2004/334/EC: Commission Decision of 31 March 2004 authorising the placing on the market of yellow fat spreads, milk type products, yoghurt type products, and spicy sauces 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) 1244)
Date: 2004-03-31
Institutions: European Commission
Subjects: fats, food inspection, food safety, foodstuff, labelling, market approval, milk product

14.4.2004

EN

Official Journal of the European Union

L 105/43

COMMISSION DECISION

of 31 March 2004

authorising the placing on the market of yellow fat spreads, milk type products, yoghurt type
products, and spicy sauces 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) 1244)

(Only the Finnish text is authentic)

(2004/334/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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:

On 24 September 2001 Pharmaconsult Oy Ltd.
(formerly MultiBene Health Oy Ltd.) made a request to
the competent authorities of Finland for placing phytos-
terols on the market.

in its opinion on an application from MultiBene for
approval of plant sterol-enriched foods of 4 April 2003,
came to the conclusion that the addition of phytosterols
is safe, provided that the daily consumption does not
exceed 3 g.

Commission Regulation (EC) No 608/2004 of 31 March
2004 concerning the labelling of foods and food ingredi-
ents with added phytosterols, phytosterol esters, phytos-
tanols and/or phytostanol esters (2) ensures that consu-
mers receive the information necessary in order to avoid
excessive intake of additional phytosterols.

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

(7)

(8)

On 17 January 2002 the competent authorities of
Finland issued their initial assessment report.

HAS ADOPTED THIS DECISION:

In their initial assessment report, Finland's competent
food assessment body came to the conclusion that the
phytosterols/stanols are safe for human consumption.

The Commission forwarded the initial assessment report
to all Member States on 5 March 2002.

Article 1

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 Com-
munity.

(1)

(2)

(3)

(4)

(5) Within the 60-day period laid down in Article 6(4) of
the Regulation, reasoned objections to the marketing of
the product were raised in accordance with that provi-
sion.

(6)

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 might induce undesirable
effects and that it was therefore prudent to avoid plant
sterol intakes exceeding 3 g/day. Furthermore, the SCF,

Article 2

The products shall be presented in such a manner that they can
be easily 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/
phytostanols.

Spicy sauces shall be packed as single portions.

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

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

(2) OJ L 97, 1.4.2004, p. 44.

L 105/44

EN

Official Journal of the European Union

14.4.2004

This Decision is addressed to Pharmaconsult Oy, Riippakoivunkuja 5, FIN — 02130 Espoo.

Article 3

Done at Brussels, 31 March 2004.

For the Commission

David BYRNE

Member of the Commission

14.4.2004

EN

Official Journal of the European Union

L 105/45

ANNEX 1

Products referred to in Article 1

Yellow fat spreads, as defined by Council Regulation (EC) No 2991/94 (1), excluding cooking and frying fats and spreads
based on butter or other animal fat.

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

Spicy sauces

ANNEX 2

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

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
< 15 % β-sitostanol
< 40 % campesterol
< 5 % 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.

(1) OJ L 316, 9.12.1994, p. 2.