The European Chemicals Agency (ECHA) is introducing a combined third-party consultation process. This new initiative is designed to gather critical information on alternatives to active substances identified as candidates for substitution by the evaluating national authority. This comprehensive information is essential for the comparative assessment necessary for authorising biocidal products containing these substances.
Criteria for Derogation
If the national authority determines that an active substance is highly hazardous and meets the exclusion criteria under the Biocidal Products Regulation (BPR), the consultation will also seek input on whether the substance could still qualify for derogation. The BPR permits derogations for up to five years when the active substance is crucial for public health, and no alternatives are available. Collecting information on potential alternatives and justifications for derogation for each supported use is vital.
Evaluation Process
These consultations will typically occur during the active substance evaluation process. They provide the evaluating national authority with additional information beyond the initial application, facilitating a thorough assessment of alternatives and the applicability of derogation conditions. Additionally, applicants will receive feedback on their applications, and the Biocidal Products Committee will incorporate this comprehensive assessment into its scientific opinion on the substance.
The first combined consultations are expected to launch at the end of May for several active substances.
Background Information
Criteria for Substitution
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;
- Is classified as a respiratory sensitiser;
- Has toxicological reference values significantly lower than those for most approved active substances of the same product type and usage;
- Meets two of the criteria for being a persistent, bioaccumulative, and toxic (PBT) substance;
- Causes concern even with very restrictive risk management measures; or
- Contains a significant proportion of non-active isomers or impurities.
Exclusion Criteria
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.
ECHA’s streamlined consultation process aims to ensure that highly hazardous substances are carefully assessed and that safer alternatives are identified and utilised whenever possible. This initiative is expected to enhance public health and safety across the EU by ensuring thorough evaluations and encouraging the use of less hazardous biocidal products.
