The Infant Formula and Follow–on Formula Regulations 1995

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)(1)	14	43	60	180
Vitamin D	(μg)(2)	0.25	0.75	1	3
Vitamin C	(mg)	1.9	—	8	—
Vitamin E	(mg*–TE)(3)	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

(1)

RE=all trans retinol equivalent.

(2)

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

(3)

*–TE=d–*–tocopherol equivalent.