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The Infant Formula and Follow–on Formula Regulations 1995

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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

MinimumMaximum
250 kJ315 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

MinimumMaximum
  • 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 kJ0.7 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)

MinimumMaximum
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 kJ0.7 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

MinimumMaximum
  • 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 kJ0.7 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

MinimumMaximum
0.8 g/100 kJ1.5 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

MinimumMaximum
15% of the total fat content

(3.3) Myristic acid

MinimumMaximum
15% of the total fat content

(3.4) Linoleic acid (in the form of glycerides=linoleates)

MinimumMaximum
70 mg/100 kJ285 mg/100 kJ
(300 mg/100 kcal)1200 mg/100 kcal)

Carbohydrates

MinimumMaximum
1.7 g/100 kJ3.4 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

MinimumMaximum
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

MinimumMaximum
20% of the total carbohydrate content

(4.4) Pre–cooked starch and/or gelatinised starch

MinimumMaximum
2 g/100 ml, and 30% of the total carbohydrate content

Mineral substances

5.—(5.1) Formulae manufactured from cows' milk proteins

per 100 kJper 100 kcal
MinimumMaximumMinimumMaximum
The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.
Sodium(mg)5142060
Potassium(mg)153560145
Chloride(mg)122950125
Calcium(mg)1250
Phosphorus(mg)6222590
Magnesium(mg)1.23.6515
Iron(mg)(1)0.120.360.51.5
Zinc(mg)0.120.360.51.5
Copper(μg)4.8192080
Iodine(μg)1.25

(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 kJper 100 kcal
    MinimumMaximumMinimumMaximum
    Iron(mg)0.250.512
    Zinc(mg)0.180.60.752.4

Vitamins

per 100 kJper 100 kcal
MinimumMaximumMinimumMaximum
Vitamin A(μg–RE)(2)144360180
Vitamin D(μg)(3)0.250.6512.5
Thiamin(μg)1040
Riboflavin(μg)1460
Nicotinamide(μg–NE)(4)60250
Pantothenic
acid(μg)70300
Vitamin B6(μg)935
Biotin(μg)0.41.5
Folic acid(μg)14
VitaminB12(μg)0.0250.1
Vitamin C(mg)1.98
Vitamin K(μg)14
Vitamin E(mg*–TE)(5)0.5/g of0.5/g of
polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJpolyunsaturated 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 2ESSENTIAL COMPOSITION OF FOLLOW–ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER(All values refer to the product ready for use)

Energy

MinimumMaximum
250 kJ/100 ml335 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.

MinimumMaximum
  • 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 kJ1 g/100 kJ
(2.25 g/100 kcal)(4.5 g/100 kcal)

Lipids

MinimumMaximum
0.8 g/100 kJ1.5 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

MinimumMaximum
15% of the total fat content

(3.3) Myristic acid

MinimumMaximum
15% of the total fat content

(3.4) Linoleic acid (in the form of glycerides=linoleates)

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

Carbohydrates

MinimumMaximum
1.7 g/100 kJ3.4 g/100 kJ
(7 g/100 kcal)(14 g/100 kcal)

(4.1) The use of ingredients containing gluten is prohibited.

(4.2) Lactose

MinimumMaximum
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

MinimumMaximum
separately or as a whole: 20% of the total carbohydrate content

Mineral substances

per 100 kJper 100 kcal
MinimumMaximumMinimumMaximum
Iron(mg)0.250.512
Iodine(μg)1.25

(5.2) Zinc

(5.2.1)Follow–on formulae manufactured entirely from cows' milk proteins

MinimumMaximum
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

MinimumMaximum
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

per 100 kJper 100 kcal
MinimumMaximumMinimumMaximum
Vitamin A(μg–RE)(6)144360180
Vitamin D(μg)(7)0.250.7513
Vitamin C(mg)1.98
Vitamin E(mg*–TE)(8)0.5/g of0.5/g of
polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJpolyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.5 mg per 100 available kcal

Regulation 11

SCHEDULE 3NUTRITIONAL SUBSTANCES

Vitamins

VitaminVitamin 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

FolateFolic acid
Pantothenic acid

D–pantothenate, calcium

D–pantothenate, sodium

Dexpanthenol

Vitamin B12

Cyanocobalamin

Hydroxocobalamin

BiotinD–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 KPhylloquinone (Phytomenadione)

Mineral substances

Mineral substancesPermitted 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 4COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM

Claim related toConditions 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 5THE 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
Arginine1669
Cystine624
Histidine1145
Isoleucine1772
Leucine37156
Lysine29 122
Methionine729
Phenylalanine1562
Threonine1980
Tryptophan730
Tyrosine1459
Valine1980

Regulations 8 and 9

SCHEDULE 6AMINO 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)
Arginine3.73.8
Cystine0.31.3
Histidine2.92.5
Isoleucine5.44.0
Leucine9.58.5
Lysine8.16.7
Methionine2.81.6
Phenylalanine5.23.4
Threonine4.74.4
Tryptophan1.61.7
Tyrosine5.83.2
Valine6.74.5

Regulation 9

SCHEDULE 7THE 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)55015
Potassium (mg)168043
Chloride (mg)105028
Calcium (mg)135035
Phosphorus (mg)107028
Magnesium (mg)1353.5
Copper (μg)2256
IodineNS(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.

Yn ôl i’r brig

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