EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10219/2016 
(POOL/E1/2016/10219/10219-EN.doc)   
D049265/01 […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
authorising a health claim made on foods, other than those referring to the reduction of 
disease risk and to children's development and health and amendi ng Regulation (EU) 
No 432/2012 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
authorising a health claim made on foods, ot her than those referring to the reduction of 
disease risk and to children's development and health and amending Regulation (EU) 
No 432/2012 
(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(4) thereof, 
Whereas: (1) Regulation (EC) No 1924/2006 provides that 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) Pursuant to Article 13(3) of Regulati on (EC) No 1924/2006, Commission Regulation 
(EU) No 432/2012
2 was adopted, which establishes a list of permitted health claims 
made on foods other than t hose referring to the reductio n of disease risk and to 
children's development and health..  
(3) 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', for a scientific assessment, as well as to the Commission and the Member States for information.  
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority.  
(5) In order to stimulate innovation, health cl aims which are based on newly developed 
scientific evidence and/or which include a request for the protection of proprietary 
data shall undergo an accelera ted type of authorisation. 
(6) Following an application from DuPont Nutr ition BioSciences ApS, submitted pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim relate d to lactitol and the maintenance of normal 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 Commission Regulation (EU) No 432/2012 of 16 Ma y 2012 establishing a list of permitted health 
claims made on foods, other than those referring to the reduction of disease risk and to children's 
development and health (OJ L 136, 25.5.2012, p. 1.).  
EN 3   EN defecation (Question No EFSA-Q-2015-003753). The claim proposed by the applicant 
was worded as follows: “lactitol cont ributes to normal bowel function”. 
(7) On 13 October 2015, the Commission and the Me mber States received the scientific 
opinion from the Authority which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had been esta blished between the consumption of lactitol 
and the maintenance of normal defecation and that the target population is the general 
adult population. Accordingly, a health claim reflecting th is conclusion should be 
considered as complying with the requir ements of Regulation (EC) No 1924/2006 and 
should be included in the Union list of pe rmitted claims, established by Regulation 
(EU) No 432/2012. 
(8) Article 13(3) of Regulation (EC) No 1924/ 2006 provides that permitted health claims 
must be accompanied with all necessary c onditions (including restrictions) for their 
use. Accordingly, the list of permitted claims should include the wording of the claims 
and specific conditions of use of the cl aims, and where applicable, conditions or 
restrictions of use and/or an additional statement or warning, in accordance with the 
rules laid down in Regulation (EC) No 1924/ 2006 and in line with the opinions of the 
Authority.  
(9) One of the objectives of Regulation (EC) No  1924/2006 is to ensure that health claims 
are truthful, clear and reliable  and useful to the consumer, and that the wording and the 
presentation are taken into account in that respect. Therefore, where the wording of a 
claim used by the applicant has the same meaning for consumers as that of an 
authorised health claim, b ecause it demonstrates the same relationship that exists 
between a food category, a food or one of its constituents and health, that claim should 
be subject to the same conditions of use,  as the one listed in  the Annex to this 
Regulation. 
(10) In accordance with Article 20 of Regula tion (EC) No 1924/2006, the Register of 
nutrition and health claims containing all au thorised health claims should be updated 
in order to take into acc ount the present Regulation. 
(11) Regulation (EU) No 432/2012 should th erefore be amended accordingly. 
(12) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claim set out in the Annex to this Regulati on shall be included in  the Union list of 
permitted claims as provided for in Artic le 13(3) of Regulation (EC) No 1924/2006.  
Article 2 
The Annex to Regulation (EU) No 432/2012 is ame nded in accordance with the Annex to this 
Regulation. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union.  
                                                 
3 EFSA Journal 2015;13(10):4252  
EN 4   EN 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