EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11330/2016 
(POOL/E1/2016/11330/11330-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise certain health 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) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
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 Eu ropean Food Safety Authority (EFSA ), hereinafter referred to as 
'the Authority', for a scientific assessment, 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 authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Granarolo S.p.A., 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 a low-fat fe rmented milk with a combination of 
fructooligosaccharides and live Lactobacillus rhamnosus  GG (ATCC 53103), 
Streptococcus thermophilus (Z57) and Lactobacillus bulgaricus  (LB2), and defence 
against reactivation of Herpes simplex viru s in the orolabial epithelia (Question No 
EFSA-Q-2015-00488
2). The claim proposed by the applicant was worded as follows: 
“Consumption of low-fat fermented m ilk with a combination of fructo-
oligosaccharides (FOS) and live Lactobacillus rhamnosus  GG (ATCC 53103), 
Streptococcus thermophilus (Z57) and Lactobacillus delbrueckii  subsp. bulgaricus  
(LB2) helps to reduce recurrence of lip co ld sores caused by Herpes simplex virus 
infection in healthy susceptible individuals”. 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2016;14(7):4538   
EN 3   EN (6) On 19 July 2016, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been established between the consumption of the 
low-fat fermented milk, which was the subject of the health claim, and defence against reactivation of Herpes simplex virus in the orolabial epithelia. Accordingly, as the claim does not comply with the requirem ents of Regulation (EC) No 1924/2006, it 
should not be authorised. 
(7) Following an application from Food for Health Ireland, 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 FHI LFC24, a bovine milk-derived casein 
hydrolysate, and a reduction of post-pra ndial blood glucose re sponses (Question 
No EFSA- Q-2015-00755
3). The claim proposed by the applicant was worded as 
follows: “FHI LFC24 helps to regulat e blood glucose levels following food 
consumption”. 
(8) On 22 July 2016, the Commission and the Member States received the scientific 
opinion from the Authority, which noted that  the evidence provided by the applicant 
does not establish that a reduction in post- prandial glycaemic responses achieved by 
an increase in insulin secr etion is a beneficial physiolo gical effect for the target 
population. Therefore, on the basis of the data  presented, the Authority concluded that 
a cause and effect relationship had not been  established between the consumption of 
the food subject to the claim and a benefi cial physiological effect for the target 
population. Accordingly, as the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(9) Following an application from Pierre Fabre Medicament, submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
opinion on a health claim rela ted to V0137, a ‘DHA-enriched fish oil’, and ‘helps to 
slow the age-related cognitive decline in domains such as memory and executive 
function’ (Question No EFSA- Q- 2016-000714). The claim proposed by the applicant 
was worded as follows: “V0137, in associati on with physical and intellectual training, 
helps to slow the age-related cognitive decline in domains such as memory and executive function”. 
(10) On 5 August 2016, the Commission and the Me mber States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been  established between the consumption of 
V0137, which was the subject of the health claim, and a reduced loss of cognitive 
function. Accordingly, as the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(11) 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 13(3) of Regulation (EC) No 1924/2006. 
                                                
 
3 EFSA Journal 2016;14(7):4540 
4 EFSA Journal 2016;14(8):4539  
EN 4   EN 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