PBT / vPvB

The identification of PBT and vPvB substances is carried out in accordance with the specific criteria of Annex XIII to the REACH Regulation. The assessment of these properties is an integral part of the Chemical Safety Assessment (CSA) and follows the ECHA guidance on the identification and designation of substances.

Substances with PBT or vPvB properties meet the criteria according to Article 57 of the REACH Regulation for substances of very high concern and are included in the Candidate List through the Article 59 procedure. Due to their persistence and bioaccumulation potential, these substances accumulate in the environment and in organisms and are difficult to degrade, posing long-term risks to human health and the environment.

Concrete obligations arise for manufacturers, importers, and downstream users: the supply chain must be systematically screened for PBT/vPvB substances, particularly when registering substances in quantities of one tonne or more per year. Substitution options should be evaluated at an early stage, as a comparative assessment may be required for PBT/vPvB substances classified as candidates for substitution.

Communication obligations extend from the extended Safety Data Sheet (eSDS) with exposure scenarios to the information requirements under Article 33 for articles containing PBT/vPvB substances above 0.1% weight by weight (w/w). Notification obligations to ECHA under Article 7(2) may also become applicable.