Commission Delegated Regulation (EU) 2023/589 of 10 January 2023 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates (Text with EEA relevance)

Article 1
Annexes I, II and III to Delegated Regulation (EU) 2016/127 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
ANNEX
ANNEX
Annexes I, II and III to Delegated 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, or point 2.3.3.
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 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, 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 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 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 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).
2.3.3.
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 conditionally indispensable amino acids and L-carnitine
For an 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 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 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:
‘2.3.
Follow-on formula manufactured from protein hydrolysates
Follow-on formula manufactured from protein hydrolysates shall comply with the protein-related requirements provided under point 2.3.1, point 2.3.2, or point 2.3.3.
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
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 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)
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
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.
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 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)
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 and 2.3.3 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:’.
Commission Delegated Regulation (EU) 2023/589 of 10 January 2023 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates (Text with EEA relevance)

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