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.
（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.
（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.
（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,
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
[1] OJ L 43, 14.2.1997, p. 1.
[2] EFSA Journal 2010; 8（7）: 1687.
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ANNEX
SPECIFICATIONS OF CHITIN-GLUCAN FROM ASPERGILLUS NIGER MYCELIUM
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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）,
- beta（1,3）-glucan, composed of repeating units of D-glucose （CAS No: 9041-22-9）.
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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