ECHA optimizes consultations on biocides

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ECHA optimizes consultations on biocides – Interested parties will soon be able to find out about alternatives to biocidal active substances in one go. Its impact on society and other relevant factors for exemption conditions. This will improve the technical assessment of the conditions under which very hazardous substances can be authorized in the EU.

May 23, 2024 – ECHA’s combined external consultation collects information on alternatives to active substances identified by the evaluating national authority as candidates for substitution. Such information is important for the comparative assessment required for the authorization of biocidal products containing these substances.

Grounds for derogation

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

Careful review process

The consultation usually takes place as part of the active substance evaluation. You provide the evaluating national authority with additional information in addition to the application. This facilitates the assessment of alternatives and the question of whether other conditions may apply. In addition, the applicant will receive feedback on their application and the Biocidal Products Committee will incorporate this comprehensive assessment into its scientific advice on the substance.

Expected start

The first joint consultations are expected to start at the end of May for a number of active substances.

Background

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

• it meets at least one of the exclusion criteria, but can be approved on the basis of a deviation;
• it is classified as an inhalation allergen;
• the toxicological reference values of the substance are significantly lower than those of most authorized active substances of the same product type and with the same uses;
• it fulfills two of the criteria to be a persistent, bioaccumulative and toxic (PBT) substance;
• it is a problem even with very restrictive risk management measures; or
• it contains a significant proportion of inactive isomers or impurities.

Active substances that fulfill the exclusion criteria are:

• classified as carcinogenic, mutagenic or toxic for reproduction according to the Classification, Labeling and Packaging Ordinance;
• endocrine disruptors;
• persistent, bioaccumulative and toxic (PBT) substances; or
• very persistent and very bioaccumulative (vPvB) substances.

More information

• Authorization of active substances
• Working procedures for the approval and renewal of active substances [PDF][EN] 

Source: ECHA
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Reservation
This information has been compiled with the greatest possible care, in some cases from different information sources. (Interpretation) errors are not excluded. No legal obligation can therefore be derived from this text. Everyone dealing with this subject has the responsibility to delve into the matter!