4.—(1) Subject to the following paragraphs, no plastic material or article shall be manufactured by any person with any prohibited monomer, other than a monomer which is—
(a)of good technical quality;
(b)identified by PM/REF No., CAS No., (if any) and name respectively in columns 1, 2 and 3 of the relevant section of Part 1 of Schedule 1; and
(c)used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 of the relevant section of that Part of that Schedule.
(2) For the purposes of this regulation the relevant section of Part I of Schedule 1 is—
(a)in the case of a plastic material or article manufactured before 1st January 1999, Section A, B, or C;
(b)in the case of a plastic material or article manufactured after 31st December 1998 and before 1st January 2002, Section A or B; and
(c)in the case of a plastic material or article manufactured after 31st December 2001, Section A.
(3) Paragraph (1) does not apply to the use of a monomer in the manufacture of any—
(a)surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;
(b)silicones;
(c)epoxy resins;
(d)products obtained by means of bacterial fermentation;
(e)adhesives and adhesion promoters; or
(f)printing inks.
(4) Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance is a mixture which falls within paragraph 3(c) of Annex II to the Directive and does not contravene paragraph 4 of that Annex.
(5) Subject to paragraph (6), where column 4 of the relevant section of Part I of Schedule 1 expresses a migration limit of mg/kg in relation to any monomer, no plastic material or article manufactured from that monomer shall be capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is—
(a)the number of milligrams expressed therein released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and
(b)one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article if the plastic material or article comprises—
(i)an article which is a container or is comparable to a container or which can be filled, with a capacity of less than 500 millilitres or more than 10 litres, or
(ii)sheet, film or other material which cannot be filled or for which it is impracticable to estimate the relationship between surface area of that material and the quantity of food in contact with that surface area.
(6) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant section of Part I of Schedule 1 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (5) if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.
(7) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with paragraph (1) because it was manufactured with any monomer (whether or not of good technical quality) other than one identified in the relevant section of Part I of Schedule 1, it shall be a defence for the person charged to prove that—
(a)each such monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product, which falls within paragraph 3(a) of Annex II to the Directive;
(b)each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex; or
(c)each such monomer falls within either sub-paragraph (a) or sub-paragraph (b)
and does not contravene paragraph 4 of that Annex
(8) Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.