EU Adopts Amendments to Regulation on Plastics in Food Contact Materials

The European Commission adopted Regulation (EU) 2025/351 on 19 February 2025, which introduces significant amendments to Regulation (EU) No 10/2011 on plastic materials and articles intended as food contact materials (FCMs). The updated rules were published on 24 February 2025 and will enter into force on 16 March 2025. Companies need to ensure compliance within the transition period, which ends on 16 September 2026, to avoid potential market restrictions.

Key Amendments in Regulation (EU) 2025/351

The newly adopted Regulation now explicitly extends compositional requirements to all plastic materials and articles, removing previous ambiguities. It also refines definitions to improve the clarity of the legislation.

• Extended Scope: The compositional requirements now apply to all plastic materials and articles, not just 'plastic layers'. This change removes ambiguity, particularly for single homogeneous materials with complex shapes and ensures consistent safety standards for all plastic products. ​

• Clearer Definition of Additives: The definition of 'additives' has been clarified to distinguish them from starting substances. In particular, solid materials that are chemically bonded to polymers are now categorized as additives, even if their surfaces react with the polymers. This clarification will ensure proper classification and regulatory oversight of substances used in the manufacture of plastics.

Alignment with Biocidal Product Regulations

To ensure that food contact materials do not introduce harmful substances, the amended Regulation strengthens alignment with existing biocidal product legislation. The amendments include a reference to the Biocidal Products Regulation (Regulation (EU) No 528/2012), ensuring that only approved biocidal active substances are used in food contact materials. This alignment strengthens consumer protection by preventing the use of unauthorised biocidal substances in FCMs. ​

Stricter Migration Limits for Plastic Food Contact Materials

The Regulation introduces updated specific migration limits (SMLs) to ensure that hazardous substances are not transferred from plastic materials into food at levels that could pose a health risk. These stricter limits apply to a wider range of substances, strengthening the safety standards for food packaging.

• Compliance for multi-layer plastic materials:

Manufacturers using adhesives, coatings, or printing inks in food packaging must ensure compliance with migration testing requirements. The updated regulations emphasise the need for reliable testing methods to verify that no harmful chemicals exceed the new SML thresholds.

• Requirement for migration test data at each production stage:

Companies involved in food contact plastics, including polymer resin producers, additive suppliers, and coating manufacturers, must now provide migration test data at each stage of the production process. This will ensure that materials comply with SMLs before reaching the final product, strengthening accountability throughout the supply chain.

These measures enhance consumer protection and regulatory oversight, ensuring that plastic food contact materials meet the highest safety standards.

High Purity Standards and Sustainability Measures

The revised regulation strengthens purity requirements and introduces stricter risk assessments to ensure safer food contact materials. Key updates include:

• Stricter purity criteria:

  • Additives and UVCB substances (substances of unknown or variable composition) must meet higher purity standards.

  • Only substances with well-defined chemical identities and minimal impurities will be allowed.

  • This is particularly important for manufacturers using recycled or naturally derived materials that may contain residual contaminants.

• More comprehensive risk assessment for NIAS:

  • Non-intentionally added substances (NIAS) will have to undergo detailed risk assessments if migration exceeds 0.00015 mg/kg of food.

  • This measure aligns food contact legislation with EU-REACH (Regulation (EC) No 1907/2006) and the latest risk evaluation framework of the European Food Safety Authority (EFSA).

  • The approach will strengthen safety assessments and ensure better control of potential contaminants in food packaging and materials.

These updates reflect the EU’s commitment to higher safety standards and greater regulatory consistency in the management of FCMs.

Recycling and Reprocessing Provisions

Regulation 2025/351 introduces measures to promote sustainability and ensure the safety of recycled materials:

• Definition of 'reprocessing of plastic': A clear definition for ‘reprocessing of plastic’ has been introduced to distinguish it from recycling. This clarification ensures that by-products from plastic manufacturing, such as off-cuts and scraps, are properly managed and reused, supporting sustainability goals.

• Alignment with the Recycled Plastics Regulation (EU) 2022/1616: The amendments ensure that recycled plastics used in food contact applications meet stringent safety criteria. This alignment requires recycled plastic materials to undergo rigorous decontamination processes and reinforces the requirement that plastic materials derived from waste maintain high purity standards to prevent contamination. ​

Transitional Measures for Compliance

To facilitate a smooth transition, the Regulation provides a grace period for products already on the market and sets clear labelling requirements for non-compliant substances.

• Plastic materials and articles that comply with previous regulations and are placed on the market before 16 September 2025 may remain available until stocks are exhausted.

• Intermediates and substances that do not comply with the new regulation may still be used until 16 September 2026 but must be clearly labelled to indicate their restricted use after the transition date.

The full text of the regulation can be accessed here.