Overview & Updates
BPA (Bisphenol A) is a chemical used in certain food contact materials and first approved by FDA in the early 1960s. In recent years, concerns have been raised about BPA's safety. In August 2008, FDA released a draft report finding that BPA remains safe in food contact materials.
On October 31, 2008, a subcommittee of FDA's science board raised questions about whether FDA's review had adequately considered the most recent scientific information available. In the fall of 2014, FDA experts from across the agency, specializing in toxicology, analytical chemistry, endocrinology, epidemiology, and other fields, completed a four-year review of more than 300 scientific studies. The FDA review has not found any information in the evaluated studies to prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.
The studies reviewed were published or available from November 1, 2009 to July 23, 2013. The review was documented in four memoranda and their attachments:
- “Final report for the review of literature and data on BPA” – 6/6/2014
- “2014 Updated Review of Literature and Data on Bisphenol A” - 6/6/2014
- “2012 Updated Review of Literature and Data on Bisphenol A” - 8/22/2013
- “Updated Review of the ‘Low-Dose’ Literature (Data) on Bisphenol A and Response to Charge Questions Regarding the Risk Assessment on Bisphenol” - 5/24/2011
Additional information on assessments and the science board is also available.
On January 15, 2010 and again updated in March 2012, March 2013, July 2014, and November 2014, FDA issued updates on BPA, including FDA's perspective. The update also includes information on:
- Additional Studies
- Public Comment and Next Steps for FDA's Assessment of BPA
- Interim Public Health Recommendations
- The Regulatory Framework for BPA
- Collaboration with International Partners.
Response to Petition on BPA
The FDA is currently reviewing a BPA petition we received and filed as provided for under the FDA’s procedural regulations for food additive petitions. When we file a food additive petition requesting that the FDA revoke an authorization, we are reviewing the information submitted in the petition to determine whether it contains sufficient data to establish the existence of safety questions significant enough to support a finding that the authorized use is no longer safe under Sections 409 or 721 of the FD&C Act. For more information about the petition process, see: Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process. We will publish our response to the petition in the Federal Register once we have completed our review. Our regulatory decisions remain grounded in a robust evaluation of the totality of the available science on the use of food additives, including substances used in food packaging.
On October 28, 2008, the Natural Resources Defense Council (NRDC) submitted a citizen petition regarding BPA. The petition requested that the Commissioner of Food and Drugs:
- Issue a regulation prohibiting the use of BPA in human food and packaging, and
- Revoke all regulations permitting the use of any food additive that may result in BPA becoming a component of food.
On March 30, 2012, the FDA denied this request in accordance with 21 CFR 10.30(e)(3). In its response, the FDA stated that:
- The information provided in the citizen petition was not sufficient to persuade FDA to initiate this rulemaking.
- The most appropriate course of action at this time is to continue scientific study and review of all new evidence regarding the safety of BPA.
- Although FDA was not persuaded by the data and information in the NRDC citizen petition to initiate rulemaking to revoke the food additive approvals for BPA, FDA will continue in its broader and more comprehensive review of emerging data and information on BPA. Depending on the results, any of these studies or data could influence FDA’s assessment and future regulatory decisions about BPA.
Additional Information from FDA about BPA and Food Contact Substances
- Draft Assessment of Bisphenol A for Use in Food Contact Applications (PDF, 7.61 Mb)
- Draft Assessment of Bisphenol A for Use in Food Contact Applications - Full Reference List (PDF, 126 Kb)
Full reference list for BPA draft assessment
- FDA Science Board Subcommittee Report on Bisphenol A (PDF, 147 Kb)
Scientific Peer-Review of the Draft Assessment of Bisphenol A For Use in Food Contact Applications
- 2008 Meetings of the Science Board to the FDA
FDA Science Board - Transcripts of September 16, 2008 meeting
- FDA Letter to Science Board October 29, 2008 (PDF, 76 Kb)
- FDA Letter to Science Board December 3, 2008 (PDF, 334 Kb)
Other Official Assessments
- Japan: National Institute of Advanced Industrial Science and Technology Risk Assessment Document (English translation)
- EFSA: Scientific Opinion of the Panel on Food Additives
Evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A
- NIEHS/NTP: Questions and Answers about BPA
- Norway: Assessment of Four Studies on Developmental Neurotoxicity of Bisphenol A
- Statement of EFSA on a Study Associating Bisphenol A with Medical Disorders