EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12273/2015 
(POOL/E4/2015/12273/12273 -EN.doc) 
D043783/01  
[…](2016) 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(4) thereof ,  
Whereas:  
(1) Regulation  (EC)  No 1924/2006  provides that health claims made on food 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 432/20122 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) The list of permitted health claims and their conditions of use are set out in the Annex 
to Regulation (EU) No 432/2012.  Two claims have been authorised for meal 
replacement for weight control . The conditions of use of th ose claims  require that in 
order to  bear the m, the food should comply with specifications laid down in 
Commission Directive 96/8/EC3. 
(4) Those claims were  included in the list of permitted health claims pursuant to  the 
favourable Opinion of the European Food Safety Authority (hereinafter 'the 
Authority')  of 2010 (Question EFSA -Q-2008 -2154, EFSA -Q-2008 -21554) which 
found  that a cause and effect relationship ha d been established between the 
consumption of meal replace ments in substitution of regular meals and the 
maintenance of body weight after weight loss and also between  the consumption of 
meal replacements in substitution of regular meals in the context of energy restricted 
diets and reduction in body weight.  It stated that i n order to bear the claims a food 
                                                 
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 Commission Directive 96/8/EC of 26 February 1996 on foods intended for use  in energy -restricted diets 
for weight reduction (OJ L 55, 6.3.1996, p. 22) . 
4 EFSA Journal 2010; 8(2):1466.   
EN 3   EN should contain a maximum of 250 kcal  per serving and comply with specifications laid 
down in Directive 96/8/EC . 
(5) Directive 96/8/EC lays down compositional requirements for foods for use in energy -
restricted diets  for weight reduction which  replace the whole or part of the total daily 
diet and specifies mandatory particulars which shall appear on the label ling of th ose 
products . It provides that  as regards  products which are presented as a replacement for 
one or more meals of the daily diet, the name under which they are sold is ‘Meal  
replacement for weight control ’. 
(6) Regulation (EU) No 609/2013 of the European Parliament and of the Council5 revises 
the legal  framework applicable to foods for particular nutritional uses . It provides that 
Directive 96/8/EC shall not apply from 20 July 2016 to foods presented as a 
replacement for one or more meals of the daily diet , which should in future be  
regulated under Regu lation (EC) No 1924/2006 and should comply with requirements 
set out therein . 
(7) Therefore, the references to Directive 96/8/EC  regarding health claims which may be 
made on meal replacement for weight control need  to be replaced by setting out the  
conditions of use  of those claims  in the Annex to Regulation (EC) No 432/2012 .  
(8) Article 13(4) of Regulation (EC) No 1924/2006  empowers the Commission , after 
consulting the Authority , to adopt changes to the list of permitted health claims based 
on generally accepted scientific evidence.  
(9) When introducing the necessary technical adaptations  regarding the health claims  for 
meal replacement for weight control the requirements as regards the amounts of 
vitamins and minerals in food set out in Directive 96/8/EC should be taken into 
account . 
(10) Regulation (EU) No 1169/2011 of the European Parliament and of the Council6 lays 
down  rules on the provision of food information to consumers . Part A of Annex XIII  
sets out nutrient reference values for vitamins and minerals  on the basis of recent 
scientific advices.  
(11) Accordingly, the Commission requested the Authority to provide  scientific  advice  on 
whether a change in the conditions of use for claims on meal replac ements for weight 
control regarding their  vitamin and mineral composition  (30% of the nutrient reference 
values  of vitamins and minerals  laid down in Regulation (EU)  No 1169/2011 instead 
of the 30% of values  of vitamins and minerals  laid down in Directive 96/8/EC ) would 
affect the conclusions reached  in the  Authority’s Opinion  of 2010  with respect to the 
                                                 
5 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food 
intended for infants and young children, food for special medical purposes, and total diet replacement 
for weight control and repealing Council Directive 92/5 2/EEC, Commission Directives 96/8/EC, 
1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of 
the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 
29.6.2013, p. 35 ). 
6 Regulation (EU ) No 1169/2011 of the European Parliament and of the Council of 25 of October 2011 
on the  provision of food information to consumers, amending Regulation (EC) No 1924/2006 and (EC) 
No 1925/2006  of the European Parliament and of the Council, and repealing C ommission Directive 
87/250/EEC, Council  Directive 90/496/EEC, Commission Directive 1999/10/EC, directive 2000/13/EC 
of the European Parliament  and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No  608/2004 (OJ  L 304, 22.11.2011 , p. 18).  
EN 4   EN scientific substantiation of health claims related to meal replacement for weight 
control . 
(12) The Authority adopted an  Opinion on 28  October  2015 (Question EFSA-Q-2015 -
00579)7 and concluded that the differences in the micronutrient composition of meal 
replacements which would derive from changing the conditions of use from Directive 
96/8/EC to Regulation (EU)  No 1169/2011 do not affect the scientific substanti ation of 
health claims related to meal replacements for weight control and reduction in body 
weight  and maintenance of body weight after weight loss . 
(13) Nutrient reference values for fluoride  and chromium are provided  in Annex  XIII to 
Regulation (EU)  No 1169/2011 . However, fluoride is not considered to be an essential 
micronutrient and d espite that beneficial effect s of chromium  have  been acknowledged  
there is  no sufficient information  to identify a dietary requirement of it in humans.  
Thus, it is not nec essary to require that meal replacement for weight control  provide s 
at least 30% of nutrient reference values of  fluoride and chromium per meal  as laid 
down in Regulation (EU) No 1169/2011 . 
(14) Annex XIII to Regulation (EU)  No 1169/2011  does not set nutrient reference value for 
sodium . However, taking into account the intended use of meal replacement for weight 
control products, the requirement to provide 30% of the sodium amount per meal as 
laid down in Annex I to Directive 96/8/EC  shou ld be further maintained in the 
conditions of use of th ose health claims .  
(15) Nutrient reference value for  potassium is  set at 2000 milligrams in  PART A of 
Annex  XIII to Regulation (EU)  No 1169/2011. Directive 96/8/EC does not require  for 
meal replacement  for weight control  to provide 30% of the potassium value , but sets a 
minimum amount  at 500 milligram per meal. This value should be further maintained.   
(16) Since t he Authority’s Opinion of 2 015 confirmed the conclusions of its Opinion of 
2010 as regards the energy content of the products concerned  a maximum of 250 kcal 
per serving should be set. The r equirements set out in Directive 96/8/EC on fat, protein  
and amino acids should  be maintained . 
(17) As regards mandatory particulars which should appear on the labelling of meal 
replacement  for weight control  food information requirements included in Directive 
96/8/EC should be maintained  in the conditions of use of the relevant health claims . 
(18) To enable food busine ss operators to adapt to the necessary changes regarding  the 
conditions of use of health claims  for meal replacement for weight control  in particular 
regarding the energy content and the vitamin and mineral  content , a transitional period 
should be provided .  
(19) Regulation (EU) No 432/2012 should therefore be amended accordingly.  
(20) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee 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.  
                                                 
7 EFSA Journal 2015; 13(11): 4287 .  
EN 5   EN 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