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26.11.2011 Official
Journal
of
the
European
Union L
313/41
COMMISSION IMPLEMENTING DECISION
of 24 November 2011
authorising the placing on the market of yeast beta-glucans as a novel food ingredient under
Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2011) 8527)
(Only the English text is authentic)
(2011/762/EU)
THE EUROPEAN COMMISSION,
(6) On
8
April
2011,
EFSA
in
the
‘Scientific
Opinion
on
the
safety of “Yeast beta-glucans” as a novel food
ingredient’ ( 2 ) came to the conclusion that yeast beta-
glucans were safe under the proposed conditions of
Having regard to the Treaty on the Functioning of the European
use. EFSA opinion did not address in its opinion the
Union,
safety for children below 1 years.
Having regard to Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning
(7) On
the
basis
of
the
EFSA
scientific
assessment
and
taking
novel foods and novel food ingredients ( 1 ), and in particular
into account Directive 2002/46/EC of the European
Article 7 thereof,
Parliament and of the Council of 10 June 2002 on the
approximation of the laws of the Member States relating
to food supplements ( 3 ), Regulation (EC) No 1925/2006
of the European Parliament and of the Council of
Whereas:
20 December 2006 on the addition of vitamins and
minerals and of certain other substances to foods ( 4 ),
Directive 2009/39/EC of the European Parliament and
of the Council of 6 May 2009 on foodstuffs intended
(1) On
23
September
2009
the
company
Biothera
Incor
for particular nutritional uses (
porated made a request to the competent authority of

5 ), Commission Directive
1999/21/EC of 25 March 1999 on dietary foods for
Ireland to place yeast beta-glucans on the market as a
special medical purposes
(
novel food ingredient for use in a variety of foods,

6 ), Commission Directive
2006/125/EC of 5 December 2006 on processed
including beverages, for the general population as well
cereal-based foods and baby foods for infants and
as in food supplements and in foods for particular nutri
young children (
tional uses with the exception of infant formulae and

7 ), it is established that yeast beta-
glucans comply with the criteria laid down in
follow-on formulae.
Article 3(1) of Regulation (EC) No 258/97.
(2) On
23
December
2009
the
competent
food
assessment
body of Ireland issued its initial assessment report. In
(8) The
measures
provided
for
in
this
Decision
are
in
that report it came to the conclusion that yeast beta-
accordance with the opinion of the Standing
glucans were acceptable as a novel food ingredient
Committee on the Food Chain and Animal Health,
provided that the product specifications and intended
use levels are maintained and that the range of foodstuffs
is limited to those presented in the application dossier.
HAS ADOPTED THIS DECISION:
(3) The
Commission
forwarded
the
initial
assessment
report
to all Member States on 18 January 2010.
Article 1
Yeast (Saccharomyces cerevisiae) beta-glucans as specified in Annex
I may be placed on the market in the Union as a novel food
(4) Within
the
60-day
period
laid
down
in
Article
6(4)
of ingredient for the uses defined and at the maximum levels
Regulation (EC) No 258/97 reasoned objections to the
established in Annex II, and without prejudice to the provisions
marketing of the product were raised in accordance with
of Directive 2002/46/EC, Regulation (EC) No 1925/2006 and
that provision.
Directive 2009/39/EC.
( 2 ) EFSA Journal 2011; 9(5):2137 [22 pp.].
(5) Therefore,
the
European
Food
Safety
Authority
(EFSA) ( 3 ) OJ L 183, 12.7.2002, p. 51.
was consulted on 2 July 2010.
( 4 ) OJ L 404, 30.12.2006, p. 26.
( 5 ) OJ L 124, 20.5.2009, p. 21.
( 6 ) OJ L 91, 7.4.1999, p. 29.
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 7 ) OJ L 339, 6.12.2006, p. 16.

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L 313/42
EN
Official Journal of the European Union
26.11.2011
Article 2
The designation of yeast (Saccharomyces cerevisiae) beta-glucans authorised by this Decision for the labelling of
the foodstuffs containing it shall be ‘yeast (Saccharomyces cerevisiae) beta-glucans’.
Article 3
This Decision is addressed to Biothera Incorporated, 3388 Mike Collins Drive, Eagan, Minnesota,
USA, 55121.
Done at Brussels, 24 November 2011.
For the Commission
John DALLI
Member of the Commission

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EN
26.11.2011 Official
Journal
of
the
European
Union L
313/43
ANNEX I
SPECIFICATIONS OF YEAST (SACCHAROMYCES CEREVISIAE) BETA-GLUCANS
Description
Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and
cereals. The chemical name for ‘yeast beta-glucans’ is (1-3), (1-6)--D-glucans.
This novel food is available both in an insoluble and soluble form, isolated from Saccharomyces cerevisiae. The insoluble
products contain at least 70 % carbohydrate in the form of beta-glucans; the soluble product contains at least 75 % beta-
glucans.
The tertiary structure of the glucan cell wall of Saccharomyces cerevisiae consists of chains of -1,3-linked glucose residues,
branched by -1,6-linkages, forming a backbone to which are linked chitin via -1,4- bonds, -1,6-glucans and some
mannoproteins.
Chemical characteristics yeast (Saccharomyces cerevisiae) beta-glucans
Soluble form Insoluble
form
Total carbohydrate More
than
75
% More
than
70
%
Beta-glucans (1,3/1,6) More
than
75
% More
than
70
%
Ash less
than
4
% Less
than
5
%
Moisture Less
than
8
% Less
than
8
%
Protein less
than
3,5
% Less
than
10
%
Fat Less
than
10
% Less
than
20
%

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L 313/44
EN
Official Journal of the European Union
26.11.2011
ANNEX II
Food category Use
level
Food supplements, as defined in Directive 2002/46/EC 375
mg
(per day as recommended by the manufacturer)
Foods for particular nutritional uses (Parnuts), as defined in
600 mg
Directive 2009/39/EC excluding infant and follow on
(per day as recommended by the manufacturer)
formula
Beverages based on fruit juices 130
mg/100
ml
Fruit-flavoured drinks 80
mg/100
ml
Other beverages 80
mg/100
ml
(RTD)
700 mg/100 g (powder)
Cereal bars 600
mg/100
g
Cookie-type biscuits 670
mg/100
g
Cracker-type biscuits
20 mg/100 g
Breakfast cereals 670
mg/100
g
Wholegrain and high fibre instant hot breakfast cereals 150
mg/100
g
Products based on yoghurt, fresh cheese and other dairy
160 mg/100 g
desserts
Soups and soup mixes 90
mg/100
g
(RTE)
180 mg/100 g (condensed)
630 mg/100 g (powder)
Chocolate and confectionery 400
mg/100
g
Protein bars and powders 600
mg/100
g
Abbreviations: RTD = ready to drink; RTE = ready to eat.

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