Article 1 · Commission Regulation (EU) 2025/351

Contents

Article 1Amendments to Regulation (EU) No 10/2011#

1.Article 2, paragraph 3 is replaced by the following:‘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.’.

10.In Article 9, paragraph 1, the phrase ‘plastic layers in’ is deleted.

11.Article 10 is replaced by the following:‘Article 10General restrictions and requirements concerning the composition of plastic materials and articles1.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^note;

(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.^note

12.Article 13 is amended as follows:

(1)in point (b) of paragraph 2, the phrase ‘in the provisional list’ is deleted;

(2)in paragraph 4 the phrase ‘or provisional list’ is deleted.

13.The title of Chapter IV is replaced by the following:‘LABELLING, DECLARATION OF COMPLIANCE AND DOCUMENTATION’.

14.A new Article 14a is added:‘Article 14aLabelling1.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.

—specific foods or groups of foods,

—contact time and/or temperature, and/or

—heating conditions such as oven and microwave use.

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: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.’.

15.Article 14 is amended as follows:

(1)in paragraphs 2 and 3, the phrase ‘or the provisional list’ is deleted;

(2)paragraph 4 is replaced by the following:‘4.Articles 11 and 12 apply to multi-material multi-layer materials and articles when the surface layer that is in contact with food is made of a material falling within the scope of this Regulation.’;

(3)paragraph 6 is replaced by the following:‘6.If the surface layer that is in contact with food is made of a material falling not within the scope of this Regulation, specific and overall migration limits for plastic layers and for the final material or article may be established by national law.’.

16.Article 16 is replaced with the following:‘Article 16Supporting documents1.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.’.

17.In Article 17, paragraph 2 is replaced with the following:‘2.By derogation from paragraph 1, a surface to volume ratio equal or higher than 6 dm² per kg of food may be applied for the following materials and articles:

(a)containers and other articles, containing or intended to contain a volume of less than 500 ml or more than 10 litres;

(b)a material or article for which, due to its form, it is impracticable to estimate the relationship between its surface area and the quantity of food in contact therewith;

(c)sheets and films that are not yet in contact with food;

(d)for sheets and films containing a volume less than 500 ml, or more than 10 litres.

This paragraph does not apply to plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council^note.^note

18.Annexes III to V are amended in accordance with Annex I to this Regulation.

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:‘Article 3aHigh degree of purityA 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.’.

4.In Article 4, the following point is added:

(f)comply with Commission Regulation (EU) 2022/1616^note if they fall within the scope of that Regulation.

^note

5.In Article 5, paragraph 1 is replaced by the following:‘1.Only the substances included in the Union list of authorised substances (hereinafter referred to as the Union list) set out in Annex I may be used in the manufacture of plastic materials and articles.’.

6.In Article 5, the following paragraph is added:‘4.In case of doubt over the resulting designated identity of a substance, a Member State or the Commission may consult the Authority.’.

7.Article 6 is amended as follows:

(1)paragraph 1 is replaced by the following:‘1.By way of derogation from Article 5, substances other than those included in the Union list may be used as polymer production aids in the manufacture of plastic materials and articles subject to national law.’;

(2)paragraph 2 is replaced by the following:‘2.By way of derogation from Article 5, colorants and solvents may be used in the manufacture of plastic materials and articles subject to national law.’;

(3)paragraph 4 is replaced by the following:‘4.The following substances not included in the Union list may be present in plastic materials or articles:

(a)non-intentionally added substances;

(b)aids to polymerisation.’

;

(4)paragraph 5 is replaced by the following:‘5.By way of derogation from Article 5, 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^note 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.^note

8.Article 7 is deleted.

9.Article 8 is replaced by the following:‘Article 8General requirements on substances1.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.’.