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European Commission approves four substances for use in plastic FCMs

European Commission adds four substances to positive list of Regulation (EU) 10/2011 on plastic food contact materials (FCMs); includes 1) chopped carbon fibers for use in polyether ether ketone, 2) uncoated nano precipitated calcium carbonate, 3) poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters for use in polylactic acid, and 4) mixture of 1,9-nonanediamine and 2-methyl-1,8-octanediamine to produce polyamide; some substances prohibited from use in FCMs holding infant formula and human milk

On October 28, 2026, the European Commission adopted Regulation (EU) 2026/2412, which adds four substances to Annex I of Regulation (EU) No 10/2011, i.e. the list of authorized substances that may be intentionally used in the manufacture of plastic food contact materials (FCMs) (FPF reported).

The four substances include:

  1. chopped carbon fibers from carbonized polyacrylonitrile – only to be used at up to 40% w/w for polyether ether ketone (PEEK) polymer; the fibers are to be manufactured from polyacrylonitrile, have a minimum carbon content of 95% w/w, and at sizes not at a nanoscale at any dimension (diameter > 100 nm);
  2. uncoated nano precipitated calcium carbonate – not to be used in the manufacture of FCMs intended to use with infant formula
  3. poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters – can only be used as an additive up to 15% w/w in FCMs made from polylactic acid (PLA) which do not contain starch or other additives with a function similar to starch that could increase migration, and which are intended to be in contact up to 40°C for up to 10 days with water
  4. mixture of 1,9-nonane-diamine (NDMA) and 2-methyl-1,8-octanediamine (MODA) (CAS 646-24-2 and 148528-05-6) – only to be used as a co-monomer with terephthalic acid, to manufacture polyamide materials and articles; not to be used in the manufacture of FCMs intended for use with infant formula and human milk.

These additions follow European Food Safety Authority (EFSA) assessments on chopped carbon fibers, nano precipitated calcium carbonate, poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters, and mixture of 1,9-nonane-diamine and 2-methyl-1,8-octanediamine, which concluded that the substances do not pose a safety concern for the specific uses that have now been approved.

The substances recently added are currently not included in the Food Packaging Forum’s (FPF) FCCdb database, which lists over 12,000 chemicals that are potentially used intentionally in the manufacture of food contact materials and articles worldwide, with hazard and regulatory information included where available. The new regulation will be included in a future version update of FCCdb.

 

References

European Commission (October 28, 2026). “Commission Regulation (EU) 2026/2412 of 28 October 2026 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.” Official Journal of the European Union.

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids et al. (April 24, 2024). “Safety assessment of mixtures of 1,9-nonanediamine (NMDA) and 2-methyl-1,8-octanediamine (MODA), for use in food contact materials.” EFSA Journal.

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids et al. (July 19, 2023). “Safety assessment of the substance poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters, for use in food contact materials.” EFSA Journal.

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids et al. (February 23, 2022). “Safety assessment of the substance nano precipitated calcium carbonate for use in plastic food contact materials.” EFSA Journal.

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids et al. (January 12, 2022). “Safety assessment of the substance chopped carbon fibres, from carbonised polyacrylonitrile, for use in food contact materials.” EFSA Journal.

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