A Guidance document jointly published by ECHA and EFSA last year describes how to identify endocrine-disrupting (ED) properties of biocidal products and plant protection products.
In short, a substance is considered as having ED properties if it has an adverse effect on an intact organism or its progeny and if this effect is a consequence of an endocrine mode of action. There must be an assessment of all the available relevant scientific data using a weight of evidence approach, in which the link between the adverse effect and the endocrine mode of action is established based on biological plausibility.
The document Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (doi: 10.2903/j.efsa.2018.5311) outlines the appropriate strategy for determining whether a substance has ED properties. The core concept of the strategy is that parameters relevant for identifying ED properties measured in experimental studies are grouped together with regard to their capacity to inform on endocrine activity and related adversity. The assessment strategy is driven by the so-called EATS (estrogenic, androgenic, thyroidal and steroidogenic)-mediated parameters, which are considered indicative of an endocrine mode of action.
The key steps to the assessment strategy are:
- gathering of all available relevant information;
- assembly of the information into lines of evidence;
- initial analysis of the evidence;
- analysis of the mode of action;
- conclusion on the ED criteria with respect to humans and non-target organisms.
The “available relevant information” includes the studies that are part of the standard information requirements for plant protection products and biocidal products, as well as other scientific data identified by conducting a systematic literature review. An Excel template is available for reporting the data and building the lines of evidence.
Addressing the ED properties of substances is a necessary and time-consuming task for both plant protection and biocidal product dossiers. At Kerona Scientific, we can help you meet your obligations by performing the systematic review and the assessment of the available evidence. Contact the team via firstname.lastname@example.org or +353 1 8495 284.