Two edited human cell organisms added

Summary#

Order 2025-112-08-01 Amending the Domestic Substances List adds two living organisms to Canada’s inventory of substances, meaning those specific organisms are no longer treated as “new” under federal new‑substance rules. The order came into force on August 29, 2025 and was published in the Canada Gazette on September 10, 2025.

What it does#

• Adds these two living organisms to the Domestic Substances List:
  • Human CD34+ hematopoietic stem cells prime edited ex vivo to correct delGT genetic mutations on the NCF1 gene (PM359) — listed under Part 5 (Organisms/Organismes).
  • Human T-cells transduced with a replication-deficient lentiviral vector encoding a chimeric antigen receptor targeting a human B-cell surface antigen (CLIC-2201) — listed with identifier 19786-4 in Part 7.
• Because they are now on the List, these two organisms are no longer subject to the notification and assessment steps in the New Substances Notification Regulations (Organisms) that apply to substances new to Canada.
• The ministers assessed the information required by the law and found no conditions were in effect that would block the addition. The order does not create new rules or approvals for other laws.

Who's affected#

• Organizations that make, import, or work with these specific edited human stem cells or these CAR‑T‑style human T‑cells — for example, biotechnology companies, research labs, or clinical developers — will notice the change because they no longer face the “new substance” notification requirement for these items.
• Hospitals, researchers, and suppliers involved in producing or using these exact organisms could be affected in how they manage regulatory paperwork.
• The order does not automatically change requirements under other laws (health, clinical trials, human tissue rules). It’s not always clear from the order which specific uses (research, clinical therapy, manufacturing) will be impacted; other federal or provincial rules may still apply.

Why it matters#

• Being added to the Domestic Substances List removes a regulatory step that applies only to substances new to Canada. That can make it administratively easier and faster for the organizations named above to bring these exact organisms into use in Canada.
• The Canada Gazette notice says this is an administrative action based on an assessment; it is not a government endorsement of safety, nor does it exempt the organisms from other laws or safety requirements.
• The change is limited in scope: it applies only to the two named organisms and does not create broader new rules or costs for businesses.