3.0 Compositional Aspects

Infant, Follow-up, Young Child Formula
Indonesia

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

1) Infant Formula [1]

• Energy: 60 kcal - 70 kcal per 100 ml
• Protein: milk 1.8 - 3.0 g/100 kcal; soy 2.25 - 3.0 g/100 kcal
• The quality of the protein shall not be less than 85% of that of casein 
• Fat: total 4.4 - 6.0 g/100kcal
• Linoleic acid 300 - 1400 mg/100 kcal
• Alpha-linolenic acid minimum 50 mg/100 kcal
• Ratio linoleic acid : alpha-linolenic acid = 5 - 15 : 1
• Partly hydrogenated oils/fat is not allowed to be used
• Lauric and myristic acid is not more than 12% of total fatty acid  
• Trans fat is not more than 3% of total fatty acid
• Erucic acid is not more than 1% of total fatty acid
• Carbohydrate: total 9.0 - 14.0 g/100 kcal
• Only naturally free gluten and precooked/gelatinized starch can be used.  Added starch not more than 30% total carbohydrate and maximum 2 g/100ml
• Sucrose maximum of 20% of total carbohydrate
• Fructose cannot be used

Amino acid composition:

Micronutrient composition:

2) Follow-up Formula [2]

• Energy: 65 kcal - 80 kcal per 100 ml
• Protein: milk 1.85 - 3.5 g/100 kcal; soy 2.25 - 3.5 g/100 kcal
• The quality of the protein shall not be less than 85% of that of casein
• Fat: total 4 - 6 g/100kcal
• Linoleic acid 300 - 1200 mg/100 kcal
• Alpha-linolenic acid minimum 50 mg/100 kcal
• Ratio linoleic acid : alpha-linolenic acid = 5 - 15 : 1
• Partly hydrogenated oils/fat is not allowed to be used
• Trans fat is not more than 3% of total fatty acid   
• Carbohydrate: total 8 - 14.2 g/100 kcal  
• Only naturally free gluten and precooked/gelatinized starch can be used.  Added starch not more than 30% total carbohydrate and maximum 2 g/100ml 
• Sucrose maximum of 20% of total carbohydrates  
• Fructose cannot be used 
  

Amino acid composition:

Micronutrient composition:

3) Young Child Formula [3]

1. Energy:  60 kcal - 85 kcal per 100 ml
2. Protein: milk 3 - 5.5 g/100 kcal; soy 3.2 - 5.8 g/100 kcal. 
3. The quality of the protein shall not be less than 85% of that of casein. Only L amino acid can be added.
4. Fat: total 3.3 - 5.6 g/100kcal
5. Linoleic acid 300 - 1200 mg/100 kcal
6. Alpha-linolenic acid minimum 50 mg/100 kcal
7. Ratio linoleic acid : alpha-linolenic acid = 5 - 15 : 1. 
8. Partly hydrogenated oils/fat is not allowed to be used.
9. Trans fat not more than 3%.
10. Carbohydrate: total minimum 7 g/100 kcal.  
11. Only naturally free gluten and precooked/gelatinized starch can be used.  Sucrose maximum 25% of total carbohydrates.

Micronutrient composition: 

3.2 Raw Material Requirements

DHA and ARA for all products need to comply with BPOM HK.03.1.23.11.11.09657 Year 2011. No other specific regulation for other raw materials. [4]

3.3 Fortification

1) Infant Formula [1]

• Taurine: max 12 mg/100kcal
• Nucleotide: max 16 mg/100kcal. At least 4 types of nucleotides adenosine, guanosine, cytidine, and uridine.
• Purine nucleotide max 45% of total added.
• DHA: min.0.2% fatty acid, GUL 0.5% fatty acid.  Added DHA must be accompanied by ARA (arachidonic acid) with a ratio: of 1: 1 - 2.  EPA (eicosapentanoic acid) cannot be more than DHA
• Only L(+) lactic acid bacteria can be added

2) Follow-up Formula [2]

• Manganese: minimum 1 mcg/100kcal, GUL 100 mcg/100kcal
• Choline: minimum 7 mg/100kcal, GUL 50 mg/100kcal
• Myo-inositol: minimum 4 mg/100kcal, GUL 40 mg/100kcal
• L-carnitine: minimum 1.2 mg/100kcal, maximum Not specified
• Taurine: max 12 mg/100kcal
• Nucleotide: max 16 mg/100kcal. At least 4 types of nucleotides adenosine, guanosine, cytidine, and uridine.
• Purine nucleotide max 45% of total added.
• DHA: min.0.2% fatty acid, GUL 0.9% fatty acid.  Added DHA must be accompanied with ARA (arachidonic acid) with a ratio: of 1: 1 - 2.  EPA (eicosapentanoic acid) cannot be more than DHA
• Only L(+) lactic acid bacteria can be added

3) Young Child Formula [3]

• Manganese: maximum 100 mcg/100kcal.
• Taurine: max 12 mg/100kcal
• Nucleotide: max 16 mg/100kcal. At least 4 types of nucleotides adenosine, guanosine, cytidine, and uridine.
• Purine nucleotide max 45% of total added.
• DHA: min.0.2% fatty acid, GUL 0.9% fatty acid. The amount of EPA (eicosapentaenoic acid) from polyunsaturated fatty acid cannot be more than DHA
• Choline:   minimum 7 mg/100kcal, GUL 50 mg/100kcal
• Myo-inositol: minimum 4 mg/100kcal, GUL 40 mg/100kcal
• L-carnitine: minimum 1.2 mg/100kcal, maximum Not specified
• Only L(+) lactic acid bacteria can be added
• Carbohydrate: total minimum 7 g/100 kcal.  
   Only naturally free gluten and precooked/gelatinized starch can be used.  
   Sucrose maximum of 25% of total carbohydrates.
  

3.4 Other Permitted Ingredients

1) Infant Formula [1]

Allowed for ingredients/nutrients naturally present in breast milk. This is to ensure that the formulation is the only source of nutrients for the baby or to provide other similar benefits to the benefits that babies get from breast milk. The safety and benefits of these nutrients/non-nutritional substances for babies must be scientifically proven. The formula must contain ingredients in sufficient quantities to provide the expected benefits, considering the amount of content in breast milk.

2) Follow-up Formula [2]

Allowed for ingredients/nutrients naturally present in breast milk. The suitability for the particular nutritional uses of infants and the safety of these substances shall be scientifically demonstrated. The formula must contain material in sufficient quantity to provide expected benefits according to the needs of the baby from age 6 (six) to 12 (twelve) months.

3) Young Child Formula [3]

Allowed for ingredients/nutrients needed for young children 1-3 years scientifically proven.

3.5 Permitted Additives

Permitted Additives for Infant Formula, Follow-up Formula, and Young Child Formula:

Permitted additives for Infant Formula, Follow-Up Formula, and Young Child Formula are regulated by the same reference: BPOM Decree No. 11 of the Year 2019 [7]. It regulates the use of Food Additives for all Processed Food.

• Infant Formula included in the Food Category 13.1.1 (regular one) and 13.1.3 (for a specific medical condition);
• Follow-Up Formula and Young Child Formula: Food Category 13.1.2

When the above Food Category is listed below the applicable food additives, it means they can be used with the maximum limits described in the regulations.

3.6 Permitted Flavors and Colors 

1) Infant Formula 

Not allowed to add flavorings. [5]

2) Follow-up Formula [6]

• Natural fruit extract (GMP)
• Vanillin extract (GMP)
• Ethyl vanillin (5mg/100 ml)
• Vanillin (5mg/100 ml)
  

3.7 Permitted Processing Aids

Processing aids listed in the regulations are allowed for designated food categories, which could have maximum limits defined or stated as GMP. If not listed, they will need to be submitted to BPOM for approval [8][9]. 

3.8 Additional Notes 

For all products, fluorine cannot be added, naturally present shall not be more than 100mcg/100kcal. If fluorine is found naturally in raw materials, fluoride content should not exceed 100 mcg/100 kcal.

3.9 References

1. Article A.1.1 BPOM Decree No. 24 Year 2020
 https://standarpangan.pom.go.id/dokumen/peraturan/202x/PerBPOM_No_24_Tahun_2020_Perubahan_PerBPOM_No_1_Tahun_2018.pd

2. Article A.1.2 BPOM Decree No. 24 Year 2020

https://standarpangan.pom.go.id/dokumen/peraturan/202x/PerBPOM_No_24_Tahun_2020_Perubahan_PerBPOM_No_1_Tahun_2018.pd

3. Article A.1.3 BPOM Decree No. 24 Year 2020

https://standarpangan.pom.go.id/dokumen/peraturan/202x/PerBPOM_No_24_Tahun_2020_Perubahan_PerBPOM_No_1_Tahun_2018.pd

4. BPOM Decree No. HK.03.1.23.11.11.09657 Year 2011

https://standarpangan.pom.go.id/dokumen/peraturan/2011/2011-HK.03.1.23.11.11.09657-Penambahan_Zat_Gizi_dan_Zat_Non_Gizi_Dalam_Pangan_Olahan.pdf

5. Article 17, BPOM Decree No. 30 Year 2020 on Flavourings

https://standarpangan.pom.go.id/dokumen/peraturan/202x/PerBPOM_Nomor_13_Tahun_2020_Bahan_Tambahan_Pangan_Perisa.pdf 

6. APPENDIX V REGULATION OF THE DRUG AND FOOD CONTROL AGENCY NO. 13 YEAR 2020 on Food Additional Ingredients, BPOM Decree No. 30 Year 2020 on Flavourings

https://standarpangan.pom.go.id/dokumen/peraturan/202x/PerBPOM_Nomor_13_Tahun_2020_Bahan_Tambahan_Pangan_Perisa.pdf 

7. BPOM Decree No. 11 of the Year 2019

https://standarpangan.pom.go.id/dokumen/peraturan/2019/PerBPOM_No_11_Tahun_2019_tentang_BTP.pdf

8. BPOM Decree No. 28 Year 2019 on Processing Aid

https://standarpangan.pom.go.id/dokumen/peraturan/2019/PBPOM-No-28-Tahun-2019-tentang-Bahan-Penolong-dalam-Pangan-Olahan.pdf

9. BPOM Decree No. 20 Year 2020 on Processing Aid

https://standarpangan.pom.go.id/dokumen/peraturan/202x/PerBPOM_No_20_Tahun_2020_Perubahan_PerBPOM_No_28_Tahun_2019.pdf