On March 31, 2023, the European Commission (EC) adopted the Commission delegated regulation (EU) 2023/707 which adds hazard classes from REACH to Regulation (EC) No 1272/2008 on the classification, labelling and packaging (CLP) of substances and mixtures (FPF reported). According to the amendment, endocrine disrupting chemicals (EDCs) will be split into two categories for both human health and the environment: (1) Known or presumed endocrine disruptors and (2) suspected endocrine disruptors.
The classification in category (1) needs to be based on evidence from at least one of the following: human data, animal data, or non-animal data providing an equivalent predictive capacity as data in humans or animals. The substance must meet all the following criteria: endocrine activity, adverse effect in an intact organism or offspring, and a biologically plausible link between the endocrine activity and the adverse effect. Substances whose evidence on endocrine activity and adverse effects “is not sufficiently convincing”, are classified as category (2).
The legislative action, effective as of April 20, 2023, also introduces hazard classes for the following properties: persistent, bioaccumulative, and toxic (PBT); very persistent, very bioaccumulative (vPvB); persistent, mobile, and toxic (PMT); and very persistent, very mobile (vPvM). The definitions of these classifications come from the REACH regulation and are detailed in the official regulation text.
For manufacturers, this means they will need to update labels on packaging, safety data sheets, and REACH registration dossiers. The European Chemical Industry Council (Cefic) states they are “committed to working with the European institutions and EU Member States […].” However, in an article from March 23, 2023, on the CLP revision they express concerns: “the technical and policy discussions over the past years have confirmed the absence of reliable and robust methodology that would make it possible to decide whether a substance can qualify as Mobile or Very Mobile.”
The coalition of civil society groups EDC-Free Europe welcomed the introduction of hazard classes. “The changes to the annexes of the CLP regulation will eventually allow for better control of these harmful chemicals on the EU market. However, they still need to be completed with urgently needed adjustments of other key pieces of EU legislation to exposure, in particular REACH, and legislation on toys, food contact materials or cosmetics, in order to truly protect health and the environment.” States Sandra Jen, campaign director at the EDC-Free Europe coalition in an article from December 19, 2022.
Reference
European Commission (March 31, 2023). “Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (Text with EEA relevance).”
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Cefic (March 23, 2023). “CLP Revision.”
EDC-Free Europe (December 19, 2022). “EDC-Free Europe welcomes introduction of hazard classes for endocrine disrupting chemicals as part of revision of the CLP regulation.”
