ECHA Launches Combined Consultations on 11 Candidates for Substitution and Derogations from Exclusion Criteria

On 24 May 2024, the European Chemicals Agency (ECHA) launched consultations on eleven active substances identified as potential candidates for substitution under the Biocidal Products Regulation (BPR). These substances meet specific criteria set out in Article 10(1) of the BPR, triggering a consultation process to gather information on potential alternatives. The consultations will end on 23 July 2024.

Exclusion Criteria

In addition, some of these substances meet exclusion criteria listed in Article 5(1) of the BPR, such as being classified as carcinogenic, mutagenic, reprotoxic substances (CMR), endocrine disrupting, or persistent, bioaccumulative and toxic (PBT). Substances meeting these criteria will normally not be authorised unless they qualify for derogations as specified in Article 5(2).

Conditions for Derogations

Derogations may be granted if:

• The risk to humans, animals, or the environment is negligible under realistic worst-case scenarios.

• The substance is essential to prevent serious risks to human health or the environment.

• Non-approval would have disproportionatly negative impact on society.

Substances Included in the Consultations

Below is the list of substances included in the current consultations. The consultation for epsilon-metofluthrin only concerns substitution candidates and not derogations from the exclusion criteria.

Details of the substances can be found here.

Consultation Process

ECHA's consultations aim to gather third-party information on the availability of alternatives and the justification for derogations to ensure a thorough evaluation of these substances. If a derogation is granted, the authorisation is limited to a maximum of five years and to specific uses. Member States can only authorise biocidal products if these conditions are met locally.

The consultations aim to strike a balance between public health, environmental safety and societal impacts, while assessing the viability of alternatives and the need for derogations for the substances in question.