The European Commission has published Regulation (EU) 2026/245, amending Annex I of Regulation (EU) No 10/2011 on plastic food contact materials. The update, published on 3 February 2026, revises the Union list of authorized substances and introduces new restrictions that packaging manufacturers, converters and brand owners will need to address quickly.
Table of Contents
For many in the packaging industry, this amendment confirms a clear trend. Compliance is no longer just about meeting specific migration limits. It now requires tighter control of formulation, stricter purity standards, and more detailed communication across the supply chain.
Updates to the Union List
Regulation (EU) 2026/245 introduces several technical changes to the positive list in Annex I.
One existing entry has been revised, with the FCM substance No. 768, amines, di-C14–C20-alkyl oxidized, from hydrogenated tallow, now carrying updated chemical naming and specifications.
The regulation also adds six new entries. Among them:
- FCM substances No. 1093 (wax, rice bran, oxidized) and No. 1096 (wax, rice bran, oxidized, calcium salt). These are authorized with a maximum content of 0.3% in PET, PLA, and rigid PVC under defined specifications.
- FCM substance No. 1094 (2,2′-oxydiethylamine), which is subject to a specific migration limit (SML) of 0.05 mg/kg. Its use is restricted to defined polyamide film applications, with limits on comonomer content and oligomer migration below 1,000 Da. It is not authorized for materials intended for contact with infant formula or human milk.
In addition, a new entry has been introduced in Table 3 of Annex I, clarifying that water must be used for verification of compliance in certain cases instead of the standard food simulants listed in Annex II.
These changes may look technical on paper, but in practice they directly affect formulation decisions, testing strategies, and product development timelines.
From Migration Limits to Composition Controls
One of the most important shifts under Regulation (EU) 2026/245 is the growing emphasis on composition limits in addition to migration limits.
Several newly listed substances are subject not only to SMLs but also to maximum content restrictions in the final polymer. This means that compliance can no longer be demonstrated solely through finished product testing. Companies must know exactly what is in their formulations and at what percentage.
For converters and compounders, this increases reliance on accurate raw material data. A laboratory report showing acceptable migration will not be enough if composition limits are exceeded at the formulation stage.
Stronger Link to Purity and Documentation Requirements
The amendment also reflects the broader compliance direction established under Regulation (EU) 2025/351, which reinforced purity criteria and documentation requirements for food contact materials.
Under the new framework, Declarations of Compliance (DoCs) must do more than confirm alignment with Regulation (EU) No 10/2011. They must showcase:
- Verification that substances meet applicable purity standards
- Precise composition limits that downstream users cannot determine through testing alone
- Any restrictions that influence safe use
In practical terms, the “restrictions and specifications” column in Annex I is becoming central. What used to be a secondary reference is now a primary compliance checkpoint.
Labelling and Use Restrictions: Article 14a in Practice
Regulation (EU) 2026/245 also reinforces the importance of communicating use restrictions clearly, especially where safety depends on correct application.
Under Article 14a on labelling, certain limitations must be passed down to end users. Examples include restrictions to specific food types or explicit exclusions for sensitive applications, such as infant formula.
For packaging producers, this creates a direct link between regulatory assessment and on-pack or accompanying documentation. If a substance is not authorized for contact with certain foods, that limitation cannot remain buried in a technical file. It must be clearly communicated to prevent misuse.
Entry into Force and Industry Impact
Regulation (EU) 2026/245 will enter into force on 23 February 2026, twenty days after its publication in the Official Journal of the European Union.
Although the amendment may appear incremental, its cumulative impact is significant. The combination of new substances, tighter specifications, composition limits and clearer labelling obligations raises the compliance bar for the entire plastics packaging sector.
Conclusion: Compliance Is Now a Data Management Exercise
Regulation (EU) 2026/245 signals that food contact compliance in the EU is becoming more data-driven and more interconnected across the supply chain. Generic statements of compliance are no longer sufficient. Manufacturers must understand the detailed restrictions in Annex I, verify purity and composition at source and ensure that critical information flows downstream without gaps. Regulatory compliance is no longer just a testing exercise, but a coordinated effort involving formulation control, documentation accuracy and transparent communication from raw materials to the finished product.
