In order to respond to the formal requests from the French Ministries of Health and the Environment, ANSES set up a dedicated working group on Endocrine disruptors and category 3 reprotoxic substances (the WG ED) reporting to the Expert Committee (CES) on Assessment of the risks related to chemical substances. This WG brought together some thirty experts specialising in a variety of different fields. Other Agency CESs and WGs were involved concerning questions falling within their spheres of competence (the CES on Assessment of the risks related to water, the CES on chemical and physical residues and contaminants, the CES on Food contact materials, and the CES on Assessment of physico-chemical risks in food). The aim of this risk assessment was to incorporate, as broadly as possible, the various potential sources of exposure to bisphenol A (food, air, dust, consumer products, etc.) and to model exposure at the different stages of life, and in certain specific exposure situations (workers, for example).
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Updated on 20/09/2016
Assessment of the health risks of bisphenol A
Conclusions of ANSES's assessment
Given the available data, the exposure doses were calculated for pregnant women, adults (men and women) and children over 3 years old. Specific exposure scenarios were also developed to take into account exposure from cash register receipts and refillable polycarbonate water containers. The analysis of all the scientific articles on the effects of BPA, published until July 2012, helped identify, based on experimental data in animals, the critical effects deemed to be relevant to the unborn children of exposed pregnant women.
Four types of effects were therefore chosen for the risk assessment: effects on the brain and behaviour, on the female reproductive system, on metabolism and obesity, and on the mammary gland.
The risk assessment, which took into account all exposure media (but excluded specific exposure situations), shows that under certain circumstances, the exposure of pregnant women to bisphenol A could pose a potential risk for the unborn child. The identified effects relate to a change in the structure of the mammary gland in the unborn child that could promote subsequent tumour development. The risks potentially affect children of both sexes.
The confidence level associated with these results was described as "moderate" by the majority of the experts, given the many uncertainties in the current state of scientific knowledge.
Concerning the other three types of effects examined for the risk assessment (effects on the brain and behaviour, effect on metabolism and obesity, effect on the female reproductive system), the risk appears to be "negligible”, depending on the assumptions made.
Sources of exposure
On average, food is the main contributor to exposure (84% for pregnant women). Regarding the main dietary sources of exposure and irrespective of the populations concerned, the expert appraisal identified three broad categories:
The calculation of exposure via refillable polycarbonate water containers shows that water bottled in such containers is a significant source of exposure to bisphenol A. Its consumption can contribute to an increase in exposure to bisphenol A and could therefore, when combined with other sources of exposure, lead to an "additional" risk to the unborn child of an exposed pregnant woman.
The specific assessment of risks associated with the handling or use of products and/or articles intended for the general public and containing bisphenol A shows that handling thermal paper receipts leads to potential risk situations for the four types of effects considered in the risk assessment, but with a confidence level considered "limited" by the experts, due to the many uncertainties. It is certainly true that the models and assumptions used lead to overestimating exposure calculated in relation to handling thermal paper receipts. As a result, additional work will be undertaken to more accurately estimate the amount of bisphenol A actually absorbed by the dermal route.
Following ANSES’s previous Opinion of September 2011, the French Parliament adopted legislation in December 2012 to suspend the manufacture, import, export and placing on the market of any packaging for food use containing bisphenol A. This new law should lead to a significant reduction in the level of exposure to bisphenol A.
In this respect, ANSES recommends:
- assessing the impact over time of the implementation of these regulations and ensuring the safety of any substitutes used. In particular, in the absence of additional scientific data, the Agency does not advocate the use of other bisphenols as an alternative to bisphenol A.
- the Agency also reiterates the relevance of the consumer recommendations issued in its previous Opinions.
Considering the identification of potential risk situations for the unborn children of pregnant women handling thermal paper containing BPA, especially as part of their occupational activities, ANSES recommends:
- taking immediate measures to reduce the exposure of women handling thermal paper containing bisphenol A or other compounds of the class of bisphenols, especially in the workplace;
- undertaking, at the first opportunity, a biometrology study of cashiers and tellers handling thermal paper containing bisphenol A and/or bisphenol S, in order to verify the results obtained from the exposure scenarios used in this work and to identify the most suitable risk-reduction measures. The Agency undertakes to support such investigations.
The Agency is also issuing recommendations to advance knowledge on the toxicity of bisphenol A, in particular for the most vulnerable populations, and improving characterisation of exposure (improving analytical methods, acquiring data on specific media and populations, acquiring data to improve exposure modelling, etc.).
Lastly, in terms of methodology, the Agency recommends reviewing the relevance of using toxicity reference values such as the tolerable daily intake for substances for which the periods of vulnerability are not always known, as well as systematically including an interdisciplinary analysis of uncertainties in the risk assessment process.