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European Commission’s Scientific Committee on Food Confirms That Products Made with Bisphenol A Are Safe

July 15, 2002

On May 3, 2002, the European Commission’s Scientific Committee on Food (SCF) issued its Opinion1 confirming that food contact products made with bisphenol A (BPA) are, and remain, safe for their intended uses. The Opinion of the SCF is consistent with the position of the U.S. Food and Drug Administration, the Japanese Ministry of Health, Labor and Welfare and other government agencies worldwide who all conclude that food contact products made with BPA pose no risk to human health. Consumers can continue to use products made with BPA with confidence, knowing that these products fully comply with the SCF’s requirements.

SCF’s Re-evaluation of BPA Confirms its Safety in Food Contact Applications

The EU Scientific Committee on Food’s re-evaluation of BPA was part of an ongoing process in the EU to protect consumers by evaluating all plastics in food contact applications and setting specific safety and migration limits. Only monomers and additives that have been reviewed, authorised, and listed under Commission Directive 90/128/EEC may be used in food contact applications.

For BPA, the SCF reviewed recent robust and comprehensive data on toxicology and migration to set the so-called Tolerable Daily Intake (TDI), which is a safety threshold for lifelong daily intake. The TDI itself is derived from scientific data (No Observed Adverse Effect Level, NOAEL) by applying safety factors.

More in depth information on the EU food contact legislation can be found at:

http://europa.eu.int/comm/food/fs/sfp/food_contact/index_en.html

In the case of BPA, which is mainly used in the manufacture of polycarbonate plastic and epoxy resins, the SCF set the TDI at 0.01 mg/kg bodyweight/day. This value is explicitly derived from the results (NOAEL) of a recent and comprehensive scientific study2, performed at the Research Triangle Institute in North Carolina, USA, under the stringent, globally accepted quality control system known as Good Laboratory Practices (GLP). The quality of this multigeneration study can be regarded as the "gold standard" of toxicology.

Part of the SCF process also included an evaluation of consumer exposure. The SCF concluded in its Opinion that realistic, worst-case estimates of consumer exposure via foodstuffs, ranging from 0.00048 mg/kg bw/day to 0.0016 mg/kg bw/day, are well below the TDI.

Recognising that industry is currently in the process of conducting further research, the Committee recommended that the temporary TDI be reviewed if data from this research changes significantly from existing studies. Industry is confident that the current research will add to the existing weight of evidence that demonstrates all products and applications made with BPA are safe for their intended uses.

References

1Opinion of the Scientific Committee on Food on Bisphenol A (Expressed on 17 April 2002), ref. SCF/CS/PM/3936 Final – 3 May 2002 – http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf

2“Three-Generation Reproductive Toxicity Study of Dietary Bisphenol A in CD Sprague-Dawley Rats”, R. W. Tyl, C. B. Myers, M. C. Marr, B. F. Thomas, A. R. Keimowitz, D. R. Brine, M. M. Veselica, P. A. Fail, T. Y. Chang, J. C. Seely, R. L. Joiner, J. H. Butala, S. S. Dimond, S. Z. Cagen, R. N. Shiotsuka, G. D. Stropp, and J. M. Waechter, Toxicol. Sci. (2002) 68 (1): 121-146.


   
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