Commission Implementing Regulation (EU) 2025/1257 of 26 June 2025 approving 2-methyl-2H-isothiazol-3-one (MIT) as an existing active substance for use in biocidal products of product-type 6 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

• CELEX: Implementing Regulation (EU) 2025/1257
• Articles: 3

Article 1

2-methyl-2H-isothiazol-3-one (MIT) is approved as an active substance for use in biocidal products of product-type 6, 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

MIT

IUPAC name: 2-methyl-2H-isothiazol-3-one

EC No: 220-239-6

CAS No: 2682-20-4

> 950 g/kg

1 February 2027

31 January 2037

6

(1)

The authorisation of biocidal products containing 2-methyl-2H-isothiazol-3-one (MIT) 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;

(ii)

non-professional users: by exposure to the active substance via treated articles;

(iii)

soil compartment;

(c)

Member States’ competent authorities or, in the case of a Union authorisation the Commission, specify in the summary of the biocidal product characteristics 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 MIT 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)

mixtures (other than paints) treated with or incorporating MIT and placed on the market for use by non-professional users do not contain MIT at a concentration triggering classification of the mixture as skin sensitiser category 1 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council  ( 2 ) , 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 MIT at a concentration triggering classification of the mixture as skin sensitiser category 1 in accordance with Regulation (EC) No 1272/2008 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.

( 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 may be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

( 2 )   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 , ELI: http://data.europa.eu/eli/reg/2008/1272/oj ).