European Commission Publishes Amendments to Plastic Food Contact Materials Regulation

On February 24, 2025, the European Union published Commission Regulation (EU) 2025/351, which mainly amended the regulation on (EU) No.10/2011 on food contact plastics. 
The revision is effective since 16 March 2025 and will come into application on 16 September 2026.

The Regulation notably aims at:

• Specify the rules on the verification of compliance testing of the specific migration and stability of the article
Significant update concerns the compliance testing for repeatedly used food contact of plastic articles in Chapter 2 of Annex V, point 2.1.6 with the introduction of new indicators to better evaluate compliance with the specific migration limit (SML) and stability rules.

New indicator used in the calculation method outlined in the regulation is the measurement uncertainty calculated according to the Horwitz equations.
The new metric is used to evaluate the difference between the 3rd specific migration result and the SML, as well as the difference between the 1st, 2nd and 3rd consecutive migrations.
The key is to judge whether these differences are significant when referring to the measurement uncertainties to draw conclusions on whether the product complies with SML and stability.

• Introduce specific requirements on labelling
Instructions of use and appropriate instructions related to the deterioration of the article shall be provided to the users.

For substances for which column 10 of Table 1 of Annex I sets out restrictions, instructions of use include restrictions relatives to:
-    specific foods or groups of foods
-    contact time and/or temperature
-    heating conditions such as oven and microwave use
-    adequate information to avoid using the article under conditions which are not mentioned

Appropriate instructions related to the deterioration of the article include:
-    advices to slow down deterioration
-    observable changes that may indicate deterioration
-    a warning in case specific damages would cause the article to become unsuitable for food contact use

• Set requirements for substances used in the manufacture of plastic materials and articles by introducing the notion of high degree of purity for substances
Documentation on the composition shall be made available to the competent authorities on request, together with any documentation regarding their degree of purity.
Samples could also be taken by the competent authorities during the carrying out of official controls.

• Set requirements concerning the composition of plastic materials and articles intended for repeated use in contact with food
The composition and the design of final food contact articles shall be such as to guarantee that no increase in the migration of constituents of the material or article to the food would occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labelling.

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