Statutory Instrument 2002 No. 3008

      The Plastic Materials and Articles in Contact with Food (Amendment) (England) (No. 2) Regulations 2002

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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 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) - 

     5. In Schedule 2 (additives and supplementary) - 

     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)



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

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)
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)
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)



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 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


 

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Prepared 11 December 2002