EUROPE – COM : Adoption of the regulation for the identification of unacceptable co-formulants
22 March 2023
FRANCE : Entry into force of the new measures to protect persons when using plant protection products
7 April 2023
Following the proposed revision of the CLP Regulation and the introduction of new hazard classes for endocrine disruptors (EDs) and other hazardous chemicals (see our previous article), the Commission published on 31 March 2023 in the Official Journal of the European Union a Delegated Regulation (EU) 2023/707 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.
Regulation 2023/707 therefore adapted the Annexes to Regulation (EC) No 1272/2008 as follows :
- Annex I : Addition of classification criteria for substances identified as endocrine disrupters for human health or the environment, PBT (persistent, bioaccumulative, toxic) or vPvB (very persistent, very bioaccumulative), PMT (persistent, mobile, toxic) or vPvM (very persistent, very mobile), as well as thresholds for the classification of mixtures and indicators (signal words, hazard statements, precautionary statements) related to the hazard communication. As the level of evidence as regards endocrine disrupting properties may be of different scientific strength, two categories of endocrine disruptors have been created: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2), both for human health and for the environment.
In order to give suppliers of substances and mixtures time to adapt to these new classification and labelling provisions, they are applicable :
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- from 1 May 2025 at the latest for substances,
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- from 1 May 2026 at the latest for mixtures.
However, substances (respectively mixtures) which were placed on the market before 1 May 2025 (respectively 1 May 2026), are not required to be classified and labelled according to these new criteria until 1 November 2026 (respectively 1 May 2028).
- Annex II : Addition of a new criterion triggering the hazard statement EUH210 – “Safety Data Sheet available on request” on the label, for mixtures not classified as hazardous but containing a substance classified as a category 2 endocrine disruptor for human health or the environment, at a content equal to or higher than 0.1%.
- Annex III : Addition of the following new hazard statements :
- EUH380 – “May cause endocrine disruption in humans”,
- EUH381 – “Suspected of causing endocrine disruption in humans”,
- EUH430 – “May cause endocrine disruption in the environment”,
- EUH431 – “Suspected of causing endocrine disruption in the environment”,
- EUH440 – “Accumulates in the environment and living organisms including in humans”,
- EUH441 – “Strongly accumulates in the environment and living organisms including in humans”,
- EUH450 – “Can cause long-lasting and diffuse contamination of water resources” and
- EUH451 – “Can cause very long-lasting and diffuse contamination of water resources”.
- Annex VI : Addition of the following new hazard classes and categories’ codes :
- Endocrine disruptor for human health : ED HH 1 or ED HH 2,
- Endocrine disruptor for the environment :ED ENV 1 or ED ENV 2,
- Persistent, bioaccumulative and toxic : PBT,
- Very persistent and very bioaccumulative : vPvB,
- Persistent, mobile and toxic : PMT and
- Very persistent and very mobile : vPvM.
In case new pictograms are created for these new hazard classes, they should be agreed at UNGHS first so that they can apply across the UNGHS members.
The Regulation comes into force from 20 April 2023.
To download:
See also our previous articles:
EUROPE – COM : Proposal for the revision of the CLP Regulation
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