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

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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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