Environmental regulatory initiative
On this page
- Strengthening environmental oversight of drugs regulated under the Food and Drugs Act
- Developing an environmental risk assessment and risk management regulatory regime
- Supporting the use of the FDA environmental risk management authorities
- Contact us
Strengthening environmental oversight of drugs regulated under the Food and Drugs Act
We are working on strengthening the protection of the environment from risks resulting from the release of Food and Drugs Act (FDA) regulated products into the environment. We are doing this by:
- developing an environmental risk assessment (ERA) and risk management regulatory regime for ingredients in new drugs regulated under the Food and Drug Regulations (FDR) of the FDA (FDA ERA Regime) and
- implementing the FDA environmental risk management authorities for authorized therapeutic products
Developing an environmental risk assessment and risk management regulatory regime
The Government of Canada created the Chemicals Management Plan (CMP) in 2006. Health Canada and Environment and Climate Change Canada lead the CMP to help protect the environment as well as the health and safety of people in Canada from harmful substances. Under the CMP, the Minister of Health committed to developing new regulations to enhance the assessment and management of the potential environmental and indirect human health risks resulting from the release of FDA regulated products into the environment. Based on this commitment, Health Canada has been working on the policy, and engaging with stakeholders, to develop the FDA ERA Regime. This FDA ERA Regime would focus on human and veterinary prescription and over-the-counter drugs.
During the development of the policy and strategy for the FDA ERA Regime, we developed and continue to develop:
- discussion documents
- options analysis papers
- issue identification papers
In addition, we held extensive consultations with:
- relevant stakeholders
- internal and international colleagues
These consultations helped build the scientific evidence base for the framework and data requirements needed to assess the environmental and indirect human health impact from these substances.
The goal of the FDA ERA Regime is to:
- increase the protection of the environment, and people in Canada from risks that may be posed by drugs
- bring the notification, assessment and risk management of drugs under one Minister and act
- better capture, assess and manage the potential long-term environmental or indirect human health risks from drugs, before they are sold in Canada
- better align with what industry is subject to internationally
- strengthen and promote greater confidence in the environmental oversight of drugs throughout their lifecycle and
- allow for enhanced environmental risk management measures, when required, such as terms and conditions on authorizations or label changes
We amended the FDA on June 13, 2023 to support the development of this regime.
Some of the FDA amendments included additional regulation making authorities and provisions that are tied to the FDA ERA Regime. These amendments won't come into force until after we have published the regulations.
We are continuing to work on the FDA ERA Regime, however the exact timing for implementing the regulations is unknown. We will continue to consult with affected parties as part of the regulatory development process.
Until the FDA ERA Regime has been brought into force and implemented, new substances contained in FDA regulated products will continue to be subject to an environmental risk assessment under 1 of the following regulations under the Canadian Environmental Protection Act, 1999:
- New Substances Notification Regulations (Organisms) or
- New Substances Notification Regulations (Chemicals and Polymers)
For more information on these regulations, including who is responsible for notification, please:
- visit the New Substances Program website
- contact the Environmental Assessment Unit in the Healthy Environments and Consumer Safety Branch of Health Canada at:
- 613-948-3591
- 1-866-996-9913
- eau-uee@hc-sc.gc.ca
Supporting the use of the FDA environmental risk management authorities
Other amendments made to the FDA on June 13, 2023, include a suite of environmental risk management authorities that build on previously established risk management authorities currently in place for health and safety purposes. These authorities came into force immediately.
We have developed a guide to support the use of these environmental risk management authorities. We are also developing operational tools and processes required to use these authorities.
We will consult with relevant parties on any risk management measure that is considered.
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
Related links
- Food and Drugs Act
- Environmental risk management amendments to the Food and Drugs Act
- Chemicals Management Plan
- Canadian Environmental Protection Act, 1999
- Domestic Substances List
- Guidance Document for the Notification and Testing of New Substances: Chemicals and Polymers
- Guidelines for the Notification and Testing of New Substances: Organisms