EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12575/2013 Rev. 1 
(POOL/E4/2013/12575/12575R1-EN.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
on the authorisation of a health claim made  on foods and referring to the reduction of 
disease risk 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
on the authorisation of a health claim made  on foods and referring to the reduction of 
disease risk 
(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 European Food Safety Au thority (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 thereof, and to deliver an opinion on the 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) Following an application from Rank Nu trition Ltd, submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority wa s asked to deliver 
an opinion on a health claim related to “Increasing maternal folate status by 
supplemental folate intake and reduced  risk of neural tube defects. ”  (Question No 
EFSA-Q-2013-00265)
2. The claim proposed by the applicant was worded as follows: 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2013; 11(7):3328. EN 3   EN “Folic acid supplementation raises maternal  red blood cell folate. Low maternal red 
blood cell folate is a risk f actor for neural tube defect s in the developing foetus”. 
(6) On the basis of the data presented, the Authority concluded in its opinion received by 
the Commission and the Member States on 26 July 2013 that a cause and effect 
relationship had been established between increasing maternal folate status by 
supplemental folate intake and a reduced risk of neural tube defects (NTD). 
Accordingly, a health claim reflecting th is conclusion should be considered as 
complying with the requirements of Regulation (EC) No 1924/2006, and should be 
included 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 th at 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 relations hip 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 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 the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claim listed in the Annex to th is Regulation may 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 . EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO