EU CLP regulation introduces new hazard classes for endocrine disruption and persistent chemicals

From 20 April 2023, Commission Delegated Regulation (EU) 2023/707 entered into force, amending Regulation (EU) No 1272/2008 as regards hazards classes and criteria for the classification, labelling and packaging of substances and mixtures (CLP). This update to CLP looks to introduce new hazard classes with a transitional period applying to items currently on the market in the EU.

An approach is now set out for determining classification concerning endocrine disruption for human health, and endocrine disruption for the environment into category 1 (known or presumed endocrine disruptors, EUH380/EUH430) or category 2 (suspected endocrine disruptors, EUH381/EUH431). The regulation also includes generic concentration limits for triggering classification of mixtures, and updated label elements required if a classification has been triggered.

Furthermore, an approach has also been set out to classify persistent chemicals – chemicals that do not break down in the environment and can accumulate in living organisms, or risk entering and spreading across the water cycle, including drinking water. The approach lays out classifications for chemicals that are; persistent, bioaccumlulative, toxic (PBT) with the hazard code EUH440 – very persistent, very bioaccumlulative (vPvB) with the hazard code EUH441 – persistent, mobile, toxic (PMT) with the hazard code EUH450 – and very persistent, very mobile (vPvM) with the hazard code EUH451.

Manufacturers, importers, downstream users and distributors can self-classify their substances and mixtures with the new classes. The timing for enforcement of these new classes depends on whether the item is a substance or a mixture, and on whether they are new to the market, or existing.

For substances placed on the market before 1 May 2025, an 18-month transitional period applies until the new classification and labelling becomes mandatory from 1 November 2026. New substances to the market from 1 May 2025 do not benefit from the transition period with the rules applying without delay.

Mixtures placed on the market before 1 May 2026 benefit from a 24-month transitional period until the new classification and labelling becomes mandatory from 1 May 2028. New mixtures to the market from 1 May 2026, again, do not benefit from the transition period.

To accompany these changes, further guidance on the application of the new CLP criteria is expected to be released in 2024.