Regulation 2025/351: A Key Update in Food Safety

Regulation (EU) 10/2011, known as the Plastics Regulation on Food Contact Materials, sets specific requirements to ensure the safety of plastic materials and articles intended to come into contact with food within the European Union. This regulation, adopted in 2011, has been periodically updated to reflect scientific, technological, and legislative advancements, with Amendment 19 (Regulation (EU) 2025/351) being one of the most significant.

Regulation (EU) 2025/351, published on February 21, 2025, introduces key modifications to align with the latest scientific developments and to enhance food safety. This new amendment aligns with the most recent regulations, such as Regulation 2022/1616 on recycled plastics and Regulation 2023/2006 on good manufacturing practices, aiming to modernize food safety and sustainability standards in Europe.

Main Objectives of the Amendments

Strengthening Purity Requirements:Substances used must meet a high level of chemical purity suitable for the intended use, including limits on non-intentionally added substances (NIAS), such as impurities, degradation products, reaction by-products, etc., generated during the plastic material or article manufacturing process.

Strict criteria are established for the evaluation of NIAS, and compliance with one of the four conditions listed in the regulation is required to ensure safety: compliance with the specifications in Table 1 of Annex I, risk assessment, toxicological evaluation, etc.

Regulation of Recycled Materials: Stricter requirements have been established for recycled materials used in plastic packaging to ensure they meet the same safety standards as virgin materials. The suitability of recycled materials will be controlled through decontamination processes backed by risk assessments.
Clarification of Definitions: Introduction of concepts such as “UVCB substances” (substances of unknown or variable composition, complex reaction products, or biological materials), commonly used in natural materials. UVCB substances are also required to meet high purity standards.

Another introduced concept is “Reprocessing and Industrial Waste.” Plastic by-products from the manufacturing process may be reused if they meet strict cleanliness and safety requirements, promoting a circular economy. These reprocessed materials must be collected according to Section C of the Annex to Regulation (EC) No. 2023/2006, which has been amended. Instructions include separate collection using piping systems, closed conveyor belts, bins, etc., to prevent contamination. Additionally, they must comply with the compositional requirements of Chapter II of Regulation 10/2011 or undergo a risk assessment considering the reprocessing conditions.

Multilayer Material Requirements: Differentiated requirements for plastic layers that are in direct and indirect contact with food. This ensures that intermediate or functional barrier materials meet safety standards without overcomplicating regulations. Specific criteria are included for multilayer plastic materials.
Information on the Use of Biocides: A biocide containing an active substance may be incorporated into food contact materials as long as both the substance and the product containing it are approved and authorized under Regulation (EU) No. 528/2012 for such use.
S/V Ratio: In cases where the 6 dm²/kg ratio (Article 17) previously applied, the actual surface-to-volume (s/v) ratio may now be used.
Changes to Food Simulants for Certain Cheese Categories: Categories are modified to better classify natural, processed, cured, and fresh cheeses.
Compliance Testing Standards:
More detailed standards are specified regarding the verification of compliance testing.
Documentation and Transparency Manufacturers of raw materials, intermediates, and final products must thoroughly document the characteristics and origin of substances used, including contaminants and degradation products (NIAS), to comply with traceability requirements. Thus, companies must ensure more detailed documentation to demonstrate the compliance of their materials with the regulation.

The amendment to Regulation (EU) 10/2011, presented in this amendment 19, introduces new provisions on the labeling of plastic materials in contact with food. These standards aim to ensure that users and end consumers receive clear and relevant information for the safe use of these products.

New Labeling Requirements

Information for Reusable Products:

Manufacturers or distributors must provide specific instructions to slow down material or article deterioration.
Labels must include indications of visible changes that may signal deterioration, such as cracks, deformations, or discolorations.
Warnings about risks related to specific damage or foreseeable misuse that could increase the migration of unwanted substances must be included.

Instructions for Final Consumers and Use Restrictions:

For articles made with substances subject to specific restrictions (temperature, contact time, or microwave/oven use), labels must clearly inform about these limitations.
This is especially important for plastics designed for food contact under specific conditions that may affect the product’s safety.
Articles not yet in contact with food must come with clear instructions to avoid uses that could violate safety restrictions. This includes multilayer materials, printed items, or those coated with varnishes and adhesives.

Benefits of Extended Labeling

For Consumers:

Facilitates the proper and safe use of plastic materials.
Promotes trust in packaging by ensuring transparency about potential risks.

For Regulators:

Improves product traceability.
Eases inspections and regulatory compliance monitoring.

Transitional Measures and Key Dates

Products marketed before September 16, 2026, may continue to be sold until stocks are exhausted.
Intermediate products manufactured before December 16, 2025, must indicate if they do not comply with the new regulation so that the buyer is aware.
A transition period will be granted for manufacturers and distributors to adjust their production processes to the new requirements.

Conclusion

Regulation (EU) 2025/351 represents a crucial step forward in the regulation of plastics in food contact, establishing new standards that balance safety, sustainability, and economic viability. While its implementation poses a challenge for the industry, the benefits in terms of public health, transparency, and environmental protection are significant.

This regulation marks a firm step toward a safer and more sustainable European market, where plastic materials are managed responsibly and efficiently. For its success, cooperation between manufacturers, regulators, and consumers will be key in transitioning toward a safer and more responsible use of recycled plastics.

At AIMPLAS, we can assist you if you need guidance on this new amendment. We are also planning to offer training in the coming months to explain the concepts discussed in this blog in more detail. If you want more information, feel free to contact us.