With Regulation (EU) 2026/245, Annex I of the Plastics Regulation (EU) No. 10/2011 and thus the Union list of authorized substances is updated; Regulation (EU) 2026/250 corrects the regulation on the use of bisphenols (BPA)
Background
- The basis for the amendments to the Plastics and Bisphenol Regulation is the Framework Regulation (EC) No. 1935/2004 on materials and articles intended to come into contact with food.
- In 2024, the European Food Safety Authority (EFSA) adopted several opinions on new substances, which, after scientific evaluation, were added to the Union list of the Plastics Regulation with restrictions. Furthermore, the designation and restriction of one substance was adjusted.
- In the Bisphenol Regulation, inconsistencies and errors were corrected to ensure the proper functioning of the regulation
Main Points of the Changes
1. Regulation (EU) 2026/245: New or Modified Substance Entries in Annex I
The regulation supplements or modifies several substance entries, including restrictions for these substances:
| Substance | Limit / Restriction (Summary) | Status |
| Amines, Di-C14-C20-alkyl, oxidized, from hydrogenated tallow (FCM No 768) | – fat-free food – max. 0.1% by weight in polyolefins or – max. 0.25% by weight in PE | revised |
| Amines, Di-C14-C20-alkyl, oxidized, from hydrogenated vegetable oil (FCM No 1092) | – fat-free food – max. 0.1% by weight in polyolefins – max. room temperature incl. hot-filling for max. 2h at 100 °C – Not for infant formula and human milk | new |
| Phosphoric acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl ester (FCM No 1084) | SML 5 mg/kg (sum phosphite and phosphate) – max. room temperature incl. hot-filling for max. 2h at 100 °C – max. 0.15% by weight in polyolefins – Not for infant formula and human milk – Fraction < 1000 Da: max. 13% by weight | new |
| Calcium tert-butylphosphonate (FCM No 1089) | – Nucleating agent – max. room temperature incl. hot-filling for max. 2h at 100 °C or 15 min at 130 °C – max. 0.15% by weight in polyolefins; – Not for infant formula and human milk | new |
| Wax, rice bran, oxidized (FCM No 1093) and Wax, rice bran, oxidized, calcium salt (FCM No 1096) | – fat-free food – max. 0.3% by weight in PET, PLA, rigid PVC – max. room temperature incl. hot-filling for max. 2h at 100 °C | new |
| 2,2′-Oxydiethylamine (FCM No 1094) | SML 0.05 mg/kg – Comonomer (max. 14% by weight) with adipic acid and caprolactam or authorized homologues – PA films up to max. 25 µm – Oligomers < 1000 Dalton max. 5 mg/kg – Not for infant formula and human milk | new |
2. Regulation (EU) 2026/250: Corrections in the Bisphenol Regulation (EU) 2024/3190
- Clarification of definitions: The wording “BPA and its salt(s)” is deleted, as the term “bisphenol” by definition already includes the salt forms.
- Addition (in Article 3(2)) that not only manufacturing in the EU, but also placing on the market in the EU of food contact materials using Bisphenol A is prohibited according to the regulation.
- Article 9(2) clarifies that the analytics explicitly refer to “BPA residues”, as their presence is prohibited, and therefore an extraction method must be used.
- In the transitional provisions (Articles 11 and 12), several date and wording errors in the original text were corrected.
- Annex III clarifies that the declaration of compliance must state either the designation of semi-finished food contact materials or that of finished food contact articles
3. Entry into Force
- The regulations enter into force on the 20th day after publication in the Official Journal of the EU (on 23.02.2026).
- It is binding in all Member States and directly applicable.
Practical Significance
Regarding the adjustments to the Plastics and Bisphenol Regulation, in our opinion there is no direct need for action for most companies, as these are additions and clarifications and no fundamental changes have been made.
Plastics
- For Amines, Di-C14-C20-alkyl, oxidized, from hydrogenated tallow (FCM No 768), the designation was changed, which has no impact on compliance. The restrictions have been textually harmonized; the quantities are identical, so in our opinion there is no direct need for action.
- The newly added substances to the Union list may now be used in food contact materials with the specified restrictions. Prior to authorization, use would only have been permissible behind a functional barrier, so manufacturers already had to indicate the presence of these substances in old declarations of compliance.
Products manufactured with bisphenols
- For imported goods that may contain bisphenols, and in case of intentional use of bisphenols, review deadlines and requirements again
- The declaration of compliance already had to be prepared for all materials mentioned in the scope of the regulation. The designation should possibly be adjusted.
