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26.7.2013 Official
Journal
of
the
European
Union L
201/49
COMMISSION REGULATION (EU) No 718/2013
of 25 July 2013
amending Regulation (EC) No 608/2004 concerning the labelling of foods and food ingredients with
added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) The
voluntary
inclusion
of
nutrition
or
health
claims
on
food labels is governed by Regulation (EC) No
1924/2006 of the European Parliament and of the
Council of 20 December 2006 on nutrition and health
claims made on foods ( 4 ). Accordingly, Commission
Regulation (EC) No 983/2009 of 21 October 2009 on
Having regard to the Treaty on the Functioning of the European
the authorisation and refusal of authorisation of certain
Union,
health claims made on food and referring to the
reduction of disease risk and to children’s development
and health
( 5 ), Commission Regulation (EU) No
384/2010 of 5 May 2010 on the authorisation and
refusal of authorisation of certain health claims made
Having regard to Directive 2000/13/EC of the European
on foods and referring to the reduction of disease risk
Parliament and of the Council of 20 March 2000 on the
and to children’s development and health
( 6 ) and
approximation of the laws of the Member States relating to
Commission Regulation (EU) No 432/2012 of 16 May
the labelling, presentation and advertising of foodstuffs (
2012 establishing a list of permitted health claims made

1 ), and
in particular Article 4(3) thereof,
on foods, other than those referring to the reduction of
disease risk and to children’s development and health ( 7 )
have authorised health claims relating to the reduction
and maintenance of blood cholesterol with respect to
foods containing plant sterols and plant stanols, subject
to certain conditions of use.
Whereas:
(4) Regulation
(EC)
No
983/2009
authorised,
under
certain
(1)
Following the Opinion of the Scientific Committee on
conditions of use, the following health claims: ‘Plant
Food (SCF) of 26 September 2002 ( 2 ) and in order to
sterols have been shown to lower/reduce blood choles
ensure that consumers receive adequate information
terol. High cholesterol is a risk factor in the development
when purchasing foods and food ingredients with
of coronary heart disease’ and ‘Plant stanol esters have
added phytosterols, phytosterol esters, phytostanols and
been shown to lower/reduce blood cholesterol. High
phytostanol esters, Commission Regulation (EC) No
cholesterol is a risk factor in the development of
608/2004 of 31 March 2004 concerning the labelling
coronary heart disease’.
of foods and food ingredients with added phytosterols,
phytosterol esters, phytostanols and/or phytostanol
esters ( 3 ) provides for mandatory particulars in addition
to those listed in Article 3 of Directive 2000/13/EC on
the labelling of such foods.
(5) Regulation
(EU)
No
384/2010
authorised,
under
certain
conditions of use, the following health claim: ‘Plant
sterols and plant stanol esters have been shown to lower/
reduce blood cholesterol. High cholesterol is a risk factor
in the development of coronary heart disease.’
(2) Regulation
(EC)
No
608/2004
provides
that
the
labelling
of such foods and food ingredients shall contain,
amongst others, a statement that the product is
intended exclusively for people who want to lower
their blood cholesterol level. The purpose of this
mandatory statement is to ensure that the product
(6) Regulation
(EU)
No
432/2012
authorised,
under
certain
reaches its target group, and thus avoid unnecessary
conditions of use, the following health claim: ‘Plant
consumption by non-targeted groups.
sterols/stanols contribute to the maintenance of normal
blood cholesterol levels’.
( 1 ) OJ L 109, 6.5.2000, p. 29.
( 2 ) Opinion of the SCF titled ‘General view on the long-term effects of
( 4 ) OJ L 404, 30.12.2006, p. 9.
the intake of elevated levels of phytosterols from multiple dietary
( 5 ) OJ L 277, 22.10.2009, p. 3.
sources’.
( 6 ) OJ L 113, 6.5.2010, p. 6.
( 3 ) OJ L 97, 1.4.2004, p. 44.
( 7 ) OJ L 136, 25.5.2012, p. 1.

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L 201/50
EN
Official Journal of the European Union
26.7.2013
(7) The
wording
of
the
authorised
health
claims
in HAS ADOPTED THIS REGULATION:
combination with the mandatory statement relating to
the target group laid down in Regulation (EC) No
Article 1
608/2004 could potentially lead consumers who do
not need to control their blood cholesterol level to use
Amendment to Regulation (EC) No 608/2004
the product. Therefore, with a view to ensure consistency
In Article 2 of Regulation (EC) No 608/2004, point 3 is
of the information provided on the labelling of foods and
replaced by the following:
food ingredients with added phytosterols, phytosterol
esters, phytostanols and/or phytostanol esters, it is appro
‘3. there shall be a statement that the product is not
priate to amend the mandatory statement laid down in
intended for people who do not need to control their
Regulation (EC) No 608/2004 while ensuring that its
blood cholesterol level.’
wording serves adequately the informative purpose for
which it was initially introduced.
Article 2
Transitional measures
(8)
In order to enable food business operators to adapt the
Food and food ingredients with added phytosterols, phytosterol
labelling of their products to the requirements introduced
esters, phytostanols and/or phytostanol esters placed on the
by this Regulation, it is important to provide for an
market or labelled prior to 15 February 2014 which do not
appropriate transition period for the application of this
comply with the requirements of this Regulation may be
Regulation.
marketed until the stocks of the foods are exhausted.
Article 3
(9) The
measures
provided
for
in
this
Regulation
are
in
Entry into force
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health and
This Regulation shall enter into force on the twentieth day
neither the European Parliament nor the Council has
following that of its publication in the Official Journal of the
opposed them,
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 July 2013.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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