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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Directive 2000/13/EC of the European 
Parliament and of the Council of 20 March 2000 on the 
approximation of the laws of the Member States relating to 
the labelling, presentation and advertising of foodstuffs (  1 ), and 
in particular Article 4(3) thereof,  
Whereas:  
(1) Following the Opinion of the Scientific Committee on 
Food (SCF) of 26 September 2002 (  2 ) and in order to 
ensure that consumers receive adequate information 
when purchasing foods and food ingredients with 
added phytosterols, phytosterol esters, phytostanols and 
phytostanol esters, 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 (  3 ) provides for mandatory particulars in addition 
to those listed in Article 3 of Directive 2000/13/EC on 
the labelling of such foods.  
(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 
reaches its target group, and thus avoid unnecessary 
consumption by non-targeted groups.  (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 
the authorisation and refusal of authorisation of certain 
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 
on foods and referring to the reduction of disease risk 
and to children’s development and health (  6 ) and 
Commission Regulation (EU) No 432/2012 of 16 May 
2012 establishing a list of permitted health claims made 
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.  
(4) Regulation (EC) No 983/2009 authorised, under certain 
conditions of use, the following health claims: ‘Plant 
sterols have been shown to lower/reduce blood choles ­
terol. High cholesterol is a risk factor in the development 
of coronary heart disease’ 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’.  
(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.’  
(6) Regulation (EU) No 432/2012 authorised, under certain 
conditions of use, the following health claim: ‘Plant 
sterols/stanols contribute to the maintenance of normal 
blood cholesterol levels’.EN 26.7.2013 Official Journal of the European Union L 201/49  
( 1 ) OJ L 109, 6.5.2000, p. 29.  
( 2 ) Opinion of the SCF titled ‘General view on the long-term effects of 
the intake of elevated levels of phytosterols from multiple dietary 
sources’.  
( 3 ) OJ L 97, 1.4.2004, p. 44.  ( 4 ) OJ L 404, 30.12.2006, p. 9.  
( 5 ) OJ L 277, 22.10.2009, p. 3.  
( 6 ) OJ L 113, 6.5.2010, p. 6.  
( 7 ) OJ L 136, 25.5.2012, p. 1.(7) The wording of the authorised health claims in 
combination with the mandatory statement relating to 
the target group laid down in Regulation (EC) No 
608/2004 could potentially lead consumers who do 
not need to control their blood cholesterol level to use 
the product. Therefore, with a view to ensure consistency 
of the information provided on the labelling of foods and 
food ingredients with added phytosterols, phytosterol 
esters, phytostanols and/or phytostanol esters, it is appro ­
priate to amend the mandatory statement laid down in 
Regulation (EC) No 608/2004 while ensuring that its 
wording serves adequately the informative purpose for 
which it was initially introduced.  
(8) In order to enable food business operators to adapt the 
labelling of their products to the requirements introduced 
by this Regulation, it is important to provide for an 
appropriate transition period for the application of this 
Regulation.  
(9) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council has 
opposed them,  HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment to Regulation (EC) No 608/2004  
In Article 2 of Regulation (EC) No 608/2004, point 3 is 
replaced by the following:  
‘3. there shall be a statement that the product is not 
intended for people who do not need to control their 
blood cholesterol level.’  
Article 2  
Transitional measures  
Food and food ingredients with added phytosterols, phytosterol 
esters, phytostanols and/or phytostanol esters placed on the 
market or labelled prior to 15 February 2014 which do not 
comply with the requirements of this Regulation may be 
marketed until the stocks of the foods are exhausted.  
Article 3  
Entry into force  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
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 BARROSOEN L 201/50 Official Journal of the European Union 26.7.2013