On September 20, 2022, the European Commission (EC) began a public consultation on a draft act that would introduce new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). Hazard classes and criteria would be added for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile, and toxic (PMT), or very persistent and very mobile (vPvM). The EC notes that comments will be taken into account for preparing in final the initiative. Responses are due October 18, 2022.
The draft explanatory memorandum indicates a need to insert new hazard classes and their criteria into the CLP regulation. The inclusion of the new hazard classes is meant to address commitments under the Chemicals Strategy for Sustainability (CSS), which is noted as a building block for the European Green Deal, and to ensure a high level of protection for human health and the environment.
Open public consultations on the revisions to the CLP regulation were held in 2021; the comment period ended November 15, 2021. The results of the consultation indicate a variety of responses from stakeholders, with more than 625 responses received. A targeted stakeholder consultation was held in late 2021 with a short comment period that ended on December 22, 2021, with the purpose of gathering expert advice from Member State authorities, national CLP help desks, academia, non-governmental organizations (NGO), and duty holders. A total of 167 responses were received, with mixed commentary. Some noted support for the introduction of new hazard classes, while others were quick to point out that the introduction of new hazard classes, which are not currently part of the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), would “lead to potential information overload in hazard communication, distort the level playing field of international trade, and lead to cost increases for various activities.”
The changes proposed include amendments to Part 3 of Annex I to CLP to incorporate new hazard classes for endocrine-disrupting properties for human health with definitions, classification criteria for both substances and mixtures, and new label elements. The definitions proposed do not align with the World Health Organization (WHO) definitions and criteria for endocrine disruptors. The table below depicts the proposed labeling elements for this new hazard class.
Table 3.11.3. Label elements of endocrine disrupting properties for human health
| Classification | Category 1 | Category 2 |
| Symbol/pictogram | ||
| Signal Word | Danger | Warning |
| Hazard Statement | EUH380: May cause endocrine disruption in humans | EUH381: Suspected of causing endocrine disruption in humans |
| Precautionary Statement Prevention | P201 P202 P263 P280 | P201 P202 P263 P280 |
| Precautionary Statement Response | P308 + P313 | P308 + P313 |
| Precautionary Statement Storage | P405 | P405 |
| Precautionary Statement Disposal | P501 | P501 |
In addition, a separate inclusion in Part 4 to Annex I of CLP would include endocrine-disrupting properties for the environment. This would add definitions, classification criteria for both substances and mixtures, and new label elements. The image below provides the details for the new labeling elements.
Table 4.2.3. Label elements of endocrine disrupting properties for the environment
| Classification | Category 1 | Category 2 |
| Symbol/pictogram | ||
| Signal Word | Danger | Warning |
| Hazard Statement | EUH430: May cause endocrine disruption in the environment | EUH431: Suspected of causing endocrine disruption in the environment |
| Precautionary Statement Prevention | P201 P202 P273 | P201 P202 P273 |
| Precautionary Statement Response | P391 | P391 |
| Precautionary Statement Storage | P405 | P405 |
| Precautionary Statement Disposal | P501 | P501 |
Part 4 of Annex I to CLP will also now include 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 toxicity criteria, consideration for endocrine disruption for humans and the environment. Classification as a PBT or vPvB will include new criteria for classification of substances and mixtures, and new label elements. The image below provides the new labeling elements.
Table 4.3.1. Label elements for PBT and vPvB properties
| PBT | vPvB | |
| Symbol/pictogram | ||
| Signal word | Danger | Danger |
| Hazard Statement | EUH440: Accumulates in living organisms including in humans with long-lasting effects | EUH441: Strongly accumulates in living organisms including in humans with possible long-lasting effects |
| Precautionary Statement Prevention | P201 P202 P273 | P201 P202 P273 |
| Precautionary Statement Response | P391 | P391 |
| Precautionary Statement Disposal | P501 | P501 |
Further proposed amendments to Part 4 of Annex I to CLP include the additions of PMT or vPvM properties. The addition includes definitions, classification criteria for substances and mixtures, and new label elements. Note that “persistent” and “very persistent” here are defined identically to P and vP from PBT and vPvB. “Toxicity” definitions are also 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. The image below provides the new labeling elements.
Table 4.4.1. Label elements for PMT and vPvM properties
| PMT | vPvM | |
| Symbol/pictogram | ||
| Signal word | Danger | Danger |
| Hazard Statement | EUH450: Persistent substance which can pollute water resources | EUH451: Very persistent substance which can pollute water resources |
| Precautionary Statement Prevention | P201 P202 P273 | P201 P202 P273 |
| Precautionary Statement Response | P391 | P391 |
| Precautionary Statement Disposal | P501 | P501 |
Amendments to Annex II and Annex III are also proposed to accommodate the changes noted above to the various Parts of Annex I.
Commentary
The European Union (EU) UN GHS adaptation into its CLP regulation is one of the most complex aspects of GHS implementation. CLP contains many variations to UN GHS that result in a hazard communication process that is consistently misaligned with other countries’ approaches. The proposed revisions, which include entirely new hazard classes that lack clarity, add layers of confusion to an already complex approach to hazard classification. Previous responses to comments agreed the criteria are important, but most expressed the view that introduction of PBT, vPvB, PMT, and vPvM was not necessary.
Adding endocrine disruption to the toxicity category also invites confusion with respect to alignment with REACH Annex XIII. Parties that were subject to the PBT and vPvB assessment under REACH now need to consider additional elements that are not part of REACH. The changes to the safety data sheet (SDS) format as part of the amendments to Annex II to REACH, which enter into force later this year, also incorporate endocrine disruption. By including these endpoints as required elements for classification, the EC appears to be pushing its agenda in advance of any consideration of the UN GHS subcommittee and the process of harmonization. Comments from responders noted that these measures should only be introduced in response to implementation at the UN GHS level.
Stakeholders are urged to consider the implications of these criteria and the impact of the hazard communication tools utilized within the EU. In addition, these endpoints are not part of the United Kingdom approach, and the addition of new hazard classes will create further separation from the post-Brexit operations for companies within the region.