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Document 32008D0413
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)
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)
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)
OJ L 146, 5.6.2008, p. 12–15
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
|
5.6.2008 |
EN |
Official Journal of the European Union |
L 146/12 |
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)
(Only the German text is authentic)
(2008/413/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,
Whereas:
|
(1) |
On 12 October 2004 the company Wacker Chemie made a request to the competent authorities of Belgium to place alpha-cyclodextrin on the market as a novel food ingredient. |
|
(2) |
On 29 June 2005 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that alpha-cyclodextrin is safe for human consumption. |
|
(3) |
The Commission forwarded the initial assessment report to all Member States on 28 September 2005. |
|
(4) |
Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision. |
|
(5) |
Therefore the European Food Safety Authority (EFSA) was consulted on 28 October 2006. |
|
(6) |
On 6 July 2007 EFSA adopted the ‘Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of alpha-cyclodextrin’. |
|
(7) |
In the opinion the panel came to the conclusion that there are no safety concerns at the proposed use levels and anticipated consumption of alpha-cyclodextrin. |
|
(8) |
On the basis of the scientific assessment, it is established that alpha-cyclodextrin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
|
(9) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS DECISION:
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
(1) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
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
(C6H10O5)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 × (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. |