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Frequently Asked Questions on bisphenol A in consumer products
Updated FAQ of 23 May 2012
The chemical substance bisphenol A (BPA) is contained in products made of polycarbonate, including containers and bottles used for packaging and storing of food. BPA is also used for manufacturing internal coatings of beverage and food cans. A further application of BPA are thermal papers onto which till receipts, transportation and car park tickets are printed.
There is an ongoing scientific debate on the risk assessment of BPA for years. At regular intervals, the media take up the topic and ask whether the substance poses a danger to consumers, especially babies and infants.
Below, the Federal Institute for Risk Assessment (BfR) answers the most frequently asked questions on BPA.
- What is bisphenol A?
- Where is bisphenol A found?
- Which are the potential effects of bisphenol A?
- Why did BfR look into the issue of bisphenol A?
- What are the results of EFSA´s risk assessment of bisphenol A?
- Do babies and infants absorb quantities of bisphenol A that pose a danger to their health?
- Why has the European Commission banned bisphenol A in baby bottles?
- Are there alternatives to baby bottles made of bisphenol A?
- Can bisphenol A also be contained in baby dummies made of latex or silicone?
- Is there a health risk for children who use dummies for extended periods of time?
- Why do the internal coatings of food and beverage cans contain bisphenol A?
- How can users tell whether internal linings of food and beverage cans contain bisphenol A?
- Why can bisphenol A be contained in till receipts, transportation and car park tickets?
- What is the bisphenol A content in these thermal papers?
- Does bisphenol A exposure from thermal papers pose a health risk for consumers?
BPA is the industrial chemical 2,2-bis(4-hydroxyphenyl)propane which is used as a starting substance in the manufacture of polycarbonate plastics and synthetic resins.
The substance can be contained in products made of polycarbonate including articles that come into contact with food. Examples include water bottles (in the past also baby bottles) and tableware. BPA can also be contained in the internal lining of beverage and food cans. In addition, BPA is used as colour former in so-called thermal papers for thermal printers and fax machines.
The substance has low acute toxicity. However, BPA belongs to a group of substances which have hormone-like (e.g. estrogenic) effects. The scientific name of these substances is “endocrine disruptors”. In principle, such substances can have effects on all hormone-dependent processes, especially on the development of organismns. Nevertheless, no detrimental BPA health effects have been demonstrated for humans so far. In the human body, BPA is quickly converted into a metabolite which no longer has any estrogenic effects and is excreted via the kidneys.
In order to investigate the potential impact of BPA on the reproductive system, multi-generation studies with mice and rats have been conducted over wide dose ranges. On the basis of the data from these studies, the health risk arising from BPA has been assessed at the European level and a safe limit value was established. BfR experts were involved in this assessment.
Among other things, the BfR has a statutory mandate to assess the risks posed by chemicals in products intended for consumers, to communicate those risks, and to propose measures for risk reduction. Against this background, the institute is also concerned with the assessment of BPA in tableware, cans and other products.
In the context of REACH Regulation (EC) No. 1907/2006, the BfR is, in its capacity as the assessment centre for “Health and Consumer Protection”, responsible for questions relating to the health aspects of BPA and for assessing risk reduction measures.
The institute informs the government authorities who have a statutory regulation mandate and the public about the results of its scientific assessment. However, the BfR cannot impose a ban on the use of BPA.
In 2010, the European Food Safety Agency (EFSA) assessed experimental studies from the years 2006 to 2010 and concluded that these data do not call for any change of the tolerable daily intake (TDI value) for BPA. The TDI had been defined by EFSA in 2006; it is 0.05 mg per kilogram of body weight.
In its expert opinion, the EFSA points out that for assessing some developmental toxicity effects of BPA, new data with so far unclear relevance for human health are now available. These are studies on the modulation of the immune system, on biochemical changes in the central nervous system and on the question to what extent BPA may enhance the sensitivity to the development of breast cancer.
Each month, a wealth of new data on BPA is published. The EFSA records and assesses these data regularly. The EFSA is currently preparing a new assessment of BPA which is scheduled to be completed by May 2013. This assessment will notably take into account new insights into the possible effects of BPA doses below the TDI. The latest data on the absorption of BPA via food and from other sources will also be taken into consideration as part of the assessment.
For BPA, a “TDI value” (tolerable daily intake) has been established at the European level. This value indicates the quantity that a person can take every day for the entire life without running the risk of any unwanted health effects.
The TDI value for BPA is 0.05 milligram per kilogram of body weight (which equals 3.0 mg for a person weighing 60 kg) and comprises a safety factor of 100. In order to ensure that this value is not exceeded, products containing BPA must only release limited quantities of the substance.
As regards the daily BPA intake by babies through polycarbonate bottles plus formula from cans, a panel of experts from the World Health Organisation (WHO, 2010) has calculated an dietary exposure (“worst-case assumptions”) of 0.005 milligrams / kg of body weight. For children aged between 3 and 11, the German Federal Environment Agency (UBA, 2009) determined a mean BPA intake of 0.00006 milligrams / kg of body weight. Both estimates are clearly below the TDI value defined by the EFSA and further support the notion that there are no health risks for babies and infants.
Due to the controversial debate on BPA, the EU member states Denmark and France banned BPA in baby bottles in 2010. The ban was imposed solely for reasons of precautionary consumer protection. In order to create a consistent legal framework within the EU, the European Commission consequently banned the use of bisphenol A in the manufacture of baby bottles and the placing on the market of baby bottles manufactured with bisphenol A within the EU member states. The ban is in effect since March and June 2011 respectively. As soon as the available scientific data provides more certainty with regard to the detrimental health effects of BPA, the ban at EU level will be discussed again.
Since the use of BPA is regulated at the European level, the European Commission is the competent authority for laying down restrictions in the use of the substance.
There are various plastic alternatives to polycarbonate, for example, baby bottles made of polypropylene and polyethersulfone are available which are advertised as BPA-free products. However, polypropylene releases significantly more substances into food than polycarbonate. Any alternative plastic used in the manufacture of baby bottles must comply with the legal requirements that apply to materials in contact with food.
Parents who would like to avoid plastic bottles altogether can use glass bottles instead. However, the risk of breakage must be taken into account.
No BPA is required for the manufacture of these materials. However, the substance may be contained in the plastic shield in which it is bound chemically. Based on current knowledge, a transfer of substances from the plastic shield into the actual dummy is not to be expected under normal conditions of use.
In 2009 BfR has tested 18 baby soothers of different manufacturers and brands made of latex and silicone for BPA. The aim was to find out how much BPA is released when the soothers are used. Only in one dummy, a release of BPA amounting to 0.0002 milligrams per soother and hour was detected. This value is considered safe in terms of its health effects. None of the other 17 dummies released any BPA. These test results are consistent with results of the Austrian Agency for Health and Food Safety (AGES) and various surveillance laboratories.
The test results of the BfR, the Austrian Agency for Health and Food Safety (AGES) and other official laboratories show that the use of baby soothers does not result in any health-relevant BPA intake.
As a contaminant resulting from the manufacturing process, BPA is found in epoxy resins (epoxide resins) which are also used in internal linings of food and beverage cans. Such coating is necessary to prevent corrosion of the tin and release of metals in contact with food which would cause contamination of the food as well as discolouration and impairment of the flavour.
BPA-free coating systems are up to now limited to a few applications and in some cases still await an evaluation of their health effects.
It is not mandatory to label cans which are coated with epoxide resins.
A further application of BPA is so-called thermal paper. Thermal paper is used for thermal printing systems which are integrated in cash registers, ticket offices, parking meters as well as printers for receipts and bank statements. There the substance is used as colour former.
According to tests done by various laboratories, thermal papers contain between 0.5 and 3.2 per cent of free BPA. “Free” in this context means that the substance is not bound in the material.
Currently no reliable data is available on the exposure of consumers to BPA from thermal papers. Since consumers usually come into contact with paper products containing BPA such as tickets or receipts only with their hands and for a short time, it can be assumed that they absorb, if any at all, very small amounts of the substance from these sources, under normal conditions of use. However, for reasons of precautionary consumer protection, it should be ensured that children do not play with till and other receipts, nor with tickets made of thermal paper. In particular in case of small children, it cannot be ruled out that they put these papers in their mouth during playing, so that they could orally ingest BPA from the paper.