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Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)
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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 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.
Textual Amendments
F1Words 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)
F2Words 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)
F3Words 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)
F4Substituted 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).
F5Words 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)
F6Word 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)
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.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F7Words in Art. 14(2) 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(10)(a) (with reg. 23)
F8Words in Art. 14(3) 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(10)(b) (with reg. 23)
F9Words in Art. 14(5) 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(10)(c) (with reg. 23)
F10Art. 14(6) 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, 72(b); 2020 c. 1, Sch. 5 para. 1(1)
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