Statement on the ANSES reports on bisphenol A

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Article
EFSA Journal 2011;9(12):2475 [10 pp.].
doi
10.2903/j.efsa.2011.2475
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Panel Members
Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Fidel Toldra and Detlef Wölfle
Acknowledgement

The CEF Panel wishes to thank: Trine Husøy, Wim Mennes, Iona Pratt and Detlef Wölfle for the preparatory work on this scientific opinion and EFSA staff: Anna F. Castoldi, Alexandre Feigenbaum and Anne Theobald for the support provided to this scientific opinion.

Type
Statement of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2011-01094
Adopted
24 November 2011
Published
1 December 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (185.47 KB)185.47 KB
Summary

EFSA has been asked to provide scientific advice in relation to possible divergences between the conclusions of the EFSA Scientific Opinion on Bisphenol A of September 2010 and those in the ANSES reports on BPA published in September 2011. The EFSA CEF Panel has analysed whether the ANSES report "Effets sanitaires du bisphénol A" contains any elements that would necessitate a revision of the EFSA opinion. The approach of the ANSES report is that of hazard identification, comprising also elements which could be relevant for the safety assessment of non-dietary exposure to BPA, whereas the EFSA opinion of 2010 addresses the assessment of risk from dietary exposure to BPA. This is the main reason for divergences between the ANSES and EFSA conclusions on BPA. The Panel overall considers that the information in the ANSES report does not change the views that the Panel expressed in 2010. To further investigate the divergences between the conclusions of ANSES in 2011 and those of EFSA in 2010 and to identify the relevant uncertainties in the data, the CEF Panel has undertaken a preliminary review of the new literature emerging on BPA. For most endpoints, the Panel considers that there is no new information that would change the views of the Panel of 2010. In 2010 the Panel noted that some studies conducted on developing animals suggest certain BPA-related effects which were not sufficiently convincing to use as pivotal effects for risk assessment, but which the Panel considered could be of possible toxicological relevance. Since then, additional studies related to these effects have become available, indicating effects of BPA in rodents at dose levels below the current NOAEL of 5 mg/kg bw/day. Uncertainties regarding the relevance to humans of these toxicological effects remain to be clarified. The Panel would need more time to review in depth these new studies. The Panel will reconsider its opinion following further evaluations of new studies and of new data from ongoing low dose studies.

Keywords
Bisphenol A, BPA, CAS No. 00080-05-7, risk assessment, TDI, low dose toxicity studies
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Number of Pages
10