EN    EN  
 EUROPEAN  
COMMISS IO N 
Brussels, XXX   
SANTE/11496/2016 
(POOL/E1/2016/11496/11496-EN.doc) 
[…](2017) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim made on foods, other than those referring to the 
reduction of disease risk and to children's development and health  
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim made on  foods, other than those referring to the 
reduction of disease risk and to ch ildren'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 18(5) 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 (EFSA ), hereinafter referred to as 
'the Authority', for a scientific assessment, as well as to the Commission and the Member States for information.  
(3) The Authority is to deliver an opini on 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 Probi AB, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to Lactobacillus plantarum  299v (Lp299v) and an increase of 
non-haem iron absorption (Question No EFSA- Q-2015-00696
2). The claim proposed 
by the applicant was worded as follows: “ Lactobacillus plantarum  299v increases 
non-haem iron absorption”. 
(6) On 25 July 2016, the Commission and the Member States received the scientific 
opinion from the Authority, which conc luded that the evidence provided was 
insufficient to establish a cause and effect  relationship between the consumption of 
Lp299v and an increase of non-haem iron abso rption. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2016;14(7):4550.  
EN 3   EN (7) The comments from the applicant receiv ed 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. 
(8) 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 
The health claim listed in the Annex to this Regulation shall not be included in the Union list 
of permitted claims as provided for in Ar ticle 13(3) 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