EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/12876/2012 
(POOL/E4/2012/12876/12876-EN 
CIS.doc) 
[…](2012) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 608/2004 conc erning the labelling of foods and food 
ingredients with added phytosterols, ph ytosterol esters, ph ytostanols and/or ph ytostanol 
esters 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 608/2004 conc erning 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 approximati on of the laws of the Memb er States relating to the 
labelling, presentation and advertising of foodstuffs
1, and in particular Ar ticle 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, Comm ission Regulation (EC) No 608/2004 of 
31 March 2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytos tanols 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 su ch foods and food 
ingredients shall contain, amongst others, a statement that the pr oduct is intended 
exclusively for people who want to lower th eir blood cholesterol level. The purpose of 
this mandatory statement is to ensure that  the product reaches its target group, and thus 
avoid unnecessary consump tion by non-targeted groups. 
(3) The voluntary inclusion of nutrition or heal th claims on food labels is governed by 
Regulation (EC) No 1924/2006 of the Europe an Parliament and of the Council of 
20 December 2006 on nutrition and h ealth claims made on foods4. Accordingly, 
Commission Regulation (EC)  No 983/2009 of 21 October 2009 on the au thorisation 
and refusal of authorisation of certain hea lth claims made on food and referring to the 
                                                 
1 OJ L 109, 6.5.2000, p. 29.  
2 Opinion of the SCF titled 'General view on the long-t erm 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. EN 3   EN reduction of disease risk and to children's development and health5, Commission 
Regulation (EU) No 384/2010 of 5 May 2010 on the authorisati on and refusal of 
authorisation of certain hea lth claims made on foods and referring to the reduction of 
disease risk and to childr en's development and health6 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 resp ect to foods containi ng plant sterols and 
plant stanols, subject to certain conditions of use.  
(4) Commission Regulation (EC) No 983/2009 aut horised, under certain conditions of 
use, the following health claims: "Plant st erols have been shown to lower/reduce blood 
cholesterol. High cholesterol is a risk fact or in the development of coronary heart 
disease" and "Plant stanol es ters have been shown to lo wer/reduce blood cholesterol. 
High cholesterol is a risk f actor in the development of coronary heart disease".  
(5) Commission Regulation (EU) No 384/2010 au thorised, under cert ain conditions of 
use, the following health claim: "Plant sterol s and plant stanol esters have been shown 
to lower/reduce blood cholesterol. High choleste rol is a risk factor in the development 
of coronary heart disease."  
(6) Commission Regulation (EU) 432/2012 authorised, under cert ain conditions of use, 
the following health claim: "Plant sterols/stanols contribute to the maintenance of normal blood cholesterol levels".  
(7) The wording of the authorised health cl aims in combination with the mandatory 
statement relating to the targ et group laid down in Regul ation (EC) No 608/2004 could 
potentially lead to consumers who do not n eed 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 ingredient s with added phytosterols, 
phytosterol esters, phytostanols and/or phytosta nol esters, it is appropriate 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 busine ss operators to adap t the labelling of th eir products to the 
requirements introduced by this Regulation,  it is important to provide for an 
appropriate transition period for th e application of this Regulation. 
(9) The measures provided for in this Regula tion 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], 
                                                
 
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.  EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Amendment to Regulation (EC) No 608/2004 
In Article 2of Commission Regulation (EC) No 608/2004, poi nt 3 is replaced by the 
following: 
'3. there shall be a statement that the produc t 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 phytostero ls, phytosterol esters, phytostanols and/or 
phytostanol esters placed on the market or labelled  prior to [six months from entry into force] 
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 follo wing 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,  
 For the Commission 
 The President  José Manuel BARROSO