Offerynnau Statudol 2002 Rhif 2834 (Cy.272)

      Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Cymru) 2002


      © Hawlfraint y Goron 2002

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      Er mwyn sicrhau mynediad cyflym drwy gyfrwng cysylltiadau araf, rhannwyd dogfennau mawrion yn "dalpiau". Pan ymddengys botwm "continue" ar waelod tudalen o'r testun, dynoda fod talp arall o'r testun ar gael.


OFFERYNNAU STATUDOL


2002 Rhif 2834 (Cy.272)

BWYD, CYMRU

Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Cymru) 2002

  Wedi'u gwneud 7 Tachwedd 2002 
  Yn dod i rym 30 Tachwedd 2002 

Drwy arfer y pwerau a roddwyd gan adrannau 16(2), 17(1), 26(1)(a), 31 a 48(1) o Ddeddf Diogelwch Bwyd 1990[1], ac sydd bellach yn arferadwy mewn perthynas â Chymru gan Gynulliad Cenedlaethol Cymru[2] ar ôl rhoi sylw yn unol ag adran 48(4A) o'r Ddeddf honno i gyngor perthnasol a roddwyd gan yr Asiantaeth Safonau Bwyd ac ar ôl ymgynghori yn unol â gofynion Erthygl 9 o Reoliad (EC) Rhif 178/2002 Senedd Ewrop a'r Cyngor sy'n pennu egwyddorion cyffredinol a gofynion cyfraith bwyd, sy'n sefydlu Awdurdod Diogelwch Bwyd Ewrop ac sy'n pennu gweithdrefnau mewn materion diogelwch bwyd[3] , ac ar ôl ymgynghori yn unol ag adran 48(4) a (4B) o'r Ddeddf honno, yn gwneud y Rheoliadau canlynol:

Enwi, cychwyn a chymhwyso
     1.  - (1) Enw'r rheoliadau hyn yw Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd (Diwygio) (Cymru) 2002 a daw i rym ar 30 Tachwedd 2002.

    (2) Mae'r Rheoliadau hyn yn gymwys i Gymru yn unig.

Diwygiadau i Reoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998
    
2. Diwygir Rheoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998[4]) ("y prif Reoliadau"), i'r graddau y maent yn gymwys i Gymru, yn unol â rheoliadau 3 i 18.

     3. Yn union ar ôl rheoliad 1 mewnosoder y rheoliad canlynol - 

     4. Yn rheoliad 2 (dehongli) - 

      (iv) yn lle'r diffiniad o "the Directive" rhodder y diffiniad canlynol - ""the Directive" means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs[7]);",

      (v) yn union ar ôl y diffiniad o "import" mewnosoder y diffiniad canlynol - 

      " "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) yn union ar ôl y diffiniad o "monomer" mewnosoder y diffiniad canlynol - 

      " "NOGE" means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;",

      (vii) ar ddiwedd y diffiniad o "plastic material or article" ychwaneger y geiriau canlynol ", 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"; a

      (viii) ar ôl y diffiniad o "sell" ychwaneger y diffiniad canlynol - 

      " "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) yn lle paragraff (2) rhodder y ddarpariaeth ganlynol - 

        " (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."; ac

    (c) yn union ar ôl paragraff (4) mewnosoder y paragraff canlynol - 

        " (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. Yn rheoliad 3 (cyfyngu ar ddefnyddio, gwerthu neu fewnforio deunyddiau ac eitemau plastig) - 

     6. Yn rheoliad 4 (cyfyngu ar weithgynhyrchu â monomerau) - 

     7. Yn union ar ôl rheoliad 4 (cyfyngu ar weithgynhyrchu â monomerau) mewnosoder y rheoliad canlynol - 

     8. Yn rheoliad 5 (cyfyngu ar weithgynhyrchu ag ychwanegion) - 

     9. Yn rheoliad 6 (dull profi'r gallu i drosglwyddo ansoddion) - 

    "(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. Yn lle rheoliad 7A (manylebau) rhodder y rheoliad canlynol - 

     11. Yn union ar ôl rheoliad 8 (labelu) mewnosoder y rheoliadau canlynol - 

     12. Yn rheoliad 10 (tramgwyddau) - 

     13. Yn rheoliad 11 (rhagdybiaeth ynghylch bwyd y mae deunydd neu eitem blastig i ddod i gysylltiad ag ef) a'r pennawd iddo, yn union ar ôl y geiriau "plastic material or article", lle bynnag y maent yn ymddangos, mewnosoder y geiriau ", adhesive or material or article covered by a surface coating,".

    
14. Yn rheoliad 12 (cymhwyso darpariaethau eraill) - 

     15. Yn Atodlen 1 (monomerau a awdurdodwyd heb derfyn amser, monomerau a awdurdodwyd tan ddiwedd 2001, monomerau a awdurdodwyd tan ddiwedd 1998 ac ategolion) - 

     16. Yn Atodlen 2 (ychwanegion ac ategolion) - 

     17. Yn Atodlen 2B (manylebau) yn achos pob sylwedd a restrir yn Atodlen 3 i'r Rheoliadau hyn, mewnsodir rhif a llythyren yr eitem, PM/REF No. a'r fanyleb a nodir ar gyfer y sylwedd hwnnw yn yr Atodlen honno yn y safle rhifiadol priodol ar gyfer rhif a llythyren yr eitem hwnnw.

    
18. Yn Atodlen 3 (y darpariaethau cymwys wrth brofi cydymffurfedd â therfynau mudo) - 

Diwygio Rheoliadau Diogelwch Bwyd (Samplo a Chymwysterau) 1990
    
19. Yn Atodlen 1 i Reoliadau Diogelwch Bwyd (Samplo a Chymwysterau) 1990[11] (darpariaethau nad yw'r Rheoliadau hyn yn gwymwys iddynt) diwygir y cyfeiriad yn yr ail golofn, gyferbyn â'r cyfeiriad yn y golofn gyntaf at Reoliadau Deunyddiau ac Eitemau Plastig mewn cysylltiad â Bwyd 1998, mewn perthynas â Chymru i ddarllen "S.I. 1998/1376 as amended by S.I. 2000/3162 and S.I. 2002/2834.



Llofnodwyd ar ran Cynulliad Cenedlaethol Cymru o dan adran 66(1) o Ddeddf Llywodraeth Cymru 1998[12]


Rhodri Morgan
Prif Weinidog y Cynulliad Cenedlaethol

7 Tachwedd 2002



ATODLEN 1
Rheoliad 15(a) a (b)



RHAN I

RHESTR O FONOMERAU I'W HYCHWANEGU AT ADRAN A O RAN I O ATODLEN 1 I'R PRIF REOLIADAU

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



RHAN II

RHESTR O FONOMERAU Y MAE'R COFNOD AMDANYNT A GYNHWYSIR YNG NGHOLOFN GYNTAF (ITEM) ADRAN A O RAN I O ATODLEN 1 I'R PRIF REOLIADAU I'W DIWYGIO

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



RHAN III

RHESTR O FONOMERAU Y MAE'R COFNOD AMDANYNT A GYNHWYSIR YNG NGHOLOFN 4 (CYFYNGIADAU A MANYLEBAU) O ADRAN A O RAN I O ATODLEN 1 I'R PRIF REOLIADAU I'W DIWYGIO

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)



RHAN IV

DARPARIAETHAU A AMNEWIDIR AM ADRAN B O RAN I O ATODLEN 1 I'R PRIF REOLIADAU



    " 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     "




ATODLEN 2
Rheoliad 16(a) a (b)



RHAN I

RHESTR O YCHWANEGION I'W HYCHWANEGU AT RAN I O ATODLEN 2 I'R PRIF REOLIADAU

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)



RHAN II

RHESTR O YCHWANEGION Y MAE'R COFNOD AMDANYNT A GYNHWYSIR YNG NGHOLOFN GYNTAF (ITEM) RHAN I O ATODLEN 1 I'R PRIF REOLIADAU I'W DIWYGIO

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



RHAN III

RHESTR O YCHWANEGION Y MAE'R COFNOD AMDANYNT A GYNHWYSIR YNG NGHOLOFN 4 (CYFYNGIADAU A MANYLEBAU) O RAN I O ATODLEN 2 I'R PRIF REOLIADAU I'W DIWYGIO

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)



RHAN IV

DARPARIAETHAU A FEWNOSODIR AR ÔL RHAN I O ATODLEN 2 I'R PRIF REOLIADAU



    " 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"




ATODLEN 3
Rheoliad 17


RHESTR O SYLWEDDAU I'W HYCHWANEGU AT ATODLEN 2B I'R PRIF REOLIADAU


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




NODYN ESBONIADOL

(Nid yw'r nodyn hwn yn rhan o'r Rheoliadau)


     1. Mae'r Rheoliadau hyn yn diwygio, mewn perthynas â Chymru, Reoliadau Deunyddiau ac Eitemau Plastig mewn Cysylltiad â Bwyd 1998, er mwyn rhoi ar waith - 

    (a) Cyfarwyddeb y Comisiwn 2001/62/EC sy'n diwygio Cyfarwyddeb 90/128/EEC ynghylch deunyddiau ac eitemau plastig y bwriedir iddynt ddod i gysylltiad â bwydydd (OJ Rhif. L221, 17.8.2001, t.18);

    (b) Cyfarwyddeb y Comisiwn 2002/16/EC ar ddefnyddio deilliadau epocsi penodol mewn deunyddiau y bwriedir iddynt ddod i gysylltiad â bwydydd (OJ Rhif. L51, 22.2.2002, t.27); a

    (c) (mewn mân agweddau) Cyfarwyddeb y Comisiwn 2002/17/EC sy'n diwygio Cyfarwyddeb 90/128/EEC ynghylch deunyddiau ac eitemau plastig y bwriedir iddynt ddod i gysylltiad â bwydydd (OJ Rhif. L58, 28.2.2002, t.19).

     2. Mae'r Rheoliadau hefyd yn adlewyrchu, yn effeithiol o 4 Medi 2002, ddiddymiad Cyfarwyddeb 90/128/EEC ynghylch deunyddiau ac eitemau plastig y bwriedir iddynt ddod i gysylltiad â bwydydd (OJ Rhif. L75, 21.3.1990) fel y'i diwygiwyd a'i hailddeddfiad mewn ffurf gyd-grynhoi gan Gyfarwyddeb y Comisiwn 2002/72/EC ynghylch deunyddiau ac eitemau plastig y bwriedir iddynt ddod i gysylltiad â bwydydd (OJ Rhif. L220 15.8.2002, t.18).

     3. Mae'r Rheoliadau yn diwygio Rheoliadau 1998 drwy wneud y canlynol - 

    (a) ychwanegu darpariaeth yn datgan bod Rheoliadau 1998, yn ychwanegol at reoleiddio (fel cynt) gysylltiad mathau penodol o ddeunyddiau ac eitemau plastig â bwyd, bellach hefyd yn cynnwys darpariaethau sy'n rheoleiddio cysylltiad â bwyd ar fathau penodol o ddeunyddiau eraill sy'n dod i gysylltiad â bwyd, sef gludyddion a deunyddiau neu eitemau orchuddiwyd â haenau arwyneb (rheoliad 3);

    (b) darparu bod y diffiniad o "plastic material or article" i gael ystyr estynedig pan ddefnyddir y term hwnnw yng nghyd-destun darpariaethau a ychwanegwyd at Reoliadau 1998 wrth weithredu Cyfarwyddeb y Comisiwn 2002/16/EC (rheoliad 4(a)(vii) a (c));

    (c) estyn, er mwyn cymhwyso i ludyddion a deunyddiau ac eitemau a orchuddiwyd â haenau arwyneb, y darpariaethau yn Rheoliadau 1998 sydd yn gwneud y canlynol - 

      (i) rhoi i'r term "sale" ystyr estynedig at ddibenion y Rheoliadau hynny,

      (ii) gwahardd defnyddio, gwerthu neu fewnforio deunyddiau ac eitemau plastig nad ydynt yn bodloni'r safonau penodedig,

      (iii) peri bod yr amddiffyniad o "due diligence" ar gael yn achos tramgwyddau sy'n ymwneud â deunyddiau ac eitemau plastig,

      (iv) creu rhagdybiaeth ynghylch cywirdeb unrhyw fanylion a ddangosir mewn perthynas â deunyddiau neu eitemau plastig a all ddod i gysylltiad â bwyd, a

      (v) cymhwyso at ddibenion y Rheoliadau hynny, mewn perthynas â deunyddiau ac eitemau plastig, ddarpariaethau amrywiol o Ddeddf Diogelwch Bwyd 1990 (rheoliadau 4(b), 5, 12(b), 13 a 14 yn ôl eu trefn);

    (ch) ychwanegu at y darpariaethau sy'n cyfyngu ar ddefnyddio sylweddau fel monomerau neu ychwanegion wrth weithgynhyrchu deunyddiau neu eitemau plastig, darpariaethau sy'n cyfyngu ar ddefnyddio 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether, ("BADGE"), bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers ("BFDGE") a novolac glycidyl ethers ("NOGE") fel monomerau neu ychwanegion mewn gweithgynhyrchu o'r fath (rheoliadau 6(a) ac 8(a));

    (d) newid y dyddiad (o 31 Rhagfyr 2001 i 31 Rhagfyr 2004) pan na cheir wedyn ddefnyddio'r monomerau a restrir yn Adran B o Atodlen 1 i Reoliadau 1998 wrth weithgynhyrchu deunyddiau neu eitemau plastig ac addasu'r rhestr o'r mathau o ddeunyddiau ac eitemau plastig nad yw'r cyfyngiadau ar ddefnyddio monomerau wrth eu gweithgynhyrchu yn gymwys iddynt (rheoliad 6(b) ac (c));

    (dd) cyflwyno cyfyngiadau newydd wrth weithgynhyrchu deunyddiau ac eitemau plastig sy'n defnyddio BADGE, BFDGE neu NOGE heblaw fel monomerau neu ychwanegion (rheoliad 7);

    (e) diwygio'r darpariaethau sy'n llywodraethu profi gallu deunyddiau ac eitemau plastig i drosglwyddo eu hansoddion i fwyd, yn benodol drwy ychwanegu darpariaethau sy'n llywodraethu profi'r gallu hwnnw yn achos BADGE, BFDGE a NOGE (rheoliadau 9 a 18);

    (f) ychwanegu darpariaeth yn cyfyngu ar faint y caniateir i ddeunyddiau neu eitemau plastig penodol drosglwyddo sylweddau penodol i fwyd (rheoliad 10);

    (ff) cyflwyno cyfyngiadau newydd ar weithgynhyrchu gludyddion neu ddeunyddiau ac eitemau a orchuddir â haenau arwyneb sy'n defnyddio BADGE, BFDGE neu NOGE a darpariaethau newydd sy'n llywodraethu profi gallu gludyddion neu ddeunyddiau ac eitemau o'r fath i drosglwyddo'r sylweddau hynny i fwyd (rheoliad 11);

    (g) ei gwneud yn dramgwydd i dorri unrhyw un o'r cyfyngiadau y cyfeirir atynt yn is-baragraffau (ch), (dd) neu (ff) uchod gan gynnwys darpariaethau trosiannol (rheoliad 12 (a) ac (c));

    (ng) ychwanegu sylweddau newydd at y rhestr o fonomerau y gellir eu defnyddio wrth weithgynhyrchu deunyddiau neu eitemau plastig a diwygio'r defnydd o fonomerau penodol a ddefnyddir mewn gweithgynhyrchu o'r fath (rheoliad 15);

    (h) ychwanegu sylweddau newydd at y rhestr anghyflawn o ychwanegion a ddefnyddir wrth weithgynhyrchu deunyddiau neu eitemau plastig, diwygio amodau defnyddio ychwanegion penodol a ddefnyddir mewn gweithgynhyrchu o'r fath a dileu un ychwanegyn o'r rhestr honno (rheoliadau 8(a) ac 16);

    (i) ychwanegu sylweddau penodol at y rhestr o sylweddau y nodir manylebau amdanynt yn Atodlen 2B i Reoliadau 1998(rheoliad 17); a

    (j) gwneud diwygiad canlyniadol i Reoliadau Diogelwch Bwyd (Samplo a Chymwysterau) 1990 (rheoliad 19).

     4. Mae arfarniad rheoliadol, sydd yn cynnwys asesiad cost cydymffurfedd o'r effaith y maent yn debygol o gael ar gostau busnes, wedi cael ei baratoi ar gyfer y Rheoliadau hyn.


Notes:

[1] 1990 p.16.back

[2] Trosglwyddwyd swyddogaethau'r "Ysgrifennydd Gwladol" i'r graddau y maent yn arferadwy mewn perthynas â Chymru i Gynulliad Cenedlaethol Cymru gan O.S. 1999/672, fel y'i diwygiwyd gan a.40(3) o Ddeddf Safonau Bwyd 1999 (1999 p.28).back

[3] OJ Rhif L31, 1.2.2002, t.1.back

[4] O.S. 1998/1376, a ddiwygiwyd gan O.S. 2001/1263.back

[5] OJ Rhif L221, 17.8.2001, t.18.back

[6] OJ Rhif L215, 9.8.2001, t.26.back

[7] OJ Rhif L220, 15.8.2002, t.18.back

[8] OJ Rhif L109, 6.5.2000, t.29.back

[9] OJ Rhif L297, 23.10.82, t.26, a ddiwygiwyd ddiwethaf gan Ggyfarwyddeb y Comisiwn 97/48/EC (OJ Rhif L222, 12.8.97, t.10).back

[10] OJ Rhif L372, 31.12.85, t.14.back

[11] O.S. 1990/2463; y mae diwygiadau iddo nad ydynt yn berthnasol i'r Rheoliadau hyn.back

[12] 1998 p.38.back



English version



ISBN 0 11090588 1


 

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