The EU Regulation 2025/351, published on February 24, 2025, and in force from March 16, 2025, introduces significant changes to ensure the safety of plastic materials intended for food contact. Let's explore the new requirements to which businesses operating in the food supply chain must pay close attention.

The key points of the new regulation include:

• High Purity Standards: Substances used in manufacturing plastic materials must meet strict purity standards to ensure they do not release harmful components into food.

• Instructions for Reusable Products: Manufacturers are required to provide clear guidance to end-users on correctly handling reusable plastic food-contact items, to prevent deterioration that could compromise food safety.

• Enhanced Quality Control: The regulation strengthens oversight throughout the production process, including sampling of intermediate substances to verify purity and compliance with safety standards.

• Transitional Period: Plastic materials and articles compliant with the previous Regulation (EU) No 10/2011 may continue to be marketed until stocks are exhausted, provided they were placed on the market before September 16, 2026.

These changes aim to safeguard consumer health and maintain high food safety standards.

Below, we explore the main changes and updates compared to previous legislation, along with their impact on food industry businesses.

Context and Objectives

The regulation amends Regulation (EU) No 10/2011 on plastic materials for food contact, Regulation (EU) 2022/1616 on recycled plastics, and Regulation (EC) No 2023/2006 concerning good manufacturing practices. The main goal is to enhance the safety and quality of plastic materials in the food industry by imposing stricter control over substances used and production methods.

Main Changes and Updates

A) New Definitions and Scope of Application

• Expanded Definition of Plastics: Now includes solid substances chemically bound to polymers.
• Introduction of "UVCB" Concept: Naturally derived substances with complex and variable composition are now covered by the regulation.
• Clarifications on Multi-layer Materials: Composition requirements apply exclusively to plastic layers, not to adhesives, inks, or coatings.

B) Stricter Purity Requirements

• New purity standards for all substances used in food-grade plastic production.
• Increased scrutiny of additives and chemical processes: Substances chemically bonded to polymers are now considered additives rather than starting substances.
• More stringent rules for plastics made from recycled materials: Specific criteria introduced to ensure recycled plastics are free from harmful contaminants.

C) Quality Control and Traceability

• Manufacturers must provide detailed information on substances used, including unintentionally added substances such as impurities and reaction by-products.
• Enhanced inspections: Competent authorities can perform sampling throughout the production process.
• More comprehensive Declaration of Compliance, including details about recycled materials.

D) Specific Rules for Reusable Plastics

• Manufacturers must provide clear instructions on preventing deterioration of reusable plastics.
• Materials must be designed to ensure they do not release harmful substances over time.

E) Restrictions on Recycled Materials

• Recycled plastics must meet the same purity standards as virgin plastics.
• Clarification that contaminants in both source materials and final products must be eliminated or reduced to safe levels.

F) New Rules for Declarations of Compliance

• Product labeling must clearly specify usage restrictions, including time, temperature, and types of food suitable for contact.
• Information must be clearly provided to both manufacturers and consumers to ensure safe product use.

Transitional Period

Until September 16, 2026, materials compliant with previous regulations may remain on the market until existing stocks are exhausted. From December 16, 2025, substances and materials produced according to previous standards must be clearly labeled as non-compliant with the new regulation and may only be used to produce items placed on the market before September 16, 2026.

Impact on Food Industry Businesses

The introduction of these new requirements represents a significant change for companies. However, these regulations also provide an opportunity for manufacturers to enhance product safety, strengthening consumer confidence in packaged foods and fostering a more responsible image focused on public health for the entire industry.

The impact on businesses can be summarized with the following key points:

• Greater traceability and documentation: Companies must provide detailed evidence of compliance.
• Changes in raw materials: Producers may need to reformulate products to meet new purity standards.
• Mandatory new labeling for reusable and recycled plastic materials.

In conclusion, Regulation (EU) 2025/351 marks a significant step towards improved food safety and sustainability. With these changes, manufacturers and distributors of plastic food-contact materials must adapt to the new rules to maintain compliance and market access within the EU. At the same time, food and beverage producers and distributors will need to ensure their packaging and labeling fully align with the current regulatory framework.