EU Releases Regulation (EU) 2025/351, Amending Key Regulations on Plastic Food Contact Materials to Enhance Quality Control

On February 24, 2025, the European Union (EU) published Commission Regulation (EU) 2025/351, which revises three key regulations related to plastic food contact materials (highlighted in red in the table below) and will take effect on March 16, 2025.

Table 1 Regulations governing plastic food contact materials (FCMs) in the EU

Key Revisions

1. Amendment to Commission Regulation (EU) No 10/2011 on plastic FCMs

i. Introducing high-purity requirements for substances used in plastic manufacturing

Commission Regulation (EU) 2025/351 (hereinafter the Regulation) mandates that substances used in the manufacture of plastic materials—including those manufactured from waste—must have a high degree of purity. The specific criteria for this purity are detailed in Article 3a. For example, they should comply with the specifications or restrictions specified in the authorisation of the substance in Table 1 of Annex I.

ii. Putting forward restrictions on plastic materials containing reprocessed plastic or intended for repeated use in contact with food

New restrictions are imposed regarding the composition of plastic materials containing reprocessed plastic. These materials may only include reprocessed plastic if specific conditions outlined in the Regulation are met, including conforming to section C of the Annex to Regulation (EC) No 2023/2006. Additionally, plastic materials intended for repeated food contact use must be designed to prevent any increase in the migration of constituents during subsequent use cycles.

iii. Adding mandatory labeling requirements for responsible entities to provide

A new article (Article 14a) introduces labeling requirements for manufacturers or other operators responsible for placing final plastic food contact articles intended for repeated use on the market. They must provide users with:

• Appropriate instructions designed to slow down deterioration of the article

• A description of observable changes of the article that may indicate the deterioration of the article or material;

• A warning in case specific damages or foreseeable misuse would cause increased migration or would cause the article to become otherwise unsuitable for further use in contact with food.     

For plastic materials and articles intended for food contact but not yet in contact with food when placed on the market, the new article requires that instructions for use be provided. These instructions must include any restrictions and offer consumers sufficient information to prevent using the article in non-compliant conditions.

iv. Strengthening supervision of the manufacturing process 

The Regulation stipulates that not only plastic materials and articles, but also substances and products from intermediate stages shall be subject to the sampling conducted by competent authorities to verify their degree of purity and composition.

v. Other clarifications and revisions

• The term "plastic layers" has been removed from several provisions to eliminate ambiguity, acknowledging that in many situations, plastic materials and articles do not conform to a layer structure but consist of a single homogenous material with a complex shape.

• The definition of “additive” is refined to include substances in a solid state the surface of which becomes bonded to the polymers that constitute the plastic.

• Revisions to Annex III (Food Simulants), Annex IV (Declaration of Compliance), and Annex V (Compliance Testing) include updates on simulants for cheese, new requirements for the Declaration of Compliance for plastic material intended for reprocessing, updated rules on the verification of compliance testing, etc.

• This Regulation cites content from the following regulations to ensure consistency, including a) Commission Regulation (EU) 2022/1616 for recycled plastic FCMs; b) Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products; and c) the concept of UVCB substances from Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

2. Amendment to Regulation (EU) 2022/1616 on recycled plastic FCMs

The amendment to Regulation (EU) 2022/1616 clarifies that the high purity requirement in Regulation (EU) No 10/2011 does not apply to substances in the input or output of the decontamination process for plastic waste, as Regulation (EU) 2022/1616 ensures the removal of incidental contamination during the manufacturing of recycled plastic materials intended for food contact.

3. Amendment to Annex of Commission Regulation (EC) No 2023/2006 on good manufacturing practice (GMP) for FCM

• Commission Regulation (EU) 2022/1616 for recycled plastic FCMs is cited as the minimum requirement for recyclers to implement the quality assurance system.

• The quality assurance system is newly required to include specific operations in the recycling process. Recyclers shall assess the quality of each batch of material directly originating from a manufacturing stage. Items to be verified during the assessment are also detailed.

• Additionally, this Regulation adds new requirement for quality assurance system regarding the reprocessing of plastics within the scope of Regulation (EU) No 10/2011, to supervise the suitable use of plastic by-product and prevent the contamination of plastic by-product during different stages.

Transitional Provisions

• Plastic materials and articles compliant with Regulation (EU) No 10/2011, as applicable before this Regulation's entry into force, and other relevant Union legislation, may continue to be marketed until stocks are exhausted, provided they were first placed on the market before September 16, 2026.

• In case a product from an intermediate stage of the manufacturing of plastic materials and articles or a substance intended for the manufacturing of such a product, material or article, which complies with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation and which is first placed on the market after December 16, 2025 does not comply with this Regulation, the accompanying declaration of compliance must indicate this non-compliance and specify that it can only be used in the manufacture of plastic materials and articles to be placed on the market before September 16, 2026.

ChemLinked Solutions

FCM team of REACH24H Consulting Group, the founder of ChemLinked, is professional in regulatory compliance services in the U.S., EU, China, Canada, MERCOSUR, Switzerland, etc. With successful experience, we have helped numerous customers solve their food contact material compliance problems in the above-mentioned countries and regions, including but not limited to ESFA/FDA Post-Consumer Recycled (PCR) Plastic for FCMs Registration Service, Declaration of Compliance (DoC) Editing/Checking, U.S. FCN Application, and China/EU New Food Contact Substance Application. For any assistance, please feel free to contact [email protected].