2003/427/EC: Commission Decision of 5 June 2003 authorising the placing on the market of oil rich in DHA (docosahexaenoic acid) from the microalgae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2003) 1790)
Date: 2003-06-05
Institutions: European Commission
Subjects: consumer information, consumer protection, labelling, marketing, vegetable oil

12.6.2003

EN

Official Journal of the European Union

L 144/13

COMMISSION DECISION

of 5 June 2003

authorising the placing on the market of oil rich in DHA (docosahexaenoic acid) 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 number C(2003) 1790)

(Only the English text is authentic)

(2003/427/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,

Having regard to the request by Martek Biosciences Corpora-
tion, formerly OmegaTech GmbH to the competent authorities
of the United Kingdom of 13 February 2001 for placing oil
rich in DHA (docosahexaenoic acid) from the microalgae Schi-
zochytrium sp. on the market as a novel food ingredient,

Having regard to the initial assessment report drawn up by the
competent authorities of the United Kingdom,

Whereas:

(1)

(2)

In their initial assessment report the United Kingdom's
competent food assessment body came to the conclusion
that DHA-rich oil from the microalgae Schizochytrium sp.
is safe for human consumption.

The Commission forwarded the initial assessment report
to all Member States on 20 June 2002.

(3) 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.

(4)

In response to the comments and objections raised,
OmegaTech GmbH amended the specifications and the
the DHA-rich oil. These amendments
applications of
were discussed with Member States' experts on 21
October 2002.

(5)

(6)

On the basis of the initial assessment report, it is estab-
lished that DHA-rich oil from the microalgae Schizochy-
trium sp. complies with the criteria laid down in Article
3(1) of the Regulation.

The measures provided for in this Decision are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

DHA-rich oil from the microalgae Schizochytrium sp. as specified
in Annex 1, 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 2.

Article 2

The designation ‘DHA-rich oil from the microalgae Schizochy-
trium sp.’ shall be displayed on the labelling of the product as
such or in the list of ingredients of foodstuffs containing it.

Article 3

This Decision is addressed to Martek Biosciences Corporation,
6480 Dobbin Road, Columbia, Maryland 21045 USA.

Done at Brussels, 5 June 2003.

For the Commission

David BYRNE

Member of the Commission

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

L 144/14

EN

Official Journal of the European Union

12.6.2003

SPECIFICATION OF OIL RICH IN DHA (DOCOSAHEXAENOIC ACID) OBTAINED BY HEXANE EXTRAC-
TION OF MICROALGAE SCHIZOCHYTRIUM SP.

ANNEX 1

Test

Specification

Acid value

Peroxide value (PV)

Moisture and volatiles

Unsaponifiables

Trans-fatty acids

DHA content

Not more than 0,5 mg KOH/g

Not more than 5,0 meq/kg oil

Not more than 0,05 %

Not more than 4,5 %

Not more than 1 %

Not less than 32,0 %

ANNEX 2

USES OF OIL RICH IN DHA (DOCOSAHEXAENOIC ACID) FROM THE MICROALGAE SCHIZOCHYTRIUM
SP.

Use group

Maximum use level of DHA

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

Spreadable fat and dressings

Breakfast cereals

Food supplements

Dietary foods for special medical purposes

for analogues

to cheese products

200 mg/100 g or
600 mg/100 g

600 mg/100 g

500 mg/100 g

200 mg per daily dose as recommended by the manu-
facturer

In accordance with the particular nutritional requirements
of the persons for whom the products are intended

Foods intended for use in energy-restricted diets for weight
reduction

200 mg/meal replacement

Note: All food products containing DHA-rich oil from Schizochytrium sp. should demonstrate oxidative stability by appropriate and recog-

nised national/international test methodology (e.g. AOAC).