Table 1.

Essential composition of infant formula in liquid or powdered form [6]

Component

Unit

Minimum

Maximum

GUL1

Energy
Proteins2
Lipids3
Total fat
Linoleic acid
-Linolenic acid
Ratio linoleic/-linolenic acid
Lauric + myristic acids
Trans fatty acids
Erucic acid
Total phospholipids
Carbohydrates4
Total carbohydrates
Vitamins
Vitamin A5
Vitamin D6
Vitamin E7
Vitamin K
Thiamin
Riboflavin
Niacin8
Vitamin B6
Vitamin B12
Pantothenic acid
Folic acid
Vitamin C9
Biotin
Minerals and trace elements
Iron
Calcium
Phosphorus
Ratio calcium/phosphorus
Magnesium
Sodium
Chloride
Potassium
Manganese
Iodine
Selenium
Copper12
Zinc
Fluoride13
Other substances
Choline
Myoinositol
L-Carnitine
Optional ingredients14, 15
Taurine
Total nucleotides16
Docosahexaenoic acid17

kcal/100 ml

60
1.8

70
3.0

g/100 kcal
mg/100 kcal
mg/100 kcal
% total fatty acids
% total fatty acids
% total fatty acids
mg/100 kcal

4.4
300
50
5:1

6.0

15:1
20
3
1
300

1,400

g/100 kcal

9.0

14.0

g RE/100 kcal
g/100 kcal
mg -TE/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
mg/100 kcal
g/100 kcal

60
1
0.5
4
60
80
300
35
0.1
400
10
10
1.5

180
2.5

5
27
300
500
1,500
175
1.5
2,000
50
70
10

mg/100 kcal
mg/100 kcal
mg/100 kcal
mg/mg
mg/100 kcal
mg/100 kcal
mg/100 kcal
mg/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
mg/100 kcal
g/100 kcal

0.45
50
25
1:1
5
20
50
60
1
10
1
35
0.5

2:1

60
160
180

100

10
140
10011

15

100
60
9
120
1.5

mg/100 kcal
mg/100 kcal
mg/100 kcal

7
4
1.2

50
40

mg/100 kcal
mg/100 kcal
% total fatty acids

12

1
C

0.5

Guidance upper levels (GULs) are for nutrients without

sufficient information for a science-based risk assessment. These values are values derived on the basis of
meeting nutritional requirements of infants and an established history of apparent safe use. Nutrient contents in infant formulae should usually not exceed the
GULs unless higher nutrient levels cannot be avoided
due to high or variable contents in constituents of infant formulae or due to technological reasons.
2 The minimum value applies to cows milk protein. For
infant formula based on non-cows milk protein other
minimum values may need to be applied. For infant formula based on soy protein isolate, a minimum value of
2.25 g/100 kcal applies. Infant formula based on nonhydrolyzed milk protein containing less than 2 g protein/100 kcal and infant formula based on hydrolyzed
protein containing less than 2.25 g protein/100 kcal
should be clinically evaluated.
3 Commercially hydrogenated oils and fats must not be
used in infant formula.
4 Lactose and glucose polymers should be the preferred
carbohydrates in formula based on cows milk protein
and hydrolysed protein. Only precooked and/or gelatinized starches, gluten-free by nature, may be added to
infant formula up to 30% of total carbohydrates and up
to 2 g/100 ml. Sucrose, unless needed, and the addition
of fructose as an ingredient should be avoided in infant
formula, because of life-threatening symptoms in
young infants with unrecognized hereditary fructose
intolerance.
5 Expressed as retinol equivalents (RE). 1 g RE = 3.33 IU.
Vitamin A = 1 g all-trans retinol. Retinol contents must
be provided by preformed retinol, while any carotenoid
content should not be included in the calculation and
declaration of vitamin A activity.
6 Calciferol: 1 g calciferol = 40 IU vitamin D.
7 1 mg -TE (-tocopherol equivalent) = 1 mg D --tocopherol. Vitamin E content must be at least 0.5 mg
-TE/g polyunsaturated fatty acid (PUFA), using the
following factors of equivalence to adapt the minimal
vitamin E content to the number of fatty acid double
bonds in the formula: 0.5 mg -TE/g linoleic acid (18:2n6); 0.75 mg -TE/g -linolenic acid (18:3n-3); 1.0 mg
-TE/g arachidonic acid (20:4n-6); 1.25 mg -TE/g eicosapentaenoic acid (20:5n-3); 1.5 mg -TE/g docosahexaenoic acid (22:6n-3).

Niacin refers to preformed niacin.

Expressed as ascorbic acid. This GUL has been set to
account for possible high losses over shelf-life in liquid
formulae; for powdered products lower upper levels
should be aimed for.
10 Levels may need to be determined by national authorities.
11 This GUL should accommodate higher needs with soy
formula.
12 Adjustment may be needed in these levels for infant
formula made in regions with a high copper content in
the water supply.
13 Fluoride should not be added to infant formula. In
any case its level should not exceed 100 g/100 kcal.
14 The following substances may be added in conformity with national legislation.
15 Only L(+)-lactic acid producing cultures may be
used.
16 Levels may need to be determined by national authorities.
17 If docosahexaenoic acid (22:6n-3) is added to infant
formula, the arachidonic acid (20:4n-6) content should
reach at least the same concentration as docosahexaenoic acid. The content of eicosapentaenoic acid (20:5n3), which can occur in sources of long-chain PUFA,
should not exceed the content of docosahexaenoic
acid. National authorities may deviate from the above
conditions, as appropriate for the nutritional needs.
9

Table 2. Essential composition of follow-on formulae (FOF) when reconstituted as instructed by the manufacturer [8]
Component

Unit

Minimum

Maximum

Energy
Proteins
FOF manufactured from cows milk proteins
FOF manufactured from protein hydrolysates
or from soy protein isolates, alone or in a
mixture with cows milk proteins
Lipids1
Total fat
Linoleic acid
-Linolenic acid
Ratio linoleic/-linolenic acid
Lauric and/or myristic acid
Trans fatty acids
Erucic acid
Phospholipids
Long-chain (20 and 22 carbon atoms)
polyunsaturated fatty acids (LCP)2
n-3 LCP
n-6 LCP
Arachidonic acid
Carbohydrates
Total carbohydrates
Lactose3
Sucrose and/or fructose and/or honey4
Glucose5
Fructo-oligosaccharides and galacto-oligosaccharides6
Vitamins
Vitamin A7
Vitamin D8
Vitamin E9
Vitamin K
Thiamin
Riboflavin
Niacin11
Vitamin B6
Vitamin B12
Pantothenic acid
Folic acid
Vitamin C
Biotin

kcal/100 ml

60

70

g/100 kcal

1.8

3.5

g/100 kcal

2.25

3.5

g/100 kcal
mg/100 kcal
mg/100 kcal

4.0
300
50
5

6.0
1,200

15
20
3
1
2

% fat
% fat
% fat
g/l
% fat

1
2
1
g/100 kcal
g/100 kcal
% carbohydrates
g/100 kcal
g/l

9.0
4.5

14.0

20
2
8

g RE/100 kcal4
g/100 kcal
mg -TE/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
g/100 kcal
mg/100 kcal
g/100 kcal

60
1
0.510
4
60
80
300
35
0.1
400
10
10
1.5

180
3
5
25
300
400
1,500
175
0.5
2,000
50
30
7.5

0.6
50
25
1
5
20
50

2
140
90
2
15
60
160

Minerals and trace elements

FOF manufactured from cows milk proteins or protein hydrolysates
Iron
mg/100 kcal
Calcium
mg/100 kcal
Phosphorus
mg/100 kcal
Ratio calcium/phosphorus
mg/mg
Magnesium
mg/100 kcal
Sodium
mg/100 kcal
Chloride
mg/100 kcal

Table 2 (continued)
Component

Unit

Minimum

Potassium
mg/100 kcal
60
Manganese
1
g/100 kcal
Iodine
10
g/100 kcal
Selenium
1
g/100 kcal
Copper
35
g/100 kcal
Zinc
mg/100 kcal
0.5
Fluoride

g/100 kcal
FOF manufactured from soy protein isolates, alone or in a mixture with cows milk proteins12
Iron
mg/100 kcal
0.9
Phosphorus
mg/100 kcal
30
Optional ingredients
Taurine
mg/100 kcal

Total nucleotides
mg/100 kcal

Cytidine 5-monophosphate

Uridine 5-monophosphate

Adenosine 5-monophosphate

Guanosine 5-monophosphate

Inosine 5-monophosphate
1

Maximum
160
100
50
9
100
1.5
100
2.5
100
12
5
2.5
1.75
1.5
0.5
1.0

The use of sesame seed oil and cotton seed oil must be
prohibited.
2
The eicosapentaenoic acid (20:5n-3) content must not
exceed the docosahexaenoic acid (22:6n-3) content.
The docosahexaenoic acid content must not exceed
that of n-6 LCP.
3
This provision does not apply to follow-on formulae in
which soy protein isolates represent more than 50% of
the total protein content.
4
Honey must be treated to destroy spores of Clostridium botulinum.
5
Glucose may only be added to follow-on formulae
manufactured from protein hydrolysates.
6
Fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS) may be added to follow-on formulae in
a combination of 90% GOS and 10% FOS.

RE = All trans retinol equivalent.

8
In the form of cholecalciferol, of which 10 g = 400 IU
of vitamin D.
9
-TE = D --Tocopherol equivalent.
10
0.5 mg -TE/g polyunsaturated fatty acids expressed
as linoleic acid as corrected for the double bonds but
in no case less than 0.5 mg/100 available kcal: 0.5 mg
-TE/1 g linoleic acid (18:2n-6); 0.75 mg -TE/1 g -linolenic acid (18:3n-3); 1.0 mg -TE/1 g arachidonic acid
(20:4n-6); 1.25 mg -TE/1 g eicosapentaenoic acid
(20:5n-3); 1.5 mg -TE/1 g docosahexaenoic acid (22:
6n-3).
11
Preformed niacin.
12
All requirements defined for FOF manufactured from
cows milk proteins or protein hydrolysates must apply.

may have some beneficial effects, there is no

unanimous agreement that an exogenous supply
is needed, at least not after the first few months of
life [11]. However, there is no evidence to suggest
that concentrations within the range found in
human milk are harmful. The addition of docosahexaenoic acid and arachidonic acids is therefore allowed in infant formula (table 1).

Ingredients Modulating the Intestinal Microflora

(see Chapter 1.7)
Prebiotics (mainly fructo-oligosaccharides and
galacto-oligosaccharides) are undigestible food
components stimulating the growth and/or activity of one or a limited number of bacteria in the
colon and thereby improving host health [12],
whereas probiotics (mainly Bifidobacterium bifi-