the new guidance helps companies analyse alternatives under the Biocidal Products Regulation for potentially dangerous active biocidal substances

Currently, there are 59 biocidal active substances identified as “candidates for substitution” (CfS) under the BPR (Art.10), and 441 active substances under assessment.

Article 5 of the BPR ensures that, during the evaluation of an application for active substance approval, active substances will be assessed against exclusion criteria which have been set to phase out substances which raise particular concerns. Active substances meeting one of such criteria shall not be approved unless at least one of the conditions set out in Art. 5(2) of the BPR is met. Art.5(2) specifies that the availability of suitable and sufficient alternative substances or technologies shall be a key consideration when deciding on the approval of substances meeting the exclusion criteria. In this sense, the submission of an analysis of alternatives by the applicant is required.

When substances meet at least one of the criteria for substitution, but do not meet any of the exclusion criteria, a comparative assessment at biocide product level is performed by the relevant competent authority. The placing on the market of the biocidal products containing an active substance which is CfS shall be prohibited/restricted in case the comparative assessment demonstrates that suitable alternatives are available. The submission of an analysis of alternatives by applicants for approval/renewal of such active substances is not legally required but strongly recommended to support the comparative assessment at product authorisation stage.

The ECHA guidance “Analysis of alternatives to biocidal active substances for applicants and authorities: a recommended framework guidance”, released on last January, is primarily aimed at:

  • The applicants to support their application for approval/renewal of a biocidal active substance meeting the exclusion/substitution criteria, and
  • The competent authorities willing to perform an analysis of alternatives for such active substances.

An alternative to a biocidal active substance is a means able to replace the function that the active substance performs, and it must fulfil the following criteria:

  • Safer, i.e. it reduces the risk to human health, animal health and the environment, and
  • Technically and economically feasible for the users in the EU (including efficacy), and
  • Available, from the perspective of production capacities, or of feasibility of the alternative technology.

The alternatives can be chemical substances or non-chemical alternatives (non-chemical means of control and prevention methods). Non-chemical alternatives can be e.g. physical means of achieving the same function of the biocidal active substance, or organisational procedures, preventive measures, devices, changes in a product manufacturing process, changes in the end-product, changes in the material of the end-product (e.g. steel pole instead of wooden pole), etc.

Overall, the analysis of alternatives should comprise:

  • A brief description of the steps taken to identify potential alternatives.
  • The main conclusions of the analysis regarding the identification of potential alternatives and the suitability and availability of these alternatives for the identified uses
  • If there are no or insufficient suitable alternatives, a summary of the actions needed to make potential alternatives suitable and available and the timescale for these actions.

For further details, you can download the guidance here: https://echa.europa.eu/documents/10162/1276600/guidance_analysis_alternatives_biocides_en.pdf/10646cd2-8ec9-36a8-2f00-201fcc49c43e?t=1675846602684

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


  • Section, information about differentiation of virucidal claims has been added;
  • Section, information about:
  • Phase 2, step 2 test used for the respective application methods has been added;
  • Section 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 Air-conditioning systems – the requirement for a quantitative suspension test (phase 2, step 1) has been removed;
  • Section 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;


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


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


  • Section 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