On March 16, 2025, Regulation (EU) 2025/351 entered into force in the European Union. This regulation introduces significant amendments to Regulation (EU) 10/2011 on plastic food contact materials (FCMs) and articles (FCAs), as well as minor updates to Regulation (EU) 2022/1616 on recycled plastics FCMs and Regulation (EC) 2023/2006 on good manufacturing practice of FCMs and FCAs.
Some of the topics addressed in the regulation include the scope of existing legislation, purity standards to address non-intentionally added substances (NIAS), as well as labeling and testing requirements for repeat use articles.
Scope
The definition of a plastics additive has been broadened. It now additionally includes “substances in a solid state whose surface becomes bonded to the polymers that constitute the plastic material.”
Purity and non-intentionally added substances
The regulation introduces stricter requirements for NIAS by incorporating the concept of a “high degree of purity” (Article 3a). Substances used in the manufacture of plastic materials that may be present in the final article must meet this standard. A high degree of purity is defined as containing minimal levels of NIAS. Each NIAS must individually meet one of the following criteria:
- Compliance with the specifications or restrictions in the Union List (Regulation (EU) 10/2011, Annex I, Table 1),
- Compliance following a risk assessment as described in Regulation (EU) 10/2011 Article 19,
- Migration not exceeding 0.05 mg/kg, provided that sufficient evidence exists that the substance is not genotoxic,
- Migration not exceeding 0.00015 mg/kg if none of the above points apply.
Repeated use and labeling
Article 14a of the new regulation introduces new labeling requirements for repeated use food contact articles. These must include:
- Instructions aimed at minimizing material deterioration,
- Descriptions of observable changes that may indicate degradation,
- Warnings regarding specific types of damage or foreseeable misuse that could result in increased migration or render the article unsuitable for further use.
The composition and design of repeated use plastic articles must ensure that the migration of constituents into food does not increase during repeated use cycles, as long as used per labeled instructions.
Additionally, plastic materials and articles not yet in contact with food must be sold or supplied with appropriate instructions for use, in line with Article 15(1) of Regulation (EC) 1935/2004. These instructions must include one or more of the following:
- Types of food or food groups intended for contact,
- Contact time and/or temperature parameters,
- Heating conditions, such as for oven or microwave use.
The instructions must contain sufficient information to ensure the safe use of the material or article.
Testing
The regulation introduces requirements for both overall and specific migration testing for plastic layers in multi-material multi-layer articles that fall under the scope of this regulation, when the plastic layer is in direct contact with food.
Testing procedures for repeated use articles are specified. To comply, they need to be tested three times, where the migration must not increase for consequent testing cycles.
Further changes in the new regulation include among others:
- requirements for reusing by-products from the plastics manufacturing process
- introduction of substances of unknown or variable composition, complex reaction products, or a material of a biological or other natural origin (UVCB substances)
- updates to the minimum requirements for quality assurance systems in plastic recycling facilities
- extended documentation requirements aimed at improving transparency along the supply chain
Plastic materials falling under the new regulation that have been placed on the market before September 16, 2026, may continue to be sold until stocks are exhausted.
Note: This article has been updated and corrected on June 6, 2025, as the scope was wrongfully stated. The updated regulation does not apply to adhesives, coatings, and inks, as stated in Regulation (EU) 2025/351.
Reference
European Union (February 24, 2025) “Commission Regulation (EU) 2025/351.”
Read more
Luke Buxton (March 14, 2025) “Amended EU plastic FCMs regulation sparks compliance concern.” Chemical Watch News & Insight
SGS (March 4, 2025) “EU revises food contact material regulations.”
UL Solutions (March 12, 2025) “European Commission releases amendments to food contact materials regulations.”
AIMPLAS (April 15, 2025) “Regulation 2025/351: A key update in food safety.”
