(This note is not part of the Regulations)

These Regulations, which extend to Scotland only, further amend the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376), (“the 1998 Regulations”), which extend to the whole of Great Britain. These Regulations implement, in Scotland, Commission Directive 2004/19/EC (O.J. No. L 71, 10.3.04, p.8) amending Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L 220, 15.8.02, p.18), (“the Directive”).

The Regulations amend the 1998 Regulations by–

(a)

substituting the definition of “additive” used in the Directive, for consistency (regulation 3(a));

(b)

removing references to lists of substances whose authorisations are now spent (regulation 4(a));

(c)

extending to articles the provisions of regulation 4(5) of the 1998 Regulations that formerly only applied to materials (regulation 4(b));

(d)

adding a restriction on the use of additives in the manufacture of plastic materials and articles which relates to substances also used as food additives or flavourings (regulation 5(a));

(e)

extending to articles the provisions of regulation 5(4) of the 1998 Regulations that formerly only applied to materials (regulation 5(b));

(f)

making provision for the procedure to be followed and the time limits to be observed by any person wishing to have an additive included in the Community list of authorised additives (regulation 6);

(g)

imposing additional labelling requirements for plastic materials and articles at the pre-retail stage so as to make additional information available to users (regulation 7);

(h)

making a consequential amendment to regulation 10 (offences) brought about by the amendment to the labelling requirements (regulation 8(a));

(i)

providing a defence to breach the 1998 Regulations as last amended by these Regulations in respect of plastic materials or articles manufactured or imported into the European Community before 1st March 2006 (regulation 8(b)).

They also amend the Schedules to the 1998 Regulations by–

(a)

inserting new entries, and amending or deleting some existing ones, in the list of monomers authorised without time limit in Section A of Part I of Schedule 1 (regulation 9(a) and Schedules 1 & 2);

(b)

removing the list of entries for monomers authorised with a time limit that has now expired (regulation 9(b));

(c)

adding further supplementary specifications in Part II of Schedule 1 (regulation 10);

(d)

inserting new entries and amending or deleting some existing entries in the list of additives used in the manufacture of plastic materials and articles in Part I of Schedule 2 (regulation 11 and Schedules 3 & 4);

(e)

inserting new entries and deleting some existing entries in the list of additives used in the manufacture of plastic materials and articles set out I Part II of Schedule 2 (regulation 12 and Schedule 5);

(f)

adding further supplementary specifications to Part III of Schedule 2, and extending the time limit applicable to substances listed in Part II of that Schedule (regulation 13);

(g)

amending the restrictions and specifications in the entry in Schedule 2A relating to products obtained by bacterial fermentation (regulation 14);

(h)

inserting new entries and amending or deleting some existing ones in the specifications set out in Schedule 2B (regulation 15 and Schedule 6);adding a provision to the basic rules for overall and specific migration testing using food simulants set out in Part I of Schedule 4, to allow for migration testing to be omitted in the specific circumstances provided for in the Directive (regulation 16).

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.