ECHA streamlines biocides consultations

ECHA/NR/24/14

Interested parties can soon provide information in one go on alternatives to biocidal active substances, as well as their impact on society and other relevant factors for derogation conditions. This will improve the technical assessment of the conditions under which highly hazardous substances could be approved in the EU.

Helsinki, 17 May 2024 – ECHA’s combined third-party consultation collects information on alternatives to active substances identified as candidates for substitution by the evaluating national authority. Such information is important for the comparative assessment that is required for authorising biocidal products containing these substances.

If the national authority concludes that an active substance is highly hazardous and meets the exclusion criteria of the Biocidal Products Regulation (BPR), the consultation also seeks information on whether the substance could still meet the derogation criteria. The BPR allows derogations for a maximum of five years, for example, when the active substance is essential for public health and no alternatives are available. Therefore, it is essential to collect information on potential alternatives and justifications for derogation for each of the supported uses outlined in the active substance application.

The consultations will generally take place during the active substance evaluation process. They will provide the evaluating national authority with additional information beyond the application, facilitating the assessment of alternatives and whether derogation conditions could apply. Moreover, the applicant will receive feedback on their application and the Biocidal Products Committee will consider this comprehensive assessment in its scientific opinion on the substance.

The first combined consultations are expected to be launched at the end of May on several active substances.

Background

An active substance may be considered a candidate for substitution if:

• it meets at least one of the exclusion criteria, but may be approved under a derogation;
• it is classified as a respiratory sensitiser;
• the toxicological reference values of the substance are significantly lower than the values for most approved active substances of the same product type and with the same usages;
• it meets two of the criteria for being a persistent, bioaccumulative and toxic (PBT) substance;
• it causes concern even with very restrictive risk management measures; or
• it contains a significant proportion of non-active isomers or impurities.

Active substances meeting the exclusion criteria are:

• classified as carcinogenic, mutagenic or reprotoxic under the Classification, Labelling and Packaging Regulation;
• endocrine disruptors;
• persistent, bioaccumulative and toxic (PBT) substances; or
• very persistent and very bioaccumulative (vPvB) substances.