Bisphenol A (BPA) hazard assessment protocol

Abstract

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, https://www.efsa.europa.eu/en/efsajournal/pub/4121), 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.

Exposure Assessment of Bisphenols in Chinese Women during Pregnancy: A Longitudinal Study

“…We calculated the sum of molar concentrations of BPA, BPS, and BPF to measure the daily intake of the three bisphenols. For BPA, the tolerable daily intake (TDI) is 4000 ng/kg body weight/day according to the European Food Safety Authority . Because the molecular weights of BPF and BPS are different from BPA and no TDI value for BPA-alternative has been established.…”

“…For BPA, the tolerable daily intake (TDI) is 4000 ng/kg body weight/day according to the European Food Safety Authority. 34 Because the molecular weights of BPF and BPS are different from BPA and no TDI value for BPA-alternative has been established. TDI of BPA was adjusted to molar concentrations, which were applied as TDIs for the other two bisphenols.…”

Occurrence, Distribution, and Human Exposure of Several Endocrine-Disrupting Chemicals in Indoor Dust: A Nationwide Study

“…According to the data from the National Bureau of Statistics of the People’s Republic of China, a family group generally includes three persons: one infant/toddler/child/teenager and two adults. The cumulative P95 EDI values for Σ 16 EDCs for a family group ranged from 26.4 to 74.6 ng/kg bw/day, which were 2 orders of magnitude lower than that recommended for BPA by EFSA (4 μg/kg bw/day) …”

“…The U.S. FDA and Health Canada also exerted the same policy regulations on their utilization . The governmental units of Canada and EU prohibited the use of BPA in baby bottles. , Since 1993, the U.S. Environmental Protection Agency (EPA) has set a tolerable daily intake for BPA at 50 μg/kg body weight (bw)/day, and it was reduced to 4 μg/kg bw/day by the European Food Safety Authority (EFSA) in 2017 …”

Biocompatibility Evaluation of Resin-Based Restorative Materials: A Review

“…[29][30][31] The tolerable daily intake is advised by governmental regulatory agencies. European Food Safety Authority (EFSA) derived a reference dose of 0,004 mg BPA/kg 32 , The United States Environmental Protection Agency (USEPA) determined the tolerable daily intake as 0,05 mg BPA/kg. 33 BPA is not included as a substance in dental materials, whereas BPA derivatives such as Bis-DMA and Bis-GMA are used in their structures.…”