12.—(1) URCF and CRCF may be manufactured using only the substances or groups of substances listed in Annex II (list of substances authorised in the manufacture of regenerated cellulose film) and subject to the restrictions set out in that Annex but, by way of derogation, substances other than those listed in Annex II may be used when these substances are employed either as —
(a)dyes and pigments; or
(b)adhesives,
provided that there is no trace of migration of the substances, detectable by a validated method, into or on to foodstuffs.
(2) PRCF may be manufactured, prior to coating, using only substances or groups of substances listed in the first part of Annex II and subject to the restrictions set out in that part.
(3) The coating to be applied to PRCF may be manufactured using only substances or groups of substances listed in Annex I to Regulation 10/2011 and subject to the restrictions in that Annex.
(4) Materials and articles made of PRCF must comply with Article 12 (overall migration limit) as read with Article 17 (expression of migration test results) and Article 18 (rules for assessing compliance with migration limits) of Regulation 10/2011.
(5) Printed surfaces of regenerated cellulose film must not come into contact with foodstuffs.
(6) Any material or article made of regenerated cellulose film that is not by its nature clearly intended to come into contact with food must, at a marketing stage other than the retail stage, be accompanied by a written declaration attesting that it complies with the legislation applicable to it.
(7) Where special conditions of use are indicated, the material or article made of regenerated cellulose film must be labelled accordingly.
(8) No person may place on the market any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (1) to (4), or which fails to comply with paragraphs (5),(6) or (7).