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Implementation of the evidence‐based risk assessment for the re‐evaluation of Bisphenol A: preparatory work on Mode of Action studies in mammalian, human and/or in vitro models.

on the Wiley Online Library


Disclaimer: The present document has been produced and adopted by the bodies identified above as author. This task has been carried out exclusively by the author in the context of a contract between the European Food Safety Authority and the author, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the author.


EFSA is implementing evidence‐based risk assessments for the re‐evaluation of the safety of bisphenol A (BPA) for human health. The aim of this project was to carry out preparatory tasks for the working group on BPA re‐evaluation, with particular reference to the preparation of individual summary tables from studies relating to BPA's toxicological mode of action or mechanism, and the production of a narrative and factual summary of these studies when grouped by health outcome category and by effect/endpoint. The first stage of the work was conducted using DistillerSR, the web‐based systematic review software used by EFSA which enabled direct access/download to the published documents and provided electronic data collection templates for data extraction and reporting. A total of 1193 published articles were considered and, using the pre‐established rules defined by EFSA, 581 were selected for inclusion. Data from these were subsequently extracted into the electronic data collection templates. Using these data with additional reference back to the published articles, a narrative report was produced that sub‐divided the studies into eight key toxicological areas: reproduction, neurotoxicity, immune system toxicity, metabolic effects, cardiovascular effects, carcinogenicity, general toxicity and genotoxicity as well as smaller groups of studies that did not fall naturally into these health categories. This narrative report briefly summarises the data extracted.