LegalizeCommission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council Text with EEA relevance
| Synonyms | D-Maltitol; Hydrogenated maltose |
| Definition | Maltitol is obtained by hydrogenation of D-maltose. It is mainly composed of D-maltitol. It may contain small amounts of sorbitol and related polyhydric alcohols. |
| Einecs | 209-567-0 |
| Chemical name | (α)-D-Glucopyranosyl-1,4-D-glucitol |
| Chemical formula | C12H24O11 |
| Molecular weight | 344,3 |
| Assay | Content not less than 98 % D-maltitol C12H24O11 on the anhydrous basis |
| Description | White crystalline powder |
| Identification | Identification |
| Solubility | Very soluble in water, slightly soluble in ethanol |
| Melting range | 148 to 151 °C |
| Specific rotation | [α]D 20 + 105,5° to + 108,5° (5 % w/v solution) |
| Purity | Purity |
| Appearance of the aqueous solution | The solution is clear and colourless |
| Water content | Not more than 1 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,1 % (expressed as glucose on an anhydrous basis) |
| Nickel | Not more than 2 mg/kg (expressed on anhydrous basis) |
| Arsenic | Not more than 3 mg/kg (expressed on anhydrous basis) |
| Lead | Not more than 1 mg/kg (expressed on anhydrous basis) |
E 965 (ii) MALTITOL SYRUP
| Synonyms | Hydrogenated high-maltose-glucose syrup; Hydrogenated glucose syrup; Maltitol liquid |
| Definition | A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product. |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis |
| Description | Colourless and odourless, clear viscous liquids or white crystalline masses |
| Identification | Identification |
| Solubility | Very soluble in water, slightly soluble in ethanol |
| HPLC test | Comparison with an appropriate reference standard of Maltitol shows that the principle peak in the chromatogram of the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution (ISO 10504:1998). |
| Purity | Purity |
| Appearance of the aqueous solution | The solution is clear and colourless |
| Water content | Not more than 31 % (Karl Fischer Method) |
| Conductivity | Not more than 10 μS/cm (on the product as such) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on an anhydrous basis) |
| Nickel | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg |
E 966 LACTITOL
| Synonyms | Lactit; Lactositol; Lactobiosit |
| Definition | Lactitol is manufactured via catalytic hydrogenation of lactose |
| Einecs | 209-566-5 |
| Chemical name | 4-O-β-D-Galactopyranosyl-D-glucitol |
| Chemical formula | C12H24O11 |
| Molecular weight | 344,3 |
| Assay | Not less than 95 % on the dry weight basis |
| Description | Crystalline powder or colourless solution. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst. |
| Identification | Identification |
| Solubility | Very soluble in water |
| Specific rotation | [α]D 20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution) |
| Purity | Purity |
| Water content | Crystalline products; not more than 10,5 % (Karl Fischer method) |
| Other polyols | Not more than 2,5 % (on the anhydrous basis) |
| Reducing sugars | Not more than 0,2 % (expressed as glucose on dry weight basis) |
| Chlorides | Not more than 100 mg/kg (expressed on dry weight basis) |
| Sulphates | Not more than 200 mg/kg (expressed on dry weight basis) |
| Sulphated ash | Not more than 0,1 % (expressed on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
E 967 XYLITOL
| Synonyms | Xylitol |
| Definition | Xylitol is mainly composed of D-xylitol. The part which is not D-xylitol is composed of related substances such as L-arabinitol, galactitol, mannitol, sorbitol |
| Einecs | 201-788-0 |
| Chemical name | D-xylitol |
| Chemical formula | C5H12O5 |
| Molecular weight | 152,2 |
| Assay | Not less than 98,5 % as xylitol on the anhydrous basis |
| Description | White, crystalline powder, practically odourless. |
| Identification | Identification |
| Solubility | Very soluble in water, sparingly soluble in ethanol |
| Melting range | 92 to 96 °C |
| pH | 5 to 7 (10 % w/v aqueous solution) |
| Infrared absorption spectroscopy | Comparison with a reference standard e.g. EP or USP. |
| Purity | Purity |
| Water content | Not more than 1 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,2 % (expressed as glucose on dry weight basis) |
| Other polyhydric alcohols | Not more than 1 % (expressed on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
E 968 ERYTHRITOL
| Synonyms | Meso-erythritol; Tetrahydroxybutane; Erythrite |
| Definition | Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Moniliella megachilensis, followed by purification and drying |
| Einecs | 205-737-3 |
| Chemical name | 1,2,3,4-Butanetetrol |
| Chemical formula | C4H10O4 |
| Molecular weight | 122,12 |
| Assay | Not less than 99 % after drying |
| Description | White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose. |
| Identification | Identification |
| Solubility | Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether. |
| Melting range | 119-123 °C |
| Purity | Purity |
| Loss on drying | Not more than 0,2 % (70 °C, 6 hours, in a vacuum desiccator) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing substances | Not more than 0,3 % expressed as D-glucose |
| Ribitol and glycerol | Not more than 0,1 % |
| Lead | Not more than 0,5 mg/kg |
E 969 ADVANTAME
| Synonyms | |
| Definition | Advantame (ANS9801) is produced by chemical synthesis in a three-step process; production of the principal manufacturing intermediate, 3-hydroxy-4-methoxycinnamaldehyde (HMCA), followed by hydrogenation to form 3-(3-hydroxy-4-methoxyphenyl) propionaldehyde (HMPA). In the final step, the HMPA methanol solution (filtrate) is combined with aspartame to give the imine that under selective hydrogenation forms advantame. The solution is allowed to crystallise and crude crystals are washed. The product is re-crystallised and crystals are separated, washed and dried. |
| CAS No. | 714229-20-6 |
| Chemical name | N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (IUPAC); L-phenylalanine, N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-L-alpha-aspartyl-, 2-methyl ester, monohydrate (CA) |
| Molecular formula | C24H30N2O7·H2O |
| Molecular weight | 476,52 g/mol (monohydrate) |
| Assay | Not less than 97,0 % and not more than 102,0 % on an anhydrous basis |
| Description | White to yellow powder |
| Identification | |
| Melting Point | 101,5 °C |
| Purity | |
| N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl-α-aspartyl]-L-phenylalanine (ANS9801-acid) | Not more than 1,0 % |
| Total other related substances | Not more than 1,5 % |
| Residual Solvents | Isopropyl acetate: Not more than 2 000 mg/kg Methyl acetate: Not more than 500 mg/kg Methanol: Not more than 500 mg/kg 2-Propanol: Not more than 500 mg/kg |
| Water content | Not more than 5,0 % (Karl Fischer method) |
| Residue on ignition | Not more than 0,2 % |
| Arsenic | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg |
| Palladium | Not more than 5,3 mg/kg |
| Platinum | Not more than 1,7 mg/kg |
E 999 QUILLAIA EXTRACT
| Synonyms | Soapbark extract; Quillay bark extract; Panama bark extract; Quillai extract; Murillo bark extract; China bark extract |
| Definition | Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. The extraction process is followed by clarification, filtration, ultrafiltration, concentration and pasteurisation. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid, polyphenols, carbohydrates, in particular polysaccharides and reducing sugars and, to a minor extent, proteins. |
| CAS number | 68990-67-0 |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | Saponin content not less than 20 % on dried basis |
| Description | Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution. |
| Identification | |
| pH | Between 3,7 and 5,5 (4 % solution) |
| Purity | |
| Water content | Not more than 6,0 % (Karl Fischer method) (powder form only) |
| Arsenic | Not more than 5 mg/kg saponins |
| Lead | Not more than 3 mg/kg saponins |
| Mercury | Not more than 0,5 mg/kg saponins |
| Cadmium | Not more than 0,5 mg/kg saponins |
| Calcium oxalate | Not more than 6 g/kg saponins |
| Microbiological criteria | |
| Total aerobic count | Not more than 100 colonies per gram |
| Salmonella spp. | Absent in 25 g |
| Staphylococcus aureus | Absent in 1 g |
| Escherichia coli | Absent in 1 g |
| Yeast | Not more than 10 colonies per gram |
| Moulds | Not more than 10 colonies per gram |
E 1103 INVERTASE
| Synonyms | |
| Definition | Invertase is produced from Saccharomyces cerevisiae |
| Einecs | 232-615-7 |
| Enzyme Commission No | EC 3.2.1.26 |
| Systematic name | β-D-Fructofuranoside fructohydrolase |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | |
| Identification | |
| Purity | Purity |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Cadmium | Not more than 0,5 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total bacterial count | Not more than 50 000 colonies per gram |
| Salmonella spp. | Absent in 25 g |
| Coliforms | Not more than 30 colonies per gram |
| Escherichia coli | Absent in 25 g |
E 1105 LYSOZYME
| Synonyms | Lysozyme hydrochloride; Muramidase |
| Definition | Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride |
| Einecs | 232-620-4 |
| Enzyme Commission No | EC 3.2.1.17 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | About 14 000 |
| Assay | Content not less than 950 mg/g on the anhydrous basis |
| Description | White, odourless powder having a slightly sweet taste |
| Identification | Identification |
| Isoelectric point | 10,7 |
| pH | Between 3,0 and 3,6 (2 % aqueous solution) |
| Spectrophotometry | Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm |
| Purity | Purity |
| Water content | Not more than 6,0 % (Karl Fischer method) (powder form only) |
| Residue on ignition | Not more than 1,5 % |
| Nitrogen | Not less than 16,8 % and not more than 17,8 % |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total bacterial count | Not more than 5 × 104 colonies per gram |
| Salmonella spp. | Absent in 25 g |
| Staphylococcus aureus | Absent in 1 g |
| Escherichia coli | Absent in 1 g |
E 1200 POLYDEXTROSE
| Synonyms | Modified polydextroses |
| Definition | Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid and/or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolourised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | Content not less than 90 % of polymer on the ash free and anhydrous basis |
| Description | White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution |
| Identification | Identification |
| Test for sugar | Passes test |
| Test for reducing sugar | Passes test |
| pH | Between 2,5 and 7,0 for polydextrose (10 % solution) Between 5,0 and 6,0 for polydextrose-N (10 % solution) |
| Purity | Purity |
| Water content | Not more than 4,0 % (Karl Fischer method) |
| Sulphated ash | Not more than 0,3 % (polydextrose) Not more than 2,0 % (polydextrose N) |
| Nickel | Not more than 2 mg/kg for hydrogenated polydextroses |
| 1,6-Anhydro-D-glucose | Not more than 4,0 % on the ash-free and the dried basis |
| Glucose and sorbitol | Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately |
| Molecular weight limit | Negative test for polymers of molecular weight greater than 22 000 |
| 5-Hydroxy-methylfurfural | Not more than 0,1 % (polydextrose) Not more than 0,05 % (polydextrose-N) |
| Lead | Not more than 0,5 mg/kg |
E 1201 POLYVINYLPYRROLIDONE
| Synonyms | Povidone; PVP; Soluble polyvinylpyrrolidone |
| Definition | Definition |
| Einecs | |
| Chemical name | Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene] |
| Chemical formula | (C6H9NO)n |
| Average molecular weight | Not less than 25 000 |
| Assay | Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis |
| Description | White or nearly white powder |
| Identification | Identification |
| Solubility | Soluble in water and in ethanol. Insoluble in ether |
| pH | Between 3,0 and 7,0 (5 % solution) |
| Purity | Purity |
| Water content | Not more than 5 % (Karl Fischer) |
| Total ash | Not more than 0,1 % |
| Aldehyde | Not more than 500 mg/kg (as acetaldehyde) |
| Free-N-vinylpyrrolidone | Not more than 10 mg/kg |
| Hydrazine | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg |
E 1202 POLYVINYLPOLYPYRROLIDONE
| Synonyms | Crospovidone; Cross-linked polyvidone; Insoluble polyvinylpyrrolidone |
| Definition | Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination |
| Einecs | |
| Chemical name | Polyvinylpyrrolidone; poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene] |
| Chemical formula | (C6H9NO)n |
| Molecular weight | |
| Assay | Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis |
| Description | A white hygroscopic powder with a faint, non-objectionable odour |
| Identification | Identification |
| Solubility | Insoluble in water, ethanol and ether |
| pH | Between 5,0 and 8,0 (1 % suspension in water) |
| Purity | Purity |
| Water content | Not more than 6 % (Karl Fischer) |
| Sulphated ash | Not more than 0,4 % |
| Water-soluble matter | Not more than 1 % |
| Free-N-vinylpyrrolidone | Not more than 10 mg/kg |
| Free-N,N'-divinyl-imidazolidone | Not more than 2 mg/kg |
| Lead | Not more than 2 mg/kg |
E 1203 POLYVINYL ALCOHOL
| Synonyms | Vinyl alcohol polymer, PVOH |
| Definition | Polyvinyl alcohol is a synthetic resin prepared by the polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis. |
| Chemical name | Ethenol homopolymer |
| Chemical formula | (C2H3OR)n where R = H or COCH3 |
| Description | Odourless, tasteless, translucent, white or cream-coloured granular powder |
| Identification | Identification |
| Solubility | Soluble in water; Practically insoluble or insoluble in ethanol (≥ 99,8 %) |
| Precipitation reaction | Dissolve 0,25 g of the sample in 5 ml of water with warming and let the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a white, turbid or flocculent precipitate. |
| Colour reaction | Dissolve 0,01 g of the sample in 100 ml of water with warming and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml solution) one drop of iodine test solution (TS) and a few drops of boric acid solution Dissolve 0,5 g of the sample in 10 ml of water with warming and let the solution cool to room temperature. A dark red to blue colour is produced after adding one drop of iodine TS to 5 ml of solution. |
| Viscosity | 4,8 to 5,8 mPa.s (4 % solution at 20 °C) corresponding to an average molecular weight of 26 000 -30 000 Da |
| Purity | Purity |
| Water insoluble matter | Not more than 0,1 % |
| Ester value | Between 125 and 153 mg KOH/g |
| Degree of hydrolysis | 86,5 to 89,0% |
| Acid value | Not more than 3,0 |
| Solvent residues | Not more than 1,0 % Methanol, 1,0 % Methyl acetate |
| pH | 5,0 to 6,5 (4 % solution) |
| Loss on drying | Not more than 5,0 % (105 °C, 3 hours) |
| Residue in ignition | Not more than 1,0 % |
| Lead | Not more than 2 mg/kg |
E 1204 PULLULAN
| Synonyms | |
| Definition | Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography |
| Einecs | 232-945-1 |
| Chemical name | |
| Chemical formula | (C6H10O5)n |
| Molecular weight | |
| Assay | Not less than 90 % of glucan on the dried basis |
| Description | White to off-white odourless powder |
| Identification | Identification |
| Solubility | Soluble in water, practically insoluble in ethanol |
| pH | 5,0 to 7,0 (10 % solution) |
| Precipitation with polyethylene glycol 600 | Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed |
| Depolymerisation with pullulanase | Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 °C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution |
| Viscosity | 100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C) |
| Purity | Purity |
| Loss on drying | Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 hours) |
| Mono-, di- and oligosaccharides | Not more than 10 % expressed as glucose |
| Lead | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Yeast and moulds | Not more than 100 colonies per gram |
| Coliforms | Absent in 25 g |
| Salmonella spp. | Absent in 25 g |
E 1205 BASIC METHACRYLATE COPOLYMER
| Synonyms | Basic butylated methacrylate copolymer; amino methacrylate copolymer; aminoalkyl methacrylate copolymer E; butyl methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methacrylate, dimethylaminoethyl methacrylate polymer |
| Definition | Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate (dissolved in propan-2-ol), by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The polymer solution is extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialized as such or undergo a milling step (micronisation). |
| Chemical name | Poly(butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate) 1:2:1 |
| Chemical formula | Poly[(CH2:C(CH3)CO2(CH2)2N(CH3)2)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)CO2(CH2)3CH3)] |
| Weight average molecular weight estimated by gel permeation chromatography | Approximately 47 000 g/mol |
| Particle size of the powder (when used forms a film) | < 50 μm at least 95 % < 20 μm at least 50 % < 3 μm not more than 10 % |
| Assay (according to Ph. Eur. 2.2.20 ‘potentiometric titration’) | 20,8-25,5 % dimethylaminoethyl (DMAE) groups on dry substance |
| Description | Granules are colourless to yellow tinged, the powder is white |
| Identification | Identification |
| Infrared absorption spectroscopy | To be identified |
| Viscosity of a 12,5 % solution in 60:40 (w/w/) propan-2-ol to acetone | 3-6 mPa.s |
| Refractive index | [n]D 20 1,380-1,385 |
| Solubility | 1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichloromethane, aqueous Hydrochloric acid 1N. Not soluble in petroleum ether. |
| Purity | Purity |
| Loss of drying | Not more than 2,0 % (105 °C, 3 h) |
| Alkali value | 162-198 mg KOH/g of dried substance |
| Sulphated ash | Not more than 0,1 % |
| Residual monomers | Butylmethacrylate < 1 000 mg/kg Methyl methacrylate < 1 000 mg/kg Dimethylaminoethyl methacrylate < 1 000 mg/kg |
| Solvent residues | propan-2-ol < 0,5 % Butanol < 0,5 % Methanol < 0,1 % |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 3 mg/kg |
| Mercury | Not more than 0,1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
E 1206 NEUTRAL METHACRYLATE COPOLYMER
| Synonyms | Ethyl acrylate methyl methacrylate polymer; Ethyl acrylate, methyl methacrylate polymer; Ethyl acrylate, polymer with methyl methacrylate; Methyl methacrylate, ethyl acrylate polymer; Methyl methacrylate, polymer with ethyl acrylate |
| Definition | Neutral methacrylate copolymer is a fully polymerised copolymer of methyl methacrylate and ethyl acrylate. It is produced using a process of emulsion polymerisation. It is manufactured by redox initiated polymerisation of the monomers ethyl acrylate, methyl methacrylate by using a free radical donor redox initiator system stabilised with polyethylene glycol monostearyl ether and vinylic acid/sodium hydroxide. Residual monomers are removed by means of water vapour distillation. |
| CAS No | 9010-88-2 |
| Chemical name | Poly(ethylacrylate-co-methyl methacrylate) 2:1 |
| Chemical formula | Poly[(CH2:CHCO2CH2CH3)-co-(CH2:C(CH3)CO2CH3)] |
| Weight average molecular weight | Approximately 600 000 g/mol |
| Assay/Residue on evaporation | 28,5–31,5 % 1 g dispersion is dried in an oven for 3 hours at 110 °C. |
| Description | Milky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour. |
| Identification | Identification |
| Infrared absorption spectroscopy | Characteristic of the compound |
| Viscosity | Max. 50 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry) |
| pH-value | 5,5–8,6 |
| Relative density (at 20 °C) | 1,037–1,047 |
| Solubility | The dispersion is miscible with water in any proportion. The polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Not soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2. |
| Purity | Purity |
| Sulphated ash | Not more than 0,4 % in the dispersion |
| Residual monomers | Total of monomers (sum of methyl methacrylate and ethyl acrylate): not more than 100 mg/kg in the dispersion |
| Residual emulsifier | Polyethylene glycol monostearyl ether (macrogol stearyl ether 20) not more than 0,7 % in the dispersion |
| Solvent residues | Ethanol not more than 0,5 % in the dispersion Methanol not more than 0,1 % in the dispersion |
| Arsenic | Not more than 0,3 mg/kg in the dispersion |
| Lead | Not more than 0,9 mg/kg in the dispersion |
| Mercury | Not more than 0,03 mg/kg in the dispersion |
| Cadmium | Not more than 0,3 mg/kg in the dispersion |
E 1207 ANIONIC METHACRYLATE COPOLYMER
| Synonyms | Methyl acrylate, methyl methacrylate, methacrylic acid polymer; Methacrylic acid, polymer with methyl acrylate and methyl methacrylate |
| Definition | Anionic methacrylate copolymer is a fully polymerised copolymer of methacrylic acid, methyl methacrylate and methyl acrylate. It is manufactured in aqueous medium by emulsion polymerisation of methyl methacrylate, methyl acrylate and methacrylic acid using a free radical initiator stabilised with sodium lauryl sulphate and polyoxyethylene sorbitan monooleate (polysorbate 80). Residual monomers are removed by means of water vapour distillation. |
| CAS No | 26936-24-3 |
| Chemical name | Poly (methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 7:3:1 |
| Chemical formula | Poly[(CH2:CHCO2CH3)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)COOH)] |
| Weight average molecular weight | Approximately 280 000 g/mol |
| Assay/Residue on evaporation | 28,5–31,5 % 1 g of the dispersion is dried in an oven for 5 hours at 110 °C. 9,2–12,3 % methacrylic acid units on dry substance. |
| Description | Milky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour. |
| Identification | Identification |
| Infrared absorption spectroscopy | Characteristic of the compound |
| Viscosity | Max. 20 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry) |
| pH-value | 2,0–3,5 |
| Relative density (at 20 °C) | 1,058–1,068 |
| Solubility | The dispersion is miscible with water in any proportion. The polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2. Soluble above pH 7,0. |
| Purity | Purity |
| Acid value | 60–80 mg KOH/g of dried substance |
| Sulphated ash | Not more than 0,2 % in the dispersion |
| Residual monomers | Total of monomers (sum of methacrylic acid, methyl methacrylate and methyl acrylate): not more than 100 mg/kg in the dispersion |
| Residual emulsifiers | Sodium lauryl sulphate not more than 0,3 % on the dry substance Polysorbate 80 not more than 1,2 % on the dry substance |
| Solvent residues | Methanol not more than 0,1 % in the dispersion |
| Arsenic | Not more than 0,3 mg/kg in the dispersion |
| Lead | Not more than 0,9 mg/kg in the dispersion |
| Mercury | Not more than 0,03 mg/kg in the dispersion |
| Cadmium | Not more than 0,3 mg/kg in the dispersion |
E 1208 POLYVINYLPYRROLIDONE-VINYL ACETATE COPOLYMER
| Synonyms | Copolyvidon; copovidone; 1-vinyl-2-pyrrolidone-vinyl acetate copolymer; 2-pyrrolidinone, 1-ethenyl-, polymer with ethenyl acetate |
| Definition | It is produced by free radical copolymerisation of N-vinyl-2-pyrrolidone and vinyl acetate in solution in propan-2-ol, in the presence of initiators. |
| Einecs | |
| Chemical name | Acetic acid, ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone |
| Chemical formula | (C6H9NO)n.(C4H6O2)m |
| Average Viscosity Molecular Weight | Between 26 000 and 46 000 g/mol. |
| Assay | Nitrogen content 7,0-8,0 % |
| Description | The physical state is described as a white to yellowish-white powder or flakes with an average particle size of 50-130 μm. |
| Identification | Identification |
| Solubility | Freely soluble in water, ethanol, ethylene chloride and ether. |
| Infrared absorption spectroscopy | To be identified |
| European Colour Test (BY Colour) | Minimum BY5 |
| K-value 16 (1 % solids in aqueous solution) | 25,2-30,8 |
| pH value | 3,0-7,0 (10 % aqueous solution) |
| Purity | Purity |
| Vinylacetate component in copolymer | Not more than 42,0 % |
| Free vinyl acetate | Not more than 5 mg/kg |
| Total ash | Not more than 0,1 % |
| Aldehyde | Not more than 2 000 mg/kg (as acetaldehyde) |
| Free-N-vinylpyrrolidone | Not more than 5 mg/kg |
| Hydrazine | Not more than 0,8 mg/kg |
| Peroxide content | Not more than 400 mg/kg |
| Propan-2-ol | Not more than 150 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
16
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K-value: dimensionless index, calculated from kinematic viscosity measurements of dilute solutions, used to indicate the likely degree of polymerisation or molecular size of a polymer.
E 1209 POLYVINYL ALCOHOL-POLYETHYLENE GLYCOL-GRAFT-COPOLYMER
| Synonyms | Macrogol poly(vinyl alcohol) grafted co-polymer; poly(ethan-1,2-diol-graft-ethanol); ethenol, polymer with oxirane, graft; oxirane, polymer with ethanol, graft; ethylene oxide-vinyl alcohol graft co-polymer |
| Definition | Polyvinyl alcohol-polyethylene glycol-graft-co-polymer is a synthetic co-polymer that consists of approximately 75 % PVA units and 25 % PEG units. |
| CAS number | 96734-39-3 |
| Chemical name | Polyvinyl alcohol-polyethylene glycol-graft-co-polymer |
| Chemical formula | |
| Weight Average Molecular Weight | 40 000 to 50 000 g/mol |
| Description | White to faintly yellow powder |
| Identification | |
| Solubility | Freely soluble in water and dilute acids and dilute solutions of alkali hydroxides; practically insoluble in ethanol, acetic acid, acetone, and chloroform |
| IR Spectrum | Must comply |
| pH value | 5,0-8,0 |
| Purity | |
| Ester Value | 10 to 75 mg/g KOH |
| Dynamic viscosity | 50 to 250 mPa·s |
| Loss on drying | Not more than 5 % |
| Sulphated Ash | Not more than 2 % |
| Vinyl Acetate | Not more than 20 mg/kg |
| Acetic acid/Total Acetate | Not more than 1,5 % |
| Ethylene glycols (mono- and di-) | Not more than 400 mg/kg (singly or in combination) |
| 1,4-Dioxane | Not more than 10 mg/kg |
| ————— | ————— |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 1 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
E 1210 CARBOMER
| Synonyms | carbomer, carboxypolymethylene; carbomer homopolymer | carbomer, carboxypolymethylene; carbomer homopolymer | carbomer, carboxypolymethylene; carbomer homopolymer |
| Definition | High-molecular mass polymers obtained by polymerisation of acrylic acid and crosslinking with allyl pentaerythritol. The polymers are synthesised in ethyl acetate using a peroxide to initiate free-radical polymerisation. | High-molecular mass polymers obtained by polymerisation of acrylic acid and crosslinking with allyl pentaerythritol. The polymers are synthesised in ethyl acetate using a peroxide to initiate free-radical polymerisation. | High-molecular mass polymers obtained by polymerisation of acrylic acid and crosslinking with allyl pentaerythritol. The polymers are synthesised in ethyl acetate using a peroxide to initiate free-radical polymerisation. |
| CAS No | 9007-20-9 (primary CAS), 9003-01-4 (secondary CAS) | 9007-20-9 (primary CAS), 9003-01-4 (secondary CAS) | 9007-20-9 (primary CAS), 9003-01-4 (secondary CAS) |
| Chemical name | Carbomer homopolymer, allyl pentaerythritol cross-linked | Carbomer homopolymer, allyl pentaerythritol cross-linked | Carbomer homopolymer, allyl pentaerythritol cross-linked |
| Chemical formula | -(CH2-CH)m-(XM)p COOH m: number of monomer units; XM: crosslinker, p: number of crosslinker units, with m>>p | -(CH2-CH)m-(XM)p COOH m: number of monomer units; XM: crosslinker, p: number of crosslinker units, with m>>p | -(CH2-CH)m-(XM)p COOH m: number of monomer units; XM: crosslinker, p: number of crosslinker units, with m>>p |
| Weight average molecular weight | |||
| Assay | Carboxylic acid content not less than 56 % and not more than 68 % (on dried substance) | Carboxylic acid content not less than 56 % and not more than 68 % (on dried substance) | Carboxylic acid content not less than 56 % and not more than 68 % (on dried substance) |
| Description | White or almost white, fluffy, hygroscopic powder or granules | White or almost white, fluffy, hygroscopic powder or granules | White or almost white, fluffy, hygroscopic powder or granules |
| Identification | |||
| Attenuated total reflective infra-red spectroscopy Proton nuclear magnetic resonance spectroscopy | Characteristic of the compound | Characteristic of the compound | Characteristic of the compound |
| Viscosity (Brookfield viscosimetry, 20 rpm) 25 °C | Type B | Type A | Type A |
| Viscosity (Brookfield viscosimetry, 20 rpm) 25 °C | 29 400 -39 400 mPa.s | 4 000 -11 000 mPa.s | 4 000 -11 000 mPa.s |
| Physical form | powder | powder | granules |
| Pass through 40 mesh, % 425 μm | - | - | 95 min |
| Pass through 100 mesh, % 150 μm | - | - | 10 max |
| Solubility | Insoluble in water. Water-swellable and forms hydrogels in aqueous dispersions. | Insoluble in water. Water-swellable and forms hydrogels in aqueous dispersions. | Insoluble in water. Water-swellable and forms hydrogels in aqueous dispersions. |
| Purity | |||
| Residual monomers | Acrylic acid not more than 100 mg/kg | Acrylic acid not more than 100 mg/kg | Acrylic acid not more than 100 mg/kg |
| Residual crosslinker | tri and tetra-allyl pentaerythritol not more than 1 000 mg/kg | tri and tetra-allyl pentaerythritol not more than 1 000 mg/kg | tri and tetra-allyl pentaerythritol not more than 1 000 mg/kg |
| Residual solvant | Ethyl acetate not more than 0,5 % w/w | Ethyl acetate not more than 0,5 % w/w | Ethyl acetate not more than 0,5 % w/w |
| 2-ethylhexanol | not more than 100 mg/kg | not more than 100 mg/kg | not more than 100 mg/kg |
| 2-ethylhexylacetate | not more than 100 mg/kg | not more than 100 mg/kg | not more than 100 mg/kg |
| Lower molecular weight fraction < 1 000 Da | Not more than 0,75 % w/w | Not more than 0,75 % w/w | Not more than 0,75 % w/w |
| Loss on drying | Not more than 2 % | Not more than 2 % | Not more than 2 % |
| Sulphated ashes | Not more than 2,5 % | Not more than 2,5 % | Not more than 2,5 % |
E 1404 OXIDISED STARCH
| Synonyms | |
| Definition | Oxidised starch is starch treated with sodium hypochlorite |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Carboxyl groups | Not more than 1,1 % (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1410 MONOSTARCH PHOSPHATE
| Synonyms | |
| Definition | Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Residual phosphate | Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,4 % (as P) for other starches (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1412 DISTARCH PHOSPHATE
| Synonyms | |
| Definition | Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Residual phosphate | Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,4 % (as P) for other starches (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1413 PHOSPHATED DISTARCH PHOSPHATE
| Synonyms | |
| Definition | Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Residual phosphate | Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,4 % (as P) for other starches (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1414 ACETYLATED DISTARCH PHOSPHATE
| Synonyms | |
| Definition | Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Acetyl groups | Not more than 2,5 % (on an anhydrous basis) |
| Residual phosphate | Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,04 % (as P) for other starches (on an anhydrous basis) |
| Vinyl acetate | Not more than 0,1 mg/kg (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1420 ACETYLATED STARCH
| Synonyms | Starch acetate |
| Definition | Acetylated starch is starch esterified with acetic anhydride or vinyl acetate |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Acetyl groups | Not more than 2,5 % (on an anhydrous basis) |
| Vinyl acetate | Not more than 0,1 mg/kg (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1422 ACETYLATED DISTARCH ADIPATE
| Synonyms | |
| Definition | Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Acetyl groups | Not more than 2,5 % (on an anhydrous basis) |
| Adipate groups | Not more than 0,135 % (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1440 HYDROXYPROPYL STARCH
| Synonyms | |
| Definition | Hydroxypropyl starch is starch etherified with propylene oxide |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Hydroxypropyl groups | Not more than 7,0 % (on an anhydrous basis) |
| Propylene chlorohydrin | Not more than 1 mg/kg (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
| Synonyms | |
| Definition | Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Hydroxypropyl groups | Not more than 7,0 % (on an anhydrous basis) |
| Residual phosphate | Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis) Not more than 0,04 % (as P) for other starches (on an anhydrous basis) |
| Propylene chlorohydrin | Not more than 1 mg/kg (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1450 STARCH SODIUM OCTENYL SUCCINATE
| Synonyms | SSOS |
| Definition | Starch sodium octenyl succinate is a modified starch. It is manufactured by treatment of a slurry of food starch with octenylsuccinic anhydride. After the appropriate extent of esterification is achieved, the modified starch is recovered by neutralisation with acid, washing with water, dewatering and drying. |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Octenylsuccinyl groups | Not more than 3 % (on an anhydrous basis) |
| Octenylsuccinic acid residue | Not more than 0,3 % (on an anhydrous basis) |
| Sulphur dioxide | Not more than 10 mg/kg on the anhydrous basis |
| Arsenic | Not more than 0,05 mg/kg (on an anhydrous basis) (only if added to foods for infants and young children) Not more than 0,1 mg/kg (on an anhydrous basis) (for all uses except for foods intended for infants and young children) |
| Lead | Not more than 0,03 mg/kg (on an anhydrous basis) (only if added to foods for infants and young children) Not more than 0,2 mg/kg (on an anhydrous basis) (for all uses except for foods intended for infants and young children) |
| Mercury | Not more than 0,05 mg/kg (on an anhydrous basis) |
| Cadmium | Not more than 0,01 mg/kg (on an anhydrous basis) (only if added to foods for infants and young children) Not more than 0,1 mg/kg (on an anhydrous basis) (for all uses except for foods intended for infants and young children) |
| Gluten | Gluten free, only in infant formula and follow-on formula, in accordance with Commission Delegated Regulation (EU) 2016/127 17 |
| Microbiological criteria | |
| Enterobacteriaceae | Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae) |
| Escherichia coli | Absent in 10 g (only if added to foods for infants) |
| Salmonella spp. | Absent in 25 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae) |
| Cronobacter spp. (Enterobacter sakazakii) | Absent in 10 g (only if added to dried infant formulae and dried foods for special medical purposes intended for infants below 6 months of age) |
17
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Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1, ELI: http://data.europa.eu/eli/reg_del/2016/127/oj).
E 1451 ACETYLATED OXIDISED STARCH
| Synonyms | |
| Definition | Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % for cereal starch Not more than 21,0 % for potato starch Not more than 18,0 % for other starches |
| Carboxyl groups | Not more than 1,3 % (on an anhydrous basis) |
| Acetyl groups | Not more than 2,5 % (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
| Synonyms | |
| Definition | Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | Identification |
| Microscopic observation | Passes test (if not pregelatinised) |
| Iodine staining | Passes test (dark blue to light red colour) |
| Purity | Purity |
| Loss on drying | Not more than 21,0 % |
| Octenylsuccinyl groups | Not more than 3 % (on an anhydrous basis) |
| Octenylsuccinic acid residue | Not more than 0,3 % (on an anhydrous basis) |
| Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis) Not more than 10 mg/kg for the other modified starches, unless otherwise specified (on an anhydrous basis) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 2 mg/kg (on an anhydrous basis) |
| Mercury | Not more than 0,1 mg/kg |
| Aluminium | Not more than 0,3 % (on an anhydrous basis) |
E 1505 TRIETHYL CITRATE
| Synonyms | Ethyl citrate |
| Definition | Definition |
| Einecs | 201-070-7 |
| Chemical name | Triethyl-2-hydroxypropan-1,2,3-tricarboxylate |
| Chemical formula | C12H20O7 |
| Molecular weight | 276,29 |
| Assay | Content not less than 99,0 % |
| Description | Odourless, practically colourless, oily liquid |
| Identification | Identification |
| Specific gravity (25° C/25 °C) | 1,135-1,139 |
| Refractive index | [n]D 20: 1,439-1,441 |
| Purity | Purity |
| Water content | Not more than 0,25 % (Karl Fischer method) |
| Acidity | Not more than 0,02 % (as citric acid) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
E 1517 GLYCERYL DIACETATE
| Synonyms | Diacetin |
| Definition | Glyceryl diacetate consist predominantly of a mixture of the 1, 2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters |
| Einecs | |
| Chemical name | Glyceryl diacetate; 1, 2, 3-propanetriol diacetate |
| Chemical formula | C7H12O5 |
| Molecular weight | 176,17 |
| Assay | Not less than 94,0 % |
| Description | Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour |
| Identification | Identification |
| Solubility | Soluble in water. Miscible with ethanol |
| Test for glycerol | Passes test |
| Test for acetate | Passes test |
| Specific gravity (20° C/20 °C) | 1,175-1,195 |
| Boiling range | Between 259 and 261 °C |
| Purity | Purity |
| Total ash | Not more than 0,02 % |
| Acidity | Not more than 0,4 % (as acetic acid) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
E 1518 GLYCERYL TRIACETATE
| Synonyms | Triacetin |
| Definition | Definition |
| Einecs | 203-051-9 |
| Chemical name | Glyceryl triacetate |
| Chemical formula | C9H14O6 |
| Molecular weight | 218,21 |
| Assay | Content not less than 98,0 % |
| Description | Colourless, somewhat oily liquid having a slightly fatty odour |
| Identification | Identification |
| Test for acetate | Passes test |
| Test for glycerol | Passes test |
| Refractive index | [n]D 25 between 1,429 and 1,431 |
| Specific gravity (25 °C/25 °C) | Between 1,154 and 1,158 |
| Boiling range | Between 258 and 270 °C |
| Purity | Purity |
| Water content | Not more than 0,2 % (Karl Fischer method) |
| Sulphated ash | Not more than 0,02 % (as citric acid) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
E 1519 BENZYL ALCOHOL
| Synonyms | Phenylcarbinol; Phenylmethyl alcohol; Benzenemethanol; Alpha-hydroxytoluene |
| Definition | Definition |
| Einecs | |
| Chemical name | Benzyl alcohol; Phenylmethanol |
| Chemical formula | C7H8O |
| Molecular weight | 108,14 |
| Assay | Not less than 98,0 % |
| Description | Colourless, clear liquid with a faint, aromatic odour |
| Identification | Identification |
| Solubility | Soluble in water, ethanol and ether |
| Refractive index | [n]D 20 1,538-1,541 |
| Specific gravity (25° C/25 °C) | 1,042-1,047 |
| Test for peroxides | Passes test |
| Distillation range | Not less than 95 % v/v distils between 202 and 208 °C |
| Purity | Purity |
| Acid value | Not more than 0,5 |
| Aldehydes | Not more than 0,2 % v/v (as benzaldehyde) |
| Lead | Not more than 2 mg/kg |
E 1520 PROPANE-1,2-DIOL
| Synonyms | Propylene glycol |
| Definition | Definition |
| Einecs | 200-338-0 |
| Chemical name | 1,2-dihydroxypropane |
| Chemical formula | C3H8O2 |
| Molecular weight | 76,10 |
| Assay | Content not less than 99,5 % on the anhydrous basis |
| Description | Clear, colourless, hygroscopic, viscous liquid |
| Identification | Identification |
| Solubility | Soluble in water, ethanol and acetone |
| Specific gravity (20° C/20 °C) | 1,035-1,040 |
| Refractive index | [n]D 20: 1,431-1,433 |
| Purity | Purity |
| Distillation test | 99,5% of the product distils between 185-189 °C. The remaining 0,5% consists mainly of dimers and traces of trimers from propylene glycol. |
| Sulphated ash | Not more than 0,07 % |
| Water content | Not more than 1,0 % (Karl Fischer method) |
| Lead | Not more than 2 mg/kg |
E 1521 POLYETHYLENE GLYCOL
| Synonyms | PEG; Macrogol; Polyethylene oxide |
| Definition | Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight. |
| Chemical name | alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol) |
| Chemical formula | (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000 , about 140) |
| Average molecular weight | 380 to 9 000 Da |
| Assay | PEG 400: Not less than 95 % and not more than 105 % PEG 3000: Not less than 90 % and not more than 110 % PEG 3350: Not less than 90 % and not more than 110 % PEG 4000: Not less than 90 % and not more than 110 % PEG 6000:Not less than 90 % and not more than 110 % PEG 8000: Not less than 87,5 % and not more than 112,5 % |
| Description | PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance |
| Identification | Identification |
| Melting range | PEG 400: 4-8 °C PEG 3000: 50-56 °C PEG 3350: 53-57 °C PEG 4000: 53-59 °C PEG 6000:55-61 °C PEG 8000: 55-62 °C |
| Viscosity | PEG 400: 105 to 130 mPa.s at 20 °C PEG 3000: 75 to 100 mPa.s at 20 °C PEG 3350: 83 to 120 mPa.s at 20 °C PEG 4000: 110 to 170 mPa.s at 20 °C PEG 6000: 200 to 270 mPa.s at 20 °C PEG 8000: 260 to 510 mPa.s at 20 °C For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water |
| Solubility | PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils. |
| Purity | Purity |
| Hydroxyl value | PEG 400: 264-300 PEG 3000: 34-42 PEG 3350: 30-38 PEG 4000: 25-32 PEG 6000: 16-22 PEG 8000: 12-16 |
| Sulphated ash | Not more than 0,2 % |
| 1,4-Dioxane | Not more than 10 mg/kg |
| ————— | ————— |
| Ethylene glycol and diethylene glycol | Total not more than 0,25 % °w/w individually or in combination |
| Lead | Not more than 1 mg/kg |
18
i.e. ethylene oxide + 0,55* 2-chloroethanol.
19
Period of application: until 31 January 2014.
20
Period of application: until 31 January 2014.
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