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On April 20th, 2023 the EU commission published a revision to the CLP regulation which introduces new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures. The new hazard classes are Endocrine Disruptors (ED), Persistent, Bioaccumulative and Toxic (PBT), very Persistent and very Bioaccumulative (vPvB), Persistent, Mobile and Toxic (PMT) and very Persistent and very Mobile (vPvM) . The substances or CAS level ingredients are expected to comply with this new set of classifications by May 1st, 2025, while mixtures have an extended period of time of May 1st 2026.

Details on criteria for classification and labelling can be found in COMMISSION DELEGATED REGULATION (EU) 2023/707, here are a few brief details on the newly adopted hazard classes:

Endocrine Disruptors:

Endocrine disruptors (EDs) have been divided into 2 categories, EDs for human health and EDs for the environment. Then each of these categories are sub divided into Category 1 and Category 2. A substance must meet all three criteria for classification with evidence for the endocrine disruption, the adverse effect and the plausible link. For mixtures, the concentration limit triggering Category 1 is ≥ 0.1 % (w/w), and ≥ 1 % (w/w) for Category 2. The new EU hazard statements for this class are:

Hazard class and category code Hazard statement code Hazard statement
ED HH 1 EUH380 May cause endocrine disruption in humans
ED HH 2 EUH381 Suspected of causing endocrine disruption in humans
ED ENV 1 EUH430 May cause endocrine disruption in the environment
ED ENV 2 EUH431 Suspected of causing endocrine disruption in the environment

PBT/vPvB:

A substance shall be considered a PBT substance when it fulfils all the three for persistence, bioaccumulation and toxicity criteria. Likewise, a substance shall be considered vPvB when it fulfills both persistent and bioaccumulation criteria. For mixtures, the concentration limit triggering PBT and vPvB is ≥ 0.1 % (w/w). The new EU hazard statements for this class are:

Hazard class and category code Hazard statement code Hazard statement
PBT EUH440 Accumulates in the environment and living organisms including in humans
vPvB EUH441 Strongly accumulates in the environment and living organisms including in humans

PMT/vPvM:

A substance shall be considered a PMT substance when it fulfils the persistence, mobility and toxicity criteria. Likewise, a substance shall be considered a vPvM when it fulfils the persistence and mobility criteria. For mixtures, the concentration limit triggering PMT and vPvM is ≥ 0.1 % (w/w). The new hazard statements for this class are:

Hazard class and category code Hazard statement code Hazard statement
PMT EUH450 Can cause long-lasting and diffuse contamination of water resources
vPvB EUH451 Can cause very long-lasting and diffuse contamination of water resources

Get in touch to learn more about how TotalSDS can help you stay in compliance with the new EU CLP revisions.