(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 1,2-Benzisothiazol-3(2H)-one (‘BIT’) (EC No: 220-120-9; CAS No: 2634-33-5) for product-types 6 and 13.

(2)

BIT has been evaluated for use in biocidal products of product-types 6 (in-can preservatives) and 13 (metalworking-fluid preservatives), as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond to product-types 6 (preservatives for products during storage) and 13 (working or cutting fluid preservatives), as described in Annex V to Regulation (EU) No 528/2012.

(3)

Spain was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 18 April 2012. After the submission of the assessment report, discussions took place in technical meetings organised by the European Chemicals Agency (‘the Agency’).

(4)

It follows from Article 90(2), first subparagraph, of Regulation (EU) No 528/2012 that applications for which the Member States’ evaluation has been completed by 1 September 2013 are to be evaluated in accordance with the substantive conditions for approval laid down in Directive 98/8/EC.

(5)

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 opinions of the Agency on 5 October 2021 (4) (5), having regard to the conclusions of the evaluating competent authority.

(6)

In its opinions, the Agency concluded that BIT may be approved as an active substance for use in biocidal products of product-types 6 and 13.

(7)

On 18 July 2023, pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012, the Commission requested the Agency (6) to revise its opinions as the efficacy of the representative biocidal products had not been appropriately assessed according to the applicable guidance document on efficacy (7), and this had not been adequately identified by the evaluating competent authority during the evaluation nor during the peer review by the Agency. Tier 2 data representing real-life conditions should have been requested and assessed.

(8)

The Biocidal Products Committee adopted the revised opinions of the Agency for product-types 6 and 13 on 18 September 2024 (8) (9). In those opinions, the Agency concluded that biocidal products of product-types 6 and 13 containing BIT may be expected to satisfy the requirements laid down in Article 5(1), points (b), (c) and (d), of Directive 98/8/EC, provided that certain requirements concerning their use are complied with.

(9)

Taking into account the opinions of the Agency, it is appropriate to approve BIT as an active substance for use in biocidal products of product-types 6 and 13 subject to compliance with certain conditions, including certain conditions for placing on the market of treated articles treated with or incorporating BIT in accordance with Article 10 of Directive 98/8/EC read in conjunction with Article 58 of Regulation (EU) No 528/2012.

(10)

Furthermore, to ensure a high level of safety for human health, the person responsible for the placing on the market for use by non-professionals of a mixture (other than paints) treated with or incorporating BIT should ensure that the mixture does not contain BIT at a concentration triggering classification of the mixture as skin sensitiser category 1A, unless exposure can be avoided by other means than the wearing of personal protective equipment.

(11)

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.

(12)

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