Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 (S.I. No. 3008 of 2002)

The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] Statutory Instrument 2002 No. 3008 The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 © Crown Copyright 2002 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 Royal Arms and the Queen's Printer imprints. The text of this Internet version of the Statutory Instrument has been prepared to reflect the text as it was Made. 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STATUTORY INSTRUMENTS 2002 No. 3008 FOOD, ENGLAND The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 Made 4th December 2002 Laid before Parliament 11th December 2002 Coming into force 28th February 2003 The Secretary of State, in exercise of the powers conferred on him by sections 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990[1] and now vested in him[2], 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) (England) (No. 2) Regulations 2002, shall extend to England only and file:///bookstore.htm?AF=A10075&FO=38383&Action=AddItem&ProductID=0110441435 http://www.tso.co.uk/howtoorder.htm http://www.tso.co.uk/howtoorder.htm The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] 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 extend to England, 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) (England) (No. 2) Regulations 2002 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) (England) (No. 2) Regulations 2002, 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 (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 The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] (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 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 The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] (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. 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 England so as to read "S.I. 1998/1376 as amended by S.I. 2000/3162, S.I. 2002/2364 and S.I. 2002/ ". Signed by authority of the Secretary of State for Health Hazel Blears Parliamentary Under Secretary of State, Department of Health 4th December 2002 SCHEDULE 1 Regulation 4(a)(i), (ii) and (iv) and (b) The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] 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[6]. 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 2 92A 16650 00127 63-9 Diphenyl sulphone SML(T) = 3 mg/kg (24) 93A 16690 01321 74-0 Divinylbenzene QMA = 0.01 mg/6 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 The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] 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 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 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) 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) The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] 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 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 I 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) The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] 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 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 tertiary amine (expressed excluding HCl) Diphenyl sulphone SML(T) = 3 mg/kg (24) The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] SCHEDULE 3 Regulation 6 SUBSTANCE TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS Item PM/REF No Specifications 1 16690 Divinylbenzene - must not contain more than 40% ethylvinylbenzene EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations, which extend to England only, amend for the third time the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, "the 1998 Regulations"), which extend to the whole of Great Britain. These Regulations implement 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) (England) Regulations 2002 (S.I. 2002/2364). 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). 3. A regulatory impact assessment has been prepared for these Regulations and has been placed in the Library of each House of Parliament, together with a transposition note setting out how the main elements of Commission Directive 2002/17/EC are transposed into domestic law by these Regulations. Copies may be obtained from the Chemical Safety and The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002 file:///D/HTML/uk35177.htm[16.01.2025 11:39:11] 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 2002 Prepared 11 December 2002 Toxicology Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH. Notes: [1] 1990 c. 16.back [2] Functions formerly exercisable by "the Ministers" (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable, in relation to England, by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c. 28). Those functions, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46) as read with section 40(2) of the 1999 Act. Section 17(1) was amended by paragraph 12(a), and section 48 by paragraph 21, of Schedule 5 to the 1999 Act. Regulation 13(4) of S.I. 2000/656 expressly authorises the Secretary of State to amend existing Regulations made by the Minister of Agriculture, Fisheries and Food (whether or not with others) under the Food Safety Act 1990.back [3] OJ No. L31, 1.2.2002, p.1.back [4] S.I. 1998/1376, amended by S.I. 2000/3162 and S.I. 2002/2364.back [5] S.I. 1990/2463. The relevant amending instruments are S.I. 1998/1376 and S.I. 2002/2364.back [6] OJ No. L330, 5.12.1998, p.32.back ISBN 0 11 044143 5 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