Welsh Statutory Instrument 2002 No. 2834 (W.272)

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

      © Crown Copyright 2002

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STATUTORY INSTRUMENTS

2002 No. 2834 (W.272)

FOOD, WALES

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

  Made 7th November 2002 
  Coming into force 30th November 2002 

In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a), 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] having 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 after consultation in accordance with section 48(4) and 4(B) of that Act, makes the following Regulations:

Title, commencement and application
     1.  - (1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 and shall come into force on 30th November 2002.

    (2) These Regulations apply to Wales only.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998
     2. The Plastic Materials and Articles in Contact with Food Regulations 1998[4] ("the principal Regulations") shall be amended, in so far as they apply to Wales, in accordance with regulations 3 to 18.

     3. Immediately after regulation 1 there shall be added the following regulation - 

     4. In regulation 2 (interpretation) - 

      (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 the following words ", except that, where it is used in any provisions referred to in paragraph (5) below, to the extent that they implement or relate to the enforcement of Commission Directive 2002/16, it means any material or article made of any type of plastic"; and

      (viii) after the definition of "sell" there shall be added the following definition - 

      " "QMA" has the same meaning as it bears in the first sentence of the sub-paragraph relating to that term in paragraph 8 of Annex II 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) of this regulation 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) - 

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

     7. Immediately after regulation 4 (restriction on manufacture with monomers) there shall be inserted the following regulation - 

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

     9. n regulation 6 (method of testing capability of transferring constituents) - 

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

     11. Immediately after regulation 8 (labelling) there shall be inserted the following regulations - 

     12. In regulation 10 (offences) - 

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

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

     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) - 

     16. In Schedule 2 (additives and supplementary) - 

     17. In Schedule 2B (specifications) in the case of each substance listed in Schedule 3 to these Regulations, the item number and letter, PM/REF No. and specification set out for that substance in that Schedule shall be inserted in the appropriate numerical position for that item number and letter.

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

Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990
     19. In Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990[11] (provisions to which those Regulations do not apply) the reference in the second column, opposite the reference in the first column 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. 2000/3162 and S.I. 2002/2834.



Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[12]


Rhodri Morgan
The First Minister of the National Assembly

7th November 2002



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=0.02mg/6dm2
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-Naphthalenedi carboxylic 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 QMA = 0.005 mg/g dm2. Not for ether 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) In any case not covered by article 1.2 of Commission Directive [ 2002/16], use must be before 1st January 2005 and be as specified in paragraph 1 of Annex I to that Directive
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

    " SECTION B:

    MONOMERS AUTHORISED UP TO THE END OF 2004

    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 68783-41-5 Acids, fatty, unsaturated (C18), 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-methylolmetha- crylamide     
    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
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 1 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
Bis(polyethylenelycol)hydroxymethyl-phosphonate SML = 0.6 mg/kg. Authorised until 1st January 2004
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





    " PART II:

    INCOMPLETE LIST OF ADDITIVES USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES (BEING ADDITIVES TO WHICH PARAGRAPH 5 OF PART III OF THIS SCHEDULE APPLIES)

    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-ethyllhexyl) 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)
    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 16260-09-6 Oleylpalmitamide SML = 5 mg/kg
    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 12627-14-4 Silicic acid, lithium salt SML(T) = 0.6 mg/kg (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
    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)


     1. These Regulations amend, in relation to Wales, the Plastic Materials and Articles in Contact with Food Regulations 1998, so as to 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 (OJ No. L221, 17.8.2001, p.18);

    (b) Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials intend to come into contact with foodstuffs (OJ 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 (OJ No. L58, 28.2.2002, p.19).

     2. 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 (OJ 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 (OJ No. L220, 15.8.2002, p.18).

     3. 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 Act 1990 (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) above 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);

    (m) adding certain substances to the list of substances whose specifications are set out in Schedule 2B to the 1998 Regulations (regulation 17); and

    (n) making a consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 (regulation 19).

     4. A regulatory appraisal, which includes a compliance cost assessment of the effect that they are likely to have on business costs, has been prepared for these Regulations.

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, p1.back

[4] S.I. 1998/1376, amended by S.I. 2001/1263.back

[5] OJ No. L221, 17.8.2001, p.18.back

[6] OJ No. L215, 9.8.2001, p.26.back

[7] OJ No. L220, 15.8.2002, p.18.back

[8] OJ No. L109, 6.5.2000, p.29.back

[9] OJ No. L297, 23.10.82, p.26, last amended by Commission Directive 97/48/EC (OJ No. L222, 12.8.97, p.10).back

[10] OJ No. L372, 31.12.85, p.14.back

[11] S.I. 1990/2463; to which there are amendments not relevant to these Regulations.back

[12] 1998 c.38.back


Cymraeg (Welsh)


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