(a) in paragraph (1)  - 


(i) for the definition of "additive" substitute ""additive" means a substance as defined in paragraph 1 of the general introduction to Annex III to the Directive as read with paragraph 3 of Article 4 of the Directive;";

(ii) in the definition of "Council Directive 82/711", omit the words "as amended" to the end;

(iii) after the definition of "Council Directive 82/711" insert the following definitions  - 

(a) amending the definition of "additive" to maintain consistency with the Directive (regulation 3(a)(i));

(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 (regulation5(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) amending the labelling requirements for plastic materials and articles at the pre-retail stage so as to require additional information to be given (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 of 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)).

     3. They also amend the Schedules to the 1998 Regulations by  - 

(a) inserting new entries, and amending or removing some existing ones, in the list of monomers authorised without time limit in Section A of Part I of Schedule 1 (regulation9(a) and Schedules 1 & 2);

(b) removing the lists 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 removing some existing entries in the list of additives used in the manufacture of plastic materials articles in Part I of Schedule 2 (regulation 11 and Schedules 3 & 4);

(e) inserting new entries and removing 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 (regulation12 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 removing some existing ones in the specifications set out in Schedule 2B (regulation 15 and Schedule 6);

(i) 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).

     4. A regulatory impact assessment has been prepared for these Regulations and has been placed in the Library of each House of Parliament, together with a transposition note setting out how the main elements of Commission Directive 2004/19/EC are transposed into domestic law by these Regulations. Copies may be obtained from the Chemical Safety Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.