2011/76/EU 根据欧洲议会和理事会条例(EC)No 258/97，授权来源于黑曲霉的甲壳�?葡聚糖作为一种新型的食品配料投放市场(Authorising the placing on the market of Chromium Picolinate as a novel food ingredient under Regulation （EC� No 258/97 of the European Parliament and of the Council)

　　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 258/97of the European Parliament and of the Council

　　（notified under document C�?011� 480（�/p>

　　（Only the French text is authentic（�/p>

　　�?011/76/EU（�/p>

　　THE EUROPEAN COMMISSION,

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

　　Having regard to Regulation（EC� No 258/97of 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:

　　�?� 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.

　　�?� 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.

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

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

　　�?� 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.

　　�?� 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�?� of Regulation （EC� No 258/97.

　　�?� 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�?（� 1687.

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　　ANNEX

　　SPECIFICATIONS OF CHITIN-GLUCAN FROM ASPERGILLUS NIGER MYCELIUM

　　De scription

　　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�?,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 % |