Living organism added to Domestic Substances List

Summary#

Order 2026-112-11-01 Amending the Domestic Substances List adds a named living organism to Canada’s public inventory of substances. The named organism, Recombinant human T‑cells transduced with a replication‑deficient lentiviral vector containing an anti‑BCMA/4‑1BB/CD3zeta chimeric antigen receptor (KITE‑772), was added to the Domestic Substances List and the order came into force on September 8, 2026. As a result, that organism is no longer treated as a “new” substance under the New Substances Notification rules for organisms.

What it does#

• Adds the living organism Recombinant human T‑cells… (KITE‑772) to Part 5 (“Organisms”) of the Domestic Substances List.
• The order took effect on the registration date: September 8, 2026.
• Because it is now on the list, the organism is no longer subject to the New Substances Notification Regulations (Organisms) notification and assessment steps that apply to new organisms.
• The federal ministers responsible — the Minister of the Environment and the Minister of Health — reviewed the information submitted about this organism and had no conditions in place that would block its addition.

Who's affected#

• Businesses that manufacture or import the specific organism named in the order.
• Any organizations that handle, ship or otherwise work with that exact living organism may notice the administrative change.
• It is not clear from the order which companies, research groups or clinical programs are directly involved; the text only names the organism itself.

Why it matters#

• Putting the organism on the Domestic Substances List generally reduces the paperwork and pre‑import/manufacture notification steps that apply to new substances. That can make it easier for companies to bring the organism into Canada or to continue using it.
• This is an administrative change, not a safety approval or endorsement. The government says the order does not replace any other legal rules or approvals that might apply to activities involving the organism.
• For the public, the main takeaway is that regulators reviewed the information submitted and decided the organism should be treated as already existing in the Canadian marketplace rather than as a new substance.