The European Commission has adopted Regulation (EU) 2025/351, bringing significant changes to the manufacturing and use of plastic food contact materials across the European Union. Effective 24 March 2025, the amendments introduce stricter purity requirements, migration limits, and labelling obligations for both virgin and recycled plastics. Businesses have until 16 September 2026 to ensure full compliance or risk market restrictions.
Key Changes in the FCM Regulation
New Purity Standards and Compliance Measures
Under the new rules, additives and UVCB substances (substances of unknown or variable composition) must meet stricter purity criteria. Only substances that comply with high-purity requirements—ensuring minimal contamination and defined chemical identity—will be permitted. This change is particularly significant for companies using natural or recycled materials, which often contain trace impurities.
Additionally, non-intentionally added substances (NIAS) are now subject to a more detailed risk assessment if migration exceeds 0.00015 mg/kg food. This requirement aligns food safety measures with REACH (Regulation (EC) No 1907/2006) and the EFSA's latest risk evaluation standards.
Stricter Migration Limits for Plastic Food Contact Materials
Regulation (EU) 2025/351 updates specific migration limits (SMLs), ensuring that hazardous chemicals do not leach into food at harmful levels. Companies producing multi-layer plastic materials must ensure compliance with migration testing, particularly when using adhesives, coatings, or printing inks in food packaging.
A key addition is the requirement for manufacturers to provide migration test data at each stage of production. This impacts suppliers of polymer resins, additives, and coatings, who must prove their materials comply with safety thresholds before they reach the final product.
Tighter Rules for Recycled Plastics and By-Products
The regulation also strengthens traceability and decontamination requirements for recycled plastics used in food contact applications. Recyclers must meet the purity criteria of Regulation (EU) 2022/1616, ensuring that contamination from previous uses is eliminated.
Additionally, plastic manufacturing by-products—such as off-cuts and scraps—can now only be reprocessed if collected under strict Good Manufacturing Practices (GMPs), as outlined in Regulation (EC) No 2023/2006. This move aims to support the Circular Economy while maintaining consumer safety.
Implications for Manufacturers and the Supply Chain
For food packaging producers, plastics manufacturers, and recyclers, these regulatory changes present both challenges and opportunities. Companies must:
- Review raw materials and additives to ensure compliance with the new purity standards.
- Adapt migration testing protocols and documentation to meet enhanced traceability requirements.
- Upgrade recycling and reprocessing systems to align with stricter contamination limits.
Businesses failing to comply by 16 September 2026 may face restrictions on market access within the EU. However, companies investing in safer materials and enhanced compliance processes could gain a competitive edge as regulatory scrutiny intensifies.
