Statement on the ANSES reports on bisphenol A

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.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.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.