EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion 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)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion 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 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. The national competent authority is to forward valid 
applications to the Eu ropean Food Safety Authority (EFSA ), hereinafter referred to as 
the Authority. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Commission of the application, and to deliver an opinion on a 
health claim concerned.  
(4) The Commission is to decide on the authorisa tion 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 Ar ticle 14(1)(a) of Regulation (EC) No 1924/2006 
and three opinions are related to applicati ons for health claims referring to children’s 
development and health, as referred to in Article 14(1 )(b) of Regulation (EC) No 
1924/2006.  
                                                
 
1 OJ L 404, 30.12.2006, p. 9.  
EN 3   EN (6) Following an application from 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 
iodine on normal growth of children ( Question No EFSA-Q-2008-324)2. The claim 
proposed by the applicant was worded as fo llows: "Iodine is nece ssary for the growth 
of children". 
(7) On the basis of the data presented, the Aut hority 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 th is conclusion should be considered as 
complying with the requirements of Re gulation (EC) No 1924/ 2006, and it should be 
included in the Union list of permitted claims.  
(8) Following an application from 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 
iron on cognitive development 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 Aut hority concluded in its opinion received by 
the Commission and the Member States on 20  November 2009 that a cause and effect 
relationship had been establis hed between the intake of ir on and the claimed effect. 
Accordingly, a health claim reflecting th is conclusion should be considered as 
complying with the requirements of Re gulation (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 f ood 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. 
(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. Ther efore, 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 healt h, they should be subject to the same 
conditions of use, as indicated in Annex I.  
(12) Following an application from GP International Holding B.V., submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No  1924/2006, the Authority was required to 
                                                
 
2 The EFSA Journal (2009) 7(11):1359. 
3 The EFSA Journal (2009) 7(11):1360.  
EN 4   EN deliver an opinion on a health claim related to the effects of OPC PremiumTM on 
reduction of blood cholesterol (Question No EFSA-Q-2009-00454)4. The claim 
proposed by the applicant was worded as follows: "OPC have been shown to reduce blood cholesterol levels  and may therefore reduce the ri sk of cardiovascular disease". 
(13) On the basis of the data presented, the Aut hority 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 doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(14) Following an application from Valosun A.S., 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)5. 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 b acteria to the bladder wall. The adhesion 
of harmful bacteria to the bladder wall is th e main risk factor in the development of 
urinary tract infections". 
(15) On the basis of the data presented, the Aut hority 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 co mply 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 effect s of a combination of bifidobacteria 
(Bifidobacterium bifidum , Bifidobacterium breve , Bifidobacterium infantis , 
Bifidobacterium longum) on decreasing potentially pathogenic intestinal 
microorganisms (Question No EFSA-Q-2009-00224)6. 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 Aut hority 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 es tablished 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 th e 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. 
                                                
 
4 The EFSA Journal (2009) 7(10):1356. 
5 The EFSA Journal (2009) 7(12):1421. 
6 The EFSA Journal (2009) 7(12):1420.  
EN 5   EN (19) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
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 th e 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 the 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. 
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 si x 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 
 José Manuel BARROSO  The President  
EN 6   EN ANNEX 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 
Transformation Laitière Française (ATLA), 42 rue de Châteaudun, 75314 Paris 
Cedex 09, France Iodine Iodine co ntributes 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 VITAMI N/S] AND/OR 
[NAME OF MINERAL/S] as listed in 
the Annex to Regulation 1924/2006  Q-2008-324 
Article 
14(1)(b) health claim referring to children’s development 
and health  Association de la 
Transformation 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 VITAMI N/S] AND/OR 
[NAME OF MINERAL/S] as listed in 
the Annex to Regulation 1924/2006  Q-2008-325 
  
EN 7   EN ANNEX 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 PremiumTM  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-2009-00224