Commission Regulation (EU) 2025/351 of 21 February 2025 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, amending Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008, and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food as regards recycled plastic and other matters related to quality control and manufacturing of plastic materials and articles intended to come into contact with food

‘3 This Regulation shall be without prejudice to Union or national provisions 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.’

2 Article 3 is amended as follows: (1) point (7) is replaced by the following: ‘(7) “additive” means a substance which is intentionally added to the plastic to achieve a physical or chemical effect during processing of the plastic or in the final material or article and it is intended to be present in the final material or article, including substances in a solid state the surface of which becomes bonded to the polymers that constitute the plastic.’; (2) the following points are added: ‘(20) “reprocessing of plastic” means the remelting, mixing, reacting or otherwise processing of plastic materials that result as a by-product from an intermediate or final manufacturing operation in the manufacture of plastic materials and articles, alone or combined with material originating from other manufacturing operations, by applying, if necessary, transfer and operations to make the use of these by-products possible again. (21) “UVCB substance” means a substance of unknown or variable composition, complex reaction products or a material of a biological or other natural origin.’.

3 A new Article 3a is added: 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.’

1 Substances used in the manufacture of plastic materials and articles that may be present in the final plastic material, including those manufactured from waste, shall be of a high degree of purity and shall be of a technical quality suitable for the intended and foreseeable use of the materials or articles. The composition shall be known to the manufacturer of the substance.

2 By derogation from paragraph 1, as regards purity, UVCB substances that are identified by a name in this Regulation that refers to a natural multi constituent material the source of which is biological or mineral, may be used as obtained from their natural origin, provided they do not contain substances or materials that do not correspond to its identity as designated by that name. Any additional specifications or requirements applicable to a substance or material of natural origin set out in Table 1 of Annex I, applicable to the substance or material, shall apply.’

1 Plastic materials and articles shall meet the restrictions on plastic materials and articles laid down in Annex II.

2 Plastic materials and articles may contain reprocessed plastic if such reprocessed plastic meets the following conditions: (a) it is a by-product in accordance with Article 5 of Directive 2008/98/EC of the European Parliament and of the Council; (b) it is collected and used in accordance with section C of the Annex to Regulation (EC) No 2023/2006; (c) it originates from one of the following off-cuts and scraps from plastic materials and articles: (i) off-cuts and scraps from plastic materials and articles referred to in point (a) of Article 2(1) that meet the compositional requirements set out in Chapter II of this Regulation, or (ii) off-cuts and scraps from plastic materials and articles referred to points (b) and (c) of Article 2(1), provided that such reprocessed plastic does not contain a layer which functions as a functional barrier and all of its individual constituents either meet the compositional requirements set out in Chapter II of this Regulation, or have been subject to risk assessment on the basis of Article 19 taking into account the conditions of reprocessing and their presence in the reprocessed material; (d) it does not contain substances in an amount which could: (i) exceed migration limits applicable for the substance as specified in this Regulation; or (ii) cause any other non-compliance of those plastic materials and articles with Article 3 of Regulation (EC) No 1935/2004.

3 Where intended for repeated use in contact with food, the composition and the design of final food contact articles shall be such, so 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.

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.

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.’.

1 Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request. For substances used in the manufacture of plastic materials and articles, documentation on the composition shall be made available to the competent authorities on request, together with any documentation regarding their degree of purity.

2 That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance. Rules for experimental demonstration of compliance are set out in Chapter V.

3 Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that documentation showing compliance with paragraphs 1 to 2 of Article 8 is part of the documentation referred to in paragraph 1.

4 Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that competent authorities can take samples during the carrying out of official controls to verify their degree of purity and their composition, including that of the substances and materials used for their manufacture.’

‘2 The requirements set out in Chapters II and III and Chapter V of Regulation (EU) No 10/2011 shall apply to recycled plastic materials and articles. Article 8(1) thereof shall not apply to the contaminants in the input and the output of decontamination processes and the quality and purity of the input and output shall be in accordance with this Regulation.’.

The Annex to Regulation (EC) No 2023/2006 is amended in accordance with Annex II to this Regulation.

1 Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and any other relevant Union legislation, which were first placed on the market before 16 September 2026 may continue to be placed on the market until the exhaustion of stocks.

2 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 16 December 2025 does not comply with this Regulation, the declaration of compliance accompanying that substance or product shall indicate that it does not comply with this Regulation, and that it can only be used in the manufacture of plastic materials and articles to be placed on the market before 16 September 2026.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.