Plastic food contact materials: four new substances on the Union list — a specific migration limit of 0.05 mg/kg for poly(2-hydroxypropanoic acid) esters and the NMDA/MODA mixture, and for nano precipitated calcium carbonate a risk of exceeding the overall migration limit in acidic foods
Commission Regulation (EU) 2026/2412, published in the Official Journal of the EU on 29 October 2026, adds four substances assessed by EFSA to the Union list of authorised substances (Table 1 of Annex I to Regulation (EU) No 10/2011): chopped carbon fibres from carbonised polyacrylonitrile (FCM No 1086), uncoated nano precipitated calcium carbonate (FCM No 1087), poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters (FCM No 1088) and the mixture of 1,9-nonanediamine (NMDA) and 2-methyl-1,8-octanediamine (MODA) (FCM No 1090). Two notes on the verification of compliance are added to Table 3; the regulation enters into force on 18 November 2026, the twentieth day following its publication.
- FCM No 1086 — chopped carbon fibres from carbonised polyacrylonitrile: only at up to 40 % w/w in polyether ether ketone (PEEK); the fibres are manufactured from polyacrylonitrile, have a minimum carbon content of 95 % w/w and sizes not at the nanoscale in any dimension (diameter > 100 nm). According to the EFSA opinion of 25 November 2021, used in this way the substance is not of safety concern for the consumer in contact with all food types and under all conditions of use; the Union list sets no specific migration limit for it.
- FCM No 1087 — nano precipitated calcium carbonate, uncoated only (the application did not cover coated particles, which could have modified properties): a filler for all types of polymers and food, except materials intended for contact with infant formula. EFSA found that a specific assessment of the nanoform is not required because the particles dissolve rapidly under simulated gastric conditions, but observed that overall migration from a material containing the substance into acidic foods may exceed the limit laid down in Article 12 of Regulation No 10/2011 — hence note (32) in Table 3. In the Polish language version of the regulation note (32) refers to the “SML level”, while the English and German versions refer to the OML, i.e. the overall migration limit discussed in recital 3.
- FCM No 1088 — poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters: an additive at up to 15 % w/w only in polylactic acid (PLA) materials without starch (FCM No 564) and without other additives with a function similar to starch, for contact at up to 40 °C for no more than 10 days with water (food category 01.01), fresh or chilled fruit and vegetables (04.01, 04.04) and vinegar (08.01); SML 0.05 mg/kg food. According to EFSA the limit is exceeded when testing in the food simulants 10 % ethanol, 95 % ethanol and isooctane or when starch is added to PLA, which is why note (33) warns that the SML could be exceeded with food simulants other than simulant B (3 % acetic acid).
- FCM No 1090 — mixture of NMDA and MODA (CAS 646-24-2 and 148528-05-6): only as a co-monomer with terephthalic acid for polyamide materials and articles, not for contact with infant formula or human milk; SML 0.05 mg/kg food (according to EFSA for the sum of the migration of NMDA and MODA), and the migration of the fraction below 1 000 Da made of NMDA/MODA-related species — oligomers of NMDA, MODA, terephthalic acid and benzoic acid formed during polyamide manufacture — no more than 5 mg/kg food.