Indonesia’s large population, coupled with a relatively high birth rate, continues to fuel demand for infant food products. The growing population of infants and toddlers presents a significant opportunity for manufacturers. As more people move to urban areas and adopt busy lifestyles, there is a growing demand for convenient, ready-to-use infant food products. This blog provides an overview of the infant food regulatory process in Indonesia.
Authorities overseeing Regulation of Infant Formula in Indonesia
BPOM (Badan Pengawas Obat dan Makanan): Indonesia's National Agency of Drug and Food Control (BPOM) is the primary body responsible for overseeing food safety, including infant food products ensuring the health standards of infant food.
Ministry of Health (Kementerian Kesehatan): Sets national health guidelines and oversees nutrition standards, including infant nutrition.
NADFC (BPOM) Regulations of Infant Formula in Indonesia
BPOM Regulation No. 31 of 2018: This regulation defines how processed food, including infant formula and complementary food, should be labeled:
Nutritional Labeling: Labels must clearly display nutritional information, including macronutrients, vitamins, and minerals.
Allergen Information: Any potential allergens (e.g., milk, soy, nuts) must be declared.
Expiry Date: A clear expiration or "best before" date is required.
Ingredient Listing: All ingredients must be listed by weight or concentration.
Breastfeeding Statement: Infant formula packaging must include a statement encouraging breastfeeding as the best source of nutrition for babies.
BPOM Regulation No. 17 of 2022: This regulation ensures that processed food, including infant food, meets safety standards for consumption. It establishes guidelines for:
Product Safety: Infant food must pass microbiological, chemical, and physical safety tests.
Packaging Standards: The materials used in packaging must not pose risks to the food's safety.
Risk-Based Approach: Food safety evaluations are conducted based on potential risks to health, particularly for vulnerable populations like infants.
BPOM Regulation No. 22 of 2022: Good Manufacturing Practices (GMP) for Processed Foods
Production Standards: Infant food manufacturers must follow stringent hygiene and quality control practices. This includes proper handling of raw materials, sanitary conditions, and thorough cleaning of production facilities.
Quality Control: Regular quality control checks are mandated to ensure consistency in product safety and nutritional quality.
Traceability: Manufacturers are required to maintain records to trace back each batch of infant food products in case of safety issues.
BPOM Regulation No. 11 of 2019:
Contaminant Limits: Limits are set for contaminants, including heavy metals, pesticide residues, and microorganisms, in infant foods.
Prohibited Ingredients: Certain preservatives, artificial colors, and additives are not allowed in infant foods to ensure safety for young children.
NADFC (BPOM) Classification of Infant Formula in Indonesia
Infant Formula: Infant formula is a breast milk substitute designed to meet the nutritional needs of infants. BPOM classifies infant formula based on the age of the child:
Infant Formula for Infants Aged 0-6 Months
Follow-On Formula for Infants Aged 6-12 Months
Specialized Infant Formula: This category includes formula products intended for infants with specific medical or dietary needs. BPOM defines several subcategories:
Lactose-Free Formula
Hypoallergenic Formula
Soy-Based Formula
Complementary Foods for Infants and Toddlers
Processed Complementary Foods for Infants (6-12 Months)
Processed Complementary Foods for Toddlers (12-24 Months)
Special Medical Foods for Infants: BPOM classifies foods designed for infants with specific medical conditions that require specialized diets. These include:
Preterm Infant Formula
Therapeutic Foods
Fortified Infant Foods: BPOM also regulates fortified infant foods that are enhanced with additional vitamins and minerals.
Toddler Formula (12-36 Months)
NADFC (BPOM) Labeling Regulations of Infant Formula in Indonesia
Nutritional Information: Labels must display the complete nutritional content, including the quantities of essential nutrients such as Recommended Daily Intake (RDI)
Ingredient Listing: It must include complete ingredient list & additives. It must also include prohibited ingredients.
Allergen Information: Labels must clearly indicate any allergens present in the formula, such as Milk proteins, Soy, Lactose, any other potential allergens
Breastfeeding Statement: All infant formula products are required to include a prominent statement that encourages breastfeeding as the best source of nutrition for infants. Typical statements include:
“Breastfeeding is best for babies.”
“Infant formula should only be used when advised by a healthcare professional.”
Preparation Instructions: The label must include detailed instructions on how to correctly prepare, use, and store the infant formula.
Expiration Date and Storage Conditions
Warning Statements: There must be a warning about the potential health risks of incorrect preparation and improper use of infant formula.
Halal Certification: Since Indonesia has a large Muslim population, all infant formula products must be Halal-certified. The Halal logo from the Indonesian Ulema Council (MUI) must be displayed on the label.
Language Requirements: The primary language on the label must be Bahasa Indonesia. Additional languages may be included, but they cannot replace the mandatory information in Bahasa.
Key Documents Required of Infant Formula in Indonesia
Product Dossier: This is a comprehensive document that includes information about the infant formula, its ingredients, nutritional composition, and production methods.
Manufacturing License (GMP certificates).
Halal Certification
Quality Control Data.
Safety and Efficacy Data.
Packaging and Labeling Information.
Product Samples.
NADFC (BPOM) Registration Process of Infant Formula in Indonesia
Company Eligibility and Registration: Before a company can register an infant formula product with BPOM, it must ensure that the company is registered in Indonesia, whether domestic or as a foreign entity with a local distributor or agent.
Submission of Product Registration Application: To start the registration process, the applicant (local manufacturer or importer) must submit the required documentation to BPOM. This process is conducted through BPOM’s e-Registration system.
Review and Evaluation Process: Once the application and documents are submitted, BPOM will review and evaluate the product's safety, quality, and compliance with regulatory standards. The process includes:
Documentation Review: BPOM will examine the submitted documents to ensure that they are complete and accurate. The agency will check whether the product meets the nutritional, safety, and labeling standards required by Indonesian law.
Laboratory Testing / Product Testing: BPOM may conduct independent testing of the infant formula to verify the composition, safety, and quality as stated in the application.
Facility Inspection (if necessary): BPOM may inspect the manufacturing facilities, particularly if the product is imported, to ensure compliance with GMP, quality control standards, and hygienic conditions for producing infant formula.
Evaluation of Labeling and Marketing Compliance: BPOM will review the product labeling and marketing materials to ensure they follow the agency’s guidelines, including the prohibition of misleading health claims, correct age appropriateness, and breastfeeding promotion messages.
Issuance of Product Registration Number: If the product passes BPOM's evaluation and testing process, a Product Registration Number (Nomor Izin Edar or NIB) will be issued. This number signifies that the product is approved for sale in Indonesia and will be displayed on the packaging. If the formula is imported, a valid import license (SKI – Surat Keterangan Impor) must also be obtained from BPOM.
Post-Market Surveillance and Compliance: Once a product is registered and marketed, BPOM continues to monitor compliance through its post-market surveillance program. This ensures that products consistently meet the approved standards.
Random Testing: BPOM conducts random market sampling and testing to ensure product safety and that the infant formula remains compliant with approved specifications.
Adverse Event Reporting: Companies must report any adverse events or product defects to BPOM, which may trigger recalls or additional inspections.
Recalls and Penalties: If an issue is identified with a registered product, BPOM may issue a recall, suspend the product’s license, or impose penalties on the company.
Summary of the BPOM Registration Process for Infant Formula:
Company Eligibility and Compliance: Ensure legal registration and GMP-compliant manufacturing facilities.
Submission of Application: Provide necessary documentation, product dossiers, and samples through BPOM’s e-Registration system.
Review and Evaluation: BPOM conducts document reviews, laboratory tests, and possibly facility inspections.
Product Registration Number Issuance: After passing the review, BPOM issues a registration number allowing the product to be sold in Indonesia.
Post-Market Surveillance: BPOM monitors the product’s compliance through random testing and requires adverse event reporting.
Validity of the License
The validity period of the BPOM registration for infant food products (including infant formula) is generally 5 years. After this period, the company must apply for re-registration to maintain the license and continue marketing the product.
Indonesia's regulatory framework for infant food, under BPOM, is comprehensive and aligned with global best practices. The registration process ensures that infant food products are safe, nutritionally adequate, and clearly labeled, while also encouraging breastfeeding. Companies seeking to enter the Indonesian market must navigate a detailed registration process and comply with ongoing regulatory oversight to ensure the quality and safety of their products.
Navigating through the regulatory framework of Indonesia requires expert guidance, we, a team of regulatory professionals at Artixio can fulfil your regulatory needs with high quality consultation services. Contact Artixio today at info@artixio.com.
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