50 N
  • Bacillus velezensis strain MDG B0-53 N
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Norway/31694/2022 (H1N1) virus (an A/Victoria/4897/2022 (H1N1)-like virus) N
  • Recombinant human T-cells transduced with a non-replicative lentiviral vector expressing a chimeric antigen receptor binding the human B-cell CD19 antigen (ALLO-501A) N
• Because they are now on the Domestic Substances List, these organisms are no longer subject to the notification rules in the New Substances Notification Regulations (Organisms).
• The Order came into force on the day it was registered (January 18, 2024).

Who's affected#

• Businesses, manufacturers or importers that handle these specific organisms in Canada.
• Research labs, biotechnology and pharmaceutical groups that work with these strains or the listed cell therapy.
• Most members of the public are unlikely to notice any difference; the government says the change is administrative and does not create new rules or costs.

Why it matters#

• Being on the Domestic Substances List means these organisms are no longer treated as “new” for regulatory notification purposes. That can make it easier and faster for companies and researchers to bring them into use in Canada.
• This is an administrative change, not a statement that the government endorses the organisms’ safety. The Order does not remove other applicable laws or safety rules (for example, health, biosafety, or product-specific regulations).
• The government says the change does not add costs or new obligations for businesses.