EU Regulation 2026/245 Updates Positive List for Food Contact Plastics Authorizing New Substances
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).
The European Union has officially published Regulation (EU) 2026/245, marking a significant update to the Union list of authorized substances for plastic food contact materials (FCMs) and articles. This revision, governed under Regulation (EU) No 10/2011, targets Annex I, commonly known as the positive list, which details authorized monomers, other starting substances, macromolecules from microbial fermentation, additives, and polymer production aids.
Scope of Food Contact Plastics
1. This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:
- materials and articles and parts thereof consisting exclusively of plastics;
- plastic multi-layer materials and articles held together by adhesives or by other means;
- materials and articles referred to in points a) or b) that are printed and/or covered by a coating;
- plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
- plastic layers in multi-material multi-layer materials and articles.
2. This Regulation shall not apply to the following materials and articles which are placed on the EU market and are intended to be covered by other specific measures:
- ion exchange resins;
- rubber;
- silicones.
3. This Regulation shall be without prejudice to Union or national provisions applicable to substances that may be used in the manufacture of adhesives, coatings and printing inks and applied on or incorporated in plastic materials and articles.
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.
In the broader context of EU plastics regulation, this update complements ongoing efforts in circular economy initiatives. While focusing on safety, it indirectly supports Plastic Recycling by clarifying allowable recycled content in FCMs under strict conditions.
Manufacturers must now integrate these changes into their compliance strategies, potentially investing in new Additives and Masterbatches that leverage the expanded positive list.
For decision-makers in Primary Plastics Processing Machinery and Auxiliary Equipment, this signals opportunities in upgrading extrusion and injection molding lines for precise additive dosing compliant with the new list.
Similarly, Moulds and Dies providers may see demand for tooling optimized for food-safe plastics. The amendment reflects the EU's commitment to harmonized standards, reducing barriers for cross-border trade within the Single Market.
