This article is provided by BRC Associate Member and Partner, UL Solutions.
Europe has banned bisphenol A (BPA), a substance used in food-contact materials for over a century.
On Dec. 19, 2024, the European Commission adopted European Regulation 2024/3190, which bans the use of BPA in various products intended to contain food and beverages. The approval took place with the full agreement of the European Parliament and the Council.
This is a significant step related to this substance that, over the years, has consistently been the topic of discussions and debates, giving rise to frequent differences of opinion among experts. Classified as toxic to reproduction and due to its endocrine-disrupting properties, BPA was officially identified as a substance of very high concern (SVHC) in 2016, and the European Food Safety Authority (EFSA) and other institutions around the world have continuously assessed its possible effects on the human body.
In 2023, EFSA stated that “BPA in food poses a health risk, constituting a cause for concern for consumers of all age groups” and lowered the tolerable daily intake by 20,000 times, down to just 0.2 nanograms per kilogram of body weight.
The new regulation 2024/3190 also establishes specifications for other bisphenol and derivatives with harmonized classification for specific hazardous properties in certain materials and articles intended to come into contact with foodstuffs.
Where BPA has been used historically
The substance 4,4’-isopropylidenediphenol (Chemical Abstracts Service (CAS) Number 80-05-7), more commonly known as bisphenol A (BPA), has long been used in the production of materials and articles intended to come into contact with foodstuffs: paints and coatings on packaging, large-scale food storage and transportation equipment, epoxy resins in cans, and metal lids for glass jars and bottles, etc.
Due to its ability to migrate into food from the material or object with which the food is in contact, this substance can expose consumers to BPA. The substance was banned for the first time in Europe in 2011 in the production of plastic baby bottles; the ban was subsequently extended in 2018 to packaging made to contain food intended for infants and children under three years of age.
What the new regulation states
Under European Commission Regulation (EU) 2024/3190, the use of BPA and its salts, as well as other hazardous bisphenols and hazardous bisphenol derivatives, is prohibited in the manufacture of the following food-contact materials:
- Plastics
- Varnishes and coatings
- Printing inks
- Adhesives
- Ion-exchange resins
- Silicones
- Rubbers
Certain exemptions have been provided and established considering the extent to which suitable alternatives currently exist while taking into account any potential exposure and any resulting health risks from such applications.
Exceptions specifically concern polysulfone filtration membrane assemblies and epoxy resins to be applied to self-supporting food-contact materials or articles with a capacity greater than 1,000 litres.
The use of other hazardous bisphenols and bisphenol derivatives (those listed in Annex VI, Part 3, of Regulation (EC) No. 1272/2008 as Category 1A or 1B, carcinogenic, mutagenic and/or toxic to reproduction; or Category 1, endocrine-disrupting for human health) is prohibited in the manufacture of food-contact materials and articles unless explicitly authorized. For this point, Article 6 of the Regulation requires EFSA to publish guidelines before Jan. 20, 2027, regarding the information needed in a petition to seek authorization for other hazardous bisphenols and derivatives.
For food-contact articles manufactured using other bisphenols or bisphenol derivatives, a limit on the residual BPA content is set; the meaning of “bisphenol derivative” is clearly defined in the legislation as a substance indicated by the general structure as shown below.
