Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters (Text with EEA relevance)
Date: 2004-03-31
Institutions: European Commission
Subjects: consumer information, food inspection, foodstuff, labelling

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 608/2004

of 31 March 2004

concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters,
phytostanols and/or phytostanol esters

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Directive 2000/13/EC of the European Parlia-
ment and of the Council of 20 March 2000 on the approxima-
tion of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs (1), as amended by
Directive 2003/89/EC (2), and in particular Article 4(2) and
Article 6(7) thereof,

Whereas:

(1)

(2)

(3)

esters,

phytosterol

phytostanols

and
Phytosterols,
phytostanol esters reduce serum cholesterol
levels but
may also reduce the β-carotene levels in blood serum.
Member States and the Commission therefore consulted
the Scientific Committee on Food (SCF) about the effects
of consumption of phytosterols, phytosterol esters,
phytostanols and phytostanol
from multiple
sources.

esters

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 confirmed the need to
label phytosterols, phytosterol esters, phytostanols and
phytostanol esters as specified in Commission Decision
2000/500/EC of 24 July 2000 on authorising the
placing on the market of ‘yellow fat spreads with added
phytosterol esters’ as a novel food or novel food ingre-
dient under Regulation (EC) No 258/97 of the European
Parliament and of the Council (3). The SCF also indicated
there was no evidence of additional benefits at
that
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.

calculated as

Products containing phytosterols/phytostanols
should
thus be presented in single portions containing either
maximum 3 g or maximum 1 g of phytosterols/phytos-
free phytosterols/phytostanols.
tanols,
Where this is not the case, there should be a clear indi-
cation of what constitutes a standard portion of the
food, expressed in g or ml, and of the amount of phytos-
terols/phytostanols,
free phytosterols/
calculated as
phytostanols, contained in such a portion. In all events,
the composition and labelling of products should be
such as to allow users to easily restrict their consump-

(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 308, 25.11.2003, p. 15.
(3) OJ L 200, 8.8.2000, p. 59.

tion to maximum 3 g/day of phytosterols/phytostanols
through the use of either one portion containing
maximum 3 g, or three portions containing maximum
1 g.

(4)

(5)

(6)

In order to facilitate consumer understanding it appears
appropriate to replace on the label the word ‘phyto’ with
the word ‘plant’.

Decision 2000/500/EC allows the addition of certain
phytosterol esters to yellow fat spreads.
It sets out
specific labelling requirements in order to ensure that
the product reaches its target group, namely people who
want to lower their blood cholesterol levels.

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

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation shall apply to foods and food ingredients with
added phytosterols, phytosterol esters, phytostanols or phytos-
tanol esters.

Article 2

For labelling purposes, phytosterol, phytosterol ester, phytos-
tanol and phytostanol ester shall be designated respectively by
the terms ‘plant sterol’,
‘plant stanol’ or
‘plant stanol ester’ or their plural form, as appropriate.

‘plant sterol ester’,

Without prejudice to the other requirements of Community or
national law concerning the labelling of foodstuffs, the labelling
of foods or food ingredients with added phytosterols, phytos-
terol esters, phytostanols or phytostanol esters shall contain the
following:

1.

in the same field of vision as the name under which the
product is sold there shall appear, easily visible and legible,
the words: ‘with added plant sterols/plant stanols’;

2. the amount of added phytosterols, phytosterol esters,
phytostanols or phytostanol esters content (expressed in %
or as g of free plant sterols/plant stanols per 100 g or
100 ml of the food) shall be stated on the list of ingredi-
ents;

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3. there shall be a statement that the product is intended exclu-
sively for people who want to lower their blood cholesterol
level;

4. there shall be a statement

that patients on cholesterol
lowering medication should only consume the product
under medical supervision;

5. there shall be an easily visible and legible statement that the
product may not be nutritionally appropriate for pregnant
and breastfeeding women and children under the age of five
years;

6. advice shall be included that the product is to be used as
part of a balanced and varied diet,
including regular
consumption of fruit and vegetables to help maintain caro-
tenoid levels;

7.

in the same field of vision as the particular required under
point 3 above, there shall be a statement that the consump-
tion of more than 3 g/day of added plant sterols/plant
stanols should be avoided;

8. there shall be a definition of a portion of the food or food
ingredient concerned (preferably in g or ml) with a state-
ment of
that each
the plant sterol/plant stanol amount
portion contains.

Article 3

Foods and food ingredients with added phytostanol esters
already on the market in the Community or ‘yellow fat spreads
with added phytosterol esters’ that were authorised by Commis-
sion Decision 2000/500/EC produced from six months after
entry into force of this Regulation shall comply with the label-
ling provisions of Article 2.

Article 4

This Regulation shall enter
into force on the 20th day
following its publication in the Official Journal of the European
Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 March 2004.

For the Commission

David BYRNE

Member of the Commission