MAY 2021

Classification and Labelling of 1,2-benzisothiazolin-3-one


The European Polymer Dispersion and Latex Association (EPDLA), a CEFIC sector group, welcomes the opportunity to comment on the proposed harmonized classification and labelling of 1,2-benzisothiazolin-3-one (BIT), and in particular with regards to the dermal sensitization hazard endpoint and the proposed Specific Concentration Limit (SCL).

EPDLA supports the proposal of the dossier submitter to maintain the current SCL of 500ppm for BIT since further reductions in the labelling limit would not result in greater public protection but would place downstream users under significant regulatory burden when placing safe products on the market. BIT should be evaluated distinctly from the other isothiazolinones, since considerable substance specific data exists which permits the Committee to do so. Whilst any report of allergic contact dermatitis is concerning, the societal benefits of the continued use of BIT are considerable and all available toxicological and clinical information indicates the current classification and labelling of BIT for the hazard of dermal sensitization are protective of the very vast majority of European population.