EU Revises Food Contact Material Regulations

SafeGuardSHardgoodsMar 04, 2025

SG 036/25

The European Union (EU) has amended three laws associated with food contact materials (FCM) and articles. The revisions will become effective on March 16, 2025.

On February 24, 2025, the EU issued Commission Regulation (EU) 2025/351 (the Regulation) to revise three pieces of legislation on food contact materials (FCM) and articles:

Regulation (EC) No. 2023/2006 on good manufacturing practice (GMP) (consolidated version to April 2008)
Regulation (EU) No.10/2011 on food contact plastics (consolidated version to January 2025)
Regulation (EU) 2022/1616 on food contact recycled plastics (consolidated version to September 2022)

The Regulation amends quality assurance system requirements for recyclers and introduces new provisions for ‘materials intended for reprocessing’ under the GMP regulation. It clarifies that Article 8(1) does not apply to contaminants in the input and output of decontamination processes in the food contact recycled plastics regulation.

Additionally, it revises several provisions in Regulation (EU) No. 10/2011 on food contact plastics. These include but are not limited to, definitions, the concept of ‘purity’ for substances used in the manufacture of FCM and articles, documentation and labeling requirements, as well as indicators for specific migration limits (SML) and the stability rule.

Highlights of several amendments to Regulation (EU) No. 10/2011 on food contact plastics are summarized in Table 1.

Amendment to Regulation (EU) No. 10/2011 ‘Food Contact Plastics’	Highlights
Article 2 ‘Scope’	Emphasizes that it is applicable to substances that may be used in the manufacture of adhesives, coatings and printing inks and applied on or incorporated in plastic materials and articles
Article 3 ‘Definitions’	Improves the definition for ‘additive’ Adds definitions for ‘reprocessing of plastic’ and substances that are of ‘unknown or variable composition, complex reaction products or of biological materials’ (UVCB)
Article 3a ‘High degree of purity’	A substance is considered as having a high degree of purity if all its constituents form part of its identity, and it otherwise contains a minor quantity of non-intentionally added substances (NIAS) that meet one of the following conditions: They comply with specifications or restrictions listed in Table 1 to Annex I (Union List) They are considered compliant after a risk assessment in accordance with internationally recognized scientific principles (Article 19) ≤ 0.05 mg/kg for an individual migration if a relevant toxicological assessment has been performed and the substances are not genotoxic ≤ 0.00015 mg/kg for the migration of each substance if they have undergone a risk assessment other than an assessment in points ii and iii above
Article 4 ‘Placing on the market of plastic materials and articles’	Emphasizes that food contact recycled plastics may only be placed on the market if they comply with Regulation (EU) 2022/1616
Article 8 ‘General requirements on substances’	Stresses that substances, including those manufactured from waste, must be of a high degree of purity if they are used in the manufacture of plastic materials and articles and are present in the finished plastic material
Article 10 ‘General restrictions and requirements concerning the composition of plastic materials and articles’	Allows the use of ‘reprocessed plastics’, subject to meeting specified conditions Food contact articles intended for repeated use must have a composition and design that guarantees no increase in the migration of constituents of the material or article to the food will occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labeling
Chapter IV ‘Labeling, Declaration of Compliance and Documentation’	Article 14a details new labeling requirements for final repeated use food contact articles with the following: Appropriate instructions designed to slow down deterioration Description of observable changes that may indicate deterioration of the material or article A warning in case of specific damage or foreseeable misuse that would cause increased migration or the article to become unsuitable for further use in food contact applications Food contact plastic materials and articles that are not yet in contact with food must be accompanied by instructions for use, in accordance with Article 15 (1) of Regulation (EC) No.1935/2004, at the moment of sale or supply to consumers at the retail stage, with one of the following elements: Specific foods or groups of foods Contact time and/or temperature, and/or Heating conditions such as oven and microwave use Instructions for use must include adequate information for safe use of the article and restrictions
Article 16 ‘Supporting documents’	Details the documentation requirements for demonstrating compliance
Article 17 ‘Expression of migration results’	Replaces language in point 2 for derogation with: A surface to volume ratio ≥ 6 dm² per kg of food may be applied for the following: Containers and other articles with a volume of less than 500 ml or more than 10 liters A material or article for which it is impracticable to estimate the ratio of its surface area and the quantity of food in contact with it Sheets and films that are not yet in contact with food Sheets and films containing a volume of less than 500 ml or more than 10 liters
Annex III Table 2 Food category specific assignment of food simulants’	Modifies language and food simulants for ‘cheeses’ (reference number 07.04)
Annex V ‘Compliance testing’	Revises introductory text indicating that the selection of an analytical method for migration testing is in accordance with Article 34 to Regulation (EU) 2017/625 by applying defined performance criteria Replaces point 2.1.6 ‘Repeated use materials and articles’: New indicators for non-compliance on migration test New indicators for compliance with the SML and stability rules Replaces point 3.3.2 ‘Repeated use materials and articles’ with new language

Table 1

Food contact plastics that comply with Regulation (EU) No.10/2011 before the Regulation enters into force, and any relevant EU legislation, and that were first placed on the market before September 16, 2026, may remain on the market until stocks are exhausted.

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