| Minimum | Maximum |
|---|---|
| 250 kJ/100 ml | 293 kJ/100 ml |
| (60 kcal/100 ml) | (70 kcal/100 ml) |
(Protein content = nitrogen content × 6,25)
| Minimum | Maximum |
|---|---|
| 0,43 g/100 kJ | 0,6 g/100 kJ |
| (1,8 g/100 kcal) | (2,5 g/100 kcal) |
For an equal energy value, infant formula manufactured from cows' milk or goats' milk proteins 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).
| Minimum | Maximum |
|---|---|
| 0,54 g/100 kJ | 0,67 g/100 kJ |
| (2,25 g/100 kcal) | (2,8 g/100 kcal) |
Only protein isolates from soya shall be used in manufacturing this infant formula.
For an equal energy value, infant formula manufactured from soya protein isolates, alone or in a mixture with cows' milk or goats' milk proteins, 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).
| Minimum | Maximum |
|---|---|
| 0,44 g/100 kJ | 0,67 g/100 kJ |
| (1,86 g/100 kcal) | (2,8 g/100 kcal) |
Demineralised sweet whey protein derived from cows' milk after enzymatic precipitation of caseins using chymosin, consisting of:
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
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 %.
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.
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).
If added to infant formula, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal).
| Minimum | Maximum |
|---|---|
| 6,0 mg/100 kJ | 12 mg/100 kJ |
| (25 mg/100 kcal) | (50 mg/100 kcal) |
| Minimum | Maximum |
|---|---|
| 1,1 g/100 kJ | 1,4 g/100 kJ |
| (4,4 g/100 kcal) | (6,0 g/100 kcal) |
sesame seed oil,
cotton seed oil.
| Minimum | Maximum |
|---|---|
| 120 mg/100 kJ | 300 mg/100 kJ |
| (500 mg/100 kcal) | (1 200 mg/100 kcal) |
| Minimum | Maximum |
|---|---|
| 12 mg/100 kJ | 24 mg/100 kJ |
| (50 mg/100 kcal) | (100 mg/100 kcal) |
| Minimum | Maximum |
|---|---|
| 4,8 mg/100 kJ | 12 mg/100 kJ |
| (20 mg/100 kcal) | (50 mg/100 kcal) |
The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.
The amount of phospholipids in infant formula shall not be greater than 2 g/l.
| Minimum | Maximum |
|---|---|
| 0,96 mg/100 kJ | 9,6 mg/100 kJ |
| (4 mg/100 kcal) | (40 mg/100 kcal) |
| Minimum | Maximum |
|---|---|
| 2,2 g/100 kJ | 3,3 g/100 kJ |
| (9 g/100 kcal) | (14 g/100 kcal) |
lactose,
maltose,
sucrose,
glucose,
glucose syrup or dried glucose syrup,
malto-dextrins,
pre-cooked starch (naturally free of gluten),
gelatinised starch (naturally free of gluten).
| Minimum | Maximum |
|---|---|
| 1,1 g/100 kJ | — |
| (4,5 g/100 kcal) | — |
Those minimum levels shall not apply to infant formula:
in which soya protein isolates represent more than 50 % of the total protein content, or
bearing the statement ‘lactose free’ in accordance with Article 9(2).
Sucrose may only be added to infant formula manufactured from protein hydrolysates. If added, the sucrose content shall not exceed 20 % of the total carbohydrate content.
Glucose may only be added to infant formula manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).
Glucose syrup or dried glucose syrup may be added to infant formula manufactured from cows' milk or goats' milk proteins or infant formula manufactured from soya protein isolates (alone or in a mixture with cows' milk or goats' milk proteins) only if its dextrose equivalent does not exceed 32. If glucose syrup or dried glucose syrup is added to these products, the glucose content resulting from glucose syrup or dried glucose syrup shall not exceed 0,2 g/100 kJ (0,84 g/100 kcal).
The maximum glucose amounts laid down in point 8.4 shall apply if glucose syrup or dried glucose syrup is added to infant formula manufactured from protein hydrolysates.
| Minimum | Maximum |
|---|---|
| — | 2 g/100 ml, and 30 % of the total carbohydrate content |
Fructo-oligosaccharides and galacto-oligosaccharides may be added to infant formula. In that case their content shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight oligofructosyl-saccharose.
Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used, provided that their suitability for infants is demonstrated in accordance with Article 3(3).
| a Total phosphorus. | ||||
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Sodium (mg) | 6 | 14,3 | 25 | 60 |
| Potassium (mg) | 19,1 | 38,2 | 80 | 160 |
| Chloride (mg) | 14,3 | 38,2 | 60 | 160 |
| Calcium (mg) | 12 | 33,5 | 50 | 140 |
| Phosphorus (mg)a | 6 | 21,5 | 25 | 90 |
| Magnesium (mg) | 1,2 | 3,6 | 5 | 15 |
| Iron (mg) | 0,07 | 0,31 | 0,3 | 1,3 |
| Zinc (mg) | 0,12 | 0,24 | 0,5 | 1 |
| Copper (μg) | 14,3 | 24 | 60 | 100 |
| Iodine (μg) | 3,6 | 6,9 | 15 | 29 |
| Selenium (μg) | 0,72 | 2 | 3 | 8,6 |
| Manganese (μg) | 0,24 | 24 | 1 | 100 |
| Molybdenum (μg) | — | 3,3 | — | 14 |
| Fluoride (μg) | — | 24 | — | 100 |
The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. The amount of available phosphorus shall be calculated as 80 % of total phosphorus for infant formula manufactured from cow's milk protein, goats' milk protein or protein hydrolysates.
All requirements of point 10.1 shall apply, except for those concerning iron, phosphorus and zinc, which shall be as follows:
| a Total phosphorus. | ||||
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Iron (mg) | 0,11 | 0,48 | 0,45 | 2 |
| Phosphorus (mg)a | 7,2 | 24 | 30 | 100 |
| Zinc (mg) | 0,18 | 0,3 | 0,75 | 1,25 |
The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. The amount of available phosphorus shall be calculated as 70 % of total phosphorus for infant formula manufactured from soya protein isolates.
| a Preformed vitamin A; RE = all trans retinol equivalent. | ||||
| b Preformed niacin. | ||||
| c Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0,6 μg folic acid from formula. | ||||
| d Based on vitamin E activity of RRR-α-tocopherol. | ||||
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (μg-RE)a | 16,7 | 27,2 | 70 | 114 |
| Vitamin D (μg) | 0,48 | 0,72 | 2 | 3 |
| Thiamine (μg) | 9,6 | 72 | 40 | 300 |
| Riboflavin (μg) | 14,3 | 95,6 | 60 | 400 |
| Niacin (mg)b | 0,1 | 0,36 | 0,4 | 1,5 |
| Pantothenic acid (mg) | 0,1 | 0,48 | 0,4 | 2 |
| Vitamin B6 (μg) | 4,8 | 41,8 | 20 | 175 |
| Biotin (μg) | 0,24 | 1,8 | 1 | 7,5 |
| Folate (μg-DFE)c | 3,6 | 11,4 | 15 | 47,6 |
| Vitamin B12 (μg) | 0,02 | 0,12 | 0,1 | 0,5 |
| Vitamin C (mg) | 0,96 | 7,2 | 4 | 30 |
| Vitamin K (μg) | 0,24 | 6 | 1 | 25 |
| Vitamin E (mg α-tocopherol)d | 0,14 | 1,2 | 0,6 | 5 |
The following nucleotides may be added:
| a The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal). | ||
| Maximuma | ||
|---|---|---|
| (mg/100 kJ) | (mg/100 kcal) | |
| cytidine 5′-monophosphate | 0,60 | 2,50 |
| uridine 5′-monophosphate | 0,42 | 1,75 |
| adenosine 5′-monophosphate | 0,36 | 1,50 |
| guanosine 5′-monophosphate | 0,12 | 0,50 |
| inosine 5′-monophosphate | 0,24 | 1,00 |