EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12090/2014 (POOL/E4/2014/12090/12090-EN.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain health claims ma de on foods and referri ng to the reduction 
of disease risk 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain he alth claims made on foods and referring to the reduction 
of disease risk 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to 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
1, and in 
particular Article 17(3) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/ 2006 health claims made on foods are 
prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims. 
(2) Regulation (EC) No 1924/2006 al so provides that applications for authorisations of 
health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid 
applications to the Eu ropean Food Safety Authority (EFS A), hereinafter referred to as 
'the Authority'. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Comm ission thereof, and to deli ver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from SANOFI-AVENTIS FRANCE submitted pursuant to 
Article 19(1) of Regulation (EC) No 1924/ 2006 and including a re quest for protection 
of proprietary data, the Authority wa s required to deliver an opinion on the 
modification of the authorisation of a health claim related to plant sterol esters and lowering blood LDL-cholesterol. That health  claim has been authorised, pursuant to 
Article 14(1)(a) of Regula tion (EC) No 1924/2006, by Comm ission Regulations (EC) 
No 983/2009
2 and (EU) No 384/20103. The applicant requested an extension of the 
conditions of use, as provided for in Regulation (EC) No 983/2009 as amended by 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 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 (OJ L 277, 22.10.2009, p. 3). 
3 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 (OJ L 113, 6.5.2010, p. 6). EN 3   EN Regulation (EC) No 376/20104 and in Regulation (EU) No 384/2010 in its original 
version, to powder supplements to be diluted in water at a dose of 2 g per day, which would lower blood LDL-cholesterol concentrat ions by “5,4-8,1 %” after six weeks of 
daily consumption. 
(6) On 21 February 2014, the Commission and the Member States received a scientific 
opinion from the Authority (Question No EFSA-Q-2013-00595)
5 which concluded 
that while plant sterols added to foods su ch as margarine-type spreads, mayonnaise, 
salad dressings, and dairy products such as milk, yoghurts, including low-fat yoghurts, 
and cheese have been shown consiste ntly to lower blood LDL-cholesterol 
concentrations in a large num ber of studies, the effectiv e dose of plant sterols (as 
powder diluted in water) need ed to achieve a given magnit ude of effect in a given 
timeframe, as requested by the applicant, canno t be established with the data provided. 
(7) In accordance with the second paragraph of  Article 16(6) of Regulation (EC) No 
1924/2006, the applicant or members of th e public may make comments to the 
Commission on opinions publishe d by the Authority pursuant to Article 16 of that 
Regulation. On 14 April 2014, th e Commission requested the Authority to respond to 
the scientific comments received from the applicant according to Article 16(6) of 
Regulation (EC) No 1924/2006. The comment s were related to  the scientific 
evaluation of the Authority on the extension of  the conditions of use to plant sterol 
esters in powder, in particular to the intervention study on which the conclusion of the adopted scientific opinion was based and to a new published meta-analysis which was 
submitted with the comments. 
(8) On 21 May 2014, the Commission received the Authority's response to the comments 
on the scientific opinion (Q uestion No EFSA-Q-2014-00310)
6 in which the Authority 
reiterated the conclusion of its scient ific opinion (Question No EFSA-Q-2013-00595) 
with respect to the intervention study. The Authority added that the new published 
meta-analysis does not provide additional info rmation for the scientific substantiation 
of the extension of the conditions of use to plant sterol esters in  powder. Accordingly, 
as under the requested conditions of use the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(9) Following an application from Jemo-pharm A/S submitted pursuant to Article 14(1)(a) 
of Regulation (EC) No 1924/2006 and including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effect of CranMax® and reduction of the risk of urin ary tract infection by inhibiting the 
adhesion of certain bacteria in the ur inary tract (Question No EFSA-Q-2013-00649)7. 
The claim proposed by the applicant was word ed as follows: "Preve nt adhesion of E. 
coli to the uroepithelial cells in women whic h is a risk factor for developing urinary 
tract infections". 
(10) On 5 May 2014, the Commission and the Memb er States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship has not been  established between the consumption of 
                                                 
4 Commission Regulation (EU) No 376/2010 of 3 May 2010 amending Regulation (EC) No 983/2009 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 (OJ L 111, 4.5.2010, p. 3). 
5 EFSA Journal 2014;12(2):3577. 
6 EFSA supporting publication 2014:EN-596. 
7 EFSA Journal 2014;12(5):3657.  EN 4   EN CranMax® and reduction of the risk of urin ary tract infection by inhibiting the 
adhesion of certain bacteria in the urinar y tract. Accordingly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(11) The comments received by the Commission pur suant to Article 16(6) of Regulation 
(EC) No 1924/2006 have been considered when  setting the measures provided for in 
this Regulation. 
(12) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claims listed in the Annex to this Regulation shall not be in cluded in the Union list 
of permitted claims as provided for in Ar ticle 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
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, 
 For the Commission 
 The President  Jean-Claude JUNCKER