
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.
Done at Brussels, 26 May 2008.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX
α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomaltohexaose, α-cycloamylase

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.

Cyclohexaamylose

10016-20-3

(C6H10O5)6

972,85

Not less than 98 % (dry basis)

Virtually odorless, white or almost white crystalline solid.

Melting rangeDecomposes above 278 °CSolubilityFreely soluble in water; very slightly soluble in ethanolSpecific rotation[α]D25: Between +145° and +151° (1 % solution)ChromatographyThe 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

WaterNot more than 11 % (Karl Fischer Method)Residual complexantNot more than 20 mg/kg(1-decanol)Reducing substancesNot more than 0,5 % (as glucose)Sulfated ashNot more than 0,1 %LeadNot more than 0,5 mg/kg

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 × (AS/AR) (WR/WS)

where


 As and AR are the areas of the peaks due to α-cyclodextrin for the sample solution and reference solution, respectively.
 Ws and WR are the weights (mg) of the test sample and reference α-cyclodextrin, respectively, after correcting for water content.
