# 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), Article 3: Definitions

Extent: E+W+S+N.I.

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 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;
(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)‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004.

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Source: https://www.legislation.gov.uk/eur/2011/10/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-10/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.