Bisphenol A

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Changed on: 23.06.2016

Bisphenol A (BPA) is a commonly used industrial chemical and is used as a building block (monomer) for the manufacture of polycarbonate plastic (PC) and epoxy resins. Polycarbonates are used to manufacture synthetic glass, CD and DVD blanks, as well as food containers such as cookware for microwave ovens, water dispensers or kettles. BPA-based epoxy resins are used in large quantities in the construction sector (boat and mould-making, pipework). Epoxy resins come into contact with food mainly in the form of protective coatings used in food tins and drinks cans. One additional use of BPA relevant to our everyday lives is the thermal paper used, for example, in the manufacture of till receipts and tickets. In addition, BPA is used in dental sealants, paint coatings, surface coatings, adhesives and electrical appliances.

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Bisphenol A (BPA) is a commonly used industrial chemical and is used as a building block (monomer) for the manufacture of polycarbonate plastic (PC) and epoxy resins. Polycarbonates are used to manufacture synthetic glass, CD and DVD blanks, as well as food containers such as cookware for microwave ovens, water dispensers or kettles. BPA-based epoxy resins are used in large quantities in the construction sector (boat and mould-making, pipework). Epoxy resins come into contact with food mainly in the form of protective coatings used in food tins and drinks cans. One additional use of BPA relevant to our everyday lives is the thermal paper used, for example, in the manufacture of till receipts and tickets. In addition, BPA is used in dental sealants, paint coatings, surface coatings, adhesives and electrical appliances.

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Toxicity

Bisphenol A has low acute toxicity. In its current toxicological assessment, the European Food Safety Authority (EFSA) comes to the conclusion that chronic intake of BPA probably has a damaging effect on the kidneys and liver and may cause changes in the mammary glands of rodents. According to currently available data, any possible effects on the reproductive, immune, cardio-vascular and nervous systems or the metabolism were deemed unlikely by EFSA experts. However, these represent factors of uncertainty and were therefore taken into account as part of the re-evaluation.

Bisphenol A is one of a group of substances that can act like hormones (oestrogen), so-called endocrine active substances or compounds (more generally known as “endocrine disruptors”. There has been controversial scientific debate with regard to the effects of such substances on fertility, reproduction and the hormonal system in conjunction with reports about so-called “low dose effects” in rodents.

According to the EFSA re-evaluation, it is not possible to conclude on the basis of the currently available data that BPA actually is an endocrine disruptor according to WHO criteria.

WHO definition according to which a substance must fulfil three criteria in order to be classed as an endocrine disruptor.

  1. the presence of adverse effects;
  2. the presence of endocrine activity; as well as
  3. a plausible causal link between the two.

Tolerable Daily Intake - TDI

BPA has already been evaluated several times by EU committees and TDI (Tolerable Daily Intake) values have been set. The TDI is the estimated amount of a chemical substance that can be ingested daily in the course of a lifetime, without posing a significant health risk.

In early 2015, the EFSA issued a reassessment of BPA, which sets a new temporary TDI of 4 µg / kg body weight / day.  The EFSA has therefore reduced the TDI value by more than a factor of 10. The previously valid TDI was set by the EFSA in 2010 and amounted to 50 µg / kg body weight / day.

No new health concerns over BPA have been identified within the framework of the re-evaluation. The new TDI has been derived from renal effects in mice, already investigated in previous evaluations. A new calculation approach was applied in the re-evaluation (Benchmark-Dose Lower Limit approach or BMDL) and new more accurate data was available, especially in the toxicokinetic field. Furthermore, uncertainties with regard to possible effects on mammary glands, reproductive organs as well as the metabolic, nervous and immune systems were quantified using the new methods and taken into account when calculating the new TDI. This all resulted in the new, lower TDI value.

The EFSA suggests setting the value at 4 µg per kg of body weight per day as a temporary TDI value (t-TDI) since the conclusion and results of research as part of the US National Toxicology Program (NTP) are still expected and these should serve to further remove some of the uncertainties.

The BfR (Federal Institute for Risk Assessment) is helping with the assessments for the EFSA re-Evaluation (German).

Absorption

The maximum total exposure for adults (including women of childbearing age) is estimated, for example, to be 1,063 µg per kg body weight per day. Adolescents have the highest maximum total exposure levels at 1,449 µg per kg of body weight per day. The EFSA is of the opinion that there are no health concerns since the highest estimated value for a combined oral and non-oral exposure to BPA in all age groups is approximately three to four times lower than the new t-TDI value of 4 µg per kg of bodyweight per day.

Food and thermal paper were identified as the most significant sources of exposure to BPA for the European population, though thermal paper plays a role in the case of children, adolescents and adults but not for infants and young children.

Exposure to BPA via food comes about due to the fact that traces of BPA may be transferred into foodstuffs from materials that come into with food (migration). Tinned foods, as well as meat and meat products are the largest contributing factor toward food-related exposure to BPA.

Testing

Testing

Compliance with bans and specified migration limits is monitored continuously in the context of official checks. The food inspection bodies take random or targeted samples which are then tested and assessed in specialist departments at AGES.

In 2012/13 baby bottles, feeding teats and baby soothers were tested for release of BPA. No release of BPA could be determined even under more stringent test conditions (extraction instead of migration).

In 2011 samples were specifically taken from the internal coatings of cans from can manufacturers or wholesalers and tested for the release of BPA and BADGE (Bisphenol A-diglycidyl ether, an epoxy derivative). As a result of these tests traces of BADGE derivatives were found in only one can totalling 0.05 mg/kg (detection limit = 0.002 mg/kg; limit of quantitation = 0,03 mg/kg). The specific migration limit for BADGE is 9 mg / kg food.

In 2009 and 2010, plastic baby bottles were tested for the migration of Bisphenol A into food. As far as the polycarbonate drinking bottles were concerned, the measurement values ranged from around 300 to 1000 times below the limit values valid across the whole of the EU.

Regulations

Bisphenol A is permitted via Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. BPA is permitted for use in the manufacture of materials that come into contact with food and food use objects made of plastic provided the specific migration limit of 600 µg BPA/kg of foodstuff is not exceeded (0.6 mg/kg food).

Usage ban in baby bottles and pacifiers (dummies/soothers)

Commission Regulation (EU) No. 10/2011 prohibits the use of BPA in the manufacture of baby bottles. Via its Regulation published in the Federal Law Gazette (BGBl.) No. 327/2011, the Austrian Ministry of Health has also banned the use of BPA in teething rings and pacifiers (dummies). This ban takes into account the results of tests conducted by AGES and other test institutes which prior to 2011 repeatedly found traces of BPA in such products and complies with the principle of preventive health in protection for infants.

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