The order adds one substance to the Domestic Substances List
Canada has added ethanol, 2-amino-, reaction products with ammonia, by-products from (CAS Registry Number 68910-05-4) to the Domestic Substances List under SOR/2026-177.
The substance had already completed the Canadian new-substance assessment process. Addition to the DSL means it is no longer treated as a new substance for its assessed activities under the New Substances Notification Regulations.
Environment and Climate Change Canada and Health Canada nevertheless identified potential concerns if the substance were used in certain new exposure scenarios, so the existing Significant New Activity provisions remain attached to the substance after its addition to the DSL.
The retained SNAc conditions target specific future uses
The order defines a Significant New Activity for products containing the substance at a concentration of at least 1.0% by weight where the activity involves:
- manufacture of a consumer product subject to the Canada Consumer Product Safety Act, other than an epoxy product;
- manufacture of a cosmetic as defined in the Food and Drugs Act; or
- import of those types of products at the specified concentration where the total quantity imported across all such products in a calendar year exceeds 10 kg.
Research and development substances, site-limited intermediates, and substances or products intended only for export are excluded from these SNAc triggers under the conditions stated in the order.
A Significant New Activity Notice is required before the activity starts
A person proposing an activity that meets the SNAc definition must submit a Significant New Activity Notification to the Minister at least 90 days before the activity begins.
The order specifies the information that must accompany the SNAN, including information relevant to skin sensitization, and provides a 90-day government assessment period after complete information is received.
This means the DSL addition does not remove regulatory controls on future uses of concern. It changes the substance’s status for existing assessed activities while preserving a pre-notification gate for the defined significant new activities.
The order is upstream materials intelligence for medical-device companies
The SNAc definition in SOR/2026-177 does not identify medical devices as a trigger category. A finished medical device containing the substance should therefore not automatically be treated as subject to this specific SNAc requirement solely because the substance appears in its material composition.
The relevance for medical-device manufacturers is more likely to arise upstream. If a supplier uses the substance in a resin, coating, adhesive, processing chemical, or another material, companies can verify the actual Canadian activity, concentration, and product category before deciding whether the SNAc provisions apply.
ECCC also notes that a safety data sheet may not disclose every ingredient in a purchased product. Where the substance is material to compliance, supplier composition and use information may be needed in addition to the SDS.
What companies can check
- Search Canadian material and supplier records for CAS 68910-05-4 and related trade or generic names.
- Confirm whether supplier activities remain within previously assessed industrial uses or move into the SNAc-defined consumer-product or cosmetic uses.
- Check the concentration and annual import conditions in the order where those product categories are involved.
- Make sure material change-control workflows can trigger a CEPA and SNAc review before a new Canadian use begins.
- Obtain sufficient supplier composition information for critical materials rather than relying only on the SDS.
For most medical-device portfolios, this order does not create an immediate product-registration action. Its practical value is as a supply-chain rule that can be mapped to the specific substance and triggered when a supplier, formulation, or use changes.
Sources
- Primary official sourceOrder 2026-87-10-01 Amending the Domestic Substances List: SOR/2026-177 (opens in a new tab)Canada Gazette
- Supporting sourceNew substances: risk assessment summary, new substances notification 19897 (opens in a new tab)Environment and Climate Change Canada
- Supporting sourceSignificant new activity requirements on the Domestic Substances List (opens in a new tab)Environment and Climate Change Canada