11.—(1) Subject to paragraph (2), a plastic multi-layer material or article meets the required standard if each layer of which it is composed complies with these Regulations.
(2) A layer which is not in direct contact with food and is separated from such contact by a plastic functional barrier is not obliged to comply with the requirements of these Regulations provided that —
(a)the finished material or article complies with the relevant specific and overall migration limits; and
(b)if any substance used in the manufacture of the layer is not included in the Directive or in national lists referred to in that Directive, that substance meets the requirements of paragraphs (3) and (4).
(3) A substance mentioned in paragraph (2)(b) must not belong to the category of those classified —
(a)as proved or suspect “carcinogenic”, “mutagenic” or “toxic to reproduction” substances in Annex I to Directive 67/548/EEC(1), or
(b)under the self-responsibility criteria as “carcinogenic”, “mutagenic” or “toxic to reproduction” substances according to the rules of Annex VI to that Directive.
(4) The migration of a substance mentioned in paragraph (2)(b) into a food or simulant must not exceed 0.01 mg/kg, measured and expressed in accordance with the requirements and specifications contained in Article 7a(3) of the Directive.
OJ No. 196, 16.8.1967, p.1.