The need to insert new hazard classes and their criteria into the CLP Regulation is part of the commitments made by EU COM under the chemicals strategy for sustainability, part of the European Green Deal.
The hazard classes which will be introduced relate to the identification of endocrine disruptive effects (EDs), substances with persistent, bioaccumulative and toxic properties (PBTs), very persistent, very bioaccumulative properties (vPvB), persistent, mobile and toxic properties (PMTs) and very persistent, very mobile properties (vPvM). For the ED-type properties, experience and scientific knowledge was gained through the process of SVHC identification under REACH. For the PBT/vPvB-type substances, knowledge originates from the application of Annex XIII from REACH. The inclusion of PMT and vPvM properties is new, with the exception that the ‘(v)P’ and ‘T’ criteria are the same compared to the PBT/vPvB properties obviously.
In practice this means that following new hazard classes which will become applicable:
Within Annex I to CLP Part 3
→ 3.11 Endocrine Disruptor for Human Health
Within Annex I to CLP Part 4
→ 4.2 Endocrine Disruptor for Environment
→ 4.3 PBT/vPvB
→ 4.4 PMT/vPvB
This means that for classification as ED for Human Health, 2 categories will be applicable:
→ ED HH Cat. 1: Known or presumed endocrine disruptors for human health (EUH380)
→ ED HH Cat. 2: Suspected endocrine disruptors for human health (EUH381)
The distinction between Cat 1 and 2 will be based on the amount of evidence that can be presented related to the following:
(a) endocrine activity
(b) an adverse effect in an intact orgasnism or its offspring or future generations;
(c) a biologically plausible link between the endocrine activity and the adverse effect
And evidence provided in function of demonstrating this may be based on:
(a) human or animal data;
(a) both human and animal data:
(a) non-animal data providing an equivalent levelof evidence as for points a or b
In case there is doubt on the relevance for humans or on criteria (a), (b), (c), Cat. 2 might be more appropriate and in cases where evidence can conclusively demonstrate that the adverse effects are not relevant to humans, it is describe that the substance ‘shall not be considered an endocrine disruptor for human health’.
For classification as ED for the environment, also 2 categories will be applicable:
→ ED ENV Cat. 1: Known or presumed endocrine disruptors for the environment (EUH430)
→ ED ENV Cat. 2: Suspected endocrine disruptors for the environment (EUH431)
The criteria that need to be fulfilled are similar to those for determining the ED properties for human health, the only difference is that this will be largely based on evidence from at least one of the following:
(a) animal data;
(b) non-animal data providing an equivalent level of evidence as for point a.
Overall, for the identification of the ED criteria, it has now been clarified in this current draft that information from structural analogues and read-across as well as non-animal data, e.g. data from new approach methodologies (NAMs) can be used to concluded on Cat.1 ED properties. This is an important clarification as it allows not only the use of non-animal test methods which are available today but also those which will be developed in the future.
For classification as PBT/vPvB, there will be a category for both PBT and vPvB, however there will be no further distinction between ‘suspected or known/presumed’:
→ Cat PBT: Accumulates in the environment and living organisms including in humans (EUH440)
→ Cat vPvB: Strongly accumulates in the environment and living organisms including in humans (EUH441)
The same is then again applicable for classification as PMT/vPvM, a category for each but no further distinction between ‘suspected or known/presumed’:
→ Cat PMT: Can cause long-lasting and diffuse contamination of water resources (EUH450)
→ Cat vPvM: Can cause very long-lasting and diffuse contamination of water resources (EUH451)
Evaluation of the (v)P, (v)B and T criteria – in function of the PBT, vPvB, PMT and vPvM hazard classes – will be evaluated based on the principles and criteria currently applied within Annex XIII of REACH. Other information, for example information relevant for the evaluation of the screening criteria, is also still relevant when used in a Weight of Evidence situation. The Mobility criterion which is new, will typically be determined based on the Log Koc value. In case the Log Koc is < 3 the substance will be identified as ‘M’, in case the log Koc is < 2, the substance will be identified as ‘vM’. This will be determined via testing, or in case of a WoE approach via well developed and reliable QSAR methods.
A link to the full draft delegated act and respective annex can be found here.
The addition the new hazard classes, part of the Annexes of CLP Regulation, will take place via delegated Acts instead of the ‘normal’ procedure. This procedure was selected as it ensures a quicker procedure compared to the ordinary route. This ‘fast-tracking’ adjustment of the CLP hazard classes fits within the broader scheme of EU COM to revise the Regulation within the framework of the Chemical strategy for sustainability.
Key question obviously remains when these new hazard classes will effectively enter into force. Although we do not know exactly when the adoption of the delegated Act will take place, expected timeline for entry into force is Q1/Q2 2023. Next to that we do know that the Annex (draft) to the delegated Act, suggested the following transitional periods for substances and mixtures:
– 24 months to classify new substances according to the new hazard classes and in case of re-classification of substances already on the market 42 months would apply.
– 36 months to classify new mixtures to the new hazard classes and in case of re-classification of mixtures already on the market industry 60 months would apply.
Essential to ensuring that the implementation of these hazard classes can take place successfully is obviously also availability of guidance. Detailed guidance to determine what sufficient evidence for classification within the new hazard classes (ED & PMT) entails will be due, as implementation of these concepts, and the interpretation of results of tests in function of these endpoints will not be straightforward. Based on information from an ECHA presentation, CLP guidance would be developed Q1 2023, with interim info becoming available Q2 2023.
The new draft version (after inclusion of the comments which were due 18/10) of the delegated Act were up for discussion during the CA meeting (CARACAL) on the 17th and 18th of November.
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