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The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002

Status:

This is the original version (as it was originally made).

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002 and shall come into force on 30th November 2002.

(2) These Regulations shall extend to Scotland only.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998

2.  The Plastic Materials and Articles in Contact with Food Regulations 1998(1) (“the principal Regulations”) shall be amended in accordance with regulations 3 to 18.

3.  After regulation 1 (title, commencement and extent) there shall be inserted–

Scope of these Regulations

1A.  Notwithstanding the title to these Regulations–

(a)regulations 3 and 9 to 12 apply also in relation to adhesives and to materials or articles covered by surface coatings; and

(b)regulations 8A and 8B apply only to adhesives and to materials or articles covered by surface coatings..

4.  In regulation 2 (interpretation)–

(a)in paragraph (1)–

(i)after the definition of “additive” there shall be inserted–

“adhesive” means anything which, for the purposes of Commission Directive 2002/16, is included among the adhesives to which that Directive applies;

BADGE” means 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether;

BFDGE” means bis(hydroxyphenyl) methane bis(2,3- epoxypropyl) ethers;;

(ii)for the definition of “capable” there shall be substituted–

  • “capable” means capable as established–

    (a)

    in relation to any plastic material or article, under regulation 6; and

    (b)

    in relation to any adhesive or material or article covered by a surface coating, under regulation 8B;;

(iii)after the definition of “capable” there shall be inserted–

“Commission Directive 2002/16” means Commission Directive 2002/16 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs(2);;

(iv)for the definition of “the Directive”, there shall be substituted–

“the Directive” means Commission Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs(3);;

(v)after the definition of “import” there shall be inserted–

“material or article covered by a surface coating” means anything which, for the purposes of Commission Directive 2002/16, is included among the materials and articles covered by surface coatings to which that Directive applies;;

(vi)after the definition of “monomer” there shall be inserted–

NOGE” means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;; and

(vii)at the end of the definition of “plastic material or article” there shall be inserted “, except that, in the provisions referred to in paragraph (5) below, to the extent that they implement or relate to the enforcement of Commission Directive 2002/16, it means a material or article made of any type of plastic”;

(b)for paragraph (2), there shall be substituted–

(2) For the purposes of these Regulations, the supply in the course of a business, otherwise than on sale, of any plastic material or article, adhesive or material or article covered by a surface coating shall be deemed to be a sale of the plastic material or article, adhesive or material or article covered by a surface coating concerned.; and

(c)after paragraph (4) there shall be inserted–

(5) The provisions referred to in the definition of “plastic material or article” in paragraph (1) above are regulations 3, 4, 4A, 5, 6, 10, 11 and 12 and Schedules 3 and 4..

5.  In regulation 3 (restriction on the use, sale or importation of plastic materials and articles)–

(a)in paragraphs (1) and (2), after the words “plastic material or article”, wherever they appear, there shall be inserted “, adhesive or material or article covered by a surface coating”;

(b)at the end of paragraph (4)(a)(i)(cc) the word “or” shall be deleted;

(c)for sub-paragraph (4)(a)(i)(dd) there shall be substituted–

(dd)it does not comply with regulation 4(5), (5A) or (5B), 4A(4), (5) or (6), 5(4), (4A), (4B) or (4C), 7 or 7A(1); or;

(d)after sub-paragraph (4)(a)(i)(dd) there shall be inserted–

(ee)it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3); and; and

(e)there shall be inserted at the end–

(5) For the purposes of this regulation, an adhesive or a material or article covered by a surface coating fails to meet the requisite standards if–

(i)it has been manufactured in contravention of a prohibition contained in regulation 8A(1), (2) or (3); or

(ii)it does not comply with regulation 8A(4), (5) or (6)..

6.  In regulation 4 (restriction on manufacture with monomers)–

(a)for paragraph (1) there shall be substituted–

(1) Subject to the following paragraphs of this regulation, no person shall use in the manufacture of any plastic material or article any prohibited monomer, that is to say–

(a)any monomer (not being one to which sub-paragraph (b) or (c) below relates) which is not–

(i)of good technical quality;

(ii)identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part I of Schedule 1; and

(iii)used in accordance with the restrictions and specifications (if any) for that monomer set out in the corresponding entry in column 4 of that relevant section;

(b)BFDGE to the extent that they are used in such manufacture–

(i)on or after 1st January 2005; or

(ii)prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or

(c)NOGE to the extent that they are used in such manufacture–

(i)on or after 1st January 2005; or

(ii)prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.;

(b)for paragraphs (2)(b) and (c) there shall be substituted–

(b)in the case of a plastic material or article manufactured on or after 30th November 2002 and before 1st January 2005, section A or B; and

(c)in the case of a plastic material or article manufactured on or after 1st January 2005, section A.;

(c)for paragraph (3) there shall be substituted–

(3) Paragraph (1)(a) of this regulation does not apply to the use of a monomer, in the manufacture of any–

(a)surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;

(b)epoxy resins;

(c)adhesives and adhesion promoters; or

(d)printing inks.;

(d)in paragraph (4), for “Paragraph (1)” there shall be substituted “Paragraph (1)(a)”;

(e)after paragraph (5) there shall be inserted–

(5A) No plastic material or article manufactured using BFDGE as a 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 specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(5B) On or after 1st March 2003, no plastic material or article manufactured using NOGE as a monomer shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.; and

(f)in paragraph (7)–

(i)for “paragraph (1)” there shall be substituted “paragraph (1)(a)”; and

(ii)after “Part I of Schedule 1” there shall be inserted “or to which paragraph (1)(b) or (1)(c) above relates”.

7.  After regulation 4 (restriction on manufacture with monomers) there shall be inserted–

Restriction on the manufacture of plastic materials and articles using certain substances other than as monomers or additives

4A.(1) No person shall use BADGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive–

(a)on or after 1st January 2005; or

(b)prior to that date in contravention of the restriction specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(2) No person shall use BFDGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive–

(a)on or after 1st January 2005; or

(b)prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(3) No person shall use NOGE in the manufacture of any plastic material or article, where the use is not as a monomer or additive–

(a)on or after 1st January 2005; or

(b)prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

(4) No plastic material or article manufactured using BADGE other than as a monomer or an additive shall be capable of transferring constituents of BADGE to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of Annex I to that Directive.

(5) No plastic material or article manufactured using BFDGE other than as a monomer or an additive shall be capable of transferring constituents of BFDGE to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of Annex II to that Directive.

(6) On or after 1st March 2003, no plastic material or article manufactured using NOGE other than as a monomer or an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16..

8.  In regulation 5 (restriction on manufacture with additives)–

(a)for paragraph (1) there shall be substituted–

(1) Subject to the following paragraphs of this regulation, no person shall use in the manufacture of any plastic material or article any prohibited additive, that is to say–

(a)any additive identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of Part I of Schedule 2 or columns 1, 2 and 3 respectively of Part II of Schedule 2, which is not–

(i)of good technical quality; and

(ii)used in accordance with the restrictions and specifications (if any) for that additive set out in the corresponding entry in column 4 of Part I or Part II of Schedule 2, as appropriate;

(b)BADGE to the extent that it is used in such manufacture–

(i)on or after 1st January 2005; or

(ii)prior to that date in contravention of the restriction specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of Annex I to that Directive;

(c)BFDGE to the extent that they are used in such manufacture–

(i)on or after 1st January 2005; or

(ii)prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of Annex II to that Directive; or

(d)NOGE to the extent that they are used in such manufacture–

(i)on or after 1st January 2005; or

(ii)prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.;

(b)in paragraph (2), after “Part I” there shall be inserted “or Part II”;

(c)for paragraph (3), there shall be substituted–

(3) Part III of Schedule 2 shall have effect to supplement this regulation and Parts I and II of Schedule 2.;

(d)in paragraph (4)–

(i)after “Schedule 2” there shall be inserted “, or column 4 of Part II of Schedule 2,”; and

(ii)in each of sub-paragraphs (a) and (b), for “therein” there shall be substituted “in column 4 of Part I or Part II of Schedule 2, as appropriate,”;

(e)after paragraph (4) there shall be inserted–

(4A) No plastic material or article manufactured using BADGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(4B) No plastic material or article manufactured using BFDGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(4C) On or after 1st March 2003, no plastic material or article manufactured using NOGE as an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.; and

(f)in paragraph (5), after “Schedule 2” there shall be inserted “, or column 4 of Part II of Schedule 2,”.

9.  In regulation 6 (method of testing capability of transferring constituents)–

(a)for paragraph (1) there shall be substituted–

(1) For the purposes of these Regulations, a plastic material or article shall be treated as being capable of transferring constituents other than NOGE to food with which it may come into contact to the extent that such capability is established–

(a)in any case other than one to which sub-paragraph (b) below relates, and subject to Article 8.4 of the Directive (which may be applied on compliance with the conditions stated therein) by the verification methods specified in Schedules 3 and 4;

(b)in any case where the extent to which vinyl chloride, as identified in Section A of Part I of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 14(2) of the 1987 Regulations.; and

(b)after paragraph (3) there shall be inserted–

(4) The specific migration of a constituent from a plastic material or article shall, where applicable, be determined in the manner specified in the relevant sub-division of paragraph 8 of Annex II to the Directive.

(5) The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

(6) The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

(7) Whether or not the detection requirement specified in Article 4 of Commission Directive 2002/16 is complied with in relation to a plastic material or article shall be determined in the manner specified in the second and third sentences of that Article.

(8) The quantity of a constituent in a plastic material or article shall, where applicable, be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II to the Directive relating to the term “QM(T)” or, as the case may be, the sub-paragraph of paragraph 8 of that Annex relating to the term “QMA”..

10.  For regulation 7A (specifications) there shall be substituted–

Specifications

7A.(1) Subject to paragraph (3), no plastic material or article manufactured using isocyanates or colourants prepared by diazo–coupling shall be capable of transferring in a detectable quantity primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which the plastic material or article may come into contact.

(2) Schedule 2B shall have effect for the purpose of prescribing, for certain items listed in Part I of Schedule 1, Part I or II of Schedule 2 or Schedule 2A, the specifications for those items which are referred to in column 4 of the relevant Part or, as the case may be, Schedule concerned.

(3) For the purposes of paragraph (1), “detectable quantity” means a quantity of at least DL0.02 milligrams per kilogram of food or food simulant (analytical tolerance included)..

11.  After regulation 8 (labelling) there shall be inserted–

Restriction on manufacture with certain substances of adhesives and materials and articles covered by surface coatings

8A.(1) No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use BADGE in the manufacture of any–

(a)adhesive; or

(b)material or article covered by a surface coating,

on or after 1st January 2005, or, prior to that date, in contravention of the restriction specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(2) No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use BFDGE in the manufacture of any–

(a)adhesive; or

(b)material or article covered by a surface coating,

on or after 1st January 2005, or, prior to that date, in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.

(3) No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use NOGE in the manufacture of any–

(a)adhesive; or

(b)material or article covered by a surface coating,

on or after 1st January 2005 or, prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.

(4) No adhesive, or material or article covered by a surface coating, manufactured using BADGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BADGE to food with which the adhesive or, as the case may be, material or article, may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to that Directive, as read with the second sentence of paragraph 2 of that Annex.

(5) No adhesive, or material or article covered by a surface coating, manufactured using BFDGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BFDGE to food with which that adhesive or, as the case may be, material or article, may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to that Directive, as read with the second sentence of paragraph 2 of that Annex.

(6) On or after 1st March 2003, no adhesive, or material or article covered by a surface coating, manufactured using NOGE and not covered by Article 1(2) of Commission Directive 2002/16, shall fail to comply with the requirements of the first sentence of Article 4 of that Directive.

Method of testing the capability of adhesives and of materials or articles covered by surface coatings to transfer constituents and methods of analysis

8B.(1) Subject to paragraphs (2) and (3) below, for the purposes of regulation 8A(1), (2), (4) and (5), an adhesive or a material or article covered by a surface coating shall be treated as being capable of transferring BADGE, or as the case may be, BFDGE, to food with which the adhesive or, as the case may be, material or article may come into contact to the extent that such capability is established for those purposes by the verification methods specified in Section A of Schedule 3 and in Schedule 4.

(2) Subject to paragraph (3) below, in Section A of Schedule 3 and in Schedule 4, references to migration or release of a substance shall be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, the food with which the substance may come into contact.

(3) For the purposes of paragraphs (1) and (2) above, Schedules 3 and 4 shall have effect as if–

(a)the references in Section A of Schedule 3 and in Schedule 4 to “plastic material or article” were references to “adhesive or a material or article covered by a surface coating”;

(b)the references in paragraph 4(3) and (4) of Section A of Schedule 3 to “a migration limit specified in regulation 7, Schedule 1 or Schedule 2” were references to “a migration limit specified in regulation 8A(4) or (5)”; and

(c)the references in paragraph 5 of Part II of Schedule 4 and paragraph 2(1)(b) of Part III of that Schedule to “regulation 7 or Schedule 1” were references to “regulation 8A(4) or (5)”.

(4) The specific migration from an adhesive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

(5) The specific migration from an adhesive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.

(6) Whether or not the detection limit specified in Article 4 of Commission Directive 2002/16 is complied with in relation to an adhesive or a material or article covered by a surface coating shall be determined in the manner specified in the second sentence and third sentences of that Article..

12.  In regulation 10 (offences)–

(a)in paragraph (1), for “regulation 3, 4(1), 5(1) or 8” there shall be substituted “regulation 3, 4(1), 4A(1), (2) or (3), 5(1), 8(1) or 8A(1), (2) or (3)”;

(b)in each of paragraphs (9) and (10), after “plastic material or article” there shall be inserted “or, as the case may be, adhesive or material or article covered by a surface coating,”; and

(c)after paragraph (15) there shall be inserted–

(16) In any proceedings for an offence under these Regulations, it shall be a defence to prove that–

(a)the act constituting the offence was committed in relation to a plastic material or article intended to come into contact with food which was put into free circulation in the European Community on or before 30th November 2002; and

(b)the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (17) below had not been in force at the time that matter occurred.

(17) For the purposes of paragraph (16) above, “free circulation” shall have the same meaning as it bears in Article 23.2 of the Treaty establishing the European Community.

(18) The provisions referred to in paragraph (16) above are regulations 5(c), 6(b), 8(a), (b) and (d), 10, 12(a), 15, 16 and 17 of the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002 to the extent that they implement or provide for the enforcement of those requirements of Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs(4) to which Article 2 of that Directive applies.

(19) In any proceedings for an offence under these Regulations, it shall be a defence to prove that–

(a)the act constituting the offence was the sale of–

(i)an adhesive; or

(ii)a material or article covered by a surface coating,

which was brought into contact with food on or before 28th February 2003, provided that the date of filling appeared on the materials and articles at the time of sale and that the labelling or marking of which complied at the time of sale with the requirements of Directive 2000/13 of the European Parliament and the Council on the approximation of the laws of the member states relating to the labelling, presentation and advertising of foodstuffs(5); and

(b)the sale would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (20) below had not been in force at the time of sale.

(20) The provisions referred to in paragraph (19) above are regulations 5(a) and (e), 11 and 12(a) of the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002 which implement or provide for the enforcement of those requirements of Commission Directive 2002/16 which relate to adhesives or materials and articles covered by surface coatings..

13.  In regulation 11 (presumption as to food with which a plastic material or article is to come into contact) after the words “plastic material or article”, wherever they appear, there shall be inserted “, adhesive or material or article covered by a surface coating,”.

14.  In regulation 12 (application of other provisions)–

(a)in paragraph (1) after “plastic materials or articles” there shall be inserted “, adhesives and materials or articles covered by a surface coating”; and

(b)in paragraph (3) for “relate to plastic materials or articles” there shall be substituted “apply to plastic materials or articles, adhesives, or materials or articles covered by a surface coating”.

15.  In Schedule 1 (monomers authorised without time limit, monomers authorised up to the end of 2001, monomers authorised up to the end of 1998 and supplementary)–

(a)in Section A of Part I–

(i)in the case of each monomer listed in Part I of Schedule 1 to these Regulations, the item number and letter, PM/REF No, CAS No. (if any), name and restriction or specification specified for that monomer in that Part shall be inserted in the appropriate numerical position for that item number and letter;

(ii)in the case of each monomer listed in the third column of Part II of Schedule 1 to these Regulations, for the item number and letter for that monomer specified opposite to it in the first column of Section A of Part I of Schedule 1 to the principal Regulations (item) there shall be substituted the item number and letter for it specified in the second column (new item) of Part II of Schedule 1 to these Regulations; and

(iii)in the case of each monomer listed in the first column of Part III of Schedule 1 to these Regulations, for the entry for that monomer specified opposite to it in column 4 of Section A of Part I of Schedule 1 to the principal Regulations (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of Part III of Schedule 1 to these Regulations;

(b)for Section B of Part I there shall be substituted Part IV of Schedule 1 to these Regulations; and

(c)in Part II, for paragraph 4 there shall be substituted–

4.  Where an entry in column 4 of Part I of this Schedule (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part:

(1) Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

(2) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

(3) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

(4) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

(5) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

(14) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(21) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670..

16.  In Schedule 2 (additives and supplementary)–

(a)in Part I–

(i)for the heading “Part I Additives” there shall be substituted the heading “Part I: Incomplete list of additives used in the manufacture of plastic materials and articles (not being additives to which paragraph 5 of Part III of this Schedule applies)”;

(ii)in the case of each additive listed in Part I of Schedule 2 to these Regulations, the item number and letter, PM/REF No. , CAS No. (if any), name and restriction or specification (if any) specified for that additive in that Part shall be inserted in the appropriate numerical position for that item number and letter;

(iii)in the case of each additive listed in the third column of Part II of Schedule 2 to these Regulations, for the item number and letter for that additive specified opposite to it in the first column in Part I of Schedule 2 to the principal Regulations (item) there shall be substituted the item number and letter for it specified in the second column (new item) of Part II of Schedule 2 to these Regulations;

(iv)in the case of each additive listed in the first column of Part III of Schedule 2 to these Regulations, for the entry for that additive specified opposite to it in column 4 in Part I of Schedule 2 to the principal Regulations (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of Part III of Schedule 2 to these Regulations; and

(v)all the entries for the additive Silicic acid, salts, (item 241) shall be omitted;

(b)after Part I there shall be inserted Part IV of Schedule 2 to these Regulations (which shall become Part II of Schedule 2 to the principal Regulations on the coming into force of these Regulations);

(c)in Part II–

(i)in the heading, for “Part II” there shall be substituted “Part III”;

(ii)in paragraph 1, for “Part I” there shall be substituted “Parts I and II”;

(iii)in each of paragraphs 2, 3 and 4, after “Part I” there shall be inserted “or Part II”;

(iv)for paragraph 4 there shall be substituted–

4.  Where an entry in column 4 of Part I or in column 4 of Part II of this Schedule (in each case restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts:

(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

(3) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

(4) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

(5) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

(6) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580.

(7) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

(8) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 42400, 64320, 73040, 85760, 85840, 85920 and 95725.

(9) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.

(10) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800.

(11) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800 and 92000.

(12) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120.

(13) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170.

(14) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(15) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599.

(16) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.

(17) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 67600, 67680 and 67760.

(18) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440.

(19) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480.

(20) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280.

(21) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.; and

(d)after paragraph 4 there shall be inserted–

5.  In the case of the substances listed in Part II of this Schedule, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect with effect from 1st January 2004 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EEC(6) and Council Directive 85/572/EEC(7)..

17.  In Schedule 2B (specifications)–

(a)in the case of each substance listed in Schedule 3 to these Regulations, the item number and letter, PM/REF No. and specification set out for that substance in that Schedule shall be inserted in the appropriate numerical position for that item number and letter; and

(b)at the end there shall be inserted–

Notes:–

Where an entry in column 2 of this Schedule (specification) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in this Schedule:–

(1)

Quantity of substance/quantity of formulation..

18.  In Schedule 3 (provisions applicable when testing compliance with the migration limits)–

(a)in paragraph 4(3) and (4) of section A, after “specified in regulation” there shall be inserted “4(5A), 4A(4) or (5), 5(4A) or (4B) or”; and

(b)for sub-paragraph (2)(b) of paragraph 8 of section B there shall be substituted–

(b)12 mg/kg or, as the case may be, 2 milligrams per square decimeter in migration tests using other simulants referred to in Schedule 4..

MARY MULLIGAN

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

7th November 2002

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