MIT approved under the BPR Regulation for PT6

MIT approved. On June 27, 2025, the European Commission officially approved 2-methyl-2H-isothiazol-3-one (MIT) as an active substance. It is authorised for use in biocidal products of product-type 6, which means preservatives for products during storage. The decision was made in line with Regulation (EU) No 528/20123. This approval will take effect on February 1, 2027, and remain valid until January 31, 2037. It marks a significant step for the preservatives sector in the European Union. MIT may be used at a purity above 950 g/kg.

This decision followed a thorough evaluation process. Slovenia served as the evaluating Member State. The European Chemicals Agency (ECHA) coordinated the assessment. The positive opinion was adopted on November 26, 2024. The review covered efficacy, risks, and exposure. Special attention was given to uses not previously assessed. Risks for industrial, professional, and non-professional users were considered. The evaluation also looked at exposure from treated articles and soil impact.

Authorisation of biocides with MIT comes with specific conditions:

• Labels for articles treated with MIT must provide clear information, as required by Article 58 of the BPR Regulation.

• Mixtures (except paints) for non-professional users cannot contain MIT at levels requiring classification as a category 1 skin sensitiser, unless protection is ensured by means other than PPE.

• Paints containing MIT and classified as category 1 skin sensitisers may only be sold to non-professionals if suitable gloves (EN 374) are provided and the label states that gloves must be worn.

This approval strengthens safety and control in the use of preservatives. It ensures protection of health and the environment in the EU.

Once MIT is approved, companies must submit their biocidal product authorisation applications before February 1, 2027.

To continue marketing biocides with MIT after approval, companies should:

• Define their application strategy.

• Carry out efficacy tests according to BPR guidelines.

• Perform stability and other physico-chemical tests if needed.

• Assess product safety for human health and the environment.

• Compile all parts of the application (PAR, IUCLID, SPC) and submit before the approval date.

• Pay the fees notified by the competent authority.

• Wait for the authority’s evaluation and respond to any requests until authorisation is granted.

Do you market biocides with MIT, BIT, Bronopol, or other approved actives for PT6 and need support? Nordiik can help—contact us!

Source: Eur-LEX

Download the document here: OJ_L_202501257_EN_TXT