# The Plastic Materials and Articles in Contact with Food (England) Regulations 2006, Schedule 4: Specifications Item 1 PM/REF No 2 Specifications (1) Quantity of substance used/quantity of formulation 1 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 As set out in Part B of Annex V to the Directive 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 Solubility Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water Restriction QMA for crotonic acid is 0.05 mg/6 dm2 Purity Prior to granulation of the raw material copolymer powder must contain: - nitrogen Not more than 2,500 mg/g 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 x 10 -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 x 10 -;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 bipheny Composition -4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w) -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 (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 112949–97-0) (< 5% w/w) 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 less than 8%, iodine number < 6 13 95859 Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications: -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 x 10 -m2/s (= 11 centistokes) at 100°C -Average molecular weight not less than 500 14 95883 White mineral oils, paraffinic, derived from petroleum based 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 x 10-m2/s (= 8.5 centistokes) at 100°C -Average molecular weight not less than 480 --- Source: https://www.legislation.gov.uk/uksi/2006/1401/schedule/4 (the official version) Page: https://openlegislation.uk/plastic-materials-and-articles-in-contact-with-food-england-regulations-2006/schedule-4 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.