▪︎ Biocidal Products Ordinance
MIT and BIT in Treated Goods: New Requirements for Consumer Products
With Implementing Regulation (EU) 2025/1257 for 2-methyl-2H-isothiazol-3-one (MIT) and Implementing Regulation (EU) 2025/929 for 1,2-benzisothiazol-3(2H)-one (BIT), the European Commission has approved two commonly used preservatives for product type 6 (preservatives for products during storage). While the authorization of BIT will take effect on October 1, 2026, the authorization of MIT will take effect on February 1, 2027. Both regulations contain similar new requirements for certain treated goods.
Preservatives with Strong Skin Sensitizing Properties
MIT and BIT are biocidal active substances with preservative properties that protect products against microbial deterioration caused by bacteria, yeasts, and fungi. They are commonly used in paints, coatings, adhesives, and other water-based mixtures.
Both substances have harmonized classification and labeling requirements under Annex VI to the CLP Regulation. Of particular relevance is their classification as Skin Sens. 1A (H317: May cause an allergic skin reaction). In addition, specific concentration limits (SCLs) apply (MIT: 0.0015%; BIT: 0.036%), meaning that even very low concentrations can trigger classification and labeling of a mixture as a skin sensitizer. Due to their sensitization potential, both active substances have been subject to regulatory scrutiny and risk management measures for many years.
Concentration Restrictions for BIT and MIT in Consumer Products
The approvals of BIT and MIT are valid for ten years. In addition to the standard requirements applicable to biocidal active substances, the Annexes to both regulations contain specific provisions for treated articles. Under the Biocidal Products Regulation (BPR), treated articles are substances, mixtures, or articles that have been treated with, or intentionally incorporate, one or more biocidal products.
A key new requirement affects certain consumer products: BIT and MIT may generally not be present at concentrations that result in classification of the mixture as Skin Sensitizer Category 1A. An exception applies only where exposure to the substance can be effectively prevented by means other than the use of personal protective equipment.
Exception for Certain Paints
Paints intended for consumer use that are classified as Skin Sensitizer Category 1A due to their BIT or MIT content are exempt from the new concentration restrictions, subject to specific conditions. Such products may continue to be placed on the market provided that suitable protective gloves compliant with EN 374 or an equivalent standard are supplied together with the product and the label indicates that protective gloves must be worn during use. However, the regulations do not provide detailed guidance on how the gloves must be supplied in practice.
Action Required for Manufacturers, Importers, and Brand Owners
Commission Implementing Regulation (EU) 2025/929 and Commission Implementing Regulation (EU) 2025/1257 introduce new requirements for certain treated articles containing BIT or MIT. Consumer products are particularly affected, as the concentration of these active substances and any resulting skin sensitization classification must now be carefully considered.
Companies using BIT or MIT in treated articles, or placing such products on the EU market, should assess whether their portfolios are affected by the new requirements. We support companies in evaluating their products and addressing all aspects of European biocides legislation.
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