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The Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) (Wales) Regulations 2005

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This is the original version (as it was originally made).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 9(a)(i)

SCHEDULE 1(ENTRIES TO BE INSERTED IN SECTION A OF PART I OF SCHEDULE 1)

1234
ItemPM/REF No.CAS No.NameRestrictions and specifications
6A10599/90A061788-89-4Acids, fatty, unsaturated (C18), dimers, distilledQMA(T) = 0.05 mg/6 dm2 (27)
6B10599/91061788-89-4Acids, fatty, unsaturated (C18), dimers, non distilledQMA(T) = 0.05 mg/6 dm2 (27)
6C10599/92A068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilledQMA(T) = 0.05 mg/6 dm2 (27)
6D10599/93068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilledQMA(T) = 0.05 mg/6 dm2 (27)
37A13323000102-40-91,3-Bis(2-hydroxyethoxy) benzeneSML = 0.05 mg/kg
68MA14800003724-65-0Crotonic acidQMA(T) = 0.05 mg/6 dm2 (33)
87A16210006864-37-53,3'-Dimethyl-4,4'-diaminodicyclohexylmethaneSML = 0.05 mg/kg (32). To be used only in polyamides.
89A16540000102-09-0Diphenyl carbonateSML = 0.05 mg/kg
101A17110016219-75-35-Ethylidenebicyclo [2,2,1]hept-2-eneQMA = 0.05 mg/6 dm2. The ratio surface / quantity of food shall be lower than 2 dm2/kg
118MA18700000629-11-81,6-HexanediolSML = 0.05 mg/kg
120ZA18896001679-51-24-(Hydroxymethyl)-1-cyclohexeneSML = 0.05 mg/kg
135BM20440000097-90-5Methacrylic acid, diester with ethyleneglycolSML = 0.05 mg/kg
142A21400054276-35-6Methacrylic acid, sulphopropyl esterQMA = 0.05 mg/6 dm2
156XA22775000144-62-7Oxalic acidSML(T) = 6 mg/kg(29)
161A23070000102-39-6(1,3-Phenylenedioxy) diacetic acidQMA = 0.05 mg/6 dm2

Regulation 9(a)(ii)

SCHEDULE 2(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN SECTION A OF PART I OF SCHEDULE 1)

1234
ItemPM/REF No.CAS No.NameRestrictions and specifications
15A1153000999-61-1Acrylic acid, 2-hydroxypropyl esterQMA = mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 2B
3913480000080-05-72,2-Bis (4-hydroxyphenyl) propaneSML(T) = 0.6 mg/kg (28)
7014950003173-53-3Cyclohexyl isocyanateQMT(T) = 1 mg/kg in FP (expressed as NCO) (26)
120B18898000103-90-2N-(4-Hydroxyphenyl) acetamideSML = 0.05 mg/kg
14722150000691-37-24-Methyl-1-penteneSML = 0.05 mg/kg
147A22331025513-64-8Mixture of (35-45% w/w) 1,6-diamino-2,2, 4-trimethylhexane and (55—65% w/w) 1,6-diamino-2,4,4-trimethylhexaneQMA = 5 mg/6 dm2
147B22332Mixture of (40% w/w) 2,2, 4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanateQM(T) — 1 mg/kg (expressed as NCO) (26)
18824190065997-05-9Rosin Wood

Regulation 11(a)

SCHEDULE 3(ENTRIES TO BE INSERTED IN PART I OF SCHEDULE 2)

1234
ItemPM/REF No.CAS No.NameRestrictions and specifications
18A34850143925-92-2Amines, bis(hydrogenated tallow alkyl) oxidised

QM = For use only:

(a)

in polyolefines at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3;

(b)

in PET at 0.25% (w/w) in contact with foods other of those for which the simulant D is laid down in Directive 85/572/EEC

18B34895000088-68-62-AminobenzamideSML = 0.05 mg/kg. To be used only for PET for water and beverages
37AA39680000080-05-72,2-Bis(4-hydroxyphenyl) propaneSML(T) = 0.6 mg/kg (28)
51A42880008001-79-4Castor oil
61A45600003724-65-0Crotonic acidQMA(T) = 0.05 mg/6 dm2 (33)
61B45640005232-99-52-Cyano-3,3-diphenylacrylic acid, ethyl esterSML = 0.05 mg/kg
69A4670015,7-di-tert-Butyl-3-(3,4- and 2,3-di-methylphenyl)-3H-benzofuran-2-one containing: 3(a)5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and 3(b)5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0-20% w/w)SML = 5 mg/kg
69B46720004130-42-12,6-Di-tert-butyl-4-ethylphenolQMA = 4.8 mg/6 dm2
109A56535Glycerol, esters with nonanoic acid
131A59280000100-97-0HexamethylenetetramineSML(T) = 15 mg/kg (21) (expressed as Formaldehyde)
178A68078027253-31-2Neodecanoic acid, cobalt saltSML(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 Directive 85/572/EEC
182A69920000144-62-7Oxalic acidSML(T) = 6 mg/kg (29)
195D76866Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and / or n-decanolSML = 30 mg/kg
240ZA85601Silicates, natural (with the exception of asbestos)
280B95000028931-67-1Trimethylolpropane trimethacrylatemethyl methacrylate copolymer

Regulation 11(b)

SCHEDULE 4(ENTRIES TO BE SUBSTITUTED FOR THE ENTRIES IN PART I OF SCHEDULE 2)

1234
ItemPM/REF No.CAS No.NameRestrictions and specifications
60A45450068610-51-5p-Cresol-dicyclopentadiene-isobutylene, copolymerSML = 5 mg/kg
198A77895068439-49-6Polyethyleneglycol (EO = 2-6) monoalkyl (C16—C18) etherSML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 2B

Regulation 12(a)

SCHEDULE 5(ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2)

1234
ItemPM/REF No.CAS No.NameRestrictions and specifications
4A34650151841-65-5Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate]SML = 5 mg/kg
7A38000000553-54-8Benzoic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as Lithium)
18A40720025013-16-5tert-Butyl-4-hydroxyanisole (= BHA)SML = 30 mg/kg
27B46640000128-37-02,6-Di-tert-butyl-p-cresol (= BHT)SML = 3.0 mg/kg
54A54880000050-00-0FormaldehydeSML(T) = 15 mg/kg (21)
54B55200001166-52-5Gallic acid, dodecyl esterSML(T) = 30 mg/kg (34)
54C55280001034-01-1Gallic acid, octyl esterSML(T) = 30 mg/kg (34)
54D55360000121-79-9Gallic acid, propyl esterSML(T) = 30 mg/kg (34)
79A67896020336-96-3Myristic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as Lithium)
83A71935007601-89-0Perchloric acid, sodium salt monohydrateSML = 0.05 mg/kg (31)
88A76680068132-00-3Polycyclopentadiene, hydrogenatedSML = 5 mg/kg (1)
101A86480007631-90-5Sodium bisulphiteSML(T) = 10 mg/kg (30) (expressed as S02)
102A86920007632-00-0Sodium nitriteSML = 0.6 mg/kg
102B86960007757-83-7Sodium sulphiteSML(T) = 10 mg/kg (30) (expressed as S02)
102C87120007772-98-7Sodium thiosulphateSML(T) = 10 mg/kg (30) (expressed as S02)
110A94400036443-68-2Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]SML = 9 mg/kg

Regulation 15

SCHEDULE 6(TABLE TO BE SUBSTITUTED FOR TABLE IN SCHEDULE 2B)

ItemPM/REF No.Specifications
111530

Acrylic acid, 2-hydroxypropyl ester.

It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2)

216690

Divinylbenzene

It may contain up to 45% (m/m) of Ethylvinylbenzene

3188883-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer
DefinitionThe 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 10422. 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-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number080181-31-3
Structural formulaCH3
CH3OCH2O
||||||
(-O-CH-CH2-C-)m-(O-CH-CH2-C-)n
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-hydroxybutanoate-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 a chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
RestrictionQMA for crotonic acid is 0.05 mg/6 dm2
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
423547

Polydimethylsiloxane (MW > 6800)

Minimum viscosity 100 centistokes at 25°C

525385

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.

638320

4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl) stilbene

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

743680Chlorodifluoromethane Content of chlorofluoromethane less than 1 substance
847210

Dibutylthiostannoic acid polymer

Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)

976721

Polydimethylsiloxane (Mw > 6800)

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

1077895

Polyethyleneglycol (EO = 2—6) monoalkyl (C16—C18) ether

The composition of this mixture is as follows:

  • polyethyleneglycol (EO = 2—6) monoalkyl (C16—C18) ether (approximately 28%)

  • fatty alcohols (C16—C18) (approximately 48%)

  • ethyleneglycol monoalkyl (C16—C18) ether (approximately 24%)

1183595Reaction 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 [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

1288640

Soyabean oil, epoxidized

Oxirane < 8%, iodine number < 6

1395859

Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks

The product has the following specifications:

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

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

  • Average molecular weight not less than 500

1495883

White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks

The product has the following specifications:

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

  • Viscosity note less than 8.5 × 10−6 m2/s (= 8.5 centistokes) at 100°C

  • Average molecular weight not less than 480

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