Forward Regulatory Plan 2023-2025: Biocides Regulations
Title of Regulatory Initiative
Health Canada plans to amend the Food and Drug Regulations, the Natural Health Products Regulations and the Pest Control Products Regulations to ensure a consistent and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers). Currently, the biocides are regulated under separate regimes, creating challenges for industry and regulators, acutely experienced during COVID-19.
The proposed amendments will :
- Create one comprehensive framework for the regulation of biocides;
- Enable regulatory oversight based on risk and evolving evidence; and,
- 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).
This initiative is 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.
Regulations will 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 people in Canada, including businesses
Regulations will apply to businesses involved in the sale of biocide products in Canada.
Health Canada expects these Regulations to reduce barriers and create efficiencies for most businesses wanting to bring biocides to the Canadian market, resulting in timely access to biocides for people in Canada. Benefits may vary between companies.
Health Canada met with industry associations in early July 2019, April 2021, January 2022 and May 2022 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 people in Canada. 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 . A consultation on an associated fee proposal took place during the same timeframe on the Health Canada website.
Additional stakeholder engagement sessions with industry associations are planned for 2023. Health Canada will take the feedback received from this consultation and pre-publication into consideration in preparing for the final publication in Canada Gazette, Part II.
Health Canada plans to publish the Regulations in the Canada Gazette, Part II, in fall 2023.
Additional information can be requested from the departmental contact.
Departmental contact information
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
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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