(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes formic acid (EC No: 200-579-1; CAS No: 64-18-6) for product-type 6.

(2)

Formic acid has been evaluated for use in biocidal products of product-type 6 (in-can preservatives), as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which corresponds to product-type 6 (preservatives for products during storage), as described in Annex V to Regulation (EU) No 528/2012.

(3)

Belgium was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘the Agency’) on 15 September 2021. The Agency discussed the assessment report and the conclusions in technical meetings.

(4)

In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for approval of active substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014 read in conjunction with Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinion of the Agency on 8 June 2022 (4), having regard to the conclusions of the evaluating competent authority. In its opinion, the Agency concluded that formic acid may be approved as an active substance for use in biocidal products of product-type 6.

(5)

On 18 July 2023, pursuant to Article 75(1), second subparagraph, point (g), of Regulation (EU) No 528/2012, the Commission requested the Agency (5) to revise its opinion as the efficacy of the representative biocidal product has not been appropriately assessed in accordance with the applicable Agency’s guidance document (6) on efficacy, and since that efficacy issue was not adequately identified by the evaluating competent authority during the evaluation nor during the review by the Agency. In particular, the Commission requested the examination of tier 2 efficacy data representing real-life conditions.

(6)

The Biocidal Products Committee adopted the revised opinion of the Agency for approval of the active substance formic acid for product-type 6 on 18 September 2024 (7). In that opinion, the Agency concluded that biocidal products of product-type 6 containing formic acid may be expected to satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain conditions concerning their use are complied with.

(7)

Taking into account the opinion of the Agency, it is appropriate to approve formic acid as an active substance for use in biocidal products of product-type 6 subject to compliance with certain conditions, including conditions for placing on the market of treated articles treated with or incorporating formic acid in accordance with Article 4(3) of Regulation (EU) No 528/2012 read in conjunction with Article 58(3) of that Regulation.

(8)

A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,