New Restrictions on the Use of Bisphenol A: What You Need to Know

On December 31, 2024, the European Commission published Regulation (EU) 2024/3190 in the Official Journal, which regulates the use of Bisphenol A (BPA) and other similar substances in materials that come into contact with food.

This Regulation, dated December 19, 2024, will come into force on January 20, 2025.
From this date, the use of BPA and its salts in the manufacturing of food contact materials from the following product families will be prohibited:

• Plastics
• Adhesives
• Varnishes and coatings
• Printing inks
• Ion-exchange resins
• Silicone
• Rubber

To verify that a material or object intended for food contact does not contain BPA, any other bisphenol, or any dangerous derivatives of bisphenol, an extraction method will be used. Such methods will have a detection limit of 1 μg/kg (1 ppb).

There are very limited exceptions to the BPA ban, which are listed in Annex II. For these exceptions, the Regulation requires the submission of periodic reports on the development of alternatives and a Declaration of Conformity (DoC).

The use of other bisphenols and dangerous bisphenol derivatives (listed in Annex VI, Part 3 of Regulation (EC) No 1272/2008 as carcinogens, mutagens, category 1A or 1B reproductive toxicants, or category 1 endocrine disruptors for human health) is also prohibited, unless specifically authorized.

Article 6 of the Regulation requires the EFSA to publish guidelines on the information that must be included in an authorization request for other bisphenols/dangerous derivatives before January 20, 2027.

Article 10 of this Regulation amends the Regulation on plastics by removing BPA (FCM 151) and BPS (FCM 154) from Annex I.

EXCEPTIONS ANNEX II

The intentional use of BPA and its salts in the manufacture of food contact materials for specific applications set out in Annex II is allowed, subject to the restrictions laid out in the same.

Varnishes and coatings → Use as a monomer or starting substance in the manufacture of liquid epoxy resins for application in self-supporting materials or articles in contact with food with a capacity of more than 1000 L.

Plastics → Use as a monomer or starting substance in the manufacture of polysulfone filtration membrane assemblies.

In both cases, migration to food must be non-detectable, ND 1 µg/kg (1 ppb). Final articles that come into contact with food must be cleaned and rinsed before being used for food contact for the first time.

Articles 11 and 12 set different transition periods for food contact materials and articles made with BPA (these provisions do not apply to food contact materials made with BPS).

Article 11. Transition Provisions for Single-Use Final Articles

1. Single-use final articles intended for food contact that have been made using BPA, and that comply with applicable standards before the entry into force of this Regulation but do not comply with its provisions, may continue to be marketed until July 20, 2026.
2. Notwithstanding paragraph 1, the following single-use final articles intended for food contact that meet applicable standards before the entry into force of this Regulation but do not comply with its provisions may continue to be marketed until January 20, 2028.

a) Single-use final articles intended for food contact for the preservation of the following food products:

i) Fruits and vegetables, except for products defined in Annex I of Directive 2001/112/EC of the Council, or

ii) Fish products, as defined in Regulation (EC) No 853/2004 of the European Parliament and Council;

b) Single-use final articles intended for food contact where only the external metal surface has been coated with a varnish or coating made with BPA.

3. Single-use final articles intended for food contact that are marketed in accordance with paragraphs 1 and 2 may be filled with food and sealed within twelve months after the applicable transition period ends. The resulting packaged food may be marketed until stocks are consumed.

Article 12. Transition Provisions for Reusable Final Articles

1. Reusable final articles intended for food contact made using BPA that comply with applicable standards before the entry into force of this Regulation but do not comply with its provisions may be introduced to the market for the first time until July 20, 2026.
2. Notwithstanding paragraph 1, reusable final articles intended for food contact that are used as professional equipment for food production, and that comply with applicable standards before the entry into force of this Regulation but do not comply with its provisions, may be introduced to the market for the first time until January 20, 2028.
3. Reusable final articles intended for food contact that have been introduced to the market for the first time in accordance with paragraphs 1 and 2 may remain on the market until January 20, 2029.

Bisphenol Analysis

At AIMPLAS, we conduct analysis of Bisphenol A, Bisphenol S, Bisphenol F, Bisphenol B, and Bisphenol AF, and continuously work to reduce our detection limits using high-resolution chromatographic techniques.

Additionally, we provide consulting services to companies to ensure compliance with various regulations and protocols in the plastics materials sector. Feel free to contact us if you have any questions about the analyses we offer or the applicable legislation for your products.