Commission Directive 2004/45/EC of 16 April 2004 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
1. The texts concerning E 407 Carrageenan and E 407a Processed Eucheuma Seaweed are replaced by the following: "E 407 CARRAGEENAN Synonyms Products of commerce are sold under different names such as: Irish moss gelose Eucheuman (from Eucheuma spp.)Iridophycan (from Iridaea spp.)Hypnean (from Hypnea spp.)Furcellaran or Danish agar (from Furcellaria fastigiata )Carrageenan (from Chondrus andGigartina spp.)Definition Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae ,Solieriaceae ,Hypneaeceae andFurcellariaceae , families of the classRhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degradedEINECS 232-524-2 Description Yellowish to colourless, coarse to fine powder which is practically odourless Identification A. Positive tests for galactose, for anhydrogalactose and for sulphate Purity Methanol, ethanol, propane-2-ol content Not more than 0,1 % singly or in combination Viscosity of a 1,5 % solution at 75 o CNot less than 5 mPa.s Loss on drying Not more than 12 % (105 o C, four hours)Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO 4 )Ash Not less than 15 % and not more than 40 % determined on the dried basis at 550 o CAcid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) Acid-insoluble matter Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid) Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) Not more than 5 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Total plate count Not more than 5000 colonies per gramYeast and moulds Not more than 300 colonies per gram E. coli Negative in 5 g Salmonella spp.Negative in 10 g E 407a PROCESSED EUCHEUMA SEAWEED Synonyms PES (acronym for processed eucheuma seaweed) Definition Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii andEucheuma spinosum , of the classRhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degradedDescription Tan to yellowish, coarse to fine powder which is practically odourless Identification A. Positive tests for galactose, for anhydrogalactose and for sulphate B. Solubility Forms cloudy viscous suspensions in water. Insoluble in ethanol Purity Methanol, ethanol, propane-2-ol content Not more than 0,1 % singly or in combination Viscosity of a 1,5 % solution at 75 o CNot less than 5 mPa.s Loss on drying Not more than 12 % (105 o C, four hours)Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO 4 )Ash Not less than 15 % and not more than 40 % determined on the dried basis at 550 o CAcid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) Acid-insoluble matter Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid) Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) Not more than 5 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Total plate count Not more than 5000 colonies per gramYeast and moulds Not more than 300 colonies per gram E. coli Negative in 5 g Salmonella spp.Negative in 10 g" 2. The following text concerning E 907 Hydrogenated poly-1-decene is inserted after E 905 Microcrystalline wax: "E 907 HYDROGENATED POLY-1-DECENE Synonyms Hydrogenated polydec-1-ene Hydrogenated poly-alpha-olefin Definition Chemical formula C 10n H20n+2 where n = 3 — 6Molecular weight 560 (average) Assay Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution: C 30 : 13 — 37 %C 40 : 35 — 70 %C 50 : 9 — 25 %C 60 : 1 — 7 %Description Colourless, odourless, viscous liquid Identification A. Solubility Insoluble in water; slightly soluble in ethanol; soluble in toluene B. Burning Burns with a bright flame and a paraffin-like characteristic smell Purity Viscosity Between 5,7 × 10-6 and6,1 × 10-6 m2 s-1 at 100 °CCompounds with carbon number less than 30 Not more than 1,5 %Readily carbonisable substances After 10 minutes shaking in a boiling water bath, a tube of sulfuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour Nickel Not more than 1 mg/kg Lead Not more than 1 mg/kg" 3. The following text concerning E 1517 Glyceryl diacetate and E 1519 Benzyl alcohol is added: "E 1517 GLYCERYL DIACETATE Synonyms Diacetin Definition Glyceryl diacetate consists predominantly of a mixture of the 1,2 - and1,3 -diacetates of glycerol, with minor amounts of the mono- and tri-estersChemical names Glyceryl diacetate 1,2,3-propanetriol diacetate Chemical formula C 7 H12 O5 Molecular weight 176,17 Assay Not less than 94,0 %Description Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour Identification A. Solubility Soluble in water. Miscible with ethanol B. Positive tests for glycerol and acetate C. Specific gravity d 20 20 :1,175 —1,195 D. Boiling range Between 259 and 261 °C 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 5 mg/kg E 1519 BENZYL ALCOHOL Synonyms Phenylcarbinol Phenylmethyl alcohol Benzenemethanol Alpha-hydroxytoluene Definition Chemical names Benzyl alcohol Phenylmethanol Chemical formula C 7 H8 OMolecular weight 108,14 Assay Not less than 98,0 %Description Colourless, clear liquid with a faint, aromatic odour Identification A. Solubility Soluble in water, ethanol and ether B. Refractive index [n] D 20 :1,538 –1,541 C. Specific gravity d 25 25 :1,042 —1,047 D. Positive test for peroxides Purity Distillation range Not less than 95 % v/v distils between 202 and 208 °C Acid value Not more than 0,5 Aldehydes Not more than 0,2 % v/v (as benzaldehyde)Lead Not more than 5 mg/kg"