COMMISSION REGULATION (EC) No 983/2009  
of 21 October 2009  
on the authorisation and refusal of authorisation of certain 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 establishing 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 foods (  1 ), and 
in particular Article 17(3) thereof,  
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 health claims 
made on food are prohibited unless they are authorised 
by the Commission in accordance with that Regulation 
and included in a list of permitted claims.  
(2) Regulation (EC) No 1924/2006 also provides that appli ­
cations 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 applications to the 
European Food Safety Authority (EFSA), hereinafter 
referred to as the Authority.  
(3) Following receipt of an application the Authority 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 authorisation of 
health claims taking into account the opinion delivered 
by the Authority.  
(5) On 19 August 2008, the Commission and the Member 
States received seven opinions on applications for health 
claim authorisation from the Authority. On 
22 September 2008, the Commission and the Member 
States received one opinion on an application for health 
claim authorisation from the Authority. On 22 October 
2008, the Commission and the Member States received eight opinions on applications for health claim authori ­
sation from the Authority. On 31 October 2008, the 
Commission and the Member States received five 
opinions on applications for health claim authorisation 
from the Authority. On 14 November 2008, the 
Commission and the Member States received two 
opinions on applications for health claim authorisation 
from the Authority.  
(6) Six opinions were related to applications for reduction of 
disease risk claims, as referred to in Article 14(1)(a) of 
Regulation (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 health claim authorisation 
was withdrawn by the applicant and one application for 
health claim authorisation will be subject to a further 
decision.  
(7) Following an application from Unilever PLC (United 
Kingdom) and Unilever NV (Netherlands), 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 
Plant sterols on blood cholesterol and the risk of 
coronary heart disease (Question No EFSA-Q-2008- 
085) (  2 ). The claim proposed by the applicant was 
worded as follows: ‘Plant sterols have been proven to 
lower/reduce blood cholesterol significantly. Blood 
cholesterol lowering has been proven to reduce the risk 
of (coronary) heart disease’.  
(8) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the consumption of plant sterols and the 
claimed effect. Subject to a revised wording the claim 
should be considered as complying with the requirements 
of Regulation (EC) No 1924/2006 and in particular 
Article 14(1)(a) thereof, and it should be included in 
the Community list of permitted claims.  
(9) Following an application from McNeil Nutritionals, 
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 plant stanol esters on blood cholesterol and 
the risk of coronary heart disease (Question No EFSA- 
Q-2008-118) (  3 ). The claim proposed by the applicant 
was worded as follows: ‘By actively lowering/reducing 
LDL-cholesterol (by up to 14 % within 2 weeks, by 
blocking cholesterol absorption,) plant stanol esters 
reduce the risk of (coronary) heart disease’.EN 22.10.2009 Official Journal of the European Union L 277/3  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The EFSA Journal (2008) 781, 1-2.  
( 3 ) The EFSA Journal (2008) 825, 1-13.(10) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the intake of plant stanol esters and the 
claimed effect. Subject to a revised wording the claim 
should be considered as complying with the requirements 
of Regulation (EC) No 1924/2006, and in particular 
Article 14(1)(a) thereof, and it should be included in 
the Community list of permitted claims.  
(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) (  1 ). The claim proposed by the 
applicant was worded as follows: ‘Regular consumption 
of essential fatty acids is important for proper growth 
and development of children’.  
(12) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the intake of ALA and LA and the 
claimed effect. A health claim reflecting this conclusion 
should be considered as complying with the requirements 
of Regulation (EC) No 1924/2006, and it should be 
included in the Community list of permitted claims.  
(13) Following an application from the Association 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) (  2 ). The claim proposed by the applicant 
was worded as follows: ‘Vitamin D is essential for the 
bone growth of children’.  
(14) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the intake of vitamin D and the claimed 
effect. A health claim reflecting this conclusion should be 
considered as complying with the requirements of Regu ­
lation (EC) No 1924/2006, and it should be included in 
the Community list of permitted claims.  
(15) Following an application from Yoplait Dairy 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 
effects of calcium and vitamin D on bone strength 
(Question No EFSA-Q-2008-116) (  3 ). 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 children and 
adolescents’.  (16) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the intake of calcium and vitamin D and 
the claimed effect. A health claim reflecting this 
conclusion should be considered as complying with the 
requirements set out in Regulation (EC) No 1924/2006, 
and it should be included in the Community list of 
permitted claims.  
(17) Following an application from the Association 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) (  4 ). The claim proposed by the applicant was 
worded as follows: ‘Calcium is needed for the healthy 
bone growth of children’.  
(18) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the intake of calcium and the claimed 
effect. A health claim reflecting this conclusion should 
be considered as complying with the requirements of 
Regulation (EC) No 1924/2006, and it should be 
included in the Community list of permitted claims.  
(19) Following an application from the Association 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) (  5 ). 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 presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the intake of total protein and the 
claimed effect. A health claim reflecting this conclusion 
should be considered as complying with the requirements 
of Regulation (EC) No 1924/2006, and it should be 
included in the Community list of permitted claims.  
(21) Article 16(4) of Regulation (EC) No 1924/2006 provides 
that an opinion in favour of authorising a health claim 
should include certain particulars. Accordingly, those 
particulars should be set out in the Annex I to the 
present Regulation as regards the seven authorised 
claims and include, as the case may be, the revised 
wording of the claim, specific conditions of use of the 
claim, and, where applicable, conditions or restrictions of 
use of the food and/or an additional statement or 
warning, in accordance with the rules laid down in Regu ­
lation (EC) No 1924/2006 and in line with the opinions 
of the Authority.EN L 277/4 Official Journal of the European Union 22.10.2009  
( 1 ) The EFSA Journal (2008) 783, 1-10.  
( 2 ) The EFSA Journal (2008) 827, 1-2.  
( 3 ) The EFSA Journal (2008) 828, 1-13.  ( 4 ) The EFSA Journal (2008) 826, 1-11.  
( 5 ) The EFSA Journal (2008) 858, 1-2.(22) One of the objectives of Regulation (EC) No 1924/2006 
is to ensure that health claims are truthful, clear and 
reliable and useful to the consumer, and that wording 
and presentation have to be taken into account in that 
respect; therefore where the wording of claims has the 
same meaning for consumers as that of an authorised 
health claim as they demonstrate the same relationship 
that exists between a food category, a food or one of its 
constituents and health, included in Annex I they should 
be subject to the same conditions 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) (  1 ). The claim proposed by the 
applicant was worded as follows: ‘NeOpuntia  ® helps to 
improve blood lipid parameters associated with cardio- 
vascular risks, especially the HDL-cholesterol’.  
(24) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship could 
not be established between the consumption of 
NeOpuntia  ® and the claimed effect. Accordingly, as the 
claim does not comply with the requirements of Regu ­
lation (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 a health claim related to the effects of  Lacto ­
bacillus helveticus  fermented Evolus  ® low-fat milk products 
on arterial stiffness (Question No EFSA-Q-2008-218) (  2 ). 
The claim proposed by the applicant was worded as 
follows: ‘Evolus  ® reduces arterial stiffness’.  
(26) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of  Lactoba ­
cillus helveticus  fermented Evolus  ® low-fat milk products 
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.  
(27) Following an application from Martek Biosciences Corpo ­
ration submitted pursuant to Article 14(1)(b) of Regu ­
lation (EC) No 1924/2006, the Authority was required 
to deliver an opinion on a health claim related to the 
effects of docosahexaenoic acid (DHA) and ara- 
chidonic acid (ARA) on neural development of the 
brain and eyes (Question No EFSA-Q-2008-120) (  3 ). 
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 presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of the food/ 
constituent (DHA and ARA) starting at six months of age 
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. In 
addition, the Authority 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 had been presented on 
the effects of DHA and ARA supplementation starting at 
six months of age on visual maturation in healthy infants 
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 general prin ­
ciples and requirements of Regulation (EC) No 
1924/2006, and especially Articles 3, 5 and 6, and 
should not be authorised.  
(29) Following an application from the National Dairy 
Council submitted pursuant to Article 14(1)(b) of Regu ­
lation (EC) No 1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects 
of dairy foods (milk and cheese) on dental health 
(Question No EFSA-Q-2008-112) (  4 ). The claim 
proposed by the applicant was worded as follows: 
‘Dairy foods (milk & cheese) promote dental health in 
children’.  
(30) On the basis of the data presented, the Authority 
concluded that the food category dairy foods (milk and 
cheese) subject of the health claim has not been 
sufficiently characterised, and a cause and effect rela ­
tionship had not been established between the 
consumption of milk or cheese 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.  
(31) Following an application from the National Dairy 
Council submitted pursuant to Article 14(1)(b) of Regu ­
lation (EC) No 1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects 
of dairy foods on healthy body weight (Question No 
EFSA-Q-2008-110) (  5 ). 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’.EN 22.10.2009 Official Journal of the European Union L 277/5  
( 1 ) The EFSA Journal (2008) 788, 1-2.  
( 2 ) The EFSA Journal (2008) 824, 1-2.  
( 3 ) The EFSA Journal (2008) 794, 1-2.  ( 4 ) The EFSA Journal (2008) 787, 1-2.  
( 5 ) The EFSA Journal (2008) 786, 1-10.(32) On the basis of the data presented, the Authority 
concluded that the food category dairy foods (milk and 
cheese) subject of the health claim has not been 
sufficiently characterised and that a cause and effect rela ­
tionship had not been established between the daily 
consumption of dairy foods (milk, cheese and yogurt) 
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.  
(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 
children during growth (Question No EFSA-Q-2008- 
082) (  1 ). 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 presented, the Authority 
concluded that the food for which the claim is made, 
‘regulat  ® .pro.kid IMMUN’, has not been sufficiently char ­
acterised, and that a cause and effect relationship had not 
been established between the consumption of 
regulat  ® .pro.kid IMMUN 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 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) (  2 ). 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 presented, the Authority 
concluded that the food for which the claim is made 
‘regulat  ® .pro.kid BRAIN’, has not been sufficiently char ­
acterised, and that a cause and effect relationship had not 
been established between the consumption of 
regulat  ® .pro.kid BRAIN 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.  
(37) Following two applications from Pharma Consulting & 
Industries 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 calming effect of I omega kids  ® /Pufan 3 kids  ® 
(Question No EFSA-Q-2008-091 and – Question No 
EFSA-Q-2008-096) (  3 ). The claim proposed by the 
applicant was worded as follows: ‘calming’.  
(38) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
eicosapentaenoic acid (EPA) 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.  
(39) Following two applications from Pharma Consulting & 
Industries 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 I omega kids  ® /Pufan 3 kids  ® on serenity 
(Question No EFSA-Q-2008-092 and Question No EFSA- 
Q-2008-097) (  4 ). The claim proposed by the applicant 
was worded as follows: ‘provide serenity and room for 
a beneficial development of the child’.  
(40) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
EPA 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.  
(41) Following two applications from Pharma Consulting & 
Industries 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 I omega kids  ® /Pufan 3 kids  ® on vision 
(Question No EFSA-Q-2008-095 and Question No EFSA- 
Q-2008-100) (  5 ). The claim proposed by the applicant 
was worded as follows: ‘help to support vision’.  
(42) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
EPA 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.  
(43) Following two applications from Pharma Consulting & 
Industries 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 I omega kids  ® /Pufan 3 kids  ® on mental 
development (Question No EFSA-Q-2008-098 and 
Question No EFSA-Q-2008-104) (  6 ). The claim 
proposed by the applicant was worded as follows: ‘help 
to support mental development’.EN L 277/6 Official Journal of the European Union 22.10.2009  
( 1 ) The EFSA Journal (2008) 782, 1-2.  
( 2 ) The EFSA Journal (2008) 829, 1-10.  ( 3 ) The EFSA Journal (2008) 830, 1-2.  
( 4 ) The EFSA Journal (2008) 831, 1-2.  
( 5 ) The EFSA Journal (2008) 832, 1-8.  
( 6 ) The EFSA Journal (2008) 847, 1-10.(44) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
EPA 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.  
(45) Following two applications from Pharma Consulting & 
Industries 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 
the effects of I omega kids  ® /Pufan 3 kids  ® on concen ­
tration (Question No EFSA-Q-2008-094 and Question 
No EFSA-Q-2008-099) (  1 ). The claim proposed by the 
applicant was worded as follows: ‘help to promote 
concentration’.  
(46) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
EPA 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.  
(47) Following two applications from Pharma Consulting & 
Industries 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 I omega kids  ® /Pufan 3 kids  ® on thinking 
capacity (Question No EFSA-Q-2008-093 and Question 
No EFSA-Q-2008-101) (  2 ). The claim proposed by the 
applicant was worded as follows: ‘helps to promote the 
thinking capacity’.  
(48) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
EPA 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.  
(49) Following two applications from Pharma Consulting & 
Industries 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 I omega kids  ® /Pufan 3 kids  ® on learning 
ability (Question No EFSA-Q-2008-102 and Question 
No EFSA-Q-2008-103) (  3 ). The claim proposed by the 
applicant was worded as follows: ‘help to support the 
learning ability’.  (50) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of DHA and 
EPA 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.  
(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 measures provided 
for in this Regulation.  
(52) In accordance with Article 28(6) of Regulation (EC) No 
1924/2006 health claims as referred to in 
Article 14(1)(b) of that Regulation and not authorised 
by this Regulation may continue to be used for six 
months after the adoption of a decision pursuant to 
Article 17(3) of Regulation (EC) No 1924/2006. 
However, for applications which were not made before 
19 January 2008, the requirement provided for in 
Article 28(6)(b) is not fulfilled, and the transition 
period laid down in that Article is not applicable. 
Accordingly, a transition period of six months should 
be provided for, to enable food business operators to 
adapt to the requirements laid down in this Regulation.  
(53) The measures provided for in this Regulation 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 set out in Annex I to this Regulation 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 set out in Annex II to this Regulation are 
rejected.  
Article 3  
Health claims as referred to in Article 14(1)(b) of Regulation 
(EC) No 1924/2006 and set out in Annex II to this Regulation 
may continue to be used for six months after the entry into 
force of this Regulation.EN 22.10.2009 Official Journal of the European Union L 277/7  
( 1 ) The EFSA Journal (2008) 846, 1-10.  
( 2 ) The EFSA Journal (2008) 845, 1-2.  
( 3 ) The EFSA Journal (2008) 848, 1-10.Article 4  
This Regulation shall enter into force on the 20th day following 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, 21 October 2009.  
For the Commission  
Androulla VASSILIOU  
Member of the CommissionEN L 277/8 Official Journal of the European Union 22.10.2009ANNEX I  
PERMITTED HEALTH CLAIMS  
Application – Relevant 
provisions of Regulation (EC) 
No 1924/2006  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 reduction of 
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 reduction of 
disease risk  McNeil Nutritionals, 1 
Landis und 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 devel ­
opment and health  Unilever PLC; Port 
Sunlight, Wirral, 
Merseyside, CH62 4ZD, 
UK and Unilever NV, 
Weena 455, Rotterdam, 
3013 AL, Nederland  α-linolenic acid & linoleic 
acid  Essential fatty acids are needed 
for normal growth and devel ­
opment 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  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Association de la Trans ­
formation Laitière 
Française (ATLA), 42, rue 
du Châteaudun, 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 (EC) No 
1924/2006  Q-2008-322  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Association de la Trans ­
formation Laitière 
Française (ATLA), 42, rue 
du Châteaudun, 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 (EC) 
No 1924/2006  Q-2008-326EN 22.10.2009 Official Journal of the European Union L 277/9Application – Relevant 
provisions of Regulation (EC) 
No 1924/2006  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 devel ­
opment 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 
(EC) No 1924/2006  Q-2008-116  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Association de la Trans ­
formation Laitière 
Française (ATLA), 42, rue 
du Châteaudun, 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 (EC) No 
1924/2006  Q-2008-323EN L 277/10 Official Journal of the European Union 22.10.2009ANNEX II  
REJECTED HEALTH CLAIMS  
Application – Relevant provisions of Regulation (EC) 
No 1924/2006  Nutrient, substance, food or food category  Claim  EFSA opinion reference  
Article 14(1)(a) health claim referring to reduction 
of disease risk  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 reduction 
of disease risk  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 mental 
and cognitive development of children  EFSA-Q-2008-083  
Article 14(1)(b) health claim referring to children’s 
development and health  Docosahexaenoic Acid (DHA) and eicosapen ­
taenoic 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 eicosapen ­
taenoic acid (EPA)  Provide serenity and room for a beneficial devel ­
opment of the child  EFSA-Q-2008-092 and 
EFSA-Q-2008-097  
Article 14(1)(b) health claim referring to children’s 
development and health  Docosahexaenoic Acid (DHA) and eicosapen ­
taenoic 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 eicosapen ­
taenoic acid (EPA)  Help to support mental development  EFSA-Q-2008-098 and 
EFSA-Q-2008-104EN 22.10.2009 Official Journal of the European Union L 277/11Application – Relevant provisions of Regulation (EC) 
No 1924/2006  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 eicosapen ­
taenoic acid (EPA)  Help to promote concentration  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 eicosapen ­
taenoic 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 eicosapen ­
taenoic acid (EPA)  Help to support the learning ability  EFSA-Q-2008-102 and 
EFSA-Q-2008-103EN L 277/12 Official Journal of the European Union 22.10.2009