Three organisms added to Domestic Substances List

Summary#

Order 2023-112-07-01 Amending the Domestic Substances List adds three living organisms to Canada’s inventory of substances. The order was registered on June 22, 2023 and published in the Canada Gazette on July 5, 2023.

What it does#

• Adds three named living organisms to Part 5 of the Domestic Substances List:
  • Human T lymphocytes stimulated with synthetic peptides specific for adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, and human herpesvirus-6 (posoleucel)
  • Recombinant and replication-competent vaccine based on vesicular stomatitis virus with the VSV G-protein removed and replaced with the Ebola virus envelope glycoprotein (rVSVΔG-ZEBOV-GP)
  • Unmodified human embryonic stem cells derived pancreatic islet cells
• Because these organisms are now on the Domestic Substances List, they are no longer subject to the New Substances Notification Regulations (Organisms) that apply to substances new to Canada.
• The order took effect on the day it was registered (see June 22, 2023).

Who's affected#

• Companies and labs that research, manufacture, import, or supply the specific cells or biological products listed.
• Hospitals, clinical trial sponsors, and biotechnology or vaccine developers working with these materials.
• Regulators and safety officers who track which organisms require pre‑notification under federal rules.
• It is unclear if any other groups beyond these will notice a direct change.

Why it matters#

• For businesses and researchers, adding these organisms to the list removes a federal pre-notification step under the New Substances rules. That can make it easier to bring these specific materials into Canada or use them in Canada for commercial or research purposes.
• This is an administrative change, not a safety approval. It does not mean the government endorses these organisms, nor does it remove other legal steps such as licences, clinical trial approvals, or product authorizations from Health Canada.
• The change can speed access to materials used in therapies, vaccines, or research, but other oversight and safety requirements may still apply.