Explaining amendment 19 to the Food Contact Regulation

Outlining the key amendments to this important European legislation.

Following the publication of Commission Regulation (EU) No 2025/351 in the first quarter of 2025, Commission Regulation (EU) No 10/2011 has been amended to incorporate a number of changes. This was the 19^th amendment to the regulation, and the current consolidated version is now dated 16^th March 2025.

A major change to the regulation of which manufacturers of food contact articles will need to be aware is an update to the food category specific assignment of food simulants given in Annex III. This amendment expands entry 07.04 (cheeses) to include a wider range of more specific types of cheese, as well as the simulants against which testing must be conducted to show that products are suitable. Suppliers will need to be aware of the new requirements and ensure that they take these into account when marketing products for specific uses.

Purity of plastics

One of the key changes introduced by the new amendment is to define requirements for the purity of plastics intended to come into contact with food. Article 8 of the regulation states that substances used in the manufacture of plastic materials and articles must have a ‘high degree of purity’. This is defined in Article 3A as ‘having all constituents correspond to the identity of the material, otherwise containing only a small amount of non-intentionally added substances’.

Such substances must comply with any applicable specifications or restrictions given in the regulation, or must have undergone risk assessments, toxicological assessments or analytical testing to demonstrate that they do not cause harm. Documentation regarding the composition of the materials and their purity must be made available to competent authorities upon request, and provision must be made to allow the sampling of products to verify this.

Recycled or re-processed plastic

The update to the regulation also addresses the use of recycled or re-processed plastic in food contact materials. This includes a stipulation within Article 4 that plastics containing recycled materials may only be placed into the market if they comply with Commission Regulation (EU) 2022/1616.

Furthermore, conditions are imposed for the use of re-processed plastics, including a requirement that these must be classified as ‘by-products’ as defined by the Waste Framework Directive (2008/98/EC) and must have been collected in accordance with Section C of the Annex to the Good Manufacturing Practice Regulation (EC) No 2023/2006. Confirmation of this must be provided in the Declaration of Compliance for the re-processed material.

In addition, the re-processed plastic must be derived from articles consisting entirely of plastic which complies with the compositional requirements of Commission Regulation (EU) No 10/2011. Plastic sourced from multi-layer materials or coated plastics may be used, provided the article they originate from does not contain a layer which forms a functional barrier, and all layers and materials present in the article comply with the composition requirements of Commission Regulation (EU) No 10/2011. The re-processed plastic must also not contain any substances in excess of applicable specific migration limits, or which could otherwise cause non-compliance of the finished article with Regulation (EC) No 1935/2004.

User instructions and warnings

Concerns regarding articles intended for repeated use are also addressed in the revision to the regulation. These include requirements that the design and composition of such products must ensure that there is no increase in the migration of substances into food after repeated uses. Products must also be accompanied by instructions on how to reduce deterioration, and a description of any visual changes which could indicate that significant deterioration has occurred.

In addition, a warning must be provided giving details of any damage or misuse that could cause increased migration of substances from the product into food, or otherwise render it unfit for purpose. The regulation also clarifies the acceptance criteria for specific and overall migration in repeat-use articles.

As well as imposing labelling requirements for repeat-use articles, the amendments also introduce several other requirements relating to labelling and documentation. These include a stipulation that products which include a Union List substance that is subject to specific restrictions must include instructions informing the end user of how the product is to be safely used. The Union List is a table of substances defined in Annex I of Commission Regulation (EU) No 10/2011.

The safety instructions must be available to the consumer at the point of sale, and should include restrictions such as unsuitable food types, restrictions upon contact time or temperature and safe heating conditions. The regulation also states that the Declaration of Compliance must include adequate information about non-intentionally added substances, where these are present at levels that could cause the finished article to be non-compliant with Regulation (EC) No 1935/2004.

Additional changes

Other notable changes to the regulation include a derogation that substances with biocidal properties which are not included in the Union List may be used as additives, provided they are made available on the market in accordance with Regulation (EU) No 528/2012 for product-type 4 (for use that includes their incorporation into plastics which may come into contact with food).

The amended regulation also clarifies the applicability of overall and specific migration limits to multi-layer articles, stating that these requirements will apply if the surface layer coming into contact with food is within the scope of the regulation. Finally, the regulation also stipulates performance criteria for analytical test methods used to assess conformity for with specific migration limits.

The changes implemented within the 19^th amendment to Commission Regulation (EU) No 10/2011 are very extensive, and manufacturers and suppliers of food contact articles will need to ensure that they understand and comply with these. The amendment will come into force on 16^th September 2026. Plastic materials and articles compliant with the previous version of the regulation which were first placed onto the market before this date will be permitted to continue to be placed onto the market until stocks are exhausted.

Intermediates or substances intended for use in the production of food contact articles which do not comply with the requirements of the 19^th amendment, must include a statement of this in their Declaration of Compliance if they are placed onto the market after 16^th December 2025. This statement should indicate that the intermediate or substance is only suitable for use in the manufacture of products which will be placed onto the market before 16^th September 2026.

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