Schedules 1,2 & 3
| 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(1) | |
| 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 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 | |||