Important Information for Importers and Manufacturers of Substances that are Regulated under the Food and Drug Act (F&DA)

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26 Mar 2025

Are your substances subject to the Canadian New Substances Notification Regulations?

The New Substances Notification Regulations (Chemicals and Polymers) assesses substances imported or manufactured in Canada for potential risks to human health and the environment and, if required, place control measures before they are introduced into the Canadian marketplace.

The regulations require that an importer or manufacturer of a substance, that is new to Canada, to submit prescribed information to the Government of Canada. The government reviews the information to determine whether there is a potential risk to human health and to the environment. When the assessment identifies a risk, various mechanisms exist under the Canadian Environmental Protection Act, 1999 (CEPA, 1999) to manage that risk.

A substance is new to Canada if it is not listed on the Domestic Substances List (DSL). In certain circumstances exemptions are also available for certain substances.

When are my F&DA-regulated products exempt from notification under the New Substances Notification Regulations?

Products containing substances on the Domestic Substances List or listed on the Revised In‑Commerce List (R-ICL) are exempt from the New Substances Notification Regulations (NSNR) requirements only if they are used under an application covered by the Food and Drugs Act (F&DA). Such substances may be imported or manufactured in Canada without the need to file a New Substance Notification (NSN).

What is the Revised In-Commerce List?

The R-ICL is a list of F&DA substances that were identified as having been in Canadian commerce between January 1, 1987, and September 13, 2001, and were therefore not eligible to be grandfathered into the DSL. Substances listed on the R‑ICL should not experience market interruption in order to comply with the NSNR of the Canadian Environmental Protection Act, 1999 (CEPA).

The R-ICL consists of substances found in pharmaceuticals, veterinary drugs, biologics and genetic therapies, cosmetics, medical devices, and food additives.

What are my obligations if substances in my F&DA-regulated product are not on the Revised In-Commerce List?

Substances intended for use only in products regulated under the F&DA, but that are not listed on the R‑ICL or the DSL, are subject to the NSNR.

If your substances are not listed on the R-ICL or the DSL and you are manufacturing or importing in excess of 100 kg/year of a chemical or 1,000 kg/year of a polymer, it is recommended that the applicable information is compiled and that an NSN is submitted to the Canadian government as soon as possible to avoid non‑compliance with CEPA.

The objective is to ensure that new substances in products regulated under the F&DA are evaluated for potential risks to the Canadian environment and to human health through environmental exposure—‍even if these substances have been evaluated by Health Canada through other regulatory instruments.

What should Importers and Manufacturers of F&DA-Regulated Products do next?

It is important to know whether your products contain substances listed on the R‑ICL, as an R-ICL exemption can save your company significant time and costs.

The R-ICL is periodically updated as new information becomes available, and substances may be removed from the R-ICL for various reasons. However, it is a company’s responsibility to remain aware of the status of substances of interest on the R-ICL. If your business may be affected by updates to or removal of substances from the R-ICL, you will be notified in advance through the Canada Gazette.

Intertek’s experts can help you stay abreast of—‍and respond effectively to—‍changes to the R-ICL. We can assess the chemistry of your substance, interpret chemical names, and complete a thorough search of the R-ICL to determine if your substances are listed and exempt from notification. If any substances in your product are found not to be on the R-ICL, Intertek can help you develop and implement the most cost-effective and timely notification strategy.

Need Assistance?

Do you have questions about this topic or a related topic? Intertek’s team of experts can help. Contact us with your questions and business needs.

Additional Links

Canadian New Substances Notification (NSN) Regulations Services

Canadian Agent Services for New Substances Notifications

Kal Bening

Regulatory Affairs & Scientific Consultant 2, Intertek

Kal Bening is a Senior Regulatory Manager and has been at Intertek for 19 years. Working with numerous clients, Kal's primary focus and role include providing clients with timely and cost-effective regulatory strategies under the various new and existing chemical notification programs. Her breadth of expertise centers around providing regulatory and scientific advice to clients to promote compliance with the New Substances Notification Regulations (NSNR) under the Canadian Environmental Protection Act (CEPA), initiatives under the Chemicals Management Plan (CMP), the Australian Industrial Chemicals Introduction Scheme (AICIS), and other similar initiatives around the world in countries such as China and South Korea.