Following the European Commission (EC) officially adopting the revised criteria to identify endocrine disrupting chemicals (EDCs) in plant protection product (PPPs), ECHA and the European Food Safety Authority have now finalized and published the guidance document (https://www.efsa.europa.eu/en/efsajournal/pub/5311).
This guidance describes how to perform hazard identification for ED 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.
The guidance document describes how to gather, evaluate and consider all relevant information for the assessment, conduct a mode of action (MoA) analysis, and apply a weight of evidence (WoE) approach, in order to establish whether the ED criteria are fulfilled. An approach is proposed for analysing the information provided in a dossier submitted for approval of a substance in the context of the PPP or BP Regulations.
Information sources that may provide suitable information for ED identification should be considered for the assessment. In addition, guidance on how to consider the scientific data generated in accordance with internationally agreed study protocols in order to facilitate the evaluation of both adverse effects and endocrine activity. The rationale for grouping effects is based on the ‘Guidance Document on standardised test guidelines for evaluating chemicals for endocrine disruption. Series on Testing and Assessment No. 150‘ provided by the OECD for their interpretation with regard to estrogenic, androgenic, thyroidal and steroidogenic (EATS) modalities and adapting the Joint Research Centres screening methodology to identify potential endocrine disruptors.
For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact ERM on +44 (0)1423 520245,firstname.lastname@example.org.
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