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.