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.
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).
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)