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5.6.2012 Official
Journal
of
the
European
Union L
144/41
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 1 June 2012
authorising the placing on the market of Gamma-Cyclodextrin as a novel food ingredient under
Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2012) 3496)
(Only the German text is authentic)
(2012/288/EU)
THE EUROPEAN COMMISSION,
(5) The
intentional
addition
of
γ-Cyclodextrin to food for
technological purposes falls within the scope of Regu
Having regard to the Treaty on the Functioning of the European
lation (EC) No 1333/2008 of the European Parliament
Union,
and of the Council of 16 December 2008 on food
additives ( 2 ) and should be authorised in accordance
Having regard to Regulation (EC) No 258/97 of the European
with that regulation.
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients ( 1 ), and in particular
(6) The
measures
provided
for
in
this
Decision
are
in
Article 7 thereof,
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Whereas:
(1) On
26
February
2010
the
company
Wacker
Chemie HAS ADOPTED THIS DECISION:
GmbH made a request to the competent authorities of
Ireland to place γ-Cyclodextrin on the market as novel
Article 1
food ingredient. Gamma-Cyclodextrin is a digestible
carbohydrate to be added to foods.
Gamma-Cyclodextrin as specified in the Annex may be placed
on the market as a novel food ingredient.
(2) On
9
July
2010
the
competent
food
assessment
body
of
Ireland issued its initial assessment report. In this report
Article 2
it came to the conclusion that the company Wacker
Chemie GmbH had provided sufficient information to
The designation of γ-Cyclodextrin authorised by this Decision
authorise the placing on the market of γ-Cyclodextrin
on the labelling of the foodstuffs containing it shall be ‘Gamma-
as a novel food ingredient.
Cyclodextrin’ or ‘γ-Cyclodextrin’.
(3) The
Commission
forwarded
the
initial
assessment
report
Article 3
to all Member States on 19 July 2010.
This Decision is addressed to Wacker Chemie AG, Hanns Seidel
Platz 4, 81737 München, Germany.
(4) Within
the
60-day
period
laid
down
in
Article
6(4)
of
Regulation (EC) No 258/97 reasoned objections were
raised in accordance with that provision. In particular,
objections which concerned the absorption of fat
Done at Brussels, 1 June 2012.
soluble vitamins were raised. In accordance with the
provisions of Article 7(1) a Commission Implementing
Decision is required that takes into account the
For the Commission
objections raised. Additional explanations by the
applicant alleviated these concerns to the satisfaction of
John DALLI
Member States and the Commission.
Member of the Commission
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 2 ) OJ L 354, 31.12.2008, p. 16.

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L 144/42
EN
Official Journal of the European Union
5.6.2012
ANNEX
SPECIFICATIONS OF γ-CYCLODEXTRIN
Synonyms
γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomaltooctaose, γ-cycloamylase
Definition
A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of
cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin
may be carried out by precipitation of a complex of γ-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the
complex with water and n-decane, steam-stripping of the aqueous phase and recovery of gamma-CD from the solution by
crystallisation.
Chemical name Cyclooctaamylose
CAS number 17465-86-0
Chemical formula (C 6 H 10 O 5 ) 8
Structural formula
Assay Not
less
than
98
%
(dry
basis)
Description
Virtually odourless, white or almost white crystalline solid
Characteristics
Identification
Melting range
Decomposes above 285 °C
Solubility
Freely soluble in water; very slightly soluble in ethanol
Specific rotation [α] 25
D : between + 174° and + 180° (1 % solution)
Purity
Water Not
more
than
11
%
Residual complexant (8-cyclohexadecen-1-one (CHDC) Not more than 4 mg/kg
Residual solvent (n-decane)
Not more than 6 mg/kg
Reducing substances
Not more than 0,5 % (as glucose)
Sulphated ash
Not more than 0,1 %

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