European Food Safety Authority Increases Bisphenol A Tolerable Daily Intake - Strong Support for Conclusion that Bisphenol A is Not a Risk to Human Health
February 1, 2007
With the release of a comprehensive risk assessment on January 29, 2007 the European Food Safety Authority has increased their Tolerable Daily Intake (TDI) for bisphenol A by a factor of five to 50 micrograms/kg body weight/day. The TDI is an estimate of the amount of a bisphenol A that can be ingested daily over a lifetime without appreciable risk. With human exposure to bisphenol A well below the TDI, the assessment strongly supports the conclusion that bisphenol A is not a risk to human health at the low levels to which people, including infants and children, might be exposed from use of consumer products. The conclusion is consistent with and supports numerous assessments conducted by government and scientific bodies worldwide, all of which support the safety of bisphenol A.
Who is EFSA and What Did They Do?
The European Food Safety Authority (EFSA), established by the European Parliament in 2002, provides the European Commission, the European Parliament and the European Member States with a sound scientific basis for legislation and policies related to food safety. Included in the scope of EFSA’s work are assessments of the safety of food packaging and other materials that contact food.
On January 29, 2007, EFSA released a comprehensive risk assessment on bisphenol A,(1 ,2) a substance of interest to EFSA since people may be exposed to trace amounts of bisphenol A through food contact products made from polycarbonate plastic and epoxy resins. The assessment was conducted by one of EFSA’s scientific expert panels, consisting of independent scientific experts from across the European Union.
Why Did EFSA Conduct the Evaluation?
The European Commission’s Scientific Committee on Food, a predecessor organization to EFSA, had previously conducted an assessment of bisphenol A in 2002. That assessment established a Tolerable Daily Intake (TDI)(3) for bisphenol A of 10 micrograms/kg body weight/day, which is well above potential human exposure and thus supports the safety of food contact products containing bisphenol A. However, due to uncertainty in the scientific database regarding potential reproductive and developmental effects from low doses of bisphenol A, the TDI was designated as a temporary value.
Since 2002 more than 200 scientific studies on bisphenol A have been published and there has been considerable controversy over the safety of bisphenol A. For these reasons, the EFSA scientific panel conducted a new assessment of bisphenol A. Most notably, a comprehensive two-generation study on the potential reproductive and developmental effects of bisphenol A in mice recently became available. The study, sponsored by industry, was conducted under the guidance of an expert panel organized by the European Chemicals Bureau that provided scientific peer-review at key stages of the study including the final report.
What Were the Findings of the Evaluation?
Most importantly, after review of some 200 new studies, EFSA established a full TDI (i.e., no longer temporary) of 50 micrograms/kg body weight/day. The strength of the scientific database, now including the robust two-generation study in mice, supported a five-fold increase in the TDI while also reducing uncertainty around the level of risk. This new TDI, backed up by a comprehensive scientific assessment, very strongly supports the safety of consumer products made from polycarbonate plastic and epoxy resins.
The overall TDI conclusion was supported by a number of significant findings that also address recent points of controversy:
- Reports of low-dose endocrine effects of bisphenol A in rodents “did not demonstrate such activity in ways that were robust or reproducible.”
- New studies have shown significant differences between humans and rodents, such as the fact that people metabolize and excrete bisphenol A from their system far more quickly than rodents, “further limiting the relevance of low-dose effects of BPA reported in some rodent studies for human risk assessment.”
- Studies have shown that mice are particularly sensitive to estrogens. Since bisphenol A is a weak estrogen, the absence of adverse effects at doses of 5 milligrams/kg/day and below in the robust two-generation study in mice adds further confidence to the conclusions of the risk assessment.
In addition, human exposure to bisphenol A, including exposure to infants and children, has been shown to be well below the TDI level, even when estimated with worst-case assumptions. As a result, the assessment strongly supports the conclusion that human exposure to trace levels of bisphenol A from use of consumer products is not a risk to human health, including the health of infants and children.
How Does the EFSA Evaluation Compare with Other Evaluations?
Although the EFSA evaluation is now the most up-to-date scientific assessment of bisphenol A, it is far from being the only evaluation. In recent years government and scientific bodies around the world have examined the scientific evidence supporting the safety of bisphenol A. The findings of this new evaluation are consistent with the findings of the earlier evaluations, all of which support the conclusion that bisphenol A is not a risk to human health at the low levels to which people might be exposed. Key examples of recent assessments include:
- An expert scientific panel weight-of-the-evidence evaluation of low-dose reproductive and developmental effects of bisphenol A (2006)(4)
- A comprehensive risk assessment conducted by the Japanese National Institute of Advanced Industrial Science and Technology (2005)(5)
- The Japanese Ministry of Environment, which conducted their own low-dose research on bisphenol A (2005)(6)
- A weight-of-evidence evaluation of low-dose reproductive and developmental effects of bisphenol A conducted by a panel of scientific experts organized by the Harvard Center for Risk Analysis (2004)(7)
- A comprehensive European Union (EU) risk assessment (2003)(8)
- An independent assessment of the EU risk assessment by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (2002)(9)
- A detailed assessment of bisphenol A focused on food contact applications by the EU Scientific Committee on Food (2002)(10)
- A scientific panel evaluation of low-dose effects from bisphenol A organized by the US National Toxicology Program (2001)(11)
1. The EFSA press release and FAQs are available on the EFSA website at http://www.efsa.europa.eu/en/press_room/press_release/pr_bpa.html.
2. A summary report and full report are available on the EFSA website at http://www.efsa.europa.eu/en/science/afc/afc_opinions/bisphenol_a.html.
3. The Tolerable Daily Intake is defined as an estimate of the amount of a substance, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable risk.
4. Goodman, J. E., McConnell, E. E., Sipes, I. G., Witorsch, R. J., Slayton, T. M., Yu, C. J., Lewis, A. S., and Rhomberg, L. R. 2006. An Updated Weight of the Evidence Evaluation of Reproductive and Developmental Effects of Low Doses of Bisphenol A. Critical Reviews in Toxicology. 36:387-457. For a summary of this study, see http://www.gradientcorp.com/coinfo/RiskBull.html.
5. An abstract and detailed summary of the bisphenol A risk assessment are available at http://unit.aist.go.jp/riss/crm/mainmenu/e_1-10.html. For further discussion on the assessment, see http://www.bisphenol-a.org/whatsNew/20060320.html.
6. Japanese Ministry of Environment. 2005. MOE’s perspectives on endocrine disrupting effects of substances. March 2005. Available on the internet at http://www.env.go.jp/en/chemi/ed/extend2005_full.pdf.
7. Gray, G. M., Cohen, J. T., Cunha, G., Hughes, C., McConnell, E. E., Rhomberg, L., Sipes, I. G., and Mattison, D. 2004. Weight of the evidence evaluation of low-dose reproductive and developmental effects of bisphenol A. Human and Ecological Risk Assessment. 10:875-921. For a description of this study and a link to the full paper, see http://www.bisphenol-a.org/whatsNew/20040903Harvard.html.
8. Available on the internet at http://ecb.jrc.it/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/SUMMARY/bisphenolasum325.pdf (summary) and http://ecb.jrc.it/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/bisphenolareport325.pdf (full report).
9. Available on the internet at http://ec.europa.eu/health/ph_risk/committees/sct/documents/out156_en.pdf.
10. See http://www.bisphenol-a.org/whatsNew/20020715EuropeanCommission.html for a discussion on the European Commission’s Scientific Committee on Food assessment of bisphenol A, and http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf for the complete assessment.
11. National Toxicology Program's Report of the Endocrine Disruptors Low Dose Peer Review, August 2001, available on the internet at http://ntp.niehs.nih.gov/go/14446.