{
  "url": "https://openlegislation.uk/eu-regulation-2011-10/article-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-10/article-3.json",
  "legislation": "eur/2011/10",
  "legislation_title": "Commission 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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-10",
  "path": "article/3",
  "kind": "article",
  "number": "3",
  "heading": "Definitions",
  "text": "For the purpose of this Regulation, the following definitions shall apply:\n(1)‘plastic materials and articles’ means:\n(a)materials and articles referred to in points (a), (b) and (c) of Article 2(1); and\n(b)plastic layers referred to in Article 2(1)(d) and (e);\n(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;\n(3)‘polymer’ means any macromolecular substance obtained by:\n(a)a polymerisation process such as polyaddition or polycondensation, or by any other similar process of monomers and other starting substances; or\n(b)chemical modification of natural or synthetic macromolecules; or\n(c)microbial fermentation;\n(4)‘plastic multi-layer’ means a material or article composed of two or more layers of plastic;\n(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;\n(6)‘monomer or other starting substance’ means:\n(a)a substance undergoing any type of polymerisation process to manufacture polymers; or\n(b)a natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or\n(c)a substance used to modify existing natural or synthetic macromolecules;\n(7)‘additive’ means a substance which is intentionally added to plastics to achieve a physical or chemical effect during processing of the plastic or in the final material or article; it is intended to be present in the final material or article;\n(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;\n(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;\n(10)‘aid to polymerisation’ means a substance which initiates polymerisation and/or controls the formation of the macromolecular structure;\n(11)‘overall migration limit’ (OML) means the maximum permitted amount of non-volatile substances released from a material or article into food simulants;\n(12)‘food simulant’ means a test medium imitating food; in its behaviour the food simulant mimics migration from food contact materials;\n(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;\n(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;\n(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;\n(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;\n(17)‘restriction’ means limitation of use of a substance or migration limit or limit of content of the substance in the material or article;\n(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;\n(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;\n(20)‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Art. 3(20) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 13(2) (with reg. 23)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/10/article/3",
    "retrieved_at": "2026-11-01T14:50:23.550534+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}