EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/10437/2013 
(POOL/E4/2013/10437/10437-EN.doc) 
[…](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
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) 
 
Ref. Ares(2013)512116 - 27/03/2013 
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'.  
(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 deliver  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 Béres Pharmaceuticals 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 glucosamine and maintenance of 
joints (Question No EFSA-Q-2011-00907)
2. The claim proposed by the applicant was 
worded as follows: “Glucosamine contribut es to the protection of joint cartilage 
exposed to excessive motion or loading and helps to improve the range of motion in 
joints”. 
(6) On 5 December 2011, 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 
glucosamine and the claimed effect. Accordi ngly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2011; 9(12):2476.  
EN 3   EN (7) Following an application from Merck Cons umer Healthcare, 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 glucosamine and maintenance of 
normal joint cartilage  (Question No EFSA-Q-2011-01113)3. The claim proposed by 
the applicant was worded, inter alia , as follows: “Glucosamine contributes to the 
maintenance of normal joint cartilage”. 
(8) On 16 May 2012, 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 
glucosamine and the claimed effect. Accordi ngly, 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 Extraction Purification Innovation France, submitted 
pursuant to Article 13(5) of Regula tion (EC) No 1924/2006, the Authority was 
required to deliver an opinion on a health claim related to the consumption of wheat 
polar lipid extract and protection of the skin against dehydration (Question No EFSA-
Q-2011-01122)4. The claim proposed by the applicant was worded, inter alia , as 
follows: "Contributes to improve skin hydration". 
(10) On 5 July 2012, 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 had not been  established between the consumption of 
wheat polar lipid extract and the claimed effect. Accordingly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(11) Following an application from Lesaffre International/Lesaffre Human Care, submitted 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a heal th claim related to the effects of 
Saccharomyces cerevisiae  var. boulardii  CNCM I-3799 and reducing gastro-intestinal 
discomfort (Question No EFSA-Q-2012-00271)5. The claim proposed by the 
applicant was worded as follows: “Sacchar omyces cerevisiae var. boulardii CNCM I-
3799 helps maintain intestinal comfort”. 
(12) On 17 July 2012, 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 could not be  established between the consumption of 
Saccharomyces cerevisiae  var. boulardii  CNCM I-3799 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. 
(13) Following two applications from Nutrilinks Sarl,  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 thiamin, riboflavin, niacin, 
pantothenic acid, py ridoxine, D-biotin  and pumpkin seed oil ( Cucurbita pepo L.) and 
maintenance of normal hair (Question No EFSA-Q- 2012-00334 and EFSA-Q-2012-
                                                 
3 The EFSA Journal 2012; 10(5):2691. 
4 The EFSA Journal 2012; 10(7):2773. 
5 The EFSA Journal 2012; 10(7):2801.  
EN 4   EN 00335)6. The claim proposed by th e applicant was worded, inter alia , as follows: 
“Helps to increase hair number”. 
(14) On 17 July 2012, 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 thiamin, riboflavin, niaci n, pantothenic acid, pyridoxine, D-biotin  and 
pumpkin seed oil ( Cucurbita pepo L.) and the claimed 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 Nutrilinks Sarl,  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 Rhodiola rosea L. extract and reduction of mental 
fatigue (Question No EFSA-Q-2012-00336)7. The claim proposed by the applicant 
was worded, inter alia , as follows: “Helps to reduce tiredness in case of stress”. 
(16) On 17 July 2012, 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 
Rhodiola rosea L. extract and the claimed effect. Accordingly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(17) Following an application from Nutrilinks Sarl,  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 flaxseed oil and vitamin E and 
maintenance of the skin permeability barrier function (Question No EFSA-Q-2012-
00337)8. The claim proposed by th e applicant was worded, inter alia , as follows: 
“Contributes to maintain skin permeability barrier function”. 
(18) On 17 July 2012, 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 flaxseed oil and vitamin E and the claimed effect. Accordingly, as the 
claim does not comply with the requirem ents of Regulation (EC) No 1924/2006, it 
should not be authorised. 
(19) Following an application from Nutrilinks Sarl,  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 Opti EFAX™ and maintenance of normal blood 
LDL-cholesterol concentrations (Question No EFSA-Q-2012-00339)9. The claim 
proposed by the applicant was worded as follows: “ Opti EFAX™ helps to maintain 
healthy blood levels of LDL cholesterol”. 
(20) On 17 July 2012, 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 
                                                 
6 The EFSA Journal 2012; 10(7):2807. 
7 The EFSA Journal 2012; 10(7):2805. 
8 The EFSA Journal 2012; 10(7):2819. 
9 The EFSA Journal 2012; 10(7):2802.  
EN 5   EN Opti EFAX™ 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. 
(21) Following an application from Nutrilinks Sarl,  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 Opti EFAX™ and maintenance of normal blood 
HDL-cholesterol concentrations (Question No EFSA-Q-2012-00340)10. The claim 
proposed by the applicant was worded as follows: “ Opti EFAX™ helps to maintain 
healthy blood levels of HDL cholesterol”. 
(22) On 17 July 2012, 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 
Opti EFAX™ 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. 
(23) Following an application from Nutrilinks Sarl , 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 KF2B L20, which is a combination of keratin, 
copper, zinc, niacin, pantothenic acid, pyr idoxine and D-biotin, and maintenance of 
normal hair (Question No EFSA-Q-2012-00381)11. The claim proposed by the 
applicant was worded, inter alia , as follows: “Helps to maintain hair strength”. 
(24) On 17 July 2012, 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 
KF2BL20 and the claimed effect. Accordingl y, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(25) Following an application from Nutrilinks Sarl,  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 hyalu ronic acid and protection of the skin against 
dehydration (Question No EFSA-Q-2012-00382)12. The claim proposed by the 
applicant was worded, inter alia , as follows: “Helps to maintain good skin hydration”. 
(26) On 17 July 2012, 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 
hyaluronic acid and the claimed effect. Acco rdingly, as the claim does not comply 
with the requirements of Regulation (E C) No 1924/2006, it should not be authorised. 
(27) Following an application from Nutrilinks Sarl,  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 Opti EFAX™ and maintenance of normal blood 
concentrations of triglycerides (Question No EFSA-Q-2012-00383)13. The claim 
proposed by the applicant was worded as follows: “ Opti EFAX™ helps to maintain 
healthy blood levels of triglycerides.” 
(28) On 17 July 2012, 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 
                                                 
10 The EFSA Journal 2012; 10(7):2803. 
11 The EFSA Journal 2012; 10(7):2808. 
12 The EFSA Journal 2012; 10(7):2806. 
13 The EFSA Journal 2012; 10(7):2804.  
EN 6   EN cause and effect relationship had not been  established between the consumption of 
Opti EFAX™ 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. 
(29) Following an application from Vivatech, 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 Tr ansitech® and “improves transit and durably 
regulates it” (Question No EFSA-Q-2012-00296)14. The claim proposed by the 
applicant was worded as follows: “Impr oves transit and durably regulates it”. 
(30) On 26 September 2012, the Commi ssion 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 could not be  established between the consumption of 
Transitech® and the claimed effect. Accord ingly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(31) Following an application from Nutrilinks Sarl , 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 Fem ilub® and maintenance of vaginal moisture 
(Question No EFSA-Q-2012-00571)15. The claim proposed by the applicant was 
worded, inter alia , as follows: “Helps to reduce vaginal dryness”. 
(32) On 26 September 2012, the Commi ssion 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 
Femilub® and the claimed effect. Accordingl y, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(33) Following an application from Nutrilinks Sarl , 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 lycopene, vitamin E, lutein and 
selenium and protection of the skin from UV-induced damage (Question No EFSA-
Q-2012-00592)16. The claim proposed by th e applicant was worded, inter alia , as 
follows: “Helps to prepare sensitive skin from  the inside to improve their tolerance to 
the sun”. 
(34) On 27 September 2012, the Commi ssion 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 lycopene, vitamin E, lute in and selenium 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. 
(35) Following an application from Glanbia Nutritionals plc, 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 Prolibra ® and “Helps to reduce body 
fat while preserving lean muscle” (Question No EFSA-Q-2012-00001)17. The claim 
proposed by the applicant was worded as follows: “Helps to reduce body fat while 
preserving lean muscle”. 
                                                 
14 The EFSA Journal 2012; 10(9):2887. 
15 The EFSA Journal 2012; 10(9):2888. 
16 The EFSA Journal 2012; 10(9):2890. 
17 The EFSA Journal 2012; 10(11):2949.  
EN 7   EN (36) On 8 November 2012, 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 could not be  established between the consumption of 
Prolibra® and the claimed effect. Accordingl y, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(37) Following an application from Nutrilinks Sarl , 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 EffEXT™ and “Helps to support joint function by 
maintaining low levels of plasma C-reactive protein”  (Question No EFSA-Q-2012-
00386)18. The claim proposed by the applicant was worded, inter alia , as follows: 
“Helps to support joint function by maintain ing low levels of plasma C-reactive 
protein”. 
(38) On 27 September 2012, the Commi ssion and the Member States received the scientific 
opinion from the Authority, which noted th at the claim refers to a reduction of 
inflammation indicated by a lo wered concentration of plas ma C-reactive protein and 
concluded that on the basis of the data pr esented, a reduction of inflammation in the 
context of diseases such as osteoarthritis or  rheumatoid arthritis is a therapeutic target 
for the treatment of a disease. 
(39) Regulation (EC) No 1924/2006 complements th e general principles of Directive 
2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the 
approximation of the laws of the Member St ates relating to the labelling, presentation 
and advertising of foodstuffs19. Article 2(1)(b) of Directive 2000/13/EC provides that 
the labelling shall not attri bute to any foodstuff the propert y of preventing, treating or 
curing a human disease, or refer to such pr operties. Accordingly, as the attribution of 
medicinal properties to foods is prohibit ed, the claim related to the effects of EffEXT™ 
should not be authorised. 
(40) The health claim related to the effects of E ffext and "Helps to s upport joint function by 
maintaining low levels of plasma C-reactiv e protein", is a heal th claim attributing 
medicinal properties to the food subject to the claim and is therefore prohibited for 
foods. 
(41) The health claim related to Prolibra® a nd “Helps to reduce body fat while preserving 
lean muscle” is a health claim as those refe rred to in point (c) of Article 13(1) of 
Regulation (EC) No 1924/2006 which are subject to the transitional period laid down in Article 28(6) of that Regul ation. However, as the appl ication was not made before 
19 January 2008, the requirement provided for in  point (b) of Article 28(6) of that 
Regulation is not fulfilled, and therefor e this claim may not benefit from the 
transitional period provided  for in that Article. 
(42) The other health claims subject to this Regul ation are health claims as referred to in 
point (a) of Article 13(1) of Regulation (EC) No 1924/2006, which are subject to the 
transitional period laid down in  Article 28(5) of that Regul ation until the adoption of 
the list of permitted health claims provided that they comply with that Regulation.  
(43) The list of permitted health claims has been established by Commission 
Regulation(EU) No 432/2012
20 and is applicable since 14 December 2012. As regards 
                                                 
18 The EFSA Journal 2012; 10(9):2889. 
19 OJ L 109, 6.5.2000, p. 29.  
20 OJ L 136, 25.5.2012, p. 1.  
EN 8   EN claims referred to in Article 13(5) of  Regulation (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 cl aims, 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 adapt to the prohibition of 
such claims. 
(44) 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 measures  provided for in this Regulation.  
(45) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them,   
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 fo r in Article 13(3) of Regulation (EC) No 
1924/2006. 
2. However, the health claims referred to in  paragraph 1 used prior 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  
EN 9   EN ANNEX  
Rejected health claims  
Application – 
Relevant provisions 
of Regulation (EC) 
No 1924/2006 Nutrient, 
substance, food 
or food category Claim EFSA 
opinion 
reference 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Glucosamine  Glucosamine contributes to the 
protection of joint cartilage 
exposed to excessive motion or loading and helps to improve the 
range of motion in joints Q-2011-
00907 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Glucosamine  Glucosamine contributes to the 
maintenance of normal joint 
cartilage Q-2011-
01113 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Wheat polar lipid 
extract Contributes to improve skin 
hydration  Q-2011-
01122 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Saccharomyces 
cerevisiae  var. 
boulardii  CNCM 
I-3799 Saccharomyces cerevisiae var. 
boulardii CNCM I-3799 helps 
maintain intestinal comfort Q-2012-
00271 
Article 13(5) health 
claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data A combination of 
thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin  and 
pumpkin seed oil (Cucurbita pepo 
L.) Helps to increase hair number Q-2012-
00334 & Q-2012-
00335  
EN 10   EN Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Rhodiola rosea L. 
extract Helps to reduce tiredness in case 
of stress  Q-2012-
00336 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data A combination of 
flaxseed oil and 
vitamin E Contributes to maintain skin 
permeability barrier function Q-2012-
00337 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Opti
EFAX™ Opti EFAX™ helps to maintain 
healthy blood levels of LDL 
cholesterol Q-2012-
00339 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Opti
EFAX™ Opti EFAX™ helps to maintain 
healthy blood levels of HDL 
cholesterol Q-2012-
00340 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data KF2BL20  Helps to maintain hair strength Q-2012-
00381 
Article 13(5) health 
claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Hyaluronic acid Helps to maintain good skin 
hydration Q-2012-
00382  
EN 11   EN Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Opti
EFAX™ Opti EFAX™ helps to maintain 
healthy blood levels of 
triglycerides Q-2012-
00383 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Transitech®  Improves transit and durably 
regulates it  Q-2012-
00296 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Femilub®  Helps to reduce vaginal dryness  Q-2012-
00571 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data A combination of 
lycopene, vitamin 
E, lutein and 
selenium  Helps to prepare sensitive skin 
from the inside to improve their 
tolerance to the sun  Q-2012-
00592 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Prolibra®  Helps to reduce body fat while 
preserving lean muscle  Q-2012-
00001 
Article 13(5) health 
claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Eff
EXT™ Helps to support joint function 
by maintaining low levels of 
plasma C-reactive protein Q-2012-
00386