CHAPTER IICOMPOSITIONAL REQUIREMENTS
SECTION 2General requirements, restrictions and specifications
Article 8General requirement on substances
Substances used in the manufacture of plastic layers in plastic materials and articles shall be of a technical quality and a purity suitable for the intended and foreseeable use of the materials or articles. The composition shall be known to the manufacturer of the substance and made available to the competent authorities on request.
Article 9Specific requirements on substances
1.
Substances used in the manufacture of plastic layers in 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.
2.
Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications in Annex I.
Article 10General restrictions on plastic materials and articles
General restrictions related to plastic materials and articles are laid down in Annex II.
Article 11Specific migration limits
1.
Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).
2.
For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.
3.
By derogation from paragraphs 1 and 2, 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.
Article 12Overall migration limit
1.
Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm2 of food contact surface (mg/dm2).