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Document 32006D0723
2006/723/EC: 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)
2006/723/EC: 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)
2006/723/EC: 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)
OJ L 296, 26.10.2006, p. 20–22
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
OJ L 142M, 5.6.2007, p. 402–404
(MT)
In force
- Date of document:
- 24/10/2006
- Date of effect:
- 24/10/2006; Entry into force Date notif.
- Date of notification:
- 24/10/2006
- Date of end of validity:
- No end date
- Author:
- European Commission
- Responsible body:
- Directorate-General for Health and Food Safety
- Form:
- Decision
- Addressee:
- LABORATOIRES EXPASCIENCE, COURBEVOIE CEDEX - FRANCE, Individual, French nationality
- Authentic language:
- French
- Treaty:
- Treaty establishing the European Community
- Legal basis:
-
- 31997R0258 - A07
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- Link
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- Select all documents mentioning this document
- Instruments cited:
- Link
- Link
- EUROVOC descriptor:
- Subject matter:
- Directory code:
|
26.10.2006 |
EN |
Official Journal of the European Union |
L 296/20 |
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. |
|
(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. |
|
(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. |
|
(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. |
|
(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. |
|
(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
(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).
(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).
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 |
|
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’.
