9.—(1) Subject to paragraph (3), a plastic material or article meets the required standard under this regulation if it is not capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit specified in paragraph (2).
(2) (a) In the case of any plastic material or article comprising–
(i)an article which is a container or comparable to a container or can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;
(ii)an article which can be filled and for which it is impracticable to estimate the surface area in contact with food; or
(iii)a cap, gasket, stopper or similar device for sealing,
the appropriate limit is an overall migration limit of 60 milligrams of constituents released per kilogram of food.
(b)In the case of any other plastic material or article, the appropriate limit is an overall migration limit of 10 milligrams per square decimetre of its surface area.
(3) For the purposes of this regulation a plastic material or article is not deemed to have failed to meet the required standard under paragraph (1) if the only food with which it may come into contact is food–
(a)which is specified in the table to Part 4 of Schedule 6; and
(b)where there is no “X” placed anywhere in the group of columns headed “Simulants to be used” in the entry for that food.
(4) In any proceedings for an offence under this regulation, the defences available in paragraph 6(2) and 7(2) of Schedule 5 shall be available as specified in those paragraphs.