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Document 32008D0968
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)
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)
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)
OJ L 344, 20.12.2008, p. 123–124
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force: This act has been changed. Current consolidated version: 30/08/2021
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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 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:
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(1) |
On 18 June 1999 the company Abbott Laboratories (now Suntory Limited, Japan) made a request to the competent authorities of the Netherlands to place arachidonic acid-rich oil from Mortierella alpina on the market as a novel food ingredient. |
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(2) |
On 19 October 2005 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that arachidonic acid-rich oil from Mortierella alpina can safely be used in infant formulae and formulae for premature infants. |
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(3) |
The Commission forwarded the initial assessment report to all Member States on 17 November 2005. |
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(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. |
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(5) |
Therefore the European Food Safety Authority (EFSA) was consulted on 26 June 2007. |
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(6) |
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”.’ |
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(7) |
In the opinion the EFSA came to the conclusion that the fungal oil from Mortierella alpina is a safe source of arachidonic acid to be used in infant formulae and follow-on formulae. |
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(8) |
Annex I and Annex II to Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (2) specify the rules for the addition of long chain (20 and 22 carbon atoms) polyunsaturated fatty acids and in particular of arachidonic acid to infant formulae and follow-on formulae. |
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(9) |
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. |
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(10) |
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
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.
The addition of fungal oil from Mortierella alpina to infant 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 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses.
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
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Arachidonic acid |
≥ 40 % |
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Peroxide value |
≤ 5 meq/kg |
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Acid value |
≤ 0,2 mg KOH/g |
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Anisidin value |
≤ 20 |
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Free fatty acids |
≤ 0,2 % |
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Unsaponifiable matter |
≤ 1 % |
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Colour (Lovibond 50,8 mm cell) yellow |
≤ 50 |
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Colour (Lovibond 50,8 mm cell) red |
≤ 10 |