
COMMISSION DECISION of 22 October 2009 concerning the extension of uses of algal oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2009) 7933) (Only the English text is authentic) (2009/778/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, and in particular Article 7 thereof,
Whereas:

(1) On 14 January 2008 the company Martek Biosciences Corporation made a request to the competent authorities of the United Kingdom for an extension of the uses as novel food ingredient of the oil from the micro-algae Schizochytrium sp.

(2) On 4 September 2008 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of uses of the oil from the micro-algae Schizochytrium sp. as a food ingredient was acceptable.

(3) The Commission forwarded the initial assessment report to all Member States on 25 September 2008.

(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) In their objections Member States raised concerns about elevated intake levels of omega-3 fatty acids and in particular DHA (docosahexaenoic acid).

(6) However, the main source of omega-3 fatty acids is fish-oil. In the foods of the categories for which the addition oil from the micro-algae Schizochytrium sp. was requested omega-3 fatty acids can be provided either from fish oil or alternatively from the micro-algae Schizochytrium sp.

(7) Therefore it is not expected that the use of oil from micro-algae in the food groups mentioned in the Annex will lead to an unacceptable increase of the overall intake of omega-3 fatty acids.

(8) The oil from the micro-algae Schizochytrium sp. 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 
Oil from the micro-algae Schizochytrium sp. as specified in Commission Decision 2003/427/EC may be placed on the market in the Community as a novel food ingredient for the uses and at the maximum levels as listed in the Annex.
Article 2 
The designation ‘oil from the micro-algae Schizochytrium sp.’ shall be displayed in the list of ingredients of the foodstuffs containing it.
Article 3 
This Decision is addressed to Martek Biosciences Corporation, 6480 Dobbin Road, Columbia, MD 21045, USA.
Done at Brussels, 22 October 2009.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX

USES OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP.Use group Maximum content of DHA (Docosahexaenoic acid)
Bakery products (breads and bread rolls) 200 mg/100 g
Cereal bars 500 mg/100 g
Non-alcoholic beverages (including milk based beverages) 60 mg/100 ml