1. Definition & classification
As per BPOM Regulation 01/2018 on Control of Processed Food for Special Nutritional Purposes,
infant formula refers to the formula as a substitute for Mother's Milk (ASI) which is specifically formulated to be the only source of nutrition for babies up to the age of 6 months in the first months of life until the baby is introduced to Complementary Food for Breast Milk (MP-ASI).
advanced formula refers to the formula obtained from cow's milk or milk of other animals and/or ingredients of animal origin and/or plant origin, which all have been proven suitable for infants aged 6 to 12 months.
growth formula refers to the formula obtained from cow's milk or milk of other animals and/or ingredients of animal origin and/or plant origin, which all have been proven suitable for children aged more than 12 months to 36 months.
2. Competent authority
Competent authority | Responsibility |
Badan Pengawas Obat dan Makanan (BPOM) | BPOM is responsible for protecting public health through the control and supervision of food products, traditional medicine, cosmetics, pharmaceuticals, biopharmaceuticals, and health supplements. It is tasked to issue import permits for food products and oversee the distribution of food products in Indonesia. |
3. Market access approval
3.1 Circulation permit
In Indonesia, in order to obtain the circulation permit of infant formula, business operators are required to register the products with BPOM. For imported products, the registrants shall be local importers. In principle, the circulation permit shall be valid for five years, and shall be prolonged via re-registration. For the specific registration procedures and requirements, please refer to BPOM Regulation 27/2017 on Processed Food Registration.
3.2 Import permit
To import infant formula into Indonesian territory, a SKI Post Border, which is the import permit from BPOM, shall be obtained through application by local importers with circulation permit. Each SKI Post Border is single-use for one import only. Local importers shall finish the importation within seven days from the date of receiving SKI Post Border. For the specific application procedures and requirements, please refer to BPOM Regulation No. 27 of 2022 on Control of the Importation of Drugs and Food into Indonesian Territory.
4. Product compliance
4.1 Product requirements
The quality requirements for ingredients and nutritional composition of infant formula are specified in BPOM Regulation 01/2018 on Control of Processed Food for Special Nutritional Purposes. To be specific, the Regulation details the requirements for energy, protein, fat, carbohydrate, vitamins, minerals, and other nutrients that can be added.
Notably, the quality requirements vary among infant formula, advanced formula and growth formula. Take protein for example, the specified protein contents of the three categories are as shown in the table below.
Protein source | Requirements | |
Infant formula | Milk protein | 1.8 – 3.0g/100g |
Soy protein isolates | 2.25 – 3.0g/100g | |
Advanced formula | Milk protein | 1.82 – 3.5g/100g |
Soy protein isolates | 2.25 – 3.5g/100g | |
Growth formula | Milk protein | 3 – 5.5g/100g |
Soy protein isolates | 3.2 – 5.8g/100g |
In addition, the use of food additives in infant formula products shall comply with BPOM Regulation No.11 of 2019 about Food Additives.
4.2 Label
The labeling of infant formula products shall meet the general food labeling requirements stated in Government Regulation 69/1999 Foods Labels and Advertisements and BPOM Regulation 20/2021 on Processed Food Labels. For example, food labels must be written or printed in the Indonesian language (Bahasa).
Additional labeling requirements for infant formula can be found at BPOM Regulation 01/2018 on Control of Processed Food for Special Nutritional Purposes. Mandatory labeling items include:
Product name
Nutritional value information
Storage instructions
Use instructions
Other information
Besides, the label shall carry a statement like "Breastfeeding is the best food for babies", and must not defame breastfeeding, or imply the formula's advantage over breastfeeding. To be more detailed, labels are not allowed to:
(1) contain images of babies and women or anything that favors the use of infant formula either in picture or text.
(2) state that infant formula has the same quality as breast milk.
(3) contain terms equivalent to human, mother or other similar terms.
In addition, as per BPOM Regulation No.1 of 2022 on Processed Food Claims and Advertisements, claims on processed foods for infants are prohibited.
* Global Food Compliance Service
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