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26.11.2011 Official
Journal
of
the
European
Union L
313/37
COMMISSION IMPLEMENTING DECISION
of 24 November 2011
authorising the placing on the market of flavonoids from Glycyrrhiza glabra L. as a novel food
ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2011) 8362)
(Only the Dutch and the French texts are authentic)
(2011/761/EU)
THE EUROPEAN COMMISSION,
came to the conclusion that Glavonoid was safe for the
general adult population at an intake of up to 120 mg
per day.
Having regard to the Treaty on the Functioning of the European
Union,
(7) In
order
not
to
exceed
an
intake
of
120
mg
per
day
of
Glavonoid, Kaneka Pharma Europe NV agreed on
11 August 2011 to limit the use of Glavonoid as an
Having regard to Regulation (EC) No 258/97 of the European
ingredient to food supplements and beverages.
Parliament and of the Council of 27 January 1997 concerning

novel foods and novel food ingredients ( 1 ), and in particular
Article 7 thereof,
(8)
On the basis of the scientific assessment, it is established
that Glavonoid complies with the criteria laid down in
Article 3(1) of Regulation (EC) No 258/97.
Whereas:
(9) The
measures
provided
for
in
this
Decision
are
in
(1)
On 1 November 2007 the company Kaneka Pharma
accordance with the opinion of the Standing
Europe made a request to the competent authorities of
Committee on the Food Chain and Animal Health,
Belgium to place flavonoids from Glycyrrhiza glabra L.
(Glavonoid) on the market as novel food ingredient.
HAS ADOPTED THIS DECISION:
(2) On
3
December
2008
the
competent
authority
for
food
assessment of Belgium issued the initial assessment
Article 1
report. In that report it came to the conclusion that
the company Kaneka provided sufficient information to
Flavonoids from Glycyrrhiza glabra L. (hereinafter referred to as
authorise the placing on the market of flavonoids from
‘Glavonoid’), as specified in Annex I, may be placed on the
Glycyrrhiza glabra L. as a novel food ingredient.
market in the Union as a novel food ingredient for the uses
specified in Annex II.
(3) The
Commission
forwarded
the
initial
assessment
report
to all Member States on 19 February 2009.
Glavonoid shall not be sold to the final consumer as such.
Article 2
(4) Within
the
60-day
period
laid
down
in
Article
6(4)
of
Regulation (EC) No 258/97 reasoned objections to the
1. The
designation
of
flavonoids
from Glycyrrhiza glabra L.
marketing of the product were raised in accordance with
authorised by this Decision on the labelling of the foodstuffs
that provision.
containing it shall be ‘flavonoids from Glycyrrhiza glabra L.’.
(5) Therefore
the
European
Food
Safety
Authority
(EFSA) 2. There shall be a statement on the labelling of the foods
was consulted on 22 July 2009.
where the product was added as a novel food ingredient indi
cating that:
(6) On
30
June
2011,
EFSA
in
the
‘Scientific
opinion
on
the
safety of “Glavonoid”, an extract derived from the roots
(a) the product should not be consumed by pregnant and
of or rootstock of Glycyrrhiza glabra L., as a novel food
breast feeding women, children and young adolescents; and
ingredient on request from the European Commission’ ( 2 )
( 1 ) OJ L 43, 14.2.1997, p. 1.
(b) people taking prescription drugs should only consume the
( 2 ) EFSA Journal 2011; 9(7): 2287.
product under medical supervision;

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L 313/38
EN
Official Journal of the European Union
26.11.2011
(c) a maximum of 120 mg of Glavonoid per day should be consumed.
3. The amount of Glavonoid in the final food shall be indicated on the labelling of the food
containing it.
4. Beverages
containing
Glavonoid
shall
be
presented
to
the
final
consumer
as
single
portions.
Article 3
This Decision is addressed to Kaneka Pharma Europe NV, Triomflaan 173, 1160 Brussels, Belgium.
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
313/39
ANNEX I
SPECIFICATIONS OF GLAVONOID
Description
Glavonoid is an extract derived from the roots or rootstock of Glycyrrhiza glabra L. by extraction with ethanol followed by
further extraction of this ethanolic extract with medium-chain triglycerides. It is a dark-brown coloured liquid, containing
2,5 % to 3,5 % of glabridin.
Specifications
Parameter
Moisture less
than
0,5
%
Ash less
than
0,1
%
Peroxide value less
than
0,5
meq/kg
Glabridin 2,5
to
3,5
%
of
fat
Glycyrrhizinic acid less
than
0,005
%
Fat including polyphenol-type substances not
less
than
99
%
Protein less
than
0,1
%
Carbohydrates not
detectable

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L 313/40
EN
Official Journal of the European Union
26.11.2011
ANNEX II
Food category Maximum
content
of
Glavonoid
Beverages based on milk
120 mg per daily portion
Beverages based on yoghurt
Beverages based on fruits or vegetables
Food supplements 120
mg
per
portion
of
daily
consumption

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