# 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), Annex II

Extent: E+W+S+N.I.

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
C29H48O
β-Sitosterol
C29H50O
Campesterol
C28H48O
Brassicasterol
C28H46O
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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Source: https://www.legislation.gov.uk/eur/2013/739/annex/II (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-739/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.