‘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

2.3.1.2.

Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:

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

2.3.2.2.

Protein source

Whey protein derived from cows’ milk, consisting of:

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.

Follow-on formula manufactured from protein hydrolysates

Follow-on 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

2.3.1.2.

Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:

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 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

2.3.2.2.

Protein source

Whey protein derived from cows’ milk, consisting of:

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.’;

(a)

Section A is amended as follows:

(b)

in Section B, the introductory sentence is replaced by the following:

‘For the purposes of point 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:’.