European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation

R Thomas Zoeller; Linda S Birnbaum; Terrence J Collins; Jerrold Heindel; Patricia A Hunt; Taisen Iguchi; Andreas Kortenkamp; John Peterson Myers; Frederick S Vom Saal; Carlos Sonnenschein; Ana M Soto

doi:10.1210/jendso/bvad107

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation

J Endocr Soc. 2023 Aug 12;7(9):bvad107. doi: 10.1210/jendso/bvad107. eCollection 2023 Aug 2.

Authors

R Thomas Zoeller^{1

2}, Linda S Birnbaum³, Terrence J Collins⁴, Jerrold Heindel⁵, Patricia A Hunt⁶, Taisen Iguchi⁷, Andreas Kortenkamp⁸, John Peterson Myers^{9

10}, Frederick S Vom Saal¹¹, Carlos Sonnenschein^{12

13

14}, Ana M Soto^{12

14}

Affiliations

¹ Department of Biology, University of Massachusetts Amherst, Amherst, MA 01003, USA.
² School of Science and Technology, University of Örebro, Örebro, Sweden.
³ Scholar in Residence, Nicholas School of the Environment, Duke University, Durham, NC, USA.
⁴ Teresa Heinz Professor of Green Chemistry, and Director, Institute for Green Science, Department of Chemistry, Carnegie Mellon University, 4400 Fifth Avenue, Pittsburgh, PA 15213, USA.
⁵ HEEDS, Environmental Health News, Charlotte, VA, USA.
⁶ School of Molecular Biosciences, Center for Reproductive Biology, Washington State University, Pullman, WA 99164, USA.
⁷ Graduate School of Nanobioscience, Yokohama City University, Yokohama, Kanagawa, 236-0027, Japan.
⁸ Centre for Pollution Research and Policy, Brunel University London, Uxbridge UB8 3PH, UK.
⁹ Environmental Health Sciences, Charlottesville, VA, USA.
¹⁰ Department of Chemistry, Carnegie, Mellon University, Pittsburgh, PA, USA.
¹¹ Division of Biological Sciences, The University of Missouri, Columbia, MO 65211, USA.
¹² Centre Cavaillès, Ecole Normale Supérieure, Paris, France.
¹³ Institut for Advanced Studies, Nantes, France.
¹⁴ Department of Immunology, Tufts University School of Medicine, Boston, USA.

Abstract

The European Food Safety Authority (EFSA) has revised their estimate of the toxicity of bisphenol A (BPA) and, as a result, have recommended reducing the tolerable daily intake (TDI) by 20 000-fold. This would essentially ban the use of BPA in food packaging such as can liners, plastic food containers, and in consumer products. To come to this conclusion, EFSA used a systematic approach according to a pre-established protocol and included all guideline and nonguideline studies in their analysis. They found that Th-17 immune cells increased with very low exposure to BPA and used this endpoint to revise the TDI to be human health protective. A number of regulatory agencies including the European Medicines Agency (EMA) have written formal disagreements with several elements of EFSA's proposal. The European Commission will now decide whether to accept EFSA's recommendation over the objections of EMA. If the Commission accepts EFSA's recommendation, it will be a landmark action using knowledge acquired through independent scientific studies focused on biomarkers of chronic disease to protect human health. The goal of this Perspective is to clearly articulate the monumental nature of this debate and decision and to explain what is at stake. Our perspective is that the weight of evidence clearly supports EFSA's proposal to reduce the TDI by 20 000-fold.

Keywords: BPA; EDCs; European Food Safety Authority; European Medicines Agency; bisphenol A; endocrine disrupting chemicals; risk assessment.