EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation of health claims made  on food and referring to the reduction of 
disease risk and to children's development and health  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
on the authorisation of health claims made  on food and referring to the reduction of 
disease risk and to children's development and health  
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 17(3) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/2006 hea lth claims made on food are prohibited 
unless they are authorised by the Commissi on 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 and are forwar ded by that authority to the European Food 
Safety Authority, hereinafter re ferred to as the Authority. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Commission of the application, and to deliver an opinion on a 
health claim concerned.  
(4) The Commission is to decide on the aut horisation taking into account the opinion 
delivered by the Authority. 
(5) On 19 August 2008, the Commission and the Me mber States received seven opinions 
on applications for health claim author isation from the European Food Safety 
Authority. On 22 September 2008, the Commission and the Member States received 
one opinion on an application for health clai m authorisation from the Authority. On 22 
October 2008, the Commission and the Member  States received eight opinions on 
applications for health claim authorisati on from the Authority. On 31 October 2008, 
the Commission and the Member States rece ived five opinions on applications for 
health claim authorisation from th e Authority. On 14 November 2008, the 
Commission and the Member Stat es received two opinions on  applications for health 
claim authorisation from the Authority. 
                                                
 
1 OJ L 404, 30.12.2006, p. 9–25 [corrigendum: OJ L 12, 18.1.2007, p. 3–18].  
EN 3   EN (6) Six opinions were related to applications for reduction of disease risk claims, as 
referred to in article 14(1)(a) of Re gulation (EC) No 1924/2006, and seventeen 
opinions were related to applications for health claims referring to children’s development and health, as referred to in  article 14(1)(b) of Regulation (EC) No 
1924/2006. Meanwhile one application for hea lth claim authorisation was withdrawn 
by the applicant and one applica tion for health claim authoris ation will be subject to a 
further decision.  
(7) Following an application from UNILEV ER PLC (United Kingdom) and UNILEVER 
N.V. (Netherlands), submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliv er an opinion on a he alth claim related 
to the effects of Plant sterols on blood chol esterol and the risk of coronary heart 
disease  (Question No EFSA-Q-2008-085) . The claim proposed by the applicant was 
worded as follows: "Plant st erols have been proven to lower/reduce blood cholesterol 
significantly. Blood cholestero l lowering has been proven  to reduce the risk of 
(coronary) heart disease".  
(8) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the cons umption of plant sterols and the claimed 
effect. Subject to a revised wording the cl aim complies with the conditions set out in 
Regulation (EC) No 1924/2006 and especially in Article  2 and Article 14(1)(b) 
thereof, and it should be authorised.  
(9) Following an application from McNeil Nutritionals, submitted pursuant to Article 
14(1)(a) of Regulation (EC) No 1924/2006, th e Authority was required to deliver an 
opinion on a health claim re lated to the effects of Plant stanol esters on blood 
cholesterol and the risk of coronary heart disease (Question No EFSA-Q-2008-118) . 
The claim proposed by the applicant was worded as follows: "By actively 
lowering/reducing LDL-chol esterol (by up to 14% with in 2 weeks, by blocking 
cholesterol absorption,) plant stanol esters re duce the risk of (coronary) heart disease".  
(10) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the intake of plant stanol esters and the claimed effect. Subject to a revised wording the cl aim complies with the conditions set out in 
Regulation (EC) No 1924/2006, and especially  in Article 2 and Article 14(1)(b) 
thereof, and it should be authorised.  
(11) Following an application from Unilever PLC/NV submitted pursuant to 
Article 14(1)(b) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects of α-linolenic acid (ALA) 
and linoleic acid (LA) on growth and development of children (Question No EFSA-
Q-2008-079) . The claim proposed by the applicant was worded as follows: "Regular 
consumption of essential fatty acids is im portant for proper growth and development 
of children". 
(12) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the inta ke of ALA and LA and the claimed effect. 
A health claim reflecting this conclusion  complies with the conditions set out in 
Regulation (EC) No 1924/2006, a nd it should be authorised.  
(13) Following an application from the Associati on de la Transformation Laitière Française 
(ATLA) submitted pursuant to Article 14(1 )(b) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver an opinion on a health claim related to the effects of 
vitamin D on bone growth ( Question No EFSA-Q-2008-323) . The claim proposed by  
EN 4   EN the applicant was worded as follows: "Vitamin D is essential for the bone growth of 
children". 
(14) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the inta ke of vitamin D and the claimed effect. A 
health claim reflecting this conclusion co mplies with the conditions set out in 
Regulation (EC) No 1924/2006, a nd it should be authorised.  
(15) Following an application from Yoplait Dair y Crest Ltd. submitted pursuant to Article 
14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an 
opinion on a health claim related to the e ffects of calcium and vitamin D on bone 
strength (Question No EFSA-Q-2008-116) . The claim proposed by the applicant was 
worded as follows: "Calcium and vitamin D, as part of a healthy diet and lifestyle, 
build stronger bones in ch ildren and adolescents". 
(16) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the intake of calcium and vitamin D and the claimed effect. A health clai m reflecting this conclusion complies with the conditions 
set out in Regulation (EC) No 1924/ 2006, and it should be authorised.  
(17) Following an application from the Associati on de la Transformation Laitière Française 
(ATLA) submitted pursuant to Article 14(1 )(b) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver an opinion on a health claim related to the effects of 
calcium on bone growth ( Question No EFSA-Q-2008-322) . The claim proposed by 
the applicant was worded as follows: "Calci um is needed for the healthy bone growth 
of children". 
(18) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the inta ke of calcium and the claimed effect. A 
health claim reflecting this conclusion co mplies with the conditions set out in 
Regulation (EC) No 1924/2006, a nd it should be authorised.  
(19) Following an application from the Associati on de la Transformation Laitière Française 
(ATLA) submitted pursuant to Article 14(1 )(b) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver an opinion on a health claim related to the effects of 
proteins of animal origin on bone growth (Question No EFSA-Q-2008-326) . The 
claim proposed by the applicant was worded as follows: "Proteins of animal origin 
contribute to children's bone growth".  
(20) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is established between the intake  of total protein and the claimed effect. A 
health claim reflecting this conclusion co mplies with the conditions set out in 
Regulation (EC) No 1924/2006, a nd it should be authorised.  
(21) With respect to the claims to be added to the list provided for in Article 14(1) of 
Regulation No 1924/2006, Annex I to the pres ent Regulation includes the particulars 
referred to in Article 16(4) of that Regulat ion; as the case may be, revised wording of 
the claim, specific conditions of use of the claim, and, where applicable, conditions or 
restrictions of use of the f ood and/or additional statement or warning are specified, in 
accordance with the principles of that Regula tion and in line with the opinions of the 
Authority. 
(22) 
Considering that one of the objectives of  Regulation (EC) No 1924/2006 is to ensure 
that health claims are truthful, clear and re liable and useful to the consumer, and that 
wording and presentation have to be taken in to account in that respect; that therefore  
EN 5   EN where the wording of claims has the same  meaning for consumers as those of an 
authorised health claim as they demonstrate the same relationship that exists between a food category, a food or one of its constituen ts and health, included in Annex I they 
should be subject to the same cond itions of use indicated therein.  
(23) Following an application from BIO SERAE submitted pursuant to Article 14(1)(a) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of NeOpuntia
® on blood lipid parameters associated 
with cardiovascular risks, especially HDL-cholesterol ( Question No EFSA-Q-2008-
214). The claim proposed by the applicant wa s worded as follows: "NeOpuntia® helps 
to improve blood lipid parameters associated with cardiovascular ri sks, especially the 
HDL-cholesterol". 
(24) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship could not be established betw een the consumption of NeOpuntia® and the 
claimed effect. Since the claim does not comply with the conditions set out in 
Regulation (EC) No 1924/2006, it should not be authorised.  
(25) Following an application from Valio Ltd. submitted pursuant to Article 14(1)(a) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on 
the effects of Lactobacillus helveticus fe rmented Evolus® low-fat milk products on 
arterial stiffness (Question No EFSA-Q-2008-218). The claim proposed by the 
applicant was worded as follows: "Evolus® reduces arterial stiffness". 
(26) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established betwee n the consumption of Lactobacillus 
helveticus fermented Evolus® low-fat milk products and the claimed effect. Since the 
claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it 
should not be authorised.  
(27) Following an application from Martek Bios ciences Corporation s ubmitted pursuant to 
Article 14(1)(b) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim relate d to the effects of docosahexaenoic acid 
(DHA) and arachidonic acid (ARA) on neural  development of the brain and eyes 
(Question No EFSA-Q-2008-120) . The claim proposed by the applicant was worded 
as follows: "DHA and ARA support neural development of the brain and eyes". 
(28) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been esta blished between the consump tion of the food/constituent 
(DHA and ARA) starting at six months of ag e and the claimed eff ect. Since the claim 
does not comply with the conditions se t out in Regulation (EC) No 1924/2006, it 
should not be authorised. In addition, the Au thority concluded that  the consumption of 
baby foods/formula supplemented with DHA and ARA from six months to one year of 
age might have a beneficial effect on visual  acuity maturation in infants breast-fed 
until the age of 4-6 months. The Authority concluded also that no evidence has been 
presented on the effects of DHA and ARA supplementation starting at six months of 
age on visual maturation in healthy infant s that had not been breastfed but fed 
unenriched formula during the first months of life. A health claim reflecting this 
conclusion could not comply with the gene ral principles and c onditions set out in 
Regulation (EC) No 1924/2006, and especially in Article 3, 5 and 6, and should not be 
authorised. 
(29) Following an application from the Nati onal Dairy Council submitted pursuant to 
Article 14(1)(b) of Regulation (EC) No  1924/2006, the Authority was required to  
EN 6   EN deliver an opinion on a health claim relate d to the effects of dairy foods (milk and 
cheese) on dental health (Question No EFSA-Q-2008-112) . The claim proposed by 
the applicant was worded as follows: "Dai ry foods (milk & cheese) promote dental 
health in children". 
(30) On the basis of the data submitted, the Au thority concluded that the food category 
dairy (milk and cheese) subject of the heal th claim is not sufficiently characterized, 
and a cause and effect relati onship has not been establis hed between the consumption 
of milk or cheese and the claimed effect. Since the claim does not comply with the 
conditions set out in Regulation (EC) No  1924/2006, it should not be authorised.  
(31) Following an application from the Nati onal Dairy Council submitted pursuant to 
Article 14(1)(b) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim rela ted to the effects of  dairy on healthy body 
weight  (Question No EFSA-Q-2008-110) . The claim proposed by the applicant was 
worded as follows: "Three portions of dairy food everyday, as part of a balanced diet, 
may help promote a healthy body weight during childhood and adolescence". 
(32) On the basis of the data submitted, the Au thority concluded that the food category 
dairy (milk and cheese) subject of the health claim has not been sufficiently 
characterized and that a cause and effect re lationship has not been established between 
the daily consumption of dairy foods (mil k, cheese and yogurt) and the claimed effect. 
Since the claim does not comply with the c onditions set out in Regulation (EC) No 
1924/2006, it should not be authorised.  
(33) Following an application from enzyme.pro.ag, submitted pursuant to Article 14(1)(b) 
of Regulation (EC) No 1924/2006, the Authority  was required to deliver an opinion on 
a health claim related to the effects of regulat®.pro.kid IMMUN on the immune 
system of childre n during growth (Question No EFSA-Q-2008-082) . The claim 
proposed by the applicant was worded  as follows: "regulat®.pro.kid IMMUN 
supports, stimulates and modulates the immune  system of children during growth”. 
(34) On the basis of the data submitted, the Aut hority concluded that the food for which the 
claim is made, "regulat®.pro.kid IMMUN", ha s not been sufficiently characterised, 
and a cause and effect relati onship has not been establis hed between the consumption 
of regulat®.pro.kid IMMUN and the claimed e ffect. Since the claim does not comply 
with the conditions set out  in Regulation (EC) No  1924/2006, it should not be 
authorised.  
(35) Following an application from enzyme.pro.ag, submitted pursuant to Article 14(1)(b) 
of Regulation (EC) No 1924/2006, the Authority  was required to deliver an opinion on 
a health claim related to the effects of  regulat®.pro.kid BRAIN on the mental and 
cognitive development of children (Question No EFSA-Q-2008-083) . The claim 
proposed by the applicant was worded  as follows: "regulat®.pro.kid BRAIN 
contributes to mental  and cognitive development of children".  
(36) On the basis of the data submitted, the Aut hority concluded that the food for which the 
claim is made "regulat®.pro.kid BRAIN", ha s not been sufficiently characterised, and 
a cause and effect relationship has not been  established between the consumption of 
regulat®.pro.kid BRAIN and the claimed effect . Since the claim does not comply with 
the conditions set out in Regulation (EC) No 1924/2006, it should not  be authorised.  
(37) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim rela ted to the calming effect of I omega  
EN 7   EN kids®/Pufan 3 kids® (Question No EFSA-Q-2008-091 and - Question No EFSA-Q-
2008-096) . The claim proposed by the applicant was worded as follows: "calming". 
(38) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised.  
(39) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim related to the effects of I omega kids®/Pufan 3 kids® on serenity (Question No EFSA-Q-2008-092 and Question No EFSA-Q-
2008-097) . The claim proposed by the applicant was worded as follows: "provide 
serenity and room for a benefici al development of the child". 
(40) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised.  
(41) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim related to the effects of I omega kids®/Pufan 3 kids® on vision  (Question No EFSA-Q-2008-095 and Question No EFSA-Q-2008-
100). The claim proposed by the applicant wa s worded as follows: "help to support 
vision". 
(42) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised.  
(43) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim related to the effects of I omega kids®/Pufan 3 kids® on mental development (Question No EFSA-Q-2008-098 and Question No 
EFSA-Q-2008-104) . The claim proposed by the applicant was worded as follows: 
"help to support mental development". 
(44) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised.  
(45) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim rela ted the effects of I omega kids®/Pufan 3 
kids® on concentration (Question No EFSA-Q-2008-094 and Question No EFSA-
Q-2008-099) . The claim proposed by the applicant was worded as follows: "help to 
promote concentration". 
(46) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised.   
EN 8   EN (47) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim related to the effects of I omega kids®/Pufan 3 kids® on thinking capacity (Question No EFSA-Q-2008-093 and Question No 
EFSA-Q-2008-101) . The claim proposed by the applicant was worded as follows: 
"helps to promote th e thinking capacity". 
(48) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised.  
(49) Following two applications from Pharma Consulting & Industries submitted pursuant 
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Author ity was required to 
deliver an opinion on a health claim related to the effects of I omega kids®/Pufan 3 kids® on learning ability (Question No EFSA-Q-2008-102  and Question No EFSA-
Q-2008-103) . The claim proposed by the applicant was worded as follows: "help to 
support the learning ability". 
(50) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship has not been established be tween the consumption of DHA and EPA and 
the claimed effect. Since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised. 
(51) The comments from the applicants and the 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. 
(52) In accordance with Article 28(6) of Re gulation (EC) No 1924/2006 health claims 
pursuant to Article 14(1)(b) of Regulation (EC) No 1924/ 2006 and not authorised by 
this Regulation may continue to be used for si x months after the entr y into force of this 
Regulation. For health claims pursuant to  Article 14(1)(b) of Regulation (EC) No 
1924/2006, for which the requirements provided unde r letter b) of Article 28(6) are not 
fulfilled, the transition period foreseen in Article 28(6) is not applicable. A transition period of six months is provided by th e Commission only to enable food business 
operators to adapt to the require ments of this Commission Regulation. 
(53) 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 Annex I may be made on food on the Community market in 
compliance with the conditions set out in that Annex. 
Those health claims shall be included in a list of permitted claims referred to in Article 14(1) 
of Regulation (EC) No 1924/2006. 
 Article 2 
The health claims listed in Annex II are rejected.  
EN 9   EN Article 2 a 
Health claims pursuant to Ar ticle 14(1)(b) of Regulation (E C) No 1924/2006 and listed in 
Annex II may continue to be used for six months  after the entry into force of this Regulation. 
Article 3 
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 
 Androulla VASSILIOU  Member of the Commission  
EN 10   EN ANNEX I  
Permitted Health Claims  
Application 
– Legal Basis Applicant – 
Address Nutrient, 
substance, food 
or food 
category Claim Conditions of use of the 
claim Conditions and/or 
restrictions of use of 
the food and/or 
additional statement 
or warning EFSA 
opinion 
reference 
Article 
14(1)(a) 
health claim referring to a reduction of a 
disease risk Unilever PLC; Port 
Sunlight, Wirral, 
Merseyside, CH62 4ZD, UK and Unilever NV, Weena 455, Rotterdam, 3013 
AL, Nederland Plant sterols: 
Sterols 
extracted from plants, free or esterified with food grade fatty 
acids. Plant sterols have been 
shown to lower/reduce 
blood cholesterol. High cholesterol is a risk factor in the development of 
coronary heart disease. Information to the consumer 
that the beneficial effect is 
obtained with a daily intake of 
at least 2 g plant sterols.  Q-2008-085 
Article 
14(1)(a) health claim referring to a reduction of a 
disease risk McNeil Nutritional, 1 
Landis and Gyr strasse, 6300 Zug; 
Switzerland Plant stanol 
esters Plant stanol esters have 
been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of 
coronary heart disease. Information to the consumer 
that the beneficial effect is obtained with a daily intake of 
at least 2 g plant stanols.  Q-2008-118 
Article 
14(1)(b) health claim referring to children’s 
development 
and health Unilever PLC; Port 
Sunlight, Wirral, Merseyside, CH62 4ZD, UK and Unilever NV, Weena 
455, Rotterdam, 3013 
AL, Nederland a-linolenic acid 
& linoleic acid Essential fatty acids are 
needed for normal growth and development 
of children.  Information to the consumer 
that the beneficial effect is obtained with a daily intake of 1% of total energy for linoleic acid and 0.2% of total energy of α-linolenic acid.  Q-2008-079  
EN 11   EN Application 
– Legal Basis Applicant – 
Address Nutrient, 
substance, food 
or food 
category Claim Conditions of use of the 
claim Conditions and/or 
restrictions of use of 
the food and/or 
additional statement 
or warning EFSA 
opinion 
reference 
Article 
14(1)(b) 
health claim referring to children’s development 
and health Association de la 
Transformation 
Laitière Française (ATLA), 42, rue du Chateaudun, 75314 Paris Cedex 09, 
FRANCE Calcium Calcium is needed for 
normal growth and 
development of bone in 
children.  The claim can be used only for 
food which is at least a source 
of calcium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to 
Regulation 1924/2006.   Q-2008-322 
Article 
14(1)(b) health claim referring to children’s development 
and health Association de la 
Transformation Laitière Française (ATLA), 42, rue du Chateaudun, 75314 Paris Cedex 09, 
FRANCE Protein Protein is needed for 
normal growth and development of bone in 
children. The claim can be used only for 
food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as listed in the Annex to 
Regulation 1924/2006.  Q-2008-326 
Article 
14(1)(b) health claim referring to children’s development and health Yoplait Dairy Crest 
Ltd, Claygate House, Claygate, Surrey, 
KT10 9PN, UK Calcium and 
vitamin D Calcium and vitamin D 
are needed for normal growth and development 
of bone in children. The claim can be used only for 
food which is at least a source of calcium and vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR 
[NAME OF MINERAL/S] as 
listed in the Annex to 
Regulation 1924/2006.  Q-2008-116  
EN 12   EN Application 
– Legal Basis Applicant – 
Address Nutrient, 
substance, food 
or food 
category Claim Conditions of use of the 
claim Conditions and/or 
restrictions of use of 
the food and/or 
additional statement 
or warning EFSA 
opinion 
reference 
Article 
14(1)(b) 
health claim referring to children’s development 
and health Association de la 
Transformation 
Laitière Française (ATLA), 42, rue du Chateaudun, 75314 Paris Cedex 09, 
FRANCE Vitamin D Vitamin D is needed for 
normal growth and 
development of bone in 
children. The claim can be used only for 
food which is at least a source 
of Vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation 
1924/2006.  Q-2008-323 
  
EN 13   EN ANNEX II  
Rejected health claims  
Application - Legal basis Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(a) health claim 
referring to disease risk reduction NeOpuntia® NeOpuntia® helps to improve 
blood lipid parameters associated 
with cardiovascular risks, 
especially the HDL-cholesterol. EFSA-Q-2008-214 
Article 14(1)(a) health claim 
referring to disease risk reduction Lactobacillus helveticus fermented 
Evolus®low-fat milk products Evolus® reduces arterial stiffness EFSA-Q-2008-218 
Article 14(1)(b) health claim 
referring to children’s development 
and health Regulat®.pro.kid IMMUN Regulat®.pro.kid IMMUN 
supports, stimulates and modulates the immune system of children 
during growth. EFSA-Q-2008-082 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Dairy products Three portions of dairy food 
everyday, as part of a balanced diet, may help promote a healthy body weight during childhood and 
adolescence. EFSA-Q-2008-110 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Dairy products Dairy foods (milk & cheese) 
promote dental health in children. EFSA-Q-2008-112 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
Arachidonic Acid (ARA) DHA and ARA support neural 
development of the brain and eyes EFSA-Q-2008-120 
Article 14(1)(b) health claim 
referring to children’s development 
and health regulat®.pro.kid.BRAIN regulat®.pro.kid.BRAIN 
contributes to ment al and cognitive 
development of children EFSA-Q-2008-083  
EN 14   EN Application - Legal basis Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Calming EFSA-Q-2008-091 and  
EFSA-Q-2008-096 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Provide serenity and room for a 
beneficial development of the child EFSA-2008-092 and  
EFSA-Q-2008-097 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Help to support vision EFSA-Q-2008-095 and  
EFSA-Q-2008-100 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Help to support mental 
development EFSA-Q-2008-098 and  
EFSA-Q-2008-104 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Help to promote concentr ation EFSA-Q-2008-094 and  
EFSA-Q-2008-099 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Helps to promote the thinking 
capacity EFSA-Q-2008-093 and  
EFSA-Q-2008-101 
Article 14(1)(b) health claim 
referring to children’s development 
and health Docosahexaenoic Acid (DHA) and 
eicosapentaenoic acid (EPA) Help to support the learning ability EFSA-Q-2008-102 and  
EFSA-Q-2008-103