2008/558/EC: Commission Decision of 27 June 2008 authorising the placing on the market of refined echium oil as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 3049)
Date: 2008-06-27
Institutions: European Commission
Subjects: food inspection, foodstuffs legislation, labelling, market approval, vegetable oil

9.7.2008

EN

Official Journal of the European Union

L 180/17

COMMISSION DECISION

of 27 June 2008

authorising the placing on the market of refined echium oil as novel food ingredient under
Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2008) 3049)

(Only the English text is authentic)

(2008/558/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,

(6)

(7)

Refined echium oil 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

HAS ADOPTED THIS DECISION:

Whereas:

Article 1

(1)

(2)

On 11 August 2006 the company Croda Chemicals Ltd.
made a request
the
United Kingdom to place refined echium oil on the
market as a novel food ingredient.

to the competent authorities of

On 12 July 2007 the competent food assessment body
the United Kingdom issued its initial assessment
of
In that report it came to the conclusion that
report.
refined echium oil
is safe for human consumption at
the proposed uses.

(3)

The Commission forwarded the initial assessment report
to all Member States on 1 August 2007.

(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)

On 10 January 2008 in his response to the comments
and objections, the applicant agreed to amend the speci-
fications of the refined echium oil and to restrict its uses
as requested by some Member States.

Refined echium oil as specified in Annex I, hereinafter called the
product, may be placed on the market in the Community as a
novel food ingredient for the uses and under the conditions
specified in Annex II.

Article 2

The designation on the novel food ingredient authorised by this
Decision on the labelling of the foodstuff containing it shall be
‘refined echium oil’.

Article 3

This Decision is addressed to Croda Chemicals Europe Ltd, Oak
Road, Clough Road, Hull, East Yorkshire, HU6 7PH, United
Kingdom.

Done at Brussels, 27 June 2008.

For the Commission

Androulla VASSILIOU
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).

L 180/18

EN

Official Journal of the European Union

9.7.2008

ANNEX I

Specifications of refined echium oil

Description

Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of Echium plantagineum.

Specifications

Test

Specification

Stearidonic acid content

Not less than 10 % w/w of total fatty acids

Trans fatty acids

Acid value

Peroxide value

Not more than 2 % (w/w of total fatty acids)

Not more than 0,6 mg KOH/g

Not more than 5 meq O2/kg

Unsaponifiable content

Not more than 2 %

Protein content (total nitrogen)

Not more than 20 μg/mL

Pyrrolizidine alkaloids

Not detectable with a detection limit 4 μg/kg

9.7.2008

EN

Official Journal of the European Union

L 180/19

ANNEX II

Uses of refined Echium oil

Use group

Maximum level of stearidonic acid (STA)

Milk-based products
delivered in a single dose

and drinkable yoghurt products

250 mg/100 g; 75 mg/100 g for drinks

Cheese preparations

Spreadable fat and dressings

Breakfast cereals

Food supplements

750 mg/100 g

750 mg/100 g

625 mg/100 g

500 mg/daily dose as recommended by the manufacturer

Dietary foods for special medical purposes

in accordance with the particular nutritional requirements
of the persons for whom the products are intended

Foods intended for use in energy-restricted diets for weight
reduction

250 mg/meal replacement