Evaluation of the endocrine-disrupting potential of two plant protection products

Client

A regulatory and toxicology consultancy.

Background

Under the recent amendment to the plant protection products regulation (Regulation (EU) 2018/605), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated.

Project goals

To evaluate the ED properties of two plant protection products following the guidance of the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA).

Approach

Bibra was provided with details of the toxicity studies included in the Human Health sections of the client’s previously-submitted plant protection product active substance dossiers. In addition, study reports describing in vitro reporter gene assays were also provided. For each substance, those studies considered relevant to the evaluation of ED were selected for inclusion in the ECHA/EFSA template, Appendix E1 (“Excel template for reporting effects”), following the instructions in Appendix E2 (“Guidance to fill in the ‘Data’ sheet template”). The “Lines of Evidence” for adversity and endocrine activity were assembled, using the macros embedded within the Excel workbook, and an expert evaluation was provided.

Project outcome

The resulting ED evaluations were delivered to the client for incorporation into their documentation for submission to the regulatory authorities.

Bibra project team

Anne Edwards
Emma Russell

 

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