The delegated regulation (EU) 2023/707 of the Commission of 19 December 2022, amending Regulation (EC) No 1272/2008 concerning the hazard classes and the criteria for the classification, labeling, and packaging of substances and mixtures, was published in the Official Journal on 31 March 2023.
Overview of the new classifications
Three new hazard classes for CLP regulation (Classification Labelling and Packaging) of substances and mixtures enter into force on 20 April 2023.
- endocrine disruptors for human health and the environment;
- PBT (Persistent, Bioaccumulative, Toxic) and vPvB (very Persistent, very Bioaccumulative);
- PMT (Persistent, Mobile, Toxic), and vPvM (very Persistent, very Mobile) substances.
The transition period for the new classifications will apply in two stages. For substances, the effective date is 1 May 2025, while for mixtures, the application date will be 1 May 2026, and the updated guidance on applying the CLP criteria is expected for 2024 (update in IUCLID for example).
Classification of Endocrine Disruptors
The regulation introduces five definitions concerning endocrine disruptors.
a) An endocrine disruptor is defined as a substance or mixture that alters one or more functions of the endocrine system, resulting in adverse effects on the health of an intact organism, its descendants, or at the level of populations or subpopulations.
b) Endocrine disruption refers to the impairment of one or more functions of the endocrine system caused by an endocrine disruptor.
c) Endocrine activity refers to an interaction with the endocrine system that can lead to a response from this system of target organs or target tissues, and that confers on a substance or mixture the potential to alter one or more functions of the endocrine system.
d) Adverse effect is defined as a change in the morphology, physiology, growth, development, reproduction, or lifespan of an organism, system, or population or subpopulation, which results in the impairment of a functional capacity or a capacity to compensate for additional stress, or an increase in sensitivity to other influences.
e) Biologically plausible link is defined as the correlation between endocrine activity and adverse effect, based on biological processes, when the correlation is consistent with existing knowledge.
For the classification of substances, there are two categories of hazards of endocrine disruptors for human health.
Category 1: This classification encompasses endocrine disruptors known or presumed to be hazardous to human health. It is based on evidence from at least one of the following:
a) data relating to humans
b) data relating to animals
c) non-animal data with an equivalent predictive capacity to the data cited in a) or b)
These 2 points demonstrate that the substance meets the following criteria:
a) endocrine activity
b) adverse effect on an intact organism or its descendants or future generations
c) biologically plausible link between endocrine activity and adverse effect
Category 2: This classification concerns endocrine disruptors suspected to be hazardous to human health. For a substance to be classified in Category 2, it must meet all of the following criteria:
a) there is evidence of endocrine activity and adverse effect on an intact organism or its descendants or future generations
b) the evidence cited in point a) is not sufficiently convincing to classify the substance in Category 1
c) there is evidence of a biologically plausible link between endocrine activity and adverse effect
In order for a mixture to be classified as an endocrine disruptor for human health, at least one of its components must be classified as an endocrine disruptor for human health in category 1 or 2 in the following concentrations:
Table extracted from Regulation (EU) 2023/707 of the Commission.
Generic concentration limit of components of a mixture classified as endocrine disruptor for human health that trigger classification of the mixture
Note: The concentration limits in this Table shall apply to solids and liquids (w/w units) as well as gases (v/v units).
Note 1: If a Category 2 endocrine disruptor for human health is present in the mixture as an ingredient at a concentration ≥ 0.1% a SDS (MSDS) shall be available for the mixture upon request.
The same definitions, classification criteria, and hazard statements will also apply to mixtures. If a mixture contains at least one substance classified as a category 1 or 2 endocrine disruptor for human health, then the mixture will be classified as a category 1 or 2 endocrine disruptor for human health as well.
Classification of PBT and vPvB Substances
The regulation defines PBT as a substance or mixture that is Persistent (P), Bioaccumulative (B), and Toxic (T), meeting the classification criteria established according to the characteristics stated in section 188.8.131.52 of the regulation.
vPvB, on the other hand, is defined as a substance or mixture that is Very Persistent (vP) and Very Bioaccumulative (vB), meeting the classification criteria established in section 184.108.40.206 of the regulation.
The hazard class assigned to these substances or mixtures is determined by their PBT and vPvB properties. The classification criteria for substances corresponding to each of these properties are detailed in section 4.3.2. Regarding the classification criteria for mixtures, details are available in section 4.3.3.
Classification of PMT and vPvM Substances
This regulation defines PMT as a substance or mixture that is Persistent (P), Mobile (M) and Toxic (T), and meets the classification criteria established according to the characteristics listed in section 220.127.116.11 of the regulation.
The vPvM, on the other hand, is defined as a substance or mixture that is very persistent (vP) and very mobile (vM) and meets the classification criteria established in section 18.104.22.168 of the regulation. The hazard class assigned to these substances or mixtures is established according to the different PMT and vPvM properties.
The classification criteria for substances corresponding to each of these properties are detailed in section 4.4.2. Regarding the classification criteria for mixtures, the details are available in section 4.4.3.
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