First RAC opinion on a very persistent substance
In 2023, following the revision of the Regulation on Classification, Labelling and Packaging (CLP), new classification endpoints were introduced, including “Persistent, Bioaccumulative and Toxic” (PBT) and “very Persistent, very Bioaccumulative” (vPvB).
At the end of 2024, Germany submitted the first dossier proposing the harmonised classification and labelling of a substance as vPvB. This concerned 4,4'-methylene bis(dibutyldithiocarbamate). This substance is used, among other things, in hydraulic fluids, lubricants and metalworking fluids.
The consultation took place in the spring. The Netherlands requested additional information and further clarification, and also noted that a complex bioaccumulation study, involving dietary exposure, contained inconsistencies. As a result, the bioaccumulation study was reassessed by the Committee for Risk Assessment (RAC). The RAC proposal is to classify the substance as vPvB with EUH441.