What is Bisphenol A?
Bisphenol A is a synthetic chemical used for more than 50 years in many different industrial applications. For a long time, its two main uses were for the manufacture of polycarbonate plastic and epoxy resins. It is also used as a component of other polymers and resins (polyester, polysulfone, vinyl ester resins, etc.). It is used in the synthesis of certain flame retardants and as a developer for thermal paper (mainly cash register receipts).
In the framework of its work on endocrine disruptors, in 2011 ANSES conducted a sector study with the aim of more systematically identifying the industry sectors using bisphenol A, and the consumer products and items concerned. It has identified nearly 60 sectors potentially using this substance in France, and has produced a non-exhaustive list of the uses, items and preparations that may contain bisphenol A (cables, sealants, adhesives, food grade containers and other containers, headlamp inserts, sporting goods, brake fluids, heat transfer fluids, electrical installation equipment, domestic appliances, medical devices and equipment, printing inks, etc.), thus showing that a very broad range of products and items was concerned.
Health risk assessment
At the request of the Ministry of Health, since 2009 the Agency has been conducting broad-scale expert appraisals on some thirty substances identified as Category 2 reprotoxic substances and/or endocrine disruptors for reproduction and fertility, including BPA.
In September 2011, the Agency published two reports relating to the health effects and the uses of BPA. In these reports, the Agency concluded that the priority should be to prevent exposure of the most susceptible populations (infants, young children and pregnant or breastfeeding women). It recommended reducing this exposure, mainly by replacing BPA in food contact materials.
As a result of the Agency's findings, in December 2012 Parliament passed a law suspending the manufacture, import, export and marketing of all food packaging containing BPA. Since 1 January 2015, therefore, it has been prohibited in infant feeding bottles and other food containers. This legislation is expected to lead to a very significant reduction in the level of dietary exposure to bisphenol A.
The assessment of the risks associated with exposure to BPA, published by ANSES in April 2013, confirmed the health effects identified in 2011, in particular for pregnant women in light of the potential risks to their unborn children. The Agency's opinion takes into account, for the first time, estimated actual population exposure to BPA through food, as well as through inhalation (via the ambient air) and skin (contact with consumer products). It highlights the fact that food contributes to more than 80% of population exposure.
Three other reports were also published in 2013: a review of potential alternatives to bisphenol A, an assessment of the hazards of other compounds of the class of bisphenols, and a report on the uncertainties surrounding endocrine disruptors.
In addition, the work led to other exposure situations being identified, in particular associated with the handling of thermal paper (cash register receipts, credit card receipts, etc.), especially in an occupational context.
Health risk assessment: the Agency's recommendations
The assessment of the health risks associated with exposure to bisphenol A led ANSES to recommend:
- assessing the impact over time of implementing these regulations and ensuring the safety of the substitutes used. In particular, in the absence of additional scientific data, the Agency discourages the use of other bisphenols as substitutes for bisphenol A;
- the Agency also reiterates the relevance of the recommendations for consumers, issued in its previous opinions.
With regard to the identification of potential risk situations for the unborn children of pregnant women handling thermal paper containing bisphenol A, especially as part of their occupational activities, ANSES recommends:
- taking 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;
- conducting, at the first opportunity, a biometrology study in female cashiers 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 management measures. The Agency undertakes to support such investigations.
The Agency has also issued recommendations to improve knowledge about the toxicity of bisphenol A, especially in the most vulnerable populations, to better characterise exposure (improving analytical methods, acquiring data on specific environments and populations, acquiring data to improve exposure modelling, etc.).
Lastly, from a methodological perspective, 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, and also systematically including an interdisciplinary analysis of the uncertainties in the risk assessment process.
Read the press kit from 9 April 2013 (PDF) to find out more.
In its Opinion of 25 March 2013 on the assessment of the risks associated with bisphenol A (BPA) for human health, ANSES demonstrated that diet was the predominant route of exposure: canned products were responsible for 50% of the dietary exposure to unconjugated BPA. With regard to non-canned foodstuffs, meat (meat, offal and delicatessen meats) accounted for 17% of this exposure and seafood products 3%, with no explanation as to the source of the contamination of these foodstuffs.
On 14 October 2013, ANSES was asked by the Directorate General for Food (DGAL) and the Directorate General for Competition, Consumer Affairs and Fraud Control to propose a sampling plan for monitoring the contamination of products of animal origin by unconjugated BPA. Relying on ANSES's recommendations, in 2015 the DGAL had implemented a sampling and analysis plan for unconjugated BPA in non-canned foodstuffs of animal origin. In 2017, the Agency published an opinion on the assessment of the results of this analytical campaign conducted by the DGAL, which concluded that in meat, contamination levels had decreased by a factor of three relative to the data from 2006-2007. Moreover, the data confirm that the BPA contamination of foodstuffs of animal origin occurs post-mortem, i.e. after slaughter of the animals. Studies are therefore needed to determine the sources of contamination along the production chain (in the slaughterhouse, cutting plant, etc.).
Proposal for classification as toxic for reproduction
In 2012, at European level, ANSES proposed a tougher classification for bisphenol A as toxic for reproduction, in the framework of Regulation (EC) No 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, known as the CLP Regulation. Indeed, since 2002, BPA has been subject to a harmonised European classification for its suspected toxicity for reproduction (Category 2). Following on from its work and in light of the observed effects (effects on fertility and on the male and female reproductive system observed in animals and substantiated by epidemiological studies in humans, whose relevance has been questioned) and the criteria of the CLP Regulation, ANSES proposed classifying bisphenol A as toxic to reproduction for humans (1B) and also discussing a classification in Category 1A, depending on the way in which the uncertainties on the human data are interpreted.
At the end of March 2014, on the basis of all the data, the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) issued a favourable opinion on the French proposal to classify BPA as a Category 1B reproductive toxicant. The direct consequences of a classification in Category 1 will be the application of stricter regulatory measures, in particular the requirement to put in place strengthened preventive measures for professional uses of bisphenol A (primarily its substitution), or a ban on the placing on the market of substances and mixtures containing more than 0.3% of bisphenol A intended for consumers.
Proposal to restrict BPA in thermal paper
In May 2014, ANSES submitted to ECHA a proposal to restrict the use of BPA in thermal paper, in the framework of the REACh Regulation. This proposal emphasised the existence of a risk to the health of workers (primarily cashiers) and consumers exposed to BPA from the handling of thermal paper (cash register receipts). In June 2015, the RAC concluded that the restriction proposal was the best response in terms of effectiveness for reducing the associated health risks. In December 2015, the Committee for Socio-Economic Analysis (SEAC) confirmed that the proposed restriction measure was an appropriate step to reduce the health risk to exposed workers. In December 2016, this restriction measure (amendment to Annex XVII of the REACh Regulation) was published in the Official Journal of the European Union. It stipulates that "bisphenol A shall not be placed on the market in thermal paper in a concentration equal to or greater than 0.02% by weight after 2 January 2020." In practice, at this concentration, this limit value is equivalent to a ban on BPA.
Proposal for classification as a Substance of Very High Concern under the REACh Regulation
Two approaches were followed successively by the Agency in 2016 and 2017, seeking to identify BPA as a Substance of Very High Concern (SVHC) under the REACh Regulation.
In June 2016, ANSES submitted a proposal to the European Chemicals Agency (ECHA) to identify BPA as a Substance of Very High Concern on the basis of its "reprotoxic" properties, as part of the implementation of the European REACh Regulation. The Member States Committee adopted this proposal in December 2016.
In February 2017, ANSES submitted a proposal to ECHA to identify BPA as a Substance of Very High Concern in the framework of the European REACh Regulation, on the basis of its "endocrine disrupting" properties. This second proposal of the Agency was adopted by the Member States Committee in June 2017.
The consequence of this adoption is that BPA is added to the list of candidate substances that may then be subject to the authorisation procedure, according to the process laid down by the REACh Regulation.
Response to the publication for consultation of EFSA’s draft opinion on the health effects of bisphenol A
On 17 January 2014, EFSA’s draft opinion on the assessment of the risks associated with bisphenol A for the human population was made available for consultation. This opinion presented the results of an analysis of more than 450 studies on the potential health risks associated with bisphenol A, and concluded, while stressing the context of very great scientific uncertainty, that bisphenol A does not present a risk to consumers at current levels of exposure, viafood and the handling of thermal paper receipts. However, EFSA proposed a decrease in the tolerable daily intake, which had been established on a temporary basis, with a view to preventing risks it regards as low with respect to consumer exposure.
In light of the work it has been conducting for many years on these issues, ANSES wanted to contribute to this consultation, and forwarded its opinion to EFSA on 13 March 2014.
The inclusion of new studies in the EFSA expert appraisal enabled additional information to be provided, in particular for certain critical effects such as metabolism, for which relatively little information was available until recently. In addition, for this new assessment of the health risks, not only were oral exposure studies assessed, but the subcutaneous route was also taken into account, which had not been the case in the previous EFSA opinion. Nevertheless, given the differences in interpretation concerning in particular the methodological limitations of toxicity studies on bisphenol A, ANSES recommends defining objective criteria, which should be harmonised between EFSA and the national health agencies.
After examining EFSA's draft opinion, ANSES considers that the conclusions of its assessment published in March 2013 remain valid, and believes it necessary to pursue active monitoring to update the data on this substance
In 2017, EFSA launched a new assessment of the risks associated with BPA.