EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12273/2015 ANNEX 
(POOL/E4/2015/12273/12273 -EN 
ANNEX.doc) D043783/01  
[…](2016) XXX  draft  
ANNEX 1  
  
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
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  
   
EN 2   EN ANNEX  
In the Annex to Regulation (EU) No 432/2012 the entries for food categor ies "Meal replacement for weight control"  are replaced by the 
following:  
Nutrient 
substance, 
food or food 
category  Claim  Conditions of use of the claim  Conditions, 
and/or 
restrictions of 
use of the food, 
and/or additional 
statement or 
warning  EFSA Journal 
number  Relevant entry 
number in the 
Consolidated 
List submitted 
to EFSA for 
its assessment  
'Meal 
replacement for 
weight control  Substituting one 
of the main daily 
meals of an 
energy restricted 
diet with a meal 
replacement 
contributes to the 
maintenance  of 
weigh t after 
weight loss  In order to bear the claim, a food should 
comply with the following requirements:  
1. Energy content  
The energy content  shall not exceed 250 kcal 
(1046 KJ). * 
2. Fat content and composition  
The energy derived from fat shall not exceed 
30% of to tal available energy content of the 
product.  
The linoleic acid (in the form of glycerides) 
shall not be less than 1 g.  
3. Protein content and composition  
The protein contained in the food shall provide 
not less than 25 % and not more than 50% of 
the total energy content of the product.  
The chemical index of protein shall be  equal to In order to bear 
the claim, 
information shall 
be provided to the 
consumer on the 
importance of 
maintaining an 
adequate daily 
fluid intake and 
on the fact that the 
products are 
useful for the 
intended use only 
as part of an 
energy -restricted 
diet and that other 
foodstuffs should 
be a necessary 
part of such diet.  2010; 8(2):14 66 
2015; 
13(11):4287  1418   
EN 3   EN that set by the World Health Organization in 
‘Energy and protein requirements’ . Report of a 
Joint WHO/FAO/UNU Meeting. Gen eva: 
World Health Organisation, 1985 ( WHO 
Technical Report Series, 724) : 
Amino acid requirement pattern  
 g/100g 
protein  
Cystine + methionine  1,7 
Histidine  1,6 
Isoleucine  1,3 
Leucine  1,9 
Lysine  1,6 
Phenylalanine + 
tyrosine  1,9 
Threonine  0,9 
Tryptophan  0,5 
Valine  1,3 In order to 
achieve the 
claimed effect, 
one main meal 
should be 
substituted with 
meal replacements 
daily.   
EN 4   EN The ‘chemical index’ shall mean the lowest of 
the ratios between the quantity of each essential 
amino acid of the test protein in and the 
quantity of each corresponding amino acid of 
the reference protein.  
If the chemical index is lower than 100 % of 
the reference protein, the minimum protein 
levels shall be correspondingly increased. In 
any case the chemical index of the protein shall 
at least be equal to 80 % of that of the reference 
protein.  
In all cases , the addition of amino acids is 
permitted solely for the purpose of improving 
the nutritional value of the proteins and only in 
the proportions necessary for that purpose.  
4. Vitamins and minerals  
The food shall provide at least 30% of the 
amounts of the nut rient reference values of 
vitamins and minerals per meal as laid down in 
Annex XIII to Regulation (EU) No 1169/2011. 
This requirement does not apply to  fluoride and 
chromium . The amount of sodium per meal 
provided by the food shall be at least 172,5 mg.  
The amount of potassium per meal provided by 
the food shall  be at least 500 mg. ** 
  
EN 5   EN Meal 
replacement for 
weight control  Substituting two 
of the main 
daily meals of 
an energy 
restricted diet 
with meal 
replacements 
contributes to 
weight loss  In order to bear the claim, a food should 
comply with the following requirements:  
1. Energy content  
The energy content  shall not exceed 250 kcal 
(1046 KJ) .* 
2. Fat content and composition  
The energy derived from fat shall not exceed 
30% of total available energy  content  of the 
product.  
The linoleic acid (in the form of glycerides) 
shall not be less than 1  g. 
3. Protein content and composition  
The protein contained in the food shall provide 
not less than 25 % and not more  than 50% of 
the total energy  content  of the product.  
The chemical index of protein shall be  equal to  
that set by the World Health Organization in 
‘Energy and protein requirements’. Report of a 
Joint WHO/FAO/UNU Meeting. Geneva: 
World Health Organisation, 1985 ( WHO 
Technical Report Series, 724) : 
 
 
 
 In order to bear 
the claim, 
information shall 
be provided to the 
consumer on the 
importance of 
maintaining an 
adequate daily 
fluid intake and 
on the fact that 
the products are 
useful for the 
intended use only 
as part of an 
energy-restricted 
diet and that other 
foodstuffs should 
be a necessary 
part of such diet.  
In order to  
achieve the 
claimed effect, 
two of the  main  
daily  meal s 
should be 
substituted with 
meal 
replacements 
daily.  2010; 8(2):1466  
2015; 
13(11):4287  1417   
EN 6   EN  
Amino acid requirement pattern  
 g/100g 
protein  
Cystine + methionine  1,7 
Histidine  1,6 
Isoleucine  1,3 
Leucine  1,9 
Lysine  1,6 
Phenylalanine + 
tyrosine  1,9 
Threonine  0,9 
Tryptophan  0,5 
Valine  1,3 
 
The ‘chemical index’ shall mean the lowest of 
the ratios between the quantity of each essential 
amino acid of the test protein in and the  
EN 7   EN quantity of each corresponding amino acid of 
the reference protein.  
If the chemical index is lower than 100 % of 
the reference protein, the minimum protein 
levels shall be correspondingly increased. In 
any case the chemical index of the protein shall 
at least be equal to 80  % of that of the reference 
protein.  
In all cases, the addition of amino acids is 
permitted solely  for the purpose of improving 
the nutritional value of the proteins, and only in 
the proportions necessary for that purpose.  
4. Vitamins and minerals  
The food shall provide at least 30% of the 
amounts of the nutrient reference values of 
vitamins and minerals per meal as laid down 
Annex XIII to Regulation (EU) No 1169/2011. 
This requirement does not apply to  fluoride  and 
chromium . The amount of sodium per meal 
provided by the food  shall be at least 172,5 mg.  
The amount of potassium per meal provided by 
the food shall  be at least 500 mg. ** 
* From 21 July 2016 until [ OPOCE please insert the exact date – 3 years after the entry into force of this Regulation ] the energy content 
of the food shall not be less than 200 kcal (840 kJ) and shall not exceed 400 kcal (1 680 kJ) . 
** From 21 July 2016 until [OPOCE please insert the exact date – 3 years after the entry into force of this Regulation]  the food shall 
provide at least 30% of the amounts of vitamins and minerals specified in the below Table per meal:   
EN 8   EN Vitamin A  (μg RE)  700 
Vitamin D  (μg) 5 
Vitamin E  (mg)  10 
Vitamin C  (mg)  45 
Thiamin  (mg)  1,1 
Riboflavin  (mg)  1,6 
Niacin  (mg-NE) 18 
Vitamin B 6  (mg)  1,5 
Folate  (μg) 200 
Vitamin B 12  (μg) 1,4 
Biotin  (μg) 15 
Pantothenic acid  (mg)  3 
Calcium  (mg)  700 
Phosphorus  (mg)  550  
EN 9   EN Iron (mg)  16 
Zinc (mg)  9,5 
Copper  (mg)  1,1 
Iodine  (μg) 130 
Selenium  (μg) 55 
Sodium  (mg)  575 
Magnesium  (mg)  150 
Manganese  (mg)  1 
From 21 July 2016 until [OPOCE please insert the exact date – 3 years after the entry into force of this Regulation]  the amount of potassium per 
meal provided by the food shall be at least 500 mg.