Summary of the amendments made to incorporate an environmental purpose into the Food and Drugs Act

On this page

• Strengthening Environmental Protection for a Healthier Canada Act
• Amendments made to the Food and Drugs Act
• Products captured by the Food and Drugs Act amendments
• Openness and transparency
• Contact us

Strengthening Environmental Protection for a Healthier Canada Act

The Strengthening Environmental Protection for a Healthier Canada Act amended the Canadian Environmental Protection Act, 1999 (CEPA) and the Food and Drugs Act (FDA). These amendments aim to better protect people in Canada and their environment from harmful substances. The FDA amendments allow the Minister of Health to strengthen the assessment and management of environmental risks resulting from products regulated under the FDA.

Amendments made to the Food and Drugs Act

The amendments made to the FDA:

• incorporate an environmental purpose into the FDA
• strengthen the environmental oversight of therapeutic products throughout their lifecycle
• expand the Minister of Health's ability to manage environmental risks resulting from the release of authorized therapeutic products into the environment
• allow us to take quick and appropriate action when a risk to the environment is identified
• enable us to make laws to strengthen the environmental risk assessment and risk management of products regulated under the FDA and
• promote confidence in the environmental oversight of therapeutic products by providing transparency, for example, by requiring the Minister of Health to make orders publicly available

The amendments that came into force on June 13, 2023, allow the Minister of Health to:

• order a person or company to provide information that is in the person's possession, relating to environmental risks from an authorized therapeutic product to help determine if it presents a serious risk to the environment
• disclose confidential business information in certain circumstances where the authorized therapeutic product may present a serious risk to the environment or for the protection of the environment
• order an authorization holder to change the product's label or to change or replace its packaging to clearly reflect environmental risk information including potential mitigation methods for those risks
• order a person who sells the therapeutic product to recall it if it is suspected there is a serious or imminent risk to the environment and
• order an authorization holder to compile information or conduct further testing, studies or monitoring on an authorized therapeutic product that is necessary to determine the environmental risk

We developed these amendments based on the existing human health risk management authorities under the FDA. (Amendments to the Food and Drugs Act: Guide to New Authorities; Vanessa's Law).

Learn more about the amendments to the FDA.

Products captured by the Food and Drugs Act amendments

The amendments that came into force on June 13, 2023, only apply to therapeutic products when an environmental risk has been identified or is suspected. This includes:

• biocides
• vaccines
• medical devices
• gene and cell therapies
• natural health products
• cells, tissues and organs
• blood and blood components
• prescription and over-the-counter human and veterinary drugs

Other amendments made to the FDA on June 13, 2023 apply to all products regulated under the FDA. These amendments won't come into force unless we develop supporting regulations. Currently we are developing an environmental risk assessment and risk management regulatory regime for drugs regulated under the FDA (FDA ERA Regime). As part of the regulatory development process, these regulations will be subject to consultations with relevant parties.

In June 2024, we made other amendments to the FDA as part of the precision regulating authorities. One of these provisions included an additional environmental risk management authority (Section 30.02 of the FDA). You can find more information on this authority in the Guide to the Precision Regulating Authorities.

We will determine which FDA authority is the most appropriate for managing environmental risks from an authorized therapeutic product on a case-by-case basis.

Openness and transparency

Ministerial orders are a type of regulation. As with the development of any regulation, we will develop any orders under these authorities transparently and after consulting with relevant parties.

To improve transparency and the quality of regulatory decision-making, we have developed a guide to support the use of these environmental risk management authorities. This guide will:

• help us apply and implement the authorities fairly, consistently and effectively
• explain what triggers the Minister's ability to use these authorities
• explain to what or whom the authorities apply
• describes the thresholds that must be met for the Minister to use the authorities
• explain the process for enacting orders under these authorities
• support the development of operational tools and processes required to use these authorities and
• supports the development of orders and future regulations related to these authorities

Contact us

Environmental Policy and CMP Coordination Team
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Email: eri-ire@hc-sc.gc.ca