EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12128/2015 CIS 
(POOL/E4/2015/12128/12128 -EN 
CIS.doc)  
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 432/2012 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  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Regulation (EU) No 432/2012 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  
(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 foods1, and in 
particular Article 13(3) 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 Regulation (EC) No 1924/2006  the Commission adopted 
Regulation (EU) No 432/2012 of 16 May 20122 which establishes 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 . 
(3) However, at the time of the adoption of the list of permitted health claims, there were a 
number of health claims whose evaluation by the European Food Safety Authority 
(‘the Authority’) or consideration by the Commission  was not finalised3. 
(4) Among those claims there were five health claims on caffeine4 which received a 
favourable assessment from the Authority . Two health claims  were  for the general 
adult population relating to increase d attention and to increased alertness with ‘at least 
75 mg caffe ine per serving ’ as proposed conditions of use5. Three health claims  were  
for adults performing endurance exercise  with two of the claimed effect s relating to an 
increase in endurance performance and to an increase in endurance capacity, with 
caffeine intake of ‘3 mg/kg body weight one hour prior to exercise’ as proposed 
conditions of use , and a claimed effect relating to the reduction in the rated perceived 
                                                 
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 children's development and health ( OJ L 
136, 25.5.2012, p. 1. ). 
3 Corresponding to 2232 entries (IDs) in the consolidated list  (http://www .efsa.europa.eu/en/topics/topic/article13 ).  
4 Corresponding to entries ID 737, ID 1486, ID 1488, ID 1490, ID 736, ID 1101, ID 1187, ID 1485, ID 1491, 
ID 2063, ID 2103  and ID 2375 in the consolidated list  (http://www.efsa.europa.eu/en/topics/topic/article13 ). 
5 EFSA Journal 2011;9(4):2054.  EN 3   EN exertion /effort  during exercise, with caffeine intake of ‘4 mg /kg body weight one hour 
prior to exercise’  as proposed conditions of use6. 
(5) However, a number of Member States raised concerns about the value of safe daily 
intake  of caffeine for the general population and the potential health risks of caffeine 
consumptio n for people performing exercise . Therefore, the Commission  requested the 
Authority to provide scientific advice . The Authority published its scientific opinion 
on the safety of caffeine  (EFSA -Q-2013 -002207) on 27 May 2015.  The Commission is 
to decide on the authorisation of health claims taking into account the opinion 
delivered by the Authority.  
(6) As regards  the health claim on the effect of caffeine on perceived exertion /effort  
during exercise8, the Authority concluded that in order to obtain the claimed effect, 
caffeine should be consumed at doses  of 4 mg/kg body weight one hour prior to 
exercise . As regards the  safety of caffeine intake, the Authority recommended  that 
single doses up to 200 mg, corresponding to 3 mg/kg body weight, from all sources, 
do not raise safety concerns for the general adult population, even if consumed less 
than 2 hours prior to intense physical exercise under normal environmental conditions. 
Given that the proposed conditions of use exceed the limit of 3 mg/kg body weight 
recomm ended by the Authority as a safe caffeine intake, the health  claim  on the effect 
of caffeine on perceived exertion/effort during exercise  should not be authorised for 
safety reasons.  
(7) Health claims corresponding to the conclusions of the Authority that a ca use and effect 
relationship has been established between a food category, a food or one of its 
constituents and the claimed effect and which comply with the requirements of 
Regulation (EC) No 1924/2006 should be authorised under Article 13(3) of that 
Regul ation, and included in the list of permitted claims established by Regulation 
(EU) No 432/2012.  Accordingly, the health claims on caffeine  relating to an increase 
in endurance performance, to an increase in endurance capacity, to increased alertness 
and to  increased attention9 which do not raise safety concerns  should be considered as 
complying with the requirements of Regulation (EC) No 1924/2006, and should be 
included in the Union list of permitted claims.  
(8) Article 13(3) of Regulation (EC) No 1924/2006 pr ovides that permitted health claims 
must be accompanied with all necessary conditions, including restrictions, for their 
use. Accordingly, the list of permitted claims should  include the wording of the claims 
and their conditions of use, and where applicab le, 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) This Regulation should apply six months after the date o f its entry into force to enable 
food business operators to adapt to its requirements , including the prohibition 
according to Article 10(1) of Regulation (EC) No 1924/2006 of those health claims 
                                                 
6 EFSA Journal 2011;9(4):2053.  
7 EFSA Journal 2015;13(5):4102.  
8 Corresponding to entries ID 1488 and ID 1490  in the consolidated list 
(http://www.efsa.europa.eu/en/topics/topic/article13 ). 
9 Corresponding to entries ID 736, ID 1101, ID 1187, ID 1485, ID 1491, ID 2063, ID 2103, ID 736, ID 1485, 
ID 1491, ID 2375, ID 737, ID 1486 and ID 1488  in the consolidated list 
(http://www.efsa.europa.eu/en/topics/topic/article13 ). EN 4   EN whose evaluation by the Authority and whose consideration by the Commission has 
been completed.  
(10) In line with Article 20(1) of Regulation (EC) No 1924/2006, the Register of nutrition 
and health claims containing all authorised health claims and those rejected and the 
reasons for their rejection should be updated in t he light of the present Regulation and 
its deferred application.  
(11) Comments and positions from the members of the public and interested stakeholders, 
received by the Commission have been adequately considered when setting the 
measures provided for in this Re gulation.  
(12) Regulation (EU) No 432/2012 should therefore be amended accordingly.  
(13) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Commi ttee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article  1 
The Annex to Regulation (EU) No 432/2012 is amended in accordance with the Annex to 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 . 
It shall apply from [six months after the date of its entry into force] . 
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