EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10128/2016 ANNEX 
(POOL/E1/2016/10128/10128 -EN 
ANNEX.doc)  
[…](2017) XXX  draft  
ANNEXES 1 to 2  
  
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION (EU) …/...  
supplementing Regulation (EU) No 609/2013 of the European Parliament and of the 
Council as regards the specific compositional and information requirements for total 
diet replacement for weight control    
EN 2   EN ANNEX I  
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE  2 
1. ENERGY  
The energy provided by total diet replacement for weight control products shall not 
be less than 2 510 kJ (600 kcal) and shall not exceed 5  020 kJ (1200 kcal) for the 
total daily ration.  
2. PROTEIN  
2.1. The protein contained in total diet replacement for w eight control products shall not 
be less than 75 g and shall not exceed 105 g for the total daily ration.  
2.2. For the purposes of point 2.1.,  'protein' shall be  understood as  protein whose Protein 
Digestibility -Corrected Amino Acid Score is 1.0 when compared to the reference 
protein as set out in Annex II.  
2.3. The addition of amino acids is permitted solely for the purpose of improving the 
nutritional value of the protein s contained in total diet replacement for weight control  
products , and only in the proportions necessary for that purpose.  
3. CHOLINE  
The choline contained in total diet replacement for weight control  products  shall not 
be less than 400 mg for the total daily ration.  
4. LIPIDS  
4.1. Linoleic acid  
The linoleic acid contained in in total diet replacement for weight control products 
shall not be less than 11 g for the total daily ration.  
4.2. Alpha -linolenic acid  
The alpha -linolenic acid contained in total diet replacement for weight control  
products  shall not be less than 1,4 g fo r the total daily ration.  
5. CARBOHYDRATES  
The carbohydrates contained in total diet replacement for weight control  products  
shall not be less than 30 g for the total daily ration.  
6. VITAMINS AND MINERALS  
Total diet replacement for weight control  product s shall provide at least  the amounts 
of vitamins and minerals specified in Table 1  for the total daily ration . 
Total diet replacement for weight control  products  shall not contain more than 250 
mg of magnesium for the total daily ration.   
EN 3   EN TABLE  
Vitamin A  (μg RE(1)) 700 
Vitamin D  (μg) 10 
Vitamin E(2) (mg)  10 
Vitamin C  (mg)  110 
Vitamin K  (μg) 70 
Thiamin  (mg)  0,8 
Riboflavin  (mg)  1,6 
Niacin  (mg-NE(3)) 17 
Vitamin B 6  (mg)  1,6 
Folate  (μg-DFE (4)) 330 
Vitamin B12  (μg) 3 
Biotin  (μg) 40 
Pantothenic acid  (mg)  5 
Calcium  (mg)  950 
Phosphorus  (mg)  730 
Potassium  (g) 3, 1 
Iron (mg)  9 
Zinc (mg)  9,4 
Copper  (mg)  1,1 
Iodine  (μg) 150 
Molydbenum  (μg) 65 
Selenium  (μg) 70 
Sodium  (mg)  575 
Magnesium  (mg)  150 
Manganese  (mg)  3 
Chloride  (mg)  830 
(1) Retinol equivalents  
(2) Vitamin E activity of RRR α -tocopherol.  
(3) Niacin equivalents  
(4) Dietary folate equivalents : 1 μg DFE = 1 μg food 
folate = 0.6 μg folic acid from total diet 
replacement for weight control .  
EN 4   EN ANNEX II  
AMINO ACID REQUIREMENT PATTERN(1) 
 g/100g 
protein  
Cystine + methionine  2,2 
Histidine  1,5 
Isoleucine  3,0 
Leucine  5,9 
Lysine  4,5 
Phenylalanine + 
tyrosine  3,8 
Threonine  2,3 
Tryptophan  0,6 
Valine  3,9 
(1) World Health Organization/Food and 
Agriculture Organization of the United 
Nations/United Nations University), 
2007. Protein and amino acid 
requirements in human nutrition. 
Report of a Joint WHO/FAO/UNU 
Expert Consultation. (WHO Technical 
Report Series, 935 , 284pp).