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.