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On April 20, 2023, the European Commission (EC) announced the implementation dates for the introduction of new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labelling, and Packaging of Substances and Mixtures (CLP). The new hazard classes and criteria rules will be phased in over several years. New substances must comply by May 1, 2025, and new mixtures by May 1, 2026. Substances placed on the market before May 1, 2025, must comply by November 1, 2026, and existing mixtures placed on the market before May 1, 2026, must comply by May 1, 2028.
As noted in our September 29, 2022, memorandum, the EC intends to add new hazard classes and criteria for endocrine disruptors for human health (ED HH) and the environment (ED ENV), hazard classes and criteria for substances that are persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and hazard classes and criteria for substances that are persistent, mobile, and toxic (PMT) or very persistent and very mobile (vPvM).
The EC noted that the inclusion of new hazard classes and the inclusion of criteria in the CLP regulation is intended to address commitments expressed under the Chemicals Strategy for Sustainability (CSS). The Strategy is a key building block of the European Green Deal and is intended to ensure a high level of protection for human health and the environment. The introduction of these new hazard classes is not currently part of the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
The changes include amendments to Part 3 of Annex I to CLP to incorporate new hazard classes for ED HH with definitions, classification criteria for both substances and mixtures, and new label elements. The proposed definitions do not align with the World Health Organization (WHO) definitions and criteria for endocrine disruptors. Part 4 to Annex I of CLP includes definitions, classification criteria for both substances and mixtures, and new label elements for ED ENV.
Part 4 of Annex I to CLP includes the introduction of PBT or vPvB properties, the criteria of which align with the concepts introduced in Annex XIII to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), except it includes, as part of the toxicity (T) criteria, consideration for ED HH and ED ENV. Classification as a PBT or vPvB includes, in Part 4, definitions, new criteria for classification of substances and mixtures, and new label elements.
Further amendments to Part 4 of Annex I to CLP include the additions of PMT or vPvM properties. The definitions, classification criteria for substances and mixtures, and new label elements are part of the amendments. Note that “persistent” and “very persistent” here are defined identically to P and vP from PBT and vPvB. “Toxicity” definitions are identical to T from the amended PBT. The introduction of “mobility” and “very mobile” centers around organic carbon partition coefficients (Koc) and Koc with pH values for ionizable substances. A log Koc of less than 3 meets the criteria for M, and a log Koc of less than 2 is considered vM.
Various amendments to Annex II and Annex III are incorporated to accommodate the changes noted above to the various Parts of Annex I.
A summary table of the new European Union (EU) hazard statements is noted below.
| 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 | 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 | EUH450 | Can cause long-lasting and diffuse contamination of water resources |
| vPvM | EUH451 | Can cause very long-lasting and diffuse contamination of water resources |
Commentary
The adoption of the EU UN GHS adaptation into its CLP regulation promises to be exceedingly complex and likely commercially painful. CLP is not in all cases congruent with UN GHS, resulting in a hazard communication process that is misaligned with other countries’ approaches. These revisions, which include entirely new hazard classes that are not defined at the UN GHS level, add new layers of confusion to an already complex approach to hazard classification.
The PBT and PMT classification criteria now include consideration for ED HH and ED ENV for endpoint “T.” Parties that were subject to the PBT assessment under REACH must now re-consider this inclusion in safety data sheet (SDS) and label classification procedures, as it was not part of the REACH assessment processes. Similar confusion arises with SDS generation. Consider, for example, that amendments to Annex II to REACH, that entered into force late last year, incorporate endocrine disruption, but did not include, at the time, consideration for these revisions to CLP, as these endpoints were not defined within CLP.
By including these endpoints as required elements for classification, the EC effectively pushes its agenda in advance of any consideration of the UN GHS subcommittee and the process for harmonization. Comments from previous consultations note that these measures should only be introduced in response to implementation at the UN GHS level, comments that to date have been ignored.
Stakeholders are urged to consider the timeframes proposed for the incorporation of these criteria and the impact on substances and mixtures. This includes the tools utilized for SDS generation and labels within the EU. In addition, these endpoints are not part of the UN GHS model nor currently incorporated into the United Kingdom approach. The addition of new hazard classes will create further separation from the post-Brexit operations for companies within the region and international companies attempting to align hazard communication content.