CHAPTER II

COMPOSITIONAL REQUIREMENTS
SECTION 1

Authorised substances

Requirement for authorisation
Article 5
1
Only substances of a type falling within paragraph 2 and which are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) 1935/2004 may be intentionally used in the manufacture of plastic layers in plastic materials and articles.
2
For the purposes of paragraph 1, the types of substances that may be authorised are:
a
monomers or other starting substances;
b
additives excluding colorants;
c
polymer production aids excluding solvents;
d
macromolecules obtained from microbial fermentation.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulations and devolved powers
Article 5A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Derogations for substances that are not authorised
Article 6
1
By way of derogation from Article 5, substances other than those that are authorised may be used as polymer production aids in the manufacture of plastic layers in plastic materials and articles subject to any relevant enactment.
2
By way of derogation from Article 5, colorants and solvents which were capable of lawful use in the manufacture of plastic layers in plastic materials and articles prior to adoption of the list may continue to be so used subject to any relevant enactment.
3
The following substances , if not otherwise authorised, are nevertheless deemed to be authorised, subject to the rules set out in Articles 8, 9, 10, 11 and 12:
a
all salts of substances for which ‘ yes ’ is indicated in column 2 in Table 1 of Annex II of authorised acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table;
b
mixtures obtained by mixing authorised substances without a chemical reaction of the components;
c
when used as additives, natural or synthetic polymeric substances of a molecular weight of at least 1 000 Da, except macromolecules obtained from microbial fermentation, complying with the requirements of this Regulation, if they are capable of functioning as the main structural component of final materials or articles;
d
when used as monomer or other starting substance, pre-polymers and natural or synthetic macromolecular substances, as well as their mixtures, except macromolecules obtained from microbial fermentation, if the monomers or starting substances required to synthesise them are included in the ... list.
4
The following substances , if not otherwise authorised, may be present in the plastic layers of plastic materials or articles:
a
non-intentionally added substances;
b
aids to polymerisation.
5
By derogation from Article 5, additives that were not authorised may continue to be used subject to national law after 1 January 2010 until a decision is taken on whether or not they are to be authorised, provided they are included in the provisional list referred to in Article 7.

Establishment and management of the provisional list
Article 7
1.
The appropriate authority must
determine whether there are to be
updates to the provisional list of additives that that was published by the European Commission in 2008.
2.
An additive must be removed from the provisional list—
a
when it is
authorised
;
b
when a decision is taken by the appropriate authority not to
authorise it
; or
c
if during the examination of the data, the appropriate authority calls for supplementary information and that information is not submitted within the time limits specified by the appropriate authority.
3
Where the appropriate authority determines that there is to be an update to the provisional list, the appropriate authority must:
a
specify the date on which the update is to have effect; and
b
communicate the determination to the Food Safety Authority.
4
The Food Safety Authority must publish and maintain the provisional list, and where the Food Safety Authority is informed by the appropriate authority that there is to be an update to the provisional list, the Food Safety Authority must publish the update.
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).
Substituted by Commission Regulation (EU) 2020/1245 of 2 September 2020 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. 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, 69(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(1) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 69(b); 2020 c. 1, Sch. 5 para. 1(1)
Art. 6(2) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 69(c); 2020 c. 1, Sch. 5 para. 1(1)
Art. 7 substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 70; 2020 c. 1, Sch. 5 para. 1(1)
Art. 5 heading 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(3)(a) (with reg. 23)
Art. 5(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(3)(d) (with reg. 23)
Art. 5(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(3)(b) (with reg. 23)
Words in Art. 5(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(3)(c) (with reg. 23)
Art. 5A 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(4) (with reg. 23)
Words in Art. 6 heading 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(5)(a) (with reg. 23)
Words in Art. 6(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(5)(b) (with reg. 23)
Words in Art. 6(3) 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(5)(c) (with reg. 23)
Words in Art. 6(4) 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(5)(d) (with reg. 23)
Words in Art. 6(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(5)(e)(i) (with reg. 23)
Words in Art. 6(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(5)(e)(ii) (with reg. 23)
Art. 7(3)(4) 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(6)(c) (with reg. 23)
Words in Art. 7(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(6)(a) (with reg. 23)
Word in Art. 7(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(6)(b)(i) (with reg. 23)
Words in Art. 7(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(6)(b)(ii) (with reg. 23)
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)