ANNEX IISupplementary provisions
ANNEX II In the Annex to Regulation (EU) No 231/2012 the following entry for E 499 is inserted after the entry for E 495: ‘ E 499 STIGMASTEROL-RICH PLANT STEROLS Synonyms Definition Stigmasterol-rich plant sterols are derived from soybeans and are a chemically defined simple mixture that comprises not less than 95 % of plant sterols (stigmasterol, β-sitosterol, campesterol and brassicasterol), with stigmasterol representing not less than 85 % of the stigmasterol-rich plant sterols. Einecs Chemical name Stigmasterol (3S,8S,9S,10R,13R,14S,17R)-17-(5-ethyl-6-methyl-hept-3-en-2-yl)-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol β-Sitosterol (3S,8S,9S,10R,13R,14S,17R)-17-[(2S,5S)-5-ethyl-6-methylheptan-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol Campesterol (3S,8S,9S,10R,13R,14S,17R)-17-(5,6-dimethylheptan-2-yl)-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol Brassicasterol (3S,8S,9S,10R,13R,14S,17R)-17-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol Chemical formula Stigmasterol C 29 H 48 O β-Sitosterol C 29 H 50 O Campesterol C 28 H 48 O Brassicasterol C 28 H 46 O Molecular weight Stigmasterol 412,6 g/mol β-Sitosterol 414,7 g/mol Campesterol 400,6 g/mol Brassicasterol 398,6 g/mol Assay (products containing only free sterols and stanols) Content not less than 95 % on a total free sterol/stanol basis on the anhydrous basis Description Free-flowing, white to off-white powders, pills or pastilles; colourless to pale yellow liquids Identification Solubility Practically insoluble in water. Phytosterols and phytostanols are soluble in acetone and ethyl acetate. Stigmasterol content Not less than 85 % (w/w) Other plant sterols/stanols: either singularly or in combination including Brassicasterol, campestanol, campesterol, Δ-7-campesterol, cholesterol, chlerosterol, sitostanol and β-sitosterol. Not more than 15 % (w/w) Purity Total Ash Not more than 0,1 % Residual Solvents Ethanol: Not more than 5 000 mg/kg Methanol: Not more than 50 mg/kg Water content Not more than 4 % (Karl Fischer method) Arsenic Not more than 3 mg/kg Lead Not more than 1 mg/kg Microbiological criteria Total plate count Not more than 1 000 CFU/g Yeasts Not more than 100 CFU/g Moulds Not more than 100 CFU/g Escherichia coli Not more than 10 CFU/g Salmonella spp. Absent in 25 g’