2004/845/EC: Commission Decision of 12 November 2004 on authorising the placing on the market of milk based beverages with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 4289)
Date: 2004-11-12
Institutions: European Commission
Subjects: foodstuffs legislation, marketing, marketing standard, milk product

L 366/14

EN

Official Journal of the European Union

11.12.2004

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 12 November 2004

on authorising the placing on the market of milk based beverages with added phytosterols/phytos-
tanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European
Parliament and of the Council

(notified under document number C(2004) 4289)

(Only the English text is authentic)

(2004/845/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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)

(3)

(4)

On 7 September 2000 Novartis (now Forbes Medi-Tech
Inc.) made a request
to the competent authorities of
Belgium to place milk based beverages with added
phytosterols on the market as a novel food or a novel
food ingredient.

On 30 March 2001 the competent authorities of Belgium
issued their initial assessment report.

(6)

In their initial assessment report, Belgium’s competent
food assessment body came to the conclusion that an
additional assessment was required.

The Commission forwarded the initial assessment report
to all Member States on 27 April 2001.

(7)

it was therefore prudent

The Scientific Committee on Food (SCF) in its opinion
‘General view on the long-term effects of the intake of
elevated levels of phytosterols from multiple dietary
sources, with particular attention to the effects on
β-carotene’ of 26 September 2002 indicated that there
was no evidence of additional benefits at intakes higher
than 3 g/day and that high intakes may induce unde-
sirable effects and that
to
avoid plant sterol intakes exceeding 3 g/day. Furthermore,
the European Food Safety Authority’s (EFSA) Panel on
Dietetic Products, Nutrition and Allergies in its opinion
‘on a request from the Commission related to a Novel
Food application from Forbes Medi-Tech for approval of
sterol-containing milk-based beverages’ of 25
plant
November 2003 concurred for that application with
the conclusions of the SCF, in its opinion on applications
for approval of a variety of plant sterol enriched foods of
5 March 2003, came to the conclusion that the addition
of
the daily
consumption does not exceed 3 g.

phytosterols

provided

safe,

that

is

(EC)

Regulation

608/2004 (2)
Commission
concerning the labelling of foods and food ingredients
with added phytostanol esters ensures that consumers
receive the information necessary in order
to avoid
excessive intake of added phytosterols/phytostanols.

No

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

(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 97, 1.4.2004, p. 44.

11.12.2004

EN

Official Journal of the European Union

L 366/15

HAS ADOPTED THIS DECISION:

Article 1

The amount of phytosterols/phytostanols added to a container
of beverages shall not exceed 3 g.

Foods and food ingredients as described in Annex 1 with added
phytosterols/phytostanols as specified in Annex 2 (hereinafter
called ‘the products’), may be placed on the market in the
Community.

Article 3

This Decision is addressed to Forbes Medi-Tech Inc., 750 West
Pender Street, Vancouver BC V6C 2T8, Canada.

Article 2

Done at Brussels, 12 November 2004.

The products shall be presented in such a manner that they can
easily be divided into portions that contain either a maximum
of 3 g (in case of one portion per day) or a maximum of 1 g (in
case of three portions per day) of added phytosterols/phytos-
tanols.

For the Commission

David BYRNE
Member of the Commission

L 366/16

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Official Journal of the European Union

11.12.2004

ANNEX 1

Products referred to in Article 1

Milk type products, such as semi-skimmed and skimmed milk type products, where the milk fat has been partly or fully
replaced by vegetable fat.

Specifications of phytosterols and phytostanols for the addition to foods and food ingredients

ANNEX 2

Definition

Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols
and stanols or esterified with food grade fatty acids.

Composition (with GC-FID or equivalent method)
< 80 % β-sitosterol

< 35 % β-sitostanol

< 40 % campesterol

< 15 % campestanol

< 30 % stigmasterol

< 3 % brassicasterol

< 3 % other sterols/stanols

Contamination/purity (GC-FID or equivalent method)

Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of
contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient.