/>iThe European Chemical Agency (ECHA) introduced new hazard classes into the classification, labelling and packaging of substances and mixtures (CLP) Annexes Regulation back in December 2022 via Commission Delegated Regulation (EU) 2023/707.
The new classes, namely 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) were further integrated into the framework of the CLP via the revision Regulation (EU) No 2024/2865 (CLP Amendment), with the intention of prioritizing them in the context of harmonized hazard classification.
In this context, the ECHA amended its Guidance on the Application of the CLP Criteria Series. The guidance previously contained in a single document is now divided in five parts which account for the consideration of the new hazard classes, as well as updated test guidelines.
Part 3 introduces criteria relating to the ED (human health) hazard. It implements certain parts of the 2018 ECHA/EFSA Guidance while adapting its structure to the CLP context, which notably does not mandate the issuance of new studies but instead relies on an assessment of existing study contrarily to the biocides and plant protection products legislations. Part 4/5 of the guidance on the other hand introduces information on the ED (environment), PBT/vPvM and PBT/vPvB hazards. Again, references are made to existing guidance documents, notably the REACH PBT Guidance. An overview of the changes made to the respective guidance documents is available within ECHA’s presentation of 21 November 2024.
The long-awaited guidance comes before the effective entry into force of the new classification and labelling obligations arising from the introduction of the new hazard classes on 1 May 2025 (for substances placed on the market after that date). The new classification is however already available on a voluntary basis for substances that are already on the market and will only become mandatory for them from 1 November 2026. A more extended timeline is foreseen for mixtures, with an application from 1 May 2026 for new substances placed on the market after that date, while substances already on the market must meet the 1 May 2028 application date.
How This Affects Your Business
In light of this timeline, registrants are expected to act on a timely basis and prepare for the entry into force of the requirement. We also suggest carefully monitoring notifications from other registrants, as any future divergence with existing entries will have to be justified, following the entry into effect of Regulation (EU) No 2024/2865 (CLP Amendment), amending Regulation (EU) No 1272/2008 (CLP Regulation).
While the self-classification requirement will only enter into force in 2025, harmonized classifications under the new hazard classes can already be proposed by the Member States and companies. Following the entry into force of the CLP Amendment at the end of the year, the European Commission will also have the possibility to initiate harmonized classification, thereby pushing forward its own agenda. As a result, important efforts of classification under the new hazard classes can also be expected on the regulators’ side in the coming months.
