This work was carried out as part of a multidisciplinary, adversarial collective expert appraisal, by a working group specifically focusing on endocrine disrupters, assisted by several of the Agency’s expert groups. It was based on a review of all the available international studies and the results of measurement campaigns conducted by the Agency on the presence of bisphenol A in different media to which the population may be exposed.
The Opinion published today confirms the health effects of bisphenol A as identified by the Agency in September 2011, particularly for pregnant women in terms of potential risks to the unborn child. For the first time, it takes into account an estimate of the population’s actual exposure to bisphenol A not only through food, but also by inhalation (via ambient air) and the dermal route (contact with consumer products).
Food contributes over 80% of the population’s exposure. The main sources of dietary exposure are products packaged in cans (1), which account for around 50% of total dietary exposure. The Agency has also identified water distributed in refillable polycarbonate containers as a major source of exposure to bisphenol A.
The conclusions of the risk assessment, carried out on the basis of hazards identified from studies conducted on animals and of characterisation of exposure, show a potential risk to the unborn children of exposed pregnant women. 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 reporting of these potential risks however comes with a confidence level described by the experts as “moderate” with regard to the current state of knowledge and uncertainties.
Moreover, the work also led to the identification of other exposure situations, mainly related to the handling of thermal paper (cash register receipts, credit card receipts, etc.), especially in an occupational environment.
Insufficient knowledge relating to other vulnerable groups, especially young children, meant that the Agency was unable to carry out a risk assessment for these populations.
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, and its impact should be assessed over time. In addition, the safety of any substitutes used must also be ensured. 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.
Finally, in order to resolve the various uncertainties identified during this work, the Agency is also issuing various recommendations to improve the state of knowledge:
In terms of research, ANSES recommends acquiring new scientific data on the toxicity of bisphenol A, in particular for the most vulnerable populations, and improving characterisation of exposure.
In terms of methodology, the Agency recommends reviewing the relevance of using toxicity reference values or tolerable daily intakes 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.
(1) With no possibility of detecting the presence or absence of a bisphenol A-releasing coating