efficacy guidance Tag

The guidance document for the Biocidal Products Regulation (BPR) Volume II – Efficacy Assessment and Evaluation (Parts B+C) has been updated. The update covers the chapter on disinfectants for product-types 1-5.

Sections on co-formulants being potential active substances, virucidal claims, room and laundry disinfection, and disinfection of packaging before aseptic filling have been added or revised.

Appendices 1 (Claim matrices), 2 (Standards and testing methods), 3 (Test organisms) and, particularly, 4 (Overview of standards, test conditions and pass criteria) have also been updated based on recently developed and published European standards.

Here below the complete list of updates:

• Section 5.4.0.4.5 ‘Co-formulant(s) being a potential active substance’ has been added.
• Section 5.4.1.2.2, Vaccinia virus as test organism has been added;

PT2

• Section 5.4.2.2.4, information about differentiation of virucidal claims has been added;
• Section 5.4.2.3.2, information about:
• Phase 2, step 2 test used for the respective application methods has been added;
• Section 5.4.2.5 Room disinfection/automated airborne disinfection of surfaces has been updated:
• requirement for a quantitative suspension test (phase 2, step 1) has been removed;
• parameters used in efficacy tests and the parameters to be taken into account in the SPC have been revised;
• requirements for biological and chemical validation in room disinfection have been added;
• Section 5.4.2.8 Air-conditioning systems – the requirement for a quantitative suspension test (phase 2, step 1) has been removed;
• Section 5.4.2.10 Textile/laundry process disinfection has been updated:
• information about products used as disinfectants in combination with detergents has been added;
• the recommended test organisms have been added;

PT3

• Section 5.4.3.2 and 5.4.3.7, recommendation for DVG guidelines has been added;
• Section 5.4.3.8 on Room disinfection/automated airborne disinfection of surfaces has been added.

PT4

• Section 5.4.4.1 has been amended in order to give a possibility to differentiate the contact time and dose for bacteria and yeasts for professional users;
• Section 5.4.4.3. on room disinfection/automated airborne disinfection of surfaces has been added;
• Section 5.4.4.7 on disinfection of inner surfaces in human drinking water systems, the requirements for phase 2, step 2 tests have been added;
• Section 5.4.4.9 on other uses in PT4 has been updated about requirements concerning disinfection of packaging before aseptic filling.

PT5

• Section 5.4.5.2 on disinfection at the drinking water suppliers and their water distribution systems has been updated about information of test requirements for chlorine-based disinfectants.

Appendix 1 (Table 5) is updated to reflect the changes made in Appendix 4.

Appendices 2, 3 and 4: the test requirements and test organisms are updated based on EN standards that have been published after Vol II Parts B+C Ver 3.0 was published (EN 1276:2019. EN 1650:2019, EN 1656:2019, EN 14476:2013+A2:2019, EN 17126:2018, EN 16777:2018, EN 17111:2018, EN 17122:2019, EN 17272:2020, EN 17387:2021). The main guidance text has been updated accordingly, where relevant.

In addition some corrections and editorial revisions have been made to both appendices.

In addition corrections revisions have been made as follows:

• Harmonising the abbreviation of litre into l (as in the BPR)
• Harmonising the abbreviation of colony forming units into cfu
• Harmonising the abbreviation of logarithmic into lg (instead of log)

In addition, some smaller editorial corrections for aligning the spelling have been made.

Efficacy Guidance: https://echa.europa.eu/documents/10162/2324906/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/ae2e9a18-82ee-2340-9354-d82913543fb9?t=1667389376408