Evidence evaluated by European Food Safety Authority does not support lowering the temporary tolerable daily intake for bisphenol A

Author: Robyn L Prueitt, Julie E Goodman from Gradient

Publication: Toxicological Sciences, Volume 198, Issue 2

Date: January 23, 2024

exposure health

The EFSA hazard assessment review process has led to a conclusion that there are low-dose effects of BPA based on very few, lower quality experimental animal studies. This conclusion is not supported by the totality of the available evidence, which includes multiple high-quality studies not considered by EFSA and indicates that the t-TDI established in 2015 is protective of human health. For more information, please click here.

At a Glance

What was tested?
This study, conducted by independent scientific research contractor Gradient, examines the key issues with the draft EFSA Opinion, including arguments brought up by commenters and in the published literature (eg, Zagorski and Kaminski, 2023), and how these issues remain in the final Opinion and bear on the derivation of the final TDI.
Findings
The EFSA hazard assessment review process has led to a conclusion that there are low-dose effects of BPA based on very few, lower quality experimental animal studies. This conclusion is not supported by the totality of the available evidence, which includes multiple high-quality studies not considered by EFSA and indicates that the t-TDI established in 2015 is protective of human health.
Study Limitations
EFSA claimed that the TDI for BPA was not based on a single study, but on the weight of the evidence from the entire dataset evaluated, and pointed to studies by Bodin et al. (2014) and Malaisé et al. (2017, 2018) as supporting studies (EFSA CEP, 2023a). However, Kimber et al. (2022) and Zagorski and Kaminski (2023) noted that these “supporting” studies had similar shortcomings and evaluated much higher doses than those studied by Luo et al. (2016), and do not provide evidence to support an increased percentage of Th17 cells as an adverse, systemic, or consistent endpoint across studies, particularly at the very low doses used in the derivation of the TDI.
Importance
The EFSA hazard assessment review process is not scientifically sound and has led to a conclusion that there are low-dose effects based on very few, lower quality experimental animal studies. These effects and the conclusions drawn are not sufficiently supported by the totality of the available evidence, which includes multiple high-quality studies not considered in EFSA’s recent review. Therefore, there is a clear risk of unfounded regulatory burdens being placed upon manufacturers, users, and consumers of BPA and polycarbonate products.