PEC-211 Stem Cell Line Added to List
Order 2023-112-05-01 Amending the Domestic Substances List: SOR/2023-77
The order adds the genetically engineered human embryonic stem cell line PEC-211 to Part 5 of the Domestic Substances List, coming into force on 2023-04-18. As a result, PEC-211 is no longer subject to pre-market notification and assessment under the New Substances Notification Regulations (Organisms), though other regulatory, biosafety and ethical requirements still apply.
- Published
- May 10, 2023
- Department
- Unavailable
- Section
- Order 2023-112-05-01 Amending the Domestic Substances List
- Comment deadline
- Unavailable
- Effective date
- April 18, 2023
- Publication part
- Part II
Summary
Summary#
Order 2023-112-05-01 Amending the Domestic Substances List (SOR/2023-77) adds one living organism to the Domestic Substances List. The organism added is Genetically engineered human embryonic stem cells containing knock-out genomic edits with homology-directed repair-mediated insertion of the knock-in genes (PEC-211). The order came into force on April 18, 2023.
What it does#
- Adds the specific stem-cell line (PEC-211) to Part 5 of the Domestic Substances List.
- As a result, that organism is no longer subject to the notification and pre-market assessment rules in the New Substances Notification Regulations (Organisms) for new-to-Canada organisms.
- Does not mean Health Canada or Environment Canada has approved the organism for safety, clinical use, or any other purpose. Other laws, ethical rules, lab standards, and approvals still apply.
Who's affected#
- Biotechnology and biomedical research teams and institutions that work with or plan to import or manufacture the PEC-211 stem-cell line in Canada.
- Companies that produce, import or supply genetically engineered cell lines.
- Clinical or research laboratories that might receive or use this cell line for experiments.
It is not clear from the order how many organizations in Canada currently hold or plan to use PEC-211.
Why it matters#
- For researchers and companies, adding PEC-211 to the Domestic Substances List removes a specific administrative step. That can make it easier and quicker to bring that cell line into Canada or use it in Canada, because the mandatory new-substance notification under the New Substances Notification Regulations (Organisms) no longer applies to this line.
- This is an administrative change, not a safety endorsement. Labs still need to follow other regulatory, ethical and biosafety rules before using or releasing such cells.
- The change is already in force as of April 18, 2023, so anyone dealing with this specific cell line should be aware the Domestic Substances List status has changed.
Key topics
Source: Canada Gazette