A new Regulation – (EU) 2018/213 – on bisphenol A (BPA for short) was published by the European Commission earlier this month. It requires manufacturers of food packaging materials to further limit the maximum concentration of BPA in plastic containers and therefore reducing the migration of the substance into foods.

What is BPA used for?

Bisphenol A is frequently used in the food packaging industry to produce certain plastic items, including water bottles and bottles for infants. It is also used to produce can-coatings as well as varnishes.

What are the effects of BPA?

The molecule has a number of effects on the human body as well, which put it in the focus of a number of organizations and governments, including the European food Safety Authority (EFSA). Bisphenol A is a xenoestrogen, i.e. mimicking the hormone estrogen. It is considered an endocrine disrupter. According to the US National Institute of Health, such substances can cause cancerous tumors, birth defects and other developmental disorders. As such, Bisphenol A falls into the same category as dioxins, polychlorinated bisphenyls and DDT . The U.S. Department of Health and Human Services produced a monograph on the potential human reproductive and developmental effects of Bisphenol A in 2008. One of its key findings was “some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to Bisphenol A.”

In short, there is a concern that exposure above certain levels of Bisphenol A has detrimental effects on human health, and in particular on the development of fetuses, infants and children.

What are the Regulations in Europe?

In Europe, EFSA also attempted to carry out an exposure assessment, but data were, as usual, scarce. Based on the available information, a specific migration limit (SML) of 600 mg/kg was written into European legislation in January 2011 (European Commission Regulation (EU) 10/2011).

In the meantime, further studies have been conducted, a total of 13 between 2009 and 2017. Several of these suggest that this limit is significantly too high. However, most of the studies are based on animals, and it is arguable if the same results would be obtained in human studies.
In 2015, EFSA conducted a review of Bisphenol A toxicity. It came to the conclusion that “BPA might affect the immune system of animals but the evidence is too limited to draw any conclusions for human health.”

And it will come as no surprise that EFSA will re-evaluate Bisphenol A again in 2018, ensuring its panel stays busy. If the new evaluation comes to different conclusions than the previous ones remains to be seen. We may learn about it in 2019 or 2020.

What are the changes in the new Regulation?

The European Commission does not want to wait that long and introduced a new regulation to lower the specific migration limits for Bisphenol A and extend this not only to plastics, but also can coatings and varnishes. The European Regulation (EU) 2018/213 reduces the Specific Migration limit for Bisphenol A from 600 mg/kg food by a factor of 12 to 50 mg/kg food. For food contact materials that are intended to come into contact with foods for infants and young children, the new regulation essentially prohibits the use of BPA:

“no migration of BPA shall be permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.”

The food packaging industry has time until September 2018 to implement the changes in order to comply with this regulation.