EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10318/2014 CIS (POOL/E4/2014/10318/10318-EN 
CIS.doc) 
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain health claims ma de on foods, other than those referring to 
the reduction of disease risk and to children's development and health  
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain he alth claims made on foods, other than those referring to 
the reduction of disease risk and to  children's development and health  
(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 18(5) 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 European Food Safety Au thority (EFSA), hereinafter referred to as 
'the Authority', for a scientific assessmen t, as well as to the Commission and the 
Member States for information.  
(3) The Authority is to deliver an opini on on the health claim concerned.  
(4) The Commission is to decide on  the authorisation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Pharmatoka S.A.S., submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006, the Authorit y was required to deliver an opinion on 
a health claim related to the effects of proanthocyanidins in Urell® and the reduction 
of bacterial colonisation of the urinary tract ( Question No EFSA-Q-2012-00700 )
2. 
The claim proposed by the applicant wa s worded, inter alia, as follows: 
“Proanthocyanidins from Ur ell® contribute to support defence against bacterial 
pathogens in the lower urinary tract”. 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2013; 11(7):3326.  
EN 3   EN (6) On 26 July 2013, 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 could not be  established between the consumption of 
proanthocyanidins in Urell® and the claimed effect. Acco rdingly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(7) Following an application from the Instit ute of Cellular Pharmacology (ICP) Ltd, 
submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of Preservation
® and rapid recovery of ce llular activity post stress (Question No EFSA-
Q-2013-00021)3. The claim proposed by the applicant was worded as follows: 
“improves the physiological response to st ress by accelerating the ap pearance of heat 
shock proteins (HSPs) and maintains an eff ective level of HSPs to ensure that the 
organism is primed should the cell encounter further stress”. 
(8) On 26 July 2013, the Commission and the Memb er States received the scientific 
opinion from the Authority, wh ich concluded that the claimed effect indicated by the 
applicant is general and non-sp ecific, and that the referen ces provided by the applicant 
did not provide information which could be used to define a specific beneficial 
physiological effect. Accordingly, as the cl aim does not comply with the requirements 
of Regulation (EC) No 1924/2006, it should not be authorised. 
(9) The health claims subject to this Regula tion are health claims as referred to in 
Article 13(1)(a) of Regulation (EC) No 1924/2006, which are subject to the 
transitional period laid down in Article 28(5 ) of that Regulation until the adoption of 
the list of permitted health claims provide d that they comply with that Regulation. 
(10) The list of permitted health claims has been established by Commission Regulation 
(EU) No 432/20124 and is applicable since 14 D ecember 2012. As regards claims 
referred to in Article 13(5) of Regulati on (EC) No 1924/2006 for which the evaluation 
by the Authority or consideration by the Commission has not been completed by 
14 December 2012 and which by virtue of this  Regulation are not included in the list 
of permitted health claims, it is appropriate to provide for a transitional period during which they may still be used, in order to  allow both food business operators and the 
competent national authorities to adap t to the prohibition of such claims. 
(11) The comments from the applicants and th e members of the public received by the 
Commission pursuant to Article 16(6) of  Regulation (EC) No 1924/2006 have been 
considered when setting the measur es 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 the Food Chain and Animal Health,   
                                                
 
3 EFSA Journal 2013; 11(7):3330. 
4 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 (OJ L 136, 25.5.2012, p. 1).  
EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims listed in the Annex to this Regulation shall not be included in the 
Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006. 
2. However, the health claims referred to in  paragraph 1 used prio r to the entry into 
force of this Regulation, may continue to  be used for a maximum period of six 
months after the entry into  force of this Regulation. 
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  José Manuel BARROSO