Guidance on efficacy requirements for biocides: Other types of claims
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Biofilms
To add claims against biofilms on the biocide label (for example, destroying or controlling), the biocide must meet the performance criteria for a general (broad-spectrum) or hospital disinfectant and demonstrate efficacy against P. aeruginosa and S. aureus biofilms. The biofilm test methods are not suitable for hard surfaces of water systems due to differences in environmental conditions found in these systems (for example, drinking water distribution systems, cooling tower systems). For this reason, we do not expect that the biofilm test methods would accurately demonstrate the efficacy of antimicrobial products against public health biofilm in water systems. You may wish to also consult the most recent version of:
- Methods and guidance for testing the efficacy of antimicrobial products against biofilms on hard, non-porous surfaces (US EPA)
| Claim | Physical form, method of application | Recommended test methods | Test organisms | Number of batches per organism, replication of carrier surfaces per batch | Inoculum or carrier count | Performance criteria for efficacy |
|---|---|---|---|---|---|---|
| Core bacteria test requirements for biofilms | ||||||
| Biofilm kill claim | Water-soluble powder or liquid – dilutableFootnote 1 or RTU spray – test as liquid Method not applicable for towelettes |
ASTM E3161 Standard Practice for Preparing a Pseudomonas aeruginosa or Staphylococcus aureus Biofilm using the CDC Biofilm Reactor and ASTM E2871 Standard Test Method for Determining Disinfectant Efficacy Against Biofilm Grown in the CDC Biofilm Reactor using the Single Tube MethodFootnote 3 US EPA's standard operating procedures MB-19: Preparing a Pseudomonas aeruginosa or Staphylococcus aureus Biofilm using the CDC Biofilm Reactor and MB-20 Single Tube Method for Determining the Efficacy of Disinfectants against Bacterial Biofilm |
Pseudomonas aeruginosa (ATCC 15442) and Staphylococcus aureus (ATCC 6538) | 3 batches at LCL per organism Conduct each of the 3 tests per organism on different test days (P. aeruginosa and S. aureus testing may be on same day) Evaluate a minimum of 5 coupons against the biocide and 3 coupons as controls per organism per batch Testing should be done on Borosilicate glass coupons |
S. aureus: Mean log density of 7.5 to 9.0 CFU per couponFootnote 2 P. aeruginosa: mean log density of 8.0 to 9.5 CFU per couponFootnote 2 |
Minimum mean 6.0 log10 reduction (CFU per coupon) across 5 coupons for each batch within or equal to 10 min |
| Additional bacteria test requirements for biofilms | ||||||
| Biofilm kill claims for additional biofilm bacteria | Contact us about:
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| Confirmatory data bacteria test requirements for biofilms | ||||||
| Biofilm kill claim | Same as core bacteria requirements Testing against additional bacteria not required |
2 batches at the LCL per organism Evaluate a minimum of 5 coupons against the biocide and 3 coupons as controls per organism per batch Testing should be done on Borosilicate glass coupons |
Same as core bacteria requirements | |||
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Prions
For information on general efficacy in reducing the infectivity of prions, consult:
Mould, mildew and odour control
You do not need to include efficacy data for general mould, mildew and odour control claims, which are considered non-therapeutic, such as:
- deodorizes surface
- prevents the growth of mould and mildew
- controls the growth of mould and mildew
- mildewstat
- controls the growth of odour causing bacteria
- bacteriostatic
However, for claims against specific bacteria or fungi, you should:
- show your biocide is for general (broad-spectrum) use or for hospital or health care use
- test the biocide against the appropriate micro-organism on carriers that represent the intended surfaces indicated on the label
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