CHAPTER IIISPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES
Article 13Plastic multi-layer materials and articles
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 Council17;
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.