Formulated products, containing the common preservative BIT (1,2-benzisothiazol-3(2H)-one (CAS number 2634-33-5)) may need to change their classification on their label and their Safety Data Sheet to skin sensitiser (H317) by the 1st of September 2025, without a grace period to sell out currently labelled stock after this date.

The specific concentration limit of BIT for skin is being lowered from 0.05% w/w (500ppm) to 0.036% w/w (360ppm) according to Commission Delegated Regulation (EU) 2024/197. This means that for currently authorised products not currently classified for skin sensitisation containing greater than 360 ppm of BIT, a classification change adding the label text for H317: “May cause an allergic skin reaction” will be required (in the absence of an acceptable negative skin sensitising result from a suitable study on the formulated product).

In that case, this change will need to be notified at zonal or national level for each product, along with label and safety data sheet updates. Corresponding poison centre notifications will also need to be updated.

The same applies for the EUH 208 supplemental label elements for products containing more than 36 ppm BIT and less than 360ppm, as « Contains BIT which can produce an allergic reaction».

Note that consumer (amateur use) products cannot be sold if classified as skin sensitisers, so products that change their classification to H317 will need to be withdrawn from the market.

For further advice, our chemistry, classification, and labelling experts are here to help you, please contact us at contact@staphyt.com.