Department of the Environment issues notices regarding potentially toxic substances

The Canadian Department of the Environment recently released three notices in the Canada Gazette pertaining to the assessment of a series of potentially toxic substances. These notices impose reporting requirements upon certain organizations, signal new approaches to assessing the toxicity of substances, and indicate new additions to schedule 1 of the Canadian Environmental Protection Act, 1999.

Summary of key notices

Information required from producers of therapeutics, natural health products, food, and cosmetics

Pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999, the Department of the Environment has given notice that it requires information from particular persons to assess whether certain substances are toxic, capable of becoming toxic, or whether to control such substances. 

This notice applies to approximately 700 substances on the Revised in Commerce List, and to any persons who, during the 2019 or 2020 calendar year: 

• manufactured or imported any of the listed substances in, or intended to be in cosmetics, novel foods, food additives, therapeutic products, or natural health products subject to the Food and Drugs Act (the Applicable Products); or,
• manufactured or imported any of the listed substances in a quantity greater than 100 kilograms. 

This notice does not apply to persons who manufactured or imported listed substances that are unprocessed and “naturally occurring,”¹ used solely for human consumption, manufactured or imported for a use under any act or regulation other than the Food and Drugs Act, or is a transient reaction intermediate, incidental reaction product, an impurity, a contaminant, or a partially unreacted material.

An organization subject to the notice must provide its organization name, address, and federal business number, along with the name and contact information of an individual authorized to act on behalf of the organization and a declaration that all provided information is complete.

Moreover, organizations must provide information pertaining to the substance they manufactured or imported for the 2019 and 2020 calendar years:

• Organizations that manufactured or imported any of the listed substances for use in the Applicable Products must provide the total quantity of such substances and particular substance identifiers and codes as set out in the notice.
• Organizations that manufactured or imported the listed substances for the purposes of distribution must provide names and addresses of the five organizations in Canada to whom the largest quantity of the substances was sold (provided that such quantities exceeded 100 kilograms) and the contact information for such organizations. 

Responses to the notice must be sent to the minister of the environment, using the online reporting system. Should an organization’s response contain confidential information, it may include a written request that the provided information be treated as confidential.

Update to methodology used in assessments of substance toxicity

In 2016, Environment and Climate Change Canada developed an ecological risk classification approach document (ERC1), which outlined an approach to classifying the risks of potentially toxic substances. This document has subsequently been updated (ERC2), and the Department of the Environment has provided notice that ERC2 may be used for future assessments by the Government of Canada when identifying and addressing substances that may be of ecological concern.

ERC2 refines key areas of uncertainty previously identified in ERC1, in part, through restructurings of ERC1’s rules, and an increased focus upon long-term developmental and reproductive toxicity and neurotoxicity. The implementation of ERC2 may have implications for organizations using substances found to be toxic under the new approach.

Persons wishing to comment on the scientific considerations presented in ERC2 may file written comments with the minister of the environment within 60 days of the publication of this notice on March 12, 2022. Parties may make such written comments by email, or through the Environment and Climate Change Canada’s Single Window.

Recommended addition of substances to Schedule 1 of the Canadian Environmental Protection Act, 1999

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the minister of the environment and the minister of health have conducted a screening assessment of 21 substances referred to collectively under the Chemicals Management Plan as “the Alcohols Group.” These particular substances were considered a priority on the basis of human health concerns, and are used in industrial processes, cosmetics, pharmaceuticals, cleaning agents, paints, adhesives, and other products. 

The ministers of health and environment are recommending that three of these substances, namely, methanol, 1 butanol, and benzenemethanol, be added to Schedule 1 of CEPA, which includes substances considered to be toxic. Organizations using these substances may be required to abide by further preventative control actions imposed through regulations or guidelines, should they be added to Schedule 1 of CEPA.

The remaining 18 substances in the Alcohols Group have been determined to present a low risk of harm to the environment, and it is not recommended they be added to Schedule 1 of CEPA.

Key takeaways

Organizations should remain apprised of developments from the Department of the Environment as new reporting and regulatory requirements arise following the assessment of potentially toxic substances. Moreover, organizations must ensure they comply with new and updating reporting requirements from the Department of the Environment.

The author would like to thank Mark Laschuk, articling student, for his contribution to this legal update.