Forward Regulatory Plan 2022-2024: Biocide Regulations
Title of Regulatory Initiative
Biocide Regulations
Enabling Act
Description
Health Canada is proposing amendments to the Food and Drug Regulations, the Natural Health Products Regulations and the Pest Control Products Regulations to ensure a harmonized and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers). Currently, they are regulated under separate regimes, creating challenges for industry and regulators, acutely experienced during COVID-19.
Specifically, the proposed amendments would: (1) create one comprehensive framework for the regulation of biocides; (2) enable regulatory oversight based on risk and evolving evidence; and, (3) introduce a use of foreign decisions pathway.
Additional note: Previously named Regulations amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and surface sanitizers).
Development of this initiative has been a part of broader work on modern regulations related to the Health and Biosciences Sector Regulatory Review Roadmap.
Regulatory cooperation efforts (domestic and international)
This regulatory initiative is not part of a formal regulatory cooperation work plan.
The proposal would allow the use of regulatory decisions from trusted foreign regulators such as the United States Environmental Protection Agency (US EPA) for these products.
Potential impacts on Canadians, including businesses
The proposed regulations would apply to businesses involved in the sale of biocide products in Canada.
Health Canada would expect this proposal to reduce barriers and create efficiencies for businesses wanting to bring biocides to the Canadian market, resulting in timely access to biocides for Canadians. Benefits may vary between companies.
Consultations
Health Canada met with three industry associations in early July 2019 on aspects of the proposal, and again in April 2021 to discuss key components of the framework.
Health Canada closely collaborated with industry stakeholders throughout the COVID-19 pandemic to help increase the availability of biocides to Canadians. Lessons learned from the pandemic will inform the proposed Biocides Regulations.
Health Canada pre-published the regulatory proposal in the Canada Gazette, Part I, on May 7, 2022, for a 70-day public comment period. A consultation on the associated fee proposal took place during the same timeframe on the Health Canada website.
Health Canada plans to publish the Regulations in the Canada Gazette, Part II, in spring 2023.
Further information
Additional information can be requested from the departmental contact.
Departmental contact information
Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Telephone: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory
February 2021
Consult Health Canada's acts and regulations web page for:
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