2008/413/EC: Commission Decision of 26 May 2008 authorising the placing on the market of alpha-cyclodextrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 1954)

Article 1

Alpha-cyclodextrin as specified in the Annex may be placed on the market in the Community as a novel food ingredient.

Article 2

The designation ‘alpha-cyclodextrin’ or ‘α-cyclodextrin’ shall be displayed in the list of ingredients of the foods containing it.

Article 3

This Decision is addressed to Wacker, Consortium für elektrochemische Chemie GmbH, Zielstattstrasse 20, D-81379 München.

ANNEX

ANNEX
SPECIFICATIONS OF ALPHA-CYCLODEXTRIN
Synonyms
α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomaltohexaose, α-cycloamylase
Definition
A non-reducing cyclic saccharide consisting of six α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and purification of α-cyclodextrin may be carried out using one of the following procedures: precipitation of a complex of α-cyclodextrin with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-stripping of the complexant, and crystallisation of α-cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation of α-cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and reverse osmosis.
Chemical name
Cyclohexaamylose
CAS. number
10016-20-3
Chemical formula
(C 6 H 10 O 5 ) 6
Structural formula
Formula weight
972,85
Assay
Not less than 98 % (dry basis)
Description
Virtually odorless, white or almost white crystalline solid.
Characteristics
Identification
Melting range
Decomposes above 278 °C
Solubility
Freely soluble in water; very slightly soluble in ethanol
Specific rotation
[α] D
25 : Between +145° and +151° (1 % solution)
Chromatography
The retention time for the major peak in a liquid chromatogram of the sample corresponds to that for α-cyclodextrin in a chromatogram of reference α-cyclodextrin (available from Consortium für Elektrochemische Industrie GmbH, München, Germany or Wacker Biochem Group, Adrian, MI, USA) using the conditions described in the METHOD OF ASSAY
Purity
Water
Not more than 11 % (Karl Fischer Method)
Residual complexant
Not more than 20 mg/kg
(1-decanol)
Reducing substances
Not more than 0,5 % (as glucose)
Sulfated ash
Not more than 0,1 %
Lead
Not more than 0,5 mg/kg
Method of assay
Determine by liquid chromatography using the following conditions:
Sample solution: Weigh accurately about 100 mg of test sample into a 10-ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a 0,45-micrometer filter.
Reference solution: Weigh accurately about 100 mg of α-cyclodextrin into a 10-ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath and dilute to the mark with purified deionised water.
Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder.
Column and packing: Nucleosil-100-NH2 (10 μm) (Macherey & Nagel Co. Düren, Germany) or similar.
Length: 250 mm
Diameter: 4 mm
Temperature: 40 °C
Mobile phase: acetonitrile/water (67/33, v/v)
Flow rate: 2,0 ml/min
Injection volume: 10 μl
Procedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of the α-CD peak. Calculate the percentage of α-cyclodextrin in the test sample as follows:
% α-cyclodextrin (dry basis) = 100 × (A S /A R ) (W R /W S )
where
A s and A R are the areas of the peaks due to α-cyclodextrin for the sample solution and reference solution, respectively.
W s and W R are the weights (mg) of the test sample and reference α-cyclodextrin, respectively, after correcting for water content.

2008/413/EC: Commission Decision of 26 May 2008 authorising the placing on the market of alpha-cyclodextrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 1954)

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