EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12135/2015 
(POOL/E4/2015/12135/12135-EN.doc) 
D043610/01 […](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim made  on foods an d referring to children's 
development and health 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim ma de 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 Cross Vet pharm Group UK Ltd, 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 β-galactosidase from Kluyveromyces  
lactis  in Colief
® and a reduction of gast rointestinal discomfort  (Question No EFSA-Q-
2014-004042). The claim proposed by the applicant was worded as follows: 
“Colief®/lactase enzyme reduces the lactose load of the infant’s feed and improves the 
consequences of lactose maldigestion in coli cky infants unable to e ffectively digest all 
the lactose in their feed”. 
(6) On 22 April 2015, the Commission and the Memb er States received  the scientific 
opinion from the Authority, which concluded that the evidence provided is insufficient 
to establish a cause and effect rela tionship between the consumption of β-
galactosidase from Kluyveromyces lactis  in Colief® and a reduction of gastrointestinal 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2015;13(7):4187.  
EN 3   EN discomfort. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(7) 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 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