On October 28, 2026, the European Commission published Regulation (EU) 2026/2412, amending Annex I to Regulation (EU) No 10/2011 regarding the list of authorized substances for plastic food contact materials and articles, thereby incorporating four new substances into the Union list.
Newly Authorized Substances
The four substances added in this revision cover various fields, ranging from high-performance engineering plastics to bio-based materials. The EU has established strict regulations regarding their application scenarios, migration limits, and specific conditions:
- FCM No 1086 — Carbonized polyacrylonitrile chopped carbon fibres
- Use: As a filler and reinforcing material in plastic food contact materials.
- Restrictions: To be used only in polyether ether ketone (PEEK) polymers at a maximum level of 40% w/w; the carbon fibres must be manufactured from polyacrylonitrile with a carbon content of not less than 95% w/w, and none of their dimensions shall be in the nanoscale (diameter > 100 nm).
- FCM No 1087 — Precipitated calcium carbonate (nano), uncoated
- Use: As a filler in all types of polymers, suitable for all food types.
- Restrictions: Not to be used for infant formula; in uncoated particle form; overall migration shall be monitored to ensure compliance, particularly for acidic foods.
- FCM No 1088 — Poly(2-hydroxypropanoic acid), esters with 1-octanol and 1-decanol
- Use: As an additive in polylactic acid (PLA) food contact materials at a maximum level of 15% w/w.
- Restrictions: No starch or additives with similar function; restricted to specific foods (water, fresh fruit and vegetables, vinegar, etc.) under contact conditions of up to 10 days at 40°C; Specific Migration Limit (SML) of 0.05 mg/kg.
- FCM No 1090 — Mixture of 1,9-nonanediamine (NMDA) and 2-methyl-1,8-octanediamine (MODA)
- Use: To manufacture polyamide materials and articles by copolymerization with terephthalic acid, suitable for all foods (except infant formula and human milk).
- Restrictions: Total migration of NMDA and MODA shall not exceed 0.05 mg/kg; migration of components with a molecular weight below 1000 Da shall not exceed 5 mg/kg.
According to the regulation, this revision will enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
