CHAPTER II

COMPOSITIONAL REQUIREMENTS
SECTION 2

General requirements, restrictions and specifications

General requirement on substances
Article 8
Substances used in the manufacture of plastic layers in plastic materials and articles shall be of a technical quality and a purity suitable for the intended and foreseeable use of the materials or articles. The composition shall be known to the manufacturer of the substance and made available to the competent authorities on request.

Specific requirements on substances
Article 9
1
Substances used in the manufacture of plastic layers in plastic materials and articles shall be subject to the following restrictions and specifications:
a
the specific migration limit set out in Article 11;
b
the overall migration limit set out in Article 12;
c
any restrictions and specifications set out in the authorisations for the substances concerned;
d
any detailed specifications set out the authorisations for the substances concerned.
2
Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications concerned.

General restrictions on plastic materials and articles
Article 10
General restrictions related to plastic materials and articles are laid down in Annex II.

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.

Overall migration limit
Article 12
1
Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm2 of food contact surface (mg/dm2).
2
By derogation from paragraph 1, plastic materials and articles intended to be brought into contact with food intended for infants and young children, as defined by Commission Directives 2006/141/EC and 2006/125/EC , shall not transfer their constituents to food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.
OJ L 401, 30.12.2006, p. 1.
OJ L 339, 6.12.2006, p. 16.
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).
Word in Art. 9(1)(c) 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(7)(a)(i)(aa) (with reg. 23)
Words in Art. 9(1)(c) 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(7)(a)(i)(bb) (with reg. 23)
Word in Art. 9(1)(d) 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(7)(a)(ii)(aa) (with reg. 23)
Words in Art. 9(1)(d) 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(7)(a)(ii)(bb) (with reg. 23)
Word in Art. 9(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(7)(b) (with reg. 23)
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)