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.