COMMISSION REGULATION (EU) No 957/2010  
of 22 October 2010  
on the authorisation and refusal of authorisation of certain health claims made on foods and 
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 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) Two opinions referred to in this Regulation are related to 
applications for reduction of disease risk claims, as 
referred to in Article 14(1)(a) of Regulation (EC) No 
1924/2006 and three opinions are 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.  
(6) Following an application from Association de la Trans ­
formation 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 iodine on normal growth 
of children (Question No EFSA-Q-2008-324) (  2 ). The 
claim proposed by the applicant was worded as 
follows: ‘Iodine is necessary for the growth of children’.  
(7) On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
and the Member States on 20 November 2009 that a 
cause and effect relationship had been established 
between the intake of iodine and the claimed effect. 
Accordingly, 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 Union list of permitted claims.  
(8) Following an application from Association de la Trans ­
formation 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 iron on cognitive devel ­
opment of children (Question No EFSA-Q-2008-325) (  3 ). 
The claim proposed by the applicant was worded as 
follows: ‘Iron is necessary for the cognitive development 
of children’.  
(9) On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
and the Member States on 20 November 2009 that a 
cause and effect relationship had been established 
between the intake of iron and the claimed effect. 
Accordingly, 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 Union list of permitted claims.  
(10) 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 authorised claims and 
include, as the case may be, the revised wording of the 
claims, specific conditions of use of the claims, 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.EN 23.10.2010 Official Journal of the European Union L 279/13  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The EFSA Journal  (2009) 7(11):1359.  
( 3 ) The EFSA Journal  (2009) 7(11):1360.(11) 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 are 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, because they demonstrate the same relationship 
that exists between a food category, a food or one of 
its constituents and health, they should be subject to the 
same conditions of use, as indicated in Annex I.  
(12) Following an application from GP International Holding 
BV, 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 OPC Premium  TM on reduction of blood 
cholesterol (Question No EFSA-Q-2009-00454) (  1 ). The 
claim proposed by the applicant was worded as 
follows: ‘OPC have been shown to reduce blood 
cholesterol levels and may therefore reduce the risk of 
cardiovascular disease’.  
(13) On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
and the Member States on 26 October 2009 that a 
cause and effect relationship had not been established 
between the intake of OPC Premium  TM 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.  
(14) Following an application from Valosun AS, 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 
Uroval® on urinary tract infections (Question No 
EFSA-Q-2009-00600) (  2 ). The claim proposed by the 
applicant was worded as follows: ‘Cranberry extract and 
D-mannose, the main active ingredients of the food 
supplement Uroval®, eliminate the adhesion of harmful 
bacteria to the bladder wall. The adhesion of harmful 
bacteria to the bladder wall is the main risk factor in 
the development of urinary tract infections’.  
(15) On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
and the Member States on 22 December 2009 that a 
cause and effect relationship had not been established 
between the intake of Uroval® 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 Töpfer GmbH, 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 a 
combination of bifidobacteria ( Bifidobacterium bifidum , 
Bifidobacterium breve , Bifidobacterium infantis , Bifidobacterium 
longum ) on decreasing potentially pathogenic intestinal 
micro-organisms (Question No EFSA-Q-2009-00224) (  3 ). 
The claim proposed by the applicant was worded as 
follows: ‘Probiotic bifidobacteria lead to a healthy 
intestinal flora comparable to the composition of the 
intestinal flora of breast-fed infants’ intestine’.  
(17) On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
and the Member States on 22 December 2009 that a 
cause and effect relationship had not been established 
between the intake of the combination of bifidobacteria 
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.  
(18) 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.  
(19) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council have 
opposed them,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The health claims set out in Annex I to this Regulation may be 
made on foods on the European Union market in compliance 
with the conditions set out in that Annex.  
Those health claims shall be included in the Union 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 Union list of permitted claims as 
provided for in Article 14(1) of Regulation (EC) No 1924/2006.EN L 279/14 Official Journal of the European Union 23.10.2010  
( 1 ) The EFSA Journal  (2009) 7(10):1356.  
( 2 ) The EFSA Journal  (2009) 7(12):1421.  (  3 ) The EFSA Journal  (2009) 7(12):1420.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.  
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, 22 October 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 23.10.2010 Official Journal of the European Union L 279/15ANNEX 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)(b) health claim 
referring to children’s 
development and health  Association de la Tran- 
sformation Laitière 
Française (ATLA), 42 
rue de Châteaudun, 
75314 Paris Cedex 
09, France  Iodine  Iodine contributes to the 
normal growth of children  The claim can be used only for 
food which is at least a source 
of iodine 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-2008-324  
Article 14(1)(b) health claim 
referring to children’s 
development and health  Association de la Tran- 
sformation Laitière 
Française (ATLA), 42 
rue de Châteaudun, 
75314 Paris Cedex 
09, France  Iron  Iron contributes to normal 
cognitive development of 
children  The claim can be used only for 
food which is at least a source 
of iron 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-2008-325EN L 279/16 Official Journal of the European Union 23.10.2010ANNEX 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 a reduction of a 
disease risk  OPC Premium™  OPC have been shown to reduce blood cholesterol levels 
and may therefore reduce the risk of cardiovascular disease  Q-2009-00454  
Article 14(1)(a) health claim referring to a reduction of a 
disease risk  Uroval®  Cranberry extract and D-mannose, the main active 
ingredients of the food supplement Uroval®, eliminate 
the adhesion of harmful bacteria to the bladder wall. The 
adhesion of harmful bacteria to the bladder wall is the 
main risk factor in the development of urinary tract 
infections  Q-2009-00600  
Article 14(1)(b) health claim referring to children’s 
development and health  Combination of bifidobacteria ( Bifidobacterium bifidum, 
Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium 
longum ) Probiotic bifidobacteria lead to a healthy intestinal flora 
comparable to the composition of the intestinal flora of 
breast-fed infants’ intestine  Q-2009-00224EN 23.10.2010 Official Journal of the European Union L 279/17