EU Regulates BPA and other Bisphenols in Certain Food Contact Materials

SafeGuardSHardgoodsJan 16, 2025

SG 005/25

The European Union (EU) has issued a comprehensive piece of legislation on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives in certain food contact materials (FCM) and articles. The new law will enter into force on January 20, 2025.

On December 31, 2024, the EU issued Commission Regulation (EU) 2024/3190 (the Regulation) on the use of BPA (CAS 80-05-7) and other bisphenols and bisphenol derivatives with harmonized classification for specific hazardous properties in certain FCM and articles.

This new law also revises Regulation (EU) No 10/2011 on food contact plastics and repeals Regulation (EU) 2018/213 on the use of BPA in varnishes and coatings.

Highlights of the Regulation are summarized in Table 1.

Section to Commission Regulation (EU) 2024/3190	Highlights
Article 1 ‘Subject matter and scope’	Establishes specific requirements for BPA, its salts and other hazardous bisphenols and hazardous bisphenol derivatives in the manufacture of the following FCM and articles: Adhesives Ion-exchange resins Plastics Printing inks Rubber Silicones Varnishes and coatings Sets requirements for BPA content in FCM and articles which have been produced using another bisphenol or bisphenol derivative
Article 2 ‘Definitions’	Provides several definitions, including but not limited to: ‘Bisphenol’ – a substance consisting of two hydroxyphenyl functional groups connected by one-bridging atom (structure A to Annex I) and includes BPA salts ‘Bisphenol derivative’ – a substance indicated by general structure B to Annex I, but does not include the salt of a bisphenol ‘Hazardous bisphenol or hazardous bisphenol derivative’ – a bisphenol or bisphenol derivative with harmonized classification as carcinogenic, mutagenic or toxic to reproduction (CMR) category 1A or 1B, or endocrine disrupting for human health category 1 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, consolidated version to December 2023 for reference)
Article 3 ‘Prohibition of the use of BPA’	Prohibits BPA and its salts in the manufacture of FCM and articles other than the specified applications and specifications in Annex II (see Table 2 below)
Article 4 ‘Prohibition on the presence of BPA in FCM and articles for which other bisphenols or bisphenol derivatives are used in their manufacture’	Prohibits residual BPA if another bisphenol or bisphenol derivative is used in the manufacture of FCM and articles
Article 5 ‘Prohibition of the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives’	Unless exempt or authorized, the use of hazardous bisphenols other than BPA, or hazardous bisphenol derivatives in the manufacture of FCM and articles and placing on the market of such products, is prohibited
Article 6 ‘Authorization for the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of FCM and articles for specific applications’	An application for authorization in accordance with Article 9 to Regulation (EC) No. 1935/2004 (consolidated version to March 2021) must be submitted for the use of such substance(s) for a specific application
Article 7 ‘Reporting obligations concerning alternatives to BPA, hazardous bisphenols and hazardous bisphenol derivatives laid down in Annex II’	Economic operators using BPA, other hazardous bisphenols or hazardous bisphenol derivatives listed in Annex II (see Table 2 below) must provide the status of alternative substances to the Commission. This is voluntary for micro, small and medium-sized enterprises (SME) This information must be made available to the commission within five years after the date from which the use of hazardous bisphenol or hazardous bisphenol derivative is authorized in the manufacture of a specific food contact application
Article 8 ‘Declaration of compliance (DoC) and supporting documentation’	A written 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 a list of bisphenols or bisphenol derivatives intended to be used as monomers or other starting substances in the manufacture of these products (Annex III)
Article 9 ‘Verification of compliance with the requirements of this Regulation’	Select appropriate test methods in accordance with Article 34 to Regulation (EU) 2017/625. The following additional rules apply for the selection of methods used to verify a FCM or article that does not contain BPA, another hazardous bisphenol or a hazardous bisphenol derivative, or does not release those substances into food above the specified detection limit (DL) or specific migration limit (SML): A method developed or recommended by the European Union Reference Laboratory (EURL) for FCM must be used A method must have a DL of 1 µg/kg, unless a different DL has been defined under Annex II, or as part of the method indicated in the sub-bullet point above An extraction method must be used to verify that a FCM or article does not contain BPA, another hazardous bisphenol or a hazardous bisphenol derivative Test results and compliance with a migration limit are in accordance with Regulation (EU) No. 10/2011 on food contact plastics
Article 10 ‘Amendment to Regulation (EU) No. 10/2011’	Amends Regulation (EU) No 10/2011 (consolidated version to August 2023) on food contact plastics by: Deleting FCM substance numbers 151 (BPA) and 154 (bisphenol S, BPS) Emphasizing that BPA and other hazardous bisphenols or hazardous bisphenol derivatives falling under the Regulation may only be used in the manufacture of food contact plastics with that piece of legislation.
Article 11 ‘Transitional provisions concerning single-use final food contact articles’	Single-use final food contact articles manufactured with BPA that are compliant with applicable rules before January 20, 2025 (date of entry into force of the Regulation), may be placed on the market until July 20, 2026 Subject to compliant with applicable rules before January 20, 2025, the following single-use final food contact articles may be placed on the market until January 20, 2028: Those for the preservation of fruits and vegetables or fishery products Those where a varnish or coating manufactured using BPA has only been applied to the exterior metal surface
Article 12 ‘Transitional provisions concerning repeat-use final food contact articles’	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
Article 13 ‘Repeal’	Repeals Regulation (EU) 2018/213 on the use of BPA in food contact varnishes and coatings, and amending Regulation (EU) No 10/2011 in relation to the use of BPA in food contact plastics

Table 1

Substance	Scope	Specific Application	Other Restrictions
BPA	Varnishes and coatings	As monomer or starting substance in liquid epoxy resins to be applied on self-supporting FCM and articles with a capacity > 1,000 liters	Not detectable (ND) for migration into food Finished FCM must be cleaned and flushed prior to first being brought into contact with food
BPA	Plastics	As monomer or starting substance in the manufacture of polysulfone filtration membrane assemblies

Table 2

SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials, helping pave the way for compliance. In the end, it’s only trusted because it’s tested. Contact us to know more or visit our website.

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