Endocrine Disruptors in the regulatory context - what you need to know
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”. In 2017, the EU finally agreed on the long awaited scientific criteria for the evaluation of substances with regard to ‘endocrine disruption‘ under Plant Protection ((EC) No 1107/2009 ) and Biocide ((EU) No 528/2012) regulations. 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 ECHA/EFSA guidance issued in June 2018 for the identification of ED in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 requires a highly complex and challenging assessment for all active 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.
As a consequence, from 07 June 2018 and 10 November 2018 respectively, the evaluating competent authorities for biocides and plant protection products are obliged to assess the potential ED properties of active substances as well as biocidal products. Please note that this also applies to any submission that was still in the evaluation phase when Regulation (EU) 2017/2100 and Regulation (EU) 2018/605 setting out scientific criteria for the determination of endocrine-disrupting properties became applicable.
ED implementation - Overview
Plant Protection Products
10 May 2018: criteria as laid down within Regulation (EU) 2018/605 entered into force
(applicable by 10 Nov 2018)
07 Dec 2017: criteria as laid down within Regulation (EU) 2017/2100 entered into force
(applicable by 07 June 2018)
01 June 2007 - considered from entry into force of EU 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.
How we can support
- 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
- Specific QSAR profiling & reporting
- Compilation, review and critical assessment of studies and published literature
- „Weight of evidence“ evaluation
- Mode of action analysis
- Assessment of ED properties of biocidal products (screening of co-formulants/non-actives)
- 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 courses by our experienced tutors (via knoell academy and third parties)