HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 29/30
EN
Official Journal of the European Union
3.2.2011
DECISIONS
COMMISSION DECISION
of 2 February 2011
authorising the placing on the market of a mycelial extract from Lentinula edodes (Shiitake
mushroom) as a novel food ingredient under Regulation (EC) No 258/97 of the European
Parliament and of the Council
(notified under document C(2011) 442)
(Only the English text is authentic)
(2011/73/EU)
THE EUROPEAN COMMISSION,
extract from Lentinula edodes was safe under the proposed
conditions of use and the proposed levels of intake.
Having regard to the Treaty on the Functioning of the European
Union,
(7)
On the basis of the scientific assessment, it is established
that mycelial extract from Lentinula edodes complies with
Having regard to Regulation (EC) No 258/97 of the European
the criteria laid down in Article 3(1) of Regulation (EC)
Parliament and of the Council of 27 January 1997 concerning
No 258/97.
novel foods and novel food ingredients ( 1 ), and in particular
Article 7 thereof,
(8) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Standing
Whereas:
Committee on the Food Chain and Animal Health,
(1) On
19
December
2007
the
company
GlycaNova
Norge HAS ADOPTED THIS DECISION:
AS made a request to the competent authorities of the
United Kingdom to place a mycelial extract from the
Article 1
Shiitake mushroom (Lentinula edodes formerly Lentinus
edodes) on the market as a novel food ingredient.
The mycelial extract from Lentinula edodes as specified in Annex

I may be placed on the market in the Union as a novel food
(2) On
3
November
2008
the
competent
food
assessment ingredient for the uses listed in Annex II.
body of the United Kingdom issued its initial assessment
report. In that report it came to the conclusion that the
Article 2
use of the mycelial extract from Lentinula edodes as a food
The designation of the mycelial extract from Lentinula edodes
ingredient was acceptable.
authorised by this Decision on the labelling of the foodstuff
containing it shall be ‘extract from the mushroom Lentinula
(3) The
Commission
forwarded
the
initial
assessment
report edodes’ or ‘extract from the Shiitake mushroom’.
to all Member States on 7 January 2009.
Article 3
(4) Within
the
60-day
period
laid
down
in
Article
6(4)
of
Regulation (EC) No 258/97 reasoned objections to the
This Decision is addressed to GlycaNova Norge AS, Oraveien 2,
marketing of the product were raised in accordance with
1630 Gamle Fredrikstad, Norway.
that provision.
(5) Therefore
the
European
Food
Safety
Authority
(EFSA) Done at Brussels, 2 February 2011.
was consulted on 24 September 2009.
(6) On 9 July 2010, EFSA (Panel on Dietetic Products,
For the Commission
Nutrition and Allergies) in the ‘Scientific opinion on
the safety of “Lentinula edodes extract” as a novel food
John DALLI
ingredient’ ( 2 ) came to the conclusion that the mycelial
Member of the Commission
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 2 ) EFSA Journal 2010; 8(7): 1685.

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EN
3.2.2011 Official
Journal
of
the
European
Union L
29/31
ANNEX I
Specifications of the mycelial extract from Lentinula edodes
Description:
The novel food ingredient is a sterile aqueous extract obtained from the mycelium of Lentinula edodes cultivated in a
submerged fermentation. It is a light brown, slightly turbid liquid.
Lentinan is a β-(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 10 5 Daltons, a degree of
branching of 2/5 and a triple helical tertiary structure.
Composition of the mycelial extract from Lentinula edodes
Moisture 98
%
Dry matter 2
%
Free glucose less
than
20
mg/ml
Total Protein (*) less
than
0,1
mg/ml
N-containing constituents (**) less
than
10
mg/ml
Lentinan
0,8 – 1,2 mg/ml
(*) Bradford method
(**) Kjeldahl method
ANNEX II
Uses of the mycelial extract from Lentinula edodes
Use group Maximum
level
of
mycelial
extract
from Lentinula edodes
Bread products 2
ml/100
g
Soft drinks 0,5
ml/100
ml
Ready prepared meals 2,5
ml
per
meal
Foods based on yoghurt 1,5
ml/100
ml
Food supplements (as defined in Directive 2002/46/EC ( 1 )) 2,5
ml
per
day
dose
( 1 ) OJ L 183, 12.7.2002, p. 51.

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