Commission Directive 2010/67/EU of 20 October 2010 amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners Text with EEA relevance
1. in the section on E 290 Carbon dioxide the subentry on "Oil content" is replaced by the following: "Oil content Not more than 5 mg/kg"; 2. after the section on additive E 385, the following section on E 392 Extracts of rosemary is inserted: " E 392 EXTRACTS OF ROSEMARY GENERAL SPECIFICATION Synonym Extract of rosemary leaf (antioxidant) Definition Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification EINECS 283-291-9 Chemical name Rosemary extract ( Rosmarinus officinalis )Description Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardisedIdentification Reference antioxidative compounds: phenolic diterpenes Carnosic acid (C 20 H28 O4 ) and Carnosol (C20 H26 O4 ) (which comprise not less than 90 % of the total phenolic diterpenes)Reference key volatiles Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone Density > 0,25 g/ml Solubility Insoluble in water Purity Loss on Drying < 5 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg 1. Extracts of rosemary produced from dried rosemary leaves by acetone extraction Description Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid Identification Content of reference antioxidative compounds ≥ 10 % w/w, expressed as the total of carnosic acid and carnosol Antioxidant/Volatiles — Ratio (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, "GC-MSD") Residual Solvents Acetone: not more than 500 mg/kg 2. Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer. Identification Content of reference antioxidative compounds ≥ 13 % w/w, expressed as the total of carnosic acid and carnosol Antioxidant/Volatiles — Ratio (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, "GC-MSD") Residual Solvents Ethanol: not more than 2 % 3. Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried. Identification Content of reference antioxidative compounds ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol Antioxidant/Volatiles — Ratio (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, "GC-MSD") Residual Solvents Ethanol: not more than 500 mg/kg 4. Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried. Identification Content of reference antioxidative compounds ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol Antioxidant/Volatiles — Ratio (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, "GC-MSD") Residual solvents Hexane: not more than 25 mg/kg Ethanol: not more than 500 mg/kg"; 3. in the section on E 426 Soybean Hemicellulose: (a) the entries on "Definition" and "Description" are replaced by the following: " Definition Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol Description Free flowing white or yellowish white powder"; (b) in the entry on "Purity", the following subentry is added: "Ethanol Not more than 2 %";
4. after the section on additive E 426, the following section on E 427 Cassia gum is inserted: " E 427 CASSIA GUM Synonyms Definition Cassia gum is the ground purified endosperm of the seeds of Cassia tora andCassia obtusifoli (Leguminosae ) containing less than 0,05 % ofCassia occidentalis . It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D-mannopyranose units linked with 1,6-α-D-galactopyranose units. The ratio of mannose to galactose is about 5:1In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with isopropanol Assay Not less than 75 % of Galactomannan Description Pale yellow to off-white, odourless powder Identification Solubility Insoluble in ethanol. Disperses well in cold water forming a colloidal solution Gel formation with borate To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed Gel formation with xanthan gum Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 °C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h A firm, viscoelastic gel forms after the temperature drops below 40 °C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner Viscosity Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an average molecular weight of 200000 -300000 DPurity Acid insoluble matter Not more than 2,0 % pH 5,5-8 (1 % aqueous solution) Crude fat Not more than 1 % Proteins Not more than 7 % Total ash Not more than 1,2 % Loss on drying Not more than 12 % (5 h, 105 °C) Total Anthraquinones Not more than 0,5 mg/kg (detection limit) Solvent residues Not more than 750 mg/kg Isopropyl alcohol Lead Not more than 1 mg/kg Microbiological criteria Total plate count Not more than 5000 colony forming units per gramYeast and mould Not more than 100 colony forming units per gram Salmonella spp.Absent in 25 g E. Coli Absent in 1 g"; 5. in the section on E 463 Hydroxypropyl cellulose, the subentry on "Assay" is replaced by the following: "Assay Content not more than 80,5 % of hydroxypropoxyl groups (-OCH 2 CHOHCH3 ) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis";6. in the section on E 949 Hydrogen, in entry on "Purity", the subentry on "Nitrogen" is replaced by the following: "Nitrogen Not more than 0,07 % v/v"; 7. after the section on additive E 1201, the following section is inserted: " 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 (C 2 H3 OR)n where R = H or COCH3 Description Odourless, tasteless, translucent, white or cream-coloured granular powder Identification Solubility Soluble in water; sparingly soluble in ethanol 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 26000 -30000 DPurity 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 H) Residue in ignition Not more than 1,0 % Lead Not more than 2,0 mg/kg"; 8. the section on "Polyethylene glycol 6000" is replaced by the following: " E 1521 POLYETHYLENE GLYCOLS 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 HOCH 2 - (CH2 - O - CH2 )n - CH2 OHAverage molecular weight 380 to 9000 DAssay 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 Melting point 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 Acidity or alkalinity Dissolve 5,0 g in 50 ml of carbon dioxide-free water and add 0,15 ml of bromothymol blue solution . The solution is yellow or green. Not more than 0,1 ml of 0,1 M sodium hydroxide is required to change the colour of the indicator to blue 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 oxide Not more than 0,2 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".