- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol). This item of legislation is currently only available in its original format.
Regulations 8, 11 and 13(1)(f)
1.
Minimum | Maximum |
---|---|
250 kJ | 315 kJ |
(60 kcal/100 ml) | (75 kcal/100 ml) |
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.
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) |
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 |
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 |
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 |
Regulations 9, 11 and 14(e)
1.
Minimum | Maximum |
---|---|
250 kJ/100 ml | 335 kJ/100 ml |
(60 kcal/100 ml) | (80 kcal/100 ml) |
2. (Protein content–nitrogen content × 6.38) for cows' milk proteins.
(Protein content–nitrogen content × 6.25) for soya protein isolates.
Minimum | Maximum |
---|---|
| |
0.5 g/100 kJ | 1 g/100 kJ |
(2.25 g/100 kcal) | (4.5 g/100 kcal) |
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 (300 mg/100 kcal): this limit applies only to follow-on formulae containing vegetable oils | — |
4.
Minimum | Maximum |
---|---|
1.7 g/100 kJ | 3.4 g/100 kJ |
(7 g/100 kcal) | (14 g/100 kcal) |
(4.1) The use of ingredients containing gluten is prohibited.
(4.2) Lactose
Minimum | Maximum |
---|---|
This provision does not apply to follow-on formulae in which soya protein isolates represent more than 50% of the total protein content. | |
0.45 g/100 kJ | — |
(1.8 g/100 kcal) | — |
(4.3) Sucrose, fructose, honey
Minimum | Maximum |
---|---|
— | separately or as a whole: 20% of the total carbohydrate content |
per 100 kJ | per 100 kcal | ||||
---|---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | ||
Iron | (mg) | 0.25 | 0.5 | 1 | 2 |
Iodine | (μg) | 1.2 | — | 5 | — |
(5.2) Zinc
(5.2.1)Follow–on formulae manufactured entirely from cows' milk proteins
Minimum | Maximum |
---|---|
0.12 mg/100 kJ | — |
(0.5mg/100 kcal) | — |
(5.2.2)Follow–on formulae containing soya protein isolates, alone or mixed with cows' milk proteins
Minimum | Maximum |
---|---|
0.18 mg/100 kJ | — |
(0.75mg/100 kcal) | — |
(5.3) Other mineral substances:
The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the protein concentration of the follow-on formulae to that of cows' milk. The typical composition of cows' milk is given, for guidance, in Schedule 7.
(5.4) The calcium/phosphorus ratio shall not exceed 2.0.
6.
per 100 kJ | per 100 kcal | ||||
---|---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | ||
Vitamin A | (μg–RE)(6) | 14 | 43 | 60 | 180 |
Vitamin D | (μg)(7) | 0.25 | 0.75 | 1 | 3 |
Vitamin C | (mg) | 1.9 | — | 8 | — |
Vitamin E | (mg*–TE)(8) | 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 |
Regulation 11
1.
Vitamin | Vitamin formulation |
---|---|
Vitamin A | Retinyl acetate Retinyl palmitate Beta–carotene Retinol |
Vitamin D | Vitamin D2 (ergocalciferol) Vitamin D3 (cholecalciferol) |
Vitamin B1 | Thiamin hydrochloride Thiamin mononitrate |
Vitamin B2 | Riboflavin Riboflavin–5'–phosphate, sodium |
Niacin | Nicotinamide Nicotinic acid |
Vitamin B6 | Pyridoxine hydrochloride Pyridoxine–5'–phosphate |
Folate | Folic acid |
Pantothenic acid | D–pantothenate, calcium D–pantothenate, sodium Dexpanthenol |
Vitamin B12 | Cyanocobalamin Hydroxocobalamin |
Biotin | D–Biotin |
Vitamin C | L–ascorbic acid Sodium L–ascorbate Calcium L–ascorbate 6–palmityl–L–ascorbic acid (ascorbyl palmitate) Potassium ascorbate |
Vitamin E | D–alpha tocopherol DL–alpha tocopherol D–alpha tocopherol acetate DL–alpha tocopherol acetate |
Vitamin K | Phylloquinone (Phytomenadione) |
2.
Mineral substances | Permitted salts |
---|---|
Calcium (Ca) | Calcium carbonate Calcium chloride Calcium salts of citric acid Calcium gluconate Calcium glycerophosphate Calcium lactate Calcium salts of orthophosphoric acid Calcium hydroxide |
Magnesium (Mg) | Magnesium carbonate Magnesium chloride Magnesium oxide Magnesium salts of orthophosphoric acid Magnesium sulphate Magnesium gluconate Magnesium hydroxide Magnesium salts of citric acid |
Iron (Fe) | Ferrous citrate Ferrous gluconate Ferrous lactate Ferrous sulphate Ferric ammonium citrate Ferrous fumarate Ferric diphosphate (Ferric pyrophosphate) |
Copper (Cu) | Cupric citrate Cupric gluconate Cupric sulphate Copper–lysine complex Cupric carbonate |
Iodine (I) | Potassium iodide Sodium iodide Potassium iodate |
Zinc (Zn) | Zinc acetate Zinc chloride Zinc lactate Zinc sulphate Zinc citrate Zinc gluconate Zinc oxide |
Manganese (Mn) | Manganese carbonate Manganese chloride Manganese citrate Manganese sulphate Manganese gluconate |
Sodium (Na) | Sodium bicarbonate Sodium chloride Sodium citrate Sodiu gluconate Sodium carbonate Sodium lactate Sodium salts of orthophosphoric acid Sodium hydroxide |
Potassium (K) | Potassium bicarbonate Potassium carbonate Potassium chloride Potassium salts of citric acid Potassium gluconate Potassium lactate Potassium salts of orthophosphoric acid Potassium hydroxide |
3. L–arginine and its hydrochloride
L–cystine and its hydrochloride
L–histidine and its hydrochloride
L–isoleucine and its hydrochloride
L–leucine and its hydrochloride
L–lysine and its hydrochloride
L–cysteine and its hydrochloride
L–methionine
L–phenylalanine
L–threonine
L–tryptophan
L–tyrosine
L–valine
L–carnitine and its hydrochloride
Taurine
4. Choline
Choline chloride
Choline citrate
Choline bitartrate
Inositol
Regulation 13(3)
Claim related to | Conditions warranting the claim |
---|---|
1. Adapted protein | The protein content is lower than 0.6 g/100 kJ (2.5 g/ 100 kcal) and the whey protein/casein ratio is not less than 1.0 |
2. Low sodium | The sodium content is lower than 9 mg/100 kJ (39 mg/100 kcal) |
3. Sucrose free | No sucrose is present |
4. Lactose only | Lactose is the only carbohydrate present |
5. Lactose free | No lactose is present(9) |
6. Iron enriched | Iron is added |
Regulation 8
For the purpose of these Regulations, the essential and semi–essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:
per 100 kJ(10) | per 100 kcal | |
---|---|---|
Arginine | 16 | 69 |
Cystine | 6 | 24 |
Histidine | 11 | 45 |
Isoleucine | 17 | 72 |
Leucine | 37 | 156 |
Lysine | 29 122 | |
Methionine | 7 | 29 |
Phenylalanine | 15 | 62 |
Threonine | 19 | 80 |
Tryptophan | 7 | 30 |
Tyrosine | 14 | 59 |
Valine | 19 | 80 |
Regulations 8 and 9
The amino acid composition of casein and breast milk protein (g/100 g of protein):
Regulation 9
As a reference, the contents of mineral elements in cows' milk expressed per 100 g of solids–non–fat and per g of proteins are the following:
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.
RE=all trans retinol equivalent.
In the form of cholecalciferol, of which 10 μg=400 i.u. of vitamin D.
*–TE=d–*–tocopherol equivalent.
When determined by a method the detection limits of which will be established at a later stage.
1 kJ=0.239 kcal.
Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383.
SNF: “solids–no fats”.
NS: non specified, varies widely according to season and stock farming conditions.
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