# L_2008146EN.01001201.xml

| 5.6.2008 | EN | Official Journal of the European Union | L 146/12 |
| --- | --- | --- | --- |

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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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’. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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).

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 |

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 |

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. |
| --- | --- |

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. |
| --- | --- |

Ws and WR are the weights (mg) of the test sample and reference α-cyclodextrin, respectively, after correcting for water content.

---