CHAPTER II

COMPOSITIONAL REQUIREMENTS
SECTION 2

General requirements, restrictions and specifications

Specific migration limits
Article 11
1
Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in the authorisations for the substances concerned. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
By derogation from paragraph 1, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:
a
exceed the restrictions provided for
pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008 or this Regulation
for foods for which their use is authorised as food additive or flavouring substances; or
b
exceed the restrictions set out in
the authorisations for the substances concerned
in foods for which their use is not authorised as food additive or flavouring substances.
4
Where it is specified that no migration of a particular substance is permitted, compliance shall be established using appropriate migration test methods selected in accordance with Article 11 of Regulation (EC) No 882/2004 that can confirm the absence of migration above a specified limit of detection.
For the purposes of the first subparagraph, unless specific detection limits have been set for particular substances or groups of substances, a detection limit of 0,01 mg/kg shall apply.
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).
Inserted 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).
Deleted 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).
Words in Art. 11(1) 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(8)(a) (with reg. 23)
Words in Art. 11(3)(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(8)(b) (with reg. 23)
Words in Art. 11(3)(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(8)(c) (with reg. 23)