2008/968/EC: Commission Decision of 12 December 2008 authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 8080)
Date: 2008-12-12
Institutions: European Commission
Subjects: food inspection, foodstuffs legislation, labelling, market approval, marketing, vegetable oil

20.12.2008

EN

Official Journal of the European Union

L 344/123

COMMISSION DECISION

of 12 December 2008
authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel
food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2008) 8080)

(Only the English text is authentic)

(2008/968/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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)

(2)

On 18 June 1999 the company Abbott Laboratories
(now Suntory Limited,
to the
competent
to place
arachidonic acid-rich oil from Mortierella alpina on the
market as a novel food ingredient.

Japan) made a request
the Netherlands

authorities of

On 19 October 2005 the competent food assessment
body of
the Netherlands issued its initial assessment
In that report it came to the conclusion that
report.
from Mortierella alpina can
arachidonic acid-rich oil
safely be used in infant
formulae and formulae for
premature infants.

(3)

The Commission forwarded the initial assessment report
to all Member States on 17 November 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)

(6)

Therefore the European Food Safety Authority (EFSA)
was consulted on 26 June 2007.

On 10 July 2008 EFSA adopted the ‘Opinion of the
Scientific Panel on Dietetic Products, Nutrition and
Allergies on a request from the Commission related to
the safety of “fungal oil from Mortierella alpina”.’

(7)

(8)

(9)

(10)

In the opinion the EFSA came to the conclusion that the
from Mortierella alpina is a safe source of
fungal oil
formulae and
arachidonic acid to be used in infant
follow-on formulae.

and Annex II

to Commission Directive
Annex I
2006/141/EC of 22 December 2006 on infant
amending
formulae
and
Directive 1999/21/EC (2)
the
addition of long chain (20 and 22 carbon atoms) poly­
unsaturated fatty acids and in particular of arachidonic
acid to infant formulae and follow-on formulae.

formulae
specify the

and
rules

follow-on

for

On the basis of the scientific assessment, it is established
that fungal oil from Mortierella alpina complies with the
criteria laid down in Article 3(1) of Regulation (EC) No
258/97.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Fungal oil from Mortierella alpina as specified in the Annex may
be placed on the market in the Community as a novel food
ingredient to be used in infant formulae and follow-on formulae
as defined in Article 2 of Directive 2006/141/EC and in
formulae for premature infants.

fungal oil

from Mortierella alpina to infant
The addition of
formulae and follow-on formulae shall be limited by its
content of arachidonic acid according to the rules specified in
Annex I, 5.7 and in Annex II, 4.7 to Directive 2006/141/EC. Its
use in formulae for premature infants shall be in accordance
with the provisions of Council Directive 89/398/EEC (3) of
the
3 May 1989 on the approximation of
Member States relating to foodstuffs intended for particular
nutritional uses.

the laws of

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

(2) OJ L 401, 30.12.2006, p. 1.
(3) OJ L 186, 30.6.1989, p. 27.

L 344/124

EN

Official Journal of the European Union

20.12.2008

Article 2

The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff
containing it shall be ‘oil from Mortierella alpina’.

Article 3

This Decision is addressed to Beverage & Food Company, Suntory Limited, 2-4-1 Shibakoen Minato-ku,
Tokyo, Japan.

Done at Brussels, 12 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

ANNEX

SPECIFICATIONS OF ARACHIDONIC ACID-RICH OIL FROM MORTIERELLA ALPINA

Description
The clear yellow arachidonic acid-rich oil is obtained by fermentation of the fungus Mortierella alpina using soy flour and
soy oil as substrates.

Specifications of arachidonic acid-rich oil from Mortierella alpina

Arachidonic acid

Peroxide value

Acid value

Anisidin value

Free fatty acids

Unsaponifiable matter

Colour (Lovibond 50,8 mm cell) yellow

Colour (Lovibond 50,8 mm cell) red

≥ 40 %
≤ 5 meq/kg
≤ 0,2 mg KOH/g
≤ 20
≤ 0,2 %
≤ 1 %
≤ 50
≤ 10