1.In a multi-material multi-layer material or article, the composition of each plastic layer shall comply with this Regulation.
2.By derogation from paragraph 1, in a multi-material multi-layer material or article a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may be manufactured with substances not listed in the Union list or the provisional list.
3.The substances not listed in the Union list or provisional list referred to in paragraph 2 shall not belong to either of the following categories:
(a)substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008;
(b)substances in nanoform.
4.By derogation from paragraph 1, Articles 11 and 12 of this Regulation do not apply to plastic layers in multi-material multi-layer materials and articles.
5.The plastic layers in a multi-material multi-layer material or article shall always comply with the restrictions for vinyl chloride monomer laid down in Annex I to this Regulation.
6.In a multi-material multi-layer material or article, specific and overall migration limits for plastic layers and for the final material or article may be established by national law.