EU Bans Bisphenol A in Food Contact Materials

EU bans the use of bisphenol A in food contact materials
The European Union published Commission Regulation (EU) 2024/3190 on December 31, 2024, to regulate the use of bisphenol A (BPA) and other bisphenols in food contact materials and products. This regulation amends the Regulation (EU) No 10/2011 and repeals the previous Regulation (EU) 2018/213 on the use of BPA in varnishes and coatings, in order to provide a more comprehensive and updated regulatory framework.

Summary of Regulation on Bisphenol A (BPA) and other bisphenols and bisphenol derivatives in Food Contact Materials:

The Regulation applies to all materials and articles that come into contact with food, including varnishes, coatings, plastics and other products that may contain bisphenols and their derivatives. It specifically targets substances that are considered as hazardous under CLP Regulation, especially bisphenol A (BPA), due to its endocrine disrupting properties and potential health risks.

The regulation prohibits the use of BPA and its salts in the manufacture and placing on the market of food contact materials and articles as well as the presence of residual BPA from articles using other bisphenol or bisphenol derivative.

This ban applies to the following materials:
a.    Adhesives
b.    Rubbers
c.    Ion-exchange resins
d.    Plastics
e.    Printing inks
f.    Silicones
g.    Varnishes and coatings

By derogation, BPA and its salts may still be used in the manufacture of food contact materials and articles for specific applications under specific conditions described in Annex II of the Regulation, as shown below: 

The use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of food contact materials and articles and the placing on the market of food contact materials and articles manufactured using hazardous bisphenols other than BPA or hazardous bisphenol derivatives are also prohibited. Article 5 of the Regulation is providing some derogation rules

BPA (substance 151) and BPS (substance 154) are removed from table 1 /Annex I of Regulation 10/2011 (Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids)

Article 9 of the Regulation is providing some rules for the verification of the compliance.
Test methods used to verify that a food contact material/article does not contain BPA, another hazardous bisphenol or a hazardous bisphenol derivative (cf prohibition) or does not release those substances into food (cf annex II) should allow to target a detection limit of 1 µg/kg. 
Some consultations will be done with European Union Reference Laboratories to identify suitable test methods.

Business operators are required to create a Declaration of Compliance (DoC) that contains:

• The name, address, and contact information including either a phone number or email address of the operator issuing the declaration.
• The name, address, and contact information either a phone number or email
  address of the manufacturer or importer.
• Identification of the food contact materials or articles, including both intermediate and final products.
• The date of the declaration. 
• A list of bisphenols or their derivatives used in the food contact article.
• A statement complies to this Regulation and requirements set out in articles 3, 15 and 17 of EC 1935/2004.

Transitional Period
Article 11 is describing various transitional periods. 
As an example, Repeat-use final food contact articles manufactured with BPA that are compliant with applicable rules before January 20, 2025, may be first placed on the market until July 20, 2026, and remain on the market until January 20, 2029, at the latest.

Additional information:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202403190 

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