EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11492/2017 
(POOL/E1/2017/11492/11492 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise a health claim made on foods and referring to children's 
development and health  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise 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 foods1, 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 are included in  a list of permitted claims.  
(2) Regulation (EC) No 1924/2006 also 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 authorit y 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 thereof, an d 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 H.J. Heinz Supply Chain Europe B.V.,  submitt ed 
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 ‘Nutrimune®’ and immune 
defence against pathogens in the gastrointestinal tract and upper respiratory tract 
(Question No  EFSA -Q-2016 -000082). The claim proposed by the applicant was 
worded as follows: “‘Nutrimune®’ supports the immune defence in the gastrointestinal 
and upper respiratory tract of young children”.  
(6) On 30 January 2017, the Commission and the Member  States received the scientific 
opinion from the Authority, which concluded that on the basis of the data presented, 
the scientific evidence is insufﬁcient to establish a cause and effect relationship 
between the consumption of ‘Nutrimune®’ (a pasteurised cow’s skim milk fermented 
with Lactobacillus paracasei CBA L74 ) and the immune defence against pathogens in 
the gastrointestinal and upper respiratory tracts . Accordingly, as the claim does not 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 201 7;15(1):4 679.  
EN 2  EN comply with the requirements of Regulation (EC) No 1924/2006, it should not be 
authorised.  
(7) The comments from the applicant received by the Commission pursuant to Article 
16(6) of Regulation (EC) No 1924/2006 have been considered when setting out the 
measures provided for in this Regulation.  
(8) The measures provided for  in this Regulation 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 pe rmitted claims as provided for in Article 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