ANSES - French Agency for Food, Environmental and Occupational Health & Safety

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Published on 07/04/2014

Bisphenol A: ANSES publishes its comments in response to the EFSA draft Opinion for consultation

On 17 January 2014, the European Food Safety Authority (EFSA) published its draft Opinion on the risks to health related to bisphenol A (BPA) on its website for consultation. On 7 February 2014, ANSES issued an internal request to analyse the main points of this draft Opinion. Today the Agency is publishing the conclusions submitted to EFSA in response to this public consultation. ANSES stresses the considerable scientific work undertaken by EFSA, which included integrating recent data and taking into account all routes of exposure.  However, ANSES points out some limitations as to the consideration of uncertainties in EFSA's work and differences in interpretation in the analysis of available studies, and recommends standardising the methods for assessing toxicological studies applied by various European authorities.


On 17 January 2014, EFSA launched a consultation on its draft Opinion on the assessment of risks to the human population related to bisphenol A (BPA). This Opinion presents the results of an analysis of over 450 studies on the potential health risks of BPA and concludes, while underlining the context of very high scientific uncertainty, that BPA does not pose risks to consumers at the current levels of exposure through food and the handling of thermal receipts. However, EFSA recommends lowering the temporary tolerable daily intake in order to prevent risks it considers to be low in the current state of consumer exposure. 

In light of the work it had undertaken on this topic for over three years, ANSES wanted to contribute to this consultation and submitted its Opinion to EFSA on 13 March 2014. The expert appraisal focused on the main key points regarding the risks of the substance and its health effects that had been mentioned in the ANSES reports published in 2011 and 2013. It also addressed new aspects of the risk assessment process proposed by EFSA.


Additional information obtained through recent studies

The inclusion of new studies in the EFSA assessment provided additional information, particularly on certain critical effects such as metabolism for which little information was available until recently.

Indeed, the EFSA risk assessment included recent publications available since June 2012, the deadline for publications taken into account by ANSES in its expert appraisal report on the assessment of health risks related to BPA published in March 2013. 

ANSES also observes that this new health risk assessment not only takes into account studies on oral exposure but also studies on subcutaneous exposure, which was not the case in previous EFSA opinions. 

Moreover, EFSA broadened its selection to studies it had not previously considered, thus taking into account additional work in its risk assessment.


Methodologies to be clarified

ANSES emphasises the considerable scientific work undertaken by EFSA. Nonetheless, it considers that the approach used has certain limitations. For example, some biochemical and histological signs that can lead to health risks are not considered by EFSA as significant enough to be taken into account (e.g. effects on the central nervous system and effects on the mammary gland), whereas ANSES still considers they should be taken into consideration for the assessment of risks.

Furthermore, uncertainties as to the effects of BPA related to the quality of the studies analysed are mentioned several times in the EFSA report. And yet in its report, EFSA often uses uncertainty as an argument to consider that an effect is not likely or even exclude an effect that is considered likely from the risk assessment. 


The Agency's recommendations

After analysing the EFSA draft Opinion, ANSES considers that the conclusions of its assessment published in March 2013 remain valid. The Agency nonetheless takes note of the number of publications since its report on the health effects of BPA and considers it is necessary to maintain an active watch to update the data on this substance. 

Lastly, considering the high stakes associated with the interpretation of BPA toxicity studies and their limitations, ANSES recommends defining objective criteria, which should be standardised between EFSA and national health and safety agencies.