(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 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).’;