PART 4Requirements for Regenerated Cellulose Film
Controls and limits
10.—(1) This Part applies to regenerated cellulose film which—
(a)constitutes a finished product in itself; or
(b)is part of a finished product containing other materials,
and is intended to come into contact with food or, by being used for that purpose, does come into contact with food.
(2) Except in paragraph (4), any reference in this regulation to Annex II is a reference to Annex II to Directive 2007/42/EC.
(3) Subject to paragraph (5) and regulation 12, no person may manufacture any regenerated cellulose film intended to come into contact with food using any substance or group of substances other than the substances named or described–
(a)in the first column (denominations) of Annex II (list of substances authorised in the manufacture of regenerated cellulose film) in the case of—
(i)uncoated film; or
(ii)coated film where the coating is derived from cellulose;
(b)in the first column of the First Part (uncoated regenerated cellulose film) of Annex II in the case of film to be coated, where the coating is to consist of plastics,
and in each case other than in accordance with the conditions and restrictions specified in the corresponding entry in the second column of the appropriate Part of Annex II, as read with the preamble to that Annex.
(4) Subject to regulation 12, no person may manufacture any coating to be applied to film referred to in paragraph (3)(b) using any substance or group of substances other than those listed in Annex II, III or IV to Directive 2002/72/EC and other than in accordance with the appropriate requirements, restrictions and specifications contained in those Annexes and in the 2009 Regulations.
(5) Substances other than those listed in Annex II may be used as colourants or adhesives in the manufacture of any film to which paragraph (3)(a) applies, provided that such film is manufactured in such a way that it does not transfer any colourant or adhesive to food in any detectable quantity.
(6) Subject to regulation 12 no person may—
(a)sell;
(b)import; or
(c)use in the course of a business in connection with the storage, preparation, packaging, sale or service of food,
any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (3) or (4), or which fails to comply with paragraph (8).
(7) No person may, in the course of a business, use in connection with the storage, preparation, packaging, sale or service of food—
(a)where the food contains water physically free at the surface, any regenerated cellulose film containing bis(2-hydroxyethyl) ether or ethanediol; or
(b)any regenerated cellulose film in such a way that any printed surface of that film comes into contact with the food.
(8) 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.
Migration limits for regenerated cellulose film coated with plastics
11.—(1) Subject to paragraph (2), no person may manufacture or import any material or article made with regenerated cellulose film coated with plastics which–
(a)is intended to come into contact with food; and
(b)is capable of transferring its constituents to food in quantities exceeding an overall migration limit of 10 milligrams per square decimetre of the surface of the material or article in contact with food.
(2) In the case of any material or article made with regenerated cellulose film coated with plastics which–
(a)is or is comparable to a container or which can be filled to a capacity of not less than 500 millilitres and not more than 10 litres;
(b)can be filled and for which it is impracticable to estimate the surface area in contact with food; or
(c)is a cap, gasket, stopper or similar device for sealing,
the overall migration limit is to be 60 milligrams of constituents transferred per kilogram of food.
(3) No person may manufacture or import any material or article made with regenerated cellulose film coated with plastics manufactured with any substance listed in Section A or B of Annex II to Directive 2002/72/EC (authorised monomers and other starting substances) which–
(a)is intended to come into contact with food; and
(b)is capable of transferring its constituents to food in quantities exceeding the specific migration limits set out in column 4 of those Sections as read with the general introduction to that Annex.
(4) Where the specific migration limit for a substance mentioned in paragraph (3) is expressed in milligrams per kilogram, in the case of regenerated cellulose film coated with plastics which–
(a)is or is comparable to a container or which can be filled to a capacity of less than 500 millilitres or more than 10 litres; or
(b)cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the film and the quantity of food in contact with it,
the migration limit is to be divided by the conversion factor of 6 in order to express it in milligrams of constituents transferred per square decimetre of the material or article in contact with food.
(5) Subject to paragraph (6), the verification of compliance with migration limits is to be conducted in accordance with the provisions of Schedules 2 and 3 to the 2009 Regulations as read with regulation 13 of those Regulations and for the purposes of this paragraph any reference in those provisions to a plastic material or article is to be construed as a reference to regenerated cellulose film coated with plastic.
(6) Paragraph (5) does not apply in any circumstance to which regulation 9 applies.
Saving provision and transitional defence
12. In any proceedings for an offence of contravening regulation 10(3), (4), (6) or (7), or regulation 11(1) or (3) it is a defence to prove that—
(a)the act constituting the offence was committed in relation to a material or article made with regenerated cellulose film which was manufactured in, or imported into, the European Union before 29 January 2006; and
(b)the act constituting the offence would not have constituted an offence under the Materials and Articles in Contact with Food Regulations 1987(1) as they stood immediately before the coming into force of the Materials and Articles in Contact with Food (Wales) Regulations 2005(2).
S.I. 2005/1647 (W. 128). Those Regulations were subsequently amended by S.I. 2005/3254 (W. 247) and S.I. 2006/2982 (W. 273), but neither of those instruments made amendments that are relevant to this provision.