EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/69/2015 (POOL/ E4/2015/69/69-
EN.doc) […](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise certain health claims made on foods and referring to children's 
development and health 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise certain health claims  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 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 Specialised  Nutrition Europe (formerly European 
Dietetic Food Industry Association), s ubmitted 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 ‘non- digestible oligo- and polys accharides including galacto-
oligosaccharides, oligofruct ose, polyfructose and inulin ’ and ‘increase in calcium 
absorption’ (Question No EFSA-Q-2008-140
2). The claim proposed by the applicant 
was worded, inter alia,  as follows: ‘With non-digestible oligo- and/or polysaccharides 
to stimulate calcium absorption’. 
(6) On the basis of the data presented, the Aut hority concluded in its opinion, received by 
the Commission and the Member States on 19 November 2014, that a cause and effect 
relationship cannot be established between th e consumption of ‘non-digestible oligo- 
and polysaccharides including galacto-oligos accharides, oligofructose, polyfructose 
and inulin’ and a beneficial physiological  effect. In particular, the Authority 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(11):3889.  
EN 3   EN considered that the food c onstituents ‘non-digestible oligo- and polysaccharides 
including galacto-oligosaccharides, oligofru ctose, polyfructose and inulin’ were not 
sufficiently characterised. Accordingly, as  the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(7) Following an application from Specialised Nutrition Europe, 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 beta-galactosidase from Streptococcus 
thermophilus  and reduction of gastrointestinal discomfort (Question No EFSA-Q-
2008-1483). The claim proposed by the applicant was worded, inter alia , as follows: 
‘Lactase for comfortable digestion’. 
(8) On the basis of the data presented, the Aut hority concluded in its opinion, received by 
the Commission and the Member States on 9 October 2014, that a cause and effect 
relationship had not been established between  the consumption of beta-galactosidase, 
which is produced by Streptococcus thermophilus  (subsequently in activated) during 
fermentation of an infant formula, and re duction of gastrointestinal discomfort. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(9) Following an application from Specialised Nutrition Europe, 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 rela ted to prunes and contribution to normal 
bowel function (Question No EFSA-Q-2008-1934). The claim proposed by the 
applicant was worded, inter alia , as follows: ‘dried plums/prunes can contribute to 
normal bowel function’. 
(10) On the basis of the data presented, the Aut hority concluded in its opinion, received by 
the Commission and the Member States on 19 November 2014, that a cause and effect 
relationship had not been established between the consumption of prunes and 
contribution to normal bowel function without the occurrence of diarrhoea for infants 
and young children from six months to three ye ars of age. In part icular, the Authority 
noted that no studies investigating the e ffect of prunes on bowel  function in infants 
and young children were provided by the applic ant. Accordingly, as  the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(11) In accordance with Article 28(6) of Regulation (EC) No 1924/2006, health claims 
referred to in Article 14(1)(b) of that Re gulation and not author ised by a decision 
pursuant to Article 17(3) of that Regulation may continue to be used for six months 
after the adoption of that d ecision, provided that the applic ation for authorisation was 
made before 19 January 2008. Accordingly, as th e health claims listed in the Annex to 
this Regulation fulfil those conditions, the transitional period laid down in Article 
28(6) of Regulation (EC) No 1924/2006 should apply. 
(12) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
                                                 
3 EFSA Journal 2014;12(10):3841. 
4 EFSA Journal 2014;12(11):3892.  
EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims 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. 
2. However, the health claims referred to in  paragraph 1 used prior to the entry into 
force of this Regulation may continue to  be used for a maximum period of six 
months after the entry into  force of this Regulation. 
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