EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1709/2023 ANNEX 
(POOL/A1/2023/1709/1709 -EN 
ANNEX.docx)  
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION DELEGATED REGULATION (EU) …/...  
amending Delegated Regulation (EU) 2016/127 as regards the protein -related 
requirements for infant and follow -on formula manufactured from protein hydrolysates    
EN 1  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 with the 
protein -related requirements provided under point 2.3.1., point 2.3.2 ., point 
2.3.3. or point 2.3.4.  
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 an equal energy value, infant formula manufactur ed 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 p urposes, 
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   
EN 2  EN 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 equ al 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 e nzymes 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 equal 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 Annex III. Nevertheless , for calculation purp oses, 
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).   
EN 3  EN 2.3.3. Protein -related requirements group  C 
2.3.3.1.  Protein content  
Minimum  Maximum  
0,45 g/100 kJ  0,67 g/100 kJ  
(1,9 g/100 kcal)  (2,8 g/100 kcal ) 
2.3.3.2.  Protein source  
Whey protein derived from cows ’ milk, consisting of 100% 
sweet whey protein concentrate  with a minimum protein content 
of 80%.  
2.3.3 .3. Protein processing  
The source material is hydrated and heated. Prior to the 
hydrolysis, the pH is adjusted to 6,5 - 7,5 at a temperature of 50 
– 65 °C. T he hydrolysis is carried out with the use of an enzyme 
mixture of a serine endopeptidase and a metalloprotease . The 
food enzymes are inactivated in a heat treatment step ( from 2 to 
10 seconds at 110 to 140 °C) during the p roduction process . 
2.3.3 .4. Indispensable and conditio nally indispensable amino acids and 
L-carnitine  
For an equal 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 Annex III. Nevertheless , for calculation purposes, 
the concentration of methionine and cysteine may be added 
together if the methion ine: 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 th an 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).  
2.3.4. Protein -related requirements group  D 
2.3.4.1. Protein content  
Minimum  Maximum  
0,57 g/100 kJ  0,67 g/100 kJ  
(2,4 g/100 kcal)  (2,8 g/100 kcal ) 
2.3.4.2.  Protein source   
EN 4  EN Whey protein  derived from cow’s milk, consisting of 100% 
sweet whey protein concentrate with a minimum protein content 
of 70%.   
2.3.4 .3. Protein processing  
The source material is hydrated and heated. Following the heat -
treatment step, the hydrolysis is carried out  at a pH of 7.0 to 8.0 
and a temperature of 50 to 60°C , using a two -stage hydrolysis 
process with the use of a serine endopeptidase and a 
metalloprotease. The food enzymes are inactivated  by heat 
treatment (at 110°C for at least 30 seconds ) during the 
production process.  
2.3.4 .4. Indispensable and conditio nally indispensable amino acids and 
L-carnitine  
For an equal 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 containe d in the reference  protein as set out in 
Section A 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 ph enylalanine 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 infan ts 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:  
‘2.3. Follow -on formula manufactured from protein hydrolysates  
Follow -on formula manufactured from protein hydroly sates  shall comply  with 
the protein -related requirements provided under point 2.3.1., point 2.3.2. , point 
2.3.3. or point 2.3.4.  
2.3.1.  Protein -related requi rements 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   
EN 5  EN 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 concentr ate 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  
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 B of Annex III. Nevertheless, for calculation 
purposes, the concentration of methionine and cysteine and the 
concent ration 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 ) 
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 s ource 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  
EN 6  EN step (from 2 to 10 seconds at 120 to  150°C) during the 
production process.  
2.3.2.4.  Indispensable and conditio nally 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 
purpos es, the concentration of methionine and cysteine and the 
concentration of phenylalanine and tyrosine may be added 
together.  
2.3.3.  Protein related requirements group  C 
2.3.3.1.  Protein content  
Minimum  Maximum  
0,45 g/100 kJ  0,67 g/100 kJ  
(1,9 g/100 kcal)  (2,8 g/100 kcal ) 
2.3.3.2.  Protein source  
Whey protein derived from cows ’ milk, consisting of 100% 
sweet whey protein concentrate  with a minimum protein content 
of 80 %.  
2.3.3 .3. Protein processing  
The source material is hydrated and heated. Prior to the 
hydrolysis, the pH is adjusted to 6,5 - 7,5 at a temperature of 50 
- 65°C. The hydrolysis is carried out with the use of an enzyme 
mixture of a serine endopeptidase and a metalloprotease . The 
food enzymes are inactivated in a heat treatment step ( from 2 to 
10 seconds at 110 to 140°C) during the production process . 
2.3.3 .4. Indispensable and conditio nally indispensable amino acids  
For an equa l energy value, follow -on 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 Annex III. Nevertheless , for calculation 
purposes, the concentration of methionine and cysteine and the 
concentration of phenylalanine and tyrosine may be added 
together.  
2.3.4. Protein -related requirements group  D 
2.3.4.1. Protein content  
Minimum  Maximum  
0,57 g/100 kJ  0,67 g/100 kJ   
EN 7  EN (2,4 g/100 kcal)  (2,8 g/100 kcal ) 
2.3.4.2.  Protein source  
Whey protein  derived from cow’s milk, consisting of 100% 
sweet whey protein concentrate with a minimum protein content 
of 70%.   
2.3.4 .3. Protein processing  
The source material is hydrated and heated. Following the heat -
treatment step, the hydrolysis is carried out  at a pH of 7.0 to 8.0 
and a temperature of 50 to 60°C , using a two -stage hydrolysis 
process with the use of a serine endopeptidase and a 
metalloprotease. The food enzymes are inactivated  by heat 
treatment (at 110°C for at least 30 seconds ) during the 
production process.  
2.3.4 .4. Indispensable and conditio nally indispensable amino acids  
For an equal 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 Annex III. Nevertheless , for calculation purposes, 
the concentration of methionine and cysteine and the 
concentration of phenylalanine and tyrosine may be adde d 
together. ’; 
3. in Annex III, the introductory sentence under section A is replaced by the following:  
‘For the purposes of points 2.1., 2.2., 2.3.2 ., 2.3.3. and 2.3.4. 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:’.