2006/722/EC: Commission Decision of 24 October 2006 authorising the placing on the market of rapeseed 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) 4975)
Date: 2006-10-24
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, market approval, vegetable oil

26.10.2006

EN

Official Journal of the European Union

L 296/17

COMMISSION DECISION

of 24 October 2006
authorising the placing on the market of ‘rapeseed 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) 4975)

(Only the French text is authentic)

(2006/722/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
‘rapeseed 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
‘rapeseed oil high in unsaponifiable matter’ proposed as
a food ingredient at a daily intake of 1,5 g per day would
make it possible to supplement vitamin E intake and also
the levels of phytosterol were not
concluded that
sufficient to reduce cholesterolaemia.

(7)

(8)

(9)

(10)

Allergies on a request from the Commission related to
“rapeseed oil high in unsaponifiable matter” as a novel
food ingredient’.

The opinion came to the conclusion that the proposed
use level of 1,5 g per day of ‘rapeseed oil high in unsa-
ponifiable matter’ was safe.

It is recognised that ‘rapeseed oil high in unsaponifiable
matter’ at the intended use level of 1,5 g is a safe source
of Vitamin E. For labelling and presentation, Directive
2002/46/EC of
the
Council of 10 June 2002 on the approximation of
laws
food
supplements (2) applies.

the European Parliament and of

the Member

relating

States

to

of

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

‘Rapeseed 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

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

Article 2

The maximum amount of ‘rapeseed oil high in unsaponifiable
matter’
daily
portion recommended
consumption by the manufacturer shall be 1,5 g.

present

in a

for

(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).

L 296/18

EN

Official Journal of the European Union

26.10.2006

The designation of the novel food ingredient shall be ‘rapeseed oil extract’.

Article 3

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

26.10.2006

EN

Official Journal of the European Union

L 296/19

ANNEX

Specifications of ‘rapeseed oil high in unsaponifiable matter’

DESCRIPTION
‘Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil
in the concentration of the unsaponifiable fraction (1 g in refined rapeseed oil and 9 g in ‘rapeseed oil high in unsapo-
nifiable matter’). There is a minor reduction of triglycerides containing monounsaturated and polyunsaturated fatty acids.

SPECIFICATIONS

Unsaponifiable matter

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

Sterols, triterpenic alcohols, methylsterols

Fatty acids in triglycerides

palmitic acid
stearic acid
oleic acid
linoleic acid
linolenic acid
erucic acid

Acid value

Peroxide value

Iron (Fe)

Copper (Cu)

Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene

> 7 g/100 g

> 0,8 g/100 g
30-50 %
50-70 %
< 6 %

> 5 g/100 g

3-8 %
0,8-2,5 %
50-70 %
15-28 %
6-14 %
< 2 %
≤ 6 mg KOH/g
≤ 10 mEq O2/kg
< 1 000 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 ‘rapeseed oil high in unsaponifiable matter’.