# L_2006296EN.01002001.xml

| 26.10.2006 | EN | Official Journal of the European Union | L 296/20 |
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26.10.2006

EN

Official Journal of the European Union

L 296/20

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COMMISSION DECISION

of 24 October 2006

authorising the placing on the market of ‘maize-germ oil high in unsaponifiable matter’ as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2006) 4980)

(Only the French text is authentic)

(2006/723/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 24 October 2001 the company Laboratoires Pharmascience (now Laboratoires Expanscience) made a request to the competent authorities of France to place ‘maize-germ oil high in unsaponifiable matter’ on the market as a novel food ingredient. |
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(1)

On 24 October 2001 the company Laboratoires Pharmascience (now Laboratoires Expanscience) made a request to the competent authorities of France to place ‘maize-germ oil high in unsaponifiable matter’ on the market as a novel food ingredient.

| (2) | On 8 January 2002 the competent authorities of France forwarded their initial assessment report to the Commission. The report came to the conclusion that maize-germ oil high in unsaponifiable matter proposed as a food ingredient at a daily intake of 2 g per day would make it possible to supplement vitamin E intake and also concluded that the levels of phytosterol were not sufficient to reduce cholesterolaemia. |
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(2)

On 8 January 2002 the competent authorities of France forwarded their initial assessment report to the Commission. The report came to the conclusion that maize-germ oil high in unsaponifiable matter proposed as a food ingredient at a daily intake of 2 g per day would make it possible to supplement vitamin E intake and also concluded that the levels of phytosterol were not sufficient to reduce cholesterolaemia.

| (3) | The Commission forwarded the initial assessment report to all Member States on 18 February 2002. |
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(3)

The Commission forwarded the initial assessment report to all Member States on 18 February 2002.

| (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) | The European Food Safety Authority (EFSA) was therefore consulted on 30 January 2004. |
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(5)

The European Food Safety Authority (EFSA) was therefore consulted on 30 January 2004.

| (6) | On 6 December 2005, EFSA adopted the ‘Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to maize-germ oil high in unsaponifiable matter as a novel food ingredient’. |
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(6)

On 6 December 2005, EFSA adopted the ‘Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to maize-germ oil high in unsaponifiable matter as a novel food ingredient’.

| (7) | The opinion came to the conclusion that the proposed use level of 2 g per day of ‘maize-germ oil high in unsaponifiable matter’ was safe. |
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(7)

The opinion came to the conclusion that the proposed use level of 2 g per day of ‘maize-germ oil high in unsaponifiable matter’ was safe.

| (8) | It is recognised that ‘maize-germ oil high in unsaponifiable matter’ at the intended use level of 2 g per day is a safe source of Vitamin E. For labelling and presentation Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (2) applies. |
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(8)

It is recognised that ‘maize-germ oil high in unsaponifiable matter’ at the intended use level of 2 g per day is a safe source of Vitamin E. For labelling and presentation Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (2) applies.

| (9) | On the basis of the scientific assessment, it is established that ‘maize-germ oil high in unsaponifiable matter’ 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 ‘maize-germ oil high in unsaponifiable matter’ 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

‘Maize-germ oil high in unsaponifiable matter’, as specified in the Annex may be placed on the market in the Community as a novel food ingredient for use in food supplements.

Article 2

The maximum amount of ‘maize-germ oil high in unsaponifiable matter’ present in a portion recommended for daily consumption by the manufacturer shall be 2 g.

Article 3

The designation of the novel food ingredient shall be ‘maize-germ oil extract’.

Article 4

This Decision is addressed to Laboratoires Expanscience, Siège Social, 10, Avenue de l’Arche, F-92419 Courbevoie Cedex.

Done at Brussels, 24 October 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

1

(2)  
  OJ L 183, 12.7.2002, p. 51. Directive as amended by Commission Directive 2006/37/EC (OJ L 94, 1.4.2006, p. 32).

2

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ANNEX

Specifications of ‘maize-germ oil high in unsaponifiable matter’

DESCRIPTION

‘Maize-germ oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined maize-germ oil in the concentration of the unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 g in ‘maize-germ oil high in unsaponifiable matter’).

SPECIFICATIONS

| Unsaponifiable matter | > 9 g/100 g |
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| Tocopherols | ≥ 1,3 g/100 g |
| α-tocopherol (%) | 10-25 % |
| β-tocopherol (%) | < 3 % |
| γ-tocopherol (%) | 68-89 % |
| δ-tocopherol (%) | < 7 % |
| Sterols, triterpenic alcohols, methylsterols | > 6,5g/100 g |
| Fatty acids in tryglycerides |
| palmitic acid | 10-20 % |
| stearic acid | < 3,3 % |
| oleic acid | 20-42,2 % |
| linoleic acid | 34-65,6 % |
| linolenic acid | < 2 % |
| Acid value | ≤ 6 mg KOH/g |
| Peroxide value | ≤ 10 mEq O2/kg |
| Iron (Fe) | < 1 500 μg/kg |
| Copper (Cu) | < 100 μg/kg |
| Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene | < 2 μg/kg |

Unsaponifiable matter

> 9 g/100 g

Tocopherols

≥ 1,3 g/100 g

α-tocopherol (%)

10-25 %

β-tocopherol (%)

< 3 %

γ-tocopherol (%)

68-89 %

δ-tocopherol (%)

< 7 %

Sterols, triterpenic alcohols, methylsterols

> 6,5g/100 g

Fatty acids in tryglycerides

palmitic acid

10-20 %

stearic acid

< 3,3 %

oleic acid

20-42,2 %

linoleic acid

34-65,6 %

linolenic acid

< 2 %

Acid value

≤ 6 mg KOH/g

Peroxide value

≤ 10 mEq O2/kg

Iron (Fe)

< 1 500 μg/kg

Copper (Cu)

< 100 μg/kg

Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene

< 2 μg/kg

Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘maize-germ oil high in unsaponifiable matter’.

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