The European Commission has adopted a Delegated Regulation amending the CLP Regulation (Classification, Labelling, and Packaging), introducing new hazard classes for chemical substances and mixtures sold in the European Union, including biocidal and plant protection products.
New Hazard Classes
The regulation introduces the following categories:
- Endocrine disruption for human health (ED HH): Categories 1 and 2.
- Endocrine disruption for the environment (ED ENV): Categories 1 and 2.
- PBT (Persistent, Bioaccumulative, Toxic) and vPvB (Very Persistent, Very Bioaccumulative).
- PMT (Persistent, Mobile, Toxic) and vPvM (Very Persistent, Very Mobile).
Each class includes specific hazard statements, such as EUH380 («May cause endocrine disruption in humans») or EUH450 («Can cause long-lasting contamination of water resources»).
Implementation and Deadlines
The regulation has been in force since April 20, 2023, with transitional periods:
- New substances: Mandatory from May 1, 2025.
- Existing substances: Compliance required by November 1, 2026.
- New mixtures: Mandatory from May 1, 2026.
- Existing mixtures: Compliance required by May 1, 2028.
Implications for Companies
Manufacturers, importers, and downstream users must classify and label substances according to the new hazard classes after the transition periods. The European Chemicals Agency (ECHA) will assess proposals for harmonized classification and has updated templates to facilitate compliance.
This change reinforces the principle of “one substance, one assessment” and promotes the harmonization of hazard identification criteria across European legislation.