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Bisphenol A in Everyday Products: Answers to Frequently Asked Questions

BfR FAQ of 16 December 2021

The plastic polycarbonate, which is used in house and vehicle construction, in consumer products such as DVDs and smartphones, as well as in food packaging and bottles, is made from the substance bisphenol A. Bisphenol A is also used in the production of internal coatings for beverage and food cans. Until the ban at the beginning of 2020, bisphenol A was also used in thermal papers.

In July 2016, bisphenol A was classified as toxic to reproduction by the European Chemicals Agency and, based on this classification, was identified in January 2017 as a Substance of Very High Concern (SVHC) according to the REACH Regulation. The REACH Regulation is the currently valid European chemicals law. "REACH" stands for registration, evaluation, authorisation and restriction of chemicals.

In June 2017, the substance was again identified as an SVHC due to its properties as a so-called endocrine disruptor for human health, and in 2018, it was identified as SVHC for being an endocrine disruptor for the environment. Endocrine disruptors are substances that can cause damage by acting similar to hormones.

The European Food Safety Authority (EFSA) has reassessed possible health risks associated with the use of bisphenol A and published the result in December 2021. The tolerable daily intake (TDI) of bisphenol A newly derived by EFSA is 0.04 nanograms per kilogram of bodyweight per day. The TDI value indicates the amount of a substance that can be taken up daily over an entire lifetime without any noticeable health risk. The new value is around 100,000 times lower than the provisional (temporary) health-based guidance value previously given by EFSA. For people of all ages, the intake of bisphenol A from food and other sources exceeds this new value - although the total intake in the population has been declining for years.

Numerous new studies have been published since EFSA's temporary TDI was published in 2015. The background to the lowering of the TDI by EFSA is above all evidence from studies on mice that an intake of bisphenol A by the dams (the mother animals) during gestation and in the first period after birth can lead to changes in cell counts in the specific immune system of their progeny. To what extent these effects on the immune system are detrimental to the organism concerned (mouse) and whether the results can be transferred to humans is, in the opinion of the BfR, currently still an unresolved scientific question. A causal relationship between bisphenol A intake and immunological effects in humans cannot be confirmed by studies in humans so far.

The BfR will comment on EFSA's statement after a comprehensive review.

The use of bisphenol A in the manufacture of polycarbonate infant bottles was banned across the EU back in 2011. The ban was generally extended to polycarbonate drinking vessels and bottles for infants and young children in 2018. A limit for the transfer of bisphenol A into food was set for all other plastic food contact materials as well as for internal coatings made of epoxy resin for canned food on the basis of EFSA's TDI from 2015.

Below, the Federal Institute for Risk Assessment (BfR) answers frequently asked questions on bisphenol A.

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16.12.2021
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Bisphenol A in Everyday Products: Answers to Frequently Asked Questions 109.4 KB
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