Forward Regulatory Plan 2019-2021: Regulations amending the Food and Drug Regulations for Environmental Risk Assessment of Active Ingredients in Drugs

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations for Environmental Risk Assessment of Active Ingredients in Drugs

Enabling Act

Food and Drugs Act


Health Canada is proposing to modernize the environmental risk assessment of drugs by creating a notification  and assessment regime in the Food and Drug Regulations.

The  new regime would replace the current environmental and indirect human health risk assessments for active ingredients  used in drugs that is required under the Canadian Environmental Protection Act, 1999  and the New Substances Notification Regulations (Chemicals and Polymers) and (Organisms).

The proposal would also tailor environmental data requirements to the type of drug being assessed and also require data that would allow the Department to better understand the potential environmental and indirect human health effects of drugs.

Regulatory cooperation efforts (domestic and international)

Health Canada is aligning with other key regulatory agencies where possible (i.e., United States' Food and Drug Administration, European Medicines Agency).

Potential impacts on Canadians, including businesses

Preliminary analysis indicates that the Canadian and international pharmaceutical industry would be impacted by increased notification and data requirements. The full extent of the impact will be assessed by Health Canada through the assessment of the Cost Benefit Analysis Survey responses which will be received by the end of summer 2019.


 In fall 2018, stakeholders were asked for feedback on a cost-benefit analysis survey. The feedback obtained from the consultation informed policy positions, which were presented to stakeholders during targeted consultations. As a result, stakeholders were asked for additional feedback through a follow-up cost-benefit analysis survey which was launched in July 2019.

Canadians will also have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2020 and last 70 days.

Further information

Further information is available on the Health Canada website. Questions regarding this initiative can be sent to

Additional information can be requested from the Departmental contact.

Departmental contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone number: 613-946-6586

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2018

Consult Health Canada's acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
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Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

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