Regulatory Situation and Human Exposure of Bisphenol A in Europe

Manufacturers mainly use the synthetic chemical Bisphenol A (BPA) in industrial processes. They employ it to produce polymers like polycarbonate plastics (e.g., tableware, reusable beverage bottles, storage containers) and epoxy resin for coating food and beverage cans, toys, thermal papers, and pipes for drinking water.

The European Chemicals Agency (ECHA) classified Bisphenol A as a hazardous chemical in the EU due to its ability to:

• Damage fertility and disrupt the hormonal systems (endocrine disruptor);
• causes serious eye damage;
• may cause an allergic skin reaction;
• may cause respiratory irritation.

Regulatory Situation of Bisphenol A in Europe

In the EU, BPA is authorized for use as a monomer in plastic Food Contact Materials (Commission Regulation (EU) 10/2011). However, there are restrictions in place. These restrictions include a specific migration limit (SML) of 0.05 mg/kg. Importantly, this SML also applies to coated Food Contact Materials. A prohibition of BPA in FCMs specifically for infants and young children also applies based on the precautionary principle. SML and prohibitions applied from September 6, 2018 (except for polycarbonate infant feeding bottles, which ban began in 2011).

In April 2023, EFSA published its latest scientific opinion which re-evaluated the risks of public health due to BPA exposure. It set a new TDI (Tolerable Daily Intake: a safe amount for lifetime daily intake). The Plain Language EFSA summary recaps the outcomes as follows:

• EFSA established a new TDI of 0.2 ng/kg body weight per day (0.2 ng is 0.2 nanograms or 0.2 billionths of a gram).
• This new TDI is 20,000 times lower than the previous TDI of 4 μg/kg body weight per day.
• Estimated dietary exposure to BPA from 2015 EFSA opinion is two to three orders of magnitude higher than the new tolerable level of 0.2 ng/kg body weight per day.
• BPA levels far higher than the new TDI are a health concern for all age groups of the general population.
• EFSA’s  scientific  advice  on  BPA  will  inform  future  discussions  among  EU  lawmakers  on  the measures to take to protect consumers.

The German Federal Institute for Risk Assessment (BfR) does not support the new TDI derived by EFSA due to several scientific and methodological inconsistencies within the reassessment (BfR statement no. 018/2023 of April 19, 2023).

EEA Recent Briefing on Human Exposure to Bisphenol A in Europe

The European Environment Agency (EEA) published a briefing on human exposure to BPA on September 14, 2023. This briefing considers recent harmonized human biomonitoring data from the European human biomonitoring initiative (HBM4EU). The data examines chemical occurrence in the European population and its health impacts. The EEA briefing highlights that Europeans are exposed to a very high concentration of BPA. The briefing relies on measurements of BPA concentrations in the urine of 2,756 individuals from 11 European countries. In the case of 92% of the participants, their urine contained BPA concentrations that exceeded the safe health thresholds. This gives rise to notable health concerns for the broader population in the EU. The briefing also contains the potential health risks individuals may face when exposed to unsafe levels of BPA.

The EEA briefing also pointed out that despite significant focus and implementation of numerous regulatory measures, biomonitoring data indicate that BPA exposure remains excessively high and presents a potential health risk. Consequently, the European Commission has expressed its intention to propose a ban on the use of Bisphenol A and other bisphenols in food contact materials. This proposal is anticipated to be ready by the first quarter of 2024.

Mérieux NutriSciences can Help Ensure your Products’ Safety from Bisphenol A Contamination and Enhance Marketability

Mérieux NutriSciences offers the analysis of Bisphenol A, F and S in food and packaging.

Our accredited laboratories with many years of analytical experience and our experts can support you to manage the risk of BPA in your packaging and in your final products.

With our state-of-the-art laboratory instrumentation and qualified experts, we developed a new method accredited and validated for different food matrices. 

We are ISO17025 accredited for the analysis of BPA in foods like coffee, meat, fish, milk, fruits and vegetables, deli products, cereals, non-alcoholic and alcoholic beverages, bakery and pastry, oils and fats, sugar, Infant food, chocolate, etc.

Our method is very sensitive to determine BPA even in the ultra-trace range to verify that your products and that of your suppliers comply with the TDI value recommended by EFSA. We provide you with comprehensive support for timely and accurate analysis of BPA to identify its entry route in your production process to ensure the safety and marketability of your food and also ensure regulatory compliance.