The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005

Regulation 15

SCHEDULE 6 (ENTRIES TO BE SUBSTITUTED FOR SCHEDULE 2B)

Item	PM/REF No.	Specifications
	11530	Acrylic acid, 2–hydroxypropyl ester.
		It may contain up to 25% (m/m) of acrylic acid, 2–hydroxyisopropyl ester (CAS No. 002918–23–2)
2	16690	Divinylbenzene
		It may contain up to 45% (m/m) of Ethylvinylbenzene
3	18888	3–Hydroxybutanoic acid–3–hydroxypentanoic acid, copolymer
		Definition		The 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 name		Poly(3–D–hydroxybutanoate–co–3–D–hydroxypentanoate)
		CAS number		080181–31–3
		Structural formula				CH3
						|
				CH3	O	CH2	O
				|	||	|	||
				(–O–CH–CH2–C–)m–(O–CH–CH2–C–)n
				where n / (m + n) greater than 0 and less or equal to 0.2
		Average molecular weight		Not less than 150 000 Daltons (measured by gel permeation chromatography)
		Assay		Not 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
		Description		White to off–white powder after isolation
		Characteristics
		Identification tests:
		Solubility		Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
		Restriction		QMA for crotonic acid is 0.05 mg/6 dm2
		Purity		Prior to granulation the raw material copolymer powder must contain:
		—	nitrogen	Not more than 2 500 mg/kg of plastic
		—	zinc	Not more than 100 mg/kg of plastic
		—	copper	Not more than 5 mg/kg of plastic
		—	lead	Not more than 2 mg/kg of plastic
		—	arsenic	Not more than 1 mg/kg of plastic
		—	chromium	Not more than 1 mg/kg of plastic
4	23547	Polydimethylsiloxane (Mw > 6800)
		Minimum viscosity 100 × 10–6 m2/s (= 100 centistokes) at 25°C
5	25385	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.
6	38320	4–(2–Benzoxazolyl)–4'–(5–methyl–2–benzoxazolyl) stilbene
		Not more than 0.05% w/w (quantity of substance used / quantity of the formulation)
7	43680	Chlorodifluoromethane
		Content of chlorofluoromethane less than 1 mg/kg of the substance
8	47210	Dibutylthiostannoic acid polymer
		Molecular unit = (C8H18S3Sn2)n (n = 1.5–2)
9	76721	Polydimethylsiloxane (Mw > 6800)
		Minimum viscosity 100 × 10−6 m2/s (= 100 centistokes) at 25°C
10	77895	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%)
11	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 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(1))
		—	3,3'–Biphenylene–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w(1))
		—	4–Biphenylene–0,0–bis [0,0–bis (2,4–di–tert–butylphenyl) phosphonite] (CAS No. 91362–37–7) (11–19% w/w(1))
		—	Tris (2,4–di–tert–butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w(1))
		—	4,4'–Biphenylene–0,0–bis (2,4–di–tert–butylphenyl) phosphonate–0,0–bis (2,4–di–tert–butylphenyl) phosphonite (CAS No. 112949–97–0) (<5% w/w((1))
		Other specifications
		—	Phosphor content of minimum 5.4% to maximum 5.9%
		—	Acid value of maximum 10 mg KOH per gram
		—	Melt range of 85–110°C
12	88640	Soybean oil, epoxidized
		Oxirane < 8%, iodine number < 6
13	95859	Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks
		Phosphor content of minimum 5.4% to maximum 5.9%
		—	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
14	95883	White mineral oils, paraffinic, derived from petroleum hydrocarbon feedstocks
		The product shall 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 × 10−6 m2/s (= 8.5 centistokes) at 100°C
		—	Average molecular weight not less than 480