Forward Regulatory Plan 2022-2024: Regulations amending the Food and Drug Regulations (Environmental Risk Assessment and Management of Ingredients in Drugs)

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations (Environmental Risk Assessment and Management of Ingredients in Drugs)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Food and Drug Regulations to modernize the environmental and indirect human health risk assessment and management of ingredients used in drugs, as required under the Canadian Environmental Protection Act, 1999, the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).

The proposed amendments would contribute to creating an environmental risk assessment and management regulatory framework under the Food and Drugs Act that is equivalent to the requirements in the Canadian Environmental Protection Act, 1999.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

This regulatory proposal would better align Health Canada requirements with those of other jurisdictions such as the United States and the European Union.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to businesses involved in the sale of drugs in Canada.

It is anticipated that the proposal would improve the assessment and management of the environmental and indirect human health risks posed by drug ingredients. While businesses may experience increased data requirements, this may be offset by greater efficiencies gained through the removal of regulatory burden as compared to the current notification scheme.

Consultations

Stakeholder engagement and consultation, were carried out in 2018 and 2019.

In April 2021, proposed amendments to the Food and Drugs Act were introduced in the House of Commons as part of Bill C-28, Strengthening Environmental Protection for a Healthier Canada Act to allow for the development of an environmental risk assessment and management regulatory framework for drugs.Timing for the regulations relies on obtaining Royal Assent on these amendments.

Canadians will 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 fall 2023 and last 70 days.

Further information

Related information can be found on:

Health Canada's Environmental Impact Initiative

Bill C-28, Strengthening Environmental Protection for a Healthier Canada Act - Summary of Amendments

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: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

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

April 2018

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

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

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:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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