5.0 Labeling Requirements

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5.0 Labeling Requirements

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Infant, Follow-up, Young Child Formula
Indonesia

This section provides information on labeling requirements and the label approval process.

5.1 Mandatory Labeling Parameters

All Products [1]

Name of product
Ingredient list
Net weight
Name, and address of manufacturer and local importer/distributor
BPJPH/MUI halal logo
Date and code of production (batch)
Expiry date
Registration number
Source of certain ingredients (for animal origin, GMO, irradiated, related to halal)
Nutrition information
Instruction of use (for a product that needs preparation before use)
Instruction for storage (for a product whose shelf life depends on storage and demand-specific conditions)
Allergen ingredient. List of allergens: milk (with lactose), cereals with gluten, eggs, fish, crustacea, mollusks, peanuts, tree nuts, sulfites min 10mg/kg (as SO2)

1) Infant Formula, 2) Follow-up Formula [2]

Nutrition Table:

It shall be in table form
Name and amount of nutrient per 100g (for powder) or 100ml (for liquid) and 100kcal
The number shall be based on testing at the accredited local laboratory. An overseas lab can be used as long as it is accredited or has MRA with an accredited lab in Indonesia

Translation:

Nutrient Reference Information	Unit	Amount
Nutrient Reference Information	Unit	Per 100 g/100 ml	Per 100 kcal
Protein	g
Total fat	g
Linoleic acid	mg
α-linolenic acid	mg
Carbohydrate	g
Vitamin:
Vitamin A	mcg RE
Vitamin D3	mcg
Vitamin E	mg α-TE
Vitamin K	mcg
Vitamin B1 (Thiamine)	mcg
Vitamin B2 (Riboflavin)	mcg
Vitamin B3 (Niacin)	mcg
Vitamin B5 (Pantothenate acid)	mcg
Vitamin B6 (Pyridoxine)	mcg
Folic acid	mcg
Vitamin B12 (Cobalamine)	mcg
Vitamin C	mg
Biotin	mcg
Choline	mg
Myo-inositol	mg
L-carnitine	mg
Minerals:
Calcium	mg
Phosphorus	mg
Magnesium	mg
Iron	mg
Zinc	mg
Manganese	mcg
Cuprum	mcg
Iodine	mcg
Natrium	mg
Potassium	mg
Chloride	mg
Selenium	mcg
Other components:
Fructooligosaccharides (FOS)	mg
Galactooligosaccharides (GOS)	mg

3) Young Child Formula [3]

Nutrition Information:

Consists of 2 parts:

1. "INFORMASI NILAI GIZI" which is Nutrition Facts in the local language, serving size, and amount of size per packaging

2. "JUMLAH PER SAJIAN" which is the Nutrient Amount per Serving size in the local language

2.1 Information on energy

2.2 Information on fat and its derivatives, protein and its derivatives, carbohydrate and its derivatives, and sodium

2.3 NRV percentage of protein, vitamin, and minerals

The number shall be based on testing at the accredited local laboratory. An overseas lab can be used as long as it is accredited or has an MRA with an accredited lab in Indonesia.

Translation:

NUTRITION FACTS Serving size … g/ml (…household metric e.g spoon) … Serving per packaging
AMOUNT PER SERVING Total energy	… kcal
Total fat Trans fat Protein Total carbohydrate	… g … g … g … g
Dietary fiber Soluble dietary fiber Non soluble dietary fiber	… g … g … g
Sugar Salt (sodium)	… g … mg
	% NRV
Protein Vitamin and mineral	… %
Vitamin A	… %
Vitamin C	… %
Another vitamin	… %
Potassium	… %
Calcium	… %
Iron	… %
Another mineral	… %

5.2 Languages

Bahasa Indonesia language [4].

5.3 Mandatory Information on Stickers

Yes, stickers are allowed as a temporary solution for imported products. In practice, the duration of stickering will depend on discussion/agreement with Authorities.

Additional stickers shall not be easy to remove. [5]

5.4 Product Legal Name

5.5 Product-specific Labeling Statements

1) Infant Formula [6]

Nutrition labelling per 100 g or per 100 ml or per 100 kcal
Storage instruction and sign when product is not fit for consumption
Instruction of use:
- "dapat dikonsumsi langsung" which is translated to "can be consumed directly" when it can be consumed directly
- instruction on how to reconstitute for powder
- illustration
Warning on health risks when the method of preparation, storage, and use is not appropriately followed.
Guidance on how to sterilize tools and serve products (can be on label or leaflet - see below)*
"Perhatian Penting" translated to 'important notice'
"Produk formula bayi bukan merupakan produk steril oleh karena itu perhatikan petunjuk penyiapan” translated to 'infant formula is not a sterile product, please pay attention to instruction of use'. To be labelled at front part of label, with size minimum 2 mm.
“ASI adalah makanan terbaik untuk bayi anda” which translates into 'breast milk is the best food for your baby' or a similar sentence to state breast milk superiority.
A statement that the product is only used under a doctor's recommendation based on medical indications and accompanied by an explanation of how to use it properly.
Information that babies aged 6 (six) months and above must be given complementary feeding, according to the baby's needs for growth and development. Complementary feeding before the age of 6 (six) months must be based on the advice of a doctor.

A. Guidance on how to clean and sterilize equipment use and serve products in the local language:

Mencuci tangan dengan sabun sebelum membersihkan dan mensterilkan peralatan minum bayi;
Mencuci semua peralatan (botol, dot, sikat botol dan sikat dot) dengan air bersih yang mengalir;
Membilas botol dan dot dengan air yang mengalir;
Sterilisasi dengan cara direbus:
1. Botol harus terendam seluruhnya sehingga tidak ada udara di dalam botol;
2. Panci ditutup dan biarkan sampai mendidih selama 5 – 10 menit;
3. Panci biarkan tertutup, biarkan botol dan dot didalamnya sampai segera akan digunakan;
Mencuci tangan dengan sabun sebelum mengambil botol dan dot;
Bila botol tidak langsung digunakan setelah direbus:
1. Botol harus disimpan ditempat yang bersih dan tertutup
2. Dot dan penutupnya terpasang dengan baik

Translation:

Wash hands with soap before cleaning and sterilizing baby drinking utensils;
Wash all equipment (bottles, pacifiers, bottle brushes and pacifier brushes) with clean running water;
Rinse bottles and teats under running water;
Sterilization by boiling:
1. The bottle must be completely submerged so that there is no air in the bottle;
2. Cover the pot and let it simmer for 5 – 10 minutes;
3. Leave the pot closed, leave the bottle and teat in it until it will be used immediately;
Wash hands with soap before taking bottles and pacifiers;
If the bottle is not used immediately after boiling:
1. Bottles must be stored in a clean and closed place
2. The pacifier and the cap are securely attached

B. Guidance on how to serve in the local language:

Membersihkan tempat penyiapan Formula Bayi;
Mencuci tangan dengan sabun dan air mengalir, kemudian keringkan;
Rebus air minum sampai mendidih selama 10 menit dalam panci tertutup;
Setelah mendidih, biarkan air tersebut didalam panci tertutup selama 10 -15 menit agar suhunya turun menjadi tidak kurang dari 70°C;
Tuangkan air tersebut (suhunya tidak kurang dari 70°C) sebanyak yang dapat dihabiskan oleh bayi (jangan berlebihan) ke dalam botol susu yang telah disterilkan;
Tambahkan bubuk Formula Bayi sesuai takaran yang dianjurkan pada label;
Tutup kembali botol susu dan kocok sampai Formula Bayi larut dengan baik;
Dinginkan segera dengan merendam bagian bawah botol susu didalam air bersih dingin, sampai suhunya sesuai untuk diminum (dicoba dengan meneteskan Formula Bayi pada pergelangan tangan, akan terasa agak hangat, tidak panas).

Translation:

Cleaning the place for preparing Infant Formula;
Wash hands with soap and running water, then dry them;
Boil drinking water for 10 minutes in a covered pot;
After boiling, leave the water in a covered pot for 10-15 minutes so that the temperature drops to not less than 70°C;
Pour the water (temperature not less than 70°C) as much as the baby can spend (don't overdo it) into a sterilized feeding bottle;
Add Infant Formula powder according to the dosage recommended on the label;
Recap the feeding bottle and shake until the Infant Formula dissolves well;
Cool immediately by soaking the bottom of the milk bottle in cold clean water, until the temperature is suitable for drinking (try it by dripping Infant Formula on the wrist, it will feel a bit warm, not hot).

2) Follow-up Formula [7]

Nutrition labelling per 100 g or per 100 ml or per 100 kcal
Consumption suggestion for baby age 6-12 months per day
Storage instruction and sign when product not fit for consumption
Instruction of use:
- "dapat dikonsumsi langsung" translated to "can be consumed directly" when it can be consumed directly
- instruction on how to reconstitute for powder
- illustration
Warning on health risk when the method of preparation, storage and use is not appropriately followed.
Guidance on how to sterilize tools and serve products (can be on label or leaflet- see below)*
Warning to show product cannot be given to baby less than 6 months.
Information to give weaning food to baby
"Perhatian Penting" translated to 'important notice'
"Produk formula bayi bukan merupakan produk steril oleh karena itu perhatikan petunjuk penyiapan” translated to 'follow on formula is not a sterile product, please pay attention to instruction of use'. To label at the front part of the label, with a size of a minimum of 2 mm.
“ASI adalah makanan terbaik untuk bayi anda” translated to 'breast milk is the best food for your baby' or a similar sentence to state breast milk superiority.
A statement that the product is only to be used under doctor's recommendation based on medical indications and accompanied by an explanation of how to use it properly.
Information that baby age 6 (six) months and above must be given complementary feeding, according to baby's needs for growth and its development. Complementary feeding before the age of 6 (six) months must be on the advice of a doctor.

A. Guidance on how to clean and sterilize equipment use and serve products in the local language:

Mencuci tangan dengan sabun sebelum membersihkan dan mensterilkan peralatan minum bayi;
Mencuci semua peralatan minum bayi (dengan air bersih yang mengalir;
Membilas peralatan minum bayi dengan air yang mengalir;
Sterilisasi dengan cara direbus:
1. Peralatan minum bayi harus terendam seluruhnya;
2. Panci ditutup dan biarkan sampai mendidih selama 5 – 10 menit;
3. Panci biarkan tertutup, biarkan peralatan minum bayi didalamnya sampai segera akan digunakan;
Mencuci tangan dengan sabun sebelum mengambil peralatan minum bayi;
Bila peralatan minum bayi tidak langsung digunakan setelah direbus, harus disimpan ditempat yang bersih dan tertutup.

Translation:

Wash hands with soap before cleaning and sterilizing baby drinking utensils;
Wash all baby drinking utensils (with clean running water;
Rinse baby drinking utensils with running water;
Sterilization by boiling:
1. Baby drinking utensils must be completely submerged;
2. Cover the pot and let it simmer for 5 – 10 minutes;
3. Leave the pot closed, leave the baby drinking utensils in it until it will be used immediately;
Wash hands with soap before taking baby drinking utensils;
If baby drinking utensils are not used immediately after boiling, they must be stored in a clean and closed place.

B. Guidance on how to serve in the local language:

Membersihkan tempat penyiapan Formula Lanjutan;
Mencuci tangan dengan sabun dan air mengalir, kemudian keringkan;
Rebus air minum sampai mendidih selama 10 menit dalam panci tertutup;
Setelah mendidih, biarkan air tersebut di dalam panci tertutup selama 10 -15 menit agar suhunya turun menjadi tidak kurang dari 70°C;
Tuangkan air tersebut (suhunya tidak kurang dari 70°C) sebanyak yang dapat dihabiskan oleh bayi (jangan berlebihan) ke dalam peralatan minum bayi yang telah disterilkan;
Tambahkan bubuk Formula Lanjutan sesuai takaran yang dianjurkan pada label;
Kocok sampai Formula Lanjutan larut dengan baik;
Dinginkan segera dengan merendam bagian bawah peralatan minum bayi di dalam air bersih dingin, sampai suhunya sesuai untuk diminum (dicoba dengan meneteskan Formula Lanjutan pada pergelangan tangan, akan terasa agak hangat, tidak panas);
Sisa Formula Lanjutan yang telah dilarutkan dibuang setelah 2 jam.

Translation:

Clean up the Follow Up Formula preparation area;
Wash hands with soap and running water, then dry them;
Boil drinking water for 10 minutes in a covered pot;
After boiling, leave the water in a covered pot for 10-15 minutes so that the temperature drops to no less than 70°C;
Pour the water (temperature not less than 70°C) as much as the baby can spend (don't overdo it) into sterilized baby drinking utensils;
Add Follow Up Formula powder according to the dosage recommended on the label;
Shake until Follow Up Formula dissolves well;
Cool down immediately by immersing the bottom of the baby drinking utensil in cold clean water, until the temperature is suitable for drinking (try dripping Advanced Formula on the wrist, it will feel a bit warm, not hot);
The remaining diluted Follow Up Formula was discarded after 2 hours.

3) Young Child Formula [8]

Nutrition labeling per 30-50 g (powder) and 200-250 ml (liquid)
Consumption suggestion for young children aged 1-3 years per day
Storage instructions and signs when the product is not fit for consumption
Instruction of use:
- "dapat dikonsumsi langsung" translated to "can be consumed directly" when it can be consumed directly
- instruction on how to reconstitute for powder
- illustration
Warning on health risks when the method of preparation, storage, and use is not appropriately followed.
Guidance on how to sterilize tools and serve products
Information not to give young child formula to baby, with specific statement

Translation: “Warning: Not for Baby”.

5.6 Authority Approval

Yes, the product label needs to be approved by the National Agency of Food and Drug Control (BPOM)/NADFC. The cost is IDR3.000.000/product (300 USD); the timeline is 30 working days (this is the timeline for registration as no separate label approval). The actual timeline could be longer (3-12 months). [9, 10, 11]