The landscape of Food Contact Materials (FCM) in the EU continues to evolve, and the recent publication of Commission Regulation (EU) 2026/245 (amending Annex I of 10/2011) marks another critical step for the industry.
If you are used to seeing the “Restrictions and Specifications” column in Annex I as mostly empty, it’s time to look again. This update demonstrates a clear trend: that last column is filling up with complex requirements that are now vital for compliance.
The “Empty Column” is Filling Up
The new amendment introduces substances where a standard migration limit (SML) isn’t the only hurdle. We are seeing a significant shift toward use limits (composition limits).
Instead of just testing the final “leakage,” we now have limits such as max 0.1% w/w in the final polymer.
This means compliance can no longer be verified by testing alone; it relies on precise data sharing within the supply chain.
Connection to EU 2025/351 & Purity Criteria
This isn’t just a list of new substances; it is the practical application of the standards set by EU 2025/351. The “Quality Amendment” era has turned these principles into mandatory requirements:
Purity Standards: New substances must meet strict purity criteria. If your Declaration of Compliance (DoC) doesn’t reflect this verification, the material is technically non-compliant.
Information Flow: The DoC is no longer a static document but a critical link for transferring compositional data that the next producer cannot find out through testing.
Article 14a: When Restrictions Meet the Label
Under the new Article 14a (Labelling) requirements, the restrictions in that “last column” must now be clearly communicated to the end-user when safety depends on it. Examples from the new amendment include:
Food Type Restrictions: “Restricted to contact with non-fatty foods only.”
Sensitive Groups: “Not authorized for infant formula or human milk.”
These are no longer just technical notes – they are mandatory labeling elements that must be visible and clear to prevent misuse.
Why this matters for your Supply Chain
The combination of EU 2026/245 and EU 2025/351 means that a generic “complies with 10/2011” statement is essentially obsolete. To be compliant, your DoC must now be the “Source of Truth” for:
- Purity verification of new substances.
- Specific Use Limits (w/w) for converters.
- Clear instructions for the final labeling of the product.
The “last column” is now the most important one. How is your team ensuring this data flows correctly from your suppliers? Let’s discuss below!