About the List of Foreign Regulatory Authorities for Biocides incorporated by reference
Effective date: May 31, 2025
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Interpreting the list
Companies may submit an application for a market authorization for a biocide based on a comparison to a foreign biocide. The List of Foreign Regulatory Authorities for Biocides sets out conditions that a foreign biocide must meet in order to be used in a use of foreign decisions application. This list is incorporated by reference into section 26 of the Biocides Regulations, and includes:
- foreign jurisdiction: relevant countries
- foreign regulatory authority: relevant governing bodies regulating biocides
- statute or legislative instrument: relevant foreign acts or regulations providing oversight for the foreign biocide
- types of applications that are ineligible for the use of foreign decisions application pathway (authorizations received under these foreign application types)
Including foreign regulatory authorities on the list
The use of foreign decisions pathway is based on the use of decisions made by foreign regulators that have regulatory frameworks and standards deemed similar to those in Canada as a result of collaboration and harmonization.
The foreign regulatory authorities listed have established application requirements and standards for authorization that meet or exceed those established in the regulations. Health Canada will consider adding another authority to the list if we determine that their requirements and standards for biocides meet or exceed those in the regulations.
Some of the requirements and standards we consider are:
- pre-market and post-authorization review frameworks and standards, including:
- overall application requirements
- labelling requirements
- safety, quality and efficacy standards, including test methods and laboratory standards (good laboratory practice)
- post-market compliance and enforcement activities, including:
- activities that would help to identify any issues with an authorized biocide once sold
The list also includes types of foreign applications from a listed foreign regulatory authority that are ineligible for the use of foreign decisions pathway. Ineligibility is usually because the foreign pre-market application requirements or review processes for the application do not meet those required to obtain Canadian market authorization for a biocide. An example is a product that's been granted authorization through an emergency exemption from the regular authorization or registration requirements by the foreign regulatory authority to address a public health need.
Updating the list
Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) manages changes to the list and reviews this list regularly.
We will consider changes to the list after conducting a thorough assessment. Changes involve adding or removing regulatory authorities or making changes to exemptions.
Before making changes to the list, we undertake the following steps:
- Publish a notice of proposal on the Government of Canada website and send a "Technical Barriers to Trade" (TBT) notification to the World Trade Organization (WTO), which:
- outlines proposed changes to the list and reasons for the proposed changes
- invites interested stakeholders and the public to comment on the proposal during the consultation period
- Consider the feedback received and reassess the proposal as needed.
- Publish a notice of modification (if applicable) describing the change to the list and its effective date, along with the TBT notification to the WTO.
- Amend the list (if applicable) on the date outlined in the notice of modification and archive the previous version of the list.
For more information, email us at nnhpd-dpsnso@hc-sc.gc.ca.
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