Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 (S.I. No. 302 (W. 44) of 2003)

The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] Welsh Statutory Instrument 2003 No. 302 (W.44) The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 © Crown Copyright 2003 Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament. 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 Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. 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STATUTORY INSTRUMENTS 2003 No. 302 (W.44) FOOD, WALES The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 Made 13th February 2002 Coming into force 28th February 2003 In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and (3), file:///bookstore.htm?AF=A10075&FO=38383&Action=AddItem&ProductID=0110906683 mailto:customer.services@tso.co.uk file:///faq.htm The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] 31 and 48(1) of the Food Safety Act 1990[1] which are now exercisable in relation to Wales by the National Assembly for Wales[2], the National Assembly for Wales having had regard, in accordance with section 48(4A) of that Act, 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 section 48(4) and (4B) of that Act, makes the following Regulations: Title, extent and commencement 1. These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 shall apply to Wales only and shall come into force on 28th February 2003. 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[4] ("the principal Regulations") shall be amended, in so far as they apply to Wales, in accordance with regulations 3 to 6. 3. In regulation 10 (offences), immediately after paragraph (20) there shall be added the following paragraphs " (21) 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 manufactured or imported into the European Community before 1st March 2004 and the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the provisions specified in paragraph (22) had not been in force at the time that matter occurred; or (b) the act constituting the offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 1st March 2003, and the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by regulation 4(a)(i) and (b) (in so far as they relate to the monomer divinylbenzene) and 6 of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 had not been in force at the time that matter occurred. (22) The provisions referred to in paragraph (21)(a) of this regulation are the provisions of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003, except in so far as they relate to the monomer divinylbenzene.". 4. 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 The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] (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. 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, (iii) in the case of the monomer Bis (4-isocyanatocyclohexyl) methane (item 43), for the entry for that monomer specified in column 1 (PM/REF/No.) there shall be substituted the entry "13560", and (iv) 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) in Section B of Part I, all the entries for the monomers named in Part IV of Schedule 1 to these Regulations shall be deleted; and (c) in Part II, at the end of paragraph 4 there shall be inserted the following provisions " (22) 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. 13620, 36840, 40320 and 87040. (23) 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. 13720 and 40580. (24) 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. 16650 and 51570. (25) QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the substances having PM/REF/Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.". 5. In Schedule 2 (additives and supplementary) (a) in Part I (i) in the case of each additive listed in Part I of Schedule 2 to these Regulations, the item number, PM/REF No. CAS No. name and restriction or specification specified for that additive in that The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] Part shall be inserted in the appropriate numerical position for that item number, (ii) in the case of the additive Bis (polyethyleneglycol) hydroxymethylphosphonate, there shall be inserted in column 2 (CAS No.) the entry "68951 - 50 - 8", and (iii) in the case of the additive named in the first column of Part II 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 (b) in Part II (i) in the case of each additive listed in Part III of Schedule 2 to these Regulations, the item number, PM/REF/No. CAS No. name and restriction or specification specified for that additive in that Part shall be inserted in the appropriate numerical position for that item number, and (ii) in the case of each additive named in the first column of Part IV 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 (c) in Part III (i) in note (11) of paragraph 4, after the figure "36800" there shall be inserted the figure ", 36840", and (ii) at the end of that paragraph there shall be added the following provisions " (22) 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. 13620, 36840, 40320 and 87040. (23) 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. 13720 and 40580. (24) 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. 16650 and 51570.". 6. In Schedule 2B (specifications) in the case of the substance specified 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 and letter. The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] Amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 7. In Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990[5] (provisions to which those Regulations do not apply) the reference in the second column, opposite the entry in the first column relating to the Plastic Materials and Articles in Contact with Food Regulations 1998, shall be amended in relation to Wales so as to read "S.I. 1998/1376 as amended by S.I. 2001/1263 (W.70) S.I. 2002/2834 (W.272) and S.I. 2003/302 (W.44)". Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[6]. Rhodri Morgan First Minister of the National Assembly for Wales 13th February 2003 SCHEDULE 1 Regulation 4(a)(i), (ii) and (iv) 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 33B 13075 00091 76-9 Benzoguanamine see "2,4-Diamino-6 Phenyl-1,3,5 Triazine" 47B 13620 10043 35-3 Boric acid SML(T) - 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption[7]. 49A 13720 00110 63-4 1,4-Butanediol SML(T) = 0.05 mg/kg (23) 76A 15310 00091 76-9 2,4-Diamino-6-phenyl 1,3,5-triazine QMA = 5 mg/6 dm2 92A 16650 00127 63-9 Diphenyl sulphone SML(T) = 3 mg/kg (24) 93A 16690 01321- Divinylbenzene QMA = 0.01 mg/6 The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] 74-0 dm2 of SML = ND (DL = 0.02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and in compliance with the specifications laid down in Schedule 2B. 93C 16697 00693 23-2 n-Dodecanedioic Acid 120A 18897 16712 64-4 6-Hydroxy-2 naphthalenecarboxylic acid SML = 0.05 mg/kg 120B 18898 103 90-2 N-(4 Hydroxyphenyl)acetamide Only to be used in liquid crystals and behind a barrier layer in multi-layered plastics. 147B 22332 28679 16-5 Mixture of (40% w/w) 2,2,4-trimethylhexane 1,6-diisocyanate and (60% w/w) 2,4,4 trimethylhexane-1,6 diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (25) 217A 25840 03290 92-4 1,1,1-trimethylolpropane trimethacrylate 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 1 OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED Item Name 49B 1,4-Butanediol bis(2.3-epoxypropyl)ether 49C 1,4-Butanediol formal 76B 1,6-Diamino-2,2,4-trimethylhexane 76C 1,6-Diamino-2,4,4-trimethylhexane 93B N,N'-Divinyl-2-imidazolidone 93D 1-Dodecene 217B Trioxane The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] PART III LIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED Name Restrictions and specifications Chlorotrifluoroethylene QMA = 0.5 mg/6 dm2 Cyclohexyl isocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25)QM(T ) = 1 mg/kg (expressed as NCO) (25) Dicyclohexylmethane-4,4' diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) 3,3'-Dimethyl-4,4' diisocyanatobiphenyl QM(T ) = 1 mg/kg (expressed as NCO) (25) Diphenylether-4,4' diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) Diphenylmethane-2,4' diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) Diphenylmethane-4,4' diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) Hexamethylene dissocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) 1-isocyanato-3 isocyanatomethyl-3,5,5 trimethylcyclohexane QM(T ) = 1 mg/kg (expressed as NCO) (25) 1,5-Naphthalene diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) Octadecyl isocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) 2,4-Toluene diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) 2,6-Toluene diisocyanate QM(T ) = 1 mg/kg (expressed as NCO) (25) 2,4-Toluene diisocyanate dimer QM(T ) = 1 mg/kg (expressed as NCO) (25) PART IV LIST OF MONOMERS FOR WHICH ALL THE ENTRIES CONTAINED IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS ARE TO BE DELETED Benzoguanamine 1,4-Butanediol The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] 2,4-Diamino-6-phenyl-1,3,5-triazine Divinylbenzene n-Dodecanedioic acid 1,1,1-Trimethylolpropane trimethacrylate SCHEDULE 2 Regulation 5(a)(I) and (iii) and (b) PART I LIST OF ADDITIVES TO BE ADDED TO PART 1 OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS Item PM/REF No. CAS No. Name Restrictions and specifications 27b 36840 12007 55-5 Barium tetraborate SML(T) = 1 mg/kg expressed as barium (11) and SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption. 38C 40320 10043 35-3 Boric acid SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption. 40A 40580 00110 63-4 1,4-Butanediol SML(T) = 0.05 mg/kg (23) 188B 71670 178671 58-4 Pentaerythritol tetrakis (2 cyano-3,3 diphenylacrylate) SML(T) = 0.05 mg/kg 246A 87040 01330 43-4 Sodium tetraborate SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption. PART II ADDITIVE FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] AMENDED Name Restrictions and specifications Bis(polyethyleneglycol) hydroxymethylphosphonate SML = 0.6 mg/kg PART III LIST OF ADDITIVES TO BE ADDED TO PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS Item PM/REF No. CAS No. Name Restrictions and specifications 27A 45650 6197 30-4 2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester SML = 0.05 mg/kg 82A 68860 04724 48-5 n-Octylphosphonic acid SML = 0.05 mg/kg 111A 95000 28931 67-1 Trimethylolpropane trimethacrylate-methyl methacrylate copolymer PART IV LIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED Name Restrictions and specifications N,N-bis(2-hydroxyethyl)alkyl (C8-C18) amine hydrochlorides SML(T) = 1.2 mg/kg (12) expressed as territory amine (expressed excluding HCl) Diphenyl sulphone SML(T) = 3 mg/kg (24) SCHEDULE 3 Regulation 6 SUBSTANCE TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS Item PM/REF Specifications The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] No. 1 16690 Divinylbenzene - must not contain more than 40% ethylvinylbenzene EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations, which apply to Wales only, amend for the third time the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, "the 1998 Regulations"), in so far as they apply to Wales. These Regulations implement Commission Directive 2002/17/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (OJ No. L58, 28.2.2002, p.19), except paragraph 1(a) of the Annex and paragraph 2(a)(ii) of the Annex in so far as it relates to the additives benzaldehyde and camphor, which were implemented by the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 (S.I. 2002/2834 (W. 272)). 2. The Regulations amend the 1998 Regulations by (a) adding a transitional provision in respect of proceedings for an offence under them (regulation 3); (b) 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 4); (c) adding new substances to the non-exhaustive list of additives used in the manufacture of plastic materials or articles and amending the conditions of use of certain additives used in such manufacture (regulation 5); (d) adding certain substances to the list of substances whose specifications are set out in Schedule 2B to the 1998 Regulations (regulation 6); and (e) making a consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 (regulation 7). Notes: [1] 1990 c. 16.back [2] Functions of "the Secretary of State" so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by S.I. 1999/672, as amended by s.40(3) of the Food Standards Act 1999 (1999 c.28).back [3] OJ No. L31, 1.2.2002, p.1.back [4] S.I. 1998/1376, amended by S.I. 2001/1263 (W.70) and S.I. 2002/2834 The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003 file:///D/HTML/uk36787.htm[16.01.2025 11:40:10] Other UK SIs | Home | National Assembly for Wales Statutory Instruments | Scottish Statutory Instruments | Statutory Rules of Northern Ireland | Her Majesty's Stationery Office We welcome your comments on this site © Crown copyright 2003 Prepared 17 March 2003 (W.272).back [5] S.I. 1990/2463. The relevant amending instruments are S.I. 1998/1376 and S.I. 2002/2834 (W.272).back [6] 1998 c.38.back [7] OJ No. L330, 5.12.1998, p.32.back Cymraeg (Welsh) ISBN 0 11090668 3 file:///stat.htm file:/// http://www.wales-legislation.hmso.gov.uk/legislation/wales/w-stat.htm http://www.scotland-legislation.hmso.gov.uk/legislation/scotland/s-stat.htm http://www.scotland-legislation.hmso.gov.uk/legislation/scotland/s-stat.htm http://www.northernireland-legislation.hmso.gov.uk/legislation/northernireland/ni-srni.htm http://www.hmso.gov.uk/ http://www.hmso.gov.uk/hmsoform.htm http://www.wales-legislation.hmso.gov.uk/legislation/wales/wsi2003/20030302w.htm