January 23, 2025
On December 31, the European Commission (EC) has published Commission Regulation (EU) 2024/3190 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonized classification for specific hazardous properties in certain materials and articles intended to come into contact with food.
This Regulation establishes specific requirements concerning 4,4’-isopropylidenediphenol (‘bisphenol A’ or ‘BPA’) (CAS No 80-05-7) and its salts as well as other hazardous bisphenols and hazardous bisphenol derivatives.
This prohibits the use of BPA and its salts in the manufacture of food-contact plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, silicones, and rubber. The BPA Regulation amends the Regulation 10/2011 by deleting BPA (FCM Substance No. 151) and 4,4-dihydroxydiphenyl sulphone or BPS (FCM Substance No. 154) from Annex I.
Under Commission Regulation (EU) 2024/3190, the use of BPA and its salts is prohibited in the manufacture of food-contact plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, silicones, and rubber.
Some very limited exceptions to the prohibition on BPA are listed in Annex II.
Permitted uses include the use of BPA (and its salts) as a monomer or starting substance in the production of:
(1) polysulfone filtration membrane assemblies;
(2) liquid epoxy resins to be applied on self-supporting food contact materials or articles with a capacity greater than 1000 liters.
Both exempted uses are subject to certain stringent migration limits.
Also, the use of other hazardous bisphenols and hazardous bisphenol derivatives (those listed in Annex VI, Part 3 of Regulation (EC) No. 1272/2008 as category 1A or 1B carcinogenic, mutagenic, toxic to reproduction or category 1 endocrine disruptor for human health) is prohibited in the manufacture of food-contact materials and articles, unless explicitly authorized. For this point, article 6 of the Regulation requires the European Food Safety Authority to publish guidelines prior to January 20, 2027, regarding information needed in a petition to seek authorization of other hazardous bisphenols and derivates.
For food contact articles manufactured using another bisphenol or a bisphenol derivative, a limit on the residual BPA content is set.
Specific information on detection methods to be used for the evaluation are defined: unless otherwise specified by the European Union reference laboratory, the detection limit is 1 µg/kg.
Following the new law, the European Regulation 10/2011 on plastic is amended and the substances BPA (FCM Substance No. 151) and 4,4-dihydroxydiphenyl sulphone or BPS (FCM Substance No. 154) are deleted from Annex I.
The new Regulation also establishes additional documental requirements: objects intended to come into contact with food products shall be accompanied, at all stages of marketing other than retail sale, by a written declaration containing specific information.
Transitional periods
Finally, transitional periods have been fixed.
- For single-use final food contact articles:
- Single-use final food contact articles manufactured using BPA and complying with the rules as applicable before the date of entry into force of this Regulation, which do not comply with the rules in this Regulation, may be placed on the market until 20 July 2026.
- By way of derogation from paragraph 1, the following single-use final food contact articles complying with the rules as applicable before the date of entry into force of this Regulation, which do not comply with the rules in this Regulation, may be placed on the market until 20 January 2028:
(a) single-use final food contact articles intended for the preservation of the following foodstuffs:
(i) fruits or vegetables, excluding products defined in Annex I to Council Directive 2001/112/EC;
(ii) fishery products as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council;
(b) single-use final food contact articles on which a varnish or coating manufactured using BPA has only been applied to the exterior metal surface. - Single-use final food contact articles placed on the market in accordance with paragraphs 1 and 2 may be filled with food and sealed during the 12 months following the expiry of the applicable transitional period. The resulting packaged food may be placed on the market until exhaustion of stocks.
- For repeat-use final food contact articles:
- Repeat-use final food contact articles manufactured using BPA and complying with the rules as applicable before the date of entry into force of this Regulation, which do not comply with the rules in this Regulation, may be first placed on the market until 20 July 2026.
- By way of derogation from paragraph 1, repeat-use final food contact articles used as professional food production equipment, complying with the rules as applicable before the date of entry into force of this Regulation, which do not comply with the rules in this Regulation, may be first placed on the market until 20 January 2028.
The new Regulation requires special attention in the choice of raw materials to be used to produce materials intended for contact with food with a focus on the possible presence of bisphenols. However, the actual presence of bisphenol A in finished products shall also be assessed.
UL Solutions can provide support in evaluating food grade declaration for raw materials used in the production of food contact materials and investigating the possible presence of bisphenols in finished products. We offer a wide range of testing and advisory services for your food contact materials, contact us today to find out how we can help you keep your product compliant in your target markets.
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