Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002 (S.R. No. 316 of 2002)

Statutory Rule 2002 No. 316 Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002 Crown Copyright 2002 Statutory Rules of Northern Ireland printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Government Printer for Northern Ireland. The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users. It should be noted that the right to reproduce the text of Statutory Rules of Northern Ireland does not extend to the Government Printer for Northern Ireland imprints which should be removed from any copies of the Statutory Rule which are issued or made available to the public. This includes reproduction of the Statutory Rule on the Internet and on intranet sites. 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STATUTORY RULES OF NORTHERN IRELAND 2002 No. 316 FOOD Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002 Made 11th October 2002 Coming into operation 30th November 2002 The Department of Health, Social Services and Public Safety[1], in exercise of the powers conferred on it by Articles 15(2), 16(1), 25(1)(a) and (3), 32 and 47(2) of the Food Safety (Northern Ireland) Order 1991[2], having had regard, in accordance with Article 47(3A) of the said Order, to relevant advice given by the Food Standards Agency, and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[3], and in accordance with Article 47(3) and (3B) of the said Order, hereby makes the following Regulations: Citation and commencement 1. These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002 and shall come into operation on 30th November 2002. Amendments to the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998 2. The Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998[4] ("the principal Regulations") shall be amended in accordance with regulations 3 to 18. 3. Immediately after regulation 1 (citation and commencement) there shall be inserted the following regulation " 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 in relation to adhesives and to materials or articles covered by surface coatings.". 4. In regulation 2 (interpretation) (a) in paragraph (1) (i) immediately after the definition of "additive" there shall be inserted the following definitions " "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 the following definition " "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) immediately after the definition of "capable" there shall be inserted the following definitions ""Commission Directive 2001/62" means Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs[5]; "Commission Directive 2002/16" means Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs[6], (iv) for the definition of "the Directive" there shall be substituted the following definition " "the Directive" means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs[7];", (v) immediately after the definition of "import" there shall be inserted the following definition " "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) immediately after the definition of "monomer" there shall be inserted the following definition " "NOGE" means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;", (vii) at the end of the definition of "plastic material or article" there shall be added ", except that, in the provisions referred to in paragraph (5), 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", and (viii) immediately after the definition of "plastic material or article" there shall be inserted the following definition " "QMA" has the same meaning as it bears in the first sentence of the sub-division relating to that term in paragraph 8 of Annex ll to the Directive;"; (b) for paragraph (2) there shall be substituted the following provision " (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) immediately after paragraph (4) there shall be inserted the following paragraph " (5) The provisions referred to in the definition of "plastic material or article" in paragraph (1) 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) for the heading there shall be substituted the following heading " Restriction on the use, sale or importation of plastic materials and articles, adhesives and materials and articles covered by surface coatings"; (b) in paragraphs (1) and (2), immediately after "plastic material or article", wherever it occurs, there shall be inserted ", adhesive or material or article covered by a surface coating"; (c) at the end of paragraph (4)(a)(iii), "or" shall be deleted; (d) for paragraph (4)(a)(iv) there shall be substituted the following provision " (iv) 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"; (e) immediately after paragraph (4)(a)(iv) there shall be inserted the following provision " (v) it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3),"; and (f) there shall be added at the end the following paragraph " (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 the heading and paragraph (1) there shall be substituted the following provisions " Restriction on the use of monomers in the manufacture of plastic materials and articles (1) Subject to the following paragraphs, 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) 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 or referred to in the corresponding entry in column 4 of that 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 it is 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) (i) for sub-paragraphs (b) and (c) there shall be substituted the following provisions " (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 the following paragraph " (3) Paragraph (1)(a) 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) immediately after paragraph (5) there shall be inserted the following provisions " (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 sub-paragraph (b) or (c) of that paragraph relates". 7. Immediately after regulation 4 there shall be inserted the following regulation " 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 1 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 that Annex. (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 that Annex. (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 the heading and paragraph (1) there shall be substituted the following provisions " Restriction on the use of additives in the manufacture of plastic materials and articles (1) Subject to the following paragraphs, 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 that Schedule, which (i) is not of good technical quality, or (ii) is not 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, 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 that Annex; (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 that Annex; or (d) NOGE to the extent that it is 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), immediately after "Part I" there shall be inserted "or Part II"; (c) for paragraph (3), there shall be substituted the following paragraph " (3) Part III of Schedule 2 shall have effect to supplement this regulation and Parts I and II of that Schedule."; (d) in paragraph (4) (i) for "Part I of Schedule 2" there shall be substituted "Part I or II of Schedule 2", and (ii) in each of sub-paragraphs (a) and (b), for "therein" there shall be substituted "that column"; (e) between paragraphs 4 and 5 there shall be inserted the following paragraphs " (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), for "Part I of Schedule 2" there shall be substituted "Part I or Part II of Schedule 2". 9. In regulation 6 (method of testing capability of transferring constituents) (a) for the heading, the introductory words and paragraph (1)(a) there shall be substituted the following provisions " Method of testing the capability of plastic materials or articles to transfer constituents and methods of analysis (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) 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;"; and (b) after paragraph (3) there shall be added the following provisions " (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-paragraph of paragraph 8 of Annex ll 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 sentence 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 that paragraph relating to the term "QMA",". 10. For regulation 7A (specifications) there shall be substituted the following regulation " 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 that 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 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. Immediately after regulation 8 (labelling) there shall be inserted the following regulations " 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 1 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 1 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 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 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 materials or articles covered by surface coatings to transfer constituents and methods of analysis 8B. - (1) Subject to paragraphs (2) and (3), for the purposes of regulation 8A(1), (2), (4) and (5), an adhesive or 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 material or article may come into contact to the extent that such capability is established by the verification methods specified in Section A of Schedule 3 and in Schedule 4. (2) Subject to paragraph (3), 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), 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 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 referred to in regulation 8A(4) or (5)"; and (c) the reference 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 a reference 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 requirement 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 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 (7) and (8), immediately after "plastic material or article", wherever it occurs, there shall be inserted "or, as the case may be, adhesive or material or article covered by a surface coating"; and (c) immediately after paragraph (13) there shall be added the following paragraphs " (14) Subject to paragraph (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 which was put into free circulation in the European Community 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 (15) had not been in operation at the time that matter occurred. (15) The provisions referred to in paragraph (14) are regulations 5(d), 6(b), 8(a), (b) and (d), 10, 12(a) and 15 to 17 of the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002, to the extent that they implement those requirements of Commission Directive 2001/62 to which Article 2 of that Directive applies. (16) For the purposes of paragraph (14), "free circulation" shall have the same meaning as in Article 2 of Commission Directive 2001/62. (17) 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 an adhesive or a material or article covered by a surface coating (i) which was brought into contact with food before 28th February 2003, (ii) on which (in the case of a material or article covered by a surface coating) the date of filling of the material or article concerned appeared at the time of the sale, and (iii) the labelling or marking of which at the time of sale (in the case of a material or article covered by a surface coating) complied with the requirement as regards labelling relating to durability contained in Article 2.1(a) of Directive 2000/13/EC 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[8]; 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 (18) had not been in operation at the time of sale. (18) The provisions referred to in paragraph (17) are regulations 5(b) and (f), 11 and 12(a) of the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2002.". 13. In regulation 11 (presumption as to food with which a plastic material or article is to come into contact) and the heading to it, immediately after "plastic material or article", wherever it occurs, 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 added ", 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, 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, (ii) in the case of each monomer named in the second column of Part II of Schedule 1 to these Regulations, for the item number for that monomer specified opposite to it in the column headed "Item" there shall be substituted the item number for it specified in the first column (item) of that Part, and (iii) in the case of each monomer named 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 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part; (b) for Section B of Part I there shall be substituted the contents of Part IV of Schedule 1 to these Regulations; and (c) in Part II, for paragraph 4 there shall be substituted the following paragraph " 4. Where an entry in column 4 of Part I (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, 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, (iii) in the case of each additive named in the second column of Part II of Schedule 2 to these Regulations, for the item number for that additive specified opposite to it in the column headed "Item" there shall be substituted the item number for it specified in the first column (item) of that Part, and (iv) in the case of each additive named 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 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part, and (v) all the entries for the additive Silicic acid, salts, (item 241) shall be deleted; (b) immediately after Part I there shall be inserted the contents of Part IV of Schedule 2 to these Regulations (which shall become Part II of Schedule 2 to the principal Regulations on the coming into operation 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 and 3, immediately after "Part I" there shall be added "or Part II"; and (iv) for paragraph 4 there shall be substituted the following paragraph " 4. Where an entry in column 4 of Part I or Part II (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) immediately after paragraph 4 there shall be inserted the following paragraph " 5. In the case of the substances listed in Part II, 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[9] and Council Directive 85/572/EEC[10].". 17. In Schedule 2B (specifications) in the case of each substance listed in Schedule 3 to these Regulations, the item number, 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. 18. In Schedule 3 (provisions applicable when testing compliance with the migration limits) (a) in each of sub-paragraphs (3) and (4) of paragraph 4, immediately 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 there shall be substituted the following sub paragraph " (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.". Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 11th October 2002. L.S. David Finnegan A Senior Officer of the Department of Health, Social Services and Public Safety SCHEDULE 1 Regulation 15(a) and (b) PART I list of monomers to be added to section a of part i of schedule 1 to the principal regulations Item PM/REF No. CAS No. Name Restrictions and specifications 15A 11530 00999 61-1 Acrylic acid, 2 hydroxypropyl ester QMA = 0.05 mg/6 dm2 28B 12763 00141 43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer 28C 12765 84434 12-8 N-(2-aminoethyl)-beta alanine, sodium salt SML = 0.05 mg/kg 38A 13395 04767 03-7 2,2-Bis(hydroxymethyl) propionic acid QMA = 0.05 mg/6 dm2 47A 13617 00080 09-1 Bisphenol S As item 86A 49B 13810 00505 65-7 1,4-Butanediol formal QMA = 0.05 mg/6 dm2 52A 13932 00598 32-3 3-Buten-2-ol QMA = ND (DL = 0.02 mg/6 dm2). To be used only as a co-monomer for the preparation of polmeric additive 70A 15030 00931 88-4 Cyclooctene SML = 0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC 76A 15370 03236 53-1 1,6-Diamino-2,2,4 trimethylhexane QMA = 5 mg/6 dm2 76B 15400 03236 54-2 1,6-Diamino-2,4,4 trimethylhexane QMA = 5 mg/6 dm2 77A 15610 00080 07-9 4,4'-Dichlorodiphenyl sulphone SML = 0.05 mg/kg 86A 16090 00080 09-01 4,4'-Dihydroxydiphenyl sulphone SML = 0.05 mg/kg 88B 16390 00126 30-7 2,2-Dimethyl-1,3 propanediol SML = 0.05 mg/kg 121B 19110 04098 71-9 1-Isocyanato-3 isocyanatomethyl-3,5,5 trimethylcyclohexane QM(T) = 1 mg/kg in FP (as NCO) 122A 19243 00078 79-5 Isoprene As item 145A 126A 19490 00947 04-6 Laurolactam SML = 5 mg/kg 135A 20260 00101 43-9 Methacrylic acid, cyclohexyl ester SML = 0.05 mg/kg 135B 20410 02082 81-7 Methacrylic acid, diester with 1,4-butanediol SML = 0.05 mg/kg 135D 20590 00106 91-2 Methacrylic acid, 2,3 epoxypropyl ester QMA = 0.02 mg/6 dm2 144A 21520 01561 92-8 Methallylsulphonic acid, sodium salt SML = 5 mg/kg 145A 21640 00078 79-5 2-Methyl-1,3-butadiene QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included) 145C 21765 106246 33-7 4,4'-Methylenebis(3-chloro 2,6-diethylaniline) QMA = 0.05 mg/6 dm2 145D 21821 00505 65-7 1,4-(Methylenedioxy)butane As item 49B 148A 22360 01141 38-4 2,6-Naphthalenedicarboxylic acid SML = 5 mg/kg 150A 22437 00126 30-7 Neopentylglycol As item 88B 156A 22778 07456 68-0 4,4' Oxybis(benzenesulphonyl azide) QMA = 0.05 mg/6 dm2 159A 22900 00109 67-1 1-Pentene SML = 5 mg/kg 184A 24073 000101 90-6 Resorcinol diglycidyl ether QMA = 0.005 mg/g dm2. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer. 214A 25380 Trialkyl acetic acid (C7 C17), vinyl esters (= vinyl versatate) QMA = 0.05 mg/g dm2 215A 25450 26896 48-0 Tricyclodecanedimethanol SML = 0.05 mg/kg 217A 25900 00110 88-3 Trioxane SML = 0.05 mg/kg PART II list of monomers for which the entry contained in the first column (item) of section a of part i of schedule 1 to the principal regulations is to be amended Item Name 52B 4-tert-Butylphenol 88C 1.3 Dioxolane 121C Isophthalic acid 135C Methacrylic acid, 2-(dimethylamino) ethyl ester 145B 3-Methyl-1-butene 159B Perfluoropropyl perfluorovinyl ether 214B Triallylamine PART III list of monomers for which the entry contained in column 4 (restrictions and specifications) of section a of part i of schedule 1 to the principal regulations is to be amended Name Restrictions and specifications 2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether (= BADGE) Use must be before 1st January 2005 and prior to that date be as specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex 4,4'-Dihydroxybenzophenone SML(T) = 6 mg/kg (14) Formaldehyde SML(T) = 15 mg/kg (21) Hexamethylenetetramine SML(T) = 15 mg/kg (expressed as formaldehyde (21) 1,3-Phenylenediamine SML = ND (DL = 0.02 mg/kg, analytical tolerance included) PART IV provisions substituted for section b of part i of schedule 1 to the principal regulations Item PM/REF No. CAS No. Name Restrictions and specifications 1 10599/90A 61788 89-4 Acids, fatty, unsaturated (C18), dimers, distilled 2 10599/91 61788 89-4 Acids, fatty, unsaturated (C18), dimers, non-distilled 3 10599/92A 68783- Acids, fatty, unsaturated (C18), 41-5 dimers, hydrogenated, distilled 4 10599/93 68783 41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled 5 11500 00103 11-7 Acrylic acid, 2-ethylhexyl ester 6 13050 00528 44-9 1,2,4-Benzenetricarboxylic acid As item 23 7 13075 00091 76-9 Benzoguanamine 8 13720 00110 63-4 1,4-Butanediol 9 14260 00502 44-3 Caprolactone 10 14800 03724 65-0 Crotonic acid 11 15310 00091 76-9 2,4-Diamino-6-phenyl-1,3,5 triazine 12 15730 00077 73-6 Dicyclopentadiene 13 16210 06864 37-5 3,3'-Dimethyl-4-4'-diaminodicyclo hexylmethane 14 16690 01321 74-0 Divinylbenzene 15 16697 00693 23-2 Dodecanedioic acid 16 17110 16219 75-3 5-Ethylidenebicyclo[2.2.1]hept-2 ene 17 18370 00592 45-0 1,4-Hexadiene 18 18700 00629 11-8 1,6-Hexanediol 19 21370 10595 80-9 Methacrylic acid, 2-sulphoethyl ester 20 21400 54276 35-6 Methacrylic acid, sulphopropyl ester 21 21970 00923 02-4 N-methylolmethacrylamide 22 22210 00098 83-9 Alpha-methylstyrene 23 25540 00528 44-9 Trimellitic acid QM(T) = 5 mg/kg in FP 24 25550 00552 30-7 Trimellitic anhydride QM(T) = 5 mg/kg in FP (expressed as trimellitic acid) 25 25840 03290 92-4 1,1,1-Trimethylopropane trimethacrylate 26 26230 00088 12-0 Vinylpyrrolidone " SCHEDULE 2 Regulation 16(a) and (b) PART I list of additives to be added to part i of schedule 2 to the principal regulations Item PM/REF No. CAS No. Name Restrictions and specifications 19A 35160 06642 31-5 6-Amino-1,3 dimethyluracil SML = 5 mg/kg 19B 35170 00141 43-5 2-Aminoethanol SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer 19C 35284 00111 41-1 N-(2 aminoethyl)ethanolamine SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer 36E 38840 154862 43-8 Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphite SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4 dicumylphenyl)pentaerythritol phosphate and its hydrolysis product (2,4-dicumylphenol) 38A 39925 129228 21-3 3,3-Bis(methoxymethyl) 2,5-dimethyl hexane SML = 0.05 mg/kg 41A 41120 10043 52-4 Calcium chloride 45A 41840 00105 60-2 Caprolactam SML(T) = 15 mg/kg (5) 72B 47210 26427 07-6 Dibutylthiostannoic acid polymer [= thiobis(butyl tin sulphide), polymer] In compliance with the specifications laid down in Schedule 2B 73A 47540 27458 90-8 Di-tert-dodecyl disulfide SML = 0.05 mg/kg 73D 48620 00123 31-9 1,4-Dihydroxybenzene SML = 0.6 mg/kg 73E 48720 00611 99-4 4,4' Dihydroxybenzophenone SML(T) = 6 mg/kg (14) 77A 52645 10436 08-5 Cis-11-eicosenamide 164A 64800 00110 16-7 Maleic acid SML(T) = 30 mg/kg (4) 167A 65920 66822 60-4 [N-methacryloyloxyethyl N,N-dimethyl-N carboxymethyl ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2 pyrrolidone, copolymers 191A 73160 - Phosphoric acid, mono and di-n-alkyl (C16 and C18) esters SML = 0.05 mg/kg 195B 76730 - Polydimethylsiloxane, gamma hydroxypropylated SML = 6 mg/kg 208A 81220 192268 64-7 Poly-[[6-[N-(2,2,6,6 tetramethyl-4 piperidinyl)-n butylamino]-1,3,5 triazine-2,4-diyl][2,2,6,6 tetramethyl- 4 piperidinyl)imino]-1,6 hexanediyl [2,2,6,6 tetramethyl-4-piperidinyl) imino]]-alpha-[N,N,N',N' tetrabutyl- N" "-(2,2,6,6 tetramethyl-4 piperidinyl)-N" [6,2,2,6,6-tetramethyl (-4 piperidinylamino) hexyl][1,3,5- triazine 2,4,6-triamine]-omega N,N, N',N'-tetrabutyl 1,3,5-triazine-2,4 diamine] SML = 5 mg/kg 229A 83599 68442 12-6 Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, SML(T) = 0.18 mg/kg (15) (expressed as tin) sodium sulphide and trichloromethyltin 240B 85680 01343 98-2 Silicic acid 271A 92150 01401 55-4 Tannic acids According to the JECFA specifications 279A 93270 00108 78-1 2,4,6-Triamino-1,3,5 triazine SML = 30 mg/kg 281A 95270 161717 32-4 2,4,6-Tris(tert butyl)phenyl 2-butyl-2 ethyl-1,3-propanediol phosphite SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP) PART II list of additives for which the entry contained in the first column (item) of part i of schedule 2 to the principal regulations is to be amended Item Name 36F Bis(3-4-dimethylbenzylidene)sorbitol 38B Bis(polyethyleneglycol)hydroxymethyl-phosphonate 73B Diethyleneglycol 73C 1,1-Difluoroethane 73F 2,4-Dimethyl-6-(1-methylpentadecyl)phenol 191B Phosphoric acid, trichloroethyl ester 195C Polyesters of 1,2-propanediol and/or 1,3-and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and or n-decanol 208B Poly (zinc glycerolate) 240C Silicic acid, lithium, magnesium, sodium salt 281B Vermiculite, reaction product with citric acid, lithium salt 281C Water 281D Waxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks 281E White mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks PART III list of additives for which the entry contained in column 4 (restrictions and specifications) of part i of schedule 2 to the principal regulations is to be amended Name Restrictions and specifications Benzaldehyde In compliance with regulation 4(2) of the 1987 Regulations Bis(polyethyleneglycol)hydroxymethyl phosphonate SML = 0.6 mg/kg. Authorised until 1st January 2004 Camphor In compliance with regulation 4(2) of the 1987 Regulations Copper iodide SML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (10) (expressed as iodine) 2'-(2-Hydroxy-3,5'-di-tert-butylphenyl)-5 chlorobenzotriazole SML(T) = 30 mg/kg (18) PART IV provisions inserted after part i of schedule 2 to the principal regulations Item PM/REF No. CAS No. Name Restrictions and specifications 1 30180 02180 18-9 Acetic acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese) 2 31520 61167 58-6 Acrylic acid, 2-tert-butyl-6-(3-tert butyl-2-hydroxy-5-methylbenzyl) 4-methylphenyl ester SML = 6 mg/kg 3 31920 00103 23-1 Adipic acid, bis(2-ethylhexyl) ester SML = 18 mg/kg (1) 4 34230 - Alkyl(C8-C22)sulphonic acids SML = 6 mg/kg 5 35760 01309 64-4 Antimony trioxide SML = 0.02 mg/kg (expressed as anti monium and analytical tolerance included) 6 36720 17194 00-2 Barium hydroxide SML(T) = 1 mg/kg (11) (expressed as barium) 7 36800 10022 31-8 Barium nitrate SML(T) = 1 mg/kg (11) (expressed as barium) 8 38240 00119 61-9 Benzophenone SML = 0.6 mg/kg 9 38560 07128 64-5 2,5-Bis(5-tert-butyl-2 benzoxazolyl) thiophene SML = 0.6 mg/kg 10 38700 63397 60-4 Bis(2-carbobutoxyethyl)tin bis(isooctylmercaptoacetate) SML = 18 mg/kg 11 38800 32687 78-8 N,N'-Bis(3-(3,5-di-tert-butyl-4 hydroxyphenyl)propionyl)hydrazide SML = 15 mg/kg 12 38820 26741 53-7 Bis(2,4-di-tert-butylphenyl) pentaery-thritol diphosphite SML = 0.6 mg/kg 13 39060 35958 30-6 1,1-Bis(2-hydroxy-3,5-di-tert butylphenyl)ethane SML = 5 mg/kg 14 39090 - N,N-bis(2-hydroxyethyl) alkyl(C8 C18)amine SML(T) = 1.2 mg/kg (12) 15 39120 - N,N-bis(2-hydroxyethyl) alkyl (C8 C18)amine hydrochlorides SML(T) = 1.2 mg/kg (12) (expressed as N,N-bis(2 hydroxyethyl)alkyl(C8 C18)amine) 16 40000 00991 84-4 2,4-Bis(octylmercapto)-6-(4 hydroxy-3,5-di-tert-butylanilino) 1,3,5-triazine SML = 30 mg/kg 17 40020 110553 27-0 2,4-Bis(octylthiomethyl)-6 methylphenol SML = 6 mg/kg 18 40160 61269 61-2 N,N'-bis(2,2,6,6-tetramethyl-4 piperidyl)hexamethylenediamine 1,2-dibromoethane, copolymer SML = 2.4 mg/kg 19 40800 13003 12-8 4,4'-Butylidene-bis(6-tert-butyl-3 methylphenyl-ditridecyl phosphite) SML = 6 mg/kg 20 40980 19664 95-0 Butyric acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese) 21 42000 63438 80-2 (2-Carbobutoxyethyl)tin tris(isooctylmercaptoacetate) SML = 30 mg/kg 22 42400 10377 37-4 Carbonic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium) 23 42480 00584 09-8 Carbonic acid, rubidium salt SML = 12 mg/kg 24 43600 04080 31-3 1-(3-Chloroallyl)-3,5,7-triaza-1 azoniaadamantane chloride SML = 0.3 mg/kg 25 43680 00075 45-6 Chlorodifluoromethane SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 2B 26 44960 11104 61-3 Cobalt oxide SML(T) = 0.05 mg/kg (13) (expressed as cobalt) 27 45440 - Cresols, butylated, styrenated SML = 12 mg/kg 28 46720 04130 42-1 2,6-Di-tert-butyl-4-ethylphenol QMA = 4.8 mg/6 dm2 29 47600 84030 61-5 Di-n-dodecyltin bis(isooctyl mercaptoacetate) SML = 12 mg/kg 30 48640 00131 56-6 2,4-Dihydroxybenzophenone SML(T) = 6 mg/kg (14) 31 48800 00097 23-4 2,2'-Dihydroxy-5,5' dichlorodiphenylmethane SML = 12 mg/kg 32 48880 00131 53-3 2,2'-Dihydroxy-4 methoxybenzophenone SML(T) = 6 mg/kg (14) 33 49600 26636 01-1 Dimethyltin bis(isooctyl mercaptoacetate) SML(T) = 0.18 mg/kg (15) (expressed as tin) 34 49840 02500 88-1 Dioctadecyl disulphide SML = 3 mg/kg 35 50160 - Di-n-octylin bis(n-alkyl(C10-C16) mercapto acetate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 36 50240 10039 33-5 Di-n-octyltin bis (2-ethyllhexyl maleate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 37 50320 15571 58-1 Di-n-octyltin bis(2-ethylhexyl mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 38 50360 - Di-n-octyltin bis(ethyl maleate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 39 50400 33568 99-9 Di-n-octyltin bis(isooctyl maleate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 40 50480 26401 97-8 Di-n-octyltin bis(isooctyl mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 41 50560 - Di-n-octyltin 1,4-butanediol bis (mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 42 50640 03648 18-8 Di-n-octyltin dilaurate SML(T) = 0.04 mg/kg (16) (expressed as tin) 43 50720 15571 60-5 Di-n-octyltin dimaleate SML(T) = 0.04 mg/kg (16) (expressed as tin) 44 50800 - Di-n-octyltin dimaleate, esterified SML(T) = 0.04 mg/kg (16) (expressed as tin) 45 50880 - Di-n-octyltin dimaleate, polymers (n = 2-4) SML(T) = 0.04 mg/kg (16) (expressed as tin) 46 50960 69226 44-4 Di-n-octyltin ethyleneglycol bis(mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin) 47 51040 15535 79-2 Di-n-octyltin mercaptoacetate SML(T) = 0.04 mg/kg (16) (expressed as tin) 48 51120 - Di-n-octyltin thiobenzoate 2-ethyl hexyl mercaptoacetate SML(T) = 0.04 mg/kg (16) (expressed as tin) 49 51570 00127 63-9 Diphenyl sulphone SML = 3 mg/kg 50 51680 00102 08-9 N,N'-diphenylthiourea SML = 3 mg/kg 51 52000 27176 87-0 Dodecylbenzenesulphonic acid SML = 30 mg/kg 52 52320 52047 59-3 2-(4-Dodecylphenyl)indole SML = 0.06 mg/kg 53 52880 23676 09-7 4-Ethoxybenzoic acid, ethyl ester SML = 3.6 mg/kg 54 53200 23949 66-8 2-Ethoxy-2'-ethyloxanilide SML = 30 mg/kg 55 58960 00057 09-0 Hexadecyltrimethylammonium bromide SML = 6 mg/kg 56 59120 23128 74-7 1,6-Hexamethylene-bis(3-(3,5-di tert-butyl-4-hydroxyphenyl) propionamide) SML = 45 mg/kg 57 59200 35074 77-2 1,6-Hexamethylene-bis(3-(3,5-di tert-butyl-4-hydroxyphenyl) propionate) SML = 6 mg/kg 58 60320 70321 86-7 2-(2-Hydroxy-3,5-bis(1,1 dimethylbenzyl)phenyl) benzotriazole SML = 1.5 mg/kg 59 60400 03896 11-5 2-(2'-Hydroxy-3'-tert-butyl-5' methylphenyl)-5 chlorobenzotriazole SML(T) = 30 mg/kg (18) 60 60800 65447 77-0 1-(2-Hydroxyethyl)-4-hydroxy 2,2,6,6-tetramethyl, piperidine succinic acid, dimethyl ester, copolymer SML = 30 mg/kg 61 61280 03293 97-8 2-Hydroxy-4-n hexyloxybenzophenone SML(T) = 6 mg/kg (14) 62 61360 00131 57-7 2-Hydroxy-4 methoxybenzophenone SML(T) = 6 mg/kg (14) 63 61440 02440 22-4 2-(2-Hydroxy-5-methylphenyl) benzotriazole SML(T) = 30 mg/kg (18) 64 61600 01843 05-6 2-Hydroxy-4-n octyloxybenzophenone SML(T) = 6 mg/kg (14) 65 63200 51877 53-3 Lactic acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese) 66 64320 10377 51-2 Lithium iodide SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8) (expressed as lithium) 67 65120 07773 01-5 Manganese chloride SML(T) = 0.6 mg/kg (9) (expressed as manganese) 68 65200 12626 88-9 Manganese hydroxide SML(T) = 0.6 mg/kg (9) (expressed as manganese) 69 65280 10043 84-2 Manganese hypophosphite SML(T) = 0.6 mg/kg (9) (expressed as manganese) 70 65360 11129 60-5 Manganese oxide SML(T) = 0.6 mg/kg (9) (expressed as manganese) 71 65440 Manganese pyrophosphite SML(T) = 0.6 mg/kg (9) (expressed as manganese) 72 66360 85209 91-2 2-2'-Methylene bis(4,6-di-tert butylphenyl)sodium phosphate SML = 5 mg/kg 73 66400 00088 24-4 2-2'-Methylenebis(4-ethyl-6-tert butylphenol) SML(T) = 1.5 mg/kg (19) 74 66480 00119 47-1 2-2'-Methylenebis(4-methyl-6-tert butylphenol) SML(T) = 1.5 mg/kg (19) 75 67360 67649 65-4 Mono-n-dodecyltin tris(isooctyl mercaptoacetate) SML = 24 mg/kg 76 67520 54849 38-6 Monomethyltin tris(isooctyl mercaptoacetate) SML(T) = 0.18 mg/kg (15) (expressed as tin) 77 67600 - Mono-n-octyltin tris(alkyl(C10 C16)-mercaptoacetate) SML(T) = 1.2 mg/kg (17) (expressed as tin) 78 67680 27107 89-7 Mono-n-octyltin tris(2-ethylhexyl mercaptoacetate) SML(T) = 1.2 mg/kg (17) (expressed as tin) 79 67760 26401 86-5 Mono-n-octyltin tris(isooctyl mercaptoacetate) SML(T) = 1.2 mg/kg (17) (expressed as tin) 80 68078 27253 31-2 Neodecanoic acid, cobalt salt SML(T) = 0.05 mg/kg (expressed as neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC 81 68320 02082 79-3 Octadecyl 3-(3,5-di-tert-butyl-4 hydroxylphenyl)propionate SML = 6 mg/kg 82 68400 10094 45-8 Octadecylerucamide SML = 5 mg/kg 83 69840 16260- Oleylpalmitamide SML = 5 mg/kg 09-6 84 72160 00948 65-2 2-Phenylindole SML = 15 mg/kg 85 72800 01241 94-7 Phosphoric acid, diphenyl 2 ethylhexyl ester SML = 2.4 mg/kg 86 73040 13763 32-1 Phosphoric acid, lithium salts SML(T) = 0.6 mg/kg (8) (expressed as lithium) 87 73120 10124 54-6 Phosphoric acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese) 88 74400 - Phosphorous acid, tris(nonyl-and/or dimonylphenyl) ester SML = 30 mg/kg 89 77440 - Polyethyleneglycol diricinoleate SML = 42 mg/kg 90 77520 61791 12-6 Polyethyleneglycol ester of castor oil SML = 42 mg/kg 91 78320 09004 97-1 Polyethyleneglycol monoricinoleate SML = 42 mg/kg 92 81200 71878 19-8 Poly[6-[(1,1,3,3 tetramethylbutyl)amino]-1,3,5 triazine-2,4-diyl]-[(2,2,6,6 tetramethyl-4-piperidyl) imino]hexamethylene [(2,2,6,6 tetramethyl-4-piperidyl)limino] SML = 3 mg/kg 93 81680 07681 11-0 Potassium iodide SML(T) = 1 mg/kg (10) (expressed as iodium) 94 82020 19019 51-3 Propionic acid, cobalt salt SML(T) = 0.05 mg/kg (13) (expressed as cobalt) 95 83595 119345 01-6 Reaction product of di-tert butylphosphonite with biphenyl, obtained by condensation of 2,4-di tert-butylphenol with friedel craft reaction product of phosphorus trichloride and biphenyl SML = 18 mg/kg and in compliance with the specifications in Schedule 2B 96 83700 00141 22-0 Ricinoleic acid SML = 42 mg/kg 97 84800 00087 18-3 Salicylic acid, 4-tert-butylphenyl ester SML = 12 mg/kg 98 84880 00119 36-8 Salicylic acid, methyl ester SML = 30 mg/kg 99 85760 12068 40-5 Silicic acid, lithium aluminium salt (2:1:1) SML(T) = 0.6 mg/kg (8) (expressed as lithium) 100 85920 12627- Silicic acid, lithium salt SML(T) = 0.6 mg/kg 14-4 (8) (expressed as lithium) 101 86800 07681 82-5 Sodium iodide SML(T) = 1 mg/kg (10) (expressed as iodium) 102 86880 - Sodium monoalkyl dialkylphenoxybenzenedi sulphonate SML = 9 mg/kg 103 89170 13586 84-0 Stearic acid, cobalt salt SML(T) = 0.05 mg/kg (13) (expressed as cobalt) 104 92000 07727 43-7 Sulphuric acid, barium salt SML(T) = 1 mg/kg (11) (expressed as barium) 105 92320 - Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acid SML = 15 mg/kg 106 92560 38613 77-3 Tetrakis(2,4-di-tert-butyl- phenyl) 4-4'-biphenylylene diphosphonite SML = 18 mg/kg 107 92800 00096 69-5 4,4'-Thiobis(6-tert-butyl-3 methylphenol) SML = 0.48 mg/kg 108 92880 41484 35-9 Thiodiethanol bis(3-(3-5-di-tert butyl-4-hydroxyphenyl)propionate) SML = 2.4 mg/kg 109 93120 00123 28-4 Thiodipropionic acid, didodecyl ester SML(T) = 5 mg/kg (20) 110 93280 00693 36-7 Thiodipropionic acid, dioctadecyl ester SML(T) = 5 mg/kg (20) 111 94560 00122 20-3 Triisopropanolamine SML = 5 mg/kg 112 95280 40601 76-1 1,3,5-Tris(4-tert-butyl-3-hydroxy 2,6-dimethylbenzyl)-1,3,5-triazine 2,4,6(1H,3H,5H)-trione SML = 6 mg/kg 113 95360 27676 62-6 1,3,5-Tris(3,5-di-tert-butyl-4 hydroxybenzyl)-1,3,5-triazine 2,4,6(1H,3H,5H)-trione SML = 5 mg/kg 114 95600 01843 03-4 1,1,3-Tris(2-methyl-4-hydroxy-5 tert-butylphenyl)butane SML = 5 mg/kg" SCHEDULE 3 Regulation 17 LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS Item PM/REF No. Specifications 4A 43680 CHLORODIFLUOROMETHANE Content of chlorofluoromethane less than 1 mg/kg of the substance 4B 47210 DIBUTYLTHIOSTANNOIC ACID POLYMER Molecular unit = (C8H18S3Sn2)n (n = 1,5-2) 5A 83595 REACTION PRODUCT OF DI-TERT-BUTYLPHOSPHONITE WITH BIPHENYL, OBTAINED BY CONDENSATION OF 2,4-DI TERT-BUTYLPHENOL WITH FRIEDEL CRAFT REACTION PRODUCT OF PHOSPHORUS TRICHLORIDE AND BIPHENYL Composition 4,4'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 38613-77-3) (36-46% w/w (1)) 4,3'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 118421-00-4) (17-23% w/w) 3,3'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 118421-01-5) (1-5% w/w) 4-Biphenylene-0,0-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 91362-37-7) (11-19% w/w) Tris(2,4-di-tert-butylphenyl)phosphite (CAS No. 31570-04-4) (9-18% w/w) 4,4'-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0 bis(2,4-di-tert-butylphenyl)phosphonite (CAS No. 112949-970) < 5% w/w) Other specifications Phosphor content of minimum 5.4% to 5.9% Acid value of maximum 10 mg KOH per gram Melt range of 85-110°C EXPLANATORY NOTE (This note is not part of the Regulations.) These Regulations amend for the second time the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998 (S.R. 1998 No. 264, "the 1998 Regulations"). The Regulations implement (a) Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L221, 17.8.2001, p. 18); (b) Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs (O.J. No. L51, 22.2.2002, p. 27); and (c) (in minor respects) Commission Directive 2002/17/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L58, 28.2.2002, p. 19). The Regulations also reflect the revocation, with effect from 4th September 2002, of Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L75, 21.3.1990) as amended and its re-enactment in consolidated form by Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J.No. L220 15.8.2002, p. 18). The Regulations amend the 1998 Regulations by (a) adding a provision declaring that, in addition to regulating (as previously) the contact with food of certain types of plastic materials and articles, the 1998 Regulations now also include provisions which regulate the contact with food of certain other types of food contact materials, namely adhesives and materials or articles covered by surface coatings (regulation 3); (b) providing for the definition of "plastic material or article" to have an extended meaning where that term is used in the context of provisions added to the 1998 Regulations in implementation of Commission Directive 2002/16/EC (regulation 4(a)(vii) and (c)); (c) extending, so as to apply to adhesives and materials and articles covered by surface coatings, the provisions in the 1998 Regulations which (i) give to the term "sale" an extended meaning for the purposes of those Regulations, (ii) prohibit the use, sale or importation of plastic materials and articles not meeting specified standards, (iii) make available the defence of "due diligence" in the case of offences relating to plastic materials and articles, (iv) create a presumption as to the accuracy of any particulars shown in relation to a plastic material or article which may come into contact with food, and (v) apply for the purposes of those Regulations, in relation to plastic materials and articles, various provisions of the Food Safety (Northern Ireland) Order 1991 (regulations 4(b), 5, 12(b), 13 and 14 respectively); (d) adding to the provisions restricting the use of certain substances as monomers or additives in the manufacture of plastic materials or articles, provisions restricting the use of 2,2-bis(4 hydroxyphenyl) propane bis(2,3-epoxypropyl) ether, ("BADGE"), bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers ("BFDGE") and novolac glycidyl ethers ("NOGE") as monomers or additives in such manufacture (regulations 6(a) and 8(a)); (e) changing (from 31st December 2001 to 31st December 2004) the date beyond which the monomers listed in Section B of Schedule 1 to the 1998 Regulations may no longer be used in the manufacture of plastic materials or articles and modifying the list of the types of plastic materials and articles to which the restrictions on the use of monomers in their manufacture do not apply (regulation 6(b) and (c)); (f) introducing new restrictions on the manufacture of plastic materials and articles using BADGE, BFDGE or NOGE other than as monomers or additives (regulation 7); (g) amending the provisions governing the testing of the capability of plastic materials and articles to transfer their constituents to food, in particular by adding provisions governing the testing of that capability in the case of BADGE, BFDGE and NOGE (regulations 9 and 18); (h) adding a provision restricting the extent to which certain plastic materials or articles are allowed to transfer certain substances to food (regulation 10); (i) introducing new restrictions on the manufacture of adhesives or materials and articles covered by surface coatings using BADGE, BFDGE or NOGE and new provisions governing the testing of the capability of such adhesives, materials or articles to transfer those substances to food (regulation 11); (j) making it an offence to contravene any of the restrictions referred to in sub-paragraphs (d), (f) or (i) and including transitional provisions (regulation 12(a) and (c)); (k) adding new substances to the list of monomers which may be used in the manufacture of plastic materials or articles and amending the conditions of use of certain monomers used in such manufacture (regulation 15); (l) adding new substances to the non-exhaustive list of additives used in the manufacture of plastic materials or articles, amending the conditions of use of certain additives used in such manufacture and deleting one additive from that list (regulations 8(a) and 16); and (m) adding certain substances to the list of substances whose specifications are set out in Schedule 2B to the 1998 Regulations (regulation 17). Notes: [1] Formerly the Department of Health and Social Services: see S.I. 1999/283 (N.I. 1) Article 3(6) [2] S.I. 1991/762 (N.I. 7) as amended by S.I. 1996/1633 (N.I. 12) and paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards Act 1999 c. 28 [3] O.J. No. L31, 1.2.2002, p. 1 [4] S.R. 1998 No. 264, as amended by S.R. 2000 No. 402 [5] O.J. No. L221, 17.8.2001, p. 18 [6] O.J. No. L51, 22.2.2002, p. 27 [7] O.J. No. L220, 15.8.2002, p. 18 [8] O.J. No. L109, 6.5.2000, p. 29 [9] O.J. No. L297, 23.10.82, p. 26, last amended by Commission Directive 97/48/EC (O.J. No. L222, 12.8.97, p.10) [10] O.J. No. L372, 31.12.85, p. 14 ISBN 0 33794378 8