On 31 December 2024, the EU Official Journal published a new Regulation (EU) 2024/3190, on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food, amending Regulation (EU) No 10/2011 and repealing Regulation (EU) 2018/213, prohibiting the use of BPA in FCM.
Below main contents of Regulation (EU) 2024/3190 :
① Scope:
This Regulation establishes specific requirements concerning BPA and its salts as well as other hazardous bisphenols and hazardous bisphenol derivatives, as regards their use in the manufacture of the following groups of food contact materials and articles(FCM): adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings.
② Prohibition of the use of BPA
1. The use of BPA and its salts in the manufacture of FCM and the placing on the Union market of FCM manufactured using BPA, is prohibited.
2. By way of derogation from paragraph 1, BPA and its salts may be used in the manufacture of FCM for a specific application set out in Annex II, subject to the restrictions laid down therein.
③ Prohibition on the presence of BPA in FCM for which other bisphenols or bisphenol derivatives are used in their manufacture:
FCM that have been manufactured using another bisphenol or bisphenol derivative shall not contain any residual BPA.
④ Prohibition of the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives:
The use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of FCM and the placing on the market of FCM manufactured using hazardous bisphenols other than BPA or hazardous bisphenol derivatives is prohibited, unless that use has been authorized and is set out in Annex II.
⑤ Amendment to Regulation (EU) No 10/2011
Regulation (EU) No 10/2011 is amended as follows:
(1) In Article 6, the following paragraph is added:‘6. By way of derogation from Article 5, 2,2-bis(4-hydroxyphenyl)propane (“bisphenol A” or “BPA”) (CAS No 80-05-7) and other hazardous bisphenols or hazardous bisphenol derivatives as defined and falling within the scope of Regulation (EU) 2024/3190 may only be used in the manufacture of plastic materials and articles in accordance with that Regulation.’;
(2) in Table 1 of Annex I, the entries concerning substance No 151 (2,2-bis(4-hydroxyphenyl)propane) and substance No 154 (4,4’-dihydroxydiphenyl sulphone) are deleted.
⑥ Transitional provisions:
For single-use final food contact articles:
1. 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.
2. 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(13); or
(ii) fishery products as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council(14);
(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.
3. 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:
1. 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.
2. 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.
3. Repeat-use final food contact articles that were first placed on the market in accordance with paragraphs 1 and 2 may remain on the market until 20 January 2029 at the latest.
Annex II
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