Guidance on efficacy requirements for biocides: Preparing your benefits package

On this page

• Summary of benefits information
  • Organisms used
  • Test product
  • Batches and carriers
  • Organic burden load (soil load)
  • Test method
  • Performance criteria (results)
  • Laboratory report identifier
• Other information
• Example of a summary template for efficacy data

Summary of benefits information

Certain applications must contain a summary of the information included in your application about the benefits and any related uncertainties of your biocide. Find information on when an efficacy summary is required and what should be included in the efficacy summary.

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

The efficacy summary should include a summary of the efficacy reports submitted in support of the benefits of your biocide.

Organisms used

You should include the following information for the test organisms you used in each efficacy study:

• name
• source (stock supplier)
  • for example, the American Type Culture Collection (ATCC) identifier and the American Society of Testing and Materials (ASTM) identifier
• identity of the specific strain, if applicable

You should also specify the purpose of the study, such as:

• adding a claim or
• confirmatory data and the changed condition that prompted confirmatory testing (refer to summary table below for an example)

Test product

For each efficacy study, describe the test product formulation used in each batch test, including :

• name of the test product
• application method used in testing
  • for example, immersion, spray, towelettes
• ready-to-use (RTU) product or dilution used (for biocides that are diluted from a concentrated formulation) and its definition in testing
  • for example, 1:256 (1 part product in 256 parts water)
• tested contact time

If you are referencing efficacy data from another biocide to support a claim, refer to the example summary template for how to indicate this.

Batches and carriers

For each efficacy study, indicate:

• the number of batches used
• the number of carriers used per batch
• the type of carrier used
  • for example, steel disk, cotton and polyester swatches

Organic burden level (soil load)

For each efficacy study, indicate:

• the specific burden load
  • for example, 5% fetal bovine serum (FBS) or no soil load

Test method

For each efficacy study, indicate the:

• name of the current test method (with additional information about modifications, if any)
  • for example, ASTM 961.02 (modified for mycobacteria)

Performance criteria (results)

For each efficacy study, as per prescribed test method used, indicate the:

• quantitative or qualitative results for each batch
  • for example, greater than or equal to 3 log₁₀ reduction in viral titer beyond the cytotoxic level for all the test carriers or 59/60 carriers negative for growth, as appropriate

Laboratory report identifier

For each efficacy study, indicate the:

• unique identification number of your efficacy report
  • for example:
    • 506-259 (Laboratory Project Identification Number) or
    • 506-259 (Project Number) or
    • 2304884-404 (Laboratory Study Number)

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 efficacy data
  • for previously approved claims against specific micro-organisms
• your biocide's regulatory status in foreign jurisdictions and any differences in its efficacy profile

Example of a summary template for efficacy data

To summarize your efficacy data for a biocide, use:

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

The summary should outline the:

• new or revised (in the case of a post-authorization change) claims for your biocide for each microbial category and
• data to support the claims