EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/10760/2013 
(POOL/E4/2013/10760/10760-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) 
 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 EJP Pharmaceu tical ApS, submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
opinion on a health clai m related to the effects of Zinc  and prevention of bad breath 
(Question No EFSA-Q-2010-01092)
2. The claim proposed by the applicant was 
worded as follows: “Prevents bad breat h by neutralising of volatile sulphur 
compounds (VSC) in the m outh and oral cavity”. 
(6) On 1 June 2011, the Commission and the Memb er States received the scientific 
opinion from the Authority, whic h concluded that the health claim is related to breath 
odour rather than to a function of the body as required by Artic le 13 of Regulation 
(EC) No 1924/2006. 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 Vitabiotics Lt d., submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2011; 9(6):2169. EN 3   EN health claim related to the e ffects of L-tyrosine and contri bution to normal synthesis of 
dopamine (Question No EFSA-Q-2011-00319)3. The claim proposed by the applicant 
was worded as follows: “L-tyrosine is essential for the natural formation of dopamine”. 
(8) On 20 July 2011, the Commission and the Member States received the scientific 
opinion from the Authority, which noted that  the role of L-tyrosine in the normal 
synthesis of catecholamines for the genera l population has already been addressed 
with a favourable outcome  in a previous opinion
4 in the context of evaluation of 
claims referred to in Article 13(1) of  Regulation (EC) No 1924/2006 and that L-
tyrosine is the starting point for the s ynthesis of all catec holamines, including 
dopamine. Thus, the Authority concluded that a cause and effect relationship had been 
established between the consumption of L-ty rosine in a protein adequate diet and 
contribution to normal synthesis of dopamine  and proposed as appr opriate conditions 
of use that 'a food should be at least a source of  protein as per Annex to Regulation 
(EC) No 1924/2006' . 
(9) The Commission and the Member States have  considered whether the health claim 
reflecting those conclusions should be au thorised under the proposed conditions of 
use, since authorisation may also legitimate ly be withheld if health claims do not 
comply with other general and specific requirements of Regulation (EC) No 
1924/2006, even in the case of a favourable scientific assessment by the Authority. In the Authority's response of 9 November 2012 to the request of the Commission, inter 
alia, for clarification in relation to the evidence submitted for the health claim on L-
tyrosine and the proposed conditions of use, the Authority noted that its conclusions for this claim were based on the well establ ished biochemical role of L-tyrosine, as 
contained in protein. It added that, on the basis of the evidence submitted, it could not provide a quantitative indication of the necessary daily intake of L-tyrosine per se  to 
produce the beneficial physiological effect. Th erefore, it is not possible to establish 
specific conditions for the use of this claim to  ensure that L-tyrosine is contained in 
the final product in a quantity that will pr oduce the beneficial physiological effect in 
accordance with point (i) of Article 5(1)(b ) of Regulation (EC) No 1924/2006. In the 
absence of such specific conditions of use, the beneficial effect of the substance to 
which the claim relates cannot be assured a nd thus this claim could be misleading to 
the consumer. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(10) Following an application from Pierre Fabre Dermo-Cosmétique, submitted pursuant to 
Article 13(5) of Regulation (EC) No 1924/ 2006, the Authority was required to deliver 
an opinion on a health claim re lated to the consumption of  iron and maintenance of 
normal hair growth (Question No EFSA-Q-2012-00059)
5. The claim proposed by the 
applicant was worded as follows: "Excessi ve hair loss in non-m enopausal women".  
(11) On 15 March 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 intake of iron and 
maintenance of normal hair growth. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
                                                
 
3 The EFSA Journal 2011; 9(7):2290. 
4 The EFSA Journal 2011; 9(6):2270. 
5 The EFSA Journal 2012; 10(3):2602. EN 4   EN (12) Following an application from Biocodex, 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 consumption of citrulline-malate and faster recovery from muscle fatigue after exercise (Question No EFSA-Q-2011-00931)
6. The claim 
proposed by the applicant was worded as  follows: "Maintenance of adenosine 
triphosphate (ATP) levels through reduction of  lactates in excess for recovery from 
muscle fatigue".  
(13) On 11 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 
citrulline-malate and the claimed effect. A ccordingly, as the claim does not comply 
with the requirements of Regulation (E C) No 1924/2006, it should not be authorised. 
(14) 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 E ffEXT™ and maintenance of normal joint 
mobility  (Question No EFSA-Q-2012-00384)7. The claim proposed by the applicant 
was worded, inter alia , as follows: “Contributes to  support joint flexibility”. 
(15) On 14 December 2012, 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 
EffEXT™ 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. 
(16) 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 krill oil and maintenance of joint comfort 
(Question No EFSA-Q-2012-00385)8. The claim proposed by the applicant was 
worded,  inter alia , as follows: “Helps to improve the comfort of sensitive joints”. 
(17) On 14 December 2012, 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 
krill oil 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. 
(18) 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 Vitis vinifera L. seeds extract and normal venous 
blood flow (Question No EFSA-Q-2012-00387)9. The claim proposed by the 
applicant was worded, inter alia , as follows: “Contributes to promote venous 
circulation in the legs”. 
(19) On 14 December 2012, 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 
Vitis vinifera L. seeds extract and the claimed eff ect. Accordingly, as the claim does 
                                                 
6 The EFSA Journal 2012; 10(5):2699. 
7 The EFSA Journal 2012; 10(12):3002. 
8 The EFSA Journal 2012; 10(12):3003. 
9 The EFSA Journal 2012; 10(12):2996. EN 5   EN not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(20) 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 Vitis vinifera L. seeds extract and “Helps to 
decrease swollen legs”  (Question No EFSA-Q-2012-00388)10. The claim proposed by 
the applicant was worded, inter alia , as follows: “Helps to decrease swollen legs”. 
(21) On 14 December 2012, the Commission and the Me mber States received the scientific 
opinion from the Authority, which noted that  the claim refers to the reduction of 
peripheral oedema in the context of chroni c clinical conditions (e.g chronic venous 
insufficiency) and concluded that on the basi s of the data presented, such reduction of 
peripheral oedema in the context of chronic cl inical conditions is a therapeutic target 
for their treatment.  
(22) 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 foodstuffs11. 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 Vitis 
vinifera L. seeds extract and “Helps to de crease swollen legs” should not be 
authorised. 
(23) Following an application from Roxlor Nutra LLC, 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 Cynatine® and maintenance of normal joint 
mobility (Question No EFSA-Q-2012-00570)12. The claim proposed by the applicant 
was worded, inter alia , as follows: “Daily consumption of 500 mg of Cynatine® helps 
to support joint flexibility”. 
(24) On 14 December 2012, 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 
Cynatine® 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. 
(25) Following an application from Actina, s ubmitted 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 OXY 280 and reduction of body weight 
(Question No EFSA-Q-2012-00572)13. The claim proposed by the applicant was 
worded, inter alia , as follows: “OXY 280 helps to lose weight”. 
(26) On 14 December 2012, 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 
OXY 280 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. 
                                                 
10 The EFSA Journal 2012; 10(12):2997. 
11 OJ L 109, 6.5.2000, p. 29.  
12 The EFSA Journal 2012; 10(12):3004. 
13 The EFSA Journal 2012; 10(12):2999. EN 6   EN (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 Vitis vinifera L. seeds extract and “Helps to drain 
the body in case of water accumulation” (Question No EFSA-Q-2012-00574)14. The 
claim proposed by the applicant was worded, inter alia , as follows: “Helps to drain the 
body in case of water accumulation”. 
(28) On 14 December 2012, the Commission and the Me mber States received the scientific 
opinion from the Authority, which noted th at the claimed effect refers to the 
maintenance of normal venous blood flow. Th e Authority noted also that the same 
health relationship was already subject to  its assessment in a previous opinion15 with 
an unfavourable outcome and that the reference provided fo r the scientific 
substantiation of this claim was alrea dy considered in the previous opinion. 
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 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 Paullinia cupana  Kunth 
(guarana) and Camellia sinensis  (L.) Kuntze (green tea) ex tracts and reduction of body 
weight (Question No EFSA-Q-2012-00590)16. The claim proposed by the applicant 
was worded, inter alia , as follows: “Helps to burn fat”. 
(30) On 14 December 2012, 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 Paullinia cupana  Kunth (guarana) and Camellia sinensis  (L.) Kuntze 
(green tea) extracts and the claimed effect. Accordingly, as  the claim does not comply 
with the requirements of Regulation (E C) 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 a combination of lycopene, vitamin E, lutein and selenium and “Helps to prepare and activate tanning” (Question No EFSA-Q-2012-
00593)
17. The claim proposed by the applicant was worded, inter alia , as follows: 
“Helps to prepare and activate tanning”. 
(32) On 14 December 2012, the Commission and the Me mber States received the scientific 
opinion from the Authority, which noted that th e claimed effect refers to increasing the 
pigmentation of the skin (i.e  tanning) which may contribut e to the protection of the 
skin against UV-induced damage. The Author ity noted also that the same health 
relationship was already subject to its assessment in a previous opinion18 with an 
unfavourable outcome and that the reference pr ovided for the scientific substantiation 
of this claim was the same as in the prev ious opinion. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(33) The health claim related to th e effects of zinc and preventio n of bad breath is a health 
claim related to breath odour rather than  to a function of the body as required by 
                                                 
14 The EFSA Journal 2012; 10(12):2998. 
15 The EFSA Journal 2012; 10(12):2996. 
16 The EFSA Journal 2012; 10(12):3000. 
17 The EFSA Journal 2012; 10(12):3001. 
18 The EFSA Journal 2012; 10(9):2890. EN 7   EN Article 13(1)(a) of Regulation (EC) No 1924/2006 and cannot benefit from the 
transitional period provided for in Article 28(5) of that Regulation. 
(34) The health claim related to the effects of Vitis vinifera  L. seeds extract and “Helps to 
decrease swollen legs” is a health claim that  attributes medicinal properties to the food 
that is the subject of the claim,  which is prohibited for foods.  
(35) The health claims related to OXY 280 and to the combination of Paullinia cupana  
Kunth (guarana) and Camellia sinensis  (L.) Kuntze (green tea) extracts are health 
claims as referred to in poi nt (c) of Article 13(1) of Regulation (EC) No 1924/2006 
and are therefore subject to the transitional period laid down in Article 28(6) of that Regulation. However, as th e applications were not ma de before 19 January 2008, the 
requirement provided for in point (b) of Article 28(6) of that  Regulation is not 
fulfilled, and therefore those claims may not benefit from the transitional period provided for in that Article. 
(36) The other health claims subjec t to this Regulation, 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 provide d that they comply with that Regulation. 
(37) The list of permitted health claims has been established by Commission Regulation 
(EU) No 432/2012
19 and is applicable since 14 December 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. 
(38) 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 . 
                                                
 
19 OJ L 136, 25.5.2012, p. 1. EN 8   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 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 Zinc Prevents bad breath by 
neutralising of volatile sulphur 
compounds (VSC) in the mouth 
and oral cavity Q-2010-
01092 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data L-tyrosine L-tyrosine is essential for the 
natural formation of dopamine Q-2011-
00319 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Iron Excessive hair loss in non-
menopausal women Q-2012-
00059 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Citrulline-malate Maintenance of adenosine 
triphosphate (ATP) levels 
through reduction of lactates in excess for recovery from muscle 
fatigue Q-2011-
00931 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Eff
EXT™  Contributes to support joint 
flexibility Q-2012-
00384 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 Krill oil Helps to improve the comfort of 
sensitive joints Q-2012-
00385 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Vitis vinifera  L. 
seeds extract  Contributes to promote venous 
circulation in the legs Q-2012-
00387 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Vitis vinifera  L. 
seeds extract  Helps to decrease swollen legs Q-2012-
00388 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Cynatine®  Daily consumption of 500mg of 
Cynatine® helps to support joint flexibility Q-2012-
00570 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data OXY 280  OXY 280 helps to lose weight Q-2012-
00572 
Article 13(5) health 
claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Vitis vinifera  L. 
seeds extract  Helps to drain the body in case 
of water accumulation Q-2012-
00574 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 A combination of 
Paullinia cupana  
Kunth (guarana) 
and Camellia 
sinensis  (L.) 
Kuntze (green tea) 
extracts  Helps to burn fat Q-2012-
00590 
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 and activate 
tanning Q-2012-
00593