2000/500/EC: Commission Decision of 24 July 2000 on authorising the placing on the market of 'yellow fat spreads with added phytosterol esters' as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2000) 2121) (Only the English text is authentic)
Date: 2000-07-24
Institutions: European Commission
Subjects: consumer information, food inspection, foodstuff, human nutrition, labelling

8.8.2000

EN

Official Journal of the European Communities

L 200/59

COMMISSION DECISION

of 24 July 2000

on authorising the placing on the market of ‘yellow fat spreads with added phytosterol esters’ as a
novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament
and of the Council

(notified under document number C(2000) 2121)

(Only the English text is authentic)

(2000/500/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 258/97 (1) of the Euro-
pean Parliament and of the Council of 27 January 1997, and in
particular Article 7 thereof,

Having regard to the request by Unilever to the competent
authorities of the Netherlands of 22 May 1998 for placing
‘yellow fat spreads with added phytosterol-esters’ on the market
as a novel food or novel food ingredient,

Having regard to the initial assessment report drawn up by the
competent authorities of the Netherlands, which the Commis-
sion forwarded to all Member States on 28 December 1998,

Whereas:

(1) Within the 60 days period laid down in Article 6(4) of
the Regulation,
reasoned objections were raised in
In accordance with
accordance with that provision.
Article 7 of the Regulation, a Decision is therefore to be
taken in accordance with the procedure laid down in
Article 13 of the Regulation.

(2)

(3)

(4)

(5)

The Scientific Committee for Food has been consulted
on this matter in accordance with Article 11 of the
Regulation. On 6 April 2000, the Scientific Committee
for Food delivered its opinion that
the ‘yellow fat
(maximum 8 %
spreads with added phytosterol-esters’
w/w phytosterol equivalent to 14 % w/w phytosterol
esters) that are the subject of this application are safe for
human consumption.

The marketing of the product will be focused on people
who try to lower their blood cholesterol

levels.

Patients on cholesterol-lowering medication should only
consume the product under medical supervision.

A reduction in plasma Beta-carotene will be relevant for
people whose vitamin A status is not optimal, in partic-
ular pregnant and lactating women as well as younger
children. Therefore information about the Beta-carotene
lowering effect of the product should be provided to the
together with appropriate dietary advice
consumer,

(1) OJ L 43, 14.2.1997, p. 1.

regarding the regular consumption of fruits and veget-
ables.

On this basis, it is established that the products comply
with the criteria laid down in Article 3(1) of the Regula-
tion.

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
for Foodstuffs,

(6)

(7)

HAS ADOPTED THIS DECISION:

Article 1

Yellow fat spreads with added phytosterol esters as specified in
the Annex, hereinafter called the products, may be placed on
the market in the Community as novel foods or novel food
ingredients.

The addressee shall ensure that the products meet the require-
ments of Article 2.

Article 2

Without prejudice to the other requirements of Community
law concerning the labelling of foodstuffs, the following addi-
tional specific labelling requirements shall apply:

(a) The product shall be labelled as: margarine (or vegetable fat
spread) with plant sterol esters, in conformity with Council
Regulation (EC) No 2991/94.

(b) The content of plant sterol esters shall be declared on the

list of ingredients.

(c) There shall be a statement that the product is for people

who want to lower their blood cholesterol

levels.

(d) There shall be a statement that patients on cholesterol
lowering medication should only consume the product
under medical supervision.

(e) There shall be an easily visible and legible statement that
the product may not be nutritionally appropriate for
certain sections of the population (pregnant and breast-
feeding women and children under the age of five years).

(f) Advice shall be given that the product should be used as
part of a healthy diet, including regular consumption of
fruit and vegetables (to help maintain carotenoid levels).

L 200/60

EN

Official Journal of the European Communities

8.8.2000

Article 3

Article 4

Unilever shall establish a surveillance programme accompa-
nying the marketing of the product. This programme should
encompass, in particular, information on individual intakes of
the product. This programme shall be submitted for approval
by the Commission prior to the placing on the market of the
product.

The data collected should be made available to the Commission
and Member States in order to estimate the extent to which the
product is reaching its target group, people who try to control
their elevated blood cholesterol, and to estimate exposures to
phytosterols from this source in other population groups.

This Decision is addressed to Unilever (UK) Central Resources
Limited, Unilever House, Blackfriars, London, United Kingdom.

Done at Brussels, 24 July 2000.

For the Commission

David BYRNE

Member of the Commission

ANNEX

Specifications of yellow fat spread with added phytosterol esters

1. The margarine/vegetable oil spread may contain up to 8 % w/w of added phytosterols (equivalent to 14 % w/w

phytosterol-esters).

2. The composition of the phytosterols is specified in the table below:

Table 1: Composition of phytosterols

Component

Minimum

Maximum

Campesterol

Stigmasterol

β-Sitosterol

Other

10 %

6 %

30 %

0 %

40 %

30 %

65 %

5 %