Incorporated by reference the list of foreign regulatory authorities for biocides

On this page

• Background
• The list
• Including foreign regulatory authorities on the list
• Updating the list

Background

Companies may submit an application for a market authorization for a biocide based on a comparison to a foreign biocide. To do so, they must meet the requirements outlined in the Biocides Regulations.

For more information on the Use of Foreign Decisions (UFD) application pathway, including eligibility criteria and regulatory requirements, please consult the following guidance:

• How to apply for a biocide market authorization

The list

The list of foreign regulatory authorities for biocides sets out conditions that a foreign biocide must meet in order to be used in a UFD application. The list is incorporated by reference (section 25, Biocides Regulations). It 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 UFD application pathway (authorizations received under these foreign application types)

Including foreign regulatory authorities on the list

The UFD pathway is based on allowing the use of decisions made by foreign regulators with 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 those established in the Biocides Regulations.

The list includes types of foreign applications from the listed foreign regulatory authority that are ineligible for the UFD 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 has been granted authorization via emergency exemption from the regular authorization or registration requirements by the foreign regulatory authority in order 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:

1. 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)
   • outlines proposed changes to the list and the reason for the proposed change
   • invites interested stakeholders and the public to provide comments on the proposal during the consultation period
2. consider the feedback received and re-assess the proposal as needed
3. publish a notice of modification (if applicable) describing the change to the list and its effective date, accompanied by a TBT notification to the WTO
4. 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, please contact the NNHPD by email at nnhpd.consultation-dpsnso@hc-sc.gc.ca.