EU bans BPA in Food Contact Materials: what does it mean for industry?
JM
On 20 January 2025, a new EU Regulation banning BPA and its salts in Food Contact Materials (FCMs) entered into force.1 The regulation aims to minimise consumer dietary exposure to BPA as much as possible, considering the potential of BPA to migrate into food and beverages.
The ban does not come as a surprise; it follows a scientific re-assessment of the safety of BPA from the European Food Safety Authority (EFSA), published in April 2023, which concluded that BPA has "potential harmful effects on the immune system". EFSA highlighted reproductive, developmental, metabolic, and immune system effects associated with BPA exposure and proposed a reduction of the tolerable daily intake (TDI) of BPA by 20,000 times compared to the TDI established in its previous safety assessment in 2015, ten years ago.
To address the challenges for industry of moving away from BPA-based FCMs, certain transition periods will apply to certain types of BPA containing FCMs to help companies adapt their products to the new requirements.
What does the ban entail?
The key elements of the Regulation are the following:
A broad EU-wide ban on BPA and other bisphenols in various FCMs and articles. The use of BPA and its salts would be prohibited in the manufacture of plastics, varnishes, coatings, printing inks, adhesives, ion-exchanging resins, silicones and rubbers coming into contact with food;
Where no suitable alternatives are available, BPA as a monomer or starting substance in the manufacture of plastics, varnishes and coatings, will continue to be allowed, to the extent that migration into food is at a non-detectable level and that finished food articles are cleaned and flushed prior to being brought into food contact. These limited applications are listed in Annex II to the Regulation and include:the use of BPA in polysulfone resins which are used in the manufacture of either separation membranes for micro- and ultra-filtration, or as a microporous support of thin-film separation membranes for nano-filtration or reverse osmosis. These processes are critical in the production of a wide range of foods, including dairy-based foods, to filter out pathogens including contaminants such as heavy metals and pesticides; and
the use of BPA in liquid epoxy based varnishes and coatings, such as those cured onto the surface of large tanks and vessels as well as large capacity piping interconnecting these containers used in the processing, storage and transport of food, including beers, oils, dairy products and cereal grains;
Economic operators using BPA, other hazardous bisphenols or hazardous bisphenol derivatives listed in Annex II must report to the Commission on the status of alternative substances. This is voluntary for micro, small and medium-sized enterprises (SME);
Authorization is required for the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of FCM and articles for specific applications;
A written Declaration of Conformity (DoC) must accompany all marketing stages other than the retail stage for FCM and articles which are not yet in contact with food, as well as bisphenols and bisphenol derivatives intended to be used as monomers or other starting substances in the production of these products and indicate whether or not BPA or other relevant bisphenols or bisphenol derivatives have been used in the manufacture of the FCM/article (Annex III); and
Economic operators should carry out regular testing and ensure compliance with applicable migration limits for BPA laid down in Regulation (EU) No 10/2011 for plastic FCMs/articles.
Transition periods
As mentioned, to address the challenges of moving away from BPA-based FCMs, transition periods are introduced to help companies adapt their products to the new requirements:
An 18-month transition period applies to single-use final food contact articles and repeat-use final food contact articles manufactured using BPA. These may be placed on the market until 20 July 2026.
A longer, 36-month, period (until 20 January 2028) applies to the following items:
single-use final food contact articles intended for the preservation of certain fruits, vegetables and fish;
single-use final food contact articles on which a varnish or coating manufactured using BPA has only been applied to the exterior metal surface; and
repeat-use final food contact articles used in professional food production equipment.
Stocks of single-use final food contact articles containing BPA that were manufactured before 20 January 2025 and were placed on the market until 20 July 2026 or 20 January 2028 by virtue of the above applicable transitional periods, can continue to be filled with food and sealed for one year after the end of the applicable transitional period (until 20 July 2027 or 20 January 2029). The resulting packaged food may be placed on the market until stocks are exhausted, in order to avoid food waste and disruption of food supply chains.
Stocks of repeat-use final food contact articles containing BPA that were manufactured before 20 January 2025 and were placed on the market until 20 July 2026 or 20 January 2028 by virtue of the above transitional periods, can remain on the market for further distribution, sale, etc. until 20 January 2029. Repeat-use food contact articles in professional food production equipment can continue to be used by food businesses until the articles cease to be functional and need to be replaced.