The European Chemicals Agency (ECHA) has initiated an expedited consultation process for biocides. This joint third-party consultation aims to gather data on substitutes for active ingredients identified by national authorities as potential replacements. The collected data is essential for the comparative analysis required to approve biocidal products containing these active ingredients.

Gathering Data on Substitutes

The consultation is seeking input concerning whether an active chemical can qualify for an exception if it is considered extremely dangerous by national authorities and meets the exclusion criteria of the Biocidal Products Regulation (BPR).The BPR provides for exceptions for up to five years if an active ingredient is essential for public health and if suitable substitutes are not available. It is important to gather data on viable substitutes and reasons for deviations for each supported use listed in the active substance application.

Ongoing Consultations

Consultations will take place throughout the active substance evaluation process. They aim to provide additional information to the reviewing national body, aiding in examining alternatives and determining the applicability of derogation criteria. Applicants will receive feedback on their applications, and the Biocidal Products Committee will consider this comprehensive assessment when forming its scientific judgment about the chemical. The first combined consultations began at the end of May, focusing on several active chemicals.

Background on Active Substance Substitution

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

1. Meets at least one of the exclusion criteria but may still be approved under a derogation.
2. Is classified as a respiratory sensitizer.
3. Has significantly lower toxicological reference values compared to most approved active substances of the same product type and use.
4. Satisfies two criteria for being persistent, bioaccumulative, and toxic (PBT).
5. Raises concerns even with very restrictive risk management measures.
6. Contains a significant proportion of non-active isomers or impurities.

Exclusion Criteria

Active substances that meet the exclusion criteria are classified as:

1. Carcinogenic, mutagenic, or reprotoxic under the Classification, Labelling, and Packaging Regulation.
2. Endocrine disruptors.
3. Persistent, bioaccumulative, and toxic (PBT) substances.
4. Very persistent and very bioaccumulative (vPvB) substances.

For more information, please refer to ECHA's official communication on streamlined biocide consultations.


Reach out to our regulation experts on chemical and product regulatory compliances