LegalizeCommission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation establishes specific requirements for the manufacture and marketing of plastic materials and articles:
(a) intended to come into contact with food; or
(b) already in contact with food; or
(c) which can reasonably be expected to come into contact with food.
Article 2
Scope
This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:
(a) materials and articles and parts thereof consisting exclusively of plastics;
(b) plastic multi-layer materials and articles held together by adhesives or by other means;
(c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating;
(d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
(e) plastic layers in multi-material multi-layer materials and articles.
This Regulation shall not apply to the following materials and articles which are placed on the EU market and are intended to be covered by other specific measures:
(a) ion exchange resins;
(b) rubber;
(c) silicones.
Article 3
Definitions
For the purpose of this Regulation, the following definitions shall apply:
(1) ‘plastic materials and articles’ means: (a) materials and articles referred to in points (a), (b) and (c) of Article 2(1); and (b) plastic layers referred to in Article 2(1)(d) and (e);
(2) ‘plastic’ means polymer to which additives or other substances may have been added, which is capable of functioning as a main structural component of final materials and articles;
(3) ‘polymer’ means any macromolecular substance obtained by: (a) a polymerisation process such as polyaddition or polycondensation, or by any other similar process of monomers and other starting substances; or (b) chemical modification of natural or synthetic macromolecules; or (c) microbial fermentation;
(4) ‘plastic multi-layer’ means a material or article composed of two or more layers of plastic;
(5) ‘multi-material multi-layer’ means a material or article composed of two or more layers of different types of materials, at least one of them a plastic layer;
(6) ‘monomer or other starting substance’ means: (a) a substance undergoing any type of polymerisation process to manufacture polymers; or (b) a natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or (c) a substance used to modify existing natural or synthetic macromolecules;
(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;
(8) ‘polymer production aid’ means any substance used to provide a suitable medium for polymer or plastic manufacturing; it may be present but is neither intended to be present in the final materials or articles nor has a physical or chemical effect in the final material or article;
(9) ‘non-intentionally added substance’ means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product;
(10) ‘aid to polymerisation’ means a substance which initiates polymerisation and/or controls the formation of the macromolecular structure;
(11) ‘overall migration limit’ (OML) means the maximum permitted amount of non-volatile substances released from a material or article into food simulants;
(12) ‘food simulant’ means a test medium imitating food; in its behaviour the food simulant mimics migration from food contact materials;
(13) ‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;
(14) ‘total specific migration limit’ (SML(T)) means the maximum permitted sum of particular substances released in food or food simulants expressed as total of moiety of the substances indicated;
(15) ‘functional barrier’ means a barrier consisting of one or more layers of any type of material which ensures that the final material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with the provisions of this Regulation;
(16) ‘non-fatty food’ means a food for which in migration testing only food simulants other than food simulants D1 or D2 are laid down in Table 2 of Annex III to this Regulation;
(17) ‘restriction’ means limitation of use of a substance or migration limit or limit of content of the substance in the material or article;
(18) ‘specification’ means composition of a substance, purity criteria for a substance, physico-chemical characteristics of a substance, details concerning the manufacturing process of a substance or further information concerning the expression of migration limits;
(19) ‘hot-fill’ means the filling of any article with a food with a temperature not exceeding 100 °C at the moment of filling, after which the food cools down to 50 °C or below within 60 minutes, or to 30 °C or below within 150 minutes;
(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.
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.
Article 4
Placing on the market of plastic materials and articles
Plastic materials and articles may only be placed on the market if they:
(a) comply with the relevant requirements set out in Article 3 of Regulation (EC) No 1935/2004 under intended and foreseeable use; and
(b) comply with the labelling requirements set out in Article 15 of Regulation (EC) No 1935/2004; and
(c) comply with the traceability requirements set out in Article 17 of Regulation (EC) No 1935/2004; and
(d) are manufactured according to good manufacturing practice as set out in Commission Regulation (EC) No 2023/2006 (1); and
(e) comply with the compositional and declaration requirements set out in Chapters II, III and IV of this Regulation; and
(f) comply with Commission Regulation (EU) 2022/1616 (2) if they fall within the scope of that Regulation.
CHAPTER II
COMPOSITIONAL REQUIREMENTS
SECTION 1
Authorised substances
Article 5
Union list of authorised substances
The Union list shall contain:
(a) monomers or other starting substances;
(b) additives excluding colorants;
(c) polymer production aids excluding solvents;
(d) macromolecules obtained from microbial fermentation.
Article 6
Derogations for substances not included in the Union list
The following substances not included in the Union list are authorised subject to the rules set out in Articles 8, 9, 10, 11 and 12:
(a) all salts of substances for which ‘yes’ is indicated in column 2 in Table 1 of Annex II of authorised acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table;
(b) mixtures obtained by mixing authorised substances without a chemical reaction of the components;
(c) when used as additives, natural or synthetic polymeric substances of a molecular weight of at least 1 000 Da, except macromolecules obtained from microbial fermentation, complying with the requirements of this Regulation, if they are capable of functioning as the main structural component of final materials or articles;
(d) when used as monomer or other starting substance, pre-polymers and natural or synthetic macromolecular substances, as well as their mixtures, except macromolecules obtained from microbial fermentation, if the monomers or starting substances required to synthesise them are included in the Union list.
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.
SECTION 2
General requirements, restrictions and specifications
Article 8
General requirements on substances
The composition shall be known to the manufacturer of the substance.
Article 9
Specific requirements on substances
Substances used in the manufacture of ————— plastic materials and articles shall be subject to the following restrictions and specifications:
(a) the specific migration limit set out in Article 11;
(b) the overall migration limit set out in Article 12;
(c) the restrictions and specifications set out in column 10 of Table 1 of point 1 of Annex I;
(d) the detailed specifications set out in point 4 of Annex I.
Article 10
General restrictions and requirements concerning the composition of plastic materials and articles
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 (4);
(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.
Article 11
Specific migration limits
By derogation from paragraph 1, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:
(a) exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or
(b) exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.
For the purposes of the first subparagraph, unless specific detection limits have been set for particular substances or groups of substances, a detection limit of 0,01 mg/kg shall apply.
Article 12
Overall migration limit
CHAPTER III
SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES
Article 13
Plastic multi-layer materials and articles
By derogation from paragraph 1, a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may:
(a) not comply with the restrictions and specifications set out in this Regulation except for vinyl chloride monomer as provided in Annex I; and/or
(b) be manufactured with substances not listed in the Union list or —————.
The substances not listed in the Union list ————— referred to in paragraph 2(b) shall not belong to either of the following categories:
(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and the Council (7);
(b) substances in nanoform.
Article 14
Multi-material multi-layer materials and articles
The substances not listed in the Union list ————— referred to in paragraph 2 shall not belong to either of the following categories:
(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008;
(b) substances in nanoform.
CHAPTER IV
LABELLING, DECLARATION OF COMPLIANCE AND DOCUMENTATION
Article 14a
Labelling
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.
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.
Article 15
Declaration of compliance
Article 16
Supporting documents
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.
CHAPTER V
COMPLIANCE
Article 17
Expression of migration test results
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 (8).
By derogation from paragraph 1, for caps, gaskets, stoppers and similar sealing articles the specific migration value shall be expressed in:
(a) mg/kg using the actual content of the container for which the closure is intended applying the total contact surface of sealing article and sealed container if the intended use of the article is known, while taking into account the provisions of paragraph 2;
(b) mg/article if the intended use of the article is unknown.
For caps, gaskets, stoppers and similar sealing articles the overall migration value shall be expressed in:
(a) mg/dm2 applying the total contact surface of sealing article and sealed container if the intended use of the article is known;
(b) mg/article if the intended use of the article is unknown.
Article 18
Rules for assessing compliance with migration limits
Article 19
Assessment of substances not included in the Union list
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