EU food contact plastic regulations update! (EU) 2025/351 regulation released

On February 24th, 2025, the EU issued the Regulation (EU) 2025/351, which revised the Regulation (EU) No.10/2011 on plastic materials and articles intended to come into contact with food, the Regulation (EU) No.2022/1616 on recycled plastic materials and articles intended to come into contact with foods, and the Regulation (EC) No.2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food, and invalidated Regulation (EC) No 282/2008. Regulation (EU) 2025/351 will come into effect on March 16th, 2025.

The main revisions are as follows:

I. Revision of the Regulation (EU) No.10/2011 on plastic materials and articles intended to come into contact with food
1. Definition adjustment and "High degree of purity" requirements
The definition of "additive" is updated, and the definitions of "reprocessing of plastic", "UVCB substance" and "High degree of purity" are added. Clarify the requirements of "High degree of purity" substances, and clearly define the requirements of "High degree of purity" substances from the aspect of "non-intentionally added substances".

A new Article 3a High degree of purity is added:
“Article 3a
High degree of purity
A substance used in the manufacture of plastic materials and articles shall be considered as having a high degree of purity where all of its constituents correspond to its identity, and it otherwise contains only a minor amount of non-intentionally added substances that individually fulfil one of the following conditions:
(i)they comply with the specifications or restrictions specified in the authorisation of the substance in Table 1 of Annex I, if any;
(ii)they have been subject to a risk assessment in accordance with Article 19 and considered compliant;
(iii)they have been subject to a toxicological assessment in accordance with the relevant guidance adopted by the Authority, which concludes that genotoxicity is ruled out, and that, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, it can be reasonably assumed that none of the substances will be present in the final plastic material or article at a level that could give rise to a migration such as to their individual presence in food exceeding 0,05 mg/kg;
(iv)they have not been subject to an assessment specified in points (ii) or (iii), but to a risk assessment which concludes, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, that it can be reasonably assumed that they cannot be present in the final plastic material or article at a level that could give rise to a migration into food such as to their individual presence in food exceeding 0,00015 mg/kg.
For the purpose of point (iii), the individual assessment of genotoxicity may be substituted with a group assessment of genotoxicity, if the assessed substances are chemically related and belong to the same or similar functional groups that could give rise to toxicity, or if the substances are obtained as a mixture representative for migration into food and this mixture is assessed through appropriate methods.”

2. Substance use regulations are refined
It is emphasized that only substances included in the list of substances authorized by the European Union can be used to manufacture plastic materials and products. It is clearly pointed out that substances not covered in the EU list can be used as polymer production AIDS, colorants, solvents, etc. in the production of plastic materials and articles subject to national laws; Standardize the use of functional substances in biocide products.

Functional substances for biocide products
“substances with a biocidal function used in biocidal products that may be made available on the Union market in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council for product-type 4 for use that covers incorporation into plastic materials and articles which may enter into contact with food, may be used as additives in the manufacturing of plastic materials and articles.”

3. Materials and products are required to be updated
It is stipulated that plastic materials and products should meet the relevant restrictions, and the use conditions of recycled plastics should be defined; For reusable food contact products, it is necessary to ensure that the ingredients and design will not increase the migration of ingredients when used according to the instructions; Improve the relevant provisions of labels, compliance statements and supporting documents.

A new Article 14a Labelling is added:
“Article 14a Labelling
14.1.   The manufacturer or other operator responsible for placing on the market a final plastic food contact article intended for repeated use, shall provide to its users in accordance with Articles 15(7) and (8) of Regulation (EC) No 1935/2004 the following:
(a)appropriate instructions designed to slow down deterioration of the article;
(b)a description of observable changes of the article that may indicate the deterioration of the article or material;
(c)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.
14.2.   Plastic materials and articles intended to be brought into contact with food but which are not yet in contact with it shall be accompanied at the moment of their sale or supply to consumers at retail stage with instructions of use, in accordance with Article 15(1) of Regulation (EC) No 1935/2004, directed at the consumer of that final food contact article, where they are manufactured with substances included in the Union list of authorised substances, for which column 10 of Table 1 of Annex I sets out restrictions related to one or more 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.
The instructions of use shall mention the restrictions and provide the consumer with adequate information to avoid using the article under conditions not complying such restrictions.”

Revision of Article 16 Supporting documents
“The manufacturer shall provide the material composition and purity documents as required by the competent authority.”

4. Revisions related to compliance testing
Adjust the migration test rules, optimize the application of surface volume ratio, and correct the calculation method of test results; Improve compliance test standards, standardize the selection of analysis methods, test times and result evaluation standards.

II. Revision of the Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods
It is clear that recycled plastic materials and products should meet the requirements specified in Chapter II, Chapter III and Chapter V of (EU) No 10/2011. In addition, it is stipulated that Article 8(1) of (EU) No.10/2011 is not applicable to pollutants in the input and output of purification process, and the quality and purity of input and output substances in the purification process should meet the requirements of (EU) 2022/1616.

III. Revision of the Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food
Improve the requirements of the quality assurance system of recycling facilities and add relevant provisions in the quality evaluation stage of recycling process; Standardize the plastic reprocessing process, including waste collection, storage, transportation and prevention of mixed pollution.

Transitional measures:
For plastic materials and products
Plastic materials and products that meet the old regulations, which are first put on the market before September 16, 2026, can continue to be sold until the inventory is exhausted.
For intermediate materials
If the intermediate materials that meet the old regulations are put on the market for the first time after December 16th, 2025, but do not meet the regulation (EU) 2025/351, the substance or product must be indicated in the attached declaration of conformity that it does not meet the regulation, and can only be used to manufacture plastic materials and products that are put on the market before September 16th, 2026.

CTT tips:
The EU officially promulgated the Regulation (EU) 2025/351, which revised and invalidated four original regulations closely related to food contact with plastic materials and products. This revision focuses on key areas such as plastic purity, biocides, compliance of recycled plastics and production specifications. Relevant enterprises should pay close attention to these new changes and requirements. Specifically, enterprises need to strictly screen raw materials to ensure that they meet the "High degree of purity" requirements of the new regulations; Enterprises related to recycled plastics should continuously optimize their production processes to improve product quality; Further improve the quality control system and strengthen the quality control of all links; At the same time, standardize the product conformity declaration and other relevant compliance documents to ensure the accuracy and completeness of the contents of the documents.