Endocrine Disruptors: Challenges and CEHTRA’s Support

What is an endocrine disruptor?

In the European Union, an endocrine disruptor is defined as a substance that interferes with the hormonal system and may have harmful effects on humans and wildlife. These substances can be of synthetic or natural origin and may impact reproduction, growth, and development. In Europe, endocrine disruptors are assessed under various regulations, particularly those related to pesticides and biocides.

The EFSA and l’ECHA, as well as the l’OCDE, have published guidance to help identify these substances.

The criteria for identifying a substance as an endocrine disruptor are as follows:

1. Endocrine activity: the substance must have endocrine activity.

2. Adverse health effect: it must cause a harmful effect on health.

3. Plausible biological link: there must be a plausible biological link between the endocrine activity and the adverse effect.

   
   

Regulatory framework: Key milestones 

• 2018: assessing endocrine disruption potential became mandatory for plant protection products and biocides.

• April 20, 2023: entry into force of new classifications under the CLP regulation, introducing the following categories:

  • ED HH (endocrine disruption for human health), Categories 1 and 2

  • ED ENV (endocrine disruption for the environment), Categories 1 and 2

  
  

• Upcoming or pending regulations: 

  • Update of the Cosmetics Regulation to include the evaluation of endocrine disruptors.

  • Upcoming REACH revisions: identification of endocrine disruptors starting at the lowest tonnage band (from 1 tonne/year).

How CEHTRA can support you?

In this demanding regulatory context, CEHTRA offers solid expertise and tailored services to support companies in the evaluation of endocrine disruptors. 

Key services provided:

• Critical review of existing data:

  • Review of available regulatory data

  • Targeted bibliographic research and analysis

  
  

• Generation of new, specific data when needed:

  • Tailored testing strategies (in vitro, in vivo)

  • In silico screening (predictive modeling)

  • Monitoring of specific ED-related studies

  
  

• Data compilation in line with the regulatory context:

  • Robust synthesis of studies

  • EFSA table and identification of levels of evidence

  • Determination of classification according to CLP criteria

  • Detailed reports for specific substances or formulations

  • Expert statements (position papers) on ED potential for humans and/or the environment

Added value:

• In silico screening by QSAR experts

• Use of digital tools to optimize analysis and related costs

• Tailored services for various sectors (biocides, cosmetics, plant protection products, chemicals, etc.)

• An experienced in-house team of ecotoxicologists and toxicologists

Digital tools

ED Pedia: CEHTRA also offers ED Pedia, an interactive tool that allows you to:

• Instantly check, via CAS number, whether a substance is likely to be an endocrine disruptor

• Access relevant documentation

• Download a PDF report of the results

• Request a CEHTRA expert’s opinion if needed

ED Pedia relies on official substance evaluation lists to determine the level of concern regarding a substance’s ED potential.

Anticipating regulatory changes

Regulation is evolving rapidly: new CLP classifications have already been introduced, and further regulatory changes regarding cosmetics and REACH are expected in the coming months. CEHTRA helps you anticipate and adapt to these developments to ensure your products remain compliant while minimizing risks.

Contact Julien Leghait, Head of the Endocrine Disruptors Service, or visit the dedicated page for more information.