COMMISSION DECISION

of 21 October 2009

concerning the extension of uses of algal oil from the micro-algae

Ulkenia 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) 7932)

(Only the English text is authentic)

(2009/777/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 4 November 2004 the company Lonza Ltd (formerly Nutrinova) made a request to the competent authorities of Germany for an extension of the uses as novel food ingredient of the oil from the micro algae

Ulkenia sp

(2) On 9 February 2005 the competent food assessment body of Germany 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

Ulkenia sp

. might bear the risk that intakes of DHA (docosahexaenoic acid) would increase in an unacceptable manner.

(3) The Commission forwarded the initial assessment report to all Member States on 21 April 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.

(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. Today, in the foods of the categories for which the addition of oil from the micro-algae

Ulkenia sp

. was requested omega-3 fatty acids can be provided either from fish oil or alternatively from the micro algae

Ulkenia 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 additional increase of the overall intake of omega-3 fatty acids.

(8) The oil from the micro-algae

Ulkenia sp

. complies with the criteria laid down in Article 3(1) of the 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

Ulkenia sp

. as specified in Annex I 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 Annex II.

Article 2

The designation ‘oil from the micro-algae

Ulkenia sp

.’ shall be displayed in the list of ingredients of the foodstuffs containing it.

Article 3

This Decision is addressed to Lonza Ltd, Muenchensteinerstrasse 38, CH – 4002 Basel.

Done at Brussels, 21 October 2009.

For the Commission

Androulla

VASSILIOU

Member of the Commission

(1)

OJ L 43, 14.2.1997, p. 1

ANNEX I

SPECIFICATIONS OF THE OIL FROM THE MICRO ALGAE

ULKENIA SP.

Acid value	Not more than 0,5 mg KOH/g
Peroxide value (PV)	Not more than 5,0 meq/kg oil
Moisture and volatiles	Not more than 0,05 %
Unsaponifiables	Not more than 4,5 %
Trans-fatty acids	Not more than 1 %
DHA content	Not less than 32,0 %

ANNEX II

USES OF OIL FROM THE MICRO-ALGAE

ULKENIA 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