For the purpose of this Regulation, the following definitions shall apply:

1. (1)

   ‘plastic materials and articles’ means:

   1. (a)

      materials and articles referred to in points (a), (b) and (c) of Article 2(1); and

   2. (b)

      plastic layers referred to in Article 2(1)(d) and (e);

2. (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. (3)

   ‘polymer’ means any macromolecular substance obtained by:

   1. (a)

      a polymerisation process such as polyaddition or polycondensation, or by any other similar process of monomers and other starting substances; or

   2. (b)

      chemical modification of natural or synthetic macromolecules; or

   3. (c)

      microbial fermentation;

4. (4)

   ‘plastic multi-layer’ means a material or article composed of two or more layers of plastic;

5. (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. (6)

   ‘monomer or other starting substance’ means:

   1. (a)

      a substance undergoing any type of polymerisation process to manufacture polymers; or

   2. (b)

      a natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or

   3. (c)

      a substance used to modify existing natural or synthetic macromolecules;

7. (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. (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. (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. (10)

    ‘aid to polymerisation’ means a substance which initiates polymerisation and/or controls the formation of the macromolecular structure;

11. (11)

    ‘overall migration limit’ (OML) means the maximum permitted amount of non-volatile substances released from a material or article into food simulants;

12. (12)

    ‘food simulant’ means a test medium imitating food; in its behaviour the food simulant mimics migration from food contact materials;

13. (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. (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. (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. (16)

    F1‘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. (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. (18)

    F1‘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. (19)

    F2‘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. (20)

    F3‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004.