1.In a plastic multi-layer material or article, the composition of each plastic layer shall comply with this Regulation.
2.By derogation from paragraph 1, a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may:
(a)not comply with the restrictions and specifications set out in this Regulation except for vinyl chloride monomer as provided in Annex I; and/or
(b)be manufactured with substances not listed in the Union list or in the provisional list.
3.The migration of the substances under paragraph 2(b) into food or food simulant shall not be detectable measured with statistical certainty by a method of analysis set out in Article 11 of Regulation (EC) No 882/2004 with a limit of detection of 0,01 mg/kg. That limit shall always be expressed as concentration in foods or food simulants. That limit shall apply to a group of compounds, if they are structurally and toxicologically related, in particular isomers or compounds with the same relevant functional group, and shall include possible set-off transfer.
4.The substances not listed in the Union list or provisional list referred to in paragraph 2(b) 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 of the European Parliament and the Council(1);
(b)substances in nanoform.
5.The final plastic multi-layer material or article shall comply with the specific migration limits set out in Article 11 and the overall migration limit set out in Article 12 of this Regulation.
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.