
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.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 30 July 2013.
For the Commission
The President
José Manuel BARROSO
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:
'
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'
