Just after the specification of endocrine disruptors in safety data sheets (article currently only available in German) under REACH, new classifications were presented in the CLP Regulation. In this article, I summarise the classification for the effect on human health and how it fits into the safety data sheet.
Where can the new classifications be found?
The new classifications were already published in the Official Journal of the EU. In the CLP Regulation, the new classifications are added to Annex I, where the other hazard classes can also be found. The new hazard classes follow the prevalent system. Hazards for the human health are added in Part 3 and hazards for the environment in Part 4.
Endocrine disruption describes a hormone-like effect and is divided into effect on human health (Annex I, Part 3, 3.11) and effect on the environment (Annex I, Part 4, 4.2).
Endocrine disruption for human health
The hazard class is used to inform about the following situation: One or more functions of the endocrine system are altered and may cause a harmful effect.
There are two categories for classification:
- Category 1 (ED HH 1, Danger, EUH380) – Strong evidence
- Category 2 (ED HH 2, Warning, EUH381) – Less conclusive than category 1
The exact methods of determination were left open, but alternatives to animal testing are already mentioned as a possibility (in vitro / in silico).
Mixture determination:
Classification of mixtures is carried out on the basis of the components, on the basis of the mixture itself, or by bridging principles. Classification on the basis of the components is not additive (individual consideration of substance concentrations). The following general concentration limits have been established:
- Category 1, ≥ 0.1 %
- Category 2, ≥ 1 %; Safety data sheet upon request: ≥ 0.1 %
EUH phrases:
The new classifications are currently part of the legal area of the EU, an adoption in GHS is still unclear. Therefore, the new classifications do not have H phrases (GHS), but EUH phrases (purely CLP).
- Category 1: EUH380: May cause endocrine disruption in humans
- Category 2: EUH381: Suspected of causing endocrine disruption in humans
Endocrine disruption in the safety data sheet
Interestingly, there are already specifications for the safety data sheet for endocrine disruption in the REACH Regulation.
As part of the classification, the new EUH phrases will be found in section 2 and for ingredients in section 3. In addition, for human toxicity data, there is a subsection 11.2 in section 11 where, among other things, information on endocrine disrupting effects can be described.
Transition periods
The following transition periods have been set for the integration of the new classification. The indication of the classification in the EU regulatory area will become mandatory at the end of the transitional period; before the end, the indication is still optional, but already possible, especially if there is enough evidence for the classification. Format: DD/MM/YYYY
- Classification for substances: 01/05/2025
- Classification for mixtures: 01/05/2026
- Time to adjust stocks for sale:
- Substances: 01/11/2026
- Mixtures: 01/05/2028
Sources:
[1] Official Journal of the European Union, L93, 31.03.2023
[2] CLP Regulation in consolidated version of 17.12.2023
