2004/333/EC: Commission Decision of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks 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) 1243)
Date: 2004-03-31
Institutions: European Commission
Subjects: fats, food inspection, food safety, foodstuff, fruit juice, labelling, market approval, milk product

L 105/40

EN

Official Journal of the European Union

14.4.2004

COMMISSION DECISION

of 31 March 2004

authorising the placing on the market of yellow fat spreads, salad dressings, milk type products,
fermented milk type products, soya drinks 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) 1243)

(Only the English text is authentic)

(2004/333/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 2 November 2001 Archer Daniels Midland
Company (ADM) made a request
to the competent
authorities of the Netherlands for placing phytosterols
and phytosterol esters on the market.

in its opinion on an application from ADM 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 3g.

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 13 December 2001 the competent authorities of the
Netherlands issued their initial assessment report.

HAS ADOPTED THIS DECISION:

initial assessment

In their
the Netherlands'
competent food assessment body came to the conclusion
for human
that
consumption.

the phytosterols/stanols

report,

safe

are

(4)

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

(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 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.

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 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.

Salad dressings 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.

(1)

(2)

(3)

14.4.2004

EN

Official Journal of the European Union

L 105/41

This Decision is addressed to Archer Daniels Midland Company, 4666 Faries Parkway, Decatur, IL. 62526-
5666, USA.

Article 3

Done at Brussels, 31 March 2004.

For the Commission

David BYRNE

Member of the Commission

L 105/42

EN

Official Journal of the European Union

14.4.2004

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.

Salad dressings including mayonnaise.

Milk type products such as semi skimmed and skimmed milk type products, possibly with the addition of fruits and/or
cereals, fermented milk type products such as yoghurt, soya drinks, and cheese type products (fat content ≤ 12 g per
100 g), where the milk fat and/or protein has been partly or fully replaced by vegetable fat 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.