# L_2008344EN.01012301.xml

| 20.12.2008 | EN | Official Journal of the European Union | L 344/123 |
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20.12.2008

EN

Official Journal of the European Union

L 344/123

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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:

| (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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(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.

| (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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(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.

| (3) | The Commission forwarded the initial assessment report to all Member States on 17 November 2005. |
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(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. |
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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.

| (5) | Therefore the European Food Safety Authority (EFSA) was consulted on 26 June 2007. |
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(5)

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

| (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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(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”.’

| (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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(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.

| (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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(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.

| (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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(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.

| (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, |
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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

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

1

(2)  
  OJ L 401, 30.12.2006, p. 1.

2

(3)  
  OJ L 186, 30.6.1989, p. 27.

3

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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 | ≥ 40 % |
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| Peroxide value | ≤ 5 meq/kg |
| Acid value | ≤ 0,2 mg KOH/g |
| Anisidin value | ≤ 20 |
| Free fatty acids | ≤ 0,2 % |
| Unsaponifiable matter | ≤ 1 % |
| Colour (Lovibond 50,8 mm cell) yellow | ≤ 50 |
| Colour (Lovibond 50,8 mm cell) red | ≤ 10 |

Arachidonic acid

≥ 40 %

Peroxide value

≤ 5 meq/kg

Acid value

≤ 0,2 mg KOH/g

Anisidin value

≤ 20

Free fatty acids

≤ 0,2 %

Unsaponifiable matter

≤ 1 %

Colour (Lovibond 50,8 mm cell) yellow

≤ 50

Colour (Lovibond 50,8 mm cell) red

≤ 10

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