Navigating the New EU Regulations for Plastic Materials

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The European Union has ushered in significant updates to its regulatory framework for plastic materials, with a particular emphasis on food-contact safety and manufacturing practices. Understanding these changes is paramount for producers aiming to maintain compliance and market access.

A pivotal revision, Commission Regulation (EU) 2025/351, which amends the Plastic Food Contact Material Regulation (EU) No. 10/2011, came into force on March 16, 2025. This regulation introduces stricter controls across the supply chain.

Key aspects of the new regulation include:

• Stricter Purity Requirements for Raw Materials: The revised regulation explicitly states that raw materials used in plastic food contact materials must be of a high degree of purity. They must contain only minimal amounts of non-intentionally added substances (NIAS), which now require compliance with specific migration limits or must have undergone a thorough toxicological assessment.

• Enhanced Supply Chain Accountability: The amendments place new obligations on all players in the supply chain. Producers may now be required to provide component information and purity data of their products to authorities upon request. Furthermore, suppliers of intermediate plastic products must also provide documentation on the purity of their components.

• New Rules for Reusable Products: For reusable plastic items, the regulation mandates specific labeling requirements. These include instructions to delay aging, a description of visible signs of aging, and warnings against misuse that could increase migration. Labels must also detail suitable food types, contact time and temperature, and heating conditions.

• Updated Good Manufacturing Practice (GMP): The regulation introduces detailed GMP requirements for the handling of plastic off-cuts and scraps that are not covered by the dedicated recycling regulation. This includes mandates for separate collection in dedicated, clean containers and measures to prevent cross-contamination during reprocessing.

Actionable Advice for Producers:
Manufacturers should immediately review their product formulations and supply chain data against the new purity standards. It is also crucial to update product labels for reusable items and implement the new GMP protocols for production waste.

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