EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12324/2020 
(POOL/E1/2020/12324/12324 -EN.docx)  
[…](2021) 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)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the C ommission.    
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 claim s 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 li st 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 authority is to forward valid 
applications to the European Food Safety Authority (‘the Authority’ ). 
(3) Following the receipt of an application , the Authority is to inform without delay the 
other Member States and the Commission, and to deliver an opinion  on the health 
claim concerned.  
(4) The Commission is to decide on the authorisation of the health claim taking into 
account the opinion delivered by the Authority.  
(5) Following an application from H.J. Heinz Supply Chain Europe BV,  submitted 
pursuant to Article 14(1) , point (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 gastrointestin al and upper respiratory tracts 
(Question No  EFSA -Q-2018 -00727 ). The claim proposed by the app licant was worded 
as follows: ‘Nutrimune®’ supports the immune system in defence against pathogens in 
the upper respiratory and gastrointestinal tracts of young children ’. 
(6) On 15 April 2019,  the Commission and the Membe r States received the scientific 
opinion from the Authority2 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 med milk 
fermented with Lactobacillus paracasei CBA L74 ), and the immune defence against 
pathogens in the gastrointestinal and upper respiratory tracts  of young children . 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2019;17(4):5656 .  
EN 2  EN Accordingly, as the claim does not comply with the requireme nts of Regulation (EC) 
No 1924/2006, it should not be authorised.  
(7) 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 permitted 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  
 Ursula VON DER LEYEN