News Details

The European Chemicals Agency (ECHA) has published version 2.0 of its guidance on the analysis of alternatives (AoA) for biocidal active substances. This provides updated recommendations for applicants and authorities under the Biocidal Products Regulation (BPR).

The revised guidance clarifies which uses should be considered in an AoA and updates the third-party consultation process. It also provides further clarification on approvals for active substances that meet the BPR exclusion criteria and brings the guidance into line with ECHA's recently adopted manual for assessing derogations under Article 5(2) of the BPR.

Scope and Purpose of the Guidance

The guidance is intended primarily for applicants seeking the approval or renewal of biocidal active substances that are candidates for substitution, including those meeting the exclusion criteria under Article 5(1) of the BPR. It may also be used by Member State Competent Authorities (MSCAs), the Biocidal Products Committee (BPC), and third parties providing information on alternatives during consultations under Article 10(3).

The framework is recommended rather than mandatory, and is intended to support the identification and assessment of suitable alternatives at the active substance approval or renewal stage.

Analysis of Alternatives

The guidance recommends assessing both chemical and non-chemical alternatives. An alternative is considered suitable for a particular use if it:

• Reduces risks to human health, animal health and the environment.
• Is technically and economically feasible, including in terms of efficacy.
• Is available, taking into account production capacity, the feasibility of the alternative technology, and the requirements for placing it on the market.

The AoA should identify potential alternatives based on the function of the active substance and assess their suitability and availability, including technical and economic feasibility and overall risk reduction. Where feasible, it should also identify actions and timescales needed to make suitable alternatives available.

Clarification for Substances Meeting the Exclusion Criteria

For active substances meeting the exclusion criteria, applicants are expected to prepare an AoA that is as comprehensive as possible. The assessment should cover all uses included in the applicant's dossier, as well as those identified through third-party consultation. The availability of alternatives and applicability of derogation conditions should be assessed and reported separately for each use.

Under Article 5 of the BPR, active substances meeting the exclusion criteria generally cannot be approved unless at least one of the derogation conditions in Article 5(2) is met. The availability of suitable and sufficient alternatives is a key consideration in this assessment.

Third-Party Consultations

The revised guidance also provides updated information on third-party consultations. For substances that meet the exclusion criteria, ECHA launches a 60-day joint consultation to gather information on the availability and suitability of chemical and non-chemical alternatives and whether the Article 5(2) derogation conditions are met.

Manufacturers, users of biocidal products, suppliers of potential alternatives, industry sectors, authorities, academia and other interested parties may contribute information to these consultations.