Guidance on biocide application pathways and general requirements: Obligations for biocides authorized based on comparison biocides

On this page

• Obligations for licensors and licensees
• Obligations placed on biocide UFD market authorization holders

Obligations for licensors and licensees

For applications based on comparison, licensors and licensees must have a direct relationship. The licensor must provide the master formula for their biocide to a licensee, as attested to via the letter of confirmation in support of the application based on a comparison biocide.

Licensors are expected to provide their licensees with the most up-to-date application information to:

• support the filing of a complete application
• support the development and maintenance of biocide labels for the biocide in the application based on comparison

Biocides authorized through the comparison - administrative application pathway

For biocides authorized through this pathway, the final biocide should be supplied by a licensor to the licensee. This means that the biocide is in a form which is ready for use by the consumer without requiring any further manufacturing. For example, a licensor cannot supply an authorized concentrate biocide (requiring dilution before use) to the licensee to obtain authorization to sell a ready-to-use biocide.

Licensees are expected to update their biocide labels consistently with those of the comparison biocide, as biocide labelling should remain identical throughout the biocide's life-cycle. Licensees are expected to reflect the comparison biocide's label changes. Licensees should submit identical safety and efficacy updates for their biocide that was authorized based on a comparison biocide within 30 days of the comparison biocide's updates.

Changes to the market status of the comparison biocide

If we suspend or revoke a licensor's market authorization for reasons related to the risks outweighing the benefits, we will take the same action on the licensee's market authorization. This is because the information on the benefits and risks for a biocide authorized based on a comparison biocide relies on the information on the benefits and risks of the comparison biocide.

Obligations placed on use of foreign decisions market authorization holders

The holder of a market authorization for a biocide that was issued for a use of foreign decisions application (new or for a major change) is required to meet all 4 of the following:

1. Possess or have immediate access to:
   1. information that was submitted to the foreign regulatory authority regarding the benefits and risks associated with the biocide and any uncertainties relating to those, including reports of tests and studies to identify and assess the benefits, risks and uncertainties
   2. the specifications for the biocide that were submitted to the foreign regulatory authority
   3. the summary of the information on the benefits, risks, and related uncertainties of the biocide, if one was submitted to the foreign regulatory authority to obtain the authorization for the foreign biocide
2. Provide us, upon request, any information referred to under obligation 1) within 48 hours after the request is made or any longer period specified by the Minister.
3. Inform us without delay if they become aware that:
   1. the foreign biocide has been recalled
   2. the foreign regulatory authority has revoked or suspended the authorization to sell the foreign biocide
4. Without delay after becoming aware that the foreign regulatory authority has required a change in respect of the foreign biocide, provide us a written description of the change and the reasons for it, if they are known.