Guidance on safety requirements for biocides: Safety summary

On this page

• Summary of risk information
• Comparison – labelling only and UFD applications
• Monograph applications
• Other information
• Example of a summary template for safety information

Summary of risk information

Certain applications must contain a summary of the information included in your application about the risks and any related uncertainties of your biocide. Find information on when a safety summary is required, and find below what should be included in a safety summary.

The safety summary should:

• outline the information included in your application on the biocide's risks
• briefly summarize any safety testing submitted for your biocide, including descriptions of the test formulation used in each batch tested:
  • name of the test product
  • ready-to-use (RTU) product or dilution used (for biocides that are diluted from concentrated formulation) and it’s definition in testing
    • for example, 1:256 (1 part product in 256 parts water)
• explain the proposed safety labelling (risk information) based on information included in your application.

Do not include detailed information on safety data reporting in your summary.

The safety summary should include:

• a summary of the potential health effects from the likely routes of exposure, and their acute toxicity endpoints
• the Canadian hazard classification system used, such as:
  • Hazardous Products Regulations
  • Consumer Chemicals and Containers Regulations, 2001
• regulatory status and/or approval with foreign regulators
• rationales for omitting potable water rinse statements, if applicable
• proposed precautionary, hazard and first aid statements, including precautionary and hazard statements that differ in other foreign jurisdictions
  • this helps us to evaluate the use of different hazard classification approaches for your biocide than those published in Canadian regulations
• a scientific rationale to confirm that the safety and quality of alternate formulations are equivalent to the basic formulation
• data waivers (when applicable)
• residue information (when applicable)
• chronic exposure potential (when applicable)

Contact us to discuss the use of different hazard classification approaches for your biocide than those published in Canadian regulations.  

The safety summary must be based on information relevant for your biocide’s formulation or a substantially similar formulation. Safety information submitted for your biocide can be in the form of test data or comprehensive scientific rationales with literature search results.

Your summary of relevant scientific literature may include both favourable and unfavourable data. You can obtain this information by conducting a systematic literature review of evidence relevant to your biocide from:

• published literature
• regulatory authority reports
• pre- and post-market experience, if applicable

Comparison – labelling only and UFD applications

We recommend you include in your safety summary for comparison - labelling only or UFD application, as applicable:

• an explanation of any differences between the comparison product or foreign biocide and the biocide in the application
• rationales for these differences
• a description of why the biocide's risks are not affected by these differences

The inclusion of this information for foreign biocides helps us to evaluate the use of different hazard classification approaches for your biocide than those published in Canadian regulations.

As indicated in the guidance on labelling requirements for biocides, editorial changes between the foreign biocide label text and Canadian label text may be acceptable and allow you to capture minor variations in the way you present the same information on labels. However, you must not change the meaning or interpretation of a given statement.

Monograph applications

The abbreviated safety summary for a monograph application should contain:

• a summary of the health effects from the likely routes of exposure
• the Canadian hazard classification system being used
• the proposed precautionary, hazard and first aid statements for the biocide

Other information

If it applies, you should also provide: 

• post-meeting notes of pre-submission meetings or discussions 
• any correspondence related to your submission (for example, emails) 
• reason(s) for submitting new safety information for previously approved biocides
• your biocide's regulatory status in foreign jurisdictions and any differences in its safety profile
  • this helps us to evaluate the use of different hazard classification approaches for your biocide than those published in Canadian regulations

Example of a summary template for safety information

To summarize your summary information for a biocide, use: 

• the following template or 
• a different format that contains the same information