Bisphenol A (BPA) is a chemical substance used to manufacture some plastics and resins. Although it has been used in food packaging for decades, BPA has been under renewed scrutiny in recent years due to gaps in older scientific studies. In April 2023, EFSA published a new evaluation of BPA’s safety, significantly reducing the tolerable daily intake set in its previous assessment.1
While EFSA’s updated evaluation is not incorporated into EU legislation yet, existing EU regulations ban bisphenol A’s use in some cases and limit its migration into food and drinking water in others. Compliance with these limitations can be verified with laboratory testing.
What is bisphenol A?
Bisphenols are a large family of chemical compounds. BPA is a widely used member of the group and is manufactured on an industrial scale by the condensation reaction of phenol and acetone. Today BPA is primarily used as a starting material to produce polycarbonate plastics and epoxy resins. Previously it was used in thermal paper, such as for sales slips, parking tickets, and parcel labels, before being banned in January 2020.2
Health concerns relating to bisphenol A migration
According to the EU’s harmonized classification and labeling regime, BPA in its pure form may damage fertility, is very toxic to aquatic life with long-lasting effects, causes serious eye damage, and may cause an allergic skin reaction and respiratory irritation.3
On 8 July 2021, bisphenol A was included on the REACH Candidate List of substances with very high concern (SVHC) due to its endocrine-disrupting properties for human health and the environment.4
The primary source of exposure to bisphenol A for most people is through diet, as BPA can leach into food and drinks from polycarbonate bottles and internal epoxy resin coatings of cans and containers.
In April 2023 EFSA published a re-evaluation of BPA’s safety based on new scientific data and research. This re-evaluation set a tolerable daily intake (TDI) of 0.2 nanograms per kilogram of body weight per day, significantly lower than the old level of 4 micrograms per kilogram of body weight per day.5
Restrictions on BPA in food contact materials, water, and cosmetics
Regulation (EU) No 10/2011 states BPA may not be used to manufacture polycarbonate infant feeding bottles or cups designed for infants and young children, such as spill-proof drinking containers. It may be used as a starting substance for other food contact materials, but migration into food must not exceed the specific migration limit (SML) of 0.05 mg/kg.6
Additionally, the updated Drinking Water Directive (EU) 2020/2184 requires water intended for human consumption to have a maximum of 2.5 μg/l of bisphenol A.7 Member States must comply with these standards by 12 January 2026.8 Polymeric materials in contact with drinking water must be tested to ensure that they do not cause BPA to migrate into water in higher concentrations.
The current BPA migration limits are based on EFSA’s old risk assessment from 2015. If the new opinion from 2023 is incorporated into law, the thresholds will be significantly lower in the future.
Bisphenol A is also listed as a prohibited substance for cosmetics in the EU Cosmetics Regulation, Regulation (EC) No 1223/2009.9 For cosmetic products to be marketed in the EU, they must undergo a safety assessment that includes information on possible traces of BPA and other prohibited substances.
Bisphenol A analysis by EU regulations
Compliance testing relating to the aforementioned restrictions can be performed using liquid chromatography-mass spectrometry (LC-MS). Measurlabs’ epoxy derivative and bisphenol test package for food contact materials includes bisphenol A and other related substances that restrictions apply to.
In addition to FCMs, we can offer BPA testing options for environmental samples, cosmetics, consumer products, and various other sample materials. You can ask our experts for more information through the form below or by emailing us at email@example.com.
2 Bisphenol A in everyday products: Answers to frequently asked questions by the German Federal Institute for Risk Assessment (BfR)
4 The ECHA Candidate List of substances of very high concern for Authorisation
5 Note the European Medicines Agency (EMA) disagrees with the new TDI, and work to rectify the opinions of EFSA and EMA is ongoing.
6 BPA is listed in Annex I of Commission Regulation (EU) No 10/2011 under FCM substance No 151 and substance name 2,2-bis(4-hydroxyphenyl)propane.
7 The chemical parameters are detailed in Annex I, Part B, of Directive (EU) 2020/2184.
8 Article 25 of Directive (EU) 2020/2184 says the Member States must have the necessary measures in place to ensure water intended for human consumption meets the new parametric values by 12 January 2026.
9 Annex II of Regulation (EC) No 1223/2009 includes the list of substances prohibited in cosmetic products. Bisphenol A is found under reference number 1176.