COMMISSION REGULATION (EC) No 1024/2009  
of 29 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 valid 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 14 November 2008 the Commission and the 
Member States received two opinions on applications 
for health claim authorisation from the Authority. On 
10 December 2008, the Commission and the Member 
States received five opinions on applications for health 
claim authorisation from the Authority. On 
19 December 2008, the Commission and the Member 
States received nine opinions on applications for health 
claim authorisation from the Authority. On 15 January 2009, the Commission and the Member States received 
one opinion on an application for health claim authori ­
sation from the Authority. Meanwhile one application for 
health claim authorisation was subject to a previous 
decision.  
(6) One opinion was related to an application for reduction 
of disease risk claim, as referred to in Article 14(1)(a) of 
Regulation (EC) No 1924/2006, and 15 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.  
(7) Following an application from Leaf Int and Leaf Holland 
and Leaf Suomi Oy 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 xylitol chewing 
gum/pastilles on the risk of tooth decay (Question No 
EFSA-Q-2008-321) (  2 ). The claim proposed by the 
applicant was worded as follows: ‘Xylitol chewing 
gum/pastilles reduces the risk of caries’.  
(8) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the consumption of chewing gum 
sweetened with 100 % xylitol and the claimed effect. 
However, it concluded that a cause and effect relationship 
had not been established between the consumption of 
pastilles sweetened with at least 56 % xylitol 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 Danone SA 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 
dairy fresh cheese with significant amounts of calcium, 
vitamin D, phosphorus and protein on bone growth 
(Question No EFSA-Q-2008-217) (  3 ). The claim 
proposed by the applicant was worded as follows: 
‘Dairy fresh cheese contains calcium, vitamin D, phos ­
phorus and protein, nutrients that contribute to healthy 
bone growth’.EN L 283/22 Official Journal of the European Union 30.10.2009  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The EFSA Journal  (2008) 852, pp. 1-16.  
( 3 ) The EFSA Journal  (2008) 895, pp. 1-10.(10) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship was estab ­
lished between the consumption of calcium, vitamin D, 
phosphorus and protein and the claimed effect. Subject 
to a revised wording and taking into account that health 
claims for the same claimed effect are authorised for 
calcium, vitamin D and protein, the claim for phos ­
phorus 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.  
(11) 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 two 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 Regulation (EC) 
No 1924/2006 and in line with the opinions of the 
Authority.  
(12) One of the objectives of the 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; that 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 
to the present Regulation, they should be subject to the 
same conditions of use indicated therein.  
(13) Following an application from the Institute of Biotech ­
nology, Sera and Vaccines Biomed SA, 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 
Lactoral on the normal functioning of the alimentary 
tract (Question No EFSA-Q-2008-269) (  1 ). The claim 
proposed by the applicant was worded as follows: 
‘Lactoral helps to bring back the normal functioning of 
the alimentary tract during its microflora disturbances 
(for example, in case of loose stools, after taking anti ­
biotics, in case of intestinal disorders caused by enteric 
pathogens)’.  
(14) On the basis of the data presented, the Authority 
concluded that the constituents of Lactoral are insuf ­
ficiently characterised, and that a cause and effect rela ­
tionship had not been established between the 
consumption of Lactoral 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.  
(15) Following an application from the Institute of Biotech ­
nology, Sera and Vaccines Biomed SA, 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 
Lactoral on the improvement of the general immunity 
(Question No EFSA-Q-2008-477) (  2 ). The claim proposed 
by the applicant was worded as follows: ‘Lactoral is 
recommended in order to improve the general 
immunity by maintaining the microbiological balance’.  
(16) On the basis of the data presented, the Authority 
concluded that the constituents of Lactoral are insuf ­
ficiently characterised, and that a cause and effect rela ­
tionship had not been established between the 
consumption of Lactoral and the claimed effect. 
Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it 
should not be authorised.  
(17) Following an application from the Institute of Biotech ­
nology, Sera and Vaccines Biomed SA, 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 
Lactoral on the building of the natural intestinal barrier 
(Question No EFSA-Q-2008-478) (  3 ). The claim proposed 
by the applicant was worded as follows: ‘Lactoral helps to 
protect the alimentary system against enteric pathogens 
because of strong antagonistic properties and helps to 
build the natural intestinal barrier’.  
(18) On the basis of the data presented, the Authority 
concluded that the constituents of Lactoral are insuf ­
ficiently characterised, and that a cause and effect rela ­
tionship had not been established between the 
consumption of Lactoral and the claimed effect. 
Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it 
should not be authorised.  
(19) Following an application from the Institute of Biotech ­
nology, Sera and Vaccines Biomed SA, 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 
Lactoral on the maintenance of natural intestinal 
microflora during travel (Question No EFSA-Q-2008- 
479) (  4 ). The claim proposed by the applicant was 
worded as follows: ‘Lactoral helps to maintain natural 
intestinal microflora during travel, changing the climatic 
zone or a diet, especially in poor hygiene conditions’.EN 30.10.2009 Official Journal of the European Union L 283/23  
( 1 ) The EFSA Journal  (2008) 861, pp. 1-9.  ( 2 ) The EFSA Journal  (2008) 860, pp. 1-8.  
( 3 ) The EFSA Journal  (2008) 859, pp. 1-9.  
( 4 ) The EFSA Journal  (2008) 863, pp. 1-8.(20) On the basis of the data presented, the Authority 
concluded that the constituents of Lactoral are insuf ­
ficiently characterised, and that a cause and effect rela ­
tionship had not been established between the 
consumption of Lactoral 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 the Institute of Biotech ­
nology, Sera and Vaccines Biomed SA, 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 
Lactoral on the living probiotic bacteria (Question No 
EFSA-Q-2008-480) (  1 ). The claim proposed by the 
applicant was worded as follows: ‘Lactoral contains 
living probiotic bacteria with strong ability to intestinal 
tract colonisation, isolated from healthy, naturally fed 
infants’.  
(22) On the basis of the data presented, the Authority 
concluded that the constituents of Lactoral are insuf ­
ficiently characterised, and that the claimed effect had 
not been shown. 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 Potters 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 
Mumomega® on central nervous system development 
(Question No EFSA-Q-2008-328) (  2 ). The claim 
proposed by the applicant was worded as follows: 
‘Mumomega® provides the nourishments that support 
healthy central nervous system development’.  
(24) 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 
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 Efamol 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 
Efalex® on coordination (Question No EFSA-Q-2008- 
121) (  3 ). The claim proposed by the applicant was 
worded as follows: ‘Efalex® may help maintain coor ­
dination’.  (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 Efalex® 
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 Efamol 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 
Efalex® on concentration (Question No EFSA-Q-2008- 
317) (  4 ). The claim proposed by the applicant was 
worded as follows: ‘Efalex® may help maintain concen ­
tration’.  
(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 Efalex® 
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 Efamol 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 
Efalex® on brain development and function (Question 
No EFSA-Q-2008-318) (  5 ). The claim proposed by the 
applicant was worded as follows: ‘Efalex® may help 
maintain and support brain development and function’.  
(30) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of Efalex® 
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 Efamol 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 
Efalex® on learning ability (Question No EFSA-Q- 
2008-319) (  6 ). The claim proposed by the applicant 
was worded as follows: ‘Efalex® may help maintain 
learning ability’.  
(32) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of Efalex® 
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.EN L 283/24 Official Journal of the European Union 30.10.2009  
( 1 ) The EFSA Journal  (2008) 862, pp. 1-2.  
( 2 ) The EFSA Journal  (2008) 902, pp. 1-9.  
( 3 ) The EFSA Journal  (2008) 896, pp. 1-9.  ( 4 ) The EFSA Journal  (2008) 897, pp. 1-10.  
( 5 ) The EFSA Journal  (2008) 898, pp. 1-2.  
( 6 ) The EFSA Journal  (2008) 899, pp. 1-10.(33) Following an application from Efamol 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 
Efalex® on eye development and function (Question 
No EFSA-Q-2008-320) (  1 ). The claim proposed by the 
applicant was worded as follows: ‘Efalex® may help 
maintain and support eye development and function’.  
(34) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the consumption of Efalex® 
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 Potters 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 Eye 
q baby® on the central nervous system development 
(Question No EFSA-Q-2008-119) (  2 ). The claim 
proposed by the applicant was worded as follows: ‘Eye 
q baby® provides the nourishments that support healthy 
central nervous system development’.  
(36) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the intake of Eye q baby® 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 an application from Potters 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 Eye 
q® on brain functions (Question No EFSA-Q-2008- 
329) (  3 ). The claim proposed by the applicant was 
worded as follows: ‘Eye q® provides the nourishments 
that help children to maintain healthy brain functions’.  
(38) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the intake of Eye q® 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 an application from Potters 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 Eye q® on concentration (Question No EFSA-Q-2008- 
330) (  4 ). The claim proposed by the applicant was 
worded as follows: ‘Eye q® provides the nourishments 
that help children to maintain concentration levels’.  
(40) On the basis of the data presented, the Authority 
concluded that a cause and effect relationship had not 
been established between the intake of Eye q® 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) 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.  
(42) In accordance with Article 28(6) of Regulation (EC) No 
1924/2006 health claims referred to in Article 14(1)(b) 
of Regulation (EC) No 1924/2006 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 appli ­
cations 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.  
(43) 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 shall 
not be included in the Community list of permitted claims as 
provided for in Article 14(1) of Regulation (EC) No 1924/2006.  
However, they may continue to be used for six months after the 
entry into force of this Regulation.EN 30.10.2009 Official Journal of the European Union L 283/25  
( 1 ) The EFSA Journal  (2008) 900, pp. 1-2.  
( 2 ) The EFSA Journal  (2008) 901, pp. 1-8.  
( 3 ) The EFSA Journal  (2008) 903, pp. 1-8.  (  4 ) The EFSA Journal  (2008) 904, pp. 1-2.Article 3  
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, 29 October 2009.  
For the Commission  
Androulla VASSILIOU  
Member of the CommissionEN L 283/26 Official Journal of the European Union 30.10.2009ANNEX 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 a reduction of a 
disease risk  Leaf Int and Leaf Holland, 
Hoevestein 26, 4903 SC 
Oosterhout NB, The 
Netherlands, and Leaf 
Suomi Oy, PO Box 25, 
FI-21381 Aura, Finland  Chewing gum sweetened 
with 100 % xylitol  Chewing gum sweetened with 
100 % xylitol has been shown 
to reduce dental plaque. High 
content/level of dental plaque is 
a risk factor in the development 
of caries in children  Information to the consumer that 
the beneficial effect is obtained 
with a consumption of 2-3 g of 
chewing gum sweetened with 
100 % xylitol at least 3 times 
per day after the meals  Q-2008-321  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Danone SA, C/Buenos 
Aires, 21, 08029 
Barcelona, Spain  Phosphorus  Phosphorus is needed for the 
normal growth and development 
of bone in children  The claim can be used only for 
food which is at least a source of 
phosphorus 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-2008-217EN 30.10.2009 Official Journal of the European Union L 283/27ANNEX 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)(b) health claim referring to children’s 
development and health  Lactoral  Lactoral helps to bring back the normal func ­
tioning of the alimentary tract during its 
microflora disturbances (for example in case of 
loose stools, after taking antibiotics, in case of 
intestinal disorders caused by enteric pathogens)  EFSA-Q-2008-269  
Article 14(1)(b) health claim referring to children’s 
development and health  Lactoral  Lactoral is recommended in order to improve the 
general immunity by maintaining the microbi ­
ological balance  EFSA-Q-2008-477  
Article 14(1)(b) health claim referring to children’s 
development and health  Lactoral  Lactoral helps to protect the alimentary system 
against enteric pathogens because of strong 
antagonistic properties and helps to build the 
natural intestinal barrier  EFSA-Q-2008-478  
Article 14(1)(b) health claim referring to children’s 
development and health  Lactoral  Lactoral helps to maintain natural intestinal 
microflora during travel, changing the climatic 
zone or a diet, especially in poor hygiene 
conditions  EFSA-Q-2008-479  
Article 14(1)(b) health claim referring to children’s 
development and health  Lactoral  Lactoral contains living probiotic bacteria with 
strong ability to intestinal tract colonisation, 
isolated from healthy, naturally fed infant  EFSA-Q-2008-480  
Article 14(1)(b) health claim referring to children’s 
development and health  Mumomega®  Mumomega® provides the nourishments that 
support healthy central nervous system devel ­
opment  EFSA-Q-2008-328  
Article 14(1)(b) health claim referring to children’s 
development and health  Efalex®  Efalex® may help maintain coordination  EFSA-Q-2008-121  
Article 14(1)(b) health claim referring to children’s 
development and health  Efalex®  Efalex® may help maintain concentration  EFSA-Q-2008-317EN L 283/28 Official Journal of the European Union 30.10.2009Application — 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  Efalex®  Efalex® may help maintain and support brain 
development and function  EFSA-Q-2008-318  
Article 14(1)(b) health claim referring to children’s 
development and health  Efalex®  Efalex® may help maintain learning ability  EFSA-Q-2008-319  
Article 14(1)(b) health claim referring to children’s 
development and health  Efalex®  Efalex® may help maintain and support eye 
development and function  EFSA-Q-2008-320  
Article 14(1)(b) health claim referring to children’s 
development and health  Eye q baby®  Eye q baby® provides the nourishments that 
support healthy central nervous system devel ­
opment  EFSA-Q-2008-119  
Article 14(1)(b) health claim referring to children’s 
development and health  Eye q®  Eye q® provides the nourishments that help 
children to maintain healthy brain functions  EFSA-Q-2008-329  
Article 14(1)(b) health claim referring to children’s 
development and health  Eye q®  Eye q® provides the nourishments that help 
children to maintain concentration levels  EFSA-Q-2008-330EN 30.10.2009 Official Journal of the European Union L 283/29