Commission Regulation (EU) No 10/2011Show full title

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 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 V 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.