EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11294/2021 ANNEX 
(POOL/E1/2021/11294/11294 -EN 
ANNEX.docx)  
[…](2021) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION DELEGATED REGULATION (EU) …/...  
amending Commission Delegated Regulation (EU) 2016/127 as regards the protein 
requirements for infant and follow -on formula manufactured from protein hydrolysates   EN 2  EN ANNEX  
Annexes I, II and III to Delega ted Regulation (EU) 2016/127 are  amended as follows:  
(1) in Annex  I,  point 2.3  is replaced by the following :  
‘2.3.   Infant formula manufactured from protein hydrolysates  
 
Infant formula manufactured from protein hydrolysates  shall comply  either 
with the protein related requirements provided under point 2.3.1., or with the 
protein related requirements provided under point 2.3.2.’ 
 
‘2.3.1. Protein related requirements group  A’ 
‘2.3.1.1 Protein content  
 
Minimum  Maximum  
0,44 g/100 kJ  0,67 g/100 kJ  
(1,86  g/100 kcal)  (2,8 g/100 kcal)  
 
2.3.1.2 Protein source  
Demineralised sweet whey protein derived from cows' milk after enzymatic 
precipitation of caseins using chymosin, consisting of:  
(a) 63 % caseino -glycomacropeptide free whey protein isolate with a minimum 
protein content of 95 % of dry matter and protein denaturation of less than 70 
% and a maximum ash content of 3 %; and  
(b) 37 % sweet whey protein concentrate with a minimum protein content of 87 
% of dry matter and protein denaturation of less than 70 % and a maximum ash 
content of 3,5 %.  
2.3.1.3 Protein  processing  
Two-stage hydrolysis process using a trypsin preparation with a heat -treatment 
step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.  
2.3.1.4 Indispensable and conditionally indispensable amino acids and L -
carnitine  
For a n equal energy value, infant formula manufactured from protein 
hydrolysates must contain an available quantity of each indispensable and 
conditionally indispensable amino acid at least equal to that contained in the 
reference protein as set out in Section B of Annex III. Nevertheless, for 
calculation purposes, the concentration of methionine and cysteine may be 
added together if the methionine:cysteine ratio is not greater than 2, and the 
concentration of phenylalanine and tyrosine may be added together if the 
tyrosine:phenylalanine ratio is not greater than 2. The ratio of 
methionine:cysteine and of tyrosine:phenylalanine may be greater than 2, EN 3  EN provided that the suitability of the product concerned for infants is 
demonstrated in accordance with Article 3(3) . 
The L -carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 
kcal) .’ 
 
 ‘2.3.2. Protein related requirements group  B’ 
‘2.3.2.1 Protein content   
Minimum  Maximum  
0,55 g/100 kJ  0,67 g/100 kJ  
(2.3 g/100 kcal)  (2,8 g/100 kcal ) 
2.3.2.2 Protein source  
Whey protein derived from cows ’ milk, consisting of:  
(a) 77 % acid whey, coming from whey protein concentrate with a 
protein content of 35 to 80% ; 
(b) 23 % sweet whey, coming from demineralised sweet whey with a 
minimum protein content of 12 .5%. 
2.3.2. 3 Protein processing   
The source material is hydrated and heated. Following the heat -treatment step, 
the hydrolysis is carried out at a pH of 7,5 to  8,5 and a temperature of 55 to  
70°C with the use of an enzyme mixture of a serine endopeptidase and a 
protease/peptidase complex . The food enzymes are inactivated in a heat 
treatment step (from 2 to 10 seconds at 120 to  150°C) during the production 
process.   
2.3.2. 4 Indispensable and conditionally indispensable amino acids and L -
carnitine  
For an equa l energy value, infant formula manufactured from protein 
hydrolysates m ust contain an available quantity of each indispensable and 
conditionally indispensable amino acid at least equal to that contained in the 
reference  protein as set out in Section A of A nnex III. Nevertheless , for 
calculation purposes, the concentration of methionine and cysteine may be 
added together if the methionine:  cysteine ratio is not greater than 2, and the 
concentration of phenylalanine and tyrosine may be added together if the 
tyrosine:phenylalanine ratio is not greater than 2. The ratio of 
methionine:cysteine and of tyrosine:phenylalanine may be greater than 2, 
provided that the suitability of the product concerned for infants is 
demonstrated in accordance with Article 3(3).  
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 
kcal).’ 
(2) In Annex II point 2.3  is replaced by the following:  
 EN 4  EN ‘2.3.   Follow -on formula manufactured from protein hydrolysates  
 
Follow -on formula manufactured from protein hydroly sates  shall comply  either 
with the protein related requirements provided under point 2.3.1., or with the 
protein related requirements provided under point 2.3.2.’ 
‘2.3.1. Protein related requirements  group  A’ 
‘2.3.1.1 Protein content  
Minimum  Maximum  
0,44 g/100 kJ  0,67 g/100 kJ  
(1,86  g/100 kcal)  (2,8 g/100 kcal)  
2.3.1.2 Protein source  
Demineralised sweet whey protein derived from cows' milk after enzymatic 
precipitation of caseins using chymosin, consisting of:  
(a) 63 % caseino -glycomacropeptide free  whey protein isolate with a minimum 
protein content of 95 % of dry matter and protein denaturation of less than 70 
% and a maximum ash content of 3 %; and  
(b) 37 % sweet whey protein concentrate with a minimum protein content of 87 
% of dry matter and pro tein denaturation of less than 70 % and a maximum ash 
content of 3,5 %.  
2.3.1.3 Protein processing  
Two-stage hydrolysis process using a trypsin preparation with a heat -treatment 
step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.  
2.3.1.4 Indispensable and conditionally indispensable amino acids and L -
carnitine  
For an equal energy value, follow -on formula manufactured from protein 
hydrolysates must contain an available quantity of each indispensable and 
conditionally indispensable a mino acid at least equal to that contained in the 
reference protein as set out in Section B of Annex III. Nevertheless, for 
calculation purposes, the concentration of methionine and cysteine and the 
concentration of phenylalanine and tyrosine may be added together .` 
  
‘2.3.2.  Protein related requirements group  B’ 
‘2.3.2.1 Protein content  
Minimum  Maximum  
0,55 g/100 kJ  0,67 g/100 kJ  
(2.3 g/100 kcal)  (2,8 g/100 kcal ) EN 5  EN 2.3.2.2 Protein source  
Whey protein derived from cows ’ milk, consisting of:  
a) 77 % acid whey, coming from whey protein concentrate with a protein 
content of 35 to 80% ; 
b) 23 % sweet whey, coming from demineralised sweet whey with a 
minimum protein  content of 12.5% . 
2.3.2.3  Protein processing   
The source material is hydrated and heated. Follow ing the heat -treatment step, 
the hydrolysis is carried out at a pH of 7,5 to  8,5 and a temperature of 55 to  
70°C with the use of an enzyme mixture of a serine endopeptidase and a 
protease/peptidase complex . The food enzymes are inactivated in a heat 
treatm ent step (from 2 to 10 seconds at 120 to  150°C) during the production 
process.    
2.3.2.4 Indispensable and conditionally indispensable amino acids  
For an equal energy value, follow -on formula manufactured from protein 
hydrolysates must contain an available quantity of each indispensable and 
conditionally indispensable amino acid at least equal to that contained in the 
reference protein as set out in Section A of Annex III. Nevertheless, for 
calculation purposes, the concentration of methionine and cysteine and the 
concentration of phenylalanine and tyrosine may be added together. ’ 
(3) Annex III is amended as follows:  
(a) section A  is amended as follows:  
(i) the title is replaced by the following:  
‘Infant formula and follow -on formula manufactured f rom cows ’ milk or goats ’ 
milk proteins and infant formula and follow -on formula manufactured from 
soya protein isolates, alone or in a mixture with cows ’ milk or goats ’ milk 
proteins  and infant formula and follow -on formula manufactured from protein 
hydrol ysates’; 
(ii) the introductory sentence  is replaced by the following:  
‘For the purposes of points 2.1, 2.2 and 2.3 .2 of Annexes I and II, the 
indispensable and conditionally indispensable amino acids in breast milk, 
expressed in mg per 100 kJ and 100 kcal, are the following: ’  
(b) in section B, the introductory sentence  is replaced by the following:  
‘For the purposes of  points 2.3.1 of Annexes I and II, the indispensable and 
conditionally indispensable amino acids in breast milk, expressed in mg per 
100 kJ and 100 kcal, are the following: ’