CHAPTER III

SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES

Plastic multi-layer materials and articles
Article 13
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 , or pursuant to, this Regulation except for vinyl chloride monomer as provided in the authorisation for the substance concerned; and/or
b
be manufactured with substances that are not authorised or not listed in the provisional list.
3
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 ... ... 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 ;
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.
OJ L 353, 31.12.2008, p. 1.
Substituted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
Word in Art. 13 omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 71; 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(2)(a) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 13(9)(a)(i)(aa) (with reg. 23)
Words in Art. 13(2)(a) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 13(9)(a)(i)(bb) (with reg. 23)
Words in Art. 13(2)(b) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 13(9)(a)(ii) (with reg. 23)
Words in Art. 13(4) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 13(9)(b) (with reg. 23)