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 F1, or pursuant to, this Regulation except for vinyl chloride monomer as provided in F2the authorisation for the substance concerned; and/or

(b)

be manufactured with substances F3that are not authorised or not listed in the provisional list.

F43.

Substances under paragraph 2(b) shall not migrate into food or food simulant, in accordance with Article 11(4). The detection limit set out in the second subparagraph of Article 11(4) shall apply to groups of substances if they are structurally and toxicologically related, including isomers or substances with the same relevant functional group, or to individual substances that are not related, and shall include possible set-off transfer.

4.

The substances F5...F6... 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.

Article 14Multi-material multi-layer materials and articles

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 F7that are not authorised or in the provisional list.

3.

The substances F8... 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 F9the authorisation for the substance concerned.

F106.

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