S.L. 449.52 Art. 12Dietary foods for special medical purposes intended specifically for infants. S.L. 449.29

The new requirements set out in regulation 7(1) and (2)

shall not apply mandatorily to dietary foods for special medical purposes intended specifically for infants, as referred to in point 4

of the Schedule to the Dietary Foods for Special Medical Purposes

Regulations until 1st January 2012. FIRST SCHEDULE

ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

set out in this Schedule refer to the final product ready for use, such or reconstituted as instructed by the manufacturer. ENERGY

Minimum Maximum 250 kJ/100 ml 295 kJ/100 ml (60 kcal/100 ml) (70 kcal/100 ml)

PROTEINS content = nitrogen content × 6,25)

formulae manufactured from cows’ milk or goats’ milk proteins Minimum (1) Maximum 0,45 g/100 kJ 0,7 g/100 kJ (1,8 g/100 kcal) (3 g/100 kcal)

formulae manufactured from cows’ milk or goats’ milk protein with a protein content between minimum and 0,5 g/100 kJ (2 g/100 kcal) shall be in accordance with the second subparagraph of 7(1). energy value, the infant formula must contain an available quantity of indispensable and conditionally indispensable amino acid at least equal to that the reference protein (breast milk, as defined in the Fifth Schedule). for calculation purposes, the concentration of methionine and cystine together if the methionine:cystine ratio is not greater than 2, and the of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine: cystine than 2 but shall not be greater than 3 provided that the suitability of for the particular nutritional use by infants is demonstrated through studies, performed following generally accepted expert guidance on the conduct of such studies. formulae manufactured from protein hydrolysates (1) Minimum Maximum 0,45 g/100 kJ 0,7 g/100 kJ (1,8 g/100 kcal) (3 g/100 kcal)

formulae manufactured from protein hydrolysates with a protein content between the 0,56 g/100 kJ (2,25 g/100 kcal) shall be in accordance with the third paragraph of energy value, the infant formula must contain an available quantity of indispensable and conditionally indispensable amino acid at least equal to that the reference protein (breast milk, as defined in the Fifth Schedule). for calculation purposes, the concentration of methionine and cystine together if the methionine:cystine ratio is not greater than 2, and the of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated appropriate studies, performed following generally accepted expert guidance design and conduct of such studies. The L-carnitine content shall be at 0,3 mg/100 kJ (1,2 mg/100 kcal).

2.3 Infant formulae manufactured from soya protein isolates, mixture with cows’ milk or goats’ milk proteins

Minimum Maximum 0,56 g/100 kJ 0,7 g/100 kJ (2,25 g/100 kcal) (3 g/100 kcal)

Only protein isolates from soya shall be used in manufacturing these infant formulae. For an equal energy value the infant formula must contain an available each indispensable and conditionally indispensable amino acid at least contained in the reference protein (breast milk, as defined in the Fifth Nevertheless, for calculation purposes, the concentration of methionine may be added together if the methionine:cystine ratio is not greater concentration of phenylalanine and tyrosine may be added together tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine may be greater than 2 but shall not be greater than 3 provided that the the product for the particular nutritional use by infants is demonstrated appropriate studies, performed following generally accepted expert guidance design and conduct of such studies. The L-carnitine content shall be at 0,3 mg/100 kJ (1,2 mg/100 kcal). 2.4 In all cases, amino acids may be added to infant formulae purpose of improving the nutritional value of the proteins, and proportions necessary for that purpose.