A Guide to the environmental risk management authorities under the Food and Drugs Act has been published. This guide highlights the principles, policies, considerations and standards that should be followed when it may be appropriate for the Minister of Health to act on an environmental risk in relation to a therapeutic product. These authorities are not new, they came into force with the passing of the Strengthening Environmental Protection for a Healthier Canada Act, on June 13, 2023. They allow the Minister to:
- order a person or company to provide information that is in the person’s possession, relating to environmental risks
- disclose confidential business information (CBI) in certain circumstances
- order an authorization holder to change the product’s label or to change or replace its packaging
- order a person who sells the product to recall it and
- order an authorization holder to compile information or conduct further tests, studies or monitoring
The definition of “therapeutic products” was taken from the provisions of Vanessa’s Law, and does include medical devices, natural health products and non-prescription drugs. However, it is anticipated that the focus will be on managing environmental risks from authorized prescription and non-prescription human and veterinary drugs, with environmental risks from other therapeutic products “likely” continuing to be managed under other authorities (CEPA, non-regulatory initiatives, etc.)
Although the guide has been published, the department is still working on developing operational tools and processes required to use these authorities. Consultations will take place with relevant parties regarding any risk management measures that are considered. The notice of publication of the guide specifically called out the regulation making authorities to support the development of a pre-market environmental risk assessment and risk management regulatory regime for ingredients in new drugs. The supporting regulations have yet to be developed or published, consultations will take place through out that process.
Your CA Team will continue to follow any developments on this file and share any new information. If you have any questions or concerns regarding this publication, please reach out to the CA Team at regulatory@cosmeticsalliance.ca or to the Environmental Policy and CMP Coordination Team in the Health Products and Food Branch of Health Canada at: eri-ire@hc-sc.gc.ca
