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 (Text with EEA relevance)

This Regulation is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004.

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:

1. adhesives;

2. rubbers;

3. ion-exchange resins;

4. plastics;

5. printing inks;

6. silicones; and

7. varnishes and coatings.

This Regulation also establishes specific requirements on the content of BPA in food contact materials and articles, which have been manufactured using another bisphenol or bisphenol derivative.

For the purposes of this Regulation, the definitions in Article 3 of Regulation (EU) No 10/2011 shall apply.

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

1. ‘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;

2. ‘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;

3. ‘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;

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

5. ‘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.

The use of BPA in the manufacture of food contact materials and articles referred to in Article 1(2) and the placing on the Union market of food contact materials and articles manufactured using BPA is prohibited.

By way of derogation from paragraph 1, BPA may be used in the manufacture of food contact materials and articles for a specific application and the placing on the Union market of such food contact materials and articles is allowed in accordance with Annex II, subject to the restrictions laid down therein.

The use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of food contact materials and articles referred to in Article 1(2) and the placing on the market of food contact materials and articles manufactured using hazardous bisphenols other than BPA or hazardous bisphenol derivatives is prohibited.

By way of derogation from paragraph 1, a hazardous bisphenol other than BPA or hazardous bisphenol derivatives may be used in the manufacture of food contact materials and articles for a specific application and those food contact materials and articles may be placed on the market if that use has been authorised in accordance with Article 6 and is set out in Annex II.

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:

1. 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:

   1. 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

   2. 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

2. the application referred to in Article 6(1) is submitted within 9 months from one of the following dates:

   1. 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

   2. 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

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

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