EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11446/2014 
(POOL/E4/2014/11446/11446-EN.doc) 
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain health claims ma de on foods, other than those referring to 
the reduction of disease risk and to children's development and health 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain he alth claims made on foods, other than those referring to 
the reduction of disease risk and 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 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) Regulation (EC) No 1924/2006 al so provides that applications for authorisations of 
health claims are to be submitted by food bus iness operators to the national competent 
authority of a Member State. The national competent authority is to forward valid 
applications to the European Food Safety Au thority (EFSA), hereinafter referred to as 
'the Authority', for a scientific assessmen t, as well as to the Commission and the 
Member States for information. 
(3) The Commission is to decide on  the authorisation of health claims taking into account 
the opinion delivered by the Authority. In so me cases, the scientific risk assessment 
alone cannot provide all the information on  which a risk management decision should 
be based and therefore ot her legitimate fact ors relevant to the matter under 
consideration should also be taken into account. 
(4) Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim rela ted to glucose and c ontribution to energy-
yielding metabolism (Question No EFSA-Q-2012-00266)
2. The claim proposed by 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2012;10(5):2694.  
EN 3   EN the applicant was worded as follows: "Glu cose is metabolised within body's normal 
energy metabolism".  
(5) On 11 May 2012, the Commission and the Member 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 glucose 
and contribution to energy-yielding metabo lism. The target population is the general 
population.  
(6) Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim rela ted to glucose and c ontribution to energy-
yielding metabolism (Question No EFSA-Q-2012-00267)3. The claim proposed by 
the applicant was worded as follows: "Glu cose supports normal physical activity".  
(7) On 11 May 2012, the Commission and the Member States received the scientific 
opinion from the Authority which concluded th at a claim on glucose and contribution 
to energy-yielding metabolism has already been assessed with a favourable outcome 
and referred to its opinion on a health clai m related to glucose and contribution to 
energy-yielding metabolism (Que stion No EFSA-Q-2012-00266).  
(8) Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim rela ted to glucose and c ontribution to energy-
yielding metabolism (Question No EFSA-Q-2012-00268)4. The claim proposed by 
the applicant was worded as follows: "Gluco se contributes to nor mal energy-yielding 
metabolism".  
(9) On 11 May 2012, the Commission and the Member States received the scientific 
opinion from the Authority which concluded th at a claim on glucose and contribution 
to energy-yielding metabolism has already been assessed with a favourable outcome 
and referred to its opinion on a health clai m related to glucose and contribution to 
energy-yielding metabolism (Que stion No EFSA-Q-2012-00266).  
(10) Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim rela ted to glucose and c ontribution to energy-
yielding metabolism (Question No EFSA-Q-2012-00269)5. The claim proposed by 
the applicant was worded as follows: "Gluco se contributes to nor mal energy-yielding 
metabolism during exercise".  
(11) On 11 May 2012, the Commission and the Member States received the scientific 
opinion from the Authority which concluded th at a claim on glucose and contribution 
to energy-yielding metabolism has already been assessed with a favourable outcome 
and referred to its opinion on a health clai m related to glucose and contribution to 
energy-yielding metabolism (Que stion No EFSA-Q-2012-00266).  
                                                 
3 The EFSA Journal 2012;10(5):2695. 
4 The EFSA Journal 2012;10(5):2696. 
5 The EFSA Journal 2012;10(5):2697.  
EN 4   EN (12) Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim rela ted to glucose and c ontribution to energy-
yielding metabolism (Question No EFSA-Q-2012-00270)6. The claim proposed by 
the applicant was worded as follows: "Glucose contributes to normal muscle function".  
(13) On 11 May 2012, the Commission and the Member States received the scientific 
opinion from the Authority which concluded th at a claim on glucose and contribution 
to energy-yielding metabolism has already been assessed with a favourable outcome 
and referred to its opinion on a health clai m related to glucose and contribution to 
energy-yielding metabolism (Q uestion No EFSA-Q-2012-00266). 
(14) Pursuant to Articles 6(1) and 13(1) of Regulation (EC) No 1924/2006 health claims 
need to be based on generall y accepted scientific eviden ce. Authorisation may also 
legitimately be withheld if h ealth claims do not comply with  other general and specific 
requirements of Regulation (EC) No 1924/ 2006, even in the case of a favourable 
scientific assessment by the Authority. Health claims inconsistent with generally accepted nutrition and health principles shoul d not be made. The Authority concluded 
that a cause and effect relationship has b een established between the consumption of 
glucose and contribution to energy-yieldi ng metabolism. However, the use of such 
health claim would convey a conflicting and confusing message to consumers, because it would encourage consump tion of sugars for which, on the basis of generally 
accepted scientific advice, national and intern ational authorities inform the consumer 
that their intake should be  reduced. Therefore, such a health claim does not comply 
with point (a) of the second paragraph of  Article 3 of Regul ation (EC) No 1924/2006 
which foresees that the us e of claims should not be  ambiguous or misleading. 
Furthermore, even if the concerned health claim was to be authorised only under 
specific conditions of use and/or accompanied  by additional statements or warnings, it 
would not be sufficient to alleviate the c onfusion of the consumer, and consequently 
the claim should not be authorised.  
(15) The health claims covered by this Regulation are health claims as referred to in 
Article 13(1)(a) of Regulat ion (EC) No 1924/2006, which, provided that they comply 
with that Regulation, are subjec t to the transitional period la id down in Article 28(5) of 
that Regulation until the adoption of the list of permitted health claims. 
(16) The list of permitted health claims has been established by Commission Regulation 
(EU) No 432/2012
7 and is applicable since 14 D ecember 2012. As regards claims 
referred to in Article 13(5) of Regulati on (EC) No 1924/2006 for which the evaluation 
by the Authority or consideration by the Commission has not been completed by 
14 December 2012 and which by virtue of this  Regulation are not included in the list 
of permitted health claims, it is appropriate to provide for a transitional period during which they may still be used, in order to  allow both food business operators and the 
competent national authorities to adap t to the prohibition of such claims. 
                                                
 
6 The EFSA Journal 2012;10(5):2698. 
7 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 children's 
development and health (OJ L 136, 25.5.2012, p. 1).  
EN 5   EN (17) The comments from the applicant and the members of the public received by the 
Commission pursuant to Article 16(6) of  Regulation (EC) No 1924/2006 have been 
considered when setting the measur es provided for in this Regulation. 
(18) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims set out in the Annex to this Regulation shall not be included in the 
Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006. 
2. However, the health claims referred to in  paragraph 1 used prio r 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  José Manuel BARROSO