Forward Regulatory Plan 2023-2025: Biocides Regulations

Title of Regulatory Initiative

Biocides Regulations

Enabling Act

Food and Drugs Act

Description

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:

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.

Consultations

Health Canada met with industry associations in 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 informed 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.

Health Canada held additional meetings and sessions with industry associations in December 2022, March 2023 and June 2023. The Department will take the feedback received from stakeholder consultations 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 spring 2024.

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 Plan

February 2021

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

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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