Specialised
infant formula in
the UK
Additional information
for health
professionals
DRAFT March 2013
DRAFT Specialised Infant Milks in the UK • March 2013 • page 1
Specialised Infant Formula in the UK: Additional Information for Health Professionals
March 2013
Authors: Susan Westland and Helen Crawley
ISBN 978-1-908924-08-7
This DRAFT report is provided for information only and individual advice on diet and health
should always be sought from appropriate health professionals.
We have attempted to provide accurate information on the current composition of
specialised infant formula sold in the UK in this report, and do so in good faith. However, it
is likely that composition will change and new scientific evidence will emerge so please
refer to the specific manufacturers for up-to-date information
First Steps Nutrition Trust would welcome any comments and information from
health professionals and manufacturers to complete and update this report.
Acknowledgements
Thanks are due to all those who provided information for this report. This report is an
annexe to the report Infant Milks in the UK: A Guide for Health Professionals which can be
accessed at www.firststepsnutrition.org and which provides all the background information
needed to interpret the data in this report.
No funding has been received to compile this report. .
First Steps Nutrition Trust
www.firststepsnutrition.org
E: [email protected]
Registered charity number 1146408
First Steps Nutrition Trust is a charity that provides objective, evidence-based information
and resources about the importance of good nutrition from pre-conception to 5 years. For
more information, see our website www.firststepsnutrition.org
DRAFT Specialised Infant Milks in the UK • March 2013 • page 2
Contents
1
Introduction
1.1
1.2
2
What does this report contain?
Macro and micronutrient requirements of the Infant Formula and
Follow-on Formula (England) Regulations 2007
6
7
8
The composition of specialised infant formula
11
2.1
2.2
13
15
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
2.12
2.13
2.14
Partially hydrolysed infant formula suitable from birth
Extensively hydrolysed peptide-based infant formula suitable
from birth
Extensively hydrolysed peptide-based infant formula for older
infants
Elemental formula for non-metabolic disorders suitable from birth
Formula milks for disorders of protein metabolism suitable
from birth
High-energy formula suitable from birth
Thickened infant formula suitable from birth
Soy protein based infant formula suitable from birth
Lactose-free formula suitable from birth
Formula milks for premature and low birthweight infants
Formula milks for premature and low birthweight babies post
discharge
Modified-fat formula milks
Modified-carbohydrate formula milks
Infant formula for management of renal disease
17
19
20
24
26
29
32
35
37
39
41
43
3
Appendix
45
4
References
47
DRAFT Specialised Infant Milks in the UK • March 2013 • page 3
List of Tables
Table 1
Macro and micronutrient requirements for infant formula and followon formula
Table 2
Macro and micronutrient composition of the three main first infant
milks and mature breast milk compared to regulations for infant
formula
Table 3
Specialised infant milks available in the UK
Table 4
The nutritional composition of partially hydrolysed infant formula
suitable from birth
Table 5
The nutritional composition of extensively hydrolysed (peptidebased) infant formula milks suitable from birth
Table 6
The nutritional composition of extensively hydrolysed (peptidebased) formula milks suitable for older infants
Table 7
The nutritional composition of elemental formula for non-metabolic
disorders, suitable from birth
Table 8
The nutritional composition of formula milks for disorders of protein
metabolism, suitable from birth
Table 9
The amino acid profile of formula milks for disorders of protein
metabolism, suitable from birth
Table 10
The nutritional composition of high-energy formula milks, suitable
from birth
Table 11
The nutritional composition of thickened infant formula suitable from
birth
Table 12
The nutritional composition of soy protein based infant formula
suitable from birth
Table 13
The nutritional composition of lactose-free formula suitable from
birth
Table 14
The nutritional composition of formula milks for premature and low
birthweight infants
Table 15
The nutritional composition of formula milks for premature and low
birth weight infants post discharge (powder formulation)
Table 16
The nutritional composition of modified-fat formula milks for
disorders of fatty acid metabolism, suitable from birth
Table 17
The nutritional composition of modified-carbohydrate formula milks,
suitable from birth
Table 18
The nutritional composition of infant formula for the dietary
management of renal disease, suitable from birth
DRAFT Specialised Infant Milks in the UK • March 2013 • page 4
Acronyms
ACBS
Advisory Committee on Borderline Substances
CMPA
cows’ milk protein allergy
COT
Committee on Toxicity of Chemicals in Food, Consumer Products and the
Environment
ESPGHAN
European Society for Paediatric Gastroenterology, Hepatology and
Nutrition
DRAFT Specialised Infant Milks in the UK • March 2013 • page 5
1 Introduction
With few exceptions, the World Health Organization (WHO, 2003) and health departments
across the developed and developing world recommend exclusive breastfeeding for the first
six months of life as the best way to feed infants. Where mothers cannot or choose not to
breastfeed, breast-milk substitutes, predominantly infant formula milks, are available.
However, infant formulas are an imperfect approximation of breast milk and there are
inherent differences between breast milk and infant formula (Renfrew et al, 2012):






The exact chemical properties of breast milk are still unknown and cannot be
reproduced.
A mother’s breast milk changes in response to the feeding habits of her baby and over
time, thus adjusting to the infant’s individual growth and development needs.
Infant formula does not promote neurological development as breast milk does.
Infant formula has no positive impact on maternal health.
Breast milk includes a mother’s antibodies and many other defensive factors that help
the baby avoid or fight off infections, and gives the baby’s immature immune system the
benefit of the mother’s mature immune system.
Infant formula requires manufacturing, storage and delivery systems, which have
inherent quality control problems.
It is essential that alternatives to breast milk are available and that these are well regulated
as food products. Infant milk is unique among foods as it is the sole source of nutrition for
infants. It is vital that all those who give advice to parents and carers about infant feeding
have access to clear and objective information about the different types of infant formula
and other infant milks currently available.
Breastfeeding
This report is about modifed infant milks. It includes infant milks designed specifically for
infants who have medically diagnosed conditions and require alternatives to standard infant
formula milks. A number of modified formula milks are available to replace or complement
breastfeeding during the first two years of a child’s life.
However, First Steps Nutrition Trust strongly believes that every infant in the UK should,
where medically possible, be breastfed for the first six months of his or her life, and that
breastfeeding should then continue alongside the introduction of complementary foods for
the first year, or longer if the mother so chooses. We strongly support greater investment to
support women to breastfeed their infants.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 6
1.1 What does this report contain?
This report provides information on specialised infant formula currently available in the UK.
This information is an annexe to the report Infant Milks in the UK (available at
www.firststepsnutrition.org) which provides information for health professionals to support
parents and carers who do not require a specialised formula. That report provides
background data on the components of infant milk, and information on feeding guidance
and on making up infant milks safely, and should ideally be read alongside this report.
1.2
Macro and micronutrient requirements of the Infant Formula and
Follow-on Formula (England) Regulations 2007
Table 1 gives a summary of the compositional requirements of the Infant Formula and
Follow-on Formula (England) Regulations 2007.
Table 2 outlines the average composition of the three main typical first milks in the UK
compared to breast milk and the regulations. Where specialised formula have a
composition in line with recommendations, it is likely to be similar to average first milk
composition and so this information is not repeated for each formula.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 7
TABLE 1 Macro and micronutrient requirements for infant formula and follow-on
formula
Infant formula
Energy kJ
kcal
Protein g
Carbohydrate g
– of which lactose g
Fat g
Linoleic acid mg
Linolenic acid mg
Prebiotic fibre g
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Copper µg
Fluoride µg
Iodine µg
Iron3 mg
Magnesium mg
Manganese µg
Phosphorus3 mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
OTHER
Choline mg
Taurine mg
Nucleotides mg
Inositol mg
L-carnitine mg
Min/100ml
250
60
Min/100kcal
1.8
9.0
4.5
4.4
300
50
N/S
Follow-on formula
Max/100ml
295
70
Max/100kcal
3.0
14.0
N/S
6.0
1200
N/S
0.81
Min/100ml
250
60
Min/100kcal
1.8
9.0
4.5
4.0
300
50
N/S
Max/100ml
295
70
Max/100kcal
3.5
14.0
N/S
6.0
1200
N/S
0.81
60
10
0.5 2
1.0
4
60
80
300
35
0.1
10
1.5
400
180
30
5.0
2.5
25
300
400
1500
175
0.5
50
7.5
2000
60
10
0.5 2
1.0
4
60
80
300
35
0.1
10
1.5
400
180
30
5.0
3.0
25
300
400
1500
175
0.5
50
7.5
2000
50
50
35
N/S
10
0.3
5.0
1.0
25
60
1.0
20
0.5
140
160
100
100
50
1.3
15
100
90
160
9.0
60
1.5
50
50
35
N/S
10
0.6
5.0
1.0
25
60
1.0
20
0.5
140
160
100
100
50
2.0
15
100
90
160
9.0
60
1.5
7
N/S
N/S
4.0
1.2 4
50
12
5.0
40
N/S
N/S
N/S
N/S
N/S
N/S
N/S
12
5.0
N/S
N/S
N/S = not significant
1 Fructo-oligosaccharides and galacto-oligosaccharides (prebiotic fibre) may be added to infant formula. In that
case their content shall not exceed: 0.8g/100ml in a combination of 90% oligogalactosyl-lactose and 10% high
molecular weight oligofructosyl-saccharose.
2 Vitamin E: 0.5mg/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds
but in no case less than 0.5mg per 100kcal, and maximum 5.0mg/100kcal.
3 For products manufactured from soya protein isolates or in a mixture with cows’ milk, minimum and maximum
values for iron for infant formula are 0.45mg and 2.0mg respectively and for follow-on formula 0.9mg and 2.5mg
respectively. For phosphorus, minimum and maximum values for both infant and follow-on formula are 30mg
and 100mg respectively.
4 The L-carnitine concentration is specified only for formula containing protein hydrolysates or soya protein
isolates.
Source: Infant Formula and Follow-on Formula (England) Regulations 2007
DRAFT Specialised Infant Milks in the UK • March 2013 • page 8
TABLE 2. Average macro and micronutrient composition of average first infant milk
and mature breast milk compared to regulationsfor infant formula.
Average for first
infant milks
Mature
breast milk
Per 100ml
Per 100ml
Regulations for infant formula
(re-calculated by volume)
Min/100ml
Max/100ml
MACRONUTRIENTS
Energy kJ
kcal
Protein g
Carbohydrate g
– of which lactose g
Fat g
Linoleic acid mg
Linolenic acid mg
280
66.3
1.3
7.4
7.1
3.5
490.7
72.3
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
58
9.1
1.0
1.2
5.2
66.7
114.0
453.3
46.7
0.2
12.3
1.7
336.7
82
4.0
0.34
0.2-3.11
0.2-0.91
20
30
200
10
0.02-0.11
5
0.7
250
40
6.7
0.34*
0.67
2.68
40.2
53.6
201
23.45
0.07
6.7
1.01
268
121
20.1
3.35
1.68
16.75
201
268
1005
117.25
0.34
33.5
5.03
1340
45.3
42.3
37.7
3.1
11.3
0.6
4.9
6.7
25.3
65.0
1.5
16.7
0.5
34
42
40
71
7
0.7
3
2.71
15
58
1
15
0.3
34
33.5
23.45
N/S
6.7
0.2
3.35
0.67
16.8
40.2
0.67
13.4
0.34
94
107.2
67
67
33.5
0.87
10
67
60.3
107.2
6.0
40.2
1.0
16 3
3.8 4
3-7 5
2.6 6
0.7 7
4.7
N/S
N/S
2.68
0.8***
33.5
8.0
3.35
26.8
N/S
MINERALS
Calcium mg
Chloride mg
Copper µg
Fluoride µg
Iodine µg
Iron** mg
Magnesium mg
Manganese µg
Phosphorus**mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
OTHER
Choline mg
Taurine mg
Nucleotides mg
Inositol mg
L-carnitine mg
See the notes on the next page.
10
5.1
3.0
3.8
1.1
290
69
1.11
7.2
6-71
3.9
5602
722
250
60
1.2
6.0
3.0
2.9
200
33.5
DRAFT Specialised Infant Milks in the UK • March 2013 • page 9
295
70
2.0
9.4
N/S
4.0
800
N/S
Note: Where regulations do not state a minimum amount, they are not considered a requirement. In these
cases, the average stated for currently available first infant milks does not include those milks where the
ingredient is not present.
N/S = not significant
*
Vitamin E: 0.5mg/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double
bonds but in no case less than 0.5mg per 100kcal, and maximum 5.0mg/100kcal.
** For products manufactured from soya protein isolates or in a mixture with cows’ milk, minimum and
maximum values for iron for infant formula are 0.45mg and 2.0mg respectively and for follow-on formula
0.9mg and 2.5mg respectively. For phosphorus, minimum and maximum values for both infant and follow-on
formula are 30mg and 100mg respectively.
*** The L-carnitine concentration is specified only for formula containing protein hydrolysates or soya protein
isolates.
Sources:
Average for first infant milks: taken from an average of the three main first infant milks sold in the UK.
Mature breast milk composition: Food Standards Agency (2002) except for: 1 Royal College of Midwives (2009);
2 Specker et al (1987); 3 Holmes-McNary et al (1996); 4 Agostoni et al (2000); 5 Carver (2003); 6 Pereira et al
(1990); 7 Mitchell et al (1991).
Regulations for infant formula: Infant Formula and Follow-on Formula (England) Regulations 2007.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 10
2. Specialised infant milks
available in the UK
Table 3 outlines specialised formula available in the UK. Lactose-free formula and partially
hydrolysed formula are available to puchase by parents and carers and are included both in
this report and in the report Infant Milks in the UK.
TABLE 3 Specialised infant milks available in the UK
Category
Names of infant milks included in
this category
Partially hydrolysed infant formula suitable from
birth1
Aptamil Comfort
Cow and Gate Comfort Milk
SMA Comfort
Extensively hydrolysed peptide-based infant
formula suitable from birth
Aptamil Pepti 1
Cow & Gate Pepti-junior
Mead Johnson Nutramigen LIPIL 1
SHS Nutricia Pepdite
SHS Nutricia Pepdite MCT
SHS Nutricia Infatrini Peptisorb
Extensively hydrolysed peptide-based formula
for older infants
Aptamil Pepti 2
Mead Johnson Pregestimil LIPIL
Mead Johnson Nutramigen LIPIL 2
SHS Nutricia Pepdite 1+
SHS Nutricia Pepdite MCT 1+
Elemental formula for non-metabolic disorders,
suitable from birth
Mead Johnson Nutramigen AA
Formula milks for disorders of protein
metabolism, suitable from birth
SHS Nutricia GA1 Anamix Infant
SHS Nutricia Neocate LCP
SHS Nutricia HCU Anamix Infant
SHS Nutricia IVA Anamix Infant
SHS Nutricia MMA/PA Anamix Infant
SHS Nutricia MSUD Anamix Infant
SHS Nutricia NKH Anamix Infant
SHS Nutricia TYR Anamix Infant
Vitaflo PKU start
1
These milks are not prescribable but have been included here as some people may consider them specialised
DRAFT Specialised Infant Milks in the UK • March 2013 • page 11
Table 3: Specialised infant milks available in the UK
Category
Names of infant milks included in
this category
High-energy formula milks, suitable from birth
Abbott Nutrition Similac High Energy
SHS Nutricia Infatrini
SMA High Energy
Thickened infant formula suitable from birth1
Aptamil Anti-Reflux
Mead Johnson Enfamil AR
Soy protein based infant formula suitable from
birth1
Lactose-free infant formula suitable from birth1
SMA Staydown
Cow & Gate Infasoy
SMA Wysoy
Mead Johnson Enfamil O-Lac
SMA LF
Formula milks for premature and low birthweight
infants
Aptamil Preterm
Cow & Gate Nutriprem 1
SMA Gold Prem 1
Formula milks for premature and low birthweight
infants post-discharge (powder formulation)
Cow & Gate Nutriprem 2
Modified fat formula milks for disorders of fatty
acidmetabolism, suitable from birth
SHS Nutricia Caprilon
SMA Gold Prem 2
SHS Nutricia Monogen
Vitaflo Lipistart
Modified carbohydrate formula milks, suitable
from birth
SHS Nutricia Galactomin 17
Infant formula for the dietary management of
renal disease, suitable from birth
SHS Nutricia Kindergen
1
SHS Nutricia Galactomin 19
Vitaflo Renastart
These milks are not prescribable but have been included here as some people may consider them specialised
DRAFT Specialised Infant Milks in the UK • March 2013 • page 12
2.1 Partially hydrolysed infant formula suitable from birth
Key points
Infant formula containing partially hydrolysed proteins are marketed as ‘easier to digest’.
They are based on modified cows’ milk with 100% whey protein.
A recent paper from a large randomised trial in healthy term infants fed formula milks
containing partially hydrolysed protein and reduced lactose, or a standard infant formula,
reported that there was no difference in tolerance of intact compared to partially hydrolysed
protein (Berseth et al, 2009).
The National Institute for Health and Clinical Excellence (NICE) considers that there is
insufficient evidence to suggest that infant formulas based on partially or extensively
hydrolysed cows’ milk protein can help prevent allergies (National Institute for Health and
Clinical Excellence, 2008).
Infant milks containing partially hydrolysed proteins are marketed as ‘easier to digest’. In
the UK there are three partially hydrolysed infant formulas available: Aptamil Comfort, SMA
Comfort and Cow & Gate Comfort. They are all modified cows’ milk formula based on 100%
whey protein and contain lactose and soya. None of these three milks is suitable for
vegetarians.
Aptamil Comfort, launched in 2007, is suggested as suitable for infants experiencing
‘feeding discomfort’ and the range of conditions it is claimed to help improve include colic,
lactose intolerance, constipation and regurgitation (also known as possetting or reflux).
Both products contain partially hydrolysed proteins, structured vegetable oils, reduced
lactose, and prebiotics. Cow & Gate Comfort is formulated for ‘comfortable digestion’ and is
claimed to help protect the immature, sensitive digestive system. It has an identical nutrient
profile to Aptamil Comfort and SMA Comfort Milk.
Partially hydrolysed formulas represent the trend towards manufacturers ‘medicalising’
infant formula. They also demonstrate that, in the absence of a consensus of scientific
opinion on the most effective method to manage minor digestive problems, manufacturers
are able to manipulate the composition of formula within the regulations to produce a range
of formulations, each of which purports to be the most effective method of easing common
conditions in infants. A recent paper from a large randomised trial of healthy-term infants
given either a standard full-lactose non-hydrolysed cows’ milk protein based infant milk or a
70% lactose, partially hydrolysed whey protein formula over 60 days reported that there
was no difference in tolerance of intact compared to partially hydrolysed protein (Berseth et
al, 2009). The authors noted that parents may mistake behaviours common in early infancy,
such as regurgitation and excessive crying, as manifestations of babies’ intolerance to their
infant milk and unnecessarily switch brands or types of milk. The National Institute for
Health and Clinical Excellence (NICE) considers that there is insufficient evidence to
suggest that infant formulas based on partially or extensively hydrolysed cows’ milk protein
can help prevent allergies (National Institute for Health and Clinical Excellence, 2008).
The nutritional composition and ingredients used in partially hydrolysed infant formula
suitable from birth are given in Table 4.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 13
TABLE 4. The nutritional composition of partially hydrolysed infant formula suitable
from birth
Nutrients per 100ml
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
Carbohydrate g
– of which lactose g
Carbohydrate source
Fat g
Added LCPs AA
DHA
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
OTHER
Structured vegetable
oils
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for
vegetarians1
Halal approved
Aptamil
Comfort
Cow & Gate
Comfort
SMA Comfort
66
1.5
100:0
66
1.5
100:0
67
1.6
100:0
7.2
2.7
Lactose,
glucose syrup,
potato and corn
starch
3.4


7.2
2.7
Lactose,
glucose syrup,
potato and corn
starch
3.4


7.1
3.9
Lactose, corn
syrup solids,
maltodextrin




































ANS
ANS

3.6


AA = arachidonic acid
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
ANS = approval not sought
1
Formula milks derived from cows’ milk are generally not suitable for vegetarians due to the inclusion of fish
oils and/or the use of the animal-derived enzyme rennet during the production process. Rennet is used to
separate curds from whey and, although vegetarian alternatives are available, they are not used by all
manufacturers.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 14
2.2 Extensively hydrolysed peptide-based infant formula suitable
from birth
These milks are designed for cows’ milk protein allergy, severe food intolerance or multiple
food allergy and malabsorption in infants from birth.
The indications given for use of these infant formula as given by the manufacturers are:
Aptamil Pepti 1:
Cows’ milk protein allergy and intolerance
Cow and Gate Pepti-junior:
Malabsorption and severe food intolerance
Mead Johnson Nutramigen LIPIL 1: Severe and multiple food allergies
Mead Johnson Pregestimil LIPIL:
Allergy, malabsorption and maldigestion
SHS Nutricia Infatrini Peptisorb:
Whole protein intolerance, malabsorption,
maldigestion, malnutrition
SHS Nutricia Pepdite:
Whole protein intolerance, malabsorption,
maldigestion
SHS Nutricua Pepdite MCT:
Whole protein intolerance, malabsorption,
maldigestion (fats)
DRAFT Specialised Infant Milks in the UK • March 2013 • page 15
TABLE 5. The nutritional composition of extensively hydrolysed (peptide-based)
infant formula milks suitable from birth
Aptamil
Pepti 1
Cow & Gate
Pepti-junior
Mead
Johnson
Nutramig
en LIPIL
1
Mead
Johnson
Pregestimi
l LIPIL
SHS Nutricia
Infatrini
Peptisorb
SHS
Nutricia
Pepdite
SHS
Nutricia
Pepdite
MCT
67
1.6
Milk
66
1.8
Milk
68
1.9
Milk
68
1.89
Milk
100
2.6
Milk
100:0
7.1
2.9
100:0
6.8
<0.1
0:100
7.5
0
0:100
6.9
0
100:0
10.3
0.1
71
2.1
Meat,
soya
NA
7.8
0
68
2.0
Pork,
soya
NA
8.8
0
Carbohydrate
source
Lactose,
maltodex
trin
Glucose
syrup
Glucose
polymers
modified
corn
starch
Glucose
polymers
modified
corn starch
Maltodextrin,
glucose
syrup
Dried
glucose
syrup
Dried
glucose
syrup
Fat g
- as MCT oils %
Added LCPs AA
DHA
LCP source
3.5
NA


Fish oil
3.5



Fish oil
3.4
12


Single
cell oils
3.8
53


Single
cell oils
5.4
50


Fish oil
3.5
5


NA
2.7
75


NA




















































































NK
280
NK
210

280

280
NK
350
NK
237
NK
290
Nutrients per 100ml
Energy kcal
Protein g
Protein source
Whey:casein ratio
Carbohydrate g
– of which lactose g
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
OTHER
Structured
vegetable oils
(beta-palmitate)
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for
vegetarians
Halal approved
Osmolality
mOsmol/kg H2O
AA = arachidonic acid
NA = not applicable
DHA = docosahexaenoic acid
NK = not known
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 16
2.3 Extensively hydrolysed peptide-based formula for older infants
These milks are designed for cows’ milk protein allergy, severe food intolerance or multiple
food allergy and malabsorption in infants from 6 months or 12 months of age.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 17
TABLE 6. The nutritional composition of extensively hydrolysed (peptide-based)
formula milks suitable for older infants
Nutrients per 100ml
Aptamil Pepti
2
Mead Johnson
Nutramigen
LIPIL 2
Energy kcal
Protein g
Protein source
Whey:casein ratio
Carbohydrate g
– of which lactose g
Carbohydrate source
Fat g
– as MCT oils %
Added LCPs AA
DHA
LCP source
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
OTHER
Structured vegetable
oils (beta-palmitate)
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for
vegetarians
Halal approved
Osmolality
mOsmol/kg H2O
SHS Nutricia
Pepdite MCT
1+
Whole protein
intolerance,
malabsorption,
maldigestion
(fats)
Severe/
multiple
food allergy
Cows' milk
protein
allergy
intolerance
SUITABLE FROM
Whole protein
intolerance,
malabsorption,
maldigestion
INDICATIONS
SHS Nutricia
Pepdite
1+
6 months
6 months
12 months
12 months
68
1.6
Milk
100:0
8.0
2.9
68
1.7
Milk
0:100
8.6
0
100
3.1
Meat, soya
NA
13.0
0
91
2.8
Pork, soya
NA
11.8
0
Lactose,
maltodextrin
Dried glucose
syrup
Dried glucose
syrup
3.1
NA


Fish oil
Glucose
polymers,
modified corn
starch, fructose
2.9
12


Single cell oils
3.9
35


NA
3.6
75


NA
















































NK
290

340
NK
465
NK
460
NK = Not known
DRAFT Specialised Infant Milks in the UK • March 2013 • page 18
2.4 Elemental formula for non-metabolic disorderssuitable from birth
TABLE 7. The nutritional composition of elemental formula for non-metabolic
disorders, suitable from birth
Nutrients per 100ml
INDICATIONS
MACRONUTRIENTS
Energy kcal
Protein g
Protein source
Carbohydrate g
– of which lactose g
SHS Nutricia Neocate LCP
Mead Johnson Nutramigen AA
Cows’ milk allergy and multiple
food protein intolerance
Severe/multiple food allergy
67
1.8
Non-allergenic amino-acids
7.2
0
68
1.89
Non-allergenic amino-acids
7.0
0
Carbohydrate source
Fat g
– as MCT oils %
Added LCPs AA
DHA
LCP source
MICRONUTRIENTS
Vitamins meeting
regulations1
Minerals meeting
regulations1
OTHER
Structured vegetable
oils (beta-palmitate)
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for
vegetarians
Halal approved
Osmolality
mOsmol/kg H2O
AA = arachidonic acid
NK = not known
Dried glucose syrup
3.4
0


Single cell vegetable oils
Glucose polymers, modified corn
starch
3.6
12


Single cell oils
























NK
340
NK
348
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 19
2.5 Formula for disorders of protein metabolism suitable from birth
Nutricia Anamix is available in a number of formulations suitable for different protein
disorders, and the amino acid composition of each individual product is given in Table 9.
There are two products that are mentioned in the literature but for which no additional data
appears to be available:

SHS Nutricia HyperLYS Anamix Infant (For dietary management of
Hyperlysinaemia)

SHS Nutricia PKU Anamix Infant SHS Nutricia SOD Anamix Infant (For dietary
management of sulphite oxidase deficiency)
DRAFT Specialised Infant Milks in the UK • March 2013 • page 20
TABLE 8. The nutritional composition of formula milks for disorders of protein
metabolism, suitable from birth
Nutrients per 100ml
SHS Nutricia Anamix
Infant1
Vitaflo PKU Start
691
2 (2.3)
7.41
0.24
68
2.0
8.3
4.4
Glucose syrup
3.5


97
Single cell oils
Glucose syrup, lactose
2.9





Manganese marginally high
58.8
7.4
0.69
1.3
5.6
80
80
330 (1)
80
0.18
8.3
2.7
420
100
17
0.70
1.7
6.0
50
100
900 (1.7)
40
0.2
8.0
1.7
400
61.5
53.3
2.1
64.5
12.5
1.2
8.7
60
1.8
45
75.2
2.3
60
34
2.0
50
10
0.8
6.0
70
4.0
45
60
2.0
MACRONUTRIENTS
Energy kcal
Protein (amino acids) g
Carbohydrate g
– of which lactose g
Carbohydrate source
Fat g
Added LCPs AA
DHA
LCT %
LCP source
Fish oil
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Chromium µg
Copper µg
Iodine µg
Iron mg
Magnesium mg
Manganese µg
Molybdenum µg
Phosphorus mg
Potassium mg
Selenium µg
DRAFT Specialised Infant Milks in the UK • March 2013 • page 21
Nutrients per 100ml
SHS Nutricia Anamix
Infant1
Vitaflo PKU Start
Sodium mg
Zinc mg
28.7
0.86
24
0.9
OTHER
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians
Halal approved
Osmolality mOsm/kg H2O








NK
NK
380










483
AA = arachidonic acid
ANS = approval not sought
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
LCT = Long-chain triglycerides
1
GA1, HCU, IVA, MMA/PA, MSUD, NKH, PKU and TYR Anamix Infant formulas vary mainly by their aminoacid profiles, (see Table 9) with the exception of NKH Anamix Infant which has a marginally higher energy
content (70 kcal/100ml) and a marginally lower carbohydrate content (7.3g/100ml).
DRAFT Specialised Infant Milks in the UK • March 2013 • page 22
TABLE 9 The amino-acid profile of formula milks for disorders of protein
metabolism, suitable from birth
Nutrients (g) per
100ml
GA1
Anamix
Infant
HCU
Anamix
Infant
IVA
Anamix
Infant
Anamix
Infant
MSUD
Anamix
Infant
NKH
Anamix
Infant
PKU
Anamix
Infant
TYR
Anamix
Infant
Vitaflo
PKU
Start
Phenylketonuria
Tyrosinaemia
Phenylketonuria
Non-ketotic
hypergycinaemia
Maple Syrup Urine
Disease
Isovaleric
acidaemia
Homocystinuria
Glutaric aciduria
Methylmalonic
acidaemia /Propionic
acidaemia
INDICATIONS
MMA/P
A
ESSENTIAL AND
CONDITIONALLY
ESSENTIAL
L-Arginine
L-Cystine
L-Histidine
L-Isoleucine
0.18
0.07
0.1
0.16
0.16
0.06
0.09
0.15
0.18
0.07
0.11
0.06
L-Leucine
0.27
0.25
0.32
nil
added
0.04
0.17
nil
added
0.16
0.05
L-Lysine
L-Methionine
0.21
0.08
0.14
0.21
0.08
0.12
nil
added
nil
added
0.22
0.17
0.06
0.1
0.16
0.16
0.06
0.09
0.14
0.18
0.07
0.1
0.16
0.15
0.06
0.09
0.16
0.26
0.24
0.27
0.25
0.18
0.17
0.19
0.17
nil
added
0.14
0.05
0.04
0.04
0.04
0.04
0.14
0.12
nil
added
0.06
0.14
0.16
0.13
nil
added
0.12
nil
added
0.13
nil
added
0.16
0.06
0.14
0.05
0.12
0.05
0.22
0.05
0.24
<0.007
0.21
L-Phenylalanine
0.12
nil
added
0.11
L-Threonine
0.13
0.12
0.11
L-Tryptophan
L-Tyrosine
0.01
0.12
0.05
0.11
0.04
0.12
L-Valine
0.17
0.16
0.07
nil
added
nil
added
0.17
0.16
0.05
nil
added
0.18
NON-ESSENTIAL
L-Aspartic acid
L-Serine
L-Glutamic acid
0.1
0.12
0.02
0.14
0.11
0.02
0.15
0.1
0.02
0.19
0.13
0.02
0.18
0.14
0.02
0.16
0.11
0.02
0.15
0.11
0.21
0.15
0.12
0.02
L-Proline
Glycine
0.19
0.16
0.18
0.15
0.33
0.33
0.1
0.1
0.23
0.19
0.17
0.14
0.2
0.16
L-Alanine
L-Carnitine
Taurine
0.1
0.002
0.005
0.1
0.002
0.005
0.11
0.002
0.005
0.24
0.002
0.005
0.12
0.002
0.005
0.18
nil
added
0.1
0.002
0.005
0.24
0.11
nil
added
0.17
0.24
0.09
0.002
0.005
0.1
0.002
0.005
0.12
0.002
0.004
0.12
DRAFT Specialised Infant Milks in the UK • March 2013 • page 23
0.18
2.6 High-energy formula suitable from birth
TABLE 10. The nutritional composition of high-energy formula milks, suitable from
birth
Nutrients per 100ml
INDICATIONS
SHS Nutricia
Infatrini
Faltering
growth, require
fluid restriction,
increased
nutritional
requirements
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
Abbott Nutrition
Similac High
Energy
Faltering growth,
require fluid
restriction,
increased
nutritional
requirements
SMA High
Energy
Disease-related
malnutrition,
growth failure,
malabsorption
100
2.6
101
2.6
60:40
91
2.0
60:40
Carbohydrate g
– of which lactose g
Carbohydrate source
10.3
5.2
Maltodextrins,
lactose
9.8
9.8
Lactose
Carbohydrate source
Maltodextrins,
lactose
5.4


10.3
5.26
Lactose,
maltodextrins,
monosaccharides
Lactose,
maltodextrins,
monosaccharides
5.4








81
12
1.2
1.7
6.7
150
150
(1.2)
60
0.41
15
2.3
450
100
12
2.0
1.7
7.0
150
250
1200 (1.98)
90
0.3
14
4.5
440
100
12
1.0
1.4
9.1
140
200
670 (1.11)
80
0.3
11
2.7
400
80
55
60
80
55
60
57
51
45
Fat g
Added LCPs AA
DHA
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Copper µg
Lactose
4.9


DRAFT Specialised Infant Milks in the UK • March 2013 • page 24
Nutrients per 100ml
Iodine µg
Iron mg
Magnesium mg
Manganese µg
Phosphorus mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
OTHER
Structured vegetable
oils
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for
vegetarians
Halal approved
Osmolality
mOsm/kg H2O
AA = arachidonic acid
SHS Nutricia
Infatrini
SMA High
Energy
15
1.0
8.3
100
40
95
2.0
25
0.9
Abbott Nutrition
Similac High
Energy
16
1.1
9.0
55
42
90
1.9
25
0.7



















1









ANS
345
ANS
333

387
14
1.1
9.1
57
42
88
1.9
22
0.82
DHA = docosahexaenoic acid
1 Contains vitamin D synthesised from cholesterol, extracted from the grease in wool sheared from live sheep.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 25
2.7 Thickened infant formula suitable from birth
Key points
Thickened infant formula with added rice, corn starch or carob bean gum are suggested to
help improve gastro-oesophageal reflux, but there is little evidence that these products offer
any such benefit.
While some studies have shown that thickened infant formula can reduce regurgitation in
some infants, their use in infants with simple reflux is not supported by the ESPGHAN
Committee on Nutrition.
It is suggested that, where infants have simple reflux and no complications, parents and
carers require advice and information rather than a different type of formula.
Thickened infant formulas have been formulated to help improve gastro-oesophageal reflux
(bringing up milk into the oesophagus) and vomiting or spitting up feeds in formula-fed
infants. Whilst reflux does not generally result in pathologic consequences and resolves
spontaneously by about 3 months of age in the majority of cases, many parents seek
remedies (Vanderhoof et al, 2003) and these milks have been developed to meet this
actual or perceived need.
In the UK there are three thickened infant formulas available – Aptamil Anti-Reflux
(Danone), Enfamil AR (Mead Johnson) and SMA Staydown (SMA Nutrition). All of these
formulas are available on prescription and over the counter at pharmacies and they can all
be used from birth. The thickening agent used in Aptamil Anti-Reflux is carob bean gum,
whilst that used in Enfamil AR is rice starch and in SMA Staydown maize (corn) and starch
is the thickening agent. SMA Staydown has a whey:casein ratio of 20:80 to slow gastric
emptying; it is suggested that the added pre-cooked maize starch thickens on contact with
stomach acid, increasing the time taken for the milk to pass through the stomach. SMA
supports the use of this milk by reference to clinical trials (Ramirez-Mayans et al, 2003;
Xinias et al, 2003), although the role of gastric emptying in the pathogenesis of gastrooesophageal reflux in infants is considered to be controversial (Tolia et al, 1992). In a
systematic review of non-pharmacological and non-surgical therapies for gastrooesophageal reflux in infants, Carroll et al (2002) concluded that thickened infant formulas
do not appear to reduce measurable reflux, although they may reduce vomiting.
. SMA Nutrition suggests that rice starch is associated with constipation, whilst Enfamil
suggest that rice starch is the natural choice for thickening milks as it is typically used as a
first weaning food. The study by Vanderhoof et al (2003) concluded that Enfamil AR did not
cause constipation, while in the study by Ramirez-Mayans et al (2003), 3 out of 24 infants
being fed milk containing 5% (5g/100ml) rice starch suffered constipation.
Aptamil Anti-Reflux is the most recent thickened milk to become available on the UK
market. The whey:casein ratio is 20:80 and the thickening agent is carob bean gum. It is
suggested that carob bean gum is not split by salivary amalyse and therefore maintains the
viscosity of the feed into the stomach (Wenzl et al, 2003). Danone support the use of their
product by reference to clinical trials using their products. A prospective, double-blinded trial
in 20 infants reported that, whilst regurgitation frequency was reduced in both groups, there
DRAFT Specialised Infant Milks in the UK • March 2013 • page 26
was no change in the regurgitation frequency between groups receiving the thickened
formula and the placebo group, although there was a significant decrease in the length of
time of oesophageal acid exposure (Vandenplas et al, 1994). In a futher placebo-controlled
cross-over study in 14 healthy infants, the frequency and amount of regurgitation were
reduced after consuming an infant formula thickened with carob bean gum, compared to
when the infants were fed the same formula without thickener, but there was no significant
reduction in the occurrence or duration of acid gastroesophageal reflux (GER). However,
the decrease in regurgitation was thought to have resulted from the decrease in the number
of non-acid GER episodes when thickened formula milk was consumed (Wenzl et al, 2003).
A more recent clinical trial, including 60 infants and their carers, was designed to evaluate
the efficacy of parental reassurance in combination with three different types of formula
milk. This trial reported that regurgitation frequency was reduced in all three groups, and
there was no significant difference in regurgitation frequency between groups receiving
standard formula milk, formula milk thickened with rice cereal, or infant formula thickened
with bean gum. All participating parents were reassured in the same way. The only
significant difference between groups was that infants receiving formula milk thickened with
bean gum experienced a greater increase in weight during the trial. The authors suggest
that this effect may be due to the greater (although not statistically significant) decrease in
regurgitation frequency in this group (Hegar et al, 2008).
It has been suggested that commercially prepared thickened infant formulas have an
advantage over thickeners added to milk at home as the latter type may lead to
inconsistencies in composition (Ramirez-Mayans et al, 2003). Milk thickeners to add to milk
include Instant Carobel (Cow & Gate), which uses carob bean gum as a thickening agent.
Whilst some studies have shown that thickened infant formula can reduce regurgitation in
some infants, their use in infants with simple reflux is not supported by the ESPGHAN
Committee on Nutrition on the grounds that there is no conclusive information available on
the potential effects of thickening agents on the bioavailability of nutrients and growth of
children, or on mucosal, metabolic and endocrine responses (Aggett et al, 2002). There is
also very little evidence to suggest that these milks confer any benefits with respect to acid
exposure of the oesophageal mucosa or bronchopulmonary complications of gastrooesophageal reflux. It is suggested that, where infants have simple reflux and no
complications, parents and carers require advice and information rather than a different
type of formula (Aggett et al, 2002).
The nutritional composition and ingredients used in thickened infant formula suitable from
birth are given in Table 11.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 27
TABLE 11. The nutritional composition of thickened infant formula suitable from birth
Nutrients per 100ml
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
Carbohydrate g
– of which lactose g
Carbohydrate source
Fat g
Added LCPs AA
DHA
In approved ratio
LCP source
MICRONUTRIENTS
Vitamins meeting regulations
Minerals meeting regulations
OTHER
Structured vegetable oils
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians1
Halal approved
AA = arachidonic acid
NA = not applicable
1
Aptamil AntiReflux
Mead Johnson
Enfamil AR
SMA Staydown
66
1.6
20:80
6.8
6.1
Lactose,
maltodextrin, carob
bean gum
3.5



Vegetable and fish
oils
68
1.7
20:80
7.6
4.6
Lactose, glucose
polymers, rice starch
67
1.6
20:80
7.0
5.2
Lactose, gelatinised
maize starch
3.5



Single cell oils
(vegetable source)
3.6



Fungal and algal oils
(vegetable source)
















ANS






















DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
Formula milks derived from cows’ milk are generally not suitable for vegetarians due to the inclusion of
fish oils and/or the use of the animal-derived enzyme rennet during the production process. Rennet is
used to separate curds from whey and, although vegetarian alternatives are available, they are not used
by all manufacturers.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 28
2.8 Soy protein based infant formula suitable from birth
Key points
Soy protein based infant formula are free of any animal products. The protein is from soya
beans, and the carbohydrate source is usually glucose and dried glucose syrup.
Soy protein based infant formula have sometimes been used for children who have an
allergy or intolerance to cows’ milk, or because they have a specific condition such as
galactosaemia or galactokinase deficiency.
Concerns have been raised over the potential allergenic effect of soy protein based milks in
infants at high risk of atopy and over the effects that the phyto-oestrogens present in soy
protein based milks might have on future reproductive health.
Whilst soy protein based infant formula have been shown to support normal growth and
development in healthy-term infants, the Chief Medical Officer has recommended that soy
protein based milks should not be used for infants under 6 months of age who have cows’
milk protein allergy or intolerance.
The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment
(COT) concluded that the high levels of phyto-oestrogens present in soy protein based
formula posed a potential risk to the future reproductive health of infants (Committee on
Toxicity, 2003).
When the carbohydrate source is glucose rather than lactose, formula have a greater
potential to cause dental caries. Parents and carers using these formula are advised to
avoid prolonged contact of milk feeds with their baby’s teeth and to ensure that they clean
their baby’s teeth after the last feed at night.
Advice in the UK is that parents should always seek advice before feeding their infant soy
protein based infant formula.
Soy protein based infant are free of any animal products, the protein source is soya bean,
and the carbohydrate source is usually glucose and dried glucose syrup. The amino-acid
profile of soy protein is deficient in sulphur-containing amino acids, and soy protein based
infant formula must therefore be fortified with the sulphur-containing amino acid LMethionine. Soy protein based infant formula are available both over the counter and by
prescription and may be used from birth. They have sometimes been used for children who
require an alternative to cows’ milk based infant milks because they have an allergy or
intolerance to cows’ milk, or because they have a specific condition such as galactosaemia
or galactokinase deficiency.
There is currently controversy over the use of soy protein based infant formula for children
aged under 6 months. Concerns have been raised over the potential allergenic effect of soy
protein based formula in infants at high risk of atopy and over the effects that the phytooestrogens present in soy protein based infant formula might have on future reproductive
health (Committee on Toxicity, 2003).
DRAFT Specialised Infant Milks in the UK • March 2013 • page 29
In a systematic review of clinical studies examining measures of infant health and
development and comparing soy protein based infant formula with cows’ milk protein based
infant milk and/or human milk, Mendez et al (2002) concluded that modern soy protein
based infant formula (supplemented with methionine) support normal growth and
development in healthy-term infants during the first year of life.
Soy protein based infant formulas have often been used as an alternative to cows’ milk
protein based infant milks in children with cows’ milk protein allergy (CMPA). In a review of
trials comparing the effect of prolonged feeding of soy protein based infant formula and of
cows’ milk protein based infant formula, meta-analysis found no significant difference in
childhood asthma incidence, childhood eczema incidence or childhood rhinitis. The authors
concluded that soy protein based infant formula cannot be recommended for allergy
prevention or food intolerance in infants at high risk of atopy (Osborn and Sinn, 2006).
It is recognised that a proportion of children with CMPA are also allergic to soy protein. The
Chief Medical Officer has recommended that soy protein based infant formula should not be
used as the first line of treatment for infants under 6 months of age who have CMPA or
cows’ milk protein intolerance, as this is the period when they are most likely to become
sensitised to soy protein (Chief Medical Officer, 2004). ESPGHAN recommends that soy
protein based infant formulas should not be used for infants under 6 months of age and that
the use of therapeutic milks based on extensively hydrolysed proteins (or amino-acid
preparations if hydrolysates are not tolerated) should be preferred to the use of soy protein
infant formula in the treatment of cows’ milk protein allergy (Agostoni et al, 2006).
Soy protein based infant formula contain much higher levels of phyto-oestrogens than
milks based on cows’ milk protein. Setchell et al (1998) estimated that infants aged 1 to 4
months who were fed soy protein based infant formula would receive 6-12mg/kg of body
weight of phyto-oestrogens per day, compared to 0.7-1.4mg/kg per day for adults
consuming soy protein based products. There has been very little research into the effects
of consumption of phyto-oestrogens from soy protein based formula in very young infants.
However, research in animals suggests that phyto-oestrogens can have detrimental effects
on reproductive function, immune function and carcinogenesis. In a review of the scientific
evidence on soy protein based infant formula , the Committee on Toxicity of Chemicals in
Food, Consumer Products and the Environment (COT) concluded that the high levels of
phyto-oestrogens present in soy protein based formula posed a potential risk to the future
reproductive health of infants (Committee on Toxicity, 2003). Advice in the UK is that
parents should always seek advice before feeding their infant soy protein based infant
formula.
The nutritional composition and ingredients used in soy protein based infant formula
suitable from birth are given in Table 12.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 30
TABLE 12. The nutritional composition of soy protein based infant formula suitable
from birth
Nutrients per 100ml
MACRONUTRIENTS
Energy kcal
Protein g
Carbohydrate g
Carbohydrate source
Fat g
Added LCPs AA
DHA
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
OTHER
Structured vegetable oils
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians
Halal approved
AA = arachidonic acid
Cow & Gate
Infasoy
SMA Wysoy
66
1.6
7.0
Glucose syrup
3.5


67
1.8
6.9
Dried glucose syrup
3.6




























DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 31
2.9 Lactose-free infant formula suitable from birth
Key points
Lactose intolerance is a clinical syndrome which can cause abdominal pain, diarrhoea,
flatulence and/or bloating after ingestion of food containing lactose. The degree of lactose
intolerance varies among individuals.
Infants who cannot tolerate any lactose can only be treated by excluding lactose from the
diet. In infants this can be achieved by using lactose-free infant formula or incubating feeds
(human milk or formula) with the enzyme lactase which breaks the sugar into its component
parts. In primary lactose intolerance where the degree of lactase deficiency varies, the use
of lactose-free formula may help to relieve the symptoms.
In the UK, the lactose-free formulas Enfamil O-Lac and SMA LF are available over the
counter from pharmacies. Both products are approved by the Advisory Committee on
Borderline Substances (ACBS) for proven lactose intolerance. They are both nutritionally
complete for infants up to 6 months of age and can be used alongside complementary
feeding after that.
In lactose-free formula the carbohydrate source is glucose rather than lactose, so these
milks have a greater potential to cause dental caries. Parents and carers using these milks
are advised to avoid prolonged contact of milk feeds with their baby’s teeth and ensure that
they clean their baby’s teeth after the last feed at night.
The main difference between lactose-free and standard cows’ milk based infant formulas is
that in lactose-free formula the carbohydrate is glucose rather than lactose. Lactose
intolerance is a clinical syndrome which can cause abdominal pain, diarrhoea, flatulence
and/or bloating after ingestion of food containing lactose. The underlying physiological
problem is lactose malabsorption which is caused by an imbalance between the amount of
lactose ingested and the capacity of the enzyme lactase to hydrolyse it, and therefore the
amount of lactose that can cause symptoms varies (Heyman, 2006).
Heyman (2006) identifed the following different types of lactose intolerance.
 Primary lactose intolerance is caused by an absolute or relative lack of the enzyme
lactase and is the most common cause of lactose malabsorption worldwide. It is known
to be more prevalent among black and Asian populations but is extremely rare in
infants.
 Secondary lactose intolerance results from injury to the small bowel such as might occur
during acute gastroenteritis and persistent diarrhoea.
 Congenital lactase deficiency is a rare condition in infants, in which the infant develops
persistent diarrhoea as soon as any lactose, from human milk or formula, is introduced.
 Developmental lactase deficiency is observed among premature infants. Lactase
production is deficient in the immature gastrointestinal tract until at least 34 weeks’
gestation.
In primary lactose intolerance, the degree of lactase deficiency varies and the use of
lactose-free formula may help to relieve the symptoms of lactose intolerance.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 32
Congenital lactase deficiency can only be treated by excluding lactose from the diet. In
infants this can be achieved by using lactose-free formula or incubating feeds (human milk
or formula) with lactase. Developmental lactose intolerance can be treated in a similar
manner, but the continued use of breast milk does not seem to have any adverse effects on
pre-term infants (Shulman et al, 1995).
In the UK, the lactose-free formulas Enfamil O-Lac (Mead Johnson) and SMA LF (Wyeth)
are available over the counter from pharmacies. Both products are approved by the
Advisory Committee on Borderline Substances (ACBS) for proven lactose intolerance. They
are both nutritionally complete for infants up to 6 months of age and can be used alongside
complementary feeding after that. SMA LF is presented as being suitable not only for
infants with congenital lactose intolerance, but also for infants who have been diagnosed
with lactose intolerance following a bout of gastroenteritis. It is also suggested to help in the
dietary management of post-infectious diarrhoea in infants who are not breastfed. Similarly,
Enfamil O-Lac is reported to manage both primary and secondary lactose intolerance and
digestive problems such as colic, diarrhoea, bloating and wind associated with lactose
intolerance. In developed countries, with the exception of very malnourished children, the
use of lactose-free formula as a treatment for acute gastroenteritis has been shown to have
no clinical advantage over standard lactose-containing formula (Kukuruzovic and Brewster,
2002). The use of lactose-free formula for the treatment of acute diarrhoea is considered by
ESPGHAN to be unjustified. Despite this assertion, in a multi-centre study conducted in 29
European countries in 2000, when doctors were asked, in a questionnaire, what they would
recommend for an infant with acute diarrhoea, 36% said they would use normal lactosecontaining infant milk, 35% would use lactose-free formula, and 19% would use a lactose
and milk protein free product (Szajewska et al, 2000). This suggests there may be
considerable confusion among health professionals about the treatment of lactose
intolerance in infants.
Lactose-free formula has a greater potential to cause dental caries than milks where the
main source of carbohydrate is lactose. This is because lactose is a non-cariogenic sugar
whereas the common replacement carbohydrate, glucose, is cariogenic (Bowen et al,
1997). It is therefore vital that parents using lactose-free formula follow advice to avoid
prolonged contact of milk feeds with their baby’s teeth and ensure that they clean their
baby’s teeth after the last feed at night.
The nutritional composition and ingredients used in lactose-free formula suitable from birth
are given in Table 13.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 33
TABLE 13. The nutritional composition of lactose-free formula suitable from birth
Nutrients per 100ml
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
Carbohydrate g
– of which lactose mg
Carbohydrate source
Fat g
Added LCPs AA
DHA
In approved ratio
LCP source
Mead Johnson
Enfamil O-Lac
SMA LF
68
1.42
NK
7.2
less than 7
Glucose
polymers, citrate
3.7



Single cell oils
(vegetable
source)
67
1.5
60:40
7.2
less than 6.7
Dried glucose syrup
3.6



Fungal and algal oils
(vegetable source)
MICRONUTRIENTS
Vitamins meeting regulations
Minerals meeting regulations

1


OTHER
Structured vegetable oils
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians2
Halal approved






















AA = arachidonic acid
NANK = not known
1
2
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
Iron content in line with the regulations for milks for special medical purposes.
Formula milks derived from cows’ milk are generally not suitable for vegetarians due to the inclusion of fish
oils and/or the use of the animal-derived enzyme rennet during the production process. Rennet is used to
separate curds from whey and, although vegetarian alternatives are available, they are not used by all
manufacturers.
DRAFT Specialised Infant Milks in the UK • March 2013 • page 34
2.10 Formula milks for premature and low birthweight infants
TABLE 14. The nutritional composition of formula milks for premature and low
birthweight infants
Nutrients per 100ml
Aptamil Preterm
Cow & Gate
Nutriprem 1
SMA Gold Prem
1
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
80
2.6
60:40
80
2.6
60:40
82
2.2
60:40
8.4
4.7
Lactose, glucose
syrup
3.9




8.4
4.7
Lactose, glucose
syrup
3.9




8.4
4.2
Maltodextrins,
lactose
4.4







361
17
3.5
3.0
6.0
140
200
(3.2)
120
0.24
35
3.5
880
361
17
3.5
3.0
6.0
140
200
(3.2)
120
0.24
35
3.5
880
185
15
3.3
3.4
6.3
140
200
2400
120
0.19
29
2.4
1000
94
76
80
26
1.6
8.0
10
62
82
4.5
70
1.1
94
76
80
26
1.6
8.0
10
62
82
4.5
70
1.1
101
67
90
10
1.4
8.2
4.8
61
74
1.7
44
0.8
Carbohydrate g
– of which lactose g
Carbohydrate source
Fat g
Added LCPs AA
DHA
MCT
Vitamins meeting
regulations
Minerals meeting
regulations
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Copper µg
Iodine µg
Iron mg
Magnesium mg
Manganese µg
Phosphorus mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
DRAFT Specialised Infant Milks in the UK • March 2013 • page 35
Nutrients per 100ml
OTHER
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians
Halal approved
Osmolality mOsm/kg H2O
AA = arachidonic acid
Aptamil Preterm
Cow & Gate
Nutriprem 1
SMA Gold Prem
1










375










375










272
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 36
2.11 Formula milks for premature and low birthweight infants postdischarge
TABLE 15. The nutritional composition of formula milks for premature and low
birthweight infants post-discharge (powder formulation)
Nutrients per 100ml
Cow & Gate
Nutriprem 2
SMA Gold Prem 2
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
75
2.0
60:40
73
1.9
60:40
Carbohydrate g
– of which lactose g
Carbohydrate source
7.5
5.9
Lactose, glucose syrup
7.5
5.7
Glucose syrup,
lactose
3.9



Fat g
Added LCPs AA
DHA
MCT
4.0



MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
MICRONUTRIENTS
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Copper µg
Iodine µg
Iron mg
Magnesium mg
Folic acid high v FSMP
infants


100
12
2.1
1.7
5.9
90
150
(1.8)
80
0.22
20
3.0
600
100
11
1.5
1.5
6.3
110
160
1000
80
0.22
15
2.1
400
87
55
60
20
1.2
7.0
73
58
62
10
1.2
6.6

DRAFT Specialised Infant Milks in the UK • March 2013 • page 37
Nutrients per 100ml
Cow & Gate
Nutriprem 2
SMA Gold Prem 2
Manganese µg
Phosphorus mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
7.0
47
77
1.7
28
0.9
5.0
42
71
1.5
27
0.73
OTHER
Structured vegetable oils
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians
Halal approved
Osmolality mOsm/kg H2O










NK
340











311
AA = arachidonic acid
NK = not known
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 38
2.12 Modified fat formula milks for disorders of fatty acid metabolism
suitable from birth.
TABLE 16. The nutritional composition of modified-fat formula milks for disorders of
fatty acid metabolism, suitable from birth
Nutrients per 100ml
SHS Nutricia
Caprilon
Vitaflo Lipistart
SHS Nutricia
Monogen
66.3
1.5
7.0
1.3
NK
68
2.1
8.3
0.7
1.2
73.5
2.2
12.0
1.2
0.12
Glucose syrup,
lactose
Dried glucose syrup,
maltodextrin
Glucose syrup,
lactose
Fat g
Added LCPs AA
DHA
MCT%
LCT%
3.6


75
25
3.1


80
20
3.9


80
20
LCP source
n6:n3
NA
7.5
Fungal/algal oils
7.1:1
NA
6.2:1
MACRONUTRIENTS
Energy kcal
Protein g
Carbohydrate g
– of which sugars g
Lactose g
Carbohydrate source
Fatty acid profile g
C6
C8
C10
C12
C14:0
C16:0
C18:0
C18:1
C18:2
C18:3
0.002
0.83
0.6
0.01
0.01
0.09
0.06
0.09
0.09
0.01
Fat source
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting regulations
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Soya oil
Coconut, palm
kernal, soyabean oils
Coconut oil, walnut
oil




Copper marginally
high

76
7.6
0.8
1.9
69.9
20.3
1.7
1.4
56.9
6.2
0.5
1.2
DRAFT Specialised Infant Milks in the UK • March 2013 • page 39
Nutrients per 100ml
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Chromium µg
Copper µg
Iodine µg
Iron mg
Magnesium mg
Manganese mg
Molybdenum µg
Phosphorus mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
OTHER
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians
Halal approved
Osmolality mOsm/kg H2O
AA = arachidonic acid
NA = not applicable
SHS Nutricia
Caprilon
5.1
Vitaflo Lipistart
4.7
SHS Nutricia
Monogen
3.7
40
100
610 (0.97)
60
0.2
10.2
1.5
390
90
120
900 (1.5)
110
0.23
15
2.9
440
60
90
680 (1.3)
70
0.2
8.2
3.9
300
53.3
40
1.31
43.2
9.9
0.51
5.1
0.05
2.35
29.2
67
1.71
20.3
0.38
73.7
44.9
2.0
70
13.8
0.75
8.6
0.06
3.8
53.9
75.5
2.4
38.7
0.71
45
37.5
1.8
60
7.1
0.74
6.1
0.06
3.7
35
63
1.9
35
0.58
















NK
233



180







?


NK
280
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 40
2.13 Formula with modified carbohydrate suitable from birth
TABLE 17. The nutritional composition of modified carbohydrate formula milks,
suitable from birth
Nutrients per 100ml
INDICATIONS
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
Carbohydrate g
– of which sugars g
lactose
Carbohydrate source
Fat g
Added LCPs AA
DHA
MICRONUTRIENTS
Vitamins meeting
regulations
Minerals meeting
regulations
MICRONUTRIENTS
VITAMINS
Vitamin A (µg-RE)
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Chromium µg
Copper µg
Iodine µg
Iron mg
Magnesium mg
Manganese µg
Molybdenum µg
SHS Nutricia
Galactomin 17
Lactose and galactose
restricted diets
SHS Nutricia
Galactomin 19
Glucose-galactose
intolerance either
primary or secondary
to another disorder
66
1.3
0:100
69
1.9
0:100
7.3
1.1
<0.01
Glucose syrup
3.5


6.4
6.3
<0.01
Fructose
4.0






55
8.3
1.2
1.2
4.5
50
100
430 (0.78)
40
0.11
8.9
1.8
330
74.2
8.1
0.98
1.2
5.3
40
100
580 (1)
40
0.21
10.2
1.5
310
55
41
nil added
40
12
0.79
5.0
40
nil added
55
40.8
1.04
49
7.1
0.5
6.1
60
2.4
DRAFT Specialised Infant Milks in the UK • March 2013 • page 41
Nutrients per 100ml
SHS Nutricia
Galactomin 17
30
SHS Nutricia
Galactomin 19
32.3
Phosphorus mg
Potassium mg
Selenium µg
Sodium mg
Zinc mg
65
0.98
17
0.56
60.2
1.19
20.4
0.41
OTHER
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians1
Halal approved
Osmolality mOsm/kg H2O








NK
NK
170








NK
NK
407
AA = arachidonic acid
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 42
2.14 Infant formula for the dietary management of renal disease,
suitable from birth
TABLE 18. The nutritional composition of infant formula for the dietary
management of renal disease, suitable from birth
Nutrients per 100ml
SHS Nutricia
Kindergen
Vitaflo Renastart
MACRONUTRIENTS
Energy kcal
Protein g
Whey:casein ratio
101
1.5
100:0
99
1.5
98:2
Carbohydrate g
– of which sugars g
lactoseg ?
Carbohydrate source
11.8
1.2
NK
Glucose syrup
Fat g
Added LCPs AA
DHA
LCP source
Vitamins meeting regulations
5.3


NA
Low vit A
12.5
1.3
0.7
Dried glucose syrup,
maltodextrin
4.8


Fungal/algal oils
Low vit A
Minerals meeting regulations
Low calcium, chloride,
phosphorus and
potassium
Low calcium, chloride,
phosphorus and
potassium
26
8.4
0.56
1.1
5.1
70
90
920 (1.4)
90
0.18
16.4
4.6
300
26
23
0.6
1.1
6.0
100
100
1000
100
0.2
17
4.5
400
22.4
17
0.09
7.0
0.96
11.0
0.09
18.6
24
2.6
46.4
23
17
0.1
16
1.0
11.0
0.016
18
23
1.9
48
VITAMINS
Vitamin A µg-RE
Vitamin C mg
Vitamin E mg
Vitamin D µg
Vitamin K µg
Thiamin (B1) µg
Riboflavin (B2) µg
Niacin µg (mg NE)
Vitamin B6 µg
Vitamin B12 µg
Folic acid µg
Biotin µg
Pantothenic acid µg
MINERALS
Calcium mg
Chloride mg
Copper mg
Iodine µg
Iron mg
Magnesium mg
Manganese mg
Phosphorus mg
Potassium mg
Selenium µg
Sodium mg
DRAFT Specialised Infant Milks in the UK • March 2013 • page 43
Nutrients per 100ml
SHS Nutricia
Kindergen
Vitaflo Renastart
Zinc mg
0.84
0.9
OTHER
Prebiotics
Nucleotides
Inositol
Taurine
Choline
Added antioxidants
Contains soya
Contains fish oil
Suitable for vegetarians
Halal approved
Osmolality mOsm/kg H2O








NK
NK
215










198
AA = arachidonic acid
DHA = docosahexaenoic acid
LCP = long chain polyunsaturated fatty acid
DRAFT Specialised Infant Milks in the UK • March 2013 • page 44
Appendix
Specialised Infant formula companies
Information about the infant milks shown in bold below is given in this report. For information on
other infant milks available in the UK, see the companion report Infant Milks in the UK.
Abbott Nutrition
Infant milks produced:
• Similac High Energy
Abbott Nutrition
Abbott House
Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire SL6 4XE
T: 01628 773 355
www.abbottnutrition.co.uk
Aptamil
Infant milks produced:
 Aptamil Anti-Reflux
• Aptamil Comfort
• Aptamil Pepti 1
• Aptamil Pepti 2
• Aptamil Preterm
Aptamil
Newmarket House
Newmarket Avenue
White Horse Business Park
Trowbridge
Wiltshire BA14 0XQ
T: 0800 996 1000
www.aptaclub.co.uk
www.aptamilprofessional.co.uk
Cow & Gate
Infant milks produced:
• Cow & Gate Comfort
• Cow & Gate Infasoy
• Cow & Gate Pepti-junior
• Nutriprem 1
• Nutriprem 2
Cow & Gate
Newmarket House
Newmarket Avenue
White Horse Business Park
Trowbridge
Wiltshire BA14 0XQ
T: 0800 977 4000
www.cowandgate.co.uk
www.in-practice.co.uk
Mead Johnson Nutrition
Infant milks produced:
• Enfamil AR
• Enfamil O-Lac
• Nutramigen 1
• Nutramigen 2
• Nutramigen AA
• Pregestimil
Mead Johnson Nutrition
BMS House
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
T: 01895 230575
www.nutramigen.co.uk
SHS Nutricia
Infant milks produced:
• Anamix Infant
Caprilon
• Galactomin 17
• Galactomin 19
• Infatrini
 Infatrini Peptisorb
• Kindergen
• Monogen
• Neocate LCP
• Pepdite
• Pepdite 1+
• Pepdite MCT
• Pepdite MCT 1+
Nutricia
White Horse Business Park
Newmarket Avenue
Trowbridge
Wiltshire BA14 0XQ
DRAFT Specialised Infant Milks in the UK • March 2013 • page 45
T: 01225 711677
E: [email protected]
www.nutricia.co.uk
SMA Nutrition
Infant milks produced:
 SMA Comfort
• SMA Gold Prem 1
• SMA Gold Prem 2
• SMA High Energy
• SMA LF
• SMA Staydown
• SMA Wysoy
Vitaflo International Ltd
Suite 1.11
South Harrington Building
182 Sefton Street
Brunswick Business Park
Liverpool
L3 4BQ
T: 0151 709 9020
www.vitaflo.co.uk
SMA Nutrition
PNUTRI UK
Vanwall Road
Maidenhead SLS 4UB
T: 01628 692 010
www.smanutrition.co.uk
www.smahcp.co.uk
Vitaflo International Ltd
Infant milks produced
 Lipistart
 PKU start
 Renastart
DRAFT Specialised Infant Milks in the UK • March 2013 • page 46
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Specialised infant formula in the UK
ISBN 978 1 908924 08-7
www.firststepsnutrition.org
DRAFT Specialised Infant Milks in the UK • March 2013 • page 49