EU to Completely Ban BPA Starting in 2025, Two-Year Transition Period

On December 31, 2024, the EU Official Journal officially announced the BPA ban (EU) 2024/3190, which further amends the plastics regulation (EU) 10/2011 and simultaneously repeals (EU) 2018/2013. This ban will officially come into effect on January 20, 2025, marking a comprehensive prohibition on the use of Bisphenol A (BPA) by the EU and its member states.

BPA (Bisphenol A, CAS No. 80-05-7) has been confirmed to possess various hazardous characteristics, including reproductive toxicity, adverse effects on children, and hormone-like effects. According to the latest scientific opinion released by the European Food Safety Authority (EFSA) in April 2023, dietary exposure to BPA is considered unsafe, with the tolerable daily intake (TDI) set at 0.2 ng/kg body weight, which is 20,000 times lower than the assessment made in 2015. Based on EFSA's assessment, the European Commission has established a ban on BPA.

The ban requires the prohibition of BPA and its salts in food contact materials, including their use in the manufacturing of adhesives, rubber, ion exchange resins, plastics, printing inks, silicones, and varnishes and coatings. Additionally, food contact materials and products made using BPA are prohibited from being placed on the EU market.

Furthermore, the use of other bisphenols or bisphenol derivatives is also prohibited in the manufacturing and sale of food contact materials (FCM), unless special authorization is obtained, ensuring no BPA residues remain.

Specific exemptions are as follows:

• Varnishes and Coatings: Limited to use as monomers or starting substances for the production of liquid epoxy resins, applicable to self-supporting food contact materials or items with a capacity exceeding 1,000 liters. These items must be cleaned and rinsed before first contact with food and must not transfer substances into the food.
• Plastics: Limited to use as monomers or starting substances for manufacturing polysulfone filtration membrane components.

The revised plastics regulation (EU) 10/2011 adds restrictions on the use of BPA and other harmful bisphenols or bisphenol derivatives in Article 6 under "Exemptions Not Included in the EU List of Substances." It also removes entries for substance 151 BPA and substance 154 BPS (CAS: 80-09-1) from Appendix I, Table 1.

The transition period provisions are as follows:

Single-use Food Contact Materials and Products: May continue to be sold until July 20, 2026. Special products, such as those for preserving vegetables or fruits (excluding products defined in Council Directive 2001/112/EC Annex I) or seafood (as defined by Regulation (EC) No. 853/2004), may continue to be sold until January 20, 2028. Products with coatings or varnishes made using BPA on their metal outer surfaces may also be sold until this date.

Reusable Food Contact Materials and Products: May first be placed on the market until July 20, 2026. Reusable food contact items used in professional food production equipment, which comply with the rules applicable before this regulation comes into effect, may first be placed on the market until January 20, 2028. The aforementioned two types of reusable food contact materials and products may remain on the market until January 20, 2029.

The declaration of conformity must include the following information:

• The identity, address, and contact details of the operator issuing the declaration of conformity, including a current phone number or email address;
• The identity, address, and contact details of the manufacturer or importer of food contact materials and products, including a current phone number or email address;
• The name information of intermediate materials or final products;
• The date of the declaration;
• A list of bisphenols or bisphenol derivatives used in the manufacture of food contact materials and products;
• Confirmation that intermediate materials and final products comply with this regulation and Articles 3, 15, and 17 of (EC) No 1935/2004.