Product Documentation Sheet

Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

Comments : New recipe

Approval
Author R&D Approver R&D
Name Lisa ZANTINGE Mostapha SALHI
Function Product Design and Development Manager Director IDDC FSMP Powder
Department SN Product Development SN Product Development
Issue date Feb 21, 2024
Address Nutricia Research, Uppsalalaan 12, 3584 CT UTRECHT, THE NETHERLANDS

A. Category
Product category Food for Special Medical Purposes
According to Regulation (EU) 2016/128 FSMP
Legal statement compliance
Dietary fibre declaration: DP=>2 and 0 kcal
Energy dense, nutritionally complete feed. For the dietary management of
disease related malnutrition and growth failure.
Product description & clinical indication
For infants from birth and young children up to 18 months of age (or 9 kg) with
growth failure, increased energy requirements and/or fluid restrictions.
Gluten Free : less than 20mg/kg according to EU Implementing Regulation n°
828/2014
Nutritional claims & exceptions
A local check is needed to make sure that the values above comply with any local
strictest regulation/rule/standard/interpretation.

Digital
unterschrieben
von Tina Staubach
Datum:
2024.02.28
13:59:54 +01'00'

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 1 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

B. Nutrition labelling (summary)

Prepared
per 100ml
Component description Unit Per 100g Per 100kcal
20,2g
powder
Energy value kJ 2.065 418 418

Energy value kcal 494 100 100

Protein g 13,2 2,7 2,7

Carbohydrate g 49,7 10,1 10,1

Sugars g 31,5 6,4 6,4

Fat g 26,9 5,4 5,4

Saturates g 12,2 2,5 2,5

Fibre g 2,9 0,59 0,59

Sodium (Na) mg 185 37,4 37,4

C. Nutritional properties

Energy percentage Unit Value

Protein (equivalent) energy % 10,7

Carbohydrate energy % 40,3

Fat energy % 49,0

TOTAL % 100

* Carbohydrates: including organic acids and polyols

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 2 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
per 100ml
Component description Unit Per 100g Per 100kcal
20,2g
powder
Protein (equivalent), total
Protein a g 13,2 2,7 2,7

Nitrogen (Protein) g 2,1 0,42 0,42

Animal protein g 13,2 2,7 2,7

Whey protein g 7,9 1,6 1,6

Casein g 5,3 1,1 1,1

Vegetable protein g 0,03 0 0

Soy protein g 0 0 0

Added amino acids g 0 0 0

Carbohydrate
Carbohydrate g 49,7 10,1 10,1

Sugars g 31,5 6,4 6,4

Glucose g 2,2 0,45 0,45

Fructose g 0 0 0

Galactose g 0,06 0,01 0,01

Lactose g 26,9 5,45 5,45

Maltose g 2,3 0,47 0,47

Sucrose g 0 0 0

Polysaccharides g 18,0 3,6 3,6

Starch g 0 0 0

Organic acids g 0,15 0,03 0,03

Polyols µg 750 152 152

Inositol mg 124 25,0 25,0

a) N-factor 6,38

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 3 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
per 100ml
Component description Unit Per 100g Per 100kcal
20,2g
powder
Fat
Fat g 26,9 5,4 5,4

Vegetable fat g 25,8 5,2 5,2

Animal fat g 1,1 0,22 0,22

Milk fat g 0,53 0,11 0,11

Saturates g 12,2 2,5 2,5

Monounsaturates g 10,4 2,1 2,1

Polyunsaturates g 4,3 0,87 0,87

Medium chain triglycerides (MCT) g 4,9 0,99 0,99

Cholesterol g 0 0 0

Phospholipids mg 13,0 2,6 2,6

Fibre, dietary
Fibre g 2,9 0,59 0,59

Soluble g 2,9 0,58 0,58

2'Fucosyllactose (2'FL) mg 99,7 20,2 20,2

Galacto-oligosaccharides (GOS) g 3,5 0,71 0,71

Fructo-oligosaccharides (FOS) g 0,40 0,08 0,08

Insoluble g 0,04 0 0

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 4 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
per 100ml
Component description Unit Per 100g Per 100kcal
20,2g
powder
Minerals and trace elements
Sodium (Na) mg 185 37,4 37,4

Sodium (Na) mmol 8,05 1,63 1,63

Potassium (K) mg 499 101 101

Potassium (K) mmol 12,8 2,58 2,58

Chloride (Cl) mg 374 75,7 75,7

Chloride (Cl) mmol 10,6 2,14 2,14

Calcium (Ca) mg 497 101 101

Calcium (Ca) mmol 12,4 2,51 2,51

Phosphorus (P) mg 268 54,3 54,3

Phosphorus (P) mmol 8,65 1,75 1,75

Phosphate (PO4) mg 822 166 166

Phosphate (PO4) mmol 8,65 1,75 1,75

Magnesium (Mg) mg 47,0 9,52 9,52

Magnesium (Mg) mmol 1,94 0,39 0,39

Iron (Fe) mg 5,97 1,21 1,21

Zinc (Zn) mg 4,20 0,85 0,85

Copper (Cu) mg 0,37 0,075 0,075

Manganese (Mn) mg 0,050 0,010 0,010

Fluoride (F) b mg

Molybdenum (Mo) µg 22,9 4,64 4,64

Selenium (Se) µg 18,7 3,78 3,78

Chromium (Cr) µg 7,48 1,51 1,51

Iodine (I) µg 94,3 19,1 19,1

b) Nil added

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 5 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
per 100ml
Component description Unit Per 100g Per 100kcal
20,2g
powder
Vitamins
Vitamin A c µg 439 88,8 88,8

Vitamin D3 µg 12,0 2,42 2,42

Vitamin E d mg 10,5 2,12 2,12

Alpha-tocopherol mg 11,9 2,41 2,41

Vitamin K µg 35,3 7,14 7,14

Thiamin (B1) mg 0,75 0,15 0,15

Riboflavin (B2) mg 1,00 0,20 0,20

Niacin (B3) (preformed) mg 5,97 1,21 1,21

Niacin (B3) (incl. tryptophan) e mg 9,35 1,89 1,89

Pantothenic acid (B5) mg 3,97 0,80 0,80

Vitamin B6 mg 0,55 0,11 0,11

Folate µg 133 26,9 26,9

Folic acid µg 79,8 16,2 16,2

Vitamin B12 µg 1,50 0,30 0,30

Biotin µg 23,3 4,72 4,72

Vitamin C mg 69,2 14,0 14,0

c) Vitamin A expressed in "μg RE/ER"

d) Vitamin E expressed in "mg alpha-TE/ET"
e) Niacin including tryptophan expressed in "mg NE/EN"

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 6 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
per 100ml
Component description Unit Per 100g Per 100kcal
20,2g
powder
Carotenoids
Carotenoids mg - - -

Alpha-carotene µg - - -

Beta Carotene µg - - -

Gamma carotene µg - - -

Lutein µg - - -

Lycopene µg - - -

Zeaxanthin µg - - -

Nucleotides
Nucleotides mg 17,9 3,63 3,63

Cytidine-5'-monophosphate (CMP) mg 5,97 1,21 1,21

Uridine-5'-monophosphate (UMP) mg 2,98 0,60 0,60

Adenosine 5'-monophosphate (AMP) mg 4,97 1,01 1,01

Guanosine-5'-monophosphate (GMP) mg 1,49 0,30 0,30

Inosine-5'-monophosphate (IMP) mg 2,49 0,50 0,50

Others
L-Carnitine mg 12,9 2,61 2,61

Choline mg 156 31,6 31,6

Taurine mg 34,8 7,04 7,04

Creatine mg - - -

Coenzyme Q10 mg - - -

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 7 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
Per 100g
per 100ml
Component description protein Per 100g Per 100kcal
20,2g
equivalent
powder
g g mg mg
Amino acids
L-Alanine 4,12 0,55 111 111

L-Arginine 2,97 0,39 79,7 79,7

L-Aspartic Acid + L-Asparagine 9,43 1,25 253 253

L-Cyst(e)ine 1,74 0,23 46,7 46,7

L-Glutamic acid + L-Glutamine 20,4 2,71 548 548

Glycine 1,88 0,25 50,6 50,6

L-Histidine 2,40 0,32 64,5 64,6

L-Isoleucine 4,91 0,65 132 132

L-Leucine 9,87 1,31 265 265

L-Lysine 8,70 1,15 234 234

L-Methionine 2,25 0,30 60,3 60,3

L-Phenylalanine 3,89 0,52 104 104

L-Proline 7,46 0,99 200 200

L-Serine 5,58 0,74 150 150

L-Threonine 5,89 0,78 158 158

L-Tryptophan 1,53 0,20 41,2 41,2

L-Tyrosine 3,90 0,52 105 105

L-Valine 5,30 0,70 142 142

L-Methionine + L-Cyst(e)ine 3,99 0,53 107 107

L-Phenylalanine + L-Tyrosine 7,78 1,03 209 209

Essential amino acids 47,4 6,29 1.273 1.273

Non essential amino acids 58,0 7,70 1.558 1.559

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 8 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition
Prepared
Per 100g per 100ml
Component description Per 100g Per 100kcal
fatty acids 20,2g
powder
g g mg mg
Fatty acids
C 4:0 Butyric acid 0,07 0,02 3,43 3,43

C 6:0 Caproic acid 0,22 0,06 11,5 11,5

C 8:0 Caprylic acid 2,13 0,54 110 110

C 10:0 Capric acid 1,87 0,47 96,1 96,1

C 12:0 Lauric acid 14,1 3,58 724 724

C 14:0 Myristic acid 5,86 1,49 302 302

C 16:0 Palmitic acid 14,5 3,69 747 747

C 16:0 beta palmitate 1,70 0,43 87,8 87,8

C 16:1 (n-7) Palmitoleic acid 0,17 0,04 9,01 9,01

C 18:0 Stearic acid 3,24 0,83 167 167

C 18:1 (n-9) Oleic acid 38,1 9,70 1.962 1.963

C 18:1t (n-9) trans- Oleic acid (Elaidic acid) 0,06 0,02 3,10 3,10

C 18:2 (n-6) Linoleic acid (LA) 13,4 3,41 690 690

C 18:2t (n-6) trans-Linoleic acid 0,01 - 0,34 0,34

C 18:3 (n-3) Alpha linolenic acid (ALA) 1,30 0,33 66,8 66,8

C 18:3t (n-3) trans-Alpha-linolenic acid 0,01 - 0,53 0,53

C 18:3 (n-6) Gamma linolenic acid (GLA) - - 0,19 0,19

C 18:4 (n-3) Stearidonic acid (STA) 0,01 - 0,77 0,77

C 20 : 0 Arachidic acid 0,27 0,07 14,0 14,0

C 20:1 (n-9) Eicosaenoic acid 0,32 0,08 16,5 16,5

C 20:3 (n-6) Dihomo gamma-linolenic acid 0,04 0,01 1,82 1,82

C 20:4 (n-6) Arachidonic acid (AA) 0,49 0,12 25,2 25,2

C 20:5 (n-3) Eicosapentaenoic acid (EPA) 0,12 0,03 6,28 6,28

C 22 : 0 Behenic acid 0,34 0,09 17,6 17,6

C 22:1 (n-9) Erucic acid 0,05 0,01 2,77 2,77

C 22:5 (n-3) Docosapentaenoic acid 0,02 0,01 1,06 1,06

C 22:6 (n-3) Docosahexaenoic acid (DHA) 0,49 0,12 25,2 25,2

C 24:0 Lignoceric acid 0,12 0,03 6,44 6,45

C 24:1 (n-9) Nervoic acid 0,04 0,01 1,98 1,98

Other fatty acids 2,88 0,73 148 148

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 9 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

D. Composition

Component description Unit Value

Total fatty acid ratio

Saturates g/100g FA 45,6

Monounsaturates g/100g FA 38,7

Polyunsaturated Fatty Acids g/100g FA 15,7

Trans fatty acids g/100g FA 0,13

Nutrient ratio
(n-6) / (n-3) ratio 7,22

LA / ALA ratio 10,3

Ca / P ratio 1,85

Ca/Available Phosphorus Milk f 1,9

f) Molar ratio. Available P is 80% of total P for IF & FO formula manufactured from cow/goat milk proteins & protein hydrolysates

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 10 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

E. Physical properties
Property Unit Value Remark
Osmolarity mOsmol/l 340

Osmolality mOsmol/kg water 400

Potential Renal Solute Load mOsmol/l 229

Density kg/l 1,045

Moisture content should be < target
Total Moisture % 3,0
value

F. Packaging & shelf life

Packaging Particular atm
Packaging type / material Temperature Temp. Unit Shelf life Shelf life unit
size conditions
Packed in a protective
Tin / Metal can 400 g 20 °C 15 Months
atmosphere
Packed in a protective
Tin / Metal can 400 g 30 °C 15 Months
atmosphere

G. Safe use instructions

Packaging type / material Tin / Metal can
Packaging size 400 g / 400 g
Storage before opening Keep tightly sealed and store in a cool and dry place (do not refrigerate).
Handling before opening Wash your hands, use clean or sterilized utensils and ensure top of packaging is clean.
Hygienic handling Use only the scoop provided in the packaging.
Heating of the feed

Storage after opening Once opened, close packaging, store in a cool and dry place (not a refrigerator) and use within one month.
Storage after reconstitution Prepare the food per serving and use within 2 hours. Always discard unfinished feeds.
Comments Tube feed flow tested - max. hanging time 2 hours

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 11 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

H. Preparation / administration

Preparation instruction
Scoop weight : 5.1g
Preparation per 100ml ready to feed.
90 ml water of 40°C (preferably) + 4 leveled scoops

Suitable as a sole source of nutrition for infants from birth to 9 kg or up to 18 months

of age.
Must be used under medical supervision.
Precautions Good dental hygiene is important for infants and children, as prolonged or frequent
contact of drinks and feeds with teeth increases the risk of tooth decay. Make sure
their teeth are cleaned after the last feed at night.
Not for parenteral use.

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 12 / 13
unless not required based on local legislation
 Product Documentation Sheet
Recipe description : CP PWD INFATRINI CG 2FL FSMP NON EU 100 KCAL Status : DRAFT
Recipe code : M120446 Variant Number : 002 Version Number : 001
Artemis output code : 000220047770 LAB number : 007520.001

I. Allergens
Description Present
Allergens
1- Cereals containing gluten, namely: wheat, rye, barley, oats or their
No
hybridised strains, and products thereof
2- Crustaceans and products thereof No

3- Eggs and products thereof No

4- Fish and products thereof Yes

5- Peanuts and products thereof No

6- Soybeans and products thereof No

7- Milk and products thereof (including lactose) Yes

8- Nuts and products thereof No

9- Celery and products thereof No

10- Mustard and products thereof No

11- Sesame seeds and products thereof No

12- Sulphur dioxide and sulphites at concentrations more than 10mg/kg No

13- Lupin and products thereof No

14- Molluscs and products thereof No

Print date: 21.02.2024 Information printed in bold is mandatory for labelling Page 13 / 13
unless not required based on local legislation