EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10371/2014 CIS (POOL/E4/2014/10371/10371-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 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 Italsur s.r.l., 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 a combination of Tuscan black cabbage, "tri-
coloured" Swiss chard, "bi-coloured" spinach and "blu savoy" cabba ge and protection 
of blood lipids from oxidative damage (Question No EFSA-Q-2013-00574)
2. The 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2013; 11(10):3413.  
EN 3   EN claim proposed by the applicant was worded as  follows: “contributes to the protection 
of blood lipids from oxidative damage”. 
(6) On 30 October 2013, the Commission and the Me mber States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of Tuscan black cabbage, "t ri-coloured" Swiss chard, "bi-coloured" 
spinach and "blu savoy" cabbage and the cl aimed effect. 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 Italsur s.r.l., 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 a co mbination of red spin ach, green spinach, red 
chicory, green chicory, green leaf chard, red leaf chard, re d Swiss chard, golden Swiss 
chard and white Swiss chard and protecti on of blood lipids from oxidative damage 
(Question No EFSA-Q-2013-00575)3. The claim proposed by the applicant was 
worded as follows: “contributes to the protection of blood lipids from oxidative damage”. 
(8) On 30 October 2013, the Commission and the Me mber States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of red spinach, green spinac h, red chicory, green chicory, green leaf 
chard, red leaf chard, red Swiss chard, golde n Swiss chard and white Swiss chard and 
the claimed effect. Accordingly, as the clai m does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(9) Following an application from Italsur s.r.l., 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 a combination of Tuscan black cabbage, "tri-
coloured" Swiss chard, "b i-coloured" spinach and "blu savoy" cabbage and 
maintenance of normal blood LDL-cholesterol concentration (Question No EFSA-Q-
2013-00576)
4. The claim proposed by the applicant was worded as follows: “maintains 
normal blood cholesterol concentration”. 
(10) On 30 October 2013, the Commission and the Me mber States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of Tuscan black cabbage, "t ri-coloured" Swiss chard, "bi-coloured" 
spinach and "blu savoy" cabbage and the cl aimed effect. 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 Italsur s.r.l., 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 a co mbination of red spin ach, green spinach, red 
                                                 
3 The EFSA Journal 2013; 11(10):3414. 
4 The EFSA Journal 2013; 11(10):3415.  
EN 4   EN chicory, green chicory, green leaf chard, red leaf chard, re d Swiss chard, golden Swiss 
chard and white Swiss chard and mainte nance of normal blood LDL-cholesterol 
concentration (Question No EFSA-Q-2013-00579)5. The claim proposed by the 
applicant was worded as follows: “maintai n normal blood cholesterol concentrations”. 
(12) On 30 October 2013, the Commission and the Me mber States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of red spinach, green spinac h, red chicory, green chicory, green leaf 
chard, red leaf chard, red Swiss chard, golde n Swiss chard and white Swiss chard and 
the claimed effect. Accordingly, as the clai m does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(13) Following an application from 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 Padina pavonica -extract in Dictyolone®  and 
increase in bone mineral density (Question No EFSA-Q-2013-00249)6. The claim 
proposed by the applicant was worded as  follows: "improves bone density through 
calcitrophic effects and th rough the physiological restau ration of proteinous bone, 
particular in bone loss brought about by the aging process on normal healthy persons". 
(14) On 10 January 2014, the Commission and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
Padina pavonica -extract in Dictyolone® and the cl aimed effect. Accordingly, as the 
claim does not comply with the requirem ents of Regulation (EC) No 1924/2006, it 
should not be authorised. 
(15) Following an application from Omikron Ita lia S.r.l., 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 relate d to the effects of a combin ation of diosmin, troxerutin 
and hesperidin and maintenance of normal venous-capillary permeability (Question 
No EFSA-Q-2013-00353)7. The claim proposed by the applicant was worded as 
follows: "the flavonoid mixt ure containing 300 mg of di osmin, 300 mg of troxerutin 
and 100 mg of hesperidin is a useful co adjuvant in maintaining physiological venous-
capillary permeability". 
(16) On 13 January 2014, the Commission and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of diosmin, troxerutin and hesperidin and the claimed effect. 
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 Omikron Ita lia S.r.l., submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
                                                 
5 The EFSA Journal 2013; 11(10):3416. 
6 The EFSA Journal 2014; 12(1):3518. 
7 The EFSA Journal 2014; 12(1):3511.  
EN 5   EN opinion on a health claim relate d to the effects of a combin ation of diosmin, troxerutin 
and hesperidin and maintenance of normal venous tone (Question No EFSA-Q-2013-
00354)8. The claim proposed by the applicant was worded as follows: "the flavonoid 
mixture containing 300 mg of diosmin, 300 mg of troxerutin and 100 mg of hesperidin 
is a useful co adjuvant in main taining physiological venous tone".  
(18) On 13 January 2014, the Commission and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of diosmin, troxerutin and hesperidin and the claimed effect. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(19) Following an application from Italsur srl,  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 the barley soup " Orzotto " and protection of blood 
lipids from oxidative damage (Question No EFSA-Q-2013-00578)9. The claim 
proposed by the applicant was worded as fo llows: "contributes to  the protection of 
blood lipids from oxidative damage".  
(20) On 10 January 2014, the Commission and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been established between the consumption of the 
barley soup " Orzotto " 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.  
(21) 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. 
(22) 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,   
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. 
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 . 
                                                 
8 The EFSA Journal 2014; 12(1):3512. 
9 The EFSA Journal 2014; 12(1):3519.  
EN 6   EN 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