Incoming: New hazard categories in CLP regulation
Incoming: New hazard categories in CLP regulation
jeudi 1 décembre 2022
On 20th of September 2022, the European Commission published, a draft for a revision of CLP. Its adoption would lead to the establishment of new hazard classes: ◾In addition of already being mentioned in sections 2.3, 11.2 and 12.6 of the SDS, endocrine disruptors as defined in Commission delegated regulation (EU) 2017/2100 of 4 September 2017, would, also need to be assessed according to the applicable requirements of two new hazard classes, one for human health and one for the environment.
• For human health:
- Category 1: Known or presumed endocrine disruptors should be labelled with the following supplemental hazard statement: « EUH380: May cause endocrine disruption in humans. ».
- Category 2: Suspected endocrine disruptors should be labelled with the following supplemental hazard statement: « EUH381: Suspected of causing endocrine disruption in humans. ».
• For the environment:
- Category 1: Known or presumed endocrine disruptors should be labelled with the following supplemental hazard statement: « EUH430: May cause endocrine disruption in the environment.».
- Category 2: Suspected endocrine disruptors should be labelled with the following supplemental hazard statement: « EUH431: Suspected of causing endocrine disruption in the environment. ».
A mixture would be classified as endocrine disruptor category 1 if it contains one component or more present in a concentration of at least 0,1% classified as category 1 and would be classified as endocrine disruptor category 2 if it contains at least 1% of a component classified as category 2. Components classified in category 1 could not lead to a classification of the mixture in category 2.
◾Substances with Persistent, Bioaccumulative and Toxic properties (PBT) or substances with very Persistent and very Bioaccumulative properties (vPvB) should now be assessed with the following 2 categories:
- PBT: Substances recognised as Persistent, Bioaccumulative and Toxic as defined in Annex XIII of REACH. From now on, this definition does also consider the endocrine disruptor property of the substances. This category should be labelled with the following supplemental hazard statement: « EUH440: Accumulates in living organisms including in humans with long- lasting effects. ».
- vPvB: Substances recognised as very Persistent and very Bioaccumulative as defined in Annex XIII of REACH. This category should be labelled with the following supplemental hazard statement: « EUH441: Strongly accumulates in living organisms including in humans with possible long- lasting effects. » A mixture would be classified as PBT/vPvB if it contains one component or more present in a concentration of at least 0,1% classified as PBT/vPvB.
◾Substances with Persistent, Mobile and Toxic properties (PMT) or very Persistent very Mobile properties (vPvM) must be assessed according to the applicable requirements of two new hazard classes:
- Substances considered as Persistent, Mobile and Toxic, for which the criteria of persistence and toxicity remain the same as for the PBT substances, and for which the mobility criterion is defined as a substance with a log Koc under 3 (this value can be calculated or measured, for ionisable substances the value must be measured between pH 4 and pH 9). This category should be labelled with the following supplemental hazard statement: « EUH450: Persistent substance which can pollute water resources. ».
- Substances considered as very Persistent, very Mobile for which persistence criterion remain the same as for PBT substances and for which the mobility criterion is defined as a substance with a log Koc under 2 (this value can be calculated or measured, for ionisable substances the value must be measured between pH 4 and pH 9). This category should be labelled with the following supplemental hazard statement: «EUH451: Very persistent substance which can pollute water resources. ».
A mixture would be classified as PMT/vPvM if it contains one component or more present in a concentration of at least 0,1% classified as PMT/vPvM.
The new hazard classes would be applicable 18 months for substances and 36 months for mixtures after the entry into force of this regulation. It could be useful to already check the potential impact of these new classifications on your substances and mixtures.
Please note that this publication is, for now, just a draft subject to numerous discussions. In particular the advisability of adding new hazard classes in Europe, when they have not yet been discussed or adopted within the framework of the United Nations GHS is far from unanimous among the stakeholders.