2004/335/EC: Commission Decision of 31 March 2004 authorising the placing on the market of milk type products and yoghurt type products with added phytosterol esters as novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 1245)
Date: 2004-03-31
Institutions: European Commission
Subjects: food inspection, labelling, market approval, milk product

L 105/46

EN

Official Journal of the European Union

14.4.2004

COMMISSION DECISION

of 31 March 2004

authorising the placing on the market of milk type products and yoghurt type products with
added phytosterol esters as novel food ingredients under Regulation (EC) No 258/97 of the Euro-
pean Parliament and of the Council

(notified under document number C(2004) 1245)

(Only the English text is authentic)

(2004/335/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 6 August 2002 Unilever made a request
to the
competent authorities of the United Kingdom to place
phytosterol esters as a novel food ingredient in a range
of foods on the market.

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.

Commission Regulation (EC) No 608/2004 of 31 March
2004 concerning the labelling of foods and food ingredi-
ents with added phytosterols, phytosterol esters (2),
that
phytostanols and/or phytostanol esters ensures
consumers 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 21 November 2002 the competent authorities of the
United Kingdom issued their initial assessment report.

HAS ADOPTED THIS DECISION:

In their initial assessment report the United Kingdom's
competent food assessment body came to the conclusion
that these extensions of uses of phytosterol esters are
safe for human consumption.

Article 1

(4)

The Commission forwarded the initial assessment report
to all Member States on 11 December 2002.

Foods and food ingredients as described in Annex 1 with added
phytosterol esters as specified in Annex 2, hereinafter called the
products, may be placed on the market in the Community.

(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 3g (in case of one portion per day) or a maximum of 1g (in
case of three portions per day) of added phytosterol esters
(calculated as free sterols/stanols).

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

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Official Journal of the European Union

L 105/47

This Decision is addressed to Unilever, London Road, Purfleet, Essex RM19 1SD, United Kingdom.

Article 3

Done at Brussels, 31 March 2004.

For the Commission

David BYRNE

Member of the Commission

L 105/48

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Official Journal of the European Union

14.4.2004

ANNEX 1

Products referred to in Article 1

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

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.