EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10701/2018 
(POOL/E1/2018/10701/10701 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION 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 amending Regulation (EU) 
No 432/2012  
(Text with EEA relevance)   EN 2  EN COMMISSION 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 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 Eur opean Parliament and of the 
Council of 20 December 2006 on nutrition and health claims made on foods1, and in 
particular Article 18(4 ) thereof , 
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are 
prohibited unless they are aut horised by the Commission in accordance with that 
Regulation and included in a list of permitted claims.  
(2) Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, Commission Regulation 
(EU) No 432/20122 was adopted, which establishes a list of permitted h ealth claims 
made on foods other than those referring to the reduction of disease risk and to 
children's development and health.   
(3) 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 
applica tions to the European Food Safety Authority (EFSA), 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 authorisation of health cla ims taking into account 
the opinion delivered by the Authority.  
(5) In order to stimulate innovation, health claims which are based on newly developed 
scientific evidence and/or which include a request for the protection of proprietary 
data shall undergo an ac celerated type of authorisation.  
(6) Following an application from Specialised Nutrition Europe ( ‘SNE ’), submitted 
pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was 
required to deliver an opinion on a health claim related to carbohydrate  (CHO)  
solutions and  contribute to the improvement of physical performance during a high -
intensity and long -lasting  physical exercis e (Question N o EFSA -Q-2017-00621 ). The 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health 
claims made on foods, other than those referring to the reduction of disease risk and to child ren’s 
development and health (OJ L 136, 25.5.2012, p. 1 ). EN 3  EN claim proposed by the applicant was worded as follows: ‘Glycaemic carbohydr ate 
intake during a high -intensity and long -lasting physical exercise contributes to the 
improvement of  physical performance ’. 
(7) On 13 March 2018, the Commission  and the Member States received the scientif ic 
opinion from the Authority3, in which it was concl uded that , on the basis of the data 
presented , a cause and effect relationship ha d been established between the 
consumption of CHO  solutions and the improvement of physical performance during 
high-intensity and long -lasting  physical exercise  for the target population of healthy 
trained adults performing high -intensity (at least at 65% of the VO2max) and long -
lasting (at least 60 min) physical exercise . Accordingly, a health claim reflecting this 
conclusion should be considered as complying with the re quirements of Regulation 
(EC) No 1924/2006 and should be included in the Union list of permitted health 
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 accompan ied with all necessary conditions (including restrictions)  for their 
use. Accordingly, the list of permitted health claims should include the wording  of the 
respective claims and specific conditions of use, 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 ir wording and 
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, because 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 
Regulat ion. 
(10) In accordance with Article 20 of Regulation (EC) No 1924/2006, the Register of 
nutrition and health claims containing all authorised health claims should be updated 
in order to take into account the health claim, authori sed with the present Regulation . 
(11) Regulation (EU) No 432/2012 should therefore 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 Regulation shall be included in the Union list of 
permitted c laims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.  
Article 2  
The Annex to Regulation (EU) No 432/2012 is amended in accordance with the Annex to this 
Regulation.  
                                                 
3 EFSA Journal 201 8;16(3):5191 . EN 4  EN Article 3  
This Regulation shall enter into force on the twentieth day fo llowing 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