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The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001

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This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Regulation 10

SCHEDULE 1

PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

ITEMPM/REF No.CAS No.NAMERestrictions and specifications
28A12761000693-57-212-Aminododecanoic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
35A13180000498-66-8Bicyclo [2.2.1] hept-2-ene (=norbornene)The specific migration of this substance shall not exceed 0.05 mg/kg
35B1321000176-71-3Bis(4-aminocyclohexyl)methaneThe specific migration of this substance shall not exceed 0.05 mg/kg
63A14650000079-38-9ChlorotrifluoroethyleneThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
68A14841000599-64-44-CumylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
93A16694013811-50-2N,N'-Divinyl-2-imidazolidinoneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
93B16704000112-41-41-DodeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
147A22331025513-64-8Mixture of (40% w/w) 1,6- diamino-2,2,4- trimethylhexane and (60% w/w) 1,6-diamino-2,4,4— trimethylhexaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/6 dm2
152A22550000498-66-8NorborneneThe specific migration of this substance shall not exceed 0.05 mg/kg
163A23175000122-52-1Phosphorous acid, triethylesterThe 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)
169A23547009016-00 6 063148-62-9Polydimethylsiloxane (MW>6800)In compliance with the specifications laid down in Schedule 2B.
206A25080001120-36-11-TetradeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
214A25385000102-70-5TriallylamineIn compliance with the specifications laid down in Schedule 2B.
218A25927027955-94-81,1,1-Tris(4-hydroxyphenyl)ethaneThe quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates
22326155001072-63-51-VinylimidazoleThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
22526320002768-02-7VinyltrimethoxysilaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
22626360007732-18-5WaterIn compliance with Directive 98/83/EC on the quality of water intended for human consumption (1).

PART IILIST OF MONOMERS IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMNRESTRICTIONS AND SPECIFICATIONSIS MODIFIED

ITEMPM/REF No.CAS No.NameRestrictions and specifications
210060000075-07-0AcetaldehydeSML (T) = 6 mg/kg (2)
4013510001675-54-32,2-Bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE)SML (T) = 1 mg/kg (9). Authorised only until 1 January 2005
5614200000105-60-2CaprolactamSML (T) = 15 mg/kg (5)
5714230002123-24-2Caprolactam, sodium saltSML (T) = 15 mg/kg (5) (expressed as caprolactam)
7915760000111-46-6DiethyleneglycolSML (T) = 30 mg/kg (3)
9816990000107-21-1EthyleneglycolSML (T) = 30 mg/kg (3)
10217160000097-53-0EugenolThe 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)
12819540000110-16-7Maleic acidSML (T) = 30 mg/kg (4)
12919960000108-31-6Maleic anhydrideSML (T) = 30 mg/kg (4) (expressed as maleic acid)
21425360-Trialkyl(C5-C15) acetic acid, 2,3-epoxypropyl esterThe 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 IIILIST OF MONOMERS IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMNRESTRICTIONSIS MODIFIED

ITEMPM/REF NoCAS/No.NameRestrictions
3416690001321-74-0DivinylbenzeneThe 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)
5620590000106-91-2Methacrylic acid, 2,3-epoxypropyl esterThe quantity of this material in the finished plastic material or article shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight = 43)
6822720000140-66-94-tert-OctylphenolThe 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 IVMONOMER TO BE ADDED TO SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

ItemsPM/REF No.CAS No.NameRestrictions
77A25185000140-66-94-(1,1,3,3-Tetramethylbutyl) phenol (=4-tert-octylphenol)As item 68

PART VLIST OF MONOMERS TRANSFERRED FROM SECTION B TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

Item No. in Section BItem No. For Section APM/REF No.CAS No.NAMERestrictions and specifications
513A1100005976-02-8Acrylic acid, dicyclopentadienyl esterThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
613B11245002156-97-0Acrylic acid, dodecyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
923A12265004074-90-2Adipic acid, divinyl dodecyl esterThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as a comonomer.
1233A13060004422-95-11,3,5 - Benzenetricarboxylic acid trichlorideThe quantity of this substance in the finished plastic material or artical shall not exceed 0.05 mg/6dm2 (measured as 1,3,5 — benzenetricarboxylic
1649A13780002425-79-81,4-Butanediol bis(2,3- epoxypropyl) etherThe 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)
1952A14020000098-54-44-tert-ButylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
2273A15130000872-05-91-DeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
3088A16360000576-26-12,6-DimethylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
3288B16450000646-06-01,3-DioxolaneThe specific migration of this substance shall not exceed 0.05 mg/kg
37111A18220068564-88-5N-Heptylaminoundeca noic acidThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
41118A18820000592-41-61-HexeneThe specific migration of this substance shall not exceed 3 mg/kg
42121A19060000109-53-5Isobutyl vinyl etherThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
43121B19150000121-91-5Isophthalic acidThe specific migration of this substance shall not exceed 5 mg/kg
49130A19990000079-39-0MethacrylamideThe 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)
50131A20050000096-05-9Methacrylic acid, allyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
55135A20530002867-47-2Methacrylic acid, 2-(dimethylamino) ethyl esterThe 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)
61145A21730000563-45-13-Methyl-1-buteneThe quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/6 dm2 For use only in polypropylene
70159A22937001623-05-8Perfluoropropyl perfluorovinyl etherThe specific migration of this substance shall not exceed 0.05 mg/kg
71173A23770000504-63-21,3-PropanediolThe specific migration of this substance shall not exceed 0.05 mg/kg
72177A23920000105-38-4Propionic acid, vinyl esterSML (T) = 6 mg/kg (2) (expressed as acetaldehyde)
74198A24760026914-43-2Styrenesulphonic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
8322426170003195-78-6N-Vinyl-N-methylacetamideThe quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg

Regulation 11

SCHEDULE 2LIST OF ADDITIVES TO BE INSERTED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

ITEMPM/REF No.CAS No.NAMERestrictions and specifications
2A30080004180-12-5Acetic acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
7A30610-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).
7B30612-Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their mono-, di— and triglycerol esters
9A31530123968-25-2Acrylic acid, 2,4-di-tert- pentyl-6-[1(3,5-di-tert-pentyl- 2-hydroxyphenyl) ethyl] phenyl esterThe specific migration of this substance shall not exceed 5 mg/kg
12A33801-n-Alkyl (C10-C13) benzenesulphonic acidThe specific migration of this substance shall not exceed 30 mg/kg
12B34240-Alkyl(C10-C20) sulphonic acid, esters with phenolsThe specific migration of this substance shall not exceed 6 mg/kg. Authorised only until 1 January 2002.
27A36640000123-77-3AzodicarbonamideFor use only as blowing agent.
31A37360000100-52-7Benzaldehyde(10)
36A38320005242-49-64-(2-Benzoxazolyl)-4'-(5- methyl-2-benzoxazolyl) stilbeneIn compliance with the specifications laid down in Schedule 2B
36B38510136504-96-61,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6- tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5— triazineThe specific migration of this substance shall not exceed 5 mg/kg
36C38515001533-45-54,4'-Bis(2-benzoxazolyl)stilbeneThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
36D38810080693-00-1Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphiteThe specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
36E38879135861-56-2Bis(3,4— dimethylbenzylidene)sorbitol
37A39200006200-40-4Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chlorideThe specific migration of this substance shall not exceed 1.8 mg/kg
37B39815182121-12-69,9 bis(methoxymethyl) fluoreneThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
38A40120-Bis(polyethyleneglycol) hydroxymethylphosphonateThe specific migration of this substance shall not exceed 0.6 mg/kg. Authorised only until 1 January 2002
44A41680000076-22-2Camphor(10)
47A42320007492-68- 4Carbonic acid, copper saltSML (T) = 30 mg/kg (7)
57A43515-Chlorides of choline esters of coconut oil fatty acidsThe quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/6 dm2
59A45195007787-70-4Copper bromideSML (T) = 30 mg/kg (7) (expressed as copper)
59B45200001335-23-5Copper iodideSML (T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (expressed as iodine)
60A45450068610-51-5p-Cresol-dicyclopentadiene-isobutylene, copolymerThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
72A46880065140-91-2 23,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium saltThe specific migration of this substance shall not exceed 6 mg/kg
73A47680000111-46-3DiethyleneglycolSML (T) = 30 mg/kg (3)
73B48460000075-37-61,1-Difluoroethane
73C49485134701-20-22,4-Dimethyl-6-(1-methylpentadecyl)phenolThe specific migration of this substance shall not exceed 1 mg/kg
75A51700147315-50-22-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy) phenolThe specific migration of this substance shall not exceed 0.05 mg/kg
86A5361054453-03-1Ethylenediaminetetraacetic acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
86B53650000107-21-1EthyleneglycolSML (T) = 30 mg/kg (3)
90A54300118337-09-02,2'-Ethylidenebis(4,6-di-tert-butyl-phenyl) fluorophosphoniteThe specific migration of this substance shall not exceed 6 mg/kg
92A54930025359-91-5Formaldehyde-1-naphthol, copolymer [=poly (1-hydroxynaphthyl-methane)]The specific migration of this substance shall not exceed 0.05 mg/kg
125A57800018641-57-1Glycerol tribehenate
140A60480003864-99-12-(2-Hydroxy-3,5-di-tert-butylphenyl)-5-Chlorobenzo ChlorobenzotriazoleThe specific migration of this substance shall not exceed 30 mg/kg
169A66560004066-02-82,2'-Methylenebis(4-methyl-6-cyclohexylphenol)SML (T) = 3 mg/kg
169B66580000077-62-32,2'-Methylenebis [4-methyl-6-(1-methylcyclo-hexyl) phenol]SML (T) = 3 mg/kg (6)
172A66755002682-20-42-Methyl-4-isothiazolin-3-oneThe 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)
173A67170-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)— benzofuranoneThe specific migration of this substance shall not exceed 5 mg/kg
173B67180-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 esterThe specific migration of this substance shall not exceed 5 mg/kg (1)
179A68145080410-33-92,2',2"-Nitrilo[triethyl tris(3,3',5,5'-tetra-tert-butyl-1- 1'-bi-phenyl-2,2'-diyl) phosphite]The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
188A71635025151-96-6Pentaerythritol dioleateThe 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 (2).
191A73720000115-96-6Phosphoric acid, trichloroethyl esterThe 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)
191B74010145650-60-8Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl esterThe specific migration of this substance shall not exceed 5 mg/kg. (covering the sum of phosphite and phosphate)
195A76721009016-00-6 063148-62-9Polydimethylsiloxane (mw > 6800)In compliance with the specifications mentioned in Schedule 2B.
195B76865-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-decanolThe specific migration of this substance shall not exceed 30 mg/kg
198A77895068439-49-6Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) etherThe specific migration of this substance shall not exceed 0.05 mg/kg
208A81515087189-25-1 1Poly(zinc glycerolate)
210A81760-Powders, flakes and fibres of stainless steel, tin and alloys of copper, tin and ironSML (T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)
239A85360000109-43-3 3Sebacic acid, dibutyl ester
240A85610-Silicates, natural, silanated (with the exception of asbestos)
240B85840053320-86-8Silicic acid, lithium magnesium sodium saltSML (T) = 0.6 mg/kg (8) (expressed as lithium)
244A86285-Silicon dioxide, silanated
259A88640008013-07-8 8Soybean oil, epoxidizedIn compliance with the specifications laid down in Schedule 2B
263A89200007617-31-4Stearic acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
263B89440-Stearic acid, esters with ethyleneglycolSML (T) = 30 mg/kg (3)
270A92030010124-44-4Sulphuric acid, copper saltSML (T) = 30 mg/kg (7) (expressed as copper)
276A92700078301-43-62,2,4,4-Tetramethyl-20-(2,3- epoxypropyl)-7-oxa-3,20- diazadispiro-[5.1.11.2]- heneicosan-21-one, polymerThe specific migration of this substance shall not exceed 5 mg/kg
276B92930120218-34-0 0Thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyri-3 - Carboxylate- dineThe specific migration of this substance shall not exceed 6 mg/kg
280A94960000077-99-6 61,1,1-TrimethylolpropaneThe specific migration of this substance shall not exceed 6 mg/kg
281A95725110638-71-6 6Vermiculite, reaction product with citric acid, lithium saltSML (T) = 0.6 mg/kg (8) (expressed as lithium)
281B95855007732-18-5WaterIn compliance with Directive 98/83/EC (i)(3).
281C95859-Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocksIn compliance with the specifications laid down in Schedule 2B
281D95883-White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocksIn compliance with the specifications laid down in Schedule 2B

Regulation 12

SCHEDULE 3

Regulation 5A

SCHEDULE 2APRODUCTS OBTAINED BY BACTERIAL FERMENTATION

ITEMPM/REF No.CAS No.NAMERestrictions and specifications
11888880181-31-33-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymerThe specific migration of this substance shall not exceed 0.05 mg/kg for croton acid (as impurity) and in compliance with the specifications laid down in Schedule 2B

Regulations 8, 13

SCHEDULE 4

Regulation 7A

SCHEDULE 2BSPECIFICATIONS

ITEMPM REF NoOTHER SPECIFICATIONS
1188883-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER
DefinitionThese copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/ working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications.
Chemical namePoly (3-D-hydroxybutanoato-co-3-D-hydroxypentanoate).
CAS number80181-31-3.
Structural formula

where n/(m+n) greater than 0 and less or equal to 0.25

Average molecular weightNot less than 150,000 Daltons (measured by gel permeation chromatography).
AssayNot less than 98% poly (3-D-hydroxybutanoato-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids.
DescriptionWhite to off-white powder after isolation.
Characteristics
Identification tests:
SolubilitySoluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water.
MigrationThe migration of crotonic acid should not exceed 0.05 mg/kg food.
PurityPrior to granulation the raw material copolymer powder must contain:
—NitrogenNot more than 2,500 mg/kg of plastic
—ZincNot more than 100 mg/kg of plastic
—CopperNot more than 5 mg/kg of plastic
—LeadNot more than 2 mg/kg of plastic
—ArsenicNot more than 1 mg/kg of plastic
—ChromiumNot more than 1 mg/kg of plastic
223547

POLYDIMETHYLSILOXANE (MW> 6800)

  • Minimum viscosity 100 centistokes at 25°C

325385

TRIALLYLAMINE

  • 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use.

438320

4-(2-BENZOXAZOLYL) -4'-(5-METHYL-2-BENZOXAZOLYL) STILBENE

  • Not more than 0.05% w/w (quantity of substance used/quantity of the formulation)

576721

POLYDIMETHYLSILOXANE (Mw>6800)

  • Minimum viscosity 100 x 10-6 m2/s (=100 centistokes) at 25°C

688640

SOYBEAN OIL, EPOXIDIZED

  • Oxirane <8%, iodine number < 6

795859

WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEEDSTOCKS

  • The product should have the following specifications:

    • Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)

    • Viscosity not less than 11 x 10−6 m2/ s (=11 centistokes) at 100°C

    • Average molecular weight not less than 500

895883

WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON FEEDSTOCKS

  • The product should have the following specifications:

    • Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)

    • Viscosity not less than 8.5 x 10−6 m2/ s (=8.5 centistokes) at 100°C

    • Average molecular weight not less than 480

(1)

OJ No. L330, 5.12.1998, p.32.

(2)

OJ No. L372, 31.12.85, p.14.

(3)

OJ No. L330, 5.12.1998, p.32.

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