Forward Regulatory Plan 2023-2025: Regulations Amending the Food and Drug Regulations (Environmental Risk Assessment and Management of Active Ingredients in Drugs)
Title of Regulatory Initiative
Regulations Amending the Food and Drug Regulations (Environmental Risk Assessment and Management of Active Ingredients in Drugs)
Enabling 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 create 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 regulatory proposal would better align Health Canada requirements with those of other jurisdictions, such as the United States and European Union.
Potential impacts on people in Canada, including businesses
It is anticipated that the proposal would improve the assessment and management of the environmental and indirect human health risks posed by drugs and their 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
Further stakeholder engagement such as webinars and public comment periods, is planned prior to bringing forward a regulatory proposal.
Further information
Related information can be found on:
Health Canada's Environmental Impact Initiative
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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