Endocrine Disruptors (ED)

According to the WHO/IPCS definition (2002) “An endocrine disruptor (ED) is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or its progeny, or (sub)populations”. The EU has finally agreed upon the long awaited scientific criteria for the evaluation of substances with a potential for ‘endocrine disruption‘ Essentially to define an ED, evidence for the combination of three key elements is required: Establishment of the correlation between (1) adverse effects and (2) their causal relationship to substance exposure by (3) a proven endocrine mode of action.

The corresponding recently issued ECHA/EFSA guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009) requires a highly complex and challenging assessment for all substances. Particularly when dealing with such substances on a global scale, you may be facing substantial uncertainty regarding data requirements as well as testing and assessment strategies. Essentially you are now required to perform hazard identification for endocrine-disrupting properties by following the scientific criteria which are outlined in Commission Delegated Regulation (EU) 2017/2100 and Commission Regulation (EU) 2018/605 for biocidal products and plant protection products, respectively.

In the field of biocides according to the CA-Document “CA-Jan18-Doc.7.3.b” (March 2018), the evaluating body for biocides is now obliged to also consider the ED properties of a biocidal product (b.p.) in any procedure that is still under the evaluation phase as soon as the Regulation (EU) 2017/2100 setting out scientific criteria for the determination of endocrine-disrupting properties becomes applicable. As a consequence, from 07 June 2018 the evaluating competent authority will assess the potential ED properties of biocidal products Please note that this means in practice that this evaluation will relate not only to the active substance(s) but also to co-formulant(s) contained in the biocidal product(s).

Key timelines and transition periods for the ED implementation:

Biocides:
07 Dec 2017: criteria as laid down within Regulation (EU) 2017/2100 entered into force
(applicable by 07 June 2018)

Plant Protection Products:
10 May 2018: criteria as laid down within Regulation (EU) 2018/605 entered into force
(applicable by 10 Nov 2018)

REACh:
01 June 2007 - considered from entry into force of REACh
(case by case*)

*It is case by case assessment, and ECHA and the member states may trigger an ED Assessment in order to identify EDs as substances of very high concern (SVHCs) in accordance with Article 57(f) of Regulation (EC)  No 1907/2006. The ECHA ED expert group serves as advisory group for the assessments.

 

Here are the services knoell’s team of ED experts can offer regarding ED assessment:

  • Prepare ED related registration strategies for various legislations, e.g. EU REACH (Regulation (EC) No. 1907/2006), Plant Protection Products (Regulation (EC) No 1107/2009), and Biocidal Product Regulation (Regulation (C) No 528/2012)
  • Assessment of potential ED properties according to the new ECHA/EFSA Guidance for the identification of endocrine disruptors (2018):
    - Tailored literature and database search (screening)
    - Specific QSAR profiling & reporting
    - Compilation, review and critical assessment of studies and published literature
    - „Weight of evidence“ evaluation
    - Mode of action analysis
  • Development and design of ED testing strategies
  • Study management and study monitoring of ED specific studies
  • Preparation of robust study summaries and their incorporation into the respective dossiers
  • Preparation of expert statements
  • Worldwide registration and assessment of global implications
  • Training: Knoell academy have an ED training planned for Spring 2019
  • Event: Workshop 'Understanding the guidance for identifying endocrine disrupting chemicals' at the Chemical Watch Biocides Europe 2018 Event (27-29 November 2018) 

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