EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11490/2017 
(POOL/E1/2017/11490/11490 -EN.doc)  
[…](2017) 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 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)  
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 foods1, 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 also provides that applications for authorisation s 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 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 opinion 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 Laboratoires Nutrition et Cardiométabolisme , 
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 Stablor® , a drink 
preparation with defined macro - and micronutrient composition and specific 
proportion of amino acids (tryptophan to neutral amino acids ratio)  and decrease in 
visceral fat while preserving lean mass (Question N o EFSA - Q-2016-003192). The 
claim proposed by the applicant was worded as follows: “ In the context of a well -
balanced diet and a mild caloric restriction, the addition of Stablor® contributes to 
decrease visceral fat while preserving lean mass in overweight or obese subjects with 
abdominal fat and cardiometabolic risk factors”.  
(6) On 2 8 February 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effe ct relationship has not been established between the consumption of 
Stablor® and reduction of visceral fat while maintaining lean body mass in the context 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 201 7;15(2):4723. EN 3  EN of an energy restricted diet . Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(7) Following an application from Suomen Terveysravinto Oy , submitted pursuant to 
Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver 
an opinion on a health claim relat ed to curcumin and normal functioning of joints  
(Question N o EFSA - Q-2016-008563). The claim proposed by the applicant was 
worded as follows: “ Curcumin contributes to the normal functioning of joints ”. 
(8) On 8 May 2017 , the Commission and the Member States re ceived the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship has not been established between the consumption of 
curcumin and the maintenance of joint function . 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 Marks and Spencer PLC , submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Authority was requir ed to deliver an 
opinion on a health claim related to a carbohydrate:protein ( CHO:P ) ratio ≤  1.8 on an 
energy basis in the context of an energy -restricted diet and body weight  (Question N o 
EFSA -Q-2016-004364). The claim proposed by the applicant was worded  as follows: 
“Helps to achieve a reduction in body weight and body fat when consumed as part of 
an energy restricted diet (< 8,368 kJ/2,000 kcal/day) for a minimum of 12 weeks ”. 
(10) On 13 June 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship has not been established between the consumption of a 
CHO:P ratio ≤  1.8 on an energy basis consumed in the context of an energy -restricted  
diet and the reduction of body weight.  Accordingly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(11) Following an application from Loc Troi group , submitted pursuant to Article 13(5) of 
Regul ation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to Vibigaba (germinated brown rice) and reduction of body weight 
in the context of an energy -restricted diet  (Question N o EFSA - Q-2017-000325). The 
claim pr oposed by the applicant was worded as follows: “ In the context of an energy -
restricted diet contributes to weight loss ”. 
(12) On 21 July 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship has not been established between the consumption of 
Vibigaba (germinated brown rice) and the reduction of body weight in the context of 
an energy -restricted diet.  Accordingly, as the claim does n ot comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(13) Following an application from Loc Troi group , submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinio n on a 
health claim related to Vibigaba (germinated brown rice) and maintenance of long -
term normal blood glucose concentration  (Question N o EFSA - Q-2017-000336). The 
                                                 
3 EFSA Journal 201 7;15(5):4774 . 
4 EFSA Journal 201 7;15(6):4839 . 
5 EFSA Journal 201 7;15(7):4915 . 
6 EFSA Journal 201 7;15(7):4916 . EN 4  EN claim proposed by the applicant was worded as follows: “ Contributes to the 
maintenance of  normal blood glucose levels ”. 
(14) On 21 July 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship has not been established betw een the consumption of 
Vibigaba (germinated brown rice) and the maintenance of long -term normal blood 
glucose concentration. Accordingly , as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(15) Follo wing an application from Loc Troi group , 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 Vibigaba (germinated brown rice) and contribution to the 
maintenance  of normal blood pressure  (Question N o EFSA - Q-2017-000317). The 
claim proposed by the applicant was worded as follows: “ Contributes to the 
maintenance of normal blood pressure ”. 
(16) On 21 July 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship has not been established between the consumption of 
Vibigaba (germinated brown rice) and the maintenance of normal BP. Accordingly , as 
the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it 
should not be authorised.  
(17) Following an application from Loc Troi group , submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to del iver an opinion on a 
health claim related to Vibigaba (germinated brown rice) and contribution to the 
maintenance of normal blood cholesterol concentration (Question N o EFSA - Q-2017-
000308). The claim proposed by the applicant was worded as follows: “ Contributes to 
the maintenance of normal blood cholesterol levels ”. 
(18) On 21 July 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship has not been established between the consumption of 
Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol 
concentration. Accordingly , as the claim does not comply with the requirements of 
Regulation (EC ) No 1924/2006, it should not be authorised.  
(19) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,   
HAS ADOPTED THIS REGULATION:  
Article 1  
The health claim s listed in th e 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.  
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 . 
                                                 
7 EFSA Journal 201 7;15(7):4914. 
8 EFSA Journal 201 7;15(7):4913 . EN 5  EN 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