2004/336/EC: Commission Decision of 31 March 2004 authorising the placing on the market of yellow fat spreads, milk based fruit drinks, yoghurt type products and cheese type products 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) 1246)
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 105/49

COMMISSION DECISION

of 31 March 2004

authorising the placing on the market of yellow fat spreads, milk based fruit drinks, yoghurt type
products and cheese type products 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) 1246)

(Only the Finnish text is authentic)

(2004/336/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:

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 phytosterols is safe,
provided that the daily consumption does not exceed 3g.

(7)

(8)

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,

(1)

(2)

(3)

(4)

On 15 May 2001 Teriaka Ltd. made a request to the
competent authorities of Finland to place phytosterols
on the market as novel food ingredients.

On 31 August
issued their initial assessment report.

the competent authorities of Finland

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.

Article 1

The Commission forwarded the initial assessment report
to all Member States on 15 October 2001.

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.

(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.

Article 2

(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,

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

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 105/50

EN

Official Journal of the European Union

14.4.2004

This Decision is addressed to Teriaka Ltd., Siirakuja 3, 01490 Vantaa.

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 105/51

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 based fruit drinks, yoghurt type products and cheese type products (fat content ≤ 12 g per 100 g) where milk fat
and or protein has been partly or fully replaced by vegetable fat and/or protein.

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.