# L_2011029EN.01003401.xml

| 3.2.2011 | EN | Official Journal of the European Union | L 29/34 |
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3.2.2011

EN

Official Journal of the European Union

L 29/34

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COMMISSION DECISION

of 2 February 2011

authorising the placing on the market of a chitin-glucan from Aspergillus niger as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2011) 480)

(Only the French text is authentic)

(2011/76/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 15 January 2008 the company Kitozyme SA made a request to the competent authorities of Belgium to place a chitin-glucan from Aspergillus niger on the market as a novel food ingredient. |
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(1)

On 15 January 2008 the company Kitozyme SA made a request to the competent authorities of Belgium to place a chitin-glucan from Aspergillus niger on the market as a novel food ingredient.

| (2) | On 5 November 2008 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that an additional assessment was required. |
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(2)

On 5 November 2008 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that an additional assessment was required.

| (3) | The Commission forwarded the initial assessment report to all Member States on 12 March 2009. Several Member States submitted additional comments. |
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(3)

The Commission forwarded the initial assessment report to all Member States on 12 March 2009. Several Member States submitted additional comments.

| (4) | Therefore the European Food Safety Authority (EFSA) was consulted on 27 August 2009. |
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(4)

Therefore the European Food Safety Authority (EFSA) was consulted on 27 August 2009.

| (5) | On 9 July 2010, EFSA (Panel on Dietetic Products, Nutrition and Allergies) in the ‘Scientific opinion on the safety of “chitin-glucan” as a novel food ingredient’ (2) came to the conclusion that chitin-glucan from Aspergillus niger was safe under the proposed conditions of use and the proposed levels of intake. |
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(5)

On 9 July 2010, EFSA (Panel on Dietetic Products, Nutrition and Allergies) in the ‘Scientific opinion on the safety of “chitin-glucan” as a novel food ingredient’ (2) came to the conclusion that chitin-glucan from Aspergillus niger was safe under the proposed conditions of use and the proposed levels of intake.

| (6) | On the basis of the scientific assessment, it is established that chitin-glucan from Aspergillus niger complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
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(6)

On the basis of the scientific assessment, it is established that chitin-glucan from Aspergillus niger complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (7) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(7)

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

Chitin-glucan from Aspergillus niger as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in food supplements with a maximum dose of 5 g per day.

Article 2

The designation of chitin-glucan from Aspergillus niger authorised by this Decision on the labelling of the foodstuff containing it shall be ‘chitin-glucan from Aspergillus niger’.

Article 3

This Decision is addressed to Kitozyme SA, Rue Haute Claire, 4, Parc Industriel des Hauts-Sarts, Zone 2, 4040 Herstal, Belgium.

Done at Brussels, 2 February 2011.

For the Commission

John DALLI

Member of the Commission

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(1)  
  OJ L 43, 14.2.1997, p. 1.

1

(2)  
  EFSA Journal 2010; 8(7): 1687.

2

EFSA Journal

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ANNEX

SPECIFICATIONS OF CHITIN-GLUCAN FROM ASPERGILLUS NIGER MYCELIUM

Description

Chitin-glucan is obtained from the mycelium of Aspergillus niger, it is a slightly yellow, odourless, free-flowing powder. It has a dry matter content of 90 % or more.

Chitin-glucan is composed largely of two polysaccharides:

| — | chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4), |
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—

chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4),

| — | beta(1,3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9). |
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—

beta(1,3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).

| Specification of chitin-glucan from Aspergillus niger |
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| Loss on drying | ≤ 10 % |
| Chitin-glucan | ≥ 90 % |
| Ratio of chitin to glucan | 30:70 to 60:40 |
| Ash | ≤ 3 % |
| Lipids | ≤ 1 % |
| Proteins | ≤ 6 % |

Specification of chitin-glucan from Aspergillus niger

Loss on drying

≤ 10 %

Chitin-glucan

≥ 90 %

Ratio of chitin to glucan

30:70 to 60:40

Ash

≤ 3 %

Lipids

≤ 1 %

Proteins

≤ 6 %

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