ECHA Streamlines Biocides Consultations to Improve Risk Assessment of Hazardous Substances

On 17 May 2024, the European Chemicals Agency (ECHA) announced a new streamlined process for third party consultations on biocidal active substances. This initiative aims to gather comprehensive information on alternatives to hazardous substances and their societal impacts, thus facilitating a more thorough technical assessment for the approval of these substances in the EU.

From the end of May, interested parties will be able to submit information on alternatives to biocidal active substances identified as candidates for substitution. This data is crucial for the comparative assessment required for the authorisation of biocidal products containing these substances.

Consultation Details and Process

When a national authority identifies an active substance as being very hazardous and meeting the exclusion criteria under the Biocidal Products Regulation (BPR), the consultation also seeks information on whether the substance can meet the criteria for  a derogation. The BPR allows derogations for up to five years if the substance is essential for public health and there are no alternatives. It is therefore important to collect detailed information on potential alternatives and justifications for each supported use of the active substance.

These consultations will be integrated into the evaluation process for active substances, providing the national authority with additional information beyond the initial application. This will improve the assessment of alternatives and the applicability of derogation conditions. The feedback received will also inform the applicant and the Biocidal Products Committee will take this comprehensive data into account when preparing its scientific opinion on the substance.

Background and Criteria

An active substance may be considered as a candidate for substitution if it

• Meets at least one exclusion criterion but could be approved under derogation.

• Is classified as a respiratory sensitizer.

• Has significantly lower toxicological reference values compared to most approved substances of the same type.

• Meets two of the criteria for being a persistent, bioaccumulative, and toxic (PBT) substance.

• Cause concern despite stringent risk management measures.

• Contains a significant amount of non-active isomers or impurities.

Active substances meeting the exclusion criteria are:

• Substances classified as carcinogenic, mutagenic or reprotoxic under the Classification, Labelling and Packaging (CLP) Regulation

• Endocrine disruptors,

• Persistent, Bioaccumulative and Toxic (PBT) substances

• Very persistent and very bioaccumulative (vPvB) substances.

Additional Information

For more details on the approval of active substances and the working procedure for the approval and renewal  of active substance, please consult the official ECHA documentation here.