Reference source : Official Journal of the European Union
European Food Safety Authority (EFSA) Positive List (Annex I) Specific Migration Limits (SMLs) Plastic Food Contact Materials Regulation (EU) No 10/2011
On 3 February 2026, the European Commission published Commission Regulation (EU) 2026/245, amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The amendment introduces six new substances to the positive list of authorised substances in Annex I, and updates existing entries and verification requirements.
Six Substances Added to the Positive List
The update expands the list of authorised substances that can be used to manufacture plastic food contact materials. The six newly authorised substances are included with specific conditions of use, including migration limits and restrictions.
|
FCM No. |
Substance Name |
CAS No. |
Key Restrictions |
|
1084 |
Phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10–16 alkyl esters |
1821217-71-3 |
Additive in polyolefins (≤0.15% w/w); SML 5 mg/kg (phosphite/phosphate); not for infant formula/human milk |
|
1089 |
Calcium tert-butylphosphonate |
81607-35-4 |
Nucleating agent in polyolefins (≤0.15% w/w); temperature limits up to 130°C; not for infant formula/human milk |
|
1092 |
Amines, di-C14–C20-alkyl, oxidised, from hydrogenated vegetable oil |
1801863-42-2 |
Additive (≤0.1% w/w); only for non-fatty foods; not for infant formula/human milk |
|
1093 |
Wax, rice bran, oxidised |
1883583-80-9 |
Additive (≤0.3% w/w) in PET, PLA, rigid PVC; only for non-fatty foods |
|
1094 |
2,2′-oxydiethylamine |
2752-17-2 |
Comonomer (≤14% w/w); SML 0.05 mg/kg; oligomer migration limit; not for infant formula/human milk |
|
1096 |
Wax, rice bran, oxidised, calcium salt |
1850357-57-1 |
Additive (≤0.3% w/w) in PET, PLA, rigid PVC; only for non-fatty foods |
These additions follow safety assessments by the European Food Safety Authority (EFSA) and reflect the ongoing updating of the positive list in line with scientific and technical progress.
Amendments to Existing Entries
The Regulation also amends existing entries in Annex I, particularly FCM No 768 (Amines, di-C14–C20-alkyl, oxidised, from hydrogenated tallow; CAS No. 143925-92-2) which has been revised, including a name change and has updated restrictions limiting its use to non-fatty foods under specified conditions.
In addition, a new verification requirement specifies that water must be used as a test medium for compliance verification of 2,2′-oxydiethylamine instead of standard food simulants.
Entry into Force
The Regulation entered into force on 23 February 2026.
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