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Canada Adds the P Flag to 204 DSL Polymer Entries, Clarifying RRR Listing Scope

Canada's September 2026 Domestic Substances List orders add the P flag to 204 polymer identifiers previously assessed as reduced regulatory requirement polymers. The final order covers fewer entries than the 220 proposed in February; suppliers and device manufacturers should confirm that the polymer form supplied still meets the RRR criteria.

By MedTech Current

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Effective

What changed

Canada’s September 23, 2026 Canada Gazette, Part II issue contains three orders amending the Domestic Substances List (DSL): SOR/2026-190, SOR/2026-191, and SOR/2026-192. SOR/2026-190 is the central change for polymer materials: it adds the “P” flag to 204 existing polymer identifiers assessed as meeting the reduced regulatory requirement (RRR) criteria.

The final order covers 102 CAS Registry Number entries in Part 1 and 102 confidential accession number entries in Part 3 of the DSL. The February 2026 notice proposed adding the flag to 220 entries; after considering responses, the final order updates 204. SOR/2026-190 was registered on September 8, 2026, and came into force on registration; September 23 is its Gazette publication date.

The P flag identifies the RRR polymer form. The accompanying regulatory impact analysis states that a form of the same polymer that does not meet RRR criteria is subject to notification under the New Substances Notification Regulations (Chemicals and Polymers) before import or manufacture.

Why it matters for medical devices

This is an inventory identifier update, not a new acceptance of the listed polymers. It does not itself establish that every finished medical device containing one of these materials is subject to a new device requirement. Its practical relevance is upstream: a supplier’s general statement that a material is “DSL listed” may not establish that the supplied polymer form meets the RRR criteria associated with a P-flagged entry.

Adhesives, coatings, plastics, elastomers, sealants, polyurethane systems, acrylic polymers, polyesters, silicones, and copolymers may warrant review where they are used in products supplied to Canada. This is a materials-screening recommendation; applicability depends on the substance identity, polymer characteristics, activities, and relevant Canadian requirements.

SOR/2026-191 separately adds nine chemicals and polymers to the DSL (four CAS-number entries and five masked-name entries). SOR/2026-192 adds one living organism, recombinant human T cells transduced with a replication-deficient lentiviral vector containing an anti-BCMA/4-1BB/CD3zeta CAR, identified as KITE-772. These are distinct inventory additions; they should not be conflated with the P-flag changes in SOR/2026-190.

What to check now

  • Screen polymer identifiers used in Canadian supply chains against the 204 entries updated by SOR/2026-190.
  • Where a supplier relies on DSL status, confirm whether the actual polymer form supplied meets the RRR criteria for the P-flagged listing.
  • Reassess when polymer formulation, molecular-weight distribution, residual monomers, or manufacturing conditions change.
  • Keep DSL inventory status distinct from Significant New Activity requirements, CEPA Schedule 1 listings, and prohibited- or restricted-substance lists.

The key question for a P-flagged polymer is whether the form supplied is the RRR form covered by that listing.

Sources

  1. Primary official sourceOrder 2026-66-11-01 Amending the Domestic Substances List: SOR/2026-190Canada Gazette
  2. Supporting sourceOrder 2026-87-11-01 Amending the Domestic Substances List: SOR/2026-191Canada Gazette
  3. Supporting sourceOrder 2026-112-11-01 Amending the Domestic Substances List: SOR/2026-192 and Regulatory Impact Analysis StatementCanada Gazette