Tests according to Regulation (EU) No. 2025/351

Commission regulation (EU) 2025/351, published in February 2025, essentially introduces the following regulations:

• It amends regulation 10/2011 on plastic materials and articles intended to come into contact with food.
• It amends regulation 2022/1616 on recycled plastic materials and articles intended to come into contact with food and repeals regulation 282/2008.
• It amends Regulation (EC) 2023/2006 on good manufacturing practices for materials and articles intended to come into contact with food, with regard to quality control and other aspects related to the production of recycled plastic and plastic materials and articles intended to come into contact with food.

In short, Regulation (EU) 2025/351 introduced significant changes to the European Union's regulatory framework for plastic materials and articles intended to come into contact with food. This regulation updates many existing regulations to improve safety standards, with a particular focus on recycled plastics and manufacturing practices.

The main objectives of this regulation are:

• To clarify and strengthen compositional requirements for food contact plastic materials and articles.
• To improve safety and quality standards for recycled plastic materials.
• Improving good manufacturing practices (GMP) for the production of food contact plastics.

Significant changes brought by this regulation include:

• Regulation (EU) No 10/2011: This regulation addresses ambiguities in products that do not conform to a layered structure by replacing the term "plastic layers" with "plastic materials and substances" and revising the compositional requirements. It also clarifies that the compositional requirements do not apply to non-plastic layers such as adhesives, printing inks, varnishes and coatings.
• Regulation (EU) 2022/1616: Adjustments have been made to align with updated purity standards and manufacturing practices for recycled plastic materials and articles intended to come into contact with food.
• Regulation (EU) No 282/2008: This regulation has been repealed to eliminate outdated provisions and streamline the regulatory framework.
• Regulation (EU) 2023/2006: Amendments have been made to improve good manufacturing practices, in particular recycled plastics and quality control measures in the production of plastic materials and products intended for contact with food.

Commission Regulation (EU) 2025/351 provides for an exemption period to facilitate a smooth transition. This means that plastic materials and products that comply with the previous regulations and were placed on the market before 16 September 2026 will continue to be sold until stocks are exhausted.

This regulation is significant because it significantly strengthens the safety, quality, and regulatory clarity for plastic materials and articles intended to come into contact with food, particularly in the context of recycled plastics and sustainability. It also modernizes and strengthens the European Union's legal framework for plastic materials and articles intended to come into contact with food.

The main reasons why this regulation is so important are:

• Protects human health: By clarifying composition rules and aligning them with the latest scientific knowledge, it ensures that plastics used in food packaging and containers do not leach harmful substances into food.
• Improves recycled plastic standards: Supports the safe use of recycled plastics, vital to circular economy goals, by updating requirements and repealing outdated rules. This helps make recycling more viable and safer.
• Improves industry clarity and compliance: Helps manufacturers comply more easily and accurately by removing ambiguous wording (for example, clarifying what counts as plastic sheeting) and clearly stating which parts of a product the rules apply to.
• Supports the European green deal: This regulation is part of the European Union's broader effort to make food systems more sustainable by reducing reliance on virgin plastics and improving the safety of recycled materials.

In short, Regulation (EU) 2025/351 plays a critical role in protecting public health, promoting sustainable materials and increasing legal clarity in the food packaging and plastics industries.

Under Regulation (EU) 2025/351, several critical tests and compliance measures are mandatory to ensure the safety and suitability of plastic materials and articles intended for food contact. These tests focus on chemical migration, material purity, and the stability of materials under repeated use:

• Specific migration test: This test measures the amount of a specific substance that migrates from plastic material into food or food simulants. The regulation stipulates:
  • Three consecutive migration tests should be performed on a single sample, each containing a fresh portion of food simulant.
  • Suitability is assessed based on the third test result and the consistency of results across all three tests.
  • The analytical methods used must meet specific performance criteria, including defined working ranges and limits of quantification.
• General migration test: This test evaluates the total amount of non-volatile substances migrating from plastic to food simulants. It is similar to the specific migration test:
  • Three sequential tests are performed on a single sample.
  • Suitability is determined by the third test and the stability of migration levels between tests.
• Purity and unintentional added substances assessment: Substances used during production must demonstrate a high degree of purity. For this test:
  • If migration exceeds 0,00015 mg per kg of food, a detailed risk assessment is required.
  • This is in line with REACH regulations and EFSA's risk assessment standards.
• Repeated use stability test: For materials designed for repeated use:
  • Three migration tests are performed to evaluate stability across multiple uses.
  • Compliance is confirmed if migration levels do not increase throughout the tests and remain within the specified limits.
• Surface-to-volume ratio considerations: The regulation allows:
  • Using the actual surface-to-volume ratio of the plastic material for testing.
  • Alternatively, a flat rate may be applied in certain cases where determining the actual rate is impractical.
• Documentation and traceability: Manufacturers must:
  • Providing detailed documentation on the composition and purity of the substances used.
  • Ensuring traceability of materials throughout the production process.

These comprehensive testing requirements aim to enhance consumer safety by ensuring that plastic materials and articles used in food contact applications do not release harmful substances into food.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services to businesses in accordance with "Testing in accordance with Regulation (EU) 2025/351."