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New classification endocrine disruption (environment)

Endocrine disruption for the environment, EUH 430 and EUH 431.

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Endocrine disruption, i.e. the new classification of hormone-like substances, distinguishes between the disruption for the environment and for human health. In this article, I describe the classification for the effect on the environment.

Where can the classification for the effect on the environment be found?

The classification can be found in the CLP Regulation, Annex II, Part 4, 4.2. This classification follows the already existing chapter on the classification hazardous to the aquatic environment in 4.1. Due to the publication in March 2023, the consolidated versions may not yet carry chapter 4.2, depending on when you are reading this article. You will certainly find the new classifications in the Official Journal of the European Union [1].

Endocrine disruption for the environment

How to create a sds

This is the official English designation of this new hazard class. A classification applies if a hormonally induced harmful effect can be triggered at the level of the population or subpopulation.

The hazard class is divided into two categories:

  • Category 1 (ED ENV 1, Danger, EUH430) – Proven connection
  • Category 2 (ED ENV 2, Warning, EUH431) – Less conclusive connection than in category 1

The law does not refer to any specific test methods. In addition to data obtained from animals, alternative methods are also mentioned as valid, as long as these alternatives correspond to the predictive capacities of animal testing.

The integration of the new classifications into ECHA’s Classification and Labelling Guidance is currently scheduled to be published in 2024.

Mixture determination

Mixture classification is primarily based on the concentration of components classified as endocrine disruptors for the environment. If there are data for the mixture that justify classification, even though the component conditions would not result in classification, classification of the mixture is justified. Interestingly, the reverse case (no classification of the mixture due to mixture data) is not mentioned.

The bridging principles based on sufficient substance information and data on similar mixtures (CLP Regulation, Annex I, Part 1, 1.1.3), are also applicable.

The classification based on component concentrations is not additive. Classification occurs when at least one substance with the corresponding classification and category exceeds the general concentration limit:

  • Category 1, ≥ 0.1 %
  • Category 2, ≥ 1 %; Safety data sheet on request: ≥ 0.1 %.

EUH phrases:

The new classifications are currently valid in 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 (strictly CLP).

  • Category 1: EUH430: May cause endocrine disruption in the environment
  • Category 2: EUH431: Suspected of causing endocrine disruption in the environment

Details in the safety data sheet

There is the possibility to provide more detailed information for ED ENV 1 and 2 in section 12, subsection 12.6. The new classifications can be found in section 2 for the described substance or mixture, for components in section 3 and more detailed information in section 12.6.

Attention: Older, no longer up-to-date safety data sheets still show other adverse effects under section 12.6, this subsection was moved to 12.7.

Transition periods

The new classifications can be used right away, but there are also transition periods to give more time for the adaption of the new regulation. Once the transitional period has elapsed, the indication of the ED ENV classification in the EU legal area is mandatory.

  • Classification for substances: 05.2025
  • Classification for mixtures: 05.2026
  • Period until stock has to be adjusted for sale:
    • Substances: 11.2026
    • Mixtures: 05.2028

Sources:

[1]        Official Journal of the European Union, L 93, 31.03.2023

[2]        CLP Regulation in consolidated version of 17.12.2023

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