The Plastic Materials and Articles in Contact with Food Regulations 1992

Monomers

5.—(1) Subject to the following paragraphs of this regulation, no plastic material or article shall be manufactured with any monomer other than a monomer which is of good technical quality and is identified by PM/REF No. (if any), CAS No. (if any) and name respectively in columns 1, 2, 3 of the relevant fraction of Part I of Schedule 1 and used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof, and for the purposes of this regulation the relevant fraction of Part I comprises—

(a) in the case of a plastic material or article manufactured before 1st January 1997, Sections A and B of Part I, and

(b) in the case of a plastic material or article manufactured after 31st December 1996, Section A of Part I.

(2) Paragraph (1) of this regulation does not apply to plastic materials or articles comprising—

(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;

(f) printing inks.

(3) Paragraph (1) of this regulation shall not be taken to prohibit the presence in any plastic material or article of any substance if the substance is a mixture of monomers of good technical quality identified in the relevant fraction of Part I of Schedule 1.

(4) Subject to the proviso in paragraph (5) of this regulation, where column 4 of the relevant fraction 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) in the case of any plastic material or article other than one specified in subparagraph (b) below, the number of milligrams expressed therein released per kilogram of food, and

(b) 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 not less than 500 millilitres and not 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 the surface area of that material and the quantity of food in contact with that surface area,

one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article.

(5) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant fraction 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 (4) of this regulation if the only food which that plastic material or article may come into contact with is a food or foods specified in the Table to Part III of Schedule 2 in relation to which no simulant is specified.

(6) In any proceedings for an offence under regulation 3 comprising the manufacture of a plastic material or article with any monomer (whether or not of good technical quality) other than those identified in the relevant fraction 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,

(b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof and every monomer required to synthesise it is of good technical quality and identified in the relevant fraction of Part I of Schedule 1, or

(c) each such monomer falls within either sub-paragraph (a) or sub-paragraph (b) above.

(7) Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.