Substances in Products Regulated Under Canada’s Food and Drugs Act

12 Jul 2022

Are you subject to the New Substances Notification Regulations?

Do you know?

It's been over 20 years since the Notice of intent to develop the Environmental Assessment Regulations (EAR) was published in the Canada Gazette Part I (01 September 2001). The Canadian Government is still proceeding with the development of this new environmental regulatory framework.

The purpose of the EAR is to ensure that substances in products regulated under the Food and Drugs Act (F&DA) are assessed for their potential environmental risks, and the human health risks stemming from them. Since environmental assessment falls outside of the purview of the F&DA, the EAR aims to fill this gap.

The EAR will target all substances contained in products regulated under the F&DA, including:

• biologics
• cosmetics
• food additives
• medical devices
• natural health products
• novel foods
• pharmaceuticals
• radiopharmaceuticals
• veterinary drugs

Until the EAR comes into force, substances intended for use only in products regulated under the F&DA that are not listed on the Revised In-Commerce List (R-ICL) or the Domestic Substances List (DSL) are subject to the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA).

Over the last few years, there have been changes to the R-ICL. The R-ICL nomination process was closed on 03 November 2019 and 602 substances were removed from the R-ICL on 19 February 2022. Moreover, a Section 71 Notice was published on 12 March 2022 to collect information on the commercial status and use of approximately 700 substances currently listed on the R-ICL, and thus further changes are expected.

What should you do next?

• If your substances are listed on the R-ICL, check if the 12 March 2022 Section 71 Notice is applicable to you and submit a report by the 14 September 2022 deadline. You should also monitor any changes being implemented to the R-ICL as well as the development and commencement of the EAR.
• 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 your company begins compiling the applicable information and submits a new substances notification to the Canadian Government to avoid being in non-compliance with CEPA.

Need Assistance?

Do you have questions about this topic, the development of the EAR, changes being implemented to the R-ICL, Section 71 reporting, the New Substance Notification program, or a related topic?

Contact our experts at Intertek Assuris. We're here to help!

References:

CEPA (1999): Canadian Environmental Protection Act, 1999 (justice.gc.ca)
F&DA: Food and Drugs Act (justice.gc.ca)
NSNR: New Substances Notification Regulations (Chemicals and Polymers) (justice.gc.ca)
Removal of substances from the R-ICL: Canada Gazette, Part I
Section 71 Notice for substances on the R-ICL: Canada Gazette, Part I
Termination of R-ICL nomination process: Canada Gazette, Part I
Intertek's page on the Canada Environmental Assessment Regulations for Food and Drug Act New Substances Services - https://www.intertek.com/assuris/chemicals/regulatory/canada-environmental-assessment-regulations/