Evaluation of the endocrine-disrupting potential of a biocidal product

Client

A regulatory consultancy.

Background

An evaluation of the endocrine-disrupting (ED) properties of biocidal products is a requirement under the biocidal products regulation, as amended by Regulation (EU) 2017/2100.

Project goals

To provide an evaluation of the ED properties of a biocidal product for submission to the regulatory authorities, and to recommend appropriate further testing. To be conducted according to the guidance of the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA).

Approach

Bibra was provided with reference lists from the human health and environmental sections of the previously-submitted biocidal active substance dossier. Those studies considered relevant to the evaluation of ED were selected for inclusion. Searches of a comprehensive range of databases were conducted to identify any further relevant studies. The details of all those determined to be relevant and reliable were entered 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. Since the available data were considered insufficient to conclude on ED potential, a proposal was made for the generation of new data.

Project outcome

The resulting ED evaluation was delivered to the client in the required format for submission to the regulatory authorities.

Bibra project team

Anne Edwards
Emma Russell

 

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