(ENGLISH VERSION) Salinan PerBPOM No 24 Tahun 2019 - Perubahan PerBPOM No 1 Tahun 2018 - Nett

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NATIONAL AGENCY FOR DRUG AND FOOD CONTROL

OF THE REPUBLIC OF INDONESIA
NATIONAL AGENCY FOR DRUG AND FOOD CONTROL
REGULATION NUMBER 24 YEAR 2019
ON
AMENDMENT TO NATIONAL AGENCY FOR DRUG AND FOOD CONTROL
ON SUPERVISION OF PROCESSED FOOD
FOR SPECIAL NUTRITIONAL PURPOSE
BY THE GRACE OF GOD ALMIGHTY
HEAD OF NATIONAL AGENCY FOR DRUG AND FOOD CONTROL

OF THE REPUBLIC OF INDONESIA,
Considering : a. that supervision on processed food for special nutritional

purpose as regulated in National Agency for Drug and Food
Control Regulation Number 1 Year 2018 on Supervision of
Processed Food for Special Nutritional Purpose requires
adjusting to scientific and technological development, and as
such change is necessary;
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b. that based on the consideration stated in letter a) needs to

stipulate a National Agency for Drug and Food Control
Regulation on Amendment to National Agency for Drug and
Food Control Regulation Number 1 Year 2018 on Supervision
of Processed Food for Special Nutritional Purpose;
In view of : 1. Law Number 18 Year 2012 on Food (State Gazette of The

Republic of Indonesia Year 2012 Number 227, Supplement to
the State Gazette of The Republic of Indonesia Number 5360);
2. Government Regulation Number 69 Year 1999 on Food
Labelling and Advertisement (State Gazette of The Republic of
Indonesia Year 1999 Number 131, Supplement to the State
Gazette of The Republic of Indonesia Number 3867);
3. Government Regulation Number 28 Year 2004 on Food Safety,
Quality and Nutrients (State Gazette of The Republic of
Indonesia Year 2004 Number 107, Supplement to the State
Gazette of The Republic of Indonesia Number 4424);
4. Presidential Regulation Number 80 of 2017 concerning the
National Agency for Drug and Food Control (State Gazette of
The Republic of Indonesia Year 2017 Number 180);
5. National Agency for Drug and Food Control Regulation
Number 26 Year 2017 on Organisation and Work Procedure of
the National Agency of Drug and Food Control (State Gazette
of the Republic of Indonesia Year 2017 Number 1745);
6. National Agency for Drug and Food Control Regulation
Number 1 Year 2018 on Supervision of Processed Food for
Special Nutritional Purpose (State Gazette of the Republic of
Indonesia Year 2018 Number 353);
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HEREBY DECREES:
To stipulate : NATIONAL AGENCY FOR DRUG AND FOOD CONTROL ON
AMENDMENT TO NATIONAL AGENCY FOR DRUG AND FOOD
CONTROL REGULATION NUMBER 1 YEAR 2018 ON
SUPERVISION OF PROCESSED FOOD FOR SPECIAL
NUTRITIONAL PURPOSE.
Article 1
Several provisions within the National Agency for Drug and Food
Control Regulation Number 1 Year 2018 on Supervision of Processed
Food for Special Nutritional Purpose (State Gazette of the Republic
of Indonesia Year 2018 Number 353) are amended as follows:
1. Provision section (3) letter a) of Article 2 is amended, so that Article 2
becomes as follows:
Article 2
(1) FSNP is grouped into:
a. FSDU; and
b. FSMP.
(2) The type of FSDU as referred to in paragraph (1) letter a) can be
in the form of:
a. FSDU for infants and children group, can be:
1. Infant Formula;
2. Follow On Formula;
3. Growing Up Formula;
4. Complementary Foods for Infants.
b. FSDU for adult group, can be:
1. Beverages for Pregnant Women and/or Lactating Mothers
2. Athlete Food; and
3. Food for Weight Control.
(3) The type of FSMP as referred to in section (1) letter b) may take
the form of:
a. FSMP for infants and children groups, which may take the
form of:
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1. FSMP for Patients with Metabolic Disorders (Inborn Errors

of Metabolism);
2. FSMP for Nutritional Support of Children at Risk of
Stunting, Undernutrition, or Malnutrition;
3. FSMP for Preterm Infants;
4. FSMP for Human Milk Fortifier;
5. FSMP for Patients with Cow Milk Protein Allergy;
6. FSMP for Children Patients with Intractable Seizure
(Epilepsy);
7. FSMP for Patients with Malabsorption;
8. FSMP for Patients with Chronic Liver Disease; and
9. FSMP for Patients with Inflammatory Bowel Disease.
b. FSMP for adult group, which may take the form of:
1. FSMP for People with Diabetes;
2. FSMP for Patients with Chronic Kidney Disease;
3. FSMP for Patients with Chronic Liver Disease;
4. FSMP for Nutritional Support for Adult Undernutrition or
Adult Malnutrition; and
5. FSMP for Patients with Metabolic Disorders (Inborn Errors
of Metabolism).
2. Provision of Article 11 is added by 1 (one) section, the section 3, so

that Article 11 becomes as follows:
Article 11
(1) Every person producing and/or distributing FSNP are obligatory
to include Label in accordance with the provisions of the laws and
regulations.
(2) In addition to the provisions referred to in paragraph (1), the
FSNP Label should include description of:
a. type name;
b. designation;
c. preparation method, if the product requires special
preparation;
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d. serving method;
e. storage method;
f. warning for the specific group; and
g. nutrition facts.
(3) Every person is prohibited from producing Processed Food
featuring trademarks and Label designs similar, either in part or in
whole, to FSMP trademark and Label design.
3. Provision section (3) of Article 12 is amended, so that Article 12

becomes as follows:
Article 12
(1) In addition to the obligation to mention the information referred
to in Article 11, FSDU Label should state the words “CONSULT
WITH HEALTH WORKER”.
(2) The articles referred to in paragraph (1) should be bold and
included in the most easily viewed Label section.
(3) The Health Worker (healthcare professionals) referred to in
section (1) includes:
a. doctors;
b. pharmacists;
c. dietitians;
d. nutritionists;
e. nurses;
f. midwives.
4. Provision section (1) letter c) of Article 13 is amended, so that Article

13 becomes as follows:
Article 13
(1) In addition to obligation to mention the information referred to in
Article 11, the FSMP Label should state the information:
a. “WITH MEDICAL PRESCRIPTION ONLY”;
b. “Product Not for Parenteral Use”; and
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c. Osmolality and/or osmolarity values are for enteral use

products using feeding tube (nasogastric tube).
(2) The information referred to in paragraph (1) letter a) is in bold
and included in the main section of the Label.
(3) The information referred to in paragraph (1) letter c) should be
listed adjacent to the preparation method.
5. Several provisions within Appendix I to National Agency for Drug

and Food Control Regulation Number 1 Year 2018 on
Supervision of Processed Food for Special Nutritional Purpose
(State Gazette of the Republic of Indonesia Year 2018 Number
353) are amended as written within the Appendix inseparable
from this Agency Regulation.
Article 2
a. FSNP in the forms of:
1. Athlete food;
2. Food for weight control;
3. FSMP for Human Milk Fortifier;
4. FSMP for Patients with Cow Milk Protein Allergy;
5. FSMP for Nutritional Support of Children at Risk of Stunting,
Undernutrition, or Malnutrition;
6. FSMP for Preterm Infants.
as regulated in this Agency Regulation is required to comply to the
provisions no later than 30 (thirty) months from the date this Agency
Regulation is statuted.
b. On the date this Agency Regulation becomes effective, applications
already submitted for FSNP registration will still be addressed
employing the National Agency for Drug and Food Control
Regulation Number 1 Year 2018 on Supervision of Processed
Food for Special Nutritional Purpose.
c. This Agency Regulation becomes effective on the date statuted.
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For public acknowledgement, orders the statutement of this Agency

Regulation by its placement within State Gazette of The Republic of
Indonesia.
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Stipulated in Jakarta
on 30 August 2019
HEAD OF NATIONAL AGENCY

FOR DRUG AND FOOD CONTROL
signed
PENNY K. LUKITO
Statuted in Jakarta
on 30 August 2019
DIRECTOR GENERAL
STATUTORY REGULATIONS
MINISTRY OF JUSTICE AND HUMAN RIGHTS
THE REPUBLIC OF INDONESIA
signed
WIDODO EKATJAHJANA
STATE GAZETTE OF THE REPUBLIC OF INDONESIA YEAR 2019 NUMBER 989
Copy is in accordance to the original

NATIONAL AGENCY OF DRUG AND FOOD CONTROL
Head of Legal and Organisation Bureau,
signed
Riati Anggriani
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APPENDIX
NATIONAL AGENCY OF DRUG AND FOOD CONTROL
ON
AMENDMENT TO NATIONAL AGENCY FOR DRUG AND
FOOD CONTROL REGULATION NUMBER 1 YEAR 2018
ON SUPERVISION OF PROCESSED FOOD FOR SPECIAL
NUTRITIONAL PURPOSE
A. REQUIREMENTS FOR SAFETY, QUALITY, NUTRITION, AND LABELLING

OF PROCESSED FOOD FOR SPECIAL DIETARY USE (FSDU)
A.1. FSDU FOR INFANTS AND CHILDREN GROUPS
A.1.1. INFANT FORMULA
1. SCOPE
1.1. This provision applies to Infant Formula in the form of liquid or powder
which if necessary is used as replacement for human breast milk to meet
normal nutritional requirements for infants. "if necessary" in this case is
conditions in which the mother cannot/may not breastfeed the baby, e.g.
when the mother is deceased or is with an infectious disease, or when the
infant is unable to consume human breast milk due to certain conditions.
1.2. This provision incorporates description of the requirements for raw
material, quality, safety, and labelling of Infant Formula.
1.3. Only products meeting criteria within this provision may be marketed as
Infant Formula. Products other than Infant Formula are neither
marketable as nor declared suitable for infant consumption that by itself
will meet the nutritional requirements for normal and healthy infant
during the first few months of life.
2. DESCRIPTION AND DEFINITION

2.1. Infant Formula is replacement formula for human breast milk to be
consumed by infants up to 6 (six) months of age, specifically formulated
as their only source of nutrition in the first months of life until
Complementary Food is introduced.
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2.2. Infant Formula product is physically processed only and packaged to

avoid damage and contamination during handling, storage, and
distribution under normal conditions where the product is sold.
2.3. Infant is a person up to 12 (twelve) months of age.
2.4. Essential amino acids are amino acids the human body cannot
synthesise, thus are only obtainable from external sources.
2.5. Upper Limit (UL) is the highest value of nutrient content obtained based
on considerations to infant nutritional requirements and safe history of
use, but is not based on risk assessment.
UL may be adjusted based on the advancements of science and
technology. UL serves as a guidance for producers and not to be
considered as a value to be achieved. A nutrient content in Infant
Formula usually does not exceed UL unless unavoidable due to diversity
of ingredients or technological reasons.
3. REQUIREMENTS FOR QUALITY

3.1. Raw Materials
3.1.1. Infant Formula is product based on milk from either cow, other animals,
or a mixture of both, and/or other ingredients proven suitable for infant
consumption. Safety and adequacy of nutrient content in Infant Formula
must be scientifically evidenced able of supporting infant growth and
development.
3.1.2. All raw materials must be clean, of good quality, safe, gluten-free, and
suitable for infant consumption. Product must meet standard
requirements for quality e.g. in colour, taste, and odour.
3.1.3. Product must be free of clumps and large particles, and presentable
according to infant needs.
3.2. Nutritional Content

3.2.1. Energy
Infant Formula ready for consumption must contain energy not less than
60 kcal and not more than 70 kcal per 100 mL when prepared according
to preparation instruction.
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3.2.2. Protein
Protein within Infant Formula may be sourced from milk or soy protein
isolate.
Protein Source Unit Minimum Maximum UL
Milk protein g/100 kcal 1.8 3.0 -
Soy protein isolate g/100 kcal 2.25 3.0 -
Quality of protein is equivalent to that of casein or with higher amount

of other proteins if the quality is less than that of casein. Protein quality
must not be less than 85% of casein quality.
Within this Regulation, the calculation of protein content in an end
product ready for consumption must be based on N x 6.25, unless there
are certain scientific considerations for different conversion factors in a
particular product. Determination of protein content in cow-milk based
product is based on nitrogen conversion factor 6.25. The 6.38 conversion
factor is generally defined as a specific factor for the conversion of
nitrogen to proteins in other dairy products, and a 5.71 conversion factor
is specifically used for the conversion of nitrogen to proteins in soy
product.
Amino acid isolates may be added into Infant Formula to increase its
nutritional value. Essential and semi-essential amino acids may be added
only to the amount needed to improve the quality of the protein. Only L-
form amino acids may be used.
For energy amount in Infant Formula to be similar to human breast milk,
the formula must contain essential and semi-essential amino acids
content in amount at least equal to that in human breast milk protein
reference. The reference of types and amount of the essential and semi-
essential amino acids that may be added is as follows:
Amino Acid Average quantity in human breast milk
(mg amino acid per)
g nitrogen g protein 100 kcal
Cysteine 131 21 38
Histidine 141 23 41
Isoleucine 319 51 92
Leucine 586 94 169
Lysine 395 63 114
Methionine 85 14 24
Phenylalanine 282 45 81
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Threonine 268 43 77
Tryptophan 114 18 33
Tyrosine 259 42 75
Valine 315 50 90
Note:
Essential and semi-essential amino acids content in human breast milk is expressed in mg per g
nitrogen, mg per g protein, and mg per 100 kcal.
The lowest protein content in human breast milk is 1.8 g/100 kcal. If calculation is based on mg
amino acid/g nitrogen use the 6.25 divider factor and multiply by 1.8. The average value is
obtained from several studies of amino acid content expressed in units per g protein (total
nitrogen x 6.25) and per 100 kcal energy.
For calculation purposes, concentrations of tyrosine and phenylalanine may be

summed together, as also concentrations of methionine and cysteine if the ratio
between them is less than 2:1. If the ratio is between 2:1 and 3:1, the formula’s
feasibility must be evidenced by clinical trial. Conditional
semi-essential/essential amino acids are amino acids which in certain conditions
cannot be produced by the human body.
If Infant Formula contains non-hydrolysate milk protein less than 2 g/100 kcal
or hydrolysate protein less than 2.25 g/100 kcal, the formula must be clinically
evaluated.
3.2.3. Fat
Nutrient Unit Requirement Note
Content Minimum Maximum UL
Total fat g/100 kcal 4.4 6.0 -
Linoleic acid mg/100 kcal 300 - 1400 N.S. = not specified
α-linolenic mg/100 kcal 50 N.S. -
acid Ratio of linoleic to α-linolenic
acid is between 5:1 and 15:1
Partially hydrogenated oils and fats must not be used in Infant Formula.
Lauric acid and myristic acid are elements of fat, and the content of both
combined must not be more than 20% of total fatty acid content. Content of
trans fatty acids must not be more than 3% of total fatty acid content. Content of
erucic acid must not be more than 1% of total fatty acid content. Content of
total phospholipids must not be more than 300 mg/100 kcal.
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3.2.4 Carbohydrates
Total Carbohydrate:
Unit Minimum Maximum UL
g/100 kcal 9.0 14.0 -
Lactose and glucose polymers are primary choices for carbohydrates in

formulae based on cow milk and hydrolysate proteins.
The only starches allowed to be added into Infant formula are precooked
naturally gluten-free starches and/or gelatinised starch. Addition of the
aforementioned starches is maximum at 30% of total carbohydrate and
maximum at 2 g/100 mL.
The addition of sucrose must be avoided, except when required (maximum 20%
of total carbohydrates), and fructose must not be used. Both substances
potentially cause life-threatening symptoms in infants with hereditary fructose
intolerance.
3.2.5. Vitamins, Minerals, and Other Nutrients
Nutrient Unit Requirements Note
Vitamin A mcg RE/100 60 180 - RE = retinol equivalent
kcal
1 mcg RE = 3.33 SI vitamin A =
1 mcg all-trans retinol
Retinol content is in the form of

preformed retinol (already in
retinol form), and all carotenoid
content is discounted and not
expressed as vitamin A activity
Vitamin D3 mcg/100 kcal 1 2.5 - 1 mcg calcipherol = 40 SI
vitamin D
Vitamin E mg α-TE/100 0.5 - 5 α-TE = α-tocopherol equivalent
kcal
1 mg α-TE = 1 mg d-α-
tocopherol
Vitamin E content must be at

least 0.5 mg α-TE/g poly-
unsaturated fatty acids. The
following equivalent factors are
used for adjusting the minimum
content of vitamin E against
poly-unsaturated fatty acids:
0.5 mg α-TE/g linoleic acid (18:2
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n-6);
0.75 mg α-TE/g α-linolenic (18:3
n-3)
1.0 mg α-TE/g arachidonic acid
(20:4 n-6)
1.25 mg α-TE/g
eicosapentaenoic acid (20:5 n-3)
1.5 mg α-TE/g docosahexaenoic
acid (22:6 n-3)
Vitamin K mcg/100 kcal 4 - 27
Thiamine mcg/100 kcal 60 - 300
(Vitamin B1)
Riboflavin mcg/100 kcal 80 - 500
(Vitamin B2)
Niacin mcg/100 kcal 300 - 1500 Niacin content is in the form of
(Vitamin B3) preformed niacin (already in the
form of niacin)
Pantothenic mcg/100 kcal 400 - 2000
acid
(Vitamin B5)
Pyridoxin mcg/100 kcal 35 - 175
(Vitamin B6)
Vitamin B12 mcg/100 kcal 0.1 - 1.5
Folic acid mcg/100 kcal 10 - 50

Vitamin C mg/100 kcal 10 - 70 Vitamin C analysis is expresssed
as ascorbic acid
UL of vitamin C is determined
for liquid product. For product in
powder form, UL must be lower
Biotin mcg/100 kcal 1.5 - 10
(Vitamin H)
Calcium mg/100 kcal 50 - 140 UL value for phosphor already
Phosphor mg/100 kcal 25 - 100 includes the higher requirement
from soy based Infant Formula
Ratio of calcium to phosphor is

not less than 1.0 and not more
than 2.0
Iron mg/100 kcal 0.45 - 2
Zinc mg/100 kcal 0.5 - 1.5
Iodine mcg/100 kcal 10 - 60
Selenium mcg/100 kcal 1 - 9
Sodium mg/100 kcal 20 60 -
Potassium mg/100 kcal 60 180 -
Chloride mg/100 kcal 50 160 -
Magnesium mg/100 kcal 5 - 15
Copper mcg/100 kcal 35 - 120
Manganese mcg/100 kcal 1 - 100
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Choline mg/100 kcal 7 - 50

Myo-inositol mg/100 kcal 4 - 40
L-carnitine mg/100 kcal 1.2 N.S. - N.S. = not specified
3.2.6. Addable Nutrient/Non-nutrient Substances

Taurine mg/100 kcal - 12 -
Nucleotides mg/100 kcal - 16 - Nucleotides consist of at least 4
(four) types:
adenosine and guanosine (both
purin nucleotides), and
cytidine and uridine (both
pirimidine nucleotides)
Maximum purin nucleotide

content is 45% of total
nucleotides added
Docosa- % fatty acid 0.2 - 0.5 DHA addition in Infant Formula
hexaenoic must be accompanied by the
acid (DHA) addition of arachidonic acid
(ARA) with 1:1-2 ratio
Eicosapentaenoic (EPA) content,

which may form from long chain
poly-unsaturated fatty acids,
must not be more than DHA
content
Only L (+) form lactic acid-producing bacteria may be used.

3.2.7. Fluorine
Fluorine must not be added into Infant Formula. When fluorine is
naturally present in an ingredient, the fluorine content must not exceed
100 mcg/100 kcal in the ready-for-consumption Infant Formula product.
3.2.8. Other Addable Nutrient/Non-Nutrient Subtances
In addition to the aforementioned requirements, other nutrient/non-
nutrient substances normally found in human breast milk may be added
into the Infant Formula. This is done in ensuring that the formulation is
adequate as the only source of nutrients for infants, or to provide
benefits similar to those obtained by breastfed infant.
Safety and benefits of these nutrient/non-nutrient substances for infants
must be scientifically evidenced. The formula must contain the
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components in amount sufficient to provide the expected benefits, with

consideration to their content amount in human breast milk.
4. FOOD ADDITIVES
Food Additives used in Infant Formula must be in accordance with the
provisions of the laws and regulations.
5. LABELLING
5.1. Type Name
5.1.1. "Infant Formula".
5.1.2. Source(s) of the protein used in the Infant Formula product must be
clearly written on the label.
5.1.3. When cow milk is the only source of protein, the product may write
"Cow-Milk Based Infant Formula".
5.1.4. Infant Formula not containing any milk or milk derivatives must include
the phrase "Does not contain milk or milk derivatives" or similar.
5.2. Nutrition Facts

Nutrition facts must be expressed in either per 100 g or per 100 mL, and
per 100 kcal.
5.3. Instruction for Storage

5.3.1. Label must include explanation for signs indicating when the Infant
Formula is no longer fit for consumption and therefore must not be fed
to the infant.
5.3.2. Where the Infant Formula may not be used up after only a single
consumption instance, Label must include storage instructions for the
Infant Formula for after the container is opened.
5.4. Instruction for Use

5.4.1. Instruction for use, which includes methods for preparation, handling,
and use, must be included on the label and/or leaflet.
5.4.2. Infant Formula in liquid form must include the phrase "ready for
consumption".
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5.4.3. Infant Formula in concentrate form must include instructions on how to

dilute with drinking water.
5.4.4. Infant Formula in powder form must include instructions on how to
reconstitute with drinking water.
5.4.5. Label must include instructions for storage and disposal of Infant
Formula after preparation, e.g. remaining milk not drunk must be
disposed of.
5.4.6. Label must include illustration of preparation method.
5.4.7. Instruction for use must be accompanied with warning on health hazards
from improper methods for preparation, storage and/or use.
5.4.8. Guidelines for cleaning and sterilising the equipment, as well as
preparing and serving Infant Formula must be included on the label and/
or leaflet as follows:
a. How to clean and sterilise equipment
1. Wash hands with soap before cleaning and sterilising infant
drinking utensils;
2. Wash all utensils (bottle, teat, bottle brush, and teat brush) with
running water;
3. Rinse bottle and teat with running water;
4. Sterilise by boiling:
- Bottle must be completely submerged that there is no air inside
the bottle;
- Close pot and leave boiling for 5-10 minutes;
- Keep pot closed, leave the bottle and teat inside the pot until
used;
5. Wash hands with soap before taking the bottle and teat out;
6. When bottle is not immediately used after being boiled:
- Bottles must be kept in a closed, clean container
- Teats and lids must be securely installed
b. How to prepare and serve Infant Formula

1. Clean the platform where Infant Formula will be prepared;
2. Wash hands with soap and running water, then dry;
3. Heat drinking water until boiling for 10 minutes in a covered pan;
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4. After boiled, leave the water in the closed pan for 10-15 minutes
until temperature lowers but still no less than 70 °C;
5. Pour the water (with temperature not less than 70 °C) as the infant
may drink (do not overspill) into a sterilised milk bottle;
6. Add Infant Formula powder in the recommended amount written
on the label;
7. Close the bottle and shake until Infant Formula dissolves well;
8. Cool down immediately by soaking the bottom of the bottle in
clean, cool water until temperature is suitable for drinking (test by
dripping the Infant Formula on the wrist: it must feel slightly
warm, not hot);
9. Remaining Infant Formula dissolved must be disposed of after 2
hours.
5.5. Other Information

5.5.1. Contents of Label must not counter breastfeeding programme. Infant
Formula product label must include:
a. The word "Caution" or similar;
b. The sentence "Infant Formula product is not a sterile product
therefore pay attention to preparation instructions". The sentence is
written on the main part of Label with font size minimum 2 mm;
c. The sentence "Human breast milk is the best food for your baby" or
another similar sentence that states the superiority of
breastfeeding/human breast milk;
d. Statement that the product is only used under doctor's
recommendation based on medical indication and with explanation on
appropriate use.
5.5.2. Label must not contain images of infant and woman, or anything
favouring the use of Infant Formula whether in picture or sentence.
Label must not state that Infant Formula has the same quality as that of
human breast milk.
5.5.3. Any term equating Infant Formula with human, mother, or similar terms
must not be used.
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5.5.4. Label must include information that infants above 6 (six) months of age
must be given complementary food suitable with the needs of infant
growth and development. Feeding complementary food before 6 (six)
months of age must be under doctor’s instructions.
5.5.5. Product Label must be obvious that consumer is able to distinguish
amongst Infant Formula, Follow On Formula, and Infant Formula For
Special Medical Purposes.
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A.1.2. FOLLOW ON FORMULA

1. SCOPE
1.1. This provision applies to Follow On Formula in the form of liquid or
powder.
material, quality, safety, and labelling of Follow On Formula.

2.1. Follow On Formula is formula derived from either cow or other animal
milk, and/or animal or plant-derived materials proven suitable for
consumption by infants 6 (six) to 12 (twelve) months of age.
2.2. Follow On Formula is physically processed only and packaged to avoid
damage and contamination during handling, storage, and distribution
under normal conditions where the product is sold.
2.3. Follow On Fomula in liquid form may be used directly or after dilution
with water. Follow On Formula in powder form needs to be added with
water in suggested amount before use. Nutrients within Follow On
Formula can contribute in normal infant growth and development if used
in accordance with instructions for use.
2.4. Infant is a person up to 12 (twelve) months of age.
2.5. Essential amino acids are amino acids the human body cannot
synthesise, thus are only obtainable from external sources.
on considerations for infant nutritional requirements and safe history of
considered as a value to be achieved. A nutrient content in Follow On
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3.1. Raw Materials
3.1.1. Follow On Formula is product based on milk from either cow, other
animals, or a mixture of both, and/or other ingredients proven suitable
for consumption by infants 6 (six) to 12 (twelve) months of age.
3.1.2. Safety and benefits of materials used in Follow On Formula must be
scientifically evidenced. Formula must contain materials in amount
sufficient to provide expected benefits for infants 6 (six) to 12 (twelve)
months of age.
suitable for digestion by infants 6 (six) to 12 (twelve) months of age.
Follow On Formula must meet standard requirements for quality e.g. in
colour, taste, and odour.
3.1.4. Follow On Formula must be free of clumps and large particles, and
presentable according to infant needs.

3.2.1. Energy
Follow On Formula ready for consumption must contain energy not less
than 65 kcal and not more than 80 kcal per 100 mL when prepared
according to preparation instruction.
3.2.2. Protein
Protein within Follow On Formula may be sourced from milk or soy
protein isolate.
Milk protein g/100 kcal 1.82 3.5 -

Within this Regulation, the calculation of protein content in Follow On
Formula ready for consumption must be based on N x 6.25, unless there
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product.
Amino acid isolates may be added into Follow On Formula to increase
its nutritional value. Essential and semi-essential amino acids may be
added only to the amount needed to improve the quality of the protein.
Only L-form amino acids may be used.
For energy amount in Follow On Formula to be similar to human breast
milk, the formula must contain essential and semi-essential amino acids
content in amount at least equal to that in human breast milk protein
reference. The reference of types and amount of the essential and semi-
essential amino acids that may be added is as follows:
Amino Acid Average range quantity in human breast milk
(mg amino acid per)
g nitrogen g protein 100 kcal
Cysteine 101-173 21 29-50
Histidine 108-255 23 31-73
Isoleucine 242-376 51 70-108
Leucine 457-713 94 132-205
Lysine 314-522 63 90-150
Methionine 73-99 14 21-29
Phenylalanine 153-440 45 44-127
Threonine 217-344 43 62-99
Tryptophan 79-172 18 23-50
Tyrosine 201-369 42 55-86
Valine 253-376 50 73-108
Note:
Essential and semi-essential amino acids content in human breast milk is expressed in mg per g
nitrogen, mg per g protein, and mg per 100 kcal.
The lowest protein content in human breast milk is 1.8 g/100 kcal. If calculation is based on mg
amino acid/g nitrogen use the 6.25 divider factor and multiply by 1.8. The average value is
obtained from several studies of amino acid content expressed in units per g protein (total
nitrogen x 6.25) and per 100 kcal energy.
For calculation purposes, concentrations of tyrosine and phenylalanine may be

summed together, as also concentrations of methionine and cysteine if the ratio
between them is less than 2:1. If the ratio is between 2:1 and 3:1, the formula’s
feasibility must be evidenced by clinical trial. Conditional
-23-
semi-essential/essential amino acids are amino acids which in certain conditions

cannot be produced by the human body.
If Follow On Formula contains non-hydrolysate milk protein less than
1.8 g/100 kcal or hydrolysate protein less than 2.25 g/100 kcal, the
formula must be clinically evaluated.
3.2.3. Fat
Total fat g/100 kcal 4 6 -
Linoleic acid mg/100 kcal 300 - 1200 N.S. = not specified
Content of trans fatty acids must not be more than 3% of total fatty acid
content.
3.2.4 Carbohydrates
Total Carbohydrate:
g/100 kcal 8.0 14.2 -
Lactose and glucose polymers (starch derivates) are primary choices for
carbohydrates in formulae based on cow milk and hydrolysate proteins, but
other carbohydrate sources may be added.
The only starches allowed to be added into Follow On formula are precooked
naturally gluten-free starches and/or gelatinised starch. Addition of the
aforementioned starches is maximum at 30% of total carbohydrate and
maximum at 2 g/100 mL.
The addition of sucrose must be avoided, except when required (maximum 20%
of total carbohydrates), and fructose must not be used. Both substances
potentially cause life-threatening symptoms in infants and children with
hereditary fructose intolerance.
Vitamin A IU/100 kcal 250 750 -
Vitamin D3 mcg/100 kcal 1 3 -
-24-
Vitamin E mg/100 kcal 0.5 - 5

Vitamin K mcg/100 kcal 4 - 27
Thiamine mcg/100 kcal 60 - 300
(Vitamin B1)
Riboflavin mcg/100 kcal 80 - 500
(Vitamin B2)
Niacin mcg/100 kcal 250 - 1500
(Vitamin B3)
Pantothenic mcg/100 kcal 300 - 2000
acid
(Vitamin B5)
Pyridoxin mcg/100 kcal 45 - 175
(Vitamin B6)
Vitamin B12 mcg/100 kcal 0.15 - 1.5
Folic acid mcg/100 kcal 4 - 50
Vitamin C mg/100 kcal 8 - 70 Vitamin C analysis is expressed
as ascorbic acid
Biotin mcg/100 kcal 1.5 - 10
(Vitamin H)
Calcium mg/100 kcal 50 - 140 Ratio of calcium to phosphor is
Phosphor mg/100 kcal 60 - 100 not less than 1.2 and not more
than 2.0
Iron mg/100 kcal 1 - 2
Zinc mg/100 kcal 0.5 - 1.5
Iodine mcg/100 kcal 5 - 60
Selenium mcg/100 kcal 1 - 9
Chloride mg/100 kcal 55 160 -
Magnesium mg/100 kcal 6 - 15
Copper mcg/100 kcal 35 100 120

Manganese mcg/100 kcal 1 - 100
(four) types:
-25-

nucleotides added
Docosa- per 100 kcal 0.2% fatty - 0.9% DHA addition in Follow On
hexaenoic acid fatty Formula must be accompanied
acid (DHA) acid by the addition of arachidonic
acid (ARA) with 1:1-2 ratio
Eicosapentaenoic (EPA) content,

content

3.2.7. Fluorine
Fluorine must not be added into Follow On Formula. When fluorine is
100 mcg/100 kcal in the ready-for-consumption Follow On Formula
product.
nutrient substances normally found in human breast milk may be added
into the Follow On Formula.
Safety and benefits of materials used in Follow On Formula for infants 6
(six) to 12 (twelve) months of age must be scientifically evidenced.
Formula must contain materials in amount sufficient to provide expected
benefits for infants 6 (six) to 12 (twelve) months of age.
4. FOOD ADDITIVES
Food Additives used in Follow On Formula must be in accordance with
the provisions of the laws and regulations.
5. LABELLING
5.1. Type Name
5.1.1. "Follow On Formula".
-26-
5.1.2. When cow milk is the only source of protein, the phrase "Cow-Milk
Based" may be added.
5.1.3. Follow On Formula not containing any milk or milk derivatives may
include the phrase "Does not contain milk or milk derivatives" or
similar.

Nutrition facts must be expressed in either per 100 g or per 100 mL, and
per 100 kcal.
5.3. Recommendation for Daily Consumption

Recommended Daily Consumption must be expressed such in order to
achieve sufficient daily nutrition of infants 6 (six) to 12 (twelve) months
of age.

5.4.1. Label must include explanation for signs indicating when the Follow On
Formula is no longer fit for consumption and therefore must not be fed
to the infant.
5.4.2. Where the Follow On Formula may not be used up after only a single
Follow On Formula for after the container is opened.

5.5.1. Follow On Formula in liquid form must include the phrase "ready for
consumption".
5.5.2. Follow On Formula in concentrate form must include instructions on
how to dilute with drinking water.
5.5.3. Follow On Formula in powder form must include instructions on how to
reconstitute with drinking water.
5.5.4. Label must include instructions for storage, handling, and use of Follow
On Formula, including its storage and disposal after preparation, e.g.
remaining milk not drunk must be disposed of.
-27-
preparing and serving Follow On Formula must be included on the label
and/or leaflet as follows:
drinking utensils;
2. Wash infant drinking utensils with running water;
3. Rinse infant drinking utensils with running water;
- Infant drinking utensils must be completely submerged;
- Keep pot closed, leave infant drinking utensils inside the pot
until used;
5. Wash hands with soap before taking infant drinking utensils out;
6. When infant drinking utensils are not immediately used after being
boiled they must be kept in a closed, clean container.
b. How to prepare and serve Follow On Formula

1. Clean the platform where Follow On Formula will be prepared;
6. Add Follow On Formula powder in the recommended amount
written on the label;
7. Close the bottle and shake until Follow On Formula dissolves well;
dripping the Infant Formula on the wrist: it must feel slightly
warm, not hot);
-28-
9. Remaining Infant Formula dissolved must be disposed of after 2

hours.

5.6.1. Label for Follow On Formula must include a sentence stating that
Follow On Formula must not be given to infants less than 6 (six) months
of age.
5.6.2 Label must include information that infants above 6 (six) months of age
must be given food complementary to human breast milk suitable with
the needs of infant growth and development.
5.6.3. Contents of Label must not counter breastfeeding programme. The Infant
Formula product label must include:
a. The word "Caution" or similar;
b. The sentence "Powder-form Follow On Formula is not a sterile
product therefore pay attention to preparation instructions";
c. The sentence "Human breast milk is the best food for your baby" or
another similar sentence that states the superiority of
breastfeeding/human breast milk.
5.6.4. Label must not contain images of infant and woman, or anything
favouring the use of Follow On Formula whether in picture or sentence.
Label must not state that Infant Formula has the same quality as that of
human breast milk.
5.6.5. Any term equating Infant Formula with human, mother, or similar terms
must not be used.
-29-
A.1.3. GROWING UP FORMULA

1. SCOPE
1.1. This provision applies to Growing Up Formula in the form of liquid or
powder.
material, quality, safety, and labelling of Growing Up Formula.

2.1. Growing Up Formula is formula derived from either cow or other animal
milk, and/or animal or plant-derived materials proven suitable for
consumption by children above 12 (twelve) months up to 36 (thirty six)
months of age.
2.2. Growing Up Formula is physically processed only and packaged to
avoid damage and contamination under normal handling, storage, and
distribution conditions.
2.3. Growing Up Formula in liquid form may be used directly or after
dilution with water. Growing Up Formula in powder form needs to be
added with water in suggested amount before use. Nutrients within
Growing Up Formula can contribute in normal child growth and
development if used in accordance with instructions for use.
on considerations for child nutritional requirements and safe history of
considered as a value to be achieved. A nutrient content in Growing Up

3.1. Raw Materials
3.1.1. Growing Up Formula is product based on milk from either cow, other
animals, or a mixture of both, and/or other ingredients proven suitable
for consumption by children. Safety and adequacy of nutrient content in
-30-
Growing Up Formula must be scientifically evidenced able of

supporting child growth and development.
3.1.2. Safety and adequacy of materials used in Growing Up Formula for
children 12 (twelve) to 36 (thirty six) months of age must be
scientifically evidenced. Formula must contain materials in amount
sufficient to provide expected benefits for children 12 (twelve) to 36
(thirty six) months of age.
suitable for digestion by children 12 (twelve) to 36 (thirty six) months of
age. Product must meet standard requirements for quality e.g. in colour,
taste, and odour.
3.1.4. Growing Up Formula must be free of clumps and large particles, and
presentable according to child needs.

3.2.1. Energy
Growing Up Formula ready for consumption must contain energy not
less than 60 kcal and not more than 85 kcal per 100 mL when prepared
according to preparation instruction.
3.2.2. Protein
Protein within Growing Up Formula may be sourced from milk or soy
protein isolate.
Milk protein g/100 kcal 3 5.5 -

Within this Regulation, the calculation of protein content in an Infant
Formula ready for consumption must be based on N x 6.25, unless there
-31-

product.
Amino acid isolates may be added into Infant Formula to increase its
nutritional value. Essential and semi-essential amino acids may be added
only to the amount needed to improve the quality of the protein. Only L-
form amino acids may be used.
3.2.3. Fat
Minimum Maximum UL
Total fat g/100 kcal 3.3 5.6 -
Linoleic acid mg/100 kcal 300 1200 - N.S. = not specified
Content of trans fatty acids must not be more than 3% of total fatty acid
content.
3.2.4 Carbohydrates
Total Carbohydrate:
g/100 kcal 7 - -
carbohydrates in formulae based on cow milk and hydrolysate proteins, but
other carbohydrate sources may be added.
The only starches allowed to be added into Growing Up formula are precooked
naturally gluten-free starches and/or gelatinised starch.
Addition of sucrose is maximum at 25% of total carbohydrates.
Vitamin A IU/100 kcal 250 750 -
RE/100 kcal 75 225 -
Vitamin D3 mcg/100 kcal 1 5 -
IU/100 kcal 40 200 -
Vitamin E mg/100 kcal 0.5 N.S. - N.S. = not specified
Vitamin K mcg/100 kcal 4 N.S. -
-32-
Thiamine mcg/100 kcal 40 N.S. -

(Vitamin B1)
Riboflavin mcg/100 kcal 60 N.S. -
(Vitamin B2)
Niacin mcg/100 kcal 250 N.S. -
(Vitamin B3)
Pantothenic mcg/100 kcal 300 N.S. -
acid
(Vitamin B5)
Pyridoxin mcg/100 kcal 45 N.S. -
(Vitamin B6)
Vitamin B12 mcg/100 kcal 0.15 N.S. -
Folic acid mcg/100 kcal 10 50 -
Vitamin C mg/100 kcal 8 N.S. - N.S. = not specified
Vitamin C analysis is expressed

as ascorbic acid
Biotin mcg/100 kcal 1.5 N.S. - N.S. = not specified
(Vitamin H)
Calcium mg/100 kcal 90 N.S. - N.S. = not specified
Phosphor mg/100 kcal 60 N.S. -
Ratio of calcium to phosphor is
not less than 1.2 and not more
than 2.0
Iron mg/100 kcal 1 2 -
Zinc mg/100 kcal 0.5 N.S. - N.S. = not specified
Iodine mcg/100 kcal 5 N.S. -
Selenium mcg/100 kcal 1 9 -
Chloride mg/100 kcal 55 N.S - N.S. = not specified
Magnesium mg/100 kcal 6 N.S. -
Copper mcg/100 kcal 35 100 -

Manganese mcg/100 kcal - 100 -
(four) types:
-33-

nucleotides added
Docosa- per 100 kcal 0.2% fatty - 0.9% Eicosapentaenoic (EPA) content,
hexaenoic acid fatty which may form from long chain
acid (DHA) acid poly-unsaturated fatty acids,
content

3.2.7. Fluorine
Fluorine must not be added into Growing Up Formula. When fluorine is
100 mcg/100 kcal in the ready-for-consumption Growing Up Formula
product.
nutrient substances suitable for children 12 (twelve) to 36 (thirty six)
months of age may be added. Safety and benefits of those nutrient/non-
nutrient substances must be scientifically evidenced.
4. FOOD ADDITIVES
Food Additives used in Growing Up Formula must be in accordance
with the provisions of the laws and regulations.
5. LABELLING
5.1. Type Name
5.1.1. "Growing Up Formula", or when milk is the only source of protein
"Growing Up Milk" may be written.
5.1.2. When cow milk is the only source of protein, in addition to "Growing
Up Formula" or "Growing Up Milk", "Cow-milk Based" may be written.
5.1.3. Growing Up Formula not containing any milk or milk derivatives may
add the writing "Does not contain milk or milk derivatives" or similar.
-34-

Nutrition facts must be expressed per serving quantity, with the serving
quantity in the range of 30-50 g (powder form) or 200-250 mL (liquid
form).

achieve sufficient daily nutrition for children 1 (one) to 3 (three) years of
age.

5.4.1. Label must include explanation for signs indicating when the Growing
Up Formula is no longer fit for consumption and therefore must not be
fed to the child.
5.4.2. Where the Growing Up Formula may not be used up after only a single
Growing Up Formula for after the container is opened.

5.5.1. Growing Up Formula in liquid form must include the phrase "ready for
consumption".
5.5.2. Growing Up Formula in concentrate form must include instructions on
how to dilute with drinking water.
5.5.3. Growing Up Formula in powder form must include instructions on how
to reconstitute with drinking water.
5.5.4. Label must include instructions for storage, handling, and use of
Growing Up Formula, including its storage and disposal after
preparation, e.g. remaining milk not drunk must be disposed of.
5.5.7. Guidelines for preparing and serving Growing Up Formula must be
included on the label.
-35-

5.6.1. Label for Growing Up Formula must include a sentence stating that
Follow On Formula must not be given to infant.
5.6.2. Label for Growing Up Formula must include the warning:
Caution:
Not suitable for infants
-36-
A.1.4. COMPLEMENTARY FOOD FOR INFANTS

1. SCOPE
1.1. This provision covers 2 (two) types of Complementary Food for Infants,
i.e. Main Complementary Food for Infants and Snack Complementary
Food for Infants.
material, quality, safety, and labelling of Main Complementary Food for
Infants and Snack Complementary Food for Infants.

2.1. Complementary Food for Infants is nutritious food given, alongside
human breast milk, to infants 6 (six) months up to 24 (twenty four)
months of age or beyond that age range based on medical indication, to
achieve nutritional adequacy.
2.2. Main Complementary Food for Infants is nutritious food given,
alongside human breast milk, to infants 6 (six) months up to 24 (twenty
four) months of age or beyond that age range based on medical
indication, to achieve nutritional adequacy.
2.2.1. Main Complementary Food for Infants is physically, enzymatically, and/
or fermentationally processed only and packaged such to create product
safe and suitable for consumption by infants and children 6 (six) to 24
(twenty four) months of age, and to avoid damage and contamination
during handling, storage, and distribution under normal conditions
according to the place where the product is sold.
2.2.2. Product may be in the form of:
a. Powder, preparable for consumption with milk, water, or other fluids
suitable.
b. Pasta that for use needs cooking with boiling water or other liquids
suitable.
c. Biscuit and rusk used directly or after crushing and softening with
addition of water, milk, or other liquids suitable.
d. Other forms suitable.
-37-
2.3. Snack Complementary Food for Infant

2.3.1. Snack Complementary Food for Infants is nutritious food given,
alongside human breast milk and Main Complementary Food for Infants,
between two meal times to infants 6 (six) months up to 24 (twenty four)
months of age or beyond that age range based on medical indication, to
achieve nutritional adequacy.
2.3.2. Snack Complementary Food for Infants is physically, enzymatically,
and/or fermentationally processed only and packaged such to create
product safe and suitable for consumption by infants and children 6 (six)
to 24 (twenty four) months of age, and to avoid damage and
contamination during handling, storage, and distribution under normal
conditions according to the place where the product is sold.
2.3.3. Snack Complementary Food for Infants is ready-to-eat product that may
take the form of biscuit, pudding, yogurt, and instant product, adjusted to
infants and children oromotor ability.

3.1. Raw Materials
3.1.1. Raw materials used should be must be clean, of good quality, safe, and
suitable for children 6 (six) to 24 (twenty four) months of age.
3.1.2. Safety and adequacy of nutrient content of materials used for production
of Main Complementary Food for Infants and Snack Complementary
Food for Infants must be scientifically evidenced able of supporting
growth and development of infants and children 6 (six) to 24 (twenty
four) months of age.
3.1.3. Main Complementary Food for Infants and Snack Complementary Food
for Infants is made from one or more of the following main raw
materials and/or it’s derivatives: cereals (e.g. rice, corn, wheat, sorghum,
barley, oat, rye, millet, buckwheat), tubers (e.g. sweet potato, cassava,
arrowroot, potato, lesser yam), starchy ingredients (e.g. sago, palm
starch, pumpkin), legumes (e.g. green beans, red beans, black eyed peas,
peanuts), oil-containing grains (e.g. soy, peanut, sesame), dairy, fish,
meat, poultry, fruits and/or other suitable ingredients.
-38-
3.1.4. In addition to the main ingredients mentioned in 3.1.3, other raw

materials and/or its derivatives suitable for infants and children 6 (six) to
24 (twenty four) months of age, e.g. oil, fat, sugar, sugar syrup, salt,
vegetables, fruit and/or spices, may be added.
3.1.5. Cacao may only be used in product designated for infants above 9 (nine)
months of age and its maximum limit of use is 1.5 g per 100 g of the
ready-to-consume product.
3.1.6. Honey may only be used in product designated for children above 12
(twelve) months of age.
3.1.7. Product using honey or sugar syrup (e.g. maple, fructose, glucose) must
be processed such that it is free (negative) of Clostridium botulinum.
3.1.8. Main Complementary Food for Infants and Snack Complementary Food
for Infants must meet standard requirements for quality e.g. in colour,
taste, and odour.

3.2.1. Water Content
Water content in Complementary Food for Infants in the form of powder,
biscuit, rusk, and instant product must not be more than 5 g per 100 g.
Water content in Complementary Food for Infants in the form of pasta or
other forms that need cooking before serving must not be more than 12.5
g per 100 g.
3.2.2. Energy
Main Complementary Food for Infants ready for consumption must
contain energy not less than 240 kcal per day for children 6 (six) to 12
(twelve) months of age, and not less than 640 kcal per day for children
12 (twelve) to 24 (twenty four) months of age when prepared according
Snack Complementary Food for Infants ready for consumption must
contain energy not less than 60 kcal per day for children 6 (six) to 12
(twelve) months of age, and not less than 160 kcal per day for children
12 (twelve) to 24 (twenty four) months of age when prepared according
-39-
Energy density of Main Complementary Food for Infants and Snack

Complementary Food for Infants is no less than 0,8 kcal/g (ready for
consumption).
3.2.3. Protein
Main Complementary Food for Infants and Snack Complementary Food
for Infants for children 6 (six) to 12 (twelve) months of age must contain
protein:
Unit Minimum Maximum
g/100 kcal 1.9 5.5

for Infants for children 12 (twelve) to 24 (twenty four) months of age
must contain protein:
Unit Minimum Maximum
g/100 kcal 0.8 5.5

3.2.4. Fat
Content Minimum Maximum
Total fat g/100 kcal - 4.5
α-linolenic mg/100 kcal 50 - N.S. = not specified
acid
Ratio of linoleic to α-linolenic
Partially hydrogenated oils and fats must not be used in Main Complementary
Food for Infants and Snack Complementary Food for Infants.
Trans fatty acids must not be added, and when there are pre-existing
trans fatty acids the content must not be more than 3% of total fatty acid
content.
3.2.5. Carbohydrates
When sucrose, fructose, glucose, glucose syrup, or honey is added to Main
Complementary Food for Infants and Snack Complementary Food for Infants:
-40-
a. The amount of carbohydrates added from sucrose, fructose, glucose, glucose

syrup or honey must not be more than 5 g/100 kcal; and
b. The amount of fructose added must not be more than 2.5 g/100 kcal.
3.2.6. Dietary Fiber
Main Complementary Food for Infants and Snack Complementary Food for
Infants must contains dietary fiber less than 1.25 g per 100 kcal.
3.2.7. Vitamins and Minerals
Required amount of vitamins and minerals in Main Complementary Food for
Infants and Snack Complementary Food for Infants is as follows:
Nutrient Unit Requirements
Content 6-12 months of age 12-24 months of age
Mandatory vitamins and minerals to add
Vitamin A mcg RE/100 kcal 60-180 60-180
Thiamine mg/100 kcal minimum 0.05 minimum 0.05
(Vitamin B1)
Vitamin B12 mcg/100 kcal minimum 0.05 minimum 0.075
Vitamin D mcg/100 kcal 1-3 1-3
Iron mg/100 kcal minimum 3.56 minimum 0.86
Zinc mg/100 kcal minimum 0.86 minimum 0.45
1
Calcium mg/100 kcal minimum 80 minimum 80
Phosphor1 mg/100 kcal minimum 67.5 minimum 48
Sodium mg/100 kcal maximum 100 maximum 100
Potassium mg/100 kcal minimum 140 minimum 266
Iodine mcg/100 kcal minimum 1.2 minimum 4.5
Magnesium mg/100 kcal minimum 13.9 minimum 6.1
Optional vitamins and minerals to add
Riboflavin mg/100 kcal minimum 0.07 minimum 0.06
(Vitamin B2)
Niacin mg/100 kcal minimum 1.12 minimum 0.68
(Vitamin B3)
Pantothenic mcg/100 kcal minimum 0.18 minimum 0.18
acid
(Vitamin B5)
Pyridoxin mg/100 kcal minimum 0.09 minimum 0.06
(Vitamin B6)
Folic acid mcg/100 kcal - minimum 4.8
Vitamin C2 mg/100 kcal minimum 2.7 minimum 2
Vitamin E mg/100 kcal minimum 0.5 minimum 0.5
Vitamin K mcg/100 kcal minimum 2.5 minimum 2.5
Note:
1. Ratio of calcium (Ca) to phosphor (P) must neither be less than 1.2 nor more than 2.
2. Analysis of vitamin C is expressed as ascorbic acid.
-41-

nutrient substances suitable for children 6 (six) to 24 (twenty four)
months of age may be added. Safety and benefits of those nutrient/non-
nutrient substances must be scientifically evidenced.
4. FOOD ADDITIVES
Food Additives used in Main Complementary Food for Infants and
Snack Complementary Food for Infants must be in accordance with the
5. LABEL
5.1. Type Name
5.1.1. Label for Main Complementary Food for Infants must write the type name
“Main Complementary Foods for Infants”.
5.1.2. Label for Snack Complementary Food for Infants must write the type name
“Snack Complementary Foods for Infants”.
5.1.3. In addition to the type name, Main Complementary Food for Infants and Snack
Complementary Food for Infants must include age designation, i.e. 6 (six) to 12
(twelve) months (6-12 months), 12 (twelve) to 24 (twenty four) months (12-24
months), or other age groups corresponding with oromotor abilities.

5.2.1. Nutrition Facts for Main Complementary Food for Infants must be expressed
per serving quantity, with the serving quantity in the range of 20-50 g.
For products ready for consumption, the serving quantity is in the range
of 75-125 g.
5.2.2. Nutrition Facts of Snack Complementary Food for Infants must be expressed
per serving quantity, with the serving quantity in the range of 10 g - 30 g.

achieve sufficient daily nutrition for infants and children 6 (six) to 24
(twenty four) months of age.
-42-

5.4.1. Label must include explanation for signs indicating when the Main
Complementary Food for Infants and Snack Complementary Food for
Infants is no longer fit for consumption and therefore must not be fed to
the infant.
5.4.2. Where the Main Complementary Food for Infants and Snack
Complementary Food for Infants may not be used up after only a single
consumption instance, Label must include storage instructions of the
for Infants for after the container is opened.

5.5.1. Label for Main Complementary Food for Infants and Snack
Complementary Food for Infants must include:
a. instruction for preparation, including illlustration for how to use;
b. instruction for handling, including storage and disposal after
preparation;
c. instruction for use; and
d. warning on health hazards from improper methods for preparation,
storage and/or use.
Complementary Food for Infants usually readily consumed must include
the phrase “ready for consumption”.

Complementary Food for Infants must include a sentence stating that
for Infants must not be given to infants under 6 (six) months of age
except under medical indication.
-43-
Complementary Food for Infants must include daily serving frequency
for infants 6 (six) to 12 (twelve) months of age and children 12 (twelve)
to 24 (twenty four) months of age.
-44-
A.2. FSDU FOR ADULT GROUP

A.2.1. SPECIAL BEVERAGE FOR PREGNANT WOMEN AND/OR LACTATING
MOTHERS
1. SCOPE
1.1. This provision applies to Special Beverage for Pregnant Women and/or
Lactating Mothers in the form of liquid, powder, or other forms suitable
to meet nutritional requirements of pregnant women and/or lactating
mothers.
material, quality, safety, and labelling of Special Beverage for Pregnant
Women and/or Lactating Mothers.

Special Beverage for Pregnant Women and/or Lactating Mothers is
product in the form of powder or liquid specifically designated for
pregnant women and/or lactating mothers, which contains energy,
protein, fat, carbohydrates, vitamins, and minerals measured based on
recommended addition for nutritional adequacy of the pertinent group,
with or without addition of either bioactive components and/or allowable
food additives.

3.1. Raw Materials
All raw materials must be clean, of good quality, safe, and suitable for
infant consumption. Product must meet standard requirements for
quality e.g. in colour, taste, and odour.

3.2.1. Energy
Special Beverage for Pregnant Women must contain energy not less than
325 kcal per 100 g or not less than 65 kcal per 100 mL of product ready
for consumption.
-45-
Special Beverage for Lactating Mothers must contain energy not less
than 400 kcal per 100 g or not less than 70 kcal per 100 mL of product
ready for consumption.
3.2.2. Nutrient content of Special Beverage for Pregnant Women and/or
Lactating Mothers must meet these requirements:
Nutrient Unit Special Beverage for Special Beverage for
Content
Pregnant Women Lactating Mothers
per 100 g per 100 mL per 100 g per 100 mL
Mandatory Nutrient Content
Protein g 18-25 3.2-4.4 20-34 3.5-6
Fat g min. 3.5 min. 0.6 min. 7 min. 1.2
Carbohydrates g max. 65 max. 11.4 max. 65 max. 11.4
Water g max. 4 - max. 4 -
Ash g max. 6 max. 1.1 max. 6 max. 1.1
Vitamin A mcg/RE 300-500 53-88 300-500 53-88
Thiamine mg 0.5-1.3 0.1-0.26 0.3-1.3 0.1-0.4
(Vitamin B1)
Riboflavin mg 0.5-1.4 0.1-0.28 0.4-1.5 0.1-0.37
(Vitamin B2)
Niacin mg 6-18 1.1-3.3 3-17 0.5-2.8
(Vitamin B3)
Pyridoxin mg 0.6-1.7 0.1-0.28 0.5-1.8 0.1-0.36
(Vitamin B6)
Vitamin B12 mcg 0.3-2.6 0.1-0.8 0.4-2.8 0.1-0.7
Folic acid mcg 285-600 49-103.1 100-500 18-90
Vitamin C mg 14-90 2.5-16 45-100 8-17.7
Calcium mg 200-950 35-166.2 150-950 26.25-166.2
Iron mg 10-33 1.8-5.9 6-32 1.05-5.6
Zinc mg 5-14.7 0.9-2.6 4.6-13.9 0.8-2.4
Fluor mg max. 2.5 max. 0.4 max. 2.5 max. 0.44
Optional Nutrient Content
Pantothenic mg max. 7 max. 1.2 max. 7 max. 1.2
acid
(Vitamin B5)
Vitamin D IU max. 200 max. 35 max. 200 max. 35
Vitamin E mg max. 15 max. 2.6 max. 19 max. 3.3
Vitamin K mcg max. 55 max. 9.6 max. 55 max. 9.6
Iodine mcg 70-200 12-34.2 50-200 8.75-35
Selenium mcg 7-35 1.2-6 5-40 0.88-7.04
Magnesium mg 40-270 7.0-47.2 50-270 9-47.2
Manganese mg 0.3-1.8 0.1-0.3 0.8-2.6 0.14-0.4
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4. FOOD ADDITIVES
Food Additives used in Special Beverage for Pregnant Women and/or
Lactating Mothers must be in accordance with the provisions of the laws
and regulations.
5. LABEL
5.1. Type Name
“Special Beverage for Pregnant Women” or “Special Beverage for
Lactating Mothers” or “Special Beverage for Pregnant Women and
Lactating Mothers”.

Nutrition Facts must be expressed per serving quantity, with the serving
quantity in the range of 30-50 g.

5.3.1. Label must include explanation for signs indicating when the Special
Beverage for Pregnant Women and/or Lactating Mothers is no longer fit
for consumption and therefore must not be fed to the child.
5.3.2. Where the Special Beverage for Pregnant Women and/or Lactating
Mothers may not be used up after only a single consumption instance,
Label must include storage instructions for the Special Beverage for
Pregnant Women and/or Lactating Mothers for after the container is
opened.

5.4.2. Special Beverage for Pregnant Women and/or Lactating Mothers in
liquid form must include the phrase "ready for consumption".
concentrate form must include instructions on how to dilute with
drinking water.
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powder form must include instructions on how to reconstitute with
drinking water.
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A.2.2. ATHLETE FOOD

Athlete Food consists of (2) two types, i.e. Sports Drink and Food Supplement
for Athletes.
A.2.2.1. SPORTS DRINK

1. SCOPE
This provision applies to Sports Drink in the form of liquid/solution
ready for consumption or powder that needs reconstitution with water to
form solution ready for consumption.
This provision incorporates description of the requirements for raw
material, quality, safety, and labelling of Sports Drink.

2.1. Athlete is a person practising sport.
2.2. Sports Drink is designated for people practising endurance sports with
considerations towards its contents of liquid, electrolytes, and energy,
used to rapidly replenish the liquid, electrolytes, and energy within the
body, that it increases, maintains, and restores stamina during endurance
sports.
2.3. Endurance sports are heavy sports with long duration (≥ 1 hour)
producing high volume of perspiration, such as pace sports e.g.
marathon, long distance bicycle racing, triathlon, and duathlon, or game
sports with long duration e.g. tennis, badminton, volleyball, football,
long distance swimming, etc.

3.1. Raw Materials
athlete consumption. Product must meet standard requirements for
3.2. Osmolality
Osmolality must not be more than 340 mOsm/kg.
Osmolality is total milliOsmol of solute per kilogram of water.
-49-

3.3.1. Energy
Energy content must not be less than 245 kcal/L. Source of energy is
from carbohydrates, i.e. glucose, sucrose, maltodextrin, and fructose.
Maximum allowed fructose addition is 3% of product.
3.3.2. Minerals
a. Sodium (Na)
Sodium content is not less than 230 mg/L or 10 mmol/L and not more
than 575 mg/L.
b. Potassium (K)
Potassium content is not more than 200 mg/L.
a. Vitamins and other minerals may be added. Content of vitamins and
other minerals refers to Daily Reference Intake guideline in
accordance with provisions of the laws and regulations.
b. Other nutrient/non-nutrient substances may be added. Safety and
benefits of these nutrient/non-nutrient substances must be
scientifically evidenced. Product must contain materials in amount
sufficient to provide the expected benefits.
3.3.4. pH
pH is not more than 8.5.
4. FOOD ADDITIVES
Food Additives used in Special Beverage for Pregnant Women and/or
Lactating Mothers must be in accordance with the provisions of the laws
and regulations.
5. LABEL
5.1. Type Name
“Sports Drink”.
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5.2. Designation
Includes information "intended for heavy sports with long duration (≥ 1
hour) producing high volume of perspiration", followed by relevant
examples of the sport, such as pace sports e.g. marathon, ultramarathon,
long distance bicycle racing, triathlon, and duathlon, or game sports with
long duration e.g. tennis, badminton, volleyball, football, long distance
swimming, etc.

Nutrition Facts for Sports Drink must be expressed per serving quantity.
Nutrition Facts must also include electrolyte content expressed in
milliequivalent per liter (mEq/L) of product ready for consumption.
5.4. Osmolality
Osmolality value must be included and expressed in measurement of
milliOsmol per kilogram of product ready for consumption.
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A.2.2.2. FOOD SUPPLEMENT FOR ATHLETES

1. SCOPE
This provision applies to Food Supplement for Athletes in the form of
liquid, powder or solid, or other forms suitable.
This provision incorporates description of the requirements for raw
material, quality, safety, and labelling of Food Supplement for Athletes.

2.1. Athlete is a person practising sport.
2.2. Food Supplement for Athletes is product served in the form of food
made from ingredients scientifically evidenced as safe and meets
nutritional adequacy necessary to help athletes achieve optimum
performance.
2.3. If product is distributed on training site, the distribution must be under
supervision of medical professional or nutritionist.
2.4. Food Supplement for Athletes is intended to to meet the requirements of
energy and intensive muscle work because of exercise.
2.5. Food Supplement for Athletes consists of Carbohydrate-based Food
Supplement for Athletes, Protein-based Food Supplement for Athletes,
and High Energy Protein Food Supplement for Athletes.
2.6. Carbohydrate-based Food Supplement for Athletes is used:
a. before, during, and after sustained heavy training.
b. to generate energy in the form of carbohydrates.
2.7. Protein-based Food Supplement for Athletes is used:
a. to provide low-bulk diet that may be necessary during training.
b. to help meet diet with high energy source that may be necessary
during training.
c. to help develop muscle mass when used as directed.
d. before, during, and after sustained heavy training.
2.8. High Energy Protein Food Supplement for Athletes is used only for
sports with high-density muscle performance, such as bodybuilding,
weightlifting, sprinting (100-m run, rowing, swimming), martial arts,
etc.
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3.1. Raw Materials
athlete consumption. Product must meet standard requirements for

3.2.1. Carbohydrate-based Food Supplement for Athletes must contain:
a. at least 90% energy content from carbohydrates; and
b. at least 15% (w/w) product weight of carbohydrates.
3.2.2. Protein-based Food Supplement for Athletes must contain:
a. 15% - 30% energy content from carbohydrates; and
b. at most 25% energy content from fat.
c. Protein content must meet requirements as follows:
- Where nutritional quality of protein added into formula is not
equal to that within either egg or milk, the standard minimum of
protein must be increased to compensate for the low quality of
protein. Protein quality is expressed as Protein Efficiency Ratio
(PER), and is not less than 80% standard/reference protein.
- Essential amino acids may be added to increase protein quality.
Amino acids may not be added only in single form. The added
amino acids are L-amino acids, except for methionine where it
may be in DL-forms.
- Added amino acids must meet maximum limits as follows:
Amino Acid Unit Daily Requirement
Alanine mg 1200
Arginine mg 1100
Aspartic acid mg 600
Cysteine mg 440
Glutamine mg 1900
Glutamic acid mg 1600
Glycine mg 1500
Histidine mg 420
Isoleucine mg 350
Leucine mg 490
Lysine mg 420
Methionine mg 180
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Ornithine mg 360
Phenylalanine mg 490
Proline mg 1100
Serine mg 1400
Taurine mg 60
Threonine mg 245
Tyrosine mg 400
Tryptophan mg 100
Valine mg 350
3.2.2.a. High Energy Protein Food Supplement for Athletes must contain:
a. 31% - 70% energy content from protein.
b. at most 25% energy content from fat.
c. pyridoxin at least 0.02 mg/g protein.
3.2.2.b. Protein content must meet requirements as follows:
- Where nutritional quality of protein added into formula is not
equal to that within either egg or milk, the standard minimum of
protein must be increased to compensate for the low quality of
protein. Protein quality is expressed as Protein Efficiency Ratio
(PER), and is not less than 80% standard/reference protein.
- Essential amino acids may be added to increase protein quality.
Amino acids may not be added only in single form. The added
amino acids are L-amino acids, except for methionine where it
may be in DL-forms.
- Added amino acids must meet maximum limits as follows:
Amino Acid Unit Daily Requirement
Alanine mg 1200
Arginine mg 1100
Aspartic acid mg 600
Cysteine mg 440
Glutamine mg 1900
Glutamic acid mg 1600
Glycine mg 1500
Histidine mg 420
Isoleucine mg 350
Leucine mg 490
Lysine mg 420
Methionine mg 180
Ornithine mg 360
Phenylalanine mg 490
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Proline mg 1100
Serine mg 1400
Taurine mg 60
Threonine mg 245
Tyrosine mg 400
Tryptophan mg 100
Valine mg 350

Vitamins and minerals may be added. Content of vitamins and minerals
is not more than 100% Daily Reference Intake guideline in accordance
with the provisions of the laws and regulations. Vitamins B1, B6, and
B12 may be added exceeding 100% Daily Reference Intake guideline
but not exceeding Upper Safe Levels in accordance with the provisions
of the laws and regulations. Where an Upper Safe Level has not been
established, other references recognised nationally, bilaterally,
regionally, or internationally may be used.

Other types of nutrients addable and their maximum amounts are:
Nutrient Content Unit Maximum daily intake
L-carnitine mg 100
Choline mg 10
Inosine mg 10
Creatine mg 3
Caffeine mg 150
3.2.5. Other Addable Nutrient/Non-nutrient Substances

nutrient substances may be added. Safety and benefits of those
nutrient/non-nutrient substances must be scientifically evidenced.
Product must contain materials in amount sufficient to provide the
expected benefits.
4. FOOD ADDITIVES
Food Additives used in Food Supplement for Athletes must be in
accordance with the provisions of the laws and regulations.
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5. LABEL
5.1. Type Name
5.1.1. Label for Carbohydrate-based Food Supplement for Athletes must write
the type name “Carbohydrate-based Food Supplement for Athletes”.
5.1.2. Label for Protein-based Food Supplement for Athletes must write the
type name “Protein-based Food Supplement for Athletes”.
5.1.3. Label for High Energy Protein Food Supplement for Athletes must write
the type name “High Energy Protein Food Supplement for Athletes”
followed by designation, i.e. for sports with high-density muscle
performance and the relevant examples of the sport, e.g. bodybuilding,
weightlifting, sprint (100-m run), rowing, swimming, martial arts, etc.

Nutrition Facts for Food Supplement for Athletes must be expressed per
serving quantity.
5.3. Cautions to include:

a. Food Supplement for Athletes is not the only nutritional source, and
individual nutritional requirements must be paid attention.
b. Exercising person with complications should consult a doctor.
c. “Excessive protein consumption may disturb renal function” for
Protein-based Food Supplement for Athletes.
d. “To build muscle mass, consumption must be combined with
adequate weight training” for Protein-based Food Supplement for
Athletes.
e. “Consumption must be combined with adequate water intake”.
f. “Not for pregnant woman and children 15 years or under”.
g. Where product contains phenylalanine, add “Phenylketonuria:
contains phenylalanine”.
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A.2.3. FSDU FOR WEIGHT CONTROL

1. SCOPE
1.1. This provision applies to FSDU for Weight Control in the form of liquid,
powder or solid, or other forms suitable.
material, quality, safety, and labelling of FSDU for Weight Control.

2.1. FSDU for Weight Control is food specifically formulated to control body
weight in people with excess body weight without comorbidities
(associated conditions).
2.2. Body Mass Index (BMI) is a method to determine nutritional status,
calculated by dividing Body Weight with Body Height. BMI = BW (kg)/
BH2 (m2).
2.3. Overweight criteria:
BMI ≥23 kg/m2, or waistline ≥90 cm (male) and ≥80 cm (female).
2.4. Associated conditions may be in the form of diabetes, hypertension,
dyslipidiemia, cardiovascular diseases, liver dysfunction, renal
dysfunction, etc.
2.5. FSDU for Weight Control is used as replacement for part of daily main
meals, with considerations towards daily nutritional requirements and
intake.

3.1. Raw Materials
consumption by persons who control body weight. Product must meet
standard requirements for quality e.g. in colour, taste, and odour.

3.2.1. Energy
FSDU for Weight Control must contain energy not less than 200 kcal
(835 kJ) and not more than 400 kcal (1670 kJ) per serving.
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3.2.2. Protein
- FSDU for Weight Control must contain protein not less than 20% and
not more than 50% of total energy per serving.
- Nutritional quality is equal to that of within either egg or milk
(standard/reference protein). Where nutritional quality of protein
added into formula is not equal to that within either egg or milk, the
standard minimum of protein should be increased to compensate for
protein quality. Protein with quality less than 80% standard/reference
protein must not be used.
- Essential amino acids may be added to increase protein quality. Only
L-amino acids may be used, except for methionine where it may be in
DL-forms.
3.2.3. Fat
Nutrient Content Unit per serving Requirement
Minimum Maximum
Total fat % of total energy - 30
Linoleic acid % of total energy 3 -
(in gliceryde form)
Partially hydrogenated oils and fats must not be used in FSDU for
Weight Control. Content of trans fatty acids must not be more than 1%
of total energy.
3.2.4. Dietary Fibre
Nutrient Content Unit Requirement
Minimum Maximum
Dietary fibre g per serving 3 10
Dietary fibre within this provision is carbohydrate polymers with three

or more monomer units, unable to be hydrolised by digestive enzymes
within human small intestines, consisting of:
- edible carbohydrate polymers naturally occuring in food; or
- carbohydrate polymers obtained from raw materials through physical,
enzymatic, or chemical process scientifically evidenced as
physiologically beneficial towards health; or synthetic carbohydrate
polymers scientifically evidenced as physiologically beneficial
towards health.
-58-

Vitamin A mcg 200 200 RE = retinol equivalent
RE/serving
1 mcg RE = 3.33 SI vitamin A
= 1 mcg all-trans retinol
Thiamine mg/serving 0.5 0.7
(Vitamin B1)
Riboflavin mg/serving 0.5 0.8
(Vitamin B2)
Niacin mg/serving 5 7.5
(Vitamin B3)
Pyridoxin mg/serving 0.4 0.65
(Vitamin B6)
Vitamin B12 mcg/serving 0.8 1.2
Folate mcg/serving 150 200
Vitamin C mg/serving 30 45
Vitamin D3 mcg/serving 5 7.5 1 mcg calcipherol = 40 SI
vitamin D
Vitamin E mcg 5 7.5 α-TE = α-tocopherol
α-TE/serving equivalent
tocopherol
Calcium mg/serving 400 550 Ratio of calcium to phosphor is
Phosphor mg/serving 250 350 between 1.5:1 and 2:1
Iron mg/serving 8 11
Zinc mg/serving 4 6.5
Sodium mg/serving 250 750
Potassium g/serving 0.75 2.35
Iodine mcg/serving 50 75
Magnesium mg/serving 120 175

Nutrient/non-nutrient substances other than as mentioned in 3.2.5 may
be added to FSDU for Weight Control as long as the nutrient/non-
nutrient substance has been provisioned within Daily Reference Intake
guideline and the content does not exceed 100% Daily Reference Intake
per serving.
3.2.7. Other Addable Nutrient/Non-nutrient Substances
Other nutrient/non-nutrient substances may be added. Safety and
benefits of those nutrient/non-nutrient substances must be scientifically
-59-
evidenced. Product must contain materials in amount sufficient to

provide the expected benefits.
4. FOOD ADDITIVES
Food Additives used in FSDU for Weight Control must be in accordance
5. LABEL
5.1. Type Name
“Food For Weight Control Special Dietary Use”.
5.2. Designation
Written information:
- “for individuals with excess body weight without associated
conditions” and
- Overweight criteria:
 BMI ≥23 kg/m2, and
 waistline ≥90 cm (male) and ≥80 cm (female)
5.3. Nutrition facts must be expressed per serving quantity.

5.4. Inform that product is a substitute for 1 or 2 main meal(s).
5.5. Warning:
Stop consumption where a health problem or similar issues arise.

Other information which may be written includes suggestions:
a. Have vegetables and fruits in the diet;
b. Eat in regular hours;
c. Avoid food high in sugar, salt, and fat;
d. Have enough rest;
e. Exercise appropriately;
f. Drink enough water.
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B. REQUIREMENTS FOR SAFETY, QUALITY, NUTRITION, AND LABELLING

OF PROCESSED FOOD FOR SPECIAL MEDICAL PURPOSE
B.1. FSMP FOR INFANTS AND CHILDREN GROUPS
B.1.1. FSMP FOR PATIENTS WITH INBORN ERRORS OF METABOLISM
1. SCOPE
1.1. This provision covers 4 (four) types of FSMP for patients with inborn
errors of metabolism as follows:
a. FSMP for Patients with Isovaleric Acidemia inborn error of
metabolism;
b. FSMP for Patients with Tyrosinemia inborn error of metabolism;
c. FSMP for Patients with Phenylketonuria (PKU) inborn error of
metabolism; and
d. FSMP for Patients with Maple Syrup Urine Disease (MSUD) inborn
error of metabolism.
1.2. This provision applies to FSMP for patients with inborn errors of
metabolism in the form of liquid, powder, solid, or other forms suitable.
1.3. This provision incorporates description of the requirements for safety,
quality, nutrients, and labelling of FSMP for patients with inborn errors
of metabolism.

2.1. FSMP for patients with inborn errors of metabolism is food specifically
formulated for patients with genetic conditions causing inborn errors of
metabolism.
2.2. FSMP for patients with Isovaleric Acidemia inborn error of metabolism
is food specifically formulated for patients with a genetic condition
where the body capability for amino acid leucine metabolism is limited.
2.3. FSMP for patients with Tyrosinemia inborn error of metabolism is food
specifically formulated for patients with a genetic condition where the
body capability for amino acids phenylalanine and tyrosine metabolism
is limited.
2.4. FSMP for patients with Phenylketonuria (PKU) inborn error of
metabolism is food specifically formulated for patients with a genetic
-61-
condition where the body capability for amino acid phenylalanine

metabolism is limited.
2.5. FSMP for patients with Maple Syrup Urine Disease inborn error of
metabolism is food specifically formulated for patients with a genetic
condition where the body capability for amino acids leucine, isoleucine,
and valine metabolism is limited.
2.6. FSMP for patients with inborn errors of metabolism may be used as
either food replacement or supplement, with considerations towards
daily nutritional requirements and intake.

3.1. Raw Materials
consumption by patients with inborn error of metabolism. Product must
meet standard requirements for quality e.g. in colour, taste, and odour.

3.2.1. FSMP for Patients with Isovaleric Acidemia Inborn Error of Metabolism
FSMP for Patients with Isolvaleric Acidemia inborn error of metabolism
must be free of the amino acid leucine.
3.2.2. FSMP for Patients with Tyrosinemia Inborn Error of Metabolism
FSMP for Patients with Tyrosinemia inborn error of metabolism must be
free of amino acids phenylalanine and tyrosine.
3.2.3. FSMP for Patients with Phenylketonuria (PKU) Inborn Error of
Metabolism
FSMP for Patients with Phenylketonuria (PKU) inborn error of
metabolism must be free of the amino acid phenylalanine.
3.2.4. FSMP for Patients with Maple Syrup Urine Disease (MSUD) Inborn
Error of Metabolism
FSMP for Patients with Maple Syrup Urine Disease (MSUD) inborn
error of metabolism should be free of amino acids leucine, isoleucine,
and valine.
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3.2.5. Macro and micronutrients may be added. Content of macro and

micronutrients refers to Daily Reference Intake guideline in accordance
with provisions of the laws and regulations.
3.2.6. Addable Nutrient/Non-Nutrient Subtances
nutrient substances may be added. Safety and benefits of the
nutrient/non-nutrient substances for patients with inborn errors of
metabolism must be scientifically evidenced. Product must contain
materials in amount sufficient to provide expected benefits.
4. FOOD ADDITIVES
Food Additives used in FSMP for patients with inborn errors of
metabolism designated for infants and children groups must be in
5. LABEL
5.1. Type Name
5.1.1 Label for FSMP for Patients with Isovaleric Acidemia inborn error of
metabolism must write the type name “Processed Food for Isovaleric
Acidemia Patients Special Medical Purpose”.
5.1.2. Label for FSMP for Patients with Tyrosinemia inborn error of
metabolism must write the type name “Processed Food for Tyrosinemia
Patients Special Medical Purpose”.
5.1.3. Label for FSMP for Patients with Phenylketonuria (PKU) inborn error of
metabolism must write the type name “Processed Food for
Phenylketonuria (PKU) Patients Special Medical Purpose”.
5.1.4. Label for FSMP for Patients with Maple Syrup Urine Disease (MSUD)
inborn error of metabolism must write the type name “Processed Food
for Maple Syrup Urine Disease (MSUD) Patients Special Medical
Purpose”.

Nutrition Facts must be expressed in either per 100 g, per 100 mL, or per
a kitchen measuring utensil, and per 100 kcal.
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5.3. Warning on hazards from consumption of FSMP for patients with inborn
errors of metabolism for one without the relevant medical disorder.
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B.1.2. FSMP FOR NUTRITIONAL SUPPORT OF CHILDREN AT RISK OF

STUNTING, UNDERNUTRITION, OR MALNUTRITION
1. SCOPE
1.1. This provision applies to FSMP for Nutritional Support of Children at
Risk of Stunting, Undernutrition, or Malnutrition in the ready for
consumption form of liquid, either ready to drink or requiring
reconstitution.
quality, nutrients, and labelling of FSMP for Nutritional Support of
Children at Risk of Stunting, Undernutrition, or Malnutrition.

2.1. FSMP for Nutritional Support of Children at Risk of Stunting,
Undernutrition, or Malnutrition is food specifically formulated for
children either at risk of or with stunting, undernutrition, or malnutrition,
which may be used as either food replacement or supplement with
considerations towards daily nutritional requirements and intake.
2.2. FSMP for Nutritional Support of Children at Risk of Stunting,
Undernutrition, or Malnutrition is used as food replacement only in
cases where the child at risk of stunting, undernutrition, or malnutrition
is unable to feed from food in regular forms.

3.1. Raw Materials
consumption by children at risk of stunting, undernutrition, or
malnutrition. Product must meet standard requirements for quality e.g. in
colour, taste, and odour.
3.2. Osmolarity
3.2.1. Osmolarity for product with energy density of 0.9-1.2 kcal/mL must not
be more than 340 mOsm/L.
3.2.2. Osmolarity for product with energy density of more than 1.2 kcal/mL
must not be more than 440 mOsm/L.
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3.2.3. Osmolality may be used, calculating the conversion per kilogram of

water.

3.3.1. Energy Density
Energy density of product ready for consumption is not less than 0.9
kcal/mL.
3.3.2. Macro and Micronutrients
Nutrient Unit Minimum Minimum Note
Content (per 100 kcal) for 0-12 for Above 1
Months of Age Year of Age
Protein 8.9% energy 8.9% energy
source from source from
protein protein
Total fat 28% energy 28% energy
source from source from
protein protein
Linoleic acid g 0.52 0.53 Ratio of linoleic to α-linolenic
α-linolenic g 0.058 0.06 acid is between 5:1 and 15:1
acid
Vitamin A mcg RE 44 35 RE = retinol equivalent


Vitamin D mcg 0.6 0.9 1 mcg calcipherol = 40 SI
vitamin D
Vitamin E mg 0.5 0.5 α-TE = α-tocopherol equivalent
tocopherol

n-6);
-66-

n-3)
(20:4 n-6)
1.25 mg α-TE/g
acid (22:6 n-3)
Vitamin K mcg 0.6 1.4
Thiamine mg 0.04 0.055
(Vitamin B1)
Riboflavin mg 0.035 0.064
(Vitamin B2)
Niacin mg 0.24 0.55 Niacin content is in the form of
form of niacin)
Pantothenic mg 0.2 0.15
acid
(Vitamin B5)
Pyridoxin mg 0.012 0.045
(Vitamin B6)
Vitamin B12 mcg 0.05 0.07
Folate mcg 0.008 0.015
Vitamin C mg 4.7 3.6 Vitamin C analysis is expresssed
as ascorbic acid
Biotin mcg 0.6 0.73
(Vitamin H)
Calcium mg 23 54 Ratio of calcium to phosphor is
Phosphor mg 12 45 between 1.2:1 and 2:1
Iron mg 0.3 0.5
Zinc mg 0.3 0.36
Iodine mcg 10 6.5
Selenium mcg 0.6 1.5
Sodium mg 14 20
Potassium mg 60 80
Magnesium mg 3.5 4.4
Copper mcg 23.5 31
Manganese mcg 0.65 15
L-carnitine mg 0.8 1.2
If sucrose is added, the addition may not be more at 10% of total

calories.
Content of dietary fibre (excluding oligosaccharides) may not be more
than 5 g per day (0.58 g/100 kcal) for product to be consumed by person
under 1 year of age, and not more than 16 g per day (1.45 g/100 kcal) for
product to be consumed by person above 1 year of age.
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Fluorine must not be added. When fluorine is naturally present in raw

material, the fluorine content must not exceed 100 mcg/100 kcal.
Macro and micronutrient content must not exceed the Upper Safe Levels
in accordance with the provisions of the laws and regulations.
Where an Upper Safe Level has not been established, other references
recognised nationally, bilaterally, regionally, or internationally may be
used.

In addition to the aforementioned requirements, other nutrients or
components may be added. Safety and benefits of those nutrients or
components must be scientifically evidenced. Product must contain
materials in amount sufficient to provide expected benefits.
4. FOOD ADDITIVES
Food Additives used in FSMP for Nutritional Support of Children at
Risk of Stunting, Undernutrition, or Malnutrition must be in accordance
5. LABEL
5.1. Type Name
“Processed Food for Special Medical Purpose for Nutritional Support of
Children at Risk of Stunting, Undernutrition, and/or Malnutrition”.
5.2. Designation
a. If for infants 0-12 of age, information “for infants 0-12 of age” is
added; or
b. If for infants 0-12 of age, information “for children above 1 (one)
year of age” is added.

a kitchen measuring utensil, or a kitchen measuring utensil, and per 100
kcal.
-68-
5.4. Osmolarity/Osmolality Value

Osmolarity/osmolality value of product ready for consumption must be
written, adjacent to preparation instruction.
5.5. Warning on hazards from consumption of FSMP for Nutritional Support
of Children at Risk of Stunting, Undernutrition, or Malnutrition for child
without risk of stunting, undernutrition, or malnutrition.
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B.1.3. FSMP FOR PRETERM INFANTS

1. SCOPE
1.1. This provision applies to FSMP for Preterm Infants in the forms of
liquid, powder, or other forms suitable.
quality, nutrients, and labelling of FSMP for Preterm Infants.

2.1. Very preterm infant within this Regulation is infant born under 32
months of gestational age.
2.2. Very low birth weight infant within this Regulation is infant with birth
weight under 1500 g.
2.3. FSMP for Preterm Infants is specifically formulated and served for
dietary management for infant patients that by itself will meet the
nutritional requirements for very preterm and/or very low birth weight
infant.
2.4. This provision applies to FSMP for Preterm Infants, which if necessary
is used as either replacement or supplement for human breast milk to
meet normal nutritional requirements for infants. "if necessary" in this
case is when feeding with human breast milk is not sufficient for
supporting optimum infant growth and development, established based
on medical indication.

3.1. Raw Materials
consumption by very preterm and/or very low birth weight infant.
Product must meet standard requirements for quality e.g. in colour, taste,
and odour.
-70-

3.2.1. Energy
FSMP for Preterm Infants ready for consumption must contain energy
not less than 80 kcal and not more than 100 kcal per 100 mL product
when prepared according to preparation instruction.
3.2.2. Protein
Protein within Infant Formula is sourced from (animal) milk.
Protein Source Unit Minimum Maximum
Milk protein g/100 kcal 2.4 4.1

nitrogen to proteins in other dairy products.
3.2.3. Fat
Total fat g/100 kcal 4.4 6.0
Linoleic acid mg/100 kcal 350 1400 Ratio of linoleic to α-linolenic
α-linolenic mg/100 kcal 50 - acid is between 5:1 and 15:1
acid
Partially hydrogenated oils and fats must not be used in FSMP for
Preterm Infants. Content of trans fatty acids must not be more than 3%
of total fatty acid content. Lauric acid and myristic acid are elements of
fat, and the content of both combined must not be more than 12% of
total fatty acid content. Content of erucic acid must not be more than 1%
of total fatty acid content. Content of total phospholipids must not be
more than 300 mg/100 kcal.
3.2.4. Carbohydrates
Nutrient Content Unit Minimum Maximum
Total carbohydrates g/100 kcal - 12.5
-71-
carbohydrates in formulae based on cow milk and hydrolysate proteins.
The only starch and/or starch derivates (e.g. maltodextrin) allowed to be added
into FSMP for Preterm Infants are precooked naturally gluten-free starches and/
or gelatinised starch. Addition of the aforementioned starches is maximum at
30% of total carbohydrate and maximum at 2 g/100 mL.
Sucrose, fructose, and fibre must not be used. The aforementioned fibre
is carbohydrates indigestible by human digestive system with degree of
polymerisation (DP) >10.
Vitamin A mcg RE/100 110 740 RE = retinol equivalent
kcal

Vitamin D3 mcg/100 kcal 1.54 8.75 1 mcg calcipherol = 40 SI
vitamin D
Vitamin E mg α-TE/100 2.7 13.6 α-TE = α-tocopherol equivalent
kcal
tocopherol

n-6);
n-3)
(20:4 n-6)
1.25 mg α-TE/g
-72-
acid (22:6 n-3)

Vitamin K mcg/100 kcal 4 27
Thiamine mcg/100 kcal 125 300
(Vitamin B1)
Riboflavin mcg/100 kcal 180 620
(Vitamin B2)
Niacin mg/100 kcal 0.34 5 Niacin content is in the form of
form of niacin)
Pantothenic mg/100 kcal 0.4 2
acid
(Vitamin B5)
Pyridoxin mcg/100 kcal 41 273
(Vitamin B6)
Vitamin B12 mcg/100 kcal 0.1 0.7
Folate mcg/100 kcal 26.3 90
Vitamin C mg/100 kcal 10 70 Vitamin C analysis is expresssed
as ascorbic acid
Biotin mcg/100 kcal 1.5 48.7
(Vitamin H)
Calcium mg/100 kcal 92.3 185 Ratio of calcium to phosphor is
Phosphor mg/100 kcal 55 111 between 1.5:1 and 2:1
Iron mg/100 kcal 1 3
Zinc mg/100 kcal 0.78 2
Iodine mcg/100 kcal 10 62
Selenium mcg/100 kcal 1.8 9
Sodium mg/100 kcal 39 105
Potassium mg/100 kcal 60 194
Chloride mg/100 kcal 60 161
Magnesium mg/100 kcal 6.8 17
Copper mcg/100 kcal 70.66 250
Manganese mcg/100 kcal 5.6 100
Choline mg/100 kcal 7 50
Myo-inositol mg/100 kcal 4 48
L-carnitine mg/100 kcal 1.75 -
Taurine mg/100 kcal 5 12
Docosahexa- mg/100 kcal 10.8 31 Ratio of DHA to ARA is between
enoic acid 1:1 and 1:2
(DHA)
ARA mg/100 kcal 16 41 Eicosapentaenoic (EPA) content,
content
-73-

Chromium ng/100 kcal 27 1120
Molybdenum mcg/100 kcal 0.3 4.5
Nucleotides mg/100 kcal - 16 Nucleotides consist of at least 4
(four) types:

nucleotides added
3.2.7. Fluorine
Fluorine must not be added into FSMP for Preterm Infants. When
fluorine is naturally present in an ingredient, the fluorine content must
not exceed 25 mcg/100 kcal in the ready-for-consumption FSMP for
Preterm Infants product.
3.2.8. Other Addable Nutrient/Non-nutrient Contents
nutrient substances may be added. Safety and benefits of these
nutrient/non-nutrient substances for very preterm and very low birth
weight infants must be scientifically evidenced. The product must
contain the components in amount sufficient to provide the expected
benefits.
4. FOOD ADDITIVES
Food Additives used in FSMP for Preterm Infants must be in accordance
5. LABELLING
5.1. Type Name
"Processed Food for Special Medical Purpose for Very Preterm and/or
Very Low Birth Weight Infants".
-74-
5.2. Designation
For very preterm infants (babies born within 32 months of pregnancy)
and/or very low birth weight infants (babies born with body weight
under 1500 g).

Nutrition facts must be expressed in either per 100 g, per 100 mL, and
per 100 kcal.


5.5.1. Where shelf life of product is heavily affected by specific condition for
storage, that specific storage condition must be written on label in the
form of storage instruction adjacent to expiry date.
5.5.2. Label must include explanation for signs indicating when the FSMP for
Preterm Infants is no longer fit for consumption and therefore must not
be fed to the infant.

5.6.2. FSMP for Preterm Infants in liquid form must include the phrase "ready
for consumption".
5.6.3. FSMP for Preterm Infants in concentrate form must include instructions
on how to dilute.
5.6.4. FSMP for Preterm Infants in powder form must include instructions on
how to reconstitute.
5.6.5. Label must include instructions for storage and disposal of product,
including storage and disposal after preparation, e.g. remaining milk not
drunk must be disposed of.
-75-
preparing and serving FSMP for Preterm Infants must be included on the
label and/or leaflet as follows:
drinking utensils;
2. Wash all utensils (bottle, teat, bottle brush, and teat brush) with
clean running water;
3. Rinse bottle and teat with running water;
- Bottle must be completely submerged that there is no air inside
the bottle;
- Keep pot closed, leave the bottle and teat inside the pot until
used;
5. Wash hands with soap before taking the bottle and teat out;
6. When bottle is not immediately used after being boiled:
- Bottles must be kept in a closed, clean container
- Teats and lids must be securely installed
b. How to prepare and serve FSMP for Preterm Infants

1. Clean the platform where Infant Formula will be prepared;
6. Add product powder in the recommended amount written on the
label;
7. Close the bottle and shake until product dissolves well;
-76-

dripping the product on the wrist: it must feel slightly warm, not
hot);
9. Remaining product dissolved must be disposed of after 2 hours.
5.7. Warning on hazards from consumption of FSMP for Preterm Infants for
infants without the relevant medical disorder. The warning must be
clearly written in bold in an area of the label separate from other texts,
images, or other information.
-77-
B.1.4. FSMP FOR HUMAN MILK FORTIFIER

1. SCOPE
1.1. This provision applies to FSMP for Human Milk Fortifier for Preterm
Infants in powder form.
quality, nutrients, and labelling of FSMP for Human Milk Fortifier for
Preterm Infants.

2.1. Very preterm infant within this Regulation is infant born under 32
months of gestational age.
2.2. Very low birth weight infant within this Regulation is infant with birth
weight under 1500 g.
2.3. FSMP for Human Milk Fortifier for Preterm Infants is food specifically
formulated for infants, added to human breast milk to supplement the
nutritional requirements for very preterm and/or very low birth weight
infant.
2.4. This provision applies to FSMP for Human Milk Fortifier for Preterm
Infants, which if necessary is used as supplement for human breast milk
to meet normal nutritional requirements for infants. "if necessary" in
this case is when feeding with human breast milk is not sufficient for
supporting optimum infant growth and development, established based
on medical indication.

3.1. Raw Materials
consumption by very preterm and/or very low birth weight infant.
Product must meet standard requirements for quality e.g. in colour, taste,
and odour.
-78-

3.2.1. Energy
FSMP for Human Milk Fortifier for Preterm Infants must contain energy
not less than 3.4 kcal and not more than 4 kcal per 1 (one) sachet as
energy supplement for that in 25 mL human breast milk.
3.2.2. Protein
Protein within Human Milk Fortifier for Preterm Infants is sourced from
(animal) milk.
Protein Source Unit per 1 sachet Minimum Maximum
Milk protein g 0.25 1

nitrogen to proteins in other dairy products.
Content per 1 sachet Minimum Maximum
Vitamin A IU/SI 155 450 RE = retinol equivalent


Vitamin D3 IU 30 90 1 mcg calcipherol = 40 SI
vitamin D
Vitamin E mg α-TE 0.54 3.5 α-TE = α-tocopherol equivalent
tocopherol

-79-

n-6);
n-3)
(20:4 n-6)
1.25 mg α-TE/g
acid (22:6 n-3)
Vitamin K mcg 1.10 6.25
Thiamine mg 0.03 0.12
(Vitamin B1)
Riboflavin mg 0.04 0.18
(Vitamin B2)
Niacin mg 0.58 2.25 Niacin content is in the form of
form of niacin)
Pantothenic mg 0.16 0.56
acid
(Vitamin B5)
Pyridoxin mcg 25.9 85.2
(Vitamin B6)
Vitamin B12 mcg 0.04 0.4
Folate mcg 5.6 21.73
Vitamin C mg 2.7 20 Vitamin C analysis is expresssed
as ascorbic acid
Calcium mg 16.4 48 Ratio of calcium to phosphor is
Phosphor mg 9.59 27 between 1.5:1 and 2:1
Iron mg 0.08 0.55
Zinc mg 0.15 0.4

nutrient/non-nutrient substances for very preterm and very low birth
weight infants must be scientifically evidenced. The product must
contain the components in amount sufficient to provide the expected
benefits.
-80-
4. FOOD ADDITIVES
Food Additives used in FSMP for Human Milk Fortifier for Preterm
Infants must be in accordance with the provisions of the laws and
regulations.
5. LABELLING
5.1. Type Name
"Human Milk Fortifier for Preterm Infants".
5.2. Designation
For very preterm infants (babies born within 32 months of pregnancy)
and/or very low birth weight infants (babies born with body weight
under 1500 g) or beyond those ranges based on medical indication.

Nutrition facts must be expressed per sachet. Product must be packaged
in single dose packaging each for 25 mL human breast milk.


a. To be added to breast milk with doctor’s consult and under doctor’s
supervision.
b. The amount of Human Milk Fortifier for Preterm Infants added into
25 mL breast milk.
c. Detailed explanation on how to prepare breast milk before addition of
Human Milk Fortifier for Preterm Infants, which must include:
- Fresh breast milk
- Thawed frozen breast milk (self or from donor)
d. To be fed immediately after addition of Human Milk Fortifier for
Preterm Infants.
-81-
5.6. Warning on hazards from consumption of FSMP for Human Milk

Fortifier for Preterm Infants for non preterm infants. The warning must
be clearly written in bold in an area of the label separate from other
texts, images, or other information.
-82-
B.1.5. FSMP FOR PATIENTS WITH COW MILK PROTEIN ALLERGY

1. SCOPE
1.1. This provision covers 2 (two) types of FSMP for patients with cow milk
protein allergy as follows:
a. Extensively hydrolised cow-milk protein based formula; or
b. Amino-acid based formula.
1.2. This provision applies to FSMP for patients with cow milk protein
allergy in the form of liquid, powder, or other forms suitable.
quality, nutrients, and labelling of FSMP for cow milk protein allergy.

2.1. FSMP for patients with cow milk protein allergy is specifically
formulated for dietary management to meet nutritional requirements for
infants/children with allergy to cow milk protein.
2.2. FSMP for patients with cow milk protein allergy may be used as either
food replacement or supplement, with considerations towards daily
nutritional requirements and intake.

3.1. Raw Materials
consumption by patients with cow milk protein allergy. Product must
meet standard requirements for quality e.g. in colour, taste, and odour.
3.1.1. Extensively-hydrolised cow-milk protein based formula
The formula contains extensively-hydrolised cow-milk protein with
criteria as follows:
- contains protein with molecular weight ≤1500 daltons at least 95% of
total protein; and
- contains protein with molecular weight ≥6000 daltons at most 0.5%
of total protein.
3.1.2. Amino-acid based formula
Amino-acid based formula is formula in which all protein is sourced
from amino acids with molecular weight criteria not exceeding the
-83-
provisions within SNI 8484: Nutrient Compounds Addable into

Processed Food.

3.2.1. For product designated for infants 0-6 months of age, requirements for
nutritional content refers to those for the infant formula; for infants 6-12
months of age, requirements for nutritional content refers to those for the
follow on formula; and for children above 1 (one) year of age,
requirements for nutritional content refers to those for the growing up
formula.
3.2.2. For product designated as complementary food, FSMP, or another type
of product, the requirements for nutritional content refers to the
3.2.3. Product may be designated for an age group other than provisioned in
the laws and regulations, as evidenced safe and beneficial for, and
appropriate to the age group.
4. FOOD ADDITIVES
Food Additives used in FSMP for patients with cow milk protein allergy
must be in accordance with the provisions of the laws and regulations.
5. LABEL
5.1. Type Name
5.1.1. Type name for extensively hydrolised cow-milk protein based formula
a. If designated for infants 0-6 months of age, type name is “Extensively
hydrolised cow-milk protein based infant formula for special medical
purpose”.
b. If designated for infants 6-12 months of age, type name is
“Extensively hydrolised cow-milk protein based follow on formula
for special medical purpose”.
c. If designated for children above 1 (one) year of age, type name is
“Extensively hydrolised cow-milk protein based growing up formula
for special medical purpose”.
-84-
d. If designated as complementary food, type name is “Extensively

hydrolised cow-milk protein based complementary food for special
medical purpose”.
e. If designated as food for special medical purpose, type name is
“Extensively hydrolised cow-milk protein based ...” (with the
appropriate FSMP type name in accordance to provisions). Example:
Extensively hydrolised cow-milk protein based Processed Food for
Special Medical Purpose for nutritional support of children at risk of
stunting, undernutrition, or malnutrition.
f. If designated as another product, type name is “Extensively
hydrolised cow-milk protein based ... for special medical purpose”
(with the appropriate type name in accordance to provisions).
5.1.2. Type name for extensively hydrolised cow-milk protein based formula
a. If designated for infants 0-6 months of age, type name is “Amino-acid
based infant formula for special medical purpose”.
b. If designated for infants 6-12 months of age, type name is “Amino-
acid based follow on formula for special medical purpose”.
c. If designated for children above 1 (one) year of age, type name is
“Amino-acid based growing up formula for special medical purpose”.
d. If designated as complementary food, type name is “Amino-acid
based complementary food for special medical purpose”.
e. If designated as food for special medical purpose, type name is
“Amino-acid based ...” (with the appropriate FSMP type name in
accordance to provisions). Example: Extensively hydrolised cow-
milk protein based Processed Food for Special Medical Purpose for
nutritional support of children at risk of stunting, undernutrition, or
malnutrition.
f. If designated as another product, type name is “Amino-acid based ...
for special medical purpose” (with the appropriate type name in
accordance to provisions).

a. If designated for infants 0-6 months of age, nutrition facts are written
following infant formula.
-85-
b. If designated for infants 6-12 months of age, nutrition facts are

written following follow on formula.
c. If designated for children above 1 (one) year of age, nutrition facts are
written following growing up formula.
d. If designated as complementary food, FSMP, or another type of
product, nutrition facts are written in accordance with the provisions
of the laws and regulations.

5.4.1. Where shelf life of product is heavily affected by specific condition for
storage, that specific storage condition must be written on label in the
form of storage instruction adjacent to expiry date.
5.4.2. Label must include explanation for signs indicating when the FSMP for
patients with cow milk protein allergy is no longer fit for consumption
and therefore must not be fed to the infant/child.

a. If designated for infants 0-6 months of age, other information is
written following infant formula.
b. If designated for infants 6-12 months of age, other information is
written following follow on formula.
c. If designated for children above 1 (one) year of age, other information
is written following growing up formula.
d. If designated as complementary food, FSMP, or another type of
product, other information is written in accordance with the
5.6. Warning
Display the warning:
“Caution! Not suitable for Infants/Children NOT allergic to cow
milk protein”
The warning must be clearly written in bold in an area of the label

separate from other texts, images, or other information.
-86-
B.2. FSMP FOR ADULT GROUP

B.2.1. FSMP FOR PEOPLE WITH DIABETES
1. SCOPE
1.1. This provision applies to FSMP for People with Diabetes in the form of
liquid, powder, solid, or other forms suitable.
quality, nutrients, and labelling of FSMP for People with Diabetes.

2.1. FSMP for People with Diabetes is food specifically formulated for
people with diabetes, and may be used as either food replacement or
supplement, with considerations towards daily nutritional requirements
and intake for people with diabetes.
2.2. FSMP for People with Diabetes as food replacement is used only when
the person with diabetes is unable to consume food in regular forms.

3.1. Raw Materials
consumption by people with diabetes. Product must meet standard
requirements for quality e.g. in colour, taste, and odour.

3.2.1. Requirements for nutritional content of FSMP for People with Diabetes
are as follows:
No. Nutrient Content Per 100 kcal
1 Protein 2.5 - 5 g
2. Carbohydrates
2.1.Carbohydrates 11.25 - 16.25 g
2.2.Sucrose and glucose ≤ 1.25 g
2.3.Fibre 1 - 1.75 g
3. Fat*
3.1.Fat 2.22 - 2.78 g
3.2.Saturated fatty acids < 0.78 g
3.3.Poly-unsaturated fatty acids ≤ 1.11 g
3.4.Mono-unsaturated fatty acids Remainder from total fat
3.5.Cholesterol < 10 mg
4. Natrium < 115 mg
-87-
Note:
*) avoid trans fatty acids for fat source.
3.2.2. Other vitamins and minerals may be added. Vitamins and minerals
content refers to Daily Reference Intake guideline in accordance with the
provisions of the laws and regulations. If designated as food
replacement, product must contain all vitamins and minerals at least at
100% Daily Reference Intake guideline in accordance with the
provisions of the laws and regulations. Other than that, vitamins and
minerals content must not exceed Upper Safe Levels in accordance with
the provisions of the laws and regulations. Where an Upper Safe Level
has not been established, other references recognised nationally,
bilaterally, regionally, or internationally may be used.
3.2.3. Sweetener may be used in FSMP for People with Diabetes in accordance
3.2.4. Fructose may not be added into FSMP for People with Diabetes as it
risks increasing triglycerides.
nutrient/non-nutrient substances for people with diabetes must be
scientifically evidenced. The product must contain the components in
amount sufficient to provide the expected benefits.
4. FOOD ADDITIVES
Food Additives used in FSMP for People with Diabetes must be in
5. LABEL
5.1. Type Name
“Processed Food for Special Medical Purpose for People with Diabetes”.
-88-
5.3. Advice of vegetables and fruit consumption to meet fibre requirements.

-89-
B.2.2. FSMP FOR PATIENTS WITH CHRONIC KIDNEY DISEASE

1. SCOPE
1.1. This provision covers 2 (two) types of FSMP for Patients with Chronic
Kidney Disease as follows:
a. FSMP for Pre-dialysis Patients with Chronic Kidney Disease.
b. FSMP for Dialysis Therapy Patients with Chronic Kidney Disease.
1.2. This provision applies to FSMP for Patients with Chronic Kidney
Disease in the form of liquid, powder, solid, or other forms suitable.
quality, nutrients, and labelling of FSMP for Patients with Chronic
Kidney Disease.

2.1. FSMP for Patients with Chronic Kidney Disease is food specifically
formulated for patients with chronic kidney disease, and may be used as
daily nutritional requirements and intake for patients with chronic
kidney disease.
2.2. FSMP for Patients with Chronic Kidney Disease as food replacement is
used only when the patient with chronic kidney disease is unable to
consume food in regular forms.

3.1. Raw Materials
consumption by people with chronic kidney disease. Product must meet

3.2.1.1. Energy density of FSMP for Pre-dialysis Patients with Chronic Kidney
Disease is no less than 1 kcal/mL.
3.2.1.2. Energy density of FSMP for Dialysis Therapy Patients with Chronic
Kidney Disease is no less than 1.5 kcal/mL.
-90-
3.2.2. Requirements for nutritional content of FSMP for Patients with Chronic
Kidney Disease are as follows:
No. Nutrient Content FSMP for FSMP for
Pre-dialysis Patients with Dialysis Therapy Patients with
Chronic Kidney Disease Chronic Kidney Disease
(per 100 kcal) (per 100 kcal)
1. Protein 1.7 - 2.5 g ≥ 3.43 g
2. Fat 2.9 - 3.9 g 2.9 - 3.9 g
Saturated fat: 1 - 2 g Saturated fat: 1 - 2 g
3. Cholesterol < 16.7 g < 16.7 g
4. Carbohydrates 8.6 - 16.7 g 9.6 - 18.9 g
5. Sodium ≤ 83.33 equal to ≤ 5 g NaCl ≤ 83.33 equal to ≤ 5 g NaCl
6. Potassium 71.4 - 130 mg 0.4 - 0.9 mg
7. Calcium 38.1 - 66.7 mg ≤ 111.1 mg
8. Phosphor 38.1 - 55.5 mg 38.1 - 55.5 mg
9. Thiamine 0.05 - 0.8 mg 0.05 - 0.07 mg
(Vitamin B1)
10. Riboflavin 0.05 - 0.11 mg 0.05 - 0.07 mg
(Vitamin B2)
11. Niacin 0.5 - 1.1 mg 0.7 - 0.9 mg
(Vitamin B3)
12. Pyridoxin > 0.2 mg 0.06 - 0.6 mg
(Vitamin B6)
13. Vitamin B12 0.1 - 0.13 mcg 0.1 - 0.13 mcg
14. Folic acid 9.5 mcg 0.05 mg
15. Vitamin C 2.9-5.6 mg
16. Vitamin K 4.3 - 6.7 mcg
17. Biotin 1.4 mcg
(Vitamin H)
Note:
Protein source is at least 50% high biological content (animal protein).

a. Other vitamins and minerals may be added. Vitamins and minerals
content refers to Daily Reference Intake guideline in accordance with
benefits of these nutrient/non-nutrient substances for patients with
chronic kidney disease must be scientifically evidenced. The product
must contain the components in amount sufficient to provide the
expected benefits.
-91-
4. FOOD ADDITIVES
Food Additives used in FSMP for patients with chronic kidney disease
5. LABEL
5.1. Type Name
5.1.1. Label for FSMP for Pre-dialysis Patients with Chronic Kidney Disease
must write the type name “FSMP for Pre-dialysis Patients with Chronic
Kidney Disease”.
5.1.2. Label for FSMP for Dialysis Therapy Patients with Chronic Kidney
Disease must write the type name “FSMP for Dialysis Therapy Patients
with Chronic Kidney Disease”.
5.3. Warning on hazards from consumption of FSMP for Chronic Kidney
Disease for one without the relevant medical disorder.
-92-
B.2.3. FSMP FOR PATIENTS WITH CHRONIC LIVER DISEASE

1. SCOPE
1.1. This provision covers 2 (two) types of FSMP for Patients with Chronic
Liver Disease as follows:
a. FSMP for Patients with Chronic Liver Disease.
b. FSMP for Patients with Chronic Liver Disease and Hepatic
Encephalopathy.
1.2. This provision applies to FSMP for Patients with Chronic Liver Disease
in the form of liquid, powder, solid, or other forms suitable.
quality, nutrients, and labelling of FSMP for Patients with Chronic Liver
Disease.

2.1. FSMP for Patients with Chronic Liver Disease is food specifically
formulated for patients with chronic liver disease, e,g. cirrhosis or liver
cancer with or without hepatic encephalopathy, and may be used as
daily nutritional requirements and intake for patients with chronic liver
disease.
2.2. FSMP for Patients with Chronic Liver Disease as food replacement is
used only when the patient with chronic liver disease is unable to
consume food in regular forms.

3.1. Raw Materials
consumption by people with chronic liver disease. Product must meet
3.2. Osmolality
Osmolality is 300-500 mOsm/kg.
-93-

Energy density of FSMP for Patients with Chronic Liver Disease is no
less than 1 kcal/mL and not more than 1.5 kcal/mL.
3.2.2. Requirements for nutritional content of FSMP for Patients with Chronic
Liver Disease are as follows:
No. Nutrient Content FSMP for Patients with FSMP for Patients with
Chronic Liver Disease Chronic Liver Disease and
(per 100 kcal) Hepatic Encephalopathy
(per 100 kcal)
1. Protein 3 - 4.3 g 2.95 - 5 g
2. Fat - 0.95 - 2.59 g
Suggested fat source: Suggested fat source:

 MCT  MCT
 Poly-unsaturated fatty acids  Poly-unsaturated fatty acids
 Mono-unsaturated fatty acids  Mono-unsaturated fatty acids
3. Carbohydrates 9.1 - 14.6 g -
4. Sodium 41.7 - 71.4 mg 41.6 - 83.3 mg
5. Zinc Max. 2.4 mg elemental zinc Max. 2.8 mg elemental zinc
(10.5 mg zinc sulfate) (12.2 mg zinc sulfate)
Per day: Per day:

Max. 50 mg elemental zinc (220 Max. 50 mg elemental zinc (220
mg zinc sulfate) mg zinc sulfate)

a. Other vitamins and minerals may be added. Vitamins and minerals
content refers to Daily Reference Intake guideline in accordance with
benefits of these nutrient/non-nutrient substances for patients with
chronic liver disease must be scientifically evidenced. The product
must contain the components in amount sufficient to provide the
expected benefits.
4. FOOD ADDITIVES
Food Additives used in FSMP for Patients with Chronic Liver Disease
-94-
5. LABEL
5.1. Type Name
5.1.1. Label for FSMP for Patients with Chronic Liver Disease must write the
type name “FSMP for Patients with Chronic Liver Disease”.
5.1.2. Label for FSMP for Patients with Chronic Liver Disease and Hepatic
Encephalopathy must write the type name “FSMP for Patients with
Chronic Liver Disease and Hepatic Encephalopathy”.
5.3. Warning must be written: “should deterioration of consciousness occur,
lower the protein amount”.
5.4. Warning on hazards from consumption of FSMP for Chronic Liver
Disease for one without the relevant medical disorder.
-95-
B.2.4. FSMP FOR PATIENTS WITH INBORN ERRORS OF METABOLISM

1. SCOPE
See section B.1.1. number 1. Scope.

See section B.1.1. number 2. Description and Definition.

See section B.1.1 number 3. Requirements for Quality.
4. FOOD ADDITIVES
Food Additives used in FSMP for patients with inborn errors of
metabolism designated for adult group must be in accordance with the
5. LABEL
See section B.1.1. number 5. Label.
C. VITAMIN AND MINERAL COMPOUNDS

Vitamin and mineral compounds used in FSNP must comply with established
standards. Where the standards are not yet established, Codex Advisory Lists of
Nutrient Compounds For Use In Foods For Special Dietary Uses Intended For
Infants And Young Children (CAC/GL 10-1979) may be used.
D. CONTAMINATION
Processed Food for Special Nutritional Purpose must meet the limit
requirements for microbial, metal, mycotoxins, and other chemical
contamination in accordance with the provisions of the laws and regulations.
E. PACKAGING
Packaging must be constructed from substances/materials safe for food contact
in accordance with the provisions of the laws and regulations.
-96-
F. ANALYSIS METHOD*)
No. Detail Method for use
1. pH SNI 01 2891 1992
2. Water content SNI 01 2891 1992
3. Ash content SNI 01 2891 1992 or AOAC 2012 Ch. 33 p. 10
4. Protein AOAC 2012 Ch. 33 pp. 10-11 or SNI 01 2891 1992
5. Essential amino acids AOAC 2012 Ch. 4 p. 20 (HPLC)
6. Fat AOAC 2012 Ch 50, p. 18 (Rose Gottlieb/Mojonnier) or SNI 01
2891 1992
7. α-linolenic acid AOAC 2012 Ch. 41, pp. 19 -25; or AOCS Official Methods Ch 1-
91, revised 2002, Preparation of Methyl Esters of Long-Chain
Fatty Acids
8. Linoleic acid AOAC 2012 Ch. 50 pp. 19-20 (GC)
9. SAFA AOAC 2012 Ch. 41 p. 16
10. PUFA AOAC 2012 Ch. 41 p. 16
11. MUFA AOAC 2012 Ch. 41 p. 16
12. Cholesterol AOAC 2012 Ch. 45 pp. 104-105
13. Carbohydrates AOAC 2012 Ch. 50 p. 18;
calculation = (100% - % protein - % fat - % water - % ash);
or SNI 01 2891 1992
14. Sucrose SNI 01 2892 1992
15. Glucose SNI 01 2892 1992
16. Dietary fiber AOAC 2012 Ch. 45 pp. 100-101
17. Vitamin A AOAC 2012 Ch. 50 p. 1
18. Thiamine AOAC 2012 Ch. 50 pp. 10-11
(Vitamin B1)
19. Riboflavin AOAC 2012 Ch. 50 pp. 57-59
(Vitamin B2)
20. Niacin AOAC 2012 Ch. 50 p. 21 (microbiological and turbidimetry
(Vitamin B3) method)
21. Pantothenic acid AOAC 2012 Ch. 50 pp. 26-28 (microbiological and turbidimetry
22. Pyridoxin AOAC 2012 Ch. 50 pp. 20-21 (microbiological and turbidimetry
23. Vitamin B12 AOAC 2012 Ch. 50 pp. 48-57
24. Vitamin C AOAC 2012 Ch. 50 pp. 11-12 (titrimetry)
25. Vitamin D AOAC 2012 Ch. 50 pp. 57-59
26. Vitamin E AOAC 2012 Ch. 50 pp. 4-5 (HPLC)
27. Vitamin K AOAC 2012 Ch. 50 pp. 32-34 (HPLC)
28. Folic AOAC 2012 Ch. 50 pp. 24-26 (microbiological) and AOAC 2012
Ch. 50 pp. 38-44 (UPLC - MS/MS)
29. Biotin Validated method
(Vitamin H)
30. Iron AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
31. Zinc AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
32. Calcium AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
33. Phosphor AOAC 2012 Ch. 50 p. 13 (spectrophotometry)
34. Sodium AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
35. Potassium AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
36. Chloride AOAC 2012 Ch. 50 p. 12 (potentiometry)
-97-
37. Iodine AOAC 2012 Ch. 50, pp. 14-15

38. Magnesium AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
39. Selenium AOAC 2012 Ch. 9 (AAS) p. 2
40. Copper AOAC 2012 Ch. 9 (AAS) p. 16 (ICPS) pp. 80-82
41. Manganese AOAC 2012 Ch. 50 (AAS) p. 15 (ICPS) p. 17
42. Choline AOAC 2012 Ch. 50 (AAS) pp. 30-32 (enzymatic-colorimetric)
43. Myo-inositol AOAC 2012 Ch. 50 pp. 77-80
44. L-carnitine Validated method
45. Taurine AOAC 2012 Ch. 50 pp. 8-10 (HPLC)
46. Nucleotides AOAC 2012 Ch. 50 pp. 84-86 (LC-MS/MS)
47. DHA Validated method
48. Fluorine Validated method
49. Caffeine In-house method (MA PPOMN Year 2015)
50. Creatine Validated method
51. Inosine Validated method
52. Osmolality Osmometer
53. Molecular weight Electrophoresis
*) Note:
1) Other equal and validated analysis methods may be used.
2) Where nutrient/non-nutrient substances do not have analysis method(s) listed for
them, validated analysis methods may be used.
HEAD OF NATIONAL AGENCY FOR

DRUG AND FOOD CONTROL
signed
PENNY K. LUKITO

(ENGLISH VERSION) Salinan PerBPOM No 24 Tahun 2019 - Perubahan PerBPOM No 1 Tahun 2018 - Nett

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-1-

NATIONAL AGENCY FOR DRUG AND FOOD CONTROL

NATIONAL AGENCY FOR DRUG AND FOOD CONTROL

REGULATION NUMBER 24 YEAR 2019

AMENDMENT TO NATIONAL AGENCY FOR DRUG AND FOOD CONTROL

REGULATION NUMBER 1 YEAR 2018

ON SUPERVISION OF PROCESSED FOOD

FOR SPECIAL NUTRITIONAL PURPOSE

BY THE GRACE OF GOD ALMIGHTY

HEAD OF NATIONAL AGENCY FOR DRUG AND FOOD CONTROL

Considering : a. that supervision on processed food for special nutritional

b. that based on the consideration stated in letter a) needs to

In view of : 1. Law Number 18 Year 2012 on Food (State Gazette of The

1. FSMP for Patients with Metabolic Disorders (Inborn Errors

2. Provision of Article 11 is added by 1 (one) section, the section 3, so

3. Provision section (3) of Article 12 is amended, so that Article 12

4. Provision section (1) letter c) of Article 13 is amended, so that Article

c. Osmolality and/or osmolarity values are for enteral use

5. Several provisions within Appendix I to National Agency for Drug

For public acknowledgement, orders the statutement of this Agency

HEAD OF NATIONAL AGENCY

STATE GAZETTE OF THE REPUBLIC OF INDONESIA YEAR 2019 NUMBER 989

Copy is in accordance to the original

A. REQUIREMENTS FOR SAFETY, QUALITY, NUTRITION, AND LABELLING

2. DESCRIPTION AND DEFINITION

2.2. Infant Formula product is physically processed only and packaged to

3. REQUIREMENTS FOR QUALITY

3.2. Nutritional Content

Quality of protein is equivalent to that of casein or with higher amount

For calculation purposes, concentrations of tyrosine and phenylalanine may be

Lactose and glucose polymers are primary choices for carbohydrates in

Retinol content is in the form of

Vitamin E content must be at

Folic acid mcg/100 kcal 10 - 50

Ratio of calcium to phosphor is

Choline mg/100 kcal 7 - 50

3.2.6. Addable Nutrient/Non-nutrient Substances

Maximum purin nucleotide

Eicosapentaenoic (EPA) content,

Only L (+) form lactic acid-producing bacteria may be used.

components in amount sufficient to provide the expected benefits, with

5.2. Nutrition Facts

5.3. Instruction for Storage

5.4. Instruction for Use

5.4.3. Infant Formula in concentrate form must include instructions on how to

b. How to prepare and serve Infant Formula

5.5. Other Information

A.1.2. FOLLOW ON FORMULA

2. DESCRIPTION AND DEFINITION

3. REQUIREMENTS FOR QUALITY

3.2. Nutritional Content

Quality of protein is equivalent to that of casein or with higher amount

product is based on nitrogen conversion factor 6.25. The 6.38 conversion

For calculation purposes, concentrations of tyrosine and phenylalanine may be

semi-essential/essential amino acids are amino acids which in certain conditions

Vitamin E mg/100 kcal 0.5 - 5

3.2.6. Addable Nutrient/Non-nutrient Substances

Maximum purin nucleotide

Eicosapentaenoic (EPA) content,

Only L (+) form lactic acid-producing bacteria may be used.

5.2. Nutrition Facts

5.3. Recommendation for Daily Consumption