Regulations 8, 11 and 13(1)(f)
SCHEDULE 1ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER(All values refer to the product ready for use)
Energy
1.
| Minimum | Maximum |
|---|---|
| 250 kJ | 315 kJ |
| (60 kcal/100 ml) | (75 kcal/100 ml) |
Proteins
2. (Protein content=nitrogen content × 6.38) for cows' milk proteins.
(Protein content=nitrogen content × 6.25) for soya protein isolates.
(2.1) Formulae manufactured from unmodified cows' milk proteins
| Minimum | Maximum |
|---|---|
| |
| 0.56 g/100 kJ | 0.7 g/100 kJ |
| (2.25 g/100 kcal) | (3 g/100 kcal) |
(2.2) Formulae manufactured from modified cows' milk proteins (alteration of the casein/ whey protein ratio)
| Minimum | Maximum |
|---|---|
| For an equal energy value, the formula must contain an available quantity of each essential and semi–essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in Schedule 5). | |
| 0.45 g/100 kJ | 0.7 g/100 kJ |
| (1.8 g/100 kcal) | (3 g/100 kcal) |
(2.3) Formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins
| Minimum | Maximum |
|---|---|
| |
| 0.56 g/100 kJ | 0.7 g/100 kJ |
| (2.25 g/100 kcal) | (3 g/100 kcal) |
(2.4) In all cases,the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.
Lipids
3.
| Minimum | Maximum |
|---|---|
| 0.8 g/100 kJ | 1.5 g/100 kJ |
| (3.3 g/100 kcal) | (6.5 g/100 kcal) |
(3.1) The use of the following substances is prohibited:
sesame seed oil;
cotton seed oil;
fats containing more than 8% trans isomers of fatty acids.
(3.2) Lauric acid
| Minimum | Maximum |
|---|---|
| — | 15% of the total fat content |
(3.3) Myristic acid
| Minimum | Maximum |
|---|---|
| — | 15% of the total fat content |
(3.4) Linoleic acid (in the form of glycerides=linoleates)
| Minimum | Maximum |
|---|---|
| 70 mg/100 kJ | 285 mg/100 kJ |
| (300 mg/100 kcal) | 1200 mg/100 kcal) |
Carbohydrates
4.
| Minimum | Maximum |
|---|---|
| 1.7 g/100 kJ | 3.4 g/100 kJ |
| (7 g/100 kcal) | (14 g/100 kcal) |
(4.1) Only the following carbohydrates may be used:
lactose;
maltose;
sucrose;
malto–dextrins;
glucose syrup or dried glucose syrup;
pre–cooked starch ) naturally free
gelatinised starch ) of gluten
(4.2) Lactose
| Minimum | Maximum |
|---|---|
| This provision does not apply to formulae in which soya proteins represent more than 50% of the total protein content. | |
| 0.85 g/100 kJ | — |
| (3.5 g/100 kcal) | — |
(4.3) Sucrose
| Minimum | Maximum |
|---|---|
| — | 20% of the total carbohydrate content |
(4.4) Pre–cooked starch and/or gelatinised starch
| Minimum | Maximum |
|---|---|
| — | 2 g/100 ml, and 30% of the total carbohydrate content |
Mineral substances
5.—(5.1) Formulae manufactured from cows' milk proteins
| per 100 kJ | per 100 kcal | ||||
|---|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | ||
| The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0. | |||||
| Sodium | (mg) | 5 | 14 | 20 | 60 |
| Potassium | (mg) | 15 | 35 | 60 | 145 |
| Chloride | (mg) | 12 | 29 | 50 | 125 |
| Calcium | (mg) | 12 | — | 50 | — |
| Phosphorus | (mg) | 6 | 22 | 25 | 90 |
| Magnesium | (mg) | 1.2 | 3.6 | 5 | 15 |
| Iron | (mg)(1) | 0.12 | 0.36 | 0.5 | 1.5 |
| Zinc | (mg) | 0.12 | 0.36 | 0.5 | 1.5 |
| Copper | (μg) | 4.8 | 19 | 20 | 80 |
| Iodine | (μg) | 1.2 | — | 5 | — |
(5.2) Formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins
All requirements of paragraph 5.1. are applicable except those concerning iron and zinc, which are as follows:
per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Iron (mg) 0.25 0.5 1 2 Zinc (mg) 0.18 0.6 0.75 2.4
Vitamins
6.
| per 100 kJ | per 100 kcal | ||||
|---|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | ||
| Vitamin A | (μg–RE)(2) | 14 | 43 | 60 | 180 |
| Vitamin D | (μg)(3) | 0.25 | 0.65 | 1 | 2.5 |
| Thiamin | (μg) | 10 | — | 40 | — |
| Riboflavin | (μg) | 14 | — | 60 | — |
| Nicotinamide | (μg–NE)(4) | 60 | — | 250 | — |
| Pantothenic | |||||
| acid | (μg) | 70 | — | 300 | — |
| Vitamin B6 | (μg) | 9 | — | 35 | — |
| Biotin | (μg) | 0.4 | — | 1.5 | — |
| Folic acid | (μg) | 1 | — | 4 | — |
| VitaminB12 | (μg) | 0.025 | — | 0.1 | — |
| Vitamin C | (mg) | 1.9 | — | 8 | — |
| Vitamin K | (μg) | 1 | — | 4 | — |
| Vitamin E | (mg*–TE)(5) | 0.5/g of | — | 0.5/g of | — |
| polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ | polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.5 mg per 100 available kcal | ||||
Limit applicable to formulae with added iron.
RE=all trans retinol equivalent.
In the form of cholecalciferol, of which 10 μg=400 i.u. of vitamin D.
NE=Niacin equivalent=mg nicotinic acid+mg tryptophan/60.
*–TE=d–*–tocopherol equivalent.