EC Begins Public Consultation on Draft CLP Amendment Concerning New Hazard Classes for Endocrine Disruptors, PBTs, vPvBs, PMTs, and vPvMs

On September 20, 2022, the European Commission (EC) began a public consultation on a draft delegated regulation that would amend Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) to add new hazard classes and their criteria. CLP would be amended to include hazard classes and criteria for:

• Endocrine disruptors;
• Substances and mixtures with persistent, bioaccumulative, and toxic (PBT) properties;
• Substances and mixtures with very persistent, very bioaccumulative (vPvB) properties;
• Substances and mixtures with persistent, mobile, and toxic (PMT) properties; and
• Substances and mixtures with very persistent, very mobile (vPvM) properties.

The draft regulation states that the level of evidence regarding endocrine disrupting properties may be of different scientific strength. The draft regulation would create two categories of endocrine disruptors: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2). According to the draft regulation, the intrinsic properties of PBT and vPvB substances and mixtures display similarities, but they differ substantially with regard to the toxicity criterion. The draft regulation would create two separate hazard classes, each with its own criteria, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and bioaccumulation. While the intrinsic properties of PMT and vPvM substances and mixtures display similarities, they differ substantially with regard to the toxicity criterion. The draft regulation would create two separate hazard classes, each with its own criteria, while establishing common rules for the scientific assessment of the intrinsic properties related to persistency and mobility.

To ensure that suppliers of substances and mixtures have time to adapt to the new classification and labeling provisions, there would be a transition period. Substances and mixtures placed on the market before the end of the transition period would be allowed to remain on the market without being re-classified and re-labeled in accordance with the new requirements, to avoid additional burden on suppliers of substances and mixtures. Suppliers could apply the new classification and labeling requirements at an earlier stage on a voluntary basis.

The consultation will end on October 18, 2022. Our forthcoming memorandum will include a detailed summary of the proposed rule and an insightful commentary.