LegalizeThe Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002
Made: 7th November 2002
Coming into force: 30th November 2002
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Title, commencement and application
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Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998
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Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990
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SCHEDULE 1
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
SCHEDULE 2
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
SCHEDULE 3 — LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS
| Item | PM/REF No. | Specifications |
|---|---|---|
| 4A | 43680— | CHLORODIFLUOROMETHANEContent of chlorofluoromethane less than 1 mg/kg of the substance |
| 4B | 47210— | DIBUTYLTHIOSTANNOIC ACID POLYMERMolecular 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 BIPHENYLComposition—4,4’-Biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (36—46% w/w (1))—4,3’- Biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (17—23% w/w)—3,3’- Biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (1—5% w/w)—4-Biphenylene-0,0-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (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 |
Signed
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998
Rhodri Morgan — The First Minister of the National Assembly — 7th November 2002
Explanatory note
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Footnotes
[^f00001]: 1990 c. 16.
[^f00002]: 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).
[^f00003]: OJ No. L31, 1.2.2002, p1.
[^f00004]: S.I. 1998/1376, amended by S.I. 2001/1263.
[^f00005]: OJ No. L221, 17.8.2001, p.18.
[^f00006]: OJ No. L215, 9.8.2001, p.26.
[^f00007]: OJ No. L220, 15.8.2002, p.18.
[^f00008]: OJ No. L109, 6.5.2000, p.29.
[^f00009]: OJ No. L297, 23.10.82, p.26, last amended by Commission Directive 97/48/EC (OJ No. L222, 12.8.97, p.10).
[^f00010]: OJ No. L372, 31.12.85, p.14.
[^f00011]: S.I. 1990/2463; to which there are amendments not relevant to these Regulations.
[^f00012]: 1998 c. 38.
Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990
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