Commission Implementing Regulation (EU) 2025/929 of 21 May 2025 approving 1,2-Benzisothiazol-3(2H)-one (BIT) as an existing active substance for use in biocidal products of product-types 6 and 13 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

• CELEX: Implementing Regulation (EU) 2025/929
• Articles: 3

Article 1

1,2-Benzisothiazol-3(2H)-one (BIT) is approved as an active substance for use in biocidal products of product-types 6 and 13, subject to the conditions set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance  ( 1 )

Date of approval

Expiry date of approval

Product type

Specific conditions

BIT (Benzisothiazolinone)

IUPAC name:

1,2-Benzisothiazol-3(2H)-one

EC No: 220-120-9

CAS No: 2634-33-5

965 g/kg (theoretical calculated dry weight)

1 October 2026

30 September 2036

6

1.

The authorisation of biocidal products containing 1,2-Benzisothiazol-3(2H)-one (‘BIT’) as an active substance is subject to the following conditions:

(a)

the product assessment pays particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level assessment of the active substance;

(b)

the product assessment pays particular attention to:

(i)

industrial and professional users, and non-professional users by exposure to BIT via treated articles;

(ii)

sewage treatment plant and surface water for the uses ‘Preservation of additives used in paper production’, ‘Preservation of additives used in textile production’ and ‘Preservation of additives used in leather production’;

(iii)

surface water and groundwater due to direct releases from the uses ‘Preservation of paints and coatings in outdoor use’ and ‘Preservation of polymer emulsions used for paints and coatings in outdoor use’;

(c)

Member States’ competent authorities or, in the case of a Union authorisation the Commission, specify in the summary of the biocidal product characteristics of a biocidal product containing BIT the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012.

2.

The placing on the market of treated articles is subject to the following conditions:

(a)

the person responsible for the placing on the market of a treated article treated with or incorporating BIT ensures that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012;

(b)

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 ensures 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;

(c)

the person responsible for the placing on the market for use by non-professionals of a paint treated with or incorporating BIT at a concentration triggering classification of the mixture as skin sensitiser category 1A, ensures that:

(i)

the paint is supplied with appropriate protective gloves in compliance with European Standard EN 374 or equivalent;

(ii)

the label indicates that protective gloves must be worn during use.

13

1.

The authorisation of biocidal products containing 1,2-Benzisothiazol-3(2H)-one (BIT) as an active substance is subject to the following conditions:

(a)

the product assessment pays particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level assessment of the active substance;

(b)

the product assessment pays particular attention to:

(i)

industrial or professional users;

(ii)

surface water, the sewage treatment plant, and sediment;

(c)

Member States’ competent authorities or, in the case of a Union authorisation the Commission, specify in the summary of the biocidal product characteristics of a biocidal product containing BIT the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012.

2.

The placing on the market of treated articles is subject to the following condition: the person responsible for the placing on the market of a treated article treated with or incorporating BIT ensures that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012.

( 1 )   The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.