CHAPTER IICOMPOSITIONAL REQUIREMENTS
SECTION 1Authorised substances
Article 5F1Requirement for authorisation
F21.
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.
F3For 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.
F43.
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F5Article 5ARegulations and devolved powers
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Article 6Derogations for substances F6that are not authorised
1.
F92.
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 F10, if not otherwise authorised, are nevertheless deemed to be authorised, subject to the rules set out in Articles 8, 9, 10, 11 and 12:
F11(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 F12... list.
4.
The following substances F13, 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.
F16Article 7Establishment and management of the provisional list
1.
The appropriate authority must F17determine 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 F18authorised;
(b)
when a decision is taken by the appropriate authority not to F19authorise 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.
F20(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 2General requirements, restrictions and specifications
Article 8General requirement on substances
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.
Article 9Specific requirements on substances
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)
2.
Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications F25concerned.
Article 10General restrictions on plastic materials and articles
General restrictions related to plastic materials and articles are laid down in Annex II.
Article 11Specific migration limits
1.
Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in F26the authorisations for the substances concerned. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).
F272.
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F283.
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 F29pursuant 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 F30the authorisations for the substances concerned in foods for which their use is not authorised as food additive or flavouring substances.
F314.
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.
Article 12Overall migration limit
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).