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, the European Food Safety Authority (EFSA) published a new evaluation of BPA’s safety, significantly reducing the tolerable daily intake set in its previous assessment.1
Prompted by the new evaluation, the European Commission is set to ban the use of bisphenol A in food contact materials in 2024.2 While the ban is not in place yet, existing EU regulations prohibit bisphenol A’s use in some cases and limit its migration into food, toys, and drinking water in others. Compliance with these limitations can be verified through 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 2020.3
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.4
On 8 July 2021, bisphenol A was included on the REACH Candidate List of substances of very high concern (SVHC) due to its endocrine-disrupting properties for human health and adverse effects on the environment.5
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.6
Restrictions on BPA in food contact materials
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.7
As per EFSA's new risk assessment, the use of bisphenol A in food contact materials will likely be banned entirely in the near future, except for use as a precursor to BADGE in heavy-duty varnishes and a monomer for polysulfone resins in filtration membranes.
When the ban takes effect, companies that produce BADGE-based coatings and polysulfone resins will need to have their products tested for BPA. Due to the risk of contamination, the testing requirement also applies to paper and board FCMs that contain recycled fiber. In their case, 5% of batches will need to be tested as a precaution.8
Materials in contact with water
According to the updated Drinking Water Directive (EU) 2020/2184, bisphenol A can be used as a starting substance or additive in plastic materials that come into contact with drinking water, but its concentration at the tap must not exceed 2.5 μg/l.9 Such materials must be tested to ensure that they do not cause BPA to migrate into water in higher concentrations.
Limits on BPA in toys and cosmetics
The Toy Safety Directive 2009/48/EC sets a strict limit of 0.04 mg/l for bisphenol A migration from toys intended for children under the age of three or intended to be placed in the mouth. Migration is to be tested by the EN 71-10 and EN 71-11 harmonized standards.10
Bisphenol A is also listed as a prohibited substance for cosmetics in the EU Cosmetics Regulation (EC) No 1223/2009.11 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 offer BPA testing options for environmental samples, cosmetics, toys, consumer products, and various other sample materials. You can read more about bisphenol A content determination or request a quote from our experts through the form below or at info@measurlabs.com.
References:
1 EFSA: Bisphenol A in food is a health risk
2 European Commission: Draft regulation on banning the use of BPA in food contact materials. Adoption is planned for the first quarter of 2024.
3 Bisphenol A in everyday products: Answers to frequently asked questions by the German Federal Institute for Risk Assessment (BfR)
5 The ECHA Candidate List of substances of very high concern for Authorisation
6 Note the European Medicines Agency (EMA) disagrees with the new TDI, and work to rectify the opinions of EFSA and EMA is ongoing.
7 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. See also German BfR's Recommendation XXXVI on paper and board FCMs.
8 See Article 3 in the draft regulation on banning BPA and restricting the use of other bisphenols and bisphenol derivatives in FCMs.
9 The chemical parameters are detailed in Annex I, Part B, of Directive (EU) 2020/2184. 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.
10 See Appendix C of the consolidated version of the Toy Safety Directive.
11 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.