Guidance on biocide application pathways and general requirements: Prepare your application
On this page
- Overview
- Full review application
- Full review - novel biocide application
- Monograph application
- Applications based on comparison
- Use of foreign decisions application
Overview
This section of the guidance will provide you with details on the information and documents that are needed for each pathway to apply for a biocide market authorization.
The documents provide us with the information needed to:
- process your application appropriately once received
- satisfy the application requirements outlined in the regulations
- determine if the benefits of the biocide outweigh its risks, taking into account any uncertainties relating to the benefits and risks
Information and documents you need to provide
For guidance on navigating the biocide application process and for the performance standards for biocide applications, consult:
Through the review of your application, we may request:
- additional information
- material, including samples of the biocide for testing
This may be necessary to determine whether the market authorization must be issued. This includes information about the benefits and risks associated with the biocide. We may request additional information or material for an application filed through any pathway, including the use of foreign decisions pathway.
The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.
Full review application
Required application contents:
- cover letter
- biocide application form
- label text
- summary of information on benefits and risks
- safety, efficacy and quality (stability) data, as applicable
- specifications
Full review - novel biocide application
Required application contents:
- cover letter
- biocide application form
- label text
- summary of information on benefits and risks
- safety, efficacy and quality (stability) data, as applicable
- specifications
When compared to an application filed through the full review pathway, your application will require additional safety, efficacy, and quality data. The information that may be requested depends on the specific characteristics of the biocide. Contact us to discuss the additional data you may need to support your biocide.
Learn more:
- safety requirements for biocides
- quality requirements for biocides
- efficacy requirements for biocides
Monograph application
Required application contents:
- cover letter
- biocide application form
- monograph attestation
- label text
- abbreviated summary of information on benefits and risks
- safety information, quality (stability) data, as applicable
- specifications
Monograph applications rely on publicly available information regarding biocide efficacy. As such, they do not require the submission of supporting efficacy data. This type of application instead requires an attestation of compliance with a biocide monograph, such as the Biocide monograph. The monograph attestation within the biocide application form certifies that the biocide outlined in the application meets all parameters presented in the monograph.
Your summary can be abbreviated as the biocide relies on the monograph for information on its benefits and risks.
Your monograph application should include information to support the determination of the labelling for the biocide, including its:
- risk information
- directions for use
You are not required to submit supporting efficacy data with your application. However, when conducting efficacy testing for your proposed formulations, you should reference the guidance on efficacy requirements for biocides for recommended efficacy test methods and expected performance criteria.
You are required to submit safety and quality information (such as product specifications), as the monograph only specifies efficacy parameters.
For more information, consult the:
- safety requirements for biocides
- quality requirements for biocides
- efficacy requirements for biocides
Learn more:
Applications based on comparison
There are 2 application pathways based on comparison:
Comparison - administrative application
Required application contents:
- cover letter
- biocide application form
- administrative attestation
- label text
- letter of confirmation
When you use this pathway and reference a letter of confirmation to support the safety and efficacy of your biocide, you must complete the administrative attestation as part of the biocide application form. The administrative attestation certifies that the biocide in the application:
- will be manufactured according to the master formula of the comparison biocide
- has the same specifications as the comparison biocide
Comparison - labelling only application
Required application contents:
- cover letter
- biocide application form
- labelling only attestation
- label text
- letter of confirmation
- optional: summary of information on benefits and risks
You may provide a summary to describe the differences between the comparison biocide and the biocide in the application based on comparison to ease review. For example, differences in packaging or inclusion of only certain formulation variations. We recommend including rationales for these differences, including how the benefits and risks of the biocide are not impacted, to reduce the need for clarification requests.
If you make a change to the packaging type from the comparison biocide, you should include stability information in the application to support that the change will not impact the shelf life of the biocide. You may also revise the shelf life, if supported by the new stability information.
When to include stability data in your application
You must also complete the labelling only attestation as part of the biocide application form, which certifies that the biocide in the application:
- will be manufactured according to the master formula of the comparison biocide
- has the same specifications as the comparison biocide, other than in respect of the:
- net quantity of the biocide in the package
- type of package
- properties and qualities of the packaging material
Use of foreign decisions application
Required application contents:
- cover letter
- biocide application form
- use of foreign decisions attestation
- Canadian label text, with risk information determined by hazard classification criteria of the foreign regulator
- foreign biocide documents:
- US EPA Confidential Statement of Formula (CSF) for the foreign biocide
- US EPA approved label text for the foreign biocide
- US EPA Form 8570-35 Data Matrix for the foreign biocide
- US EPA registration notice for the foreign biocide
- evidence that the authorization for the foreign biocide has not been suspended (for example, a screen shot of the foreign biocide registration status in the US EPA Pesticide Product and Label System database)
Applications filed through this pathway should include a summary to describe any differences between the foreign biocide and the biocide in the application (for example, packaging) to ease review. We recommend including rationales for these differences, including how the benefits and risks of the biocide are not impacted, to reduce the need for clarification requests.
Where you reference a foreign biocide to support the safety and efficacy of your biocide, you must complete the use of foreign decisions attestation as part of the biocide application form. This attestation is specific to the requirements of this pathway, including aspects related to the:
- Canadian biocide application
- foreign biocide information
- responsibilities for the market authorization holder
Brand names must be unique to be authorized in Canada. If a brand name that has been authorized by the foreign regulatory authority for the foreign biocide is already authorized for a biocide in Canada, it cannot be included in the application. The brand name in the application does not need to be the same as that of the foreign biocide.
You should include stability information in the application to support the shelf life of the biocide if you make a change to the:
- net quantity of the biocide in the package
- packaging type
- packaging material compared to that of the foreign biocide
- shelf life compared to that of the foreign biocide