Bisphenol A (BPA) hazard assessment protocol

BPA, Protocol, Hazard assessment methodology, evidence integration, internal validity, external validity, weight of evidence
First published in EFSA Supporting Publications
21 December 2017
30 November 2017
Technical Report

To ensure an efficient, transparent and methodologically rigorous re-assessment of the safety for consumers of bisphenol A (BPA), the European Food Safety Authority (EFSA) has undertaken the task to develop a protocol detailing a priori the approach and methodology for performing BPA hazard identification and characterisation. The general aim of this hazard assessment will be to assess whether the new scientific evidence (published from 2013 onwards and not previously appraised by EFSA) still supports the current temporary Tolerable Daily Intake (t-TDI) for BPA of 4 µg/kg bw per day. In line with the principles highlighted in the EFSA project PROmoting METHods for Evidence Use in scientific assessments (PROMETHEUS,, the protocol states upfront and in detail the methods and/or the criteria that will be used in the planned BPA re-evaluation for data collection, study inclusion, evidence appraisal and integration. To pursue the goal of openness, this protocol was subjected to a web-based public consultation and was presented publicly in a stakeholder event. All the relevant comments and feedback received through these procedures were considered in this version of the protocol which will be implemented in the next BPA re-evaluation

FIP [at]
On request from