The Infant Formula and Follow–on Formula Regulations 1995

Regulations 8, 11 and 13(1)(f)

SCHEDULE 1 ESSENTIAL 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
The chemical index of the proteins present shall be equal to at least 80% of that of the reference protein (breast milk, as defined in Schedule 6); nevertheless, for calculation purposes, the concentrations of methionine and cystine may be added together. The “chemical index” shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein.
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
Only soya protein isolates may be used in manufacturing these formulae. The chemical index shall be equal to at least 80% of that of the reference protein (breast milk, as defined in Schedule 6). For an equal energy value the formula must contain an available quantity of methionine at least equal to that contained in the reference protein (breast milk, as defined in Schedule 5). The L–carnitine content shall be at least equal to 1.8 μmoles/100 kJ (7.5 μmoles/100 kcal).
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

Regulations 9, 11 and 14(e)

SCHEDULE 2 ESSENTIAL COMPOSITION OF FOLLOW–ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER(All values refer to the product ready for use)

Energy

1.  

Minimum	Maximum
250 kJ/100 ml	335 kJ/100 ml
(60 kcal/100 ml)	(80 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.

Minimum	Maximum
The chemical index of the proteins present shall be at least equal to 80% of that of the reference protein (casein as defined in Schedule 6). The “chemical index” shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein. For follow-on formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins, only protein isolates from soya may be used. Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of the proteins, in the proportions necessary for that purpose.
0.5 g/100 kJ	1 g/100 kJ
(2.25 g/100 kcal)	(4.5 g/100 kcal)

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 (300 mg/100 kcal): this limit applies only to follow-on formulae containing vegetable oils	—

Carbohydrates

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

Mineral substances

		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.

Vitamins

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

SCHEDULE 3 NUTRITIONAL SUBSTANCES

Vitamins

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)

Mineral substances

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

Amino acids and other nitrogen compounds

• 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

Others

• 4.  Choline

• Choline chloride

• Choline citrate

• Choline bitartrate

• Inositol

Regulation 13(3)

SCHEDULE 4 COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM

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

SCHEDULE 5 THE ESSENTIAL AND SEMI–ESSENTIAL AMINO ACIDS IN BREAST MILK

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

SCHEDULE 6 AMINO ACID COMPOSITION OF CASEIN AND BREAST MILK PROTEIN

The amino acid composition of casein and breast milk protein (g/100 g of protein):

	Casein(11)	Breast milk(11)
Arginine	3.7	3.8
Cystine	0.3	1.3
Histidine	2.9	2.5
Isoleucine	5.4	4.0
Leucine	9.5	8.5
Lysine	8.1	6.7
Methionine	2.8	1.6
Phenylalanine	5.2	3.4
Threonine	4.7	4.4
Tryptophan	1.6	1.7
Tyrosine	5.8	3.2
Valine	6.7	4.5

Regulation 9

SCHEDULE 7 THE MINERAL ELEMENTS IN COWS' MILK

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:

	per 100 g SNF(12)	per g of proteins
Sodium (mg)	550	15
Potassium (mg)	1680	43
Chloride (mg)	1050	28
Calcium (mg)	1350	35
Phosphorus (mg)	1070	28
Magnesium (mg)	135	3.5
Copper (μg)	225	6
Iodine	NS(13)	NS

(1)

Limit applicable to formulae with added iron.

(2)

RE=all trans retinol equivalent.

(3)

In the form of cholecalciferol, of which 10 μg=400 i.u. of vitamin D.

(4)

NE=Niacin equivalent=mg nicotinic acid+mg tryptophan/60.

(5)

*–TE=d–*–tocopherol equivalent.

(6)

RE=all trans retinol equivalent.

(7)

In the form of cholecalciferol, of which 10 μg=400 i.u. of vitamin D.

(8)

*–TE=d–*–tocopherol equivalent.

(9)

When determined by a method the detection limits of which will be established at a later stage.

(10)

1 kJ=0.239 kcal.

(11)

Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383.

(12)

SNF: “solids–no fats”.

(13)

NS: non specified, varies widely according to season and stock farming conditions.