Biocidal product guidance on efficacy: future changes

WG-I discussed the possible changes to Vol. II. Parts B+C, at the 23 and 25 March 2021 meeting. The outcome of the meeting is summarised in WGI2021_EFF_minutes_final_public.pdf document (see link). The publication of the revised guidance is expected at the beginning of 2022.

The assessment and evaluation of disinfectants (PTs 1-5) sections have been revised during the meeting. Below you will find the key changes.

Room disinfection/automated airborne disinfection of surfaces in PT2:

• The paragraph describing automated airborne systems was clarified and simplified;
• The detailed descriptions of the different diffusion types were removed;
• The average flow rate and average droplet diameter will be kept as parameters that need to be reported from the efficacy tests;
• The part “if a pre-cleaning step has been made” was replaced by “clean/dirty conditions” to be reported from the efficacy tests;
• The sentence extracted from EN 17272 standard describing the testing approach for claimed room sizes larger than 150 m³ was clarified;
• The requirement to give the flow rate in the SPC will be discussed by Partner Expert Group (PEG);
• Humidity will be kept as a parameter to be reported in the SPC, but it was amended into “humidity recommendation”;
• Biological/chemical validation should be a requirement not a recommendation.

Textile disinfection in PT 2 

• “Textile disinfection” was amended into “Textile / Laundry process disinfection”;
• The requirement for testing the standard non-temperature resistant test organisms at the maximum validated temperature of phase 2, step 1 test was removed accordingly;
• Additional clarification on the test organisms and intended claims in different temperature regimes was added as follows:

1. - ≥60 °C: Valid tests against E. faecium permits claims against bacteria, yeast, fungi and mycobacteria
2. - 40 °C < T < 60 °C: All claimed groups of target organisms need to be tested. If test organisms from one group are not valid in the water control but reach a sufficient log reduction in the biocide sample, this target organism group can be claimed if valid tests with E. faecium have been submitted.

These changes need to be taken into account when planning a test strategy, when drafting a product label and when preparing a dossier. Your consultant should be updated on all the decisions taken by the PEG and by the BPC and have a group of efficacy experts able to monitor the study scopes and processes. Please feel free to contact us. Our efficacy experts will be happy to support you with the choice of the correct testing strategy for your products.