Risk assessment of food contact materials

Bisphenol A (BPA) is authorised for use as a chemical compound for the production of plastic food contact materials (FCMs) under Regulation (EU) No 10/2011. But according to requirements of the Regulation (EU) No 2018/213, BPA has been banned in the manufacture of polycarbonate drinking cups or feeding bottles intended for infants and young children. Food has been identified as the main source of human exposure to BPA, followed by dermal absorption, air and dust inhalation, revealing ubiquitous and continuous contact with BPA. Considering that BPA is able to enter the food chain through the migration from food packaging into foodstuffs, assessment of dietary exposure is necessary for accurate estimations and identification of potential exposure from food sources. In 2015, EFSA set a temporary tolerable daily intake (TDI) for BPA of 4 μg/kg body weight (bw) per day and concluded that no health concern from BPA exposure for any age group was to be expected. In 2023, EFSA has re-evaluated BPA safety and the new TDI was reduced by a factor of 20,000 resulting in a TDI of 0.2 ng/kg bw per day. In this case, the CEP Panel concluded that there is a health concern from dietary exposure to BPA. Amongst others, the BfR identified several points of criticism which, in the opinion of the BfR, call into question the risk assessment carried out by EFSA. The BfR derived a TDI of 200 ng/kg bw per day and suggests taking this into account for risk assessment. In the proposed EU-FORA programme, the fellow had the opportunity to gain experience in the exposure assessment and then integrate the data together with the BfR hazard assessment to perform a comprehensive risk assessment. As second objective of the work programme, the fellow was in charge of performing a toxicokinetic analysis in an attempt to correlate external exposure with urinary BPA levels.