EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12500/2015 CIS 
(POOL/E4/2015/12500/12500-EN 
CIS.doc) 
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
authorising a health claim made on foods and referring to children's development and 
health 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
authorising a health claim made on foods and referring 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 foods 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 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 (EFS A), 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 Comm ission thereof, and to deli ver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from VAB-nutrition,  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 vitamin D and contribution to the normal function of the 
immune system (Question No EFSA-Q-2014-00826
2). The claim proposed by the 
applicant was worded as follows: 'Vitamin D contributes to the normal function of the immune system'. 
(6) On 13 May 2015, the Commission and the Member States received the scientific 
opinion from the Authority, wh ich concluded that a cause and effect relationship had 
been established between the dietary inta ke of vitamin D and contribution to the 
normal function of the immune system in children. Accordingly, a health claim reflecting this conclusion should be consider ed as complying with the requirements of 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2015;13(5):4096.  
EN 3   EN Regulation (EC) No 1924/2006, and should be in cluded in the Union list of permitted 
claims. 
(7) Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of 
authorising a health claim is to include certain particulars. Accordingly, those particulars should be set out in  the Annex to this Regulatio n as regards the authorised 
claim and include, as the case may be, the revised wording of the claim, specific 
conditions of use of the claim, and, where a pplicable, 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 li ne with the opinion of the Authority.  
(8) 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 healt h, they should be subject to the same 
conditions of use as those indicated in the Annex to this Regulation.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claim listed in th e Annex to this Regulation ma y be made on foods placed 
on the Union market in compliance with the conditions laid down in that Annex. 
2. The health claim referred to in paragraph 1 shall be included in the Union list of 
permitted claims as provided for in Artic le 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
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 
 The President  Jean-Claude JUNCKER