Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation. The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Commission Regulation (EU) No 739/2013 of 30 July 2013 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Stigmasterol-rich plant sterols as a stabiliser in ready-to-freeze alcoholic cocktails, and the Annex to Commission Regulation (EU) No 231/2012 as regards specifications for Stigmasterol-rich plant sterols food additive Text with EEA relevance
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation. The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX I Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) in point 3 of Part B, the following entry for E 499 is inserted after the entry for E 495: ‘E 499 Stigmasterol-rich plant sterols’ (2) Part E, food category 14.2.8 ‘Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol’ is amended as follows: (a) the following entries for E 499 are inserted after the entry for E 481-482: ‘E 499 Stigmasterol-rich plant sterols 80 (80) Only to water based ready-to-freeze alcoholic cocktails E 499 Stigmasterol-rich plant sterols 800 (80) Only to cream based ready-to-freeze alcoholic cocktails’ (b) the following footnote is added: ‘(80): The labelling requirements set out by Commission Regulation (EC) No 608/2004 ( OJ L 97, 1.4.2004, p. 44 ) shall not apply.’
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’
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