Guidance on how to identify substances with endocrine disrupting properties in pesticides and biocides

Date: 12 July 2018

The European Commission tasked EFSA and ECHA with developing harmonised guidance to ensure that the endocrine disruptor criteria adopted by the EU in 2017 are applied consistently for the assessment of biocides and pesticides in the EU.
The “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 Pre-publication version” was drafted with the support of the Joint Research Centre and published in June 2018.
It aims to assist in complying with obligations under the Biocidal Products Regulation (BPR). With regard to the Plant Protection Products Regulation (PPPR), it will be used in the assessments of all active substances for which a decision is scheduled on or after 10 November 2018*.

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This guidance document is based on the WHO/IPCS definition of an endocrine disruptor (WHO/IPCS, 2002). In order to establish whether the ED criteria are fulfilled, gathering, evaluating and considering all relevant information for the assessment, conducting of a mode of action (MoA) analysis, and applying of a weight of evidence (WoE) approach is necessary.
ED criteria cover all endocrine disrupting modes of action. However, the effects caused by estrogenic, androgenic, thyroidal and steroidogenic (EATS) modalities are referenced in detail in this GD since there are standardised test guidelines for in vivo and in vitro testing available (compiled in the OECD Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption, OECD GD 150). So, mammals, fish, and amphibians are the addressed species.
An assessment strategy whether a substance meets the endocrine disruptor criteria (incl. a mode of action analysis), information sources that may provide suitable information for ED identification, and recommendations for applicants and assessors from evaluating authorities are part of the GD.
Last but not least, several appendices providing information on some specific scientific or technical issues (e.g. databases, software tools and literature-derived (Q)SARs). To download the guidance, please click here.

Even with the enforced EU ED criteria and the ED guidance on hand, expert work and judgement will be needed to evaluate the putative ED properties of compounds in the forthcoming process, especially in cases where the scientific evidence is ambiguous or contradictory.
SCC has a wide spectrum of expertise in the assessment of potential endocrine disruption. This allows us to successfully anticipate regulatory challenges and confidently guide our clients through the difficulties in developing target-specific strategies. To keep up to date with every new requirement, we continuously monitor the current regulatory and scientific developments in this field, both in the EU and worldwide.
Our expertise covers the entire range of methods that can be used in the development of an appropriate assessment strategy, including mode of action (MoA) analyses and adverse outcome pathway (AOP) concepts as well as weight of evidence (WoE) approaches.
SCC will serve you as a dedicated and highly experienced partner when it comes to assembling the lines of evidence. We will support you in gathering, evaluating and putting together all relevant information required for establishing whether the ED criteria are fulfilled. 

* Date has been changed from 20 October 2018 to 10 November 2018; Corrigendum to Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties [L 111/10, 2018, Document 32018R0605R(01)]

For more information, please contactThis email address is being protected from spambots. You need JavaScript enabled to view it., Vice President / Head of Regulatory Science, Pharma Pre-Clinical.
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Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties

Date: 16 May 2018

The European Union is the first region and regulatory system worldwide to define scientific criteria for endocrine disruptors (EDs). Under EU’s Biocidal Products and Plant Protection Products Regulations (EU No 528/2012 (BPR) and EC No 1107/2009 (PPPR)), an active substance, which is considered as having ED potential will not be approved unless the risk from exposure is negligible (BPR), unless exposure is negligible (PPPR), or there is evidence that it is essential to prevent or control serious pests or it is required on socioeconomic grounds (BPR).

The ED-criteria for plant protection products (EC No 1107/2009) have been under scrutiny of the European Council and the European Parliament (EP). The initial regulation was rejected by the EP in October 2017. The new proposal taking into consideration the claims of the EP (the criteria contain no more the specific provision for the so-called “growth regulators”) was adopted by a narrow Qualified Majority during the Standing Committee on Plants, Animals, Food, and Feed (PAFF) meeting dated 12-13 December 2017. The final adoption by the Commission has been recently performed in April 2018. To read the whole article, please click here.

Article originally published in SCC Newsletter – EXTRA, May 2018
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