Commission Regulation (EU) 2025/351, also called ‘quality amendment’ was adopted on February 21, 2025 and introduced significant changes to the existing Regulation (EU) 10/2011, which governs plastic materials and articles intended to come into contact with food. This amendment also revises Regulation (EU) 2022/1616 concerning recycled plastic materials and repeals Regulation (EC) No 282/2008. Furthermore, it modifies Regulation (EC) No 2023/2006, which outlines good manufacturing practices for these materials. The updates primarily focus on improving safety measures, clarifying compositional requirements, and enhancing quality control processes.

Key Amendments and Their Implications

1. Clarification of Compositional Requirements

The amendment refines the language concerning the composition of plastic materials. Previously, Regulation (EU) 10/2011 referred specifically to "plastic layers." However, recognizing that many plastic products do not conform to a layered structure, the updated regulation now applies to plastic materials and articles as a whole. This change ensures that all plastic components, whether multi-layered or homogenous, adhere to safety standards.

Additionally, the regulation differentiates between additives and starting substances. Additives, which are not chemically bonded to polymers, differ from starting substances that undergo polymerization. The amendment clarifies that solid materials chemically bonded to polymers function as additives rather than starting substances.

2. Enhanced Safety Standards for Recycled Plastics

The revised regulation aims to ensure that recycled plastics used in food-contact applications meet stringent safety criteria. It aligns with Regulation (EU) 2022/1616, which mandates that recycled plastic materials undergo rigorous decontamination processes. The amendment also reinforces the requirement that plastic materials derived from waste maintain high purity standards to prevent contamination.

3. Introduction of a definition for “reprocessing of plastic”

The production of off-cuts, scraps and other by-products during the manufacturing of plastics cannot be avoided. A definition of “reprocessing” is included to have a clear delineation between the products to which Regulation (EU) No 10/2011 apply and those to which Regulation (EU) 2022/1616 applies, and to lay down rules for the safe reprocessing of these by-products.

4. Introduction of the concept of UVCB Substances under EU n° 10/2011

The regulation incorporates the concept of "substances of unknown or variable composition, complex reaction products, or biological materials" (UVCB), a concept which originates from REACH (Regulation (EC) No 1907/2006). This category includes natural-origin materials such as minerals and organic compounds used in plastic manufacturing. Given their complex and variable nature, UVCB substances require a more detailed risk assessment to ensure compliance with food safety standards.

5. Strengthened Purity and Risk Assessment Criteria

Under the new amendment, substances used in plastic food-contact materials must meet stringent purity requirements. Manufacturers must ensure that:

• Non-intentionally added substances do not exceed migration limits.
• Genotoxicity risks are assessed, particularly when a substance’s migration into food exceeds 0.15 µg/kg.
• High-purity standards apply equally to substances sourced from recycled materials.

6. Improved Labelling and Consumer Information

The regulation introduces enhanced labelling requirements for reusable plastic materials in food contact applications. Manufacturers must provide clear instructions on:

• How to maintain the integrity of the plastic article (slow down deterioration).
• Signs of deterioration, such as cracks or discoloration, that may compromise safety.
• A warning in case specific damages or foreseeable misuse would cause increased migration. 
• At retail stage, instructions of use like restrictions to certain foods, temperatures heating methods (oven, microwave,...)

7. Changes and clarifications concerning compliance testing

• In Table 2 of Annex III, the descriptions and simulant assignments for cheeses with reference number 07.04 are replaced. The present terminology is aligned used in the ‘FoodEx2 classification’ established by EFSA, in particular regarding unripened (fresh) and ripened cheese
• Performance criteria on analytical methods for compliance testing and criteria on the stability rule when testing materials or articles intended for repeated use are specified. Laboratories
• Surface to volume ratio: business operators have the possibility to opt for the real surface-to-volume ratio instead of being obliged to use the fixed surface-to-volume ratio established for certain materials and articles

8. Transition Period and Implementation Timeline

The regulation provides an 18-month transition period. Plastic materials complying with the previous version of Regulation (EU) 10/2011 can continue to be placed on the market until stocks are depleted. However, any intermediate manufacturing products introduced nine months before the transition period ends must carry a declaration indicating their compliance status.

The 18th amendment to Regulation (EU) 10/2011 reflects the European Union’s commitment to ensuring food safety and environmental sustainability in plastic food-contact materials. By strengthening purity standards, refining compositional requirements, and enhancing consumer information, these changes contribute to safer, more transparent, and environmentally responsible plastic manufacturing practices. Stakeholders in the food packaging and plastic industries must align their practices with these new standards to ensure compliance and protect public health.

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