ECHA’s biocides committee raises concern over missing data in applications

ECHA/NR/24/15

The Biocidal Products Committee (BPC) of ECHA adopted four opinions on active substances and seven on Union authorisations. The number of opinions not supporting active substance approvals and Union authorisations due to incomplete data is on the rise.

Helsinki, 5 June 2024 – The BPC, in its May meeting, adopted the following opinions on active substances, supporting:

• renewal of dinotefuran for product-type 18 (insecticides, acaricides and products to control other arthropods); and
• approval of polymeric betaine for product-type 8 (wood preservatives).

The committee did not support:

• renewal of medetomidine for product-type 21 (antifouling products); and
• approval of 5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) for product-type 6 (preservatives for products during storage).

The committee adopted seven opinions on Union authorisations, supporting authorisations for:

• biocidal product containing propan-2-ol for product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals);
• biocidal product family containing propan-1-ol and propan-2-ol for product-type 1 (disinfectants for human hygiene);
• biocidal product family containing Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide for product-type 19 (repellents and attractants for pest control);
• biocidal product containing Glutaral (Glutaraldehyde); Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) for product-type 6, 11 (preservatives for liquid-cooling and processing systems) and 12 (slimicides);
• biocidal product family containing Reaction mass of 5-chloro-2-methyl-2h-isothiazol 3-one and 2-methyl-2h-is thiazol-3-one (3:1) for product-type 4 (disinfectants for food and feed area), 11 and 12; and
• biocidal product family containing peracetic acid for product-type 2, 3 (disinfectants for veterinary hygiene) and 4.

The BPC did not support authorisation for a product family containing hydrogen peroxide for product-type 4.

The evaluating Member States recommend non-approvals and non-authorisations if companies fail to provide the required data, such as information on efficacy or endocrine disruption, within the process deadlines. Consequently, the opinion of the Biocidal Products Committee will not be favourable.

Joost van Galen, the BPC Chair, says in the Safer Chemicals podcast that companies are responsible for providing a complete dataset in their applications:

“It is not the responsibility of the evaluating competent authority to ensure that the dossier is complete, but the responsibility of the applicant. So, make sure your dossier is complete before you submit it."

“Also, remember that help is available. The data requirements are in the regulation and there are guidance documents on the procedure and on data. There’s also the possibility for the evaluating competent authority to have early BPC working group discussions to exchange thoughts with other Member States.”

More details of the committee opinions are available in the annex. The European Commission together with the EU Member States will take the final decisions based on BPC’s opinions.

The committee met from 27 to 31 May 2024. The adopted opinions will be available on ECHA’s website in the near future. The next meeting will take place on 17 and 18 September 2024.

Listen to the topical highlights from the committee Chair Joost van Galen.

Press contact: Hanna-Kaisa Torkkeli, press@echa.europa.eu, +358 50 416 8585