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31.7.2013 Official
Journal
of
the
European
Union L
204/35
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)
THE EUROPEAN COMMISSION,
consumer in liquid form and placed in domestic freezers
to produce a semi-frozen beverage. Stigmasterol-rich
plant sterols when added to the cocktails as an ice-
Having regard to the Treaty on the Functioning of the European
nucleating agent (stabiliser) ensure that the cocktails
Union,
will freeze and produce a satisfactory semi-frozen
beverage in the consumer’s freezer. Without the use of
stigmasterol-rich plant sterols, supercooling of the
Having regard to Regulation (EC) No 1333/2008 of the
beverage can occur and ice formation cannot be guar
European Parliament and of the Council of 16 December
anteed resulting in product failure.
2008 on food additives ( 1 ), and in particular Article 10(3) and
Article 14 thereof,
(6) Pursuant
to
Article
3(2)
of
Regulation
(EC)
No
1331/2008, the Commission is to seek the opinion of
Having regard to Regulation (EC) No 1331/2008 of the
the European Food Safety Authority in order to update
European Parliament and of the Council of 16 December
the Union list of food additives set out in Annex II to
2008 establishing a common authorisation procedure for
Regulation (EC) No 1333/2008.
food additives, food enzymes and food flavourings ( 2 ), and in
particular Article 7(5) thereof,
(7) The
European
Food
Safety
Authority
evaluated
the
safety
of Stigmasterol-rich plant sterols when used as a food
Whereas:
additive in ready-to-freeze alcoholic cocktails and
expressed its opinion on 14 May 2012 ( 4 ). It considered
that the toxicological data available for stigmasterol-rich
plant sterols are insufficient to establish an acceptable
(1) Annex
II
to
Regulation
(EC)
No
1333/2008
lays
down
a
daily intake. However, based on the available data, it
Union list of food additives approved for use in foods
concluded that the proposed use and use levels of stig
and their conditions of use.
masterol-rich plant sterols as a stabiliser in ready-to-
freeze alcoholic cocktails are not of a safety concern.
Furthermore, the Authority considers that the average
(2) Commission
Regulation
(EU)
No
231/2012
( 3 ) lays down
daily intake, taking into account the estimated exposure
specifications for food additives listed in Annex II to
to plant sterols from all sources (i.e. from new appli
Regulation (EC) No 1333/2008.
cations, from natural sources and added as novel food
ingredient) will not exceed 3 g/day.
(3) Those
lists
may
be
updated
in
accordance
with
the
common procedure referred to in Article 3(1) of Regu
(8)
Therefore, it is appropriate to authorise the use of Stig
lation (EC) No 1331/2008, either on the initiative of the
masterol-rich plant sterols as a stabiliser in ready-to-
Commission or following an application.
freeze alcoholic cocktails and to assign E 499 as an E-
number to that food additive.
(4) An application for the authorisation of use of Stig
masterol-rich plant sterols as a stabiliser in ready-to-
(9) Phytosterols,
phytostanols
and
their
esters
have
been
freeze alcoholic cocktails was submitted on 11 February
previously evaluated by several scientific authorities,
2011 and was made available to the Member States.
including the Scientific Committee for Food, the Joint
FAO/WHO Expert Committee on Food Additives and
the European Food Safety Authority and are approved
(5)
There is a technological need for the use of Stigmasterol-
for use in various foods within the Union at levels of
rich plant sterols as a stabiliser, ice nucleating agent, to
intake of up to 3 g/day. Those substances are used as
generate and maintain the presence of ice dispersions
novel food ingredients with the purpose of helping
within a range of ready-to-freeze alcoholic cocktails.
hypercholesterolaemic individuals control their LDL-
These products are designed to be purchased by the
cholesterol blood levels.
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 4 ) EFSA Panel on Food Additives and Nutrient Sources added to Food
( 2 ) OJ L 354, 31.12.2008, p. 1.
(ANS); Scientific Opinion on the safety of stigmasterol-rich plant
( 3 ) OJ L 83, 22.3.2012, p. 1.
sterols as food additive. EFSA Journal 2012;10(5):2659.

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L 204/36
EN
Official Journal of the European Union
31.7.2013
(10) Commission
Regulation
(EC)
No
608/2004
of
31
March
verified that the production process produces a
2004 concerning the labelling of foods and food
consistent product that falls within the proposed specifi
ingredients with added phytosterols, phytosterol esters,
cations.
phytostanols and/or phytostanol esters ( 1 ) provides for
mandatory particulars on the labelling of such foods, in
(14) When
updating
specifications
laid
down
in
Regulation
addition to those listed in Article 3 of Directive
(EU) No 231/2012, it is necessary to take into account
2000/13/EC of the European Parliament and of the
the specifications and analytical techniques for additives
Council of 20 March 2000 on the approximation of
set out in the Codex Alimentarius as drafted by the Joint
the laws of the Member States relating to the labelling,
FAO/WHO Expert Committee on Food Additives.
presentation and advertising of foodstuffs ( 2 ). Those
labelling requirements relate to the effects of phytos
(15) Regulations (EC) No 1333/2008 and (EU) No 231/2012
terols, phytosterol esters, phytostanols and/or
should therefore be amended accordingly.
phytostanol esters on blood cholesterol levels.
(16) The
measures
provided
for
in
this
Regulation
are
in
(11) As
the
levels
of
stigmasterol-rich
plant
sterols
for
the
accordance with the opinion of the Standing
intended use on alcoholic beverages are not sufficient
Committee on the Food Chain and Animal Health and
to affect blood cholesterol levels, ready-to-freeze
neither the European Parliament nor the Council has
alcoholic cocktail beverages containing the stigmasterol-
opposed them,
rich plant sterols should be exempted from complying
with the labelling requirements laid down by Regulation
(EC) No 608/2004.
HAS ADOPTED THIS REGULATION:
(12) The specifications for stigmasterol-rich plant sterols
Article 1
should be included in Regulation (EU) No 231/2012.
Annex II to Regulation (EC) No 1333/2008 is amended in
accordance with Annex I to this Regulation.
(13) The
European
Food
Safety
Authority’s
opinion
on
the
safety of Stigmasterol-rich plant sterols of 14 May
The Annex to Regulation (EU) No 231/2012 is amended in
2012 considered the specifications for that food
accordance with Annex II to this Regulation.
additive as proposed by the applicant and as laid down
in Annex II to this Regulation. It concluded that the
Article 2
specifications are based on the ones established for
phytosterols, phytostanols, and their esters by the Joint
This Regulation shall enter into force on the twentieth day
FAO/WHO Expert Committee on Food Additives ( 3 ) and
following that of its publication in the Official Journal of the
results from analysis of stigmasterol-rich plant sterols
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
( 1 ) OJ L 97, 1.4.2004, p. 44.
( 2 ) OJ L 109, 6.5.2000, p. 29.
( 3 ) Joint FAO/WHO Expert Committee on Food Additives, 2008.
Phytosterols, phytostanols and their esters. In: Compendium of
Food Additive Specifications. Prepared at the 69th JECFA (2008),
FAO JECFA Monographs 5.

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31.7.2013 Off
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’
EN

(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:
icial
‘(80): The labelling requirements set out by Commission Regulation (EC) No 608/2004 (OJ L 97, 1.4.2004, p. 44) shall not apply.’
Jour
nal
of
the
European
Union
L
204/37

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L 204/38
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
EN

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
Off
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
icial
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
Jour
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
nal
of
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
the
European
Chemical formula
Stigmasterol
C 29H 48O
Union
β-Sitosterol
C 29H 50O
Campesterol
C 28H 48O
Brassicasterol
C 28H 46O
Molecular weight
Stigmasterol 412,6
g/mol
β-Sitosterol 414,7
g/mol
Campesterol 400,6
g/mol
Brassicasterol 398,6
g/mol
Assay
Content not less than 95 % on a total free sterol/stanol basis on the anhydrous basis
31.7.2013
(products containing
only free sterols and
stanols)

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31.7.2013 Off
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)
EN

Other plant sterols/ Not more than 15 % (w/w)
stanols: either
singularly or in
combination
including Brassic
asterol,
campestanol,
campesterol, Δ-7-
campesterol, choles
terol, chlerosterol,
sitostanol and β-
sitosterol.
icial
Jour
Purity
nal
Total Ash Not
more
than
0,1
%
of
the
Residual Solvents Ethanol:
Not
more
than
5
000
mg/kg
European
Methanol: Not more than 50 mg/kg
Water content Not
more
than
4
%
(Karl
Fischer
method)
Union
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’
L
204/39

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Document Outline

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