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)
Date: 2006-10-24
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, maize oil, market approval

L 296/20

EN

Official Journal of the European Union

26.10.2006

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
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 24 October 2001 the company Laboratoires Phar-
mascience
(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.

their

initial

report

assessment

On 8 January 2002 the competent authorities of France
to the
forwarded
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.

(7)

(8)

(9)

(10)

Allergies on a request from the Commission related to
maize-germ oil high in unsaponifiable matter as a novel
food ingredient’.

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

It is recognised that ‘maize-germ oil high in unsaponi-
fiable 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
relating to food
supplements (2) applies.

the Member States

laws of

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

(3)

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

HAS ADOPTED THIS DECISION:

(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.

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.

(5)

(6)

The European Food Safety Authority
therefore consulted on 30 January 2004.

(EFSA) was

Article 2

On 6 December 2005, EFSA adopted the ‘Opinion of the
Scientific Panel on Dietetic Products, Nutrition and

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

(1) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

(2) OJ L 183, 12.7.2002, p. 51. Directive as amended by Commission

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

Directive 2006/37/EC (OJ L 94, 1.4.2006, p. 32).

26.10.2006

EN

Official Journal of the European Union

L 296/21

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

Article 3

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

Article 4

Done at Brussels, 24 October 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 296/22

EN

Official Journal of the European Union

26.10.2006

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

Tocopherols
α-tocopherol (%)
β-tocopherol (%)
γ-tocopherol (%)
δ-tocopherol (%)

Sterols, triterpenic alcohols, methylsterols

Fatty acids in tryglycerides

palmitic acid
stearic acid
oleic acid
linoleic acid
linolenic acid

Acid value

Peroxide value

Iron (Fe)

Copper (Cu)

Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene

> 9 g/100 g

≥ 1,3 g/100 g
10-25 %
< 3 %
68-89 %
< 7 %

> 6,5g/100 g

10-20 %
< 3,3 %
20-42,2 %
34-65,6 %
< 2 %
≤ 6 mg KOH/g
≤ 10 mEq O2/kg
< 1 500 μg/kg
< 100 μg/kg
< 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’.