ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER
Composition |
Minimum |
Maximum |
Comments |
|
|
|
|
Energy – kcal / 100ml |
60 |
70 |
|
Protein - g/100kcal : |
|
|
L-carnitine content shall be at least equal to 1.2 mg/100 kcal |
Taurine - mg/100 kcal |
0 |
12 |
|
Choline - mg/100 kcal |
7 |
50 |
|
Lipids – g/100kcal |
4.4 |
6 |
|
|
- |
separately or as a whole: 20 % of the total fat content |
The trans fatty acid content shall not exceed 3 % of the total fat content. The erucic acid content shall not exceed 1 % of the total fat content. |
Linoleic acid (in the form of glycerides = linoleates) - mg/100 kcal |
|
|
The alpha-linolenic acid content shall not be less than 50 mg/100 kcal; the linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15. |
|
|
1 % of the total fat content for n-3 LCP |
The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content. |
PHOSPHOLIPIDS |
- |
2 g/l |
|
INOSITOL - mg/100 kcal |
4 |
40 |
|
|
|
|
Only the following carbohydrates may be used: lactose; maltose; sucrose; glucose; malto-dextrins; glucose syrup or dried glucose syrup; pre-cooked starch or gelatinised starch - naturally free of gluten. |
|
|
|
This provision shall not apply to infant formulae in which soya protein isolates represent more than 50 % of the total protein content. |
pre-cooked starch and/or gelatinised starch |
- |
2 g/100 ml, and 30 % of the total carbohydrate content |
|
Sodium – mg / 100 kcal |
20 |
60 |
|
Potassium - mg / 100 kcal |
60 |
160 |
|
Chloride – mg / 100 kcal |
50 |
160 |
|
Calcium – mg / 100 kcal |
50 |
140 |
The calcium:phosphorus ratio shall not be less than 1 nor greater than 2. |
Phosphorus – mg / 100 kcal |
25 |
90 |
|
Magnesium – mg / 100 kcal |
5 |
15 |
|
Iron – mg / 100 kcal |
0.3 |
1.3 |
|
Zinc – mg / 100 kcal |
0.5 |
1.5 |
|
Copper – µ g / 100kcal |
35 |
100 |
|
Iodine – µ g / 100kcal |
10 |
50 |
|
Selenium – µ g / 100kcal |
1 |
9 |
|
Manganese – µ g / 100kcal |
1 |
100 |
|
Fluoride – µ g / 100kcal |
- |
100 |
|
Sucrose |
|
20 % total carbohydrate content |
may only be added to infant formulae manufactured from protein hydrolysates. |
Glucose |
|
2 g/100 kcal |
may only be added to infant formulae manufactured from protein hydrolysates |
|
- |
0.8 g/100 ml in a combination of 90% oligogalactosyl-lactose and 10% high molecular weight oligofructosyl-saccharose. |
|
Vitamin A - µg / 100kcal all trans retinol equivalent |
60 |
180 |
|
Vitamin D - µg / 100kcal |
1 |
2.5 |
In the form of cholecalciferol, of which 10 µ g = 400 i.u. of vitamin D. |
Thiamin - µg / 100kcal |
60 |
300 |
|
Riboflavin - µg / 100kcal |
80 |
400 |
|
Niacin (µg) - µg / 100kcal |
1 |
500 |
Preformed niacin. |
Pantothenic acid - µg / 100kcal |
400 |
2000 |
|
Vitamin B 6 - µg / 100kcal |
35 |
175 |
|
Biotin - µg / 100kcal |
1.5 |
7.5 |
|
Folic Acid - µg / 100kcal |
10 |
50 |
|
Vitamin B 12 - µg / 100kcal |
0.1 |
0.5 |
|
Vitamin C - µg / 100kcal |
10 |
30 |
|
Vitamin K - µg / 100kcal |
4 |
25 |
|
Vitamin E – mg/100kcal d-a-tocopherol equivalent |
0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds but in no case less than 0,5 mg per 100 available kcal |
5 |
|
NUCLEOTIDES The following nucleotides may be added: cytidine 5 ' -monophosphate - mg/100 kcal uridine 5 ' -monophosphate - mg/100 kcal adenosine 5 ' -monophosphate - mg/100 kcal guanosine 5 ' -monophosphate - mg/100 kcal inosine 5 ' -monophosphate - mg/100 kcal |
|
1.75 1.50 0.50 1.00 |
The total concentration of nucleotides shall not exceed 5 mg/100 kcal |
Additional notes:
In all cases, amino acids may be added to infant formulae solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.
The following are prohibited: sesame seed oil, cotton seed oil.
Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins
All requirements above shall apply, except for those concerning iron and phosphorus, which shall be as follows:
Per 100 kcal |
Minimum |
Maximum |
Iron (mg) |
0.45 |
2 |
Phosphorus (mg) |
30 |
100 |