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European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation
Örebro University, School of Science and Technology. Department of Biology, University of Massachusetts Amherst, Amherst, MA, USA.
Scholar in Residence, Nicholas School of the Environment, Duke University, Durham, NC, USA.
Teresa Heinz Professor of Green Chemistry, and Director, Institute for Green Science, Department of Chemistry, Carnegie Mellon University, 4400 Fifth Avenue, Pittsburgh, PA, USA.
HEEDS, Environmental Health News, Charlotte, VA, USA.
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2023 (English)In: Journal of the Endocrine Society, E-ISSN 2472-1972, Vol. 7, no 9, article id bvad107Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Oxford University Press, 2023. Vol. 7, no 9, article id bvad107
Keywords [en]
BPA, EDCs, European Food Safety Authority, European Medicines Agency, bisphenol A, endocrine disrupting chemicals, risk assessment
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
URN: urn:nbn:se:oru:diva-109426DOI: 10.1210/jendso/bvad107ISI: 001186829900001PubMedID: 37873497Scopus ID: 2-s2.0-85188729408OAI: oai:DiVA.org:oru-109426DiVA, id: diva2:1807205
Available from: 2023-10-25 Created: 2023-10-25 Last updated: 2025-01-20Bibliographically approved

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Zoeller, R. Thomas

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