Commission Regulation (EU) 2024/3190 of 19 December 2024 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

Article 1

Subject matter and scope

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, as regards their use in the manufacture of the following groups of food contact materials and articles falling within the scope of Article 1(2) of Regulation (EC) No 1935/2004, which are placed on the Union market:

(a) adhesives;

(b) rubbers;

(c) ion-exchange resins;

(d) plastics;

(e) printing inks;

(f) silicones; and

(g) varnishes and coatings.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall also apply:

(a) ‘final food contact articles’ means products composed of one or more food contact materials and articles that fall within the scope of Article 1(2) of Regulation (EC) No 1935/2004, which are in their finished state for end use, without undergoing any further chemical, biological or physical processing or modification, except their further processing or modification for filling with food, in order for them to be used for single-use packaging, including the sealing process;

(b) ‘intermediate food contact materials’ means materials that are intended to undergo further chemical, biological or physical processing or modification in order to become all or part of a final food contact article, other than the further processing or modification for filling with food, in order for them to be used for single-use packaging, including the sealing process;

(c) ‘bisphenol’ means a substance consisting of two hydroxyphenyl functional groups linked by one bridging atom, in accordance with structure A laid down in Annex I and includes the salt form of the bisphenol. Additional groups may be attached to the bridging atom;

(d) ‘bisphenol derivative’ means a substance indicated by the general structure B laid down in Annex I, not including the salt form of a bisphenol;

(e) ‘hazardous bisphenol or hazardous bisphenol derivative’ means a bisphenol or a bisphenol derivative listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 due to its harmonised classification as category 1A or 1B ‘mutagenic’, ‘carcinogenic’, ‘toxic to reproduction’ or category 1 ‘endocrine disrupting’ for human health.

Article 3

Prohibition of the use of BPA

Article 4

Prohibition on the presence of BPA in food contact materials and articles for which other bisphenols or bisphenol derivatives are used in their manufacture

Food contact materials and articles that have been manufactured using another bisphenol or bisphenol derivative shall not contain any residual BPA.

Article 5

Prohibition of the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives

By way of derogation from paragraph 1, a hazardous bisphenol other than BPA or hazardous bisphenol derivative, the use of which has not been authorised in accordance with Article 6 and set out in Annex II, may be used in the manufacture of food contact materials and articles for a specific application and the placing on the market of those food contact materials and articles is allowed if the following conditions are fulfilled:

(a) it was already used in the manufacture of the same food contact materials and articles for that specific application on one of the following dates: (i) either the date on which the European Food Safety Authority (‘the Authority’) publishes the information referred to in Article 6(4) for hazardous bisphenols and bisphenol derivatives for which the harmonised classification applies on that date; or (ii) once the Authority has published the information referred to in Article 6(4), the date on which the harmonised classification applies to the hazardous bisphenol or hazardous bisphenol derivative listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008; and

(b) the application referred to in Article 6(1) is submitted within 9 months from one of the following dates: (i) either the date on which the Authority publishes the information referred to Article 6(4) for hazardous bisphenols and bisphenol derivatives for which the harmonised classification applies on that date; or (ii) once the Authority has published the information referred to in Article 6(4), the date on which the harmonised classification applies to the hazardous bisphenol or hazardous bisphenol derivative listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008; and

(c) the food contact materials and articles comply with the rules as applicable before the date of entry into force of this Regulation; and

(d) the Commission has not taken a decision on the application pursuant to Article 6(3).

Article 6

Authorisation for the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of food contact materials and articles for a specific application

Article 7

Reporting obligations concerning alternative substances to BPA, hazardous bisphenols and hazardous bisphenol derivatives laid down in Annex II

By derogation, such reporting shall be voluntary for micro, small and medium-sized enterprises as defined by Commission Recommendation of 6 May 2003 (¹).

Article 8

Declaration of compliance and supporting documentation

Article 9

Verification of compliance with the requirements of this Regulation

For the selection of methods used to verify that a food contact material or article does not contain residual BPA, another hazardous bisphenol or a hazardous bisphenol derivative, or does not release those substances into food above the specified detection limit or specific migration limit, the following additional rules apply:

(a) where the European Union Reference Laboratory (‘EURL’) for food contact materials has developed or recommended a method, that method shall be used;

(b) a method shall have a detection limit of 1 μg/kg unless a different detection limit is set out in Annex II, or as part of the method recommended in accordance with point (a);

(c) to verify that a food contact material or article does not contain residual BPA, another hazardous bisphenol or a hazardous bisphenol derivative, an extraction method shall be used.

The following rules shall apply for the purposes of verification with specific detection or migration limits:

(a) test results shall be expressed in accordance with the rules laid down in Article 17 of Regulation (EU) No 10/2011;

(b) compliance with a migration limit shall be established in accordance with Article 18, Annex III and Chapters 1 and 2 of Annex V to Regulation (EU) No 10/2011;

(c) in case the foreseeable contact occurs under continuous flow conditions, such as in pipes or filtration assemblies, the testing time shall equal the average residence time of the food in that pipe or filtration assembly.

Article 10

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.

Article 11

Transitional provisions concerning single-use final food contact articles

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 first 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 (³); or (ii) fishery products as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council (⁴);

(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.

Article 12

Transitional provisions concerning repeat-use final food contact articles

Article 13

Repeal

Regulation (EU) 2018/213 is repealed.

Article 14

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

The chemical structure of substances for which the definition ‘bisphenol’ and ‘bisphenol derivative’ applies is as follows:

Notes. X refers to any bridging group separating the two phenyl rings by one single atom, but the atom can have any substituent(s).

R1 to R10 refers to any substituent. At least one of the substituents is not a hydrogen atom (H).

ANNEX II

Column 1 (FCM substance No): the Food Contact Materials (FCM) substance number

Column 2 (CAS No): the Chemical Abstracts Service (CAS) registry number

Column 3 (Substance name): the IUPAC chemical name

Column 4 (Material type): the group of materials and articles which may be covered by specific measures

Column 5 (Specific application): the specific application for which the use of the substance is restricted and for which the derogation applies

Column 6 (Other restrictions): other restrictions that apply

ANNEX III

The declaration of compliance referred to in Article 8 shall contain the following information:

(1) the identity and address as well as contact details including either a current telephone number or email address of the business operator issuing the declaration of compliance;

(2) the identity and address as well as contact details including either a current telephone number or email address of the business operator which manufactures or imports the food contact material or article;

(3) the identity of the intermediate food contact materials or final food contact articles;

(4) the date of the declaration;

(5) a list of any bisphenols or bisphenol derivatives used in the manufacture of the food contact material or article;

(6) a statement that the intermediate food contact material or article or final food contact article complies with this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004.