LegalizeThe Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001
Made: 20th March 2001
Coming into force: 1st April 2001
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Title, commencement and application
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Amendment of Regulations
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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 |
|---|---|---|---|---|
| 28A | 12761 | 000693-57-2 | 12-Aminododecanoic acid | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 35A | 13180 | 000498-66-8 | Bicyclo [2.2.1] hept-2-ene (=norbornene) | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 35B | 13210 | 00176-71-3 | Bis(4-aminocyclohexyl)methane | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 63A | 14650 | 000079-38-9 | Chlorotrifluoroethylene | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm² |
| 68A | 14841 | 000599-64-4 | 4-Cumylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 93A | 16694 | 013811-50-2 | N,Ni-Divinyl-2-imidazolidinone | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
| 93B | 16704 | 000112-41-4 | 1-Dodecene | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 147A | 22331 | 025513-64-8 | Mixture of (40% w/w) 1,6- diamino-2,2,4- trimethylhexane and (60% w/w) 1,6-diamino-2,4,4— trimethylhexane | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/6 dm² |
| 152A | 22550 | 000498-66-8 | Norbornene | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 163A | 23175 | 000122-52-1 | Phosphorous acid, triethylester | The quantity of this substance in the finished plastic material or article shall be not detectable (when measured by a method with a detection limit of 1 mg/kg) |
| 169A | 23547 | 009016-00 6 063148-62-9 | Polydimethylsiloxane (MW>6800) | In compliance with the specifications laid down in Schedule 2B. |
| 206A | 25080 | 001120-36-1 | 1-Tetradecene | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 214A | 25385 | 000102-70-5 | Triallylamine | In compliance with the specifications laid down in Schedule 2B. |
| 218A | 25927 | 027955-94-8 | 1,1,1-Tris(4-hydroxyphenyl)ethane | The quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates |
| 223 | 26155 | 001072-63-5 | 1-Vinylimidazole | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
| 225 | 26320 | 002768-02-7 | Vinyltrimethoxysilane | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
| 226 | 26360 | 007732-18-5 | Water | In compliance with Directive 98/83/EC on the quality of water intended for human consumption . |
PART II — LIST OF MONOMERS IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMN “RESTRICTIONS AND SPECIFICATIONS” IS MODIFIED
| ITEM | PM/REF No. | CAS No. | Name | Restrictions and specifications |
|---|---|---|---|---|
| 2 | 10060 | 000075-07-0 | Acetaldehyde | SML (T) = 6 mg/kg (2) |
| 40 | 13510 | 001675-54-3 | 2,2-Bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE) | SML (T) = 1 mg/kg (9). Authorised only until 1 January 2005 |
| 56 | 14200 | 000105-60-2 | Caprolactam | SML (T) = 15 mg/kg (5) |
| 57 | 14230 | 002123-24-2 | Caprolactam, sodium salt | SML (T) = 15 mg/kg (5) (expressed as caprolactam) |
| 79 | 15760 | 000111-46-6 | Diethyleneglycol | SML (T) = 30 mg/kg (3) |
| 98 | 16990 | 000107-21-1 | Ethyleneglycol | SML (T) = 30 mg/kg (3) |
| 102 | 17160 | 000097-53-0 | Eugenol | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
| 128 | 19540 | 000110-16-7 | Maleic acid | SML (T) = 30 mg/kg (4) |
| 129 | 19960 | 000108-31-6 | Maleic anhydride | SML (T) = 30 mg/kg (4) (expressed as maleic acid) |
| 214 | 25360 | Trialkyl(C5-C15) acetic acid, 2,3-epoxypropyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight = 43) |
PART III — LIST OF MONOMERS IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMN “RESTRICTIONS” IS MODIFIED
| ITEM | PM/REF No | CAS/No. | Name | Restrictions |
|---|---|---|---|---|
| 34 | 16690 | 001321-74-0 | Divinylbenzene | The quantity of this material in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
| 56 | 20590 | 000106-91-2 | Methacrylic acid, 2,3-epoxypropyl ester | The quantity of this material in the finished plastic material or article shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight = 43) |
| 68 | 22720 | 000140-66-9 | 4-tert-Octylphenol | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01mg/kg, analytical tolerance included) |
PART IV — MONOMER TO BE ADDED TO SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
| Items | PM/REF No. | CAS No. | Name | Restrictions |
|---|---|---|---|---|
| 77A | 25185 | 000140-66-9 | 4-(1,1,3,3-Tetramethylbutyl) phenol (=4-tert-octylphenol) | As item 68 |
PART V — LIST OF MONOMERS TRANSFERRED FROM SECTION B TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
| Item No. in Section B | Item No. For Section A | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
|---|---|---|---|---|---|
| 5 | 13A | 11000 | 05976-02-8 | Acrylic acid, dicyclopentadienyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2 |
| 6 | 13B | 11245 | 002156-97-0 | Acrylic acid, dodecyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
| 9 | 23A | 12265 | 004074-90-2 | Adipic acid, divinyl dodecyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as a comonomer. |
| 12 | 33A | 13060 | 004422-95-1 | 1,3,5 - Benzenetricarboxylic acid trichloride | The quantity of this substance in the finished plastic material or artical shall not exceed 0.05 mg/6dm² (measured as 1,3,5 — benzenetricarboxylic |
| 16 | 49A | 13780 | 002425-79-8 | 1,4-Butanediol bis(2,3- epoxypropyl) ether | The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight equal to 43) |
| 19 | 52A | 14020 | 000098-54-4 | 4-tert-Butylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 22 | 73A | 15130 | 000872-05-9 | 1-Decene | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 30 | 88A | 16360 | 000576-26-1 | 2,6-Dimethylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 32 | 88B | 16450 | 000646-06-0 | 1,3-Dioxolane | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 37 | 111A | 18220 | 068564-88-5 | N-Heptylaminoundeca noic acid | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
| 41 | 118A | 18820 | 000592-41-6 | 1-Hexene | The specific migration of this substance shall not exceed 3 mg/kg |
| 42 | 121A | 19060 | 000109-53-5 | Isobutyl vinyl ether | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg |
| 43 | 121B | 19150 | 000121-91-5 | Isophthalic acid | The specific migration of this substance shall not exceed 5 mg/kg |
| 49 | 130A | 19990 | 000079-39-0 | Methacrylamide | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
| 50 | 131A | 20050 | 000096-05-9 | Methacrylic acid, allyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 55 | 135A | 20530 | 002867-47-2 | Methacrylic acid, 2-(dimethylamino) ethyl ester | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
| 61 | 145A | 21730 | 000563-45-1 | 3-Methyl-1-butene | The quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/6 dm2 For use only in polypropylene |
| 70 | 159A | 22937 | 001623-05-8 | Perfluoropropyl perfluorovinyl ether | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 71 | 173A | 23770 | 000504-63-2 | 1,3-Propanediol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 72 | 177A | 23920 | 000105-38-4 | Propionic acid, vinyl ester | SML (T) = 6 mg/kg (2) (expressed as acetaldehyde) |
| 74 | 198A | 24760 | 026914-43-2 | Styrenesulphonic acid | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 83 | 224 | 26170 | 003195-78-6 | N-Vinyl-N-methylacetamide | The quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg |
SCHEDULE 2 — LIST OF ADDITIVES TO BE INSERTED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
| ITEM | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
|---|---|---|---|---|
| 2A | 30080 | 004180-12-5 | Acetic acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
| 7A | 30610 | Acids C2-C24 aliphatic, linear monocarboxylic, from natural oils and fats and their mono-, di- and triglycerol esters (branched fatty acids at naturally occurring levels are included). | ||
| 7B | 30612 | Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their mono-, di— and triglycerol esters | ||
| 9A | 31530 | 123968-25-2 | Acrylic acid, 2,4-di-tert- pentyl-6-[1(3,5-di-tert-pentyl- 2-hydroxyphenyl) ethyl] phenyl ester | The specific migration of this substance shall not exceed 5 mg/kg |
| 12A | 33801 | n-Alkyl (C10-C13) benzenesulphonic acid | The specific migration of this substance shall not exceed 30 mg/kg | |
| 12B | 34240 | Alkyl(C10-C20) sulphonic acid, esters with phenols | The specific migration of this substance shall not exceed 6 mg/kg. Authorised only until 1 January 2002. | |
| 27A | 36640 | 000123-77-3 | Azodicarbonamide | For use only as blowing agent. |
| 31A | 37360 | 000100-52-7 | Benzaldehyde | (10) |
| 36A | 38320 | 005242-49-6 | 4-(2-Benzoxazolyl)-4i-(5- methyl-2-benzoxazolyl) stilbene | In compliance with the specifications laid down in Schedule 2B |
| 36B | 38510 | 136504-96-6 | 1,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6- tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5— triazine | The specific migration of this substance shall not exceed 5 mg/kg |
| 36C | 38515 | 001533-45-5 | 4,4i-Bis(2-benzoxazolyl)stilbene | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
| 36D | 38810 | 080693-00-1 | Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphite | The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate) |
| 36E | 38879 | 135861-56-2 | Bis(3,4— dimethylbenzylidene)sorbitol | |
| 37A | 39200 | 006200-40-4 | Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride | The specific migration of this substance shall not exceed 1.8 mg/kg |
| 37B | 39815 | 182121-12-6 | 9,9 bis(methoxymethyl) fluorene | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm² |
| 38A | 40120 | Bis(polyethyleneglycol) hydroxymethylphosphonate | The specific migration of this substance shall not exceed 0.6 mg/kg. Authorised only until 1 January 2002 | |
| 44A | 41680 | 000076-22-2 | Camphor | (10) |
| 47A | 42320 | 007492-68- 4 | Carbonic acid, copper salt | SML (T) = 30 mg/kg (7) |
| 57A | 43515 | Chlorides of choline esters of coconut oil fatty acids | The quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/6 dm² | |
| 59A | 45195 | 007787-70-4 | Copper bromide | SML (T) = 30 mg/kg (7) (expressed as copper) |
| 59B | 45200 | 001335-23-5 | Copper iodide | SML (T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (expressed as iodine) |
| 60A | 45450 | 068610-51-5 | p-Cresol-dicyclopentadiene-isobutylene, copolymer | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
| 72A | 46880 | 065140-91-2 2 | 3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt | The specific migration of this substance shall not exceed 6 mg/kg |
| 73A | 47680 | 000111-46-3 | Diethyleneglycol | SML (T) = 30 mg/kg (3) |
| 73B | 48460 | 000075-37-6 | 1,1-Difluoroethane | |
| 73C | 49485 | 134701-20-2 | 2,4-Dimethyl-6-(1-methylpentadecyl)phenol | The specific migration of this substance shall not exceed 1 mg/kg |
| 75A | 51700 | 147315-50-2 | 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy) phenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 86A | 53610 | 54453-03-1 | Ethylenediaminetetraacetic acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
| 86B | 53650 | 000107-21-1 | Ethyleneglycol | SML (T) = 30 mg/kg (3) |
| 90A | 54300 | 118337-09-0 | 2,2i-Ethylidenebis(4,6-di-tert-butyl-phenyl) fluorophosphonite | The specific migration of this substance shall not exceed 6 mg/kg |
| 92A | 54930 | 025359-91-5 | Formaldehyde-1-naphthol, copolymer [=poly (1-hydroxynaphthyl-methane)] | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 125A | 57800 | 018641-57-1 | Glycerol tribehenate | |
| 140A | 60480 | 003864-99-1 | 2-(2-Hydroxy-3,5-di-tert-butylphenyl)-5-Chlorobenzo Chlorobenzotriazole | The specific migration of this substance shall not exceed 30 mg/kg |
| 169A | 66560 | 004066-02-8 | 2,2i-Methylenebis(4-methyl-6-cyclohexylphenol) | SML (T) = 3 mg/kg |
| 169B | 66580 | 000077-62-3 | 2,2i-Methylenebis [4-methyl-6-(1-methylcyclo-hexyl) phenol] | SML (T) = 3 mg/kg (6) |
| 172A | 66755 | 002682-20-4 | 2-Methyl-4-isothiazolin-3-one | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg analytical tolerance included) |
| 173A | 67170 | Mixture of (80 to100% w/w) 5,7-di-tert-butyl-3-(3,4- dimethylphenyl)-2(3H)- benzofuranone and (0-20% w/w) 5,7-di-tert-butyl-3-(2,3— di-methylphenyl)-2(3H)— benzofuranone | The specific migration of this substance shall not exceed 5 mg/kg | |
| 173B | 67180 | Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n- decyl ester, and (25% w/w) phthalic acid di-n-octyl ester | The specific migration of this substance shall not exceed 5 mg/kg (1) | |
| 179A | 68145 | 080410-33-9 | 2,2i,2 -Nitrilo[triethyl tris(3,3i,5,5i-tetra-tert-butyl-1- 1i-bi-phenyl-2,2i-diyl) phosphite] | The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate) |
| 188A | 71635 | 025151-96-6 | Pentaerythritol dioleate | The specific migration of this substance shall not exceed 0.05 mg/kg. Not for use with foods for which simulant D is laid down in Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs . |
| 191A | 73720 | 000115-96-6 | Phosphoric acid, trichloroethyl ester | The specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
| 191B | 74010 | 145650-60-8 | Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester | The specific migration of this substance shall not exceed 5 mg/kg. (covering the sum of phosphite and phosphate) |
| 195A | 76721 | 009016-00-6 063148-62-9 | Polydimethylsiloxane (mw > 6800) | In compliance with the specifications mentioned in Schedule 2B. |
| 195B | 76865 | Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol | The specific migration of this substance shall not exceed 30 mg/kg | |
| 198A | 77895 | 068439-49-6 | Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 208A | 81515 | 087189-25-1 1 | Poly(zinc glycerolate) | |
| 210A | 81760 | Powders, flakes and fibres of stainless steel, tin and alloys of copper, tin and iron | SML (T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron) | |
| 239A | 85360 | 000109-43-3 3 | Sebacic acid, dibutyl ester | |
| 240A | 85610 | Silicates, natural, silanated (with the exception of asbestos) | ||
| 240B | 85840 | 053320-86-8 | Silicic acid, lithium magnesium sodium salt | SML (T) = 0.6 mg/kg (8) (expressed as lithium) |
| 244A | 86285 | Silicon dioxide, silanated | ||
| 259A | 88640 | 008013-07-8 8 | Soybean oil, epoxidized | In compliance with the specifications laid down in Schedule 2B |
| 263A | 89200 | 007617-31-4 | Stearic acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
| 263B | 89440 | Stearic acid, esters with ethyleneglycol | SML (T) = 30 mg/kg (3) | |
| 270A | 92030 | 010124-44-4 | Sulphuric acid, copper salt | SML (T) = 30 mg/kg (7) (expressed as copper) |
| 276A | 92700 | 078301-43-6 | 2,2,4,4-Tetramethyl-20-(2,3- epoxypropyl)-7-oxa-3,20- diazadispiro-[5.1.11.2]- heneicosan-21-one, polymer | The specific migration of this substance shall not exceed 5 mg/kg |
| 276B | 92930 | 120218-34-0 0 | Thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyri-3 - Carboxylate- dine | The specific migration of this substance shall not exceed 6 mg/kg |
| 280A | 94960 | 000077-99-6 6 | 1,1,1-Trimethylolpropane | The specific migration of this substance shall not exceed 6 mg/kg |
| 281A | 95725 | 110638-71-6 6 | Vermiculite, reaction product with citric acid, lithium salt | SML (T) = 0.6 mg/kg (8) (expressed as lithium) |
| 281B | 95855 | 007732-18-5 | Water | In compliance with Directive 98/83/EC (i) . |
| 281C | 95859 | Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks | In compliance with the specifications laid down in Schedule 2B | |
| 281D | 95883 | White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks | In compliance with the specifications laid down in Schedule 2B |
SCHEDULE 3
SCHEDULE 4
Signed
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998
D.Elis Thomas — The Presiding Officer of the National Assembly — 20th March 2001
Explanatory note
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Footnotes
[^f00001]: 1990 c. 16.
[^f00002]: The National Assembly for Wales (Transfer of Functions) Order 1999 (SI 1999/672)
[^f00003]: S.I. 1998/1376.
[^f00004]: OJ No. L161, 12.3.96, p.26.
[^f00005]: OJ No. L310, 4.12.99, p.41.(f) OJ No. L249, 4.10.2000, p.26.
[^f00006]: OJ No. L249, 4.10.2000, p.26.
[^f00007]: SI 1987/1523, to which there are amendments not relevant to these Regulations.
[^f00008]: 1998 c. 38.
[^f00009]: OJ No. L330, 5.12.1998, p.32.
[^f00010]: OJ No. L372, 31.12.85, p.14.
[^f00011]: OJ No. L330, 5.12.1998, p.32.
Editorial notes
[^key-f01e11b023cd8f031c5ceab08e614762]: Regulations revoked (19.11.2006) by The Plastic Materials and Articles in Contact with Food (Wales) Regulations 2006 (S.I. 2006/2982), regs. 1, 25(b) (with reg. 18(1))
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