EU Amends Plastics for Food Contact (EU) Regulation 2026/245

In the EU, the specific measures for food contact plastics are governed by Regulation (EU) No 10/2011, including its Union list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids under Annex I (aka the positive list, current consolidated version to March 2025).

On February 3, 2026, the EU issued Regulation (EU) 2026/245, updating the positive list of substances for food contact plastics.

Key changes in the latest amendment include:

Revising the chemical name and specifications for FCM substance no. 768 (amines, di-C14-C20-alkyl oxidized, from hydrogenated tallow)

Adding six entries, including:

FCM substances nos. 1093 (wax, rice bran, oxidized) and 1096 (wax, rice bran, oxidized, calcium salt). Each substance is limited to no more than 0.3% in food contact polyethylene terephthalates (PET), polylactic acid (PLA) and rigid polyvinyl chloride (PVC) materials under defined specifications

FCM substance no. 1094 (2,2′-oxydiethylamine) with a specific migration limit (SML) of 0.05 mg/kg and the following conditions:

No more than 14% as a comonomer with adipic acid and caprolactam, or their authorized homologues with a longer carbon (C) chain, to manufacture polyamide films with a thickness of up to 25 µm

≤ 5 mg/kg for the migration of oligomers containing the substance with a molecular weight below 1,000 Da

Must not be used in the manufacture of materials and articles that come into contact with infant formula and human milk

Introducing entry 31 to Table 3 in point 3 of Annex I to the Food Contact Plastics Regulation, specifying that water must be used for verification of compliance instead of food simulants listed in Table 1 of Annex II

Regulation (EU) 2026/245 will enter into force on February 23, 2026 – 20 days following its publication in the Official Journal of the EU.One of the most significant bans is the prohibition on the use of novel chemicals such as triphenyl phosphite polymers in the manufacture of infant formula or breast milk contact materials. This means that the review of ingredients containing plasticizers and additives for products such as baby sippy bags and bottles exported to Europe will become much stricter.