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New classification in EU CLP regulation
Posted Date:2023/8/30
On March 31, 2023, the EU published amendments to Annex 1 of the CLP, mainly concerning the following hazard classification levels:
Endocrine disruptors that are harmful to human health or the environment;
Persistent, bioaccumulative and toxic substances (PBT); Highly persistent and bioaccumulative substances (vPvB);
Persistent, mobile and toxic substances (PMTS); Highly persistent, highly migratory substances (VPVMS).
The above classification applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in bactericidal products and plant protection products, which are usually prioritised for harmonised classification in the EU.
New hazard classification and risk description:
ED HH Categories 1 and 2 (Endocrine disturbances to human health)
ED ENV Category 1 and Category 2 Environmental Assessment (Endocrine disruption to the environment)
PBT(persistent, bioaccumulative, toxic), vPvB(very persistent, very Bioaccumulative)
PMT(Persistent, mobile, toxic), vPvM(very persistent, very mobile)
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Hazard category and category code
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Hazard code
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Hazard statement
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ED HH 1
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EUH380
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May cause endocrine disruption in humans
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ED HH 2
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EUH381
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Suspected of causing endocrine disruption in humans
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ED ENV 1
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EUH430
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May cause endocrine disruption in the environment
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ED ENV 2
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EUH431
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Suspected of causing endocrine disruption in the environment
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PBT
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EUH440
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Accumulates in the environment and living organisms including in humans
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vPvB
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EUH441
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Strongly accumulates in the environment and living organisms including in humans
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PMT
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EUH450
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Can cause long-lasting and diffuse contamination of water resources
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vPvM
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EUH451
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Can cause very long-lasting and diffuse contamination of water resources
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The new rules come into effect on April 20, 2023. From this date, member States can make proposals for Harmonised Classification and Labelling (CLH) for new hazard levels, and manufacturers, importers, downstream users and distributors can self-classify their substances and mixtures accordingly
There is a transition period following the entry into force of the authorisation regulation, during which manufacturers, importers, downstream users and distributors are not yet required to classify their substances or mixtures according to the new hazard level. In the meantime, the new risk levels can be applied on a voluntary basis.
For new substances on the market, companies need to comply with the new rules from May 1, 2025, while for substances already on the EU market, companies must comply by November 1, 2026.
Different transition times apply to the mixture. The new hazard category applies to new mixtures from May 1, 2026, while companies must update the classification and labelling of existing mixtures by May 1, 2028.