The Commission released on September 20, 2022, a Draft Delegated Regulation[1] amending Regulation (EC) No 1272/2008 (‘CLP Regulation’)[2] for the purpose of adding new hazard classes (‘CLP Amendment’). This groundbreaking amendment will add five new hazard classes, namely ED, PBT/vPvB, and PMT/vPvM. The draft is under public consultation until October 18, 2022 (midnight Brussels time). The final adoption is expected by the end of 2022.

In addition to the CLP Amendment, the Commission is also going to issue (likely later in October 2022) a legislative proposal to amend the CLP with some additional provisions, including changes in the procedure for harmonized classification and labeling and provisions related to fold-out multilingual labels. This proposal will be independent from the current CLP Amendment and will be subject to the full legislative procedure involving the European Parliament and the Council. As elaborated below, the choice of the Commission to subject the CLP Amendment to a non-legislative delegated act rather than to the full legislative procedure is problematic and may be subject to legal challenge. 

• New Hazard Classes

So far, the new hazard classes have only been identified on an ad hoc basis under REACH and sectoral legislation (notably for EDs, pesticides, and biocides legislation). The CLP Amendment will introduce these classes into the CLP as follows.

Endocrine disruptors (‘ED’)

The Commission’s Draft integrates two categories, namely ‘presumed’ (Cat. 1) and ‘suspected’ (Cat. 2) EDs. Substances classified as ED would be the ones 1) presenting an endocrine activity, 2) having an effect on an intact organism or its offspring and future generation, and 3) having a biologically plausible link identified between the endocrine activity and the adverse effect. 

To address the issue of the potential overlap of ED hazard classes with existing ones, the amendment provides that where the endocrine-related adverse effects occur together with other toxic effects, endocrine-related adverse effects shall be considered to be present where they are not conclusively demonstrated to be a solely non-specific consequence of the other toxic effects. However, the usability of this provision may be limited to only include a situation where the toxic effect affects the endocrine organ (such as the thyroid). It will not exclude substances such as, e.g., phthalates that are reprotoxic and also have ED properties.

As is the case for the other hazards included in the Draft, the Commission foresees that the classification should be based on a weight of evidence determination using all available data. Thus, the relevant actors should gather all available data on the ED endpoint (such as animal data on the reprotoxic endpoint), including read-across data. There is currently an abundance of available in vitro data in the public domain for this endpoint. The extent to which the outcome of these screening studies would trigger the need for the relevant actors to generate additional in vivo data is, however, uncertain in the absence of further precision in the draft. 

In this respect, we note that next year, the European Commission is planning to issue a REACH revision proposal to introduce new data requirements, including those related to the ED endpoint. Thus, REACH registrants will have to generate new data related to ED anyway (the Commission is envisaging a tiered approach to the testing, with screening data being a trigger for animal data). 

Persistent, Bioaccumulative, Toxic (PBT), and Very Persistent and Very Bioaccumulative (vPvB) Substances 

The criteria to identify PBT and vPvB substances are identical to those currently included in Annex XIII REACH. Importantly, the CLP amendment does not include a subcategory for ‘suspected’ PBT/vPvB that would typically be based on the screening data. Thus, it is expected that only substances that meet the numerical identification criteria for P and B will be considered PBT. That said, based on the REACH registration dissemination website, so far only 98 registrants identified their substance to be PBT/vPvB. In addition, the PBT/vPvB assessment is only mandatory for substances above 10 tons. We expect that as a result of the CLP Amendment, more substances will be identified, also because the CLP Amendment will make the enforcement of the PBT/vPvB classification easier.

Persistent, Mobile, Toxic (PMT), and very Persistent and very Mobile (vPvM)

PMT (vPvM) is a relatively new hazard category first introduced by the German Environmental Agency and then taken over by ECHA (in 2019) as a new category of Substances of Very High Concern (SVHC) identified under Article 57(f) REACH.

Substances classified as PMT/vPvB are targeted due to their high persistence, low absorption, and high mobility, enabling them to enter the water cycle and spread across long distances. These properties result in a risk of cumulative exposure. 

The M element will be based exclusively on the logarithm of the water to organic carbon partition coefficient (logKoc). The relevant actors will either have to use results of adsorption/desorption testing, or other suitable information, such as QSAR models. As these data are typically not available, we are of the view that the actors may have to generate some M data to fulfill their CLP obligations, if warranted. 

• Impact of the CLP Amendment 

The CLP Amendment will require all manufacturers and importers to gather relevant data (see above) to make classification decisions and label substances accordingly (and notify the classification to ECHA and update the REACH dossier). This also indirectly applies to non-EU manufacturers/formulators who market in the EU. 

In Commission’s estimations,[3] while 67 substances are currently identified under the REACH Candidate List as presenting one of those properties, the introduction of the new classes would raise that number to a minimum of 1650 substances.

The CLP Amendment will also provide a basis for the consideration of the new hazards in the safety assessment and prioritization of certain substances for phase-out under REACH, but also under other pieces of chemicals legislation. In the context of the revision of the Framework Regulation (EC) 1935/2004 on food contact materials, for instance, the Commission foresees the prioritization of certain hazard classes in the safety assessment, including CMRs, EDs, PBTs, and vPvBs. The classification of a substance for such classes under the CLP would therefore have a direct impact on the safety assessment relating to its use in food contact materials, potentially leading to their phase-out.

The new classes will also introduce discrepancies between the EU and GHS, thereby affecting non-EU companies selling on the EU market.

• A Contestable Procedural Choice

With such a substantial impact, the Commission’s decision to rely on a Delegated Act, a non-legislative instrument that is intended for the adaptation of non-essential elements to technical and scientific progress, appears contestable.

The Commission’s power to adopt such acts is circumscribed by the scope of the mandate conferred upon it in the basic legislation (here, the CLP Regulation). However, what the Commission considers here as a mere adaptation of the CLP to scientific and technical progress actually entails a political choice that does not stem from the language of the CLP Regulation. Also, other arguments used by the European Commission during the procedure to justify the choice of a Delegated Act are not very convincing. Thus, we are of the view that there are reasonable grounds to file an action for annulment of the CLP Amendment in the General Court of the EU. The action for annulment will have to be filed within 2 months (+10 days) of the date when the CLP Amendment will be published in the EU Official Journal.

[1] The Draft is available on the Commission’s dedicated consultation page, at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13578-Hazardous-chemicals-updated-rules-on-classification-labelling-and-packaging_en 

[2] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1–1355.

[3] Commission non-paper, “Impact assessment for the revision of the CLP Regulation”, p. 3. Available at: https://circabc.europa.eu/ui/group/a0b483a2-4c05-4058-addf-2a4de71b9a98/library/9d5b03e5-6a0b-4214-8ef4-622bd7f50ad6/details