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Vietnam represents an attractive and rapidly growing market for infant nutrition products. Yet the regulatory environment is stringent, especially for formula products intended for babies and young children. Over recent years, Vietnam’s Ministry of Health has tightened oversight, issuing specialized rules that combine food safety standards with infant-nutrition requirements. Unless an importer fully understands registration protocols, safety testing, labeling rules, and customs procedures, it is easy to hit regulatory roadblocks. This article provides a step-by-step guide to import formula milk into Vietnam in 2025, helping businesses understand exactly what’s required and how to stay compliant.
Key Legal Frameworks and Regulation Overview
In Vietnam, the importation and distribution of infant formula are governed by a comprehensive legal framework. While there is no single “infant formula law,” the infant formula import regulations in Vietnam are primarily defined through several key documents:
- Law on Food Safety (2010): Establishes the general legal foundation for safety, labeling, and quality standards.
- Decree 15/2018/ND-CP: Provides detailed guidance on the procedures for Product Declaration Registration (for children under 36 months) and Self-Declaration of Products (for children over 36 months).
- National Technical Regulations (QCVN) issued by the Ministry of Health: These define mandatory safety and quality criteria. Examples include QCVN 11-1:2012/BYT for infants up to 12 months and QCVN 11-2:2012/BYT for children from 6-36 months.
- Decree 111/2021/ND-CP (amending Decree 43/2017/ND-CP): Sets critical regulations on labeling for imported goods, ensuring mandatory details—such as product origin and importer information—are correctly displayed on secondary labels.
- Decree 100/2014/ND-CP: Strictly manages business activities and enforces a ban on advertising breast-milk substitutes for children under 24 months, as well as feeding bottles and artificial teats..
Because infants are an especially vulnerable population, regulators require heavier scrutiny for formula intended for children under 36 months. After market entry, importers must also comply with ongoing post-market surveillance, including inspections and testing, to ensure products remain fully compliant with Vietnamese standards.
Product Registration Process Based on Age Group
Importing infant formula milk requires a clear understanding of product registration procedures, which vary significantly depending on the target consumer’s age group. Regulatory frameworks impose stricter controls for infant formula intended for children under 36 months compared to formula for older children. Below is an in-depth, step-by-step guide to the registration and compliance process for both categories.
A. Infant Formula for Children Under 36 Months: Mandatory Product Registration
In Vietnam, the importation of infant formula for children under 36 months requires mandatory product registration, officially known as the “Product Declaration Registration,” as stipulated in Article 6 of Decree 15/2018/ND-CP. This process is complex due to stringent documentation requirements and strict safety and nutritional standards.
Step 1: Sample Import and Laboratory Testing
Importers must first bring sample products of infant formula into Vietnam for mandatory laboratory testing. Samples are sent to laboratories designated by authorities or accredited under ISO 17025 standards. Mandatory tests include:
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Microbiological safety: Screening for pathogens such as Salmonella, E. coli, and Listeria.
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Heavy metals and contaminants: Testing for lead, mercury, arsenic, cadmium, and other regulated substances.
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Nutritional compliance: Verifying that essential nutrients, including proteins, fats, vitamins, and minerals, meet Vietnamese nutritional standards.
The results are compiled into a Food Safety Test Report, which is a required document for the registration dossier.
Step 2: Prepare Registration Dossier
After receiving test results, importers compile the full registration dossier. This step is technically and administratively demanding because all documents must meet Vietnamese regulatory standards. The required documents include:
| Document / Requirement | Description / Purpose |
|---|---|
| Product Declaration Form | Official declaration detailing product specifications, intended use, and compliance with nutritional standards. |
| Certificate of Free Sale (CFS), Export Certificate, or Health Certificate | Confirms that the product is legally sold and safe for consumption in the country of origin; must be legalized for use in Vietnam. |
| Test Results | Laboratory reports issued within 12 months prior to submission, from ISO 17025-accredited labs, covering microbiological, chemical, and contaminant safety parameters defined by the Ministry of Health or international standards. |
| Scientific Evidence Supporting Product Claims | Documentation verifying the product’s claimed benefits or benefits of its constituent ingredients. If ingredient-based evidence is used, the product’s daily dosage must be at least 15% of the ingredient quantity cited in the scientific documentation. |
Step 3: Submit Dossier to Competent Authority
Importers must submit the complete registration dossier to the Ministry of Health (MOH), specifically to the Vietnam Food Administration (VFA). The dossier should be submitted through the official online service portal or by postal service. The MOH reviews the documents for completeness, accuracy, and compliance with Vietnamese regulations.
Step 4: Approval and Issuance of Registration Receipt
According to Decree 15/2018/ND-CP, the official timeframe for dossier appraisal is 7 working days. However, in practice, the process may extend up to 90 working days from the receipt of a valid dossier for the authorities to issue the Product Declaration Registration Receipt. If the dossier is incomplete, the importer will be notified and required to provide supplementary documents within 60 days. Failure to meet this deadline may result in the cancellation of the application.
B. Import formula Milk for Children Over 36 Months: Simplified Self-Declaration Registration
Importing formula milk for children over 36 months into Vietnam involves a simpler administrative process compared to products for children under 36 months. Instead of mandatory product registration, importers use a self-declaration mechanism to confirm that the product meets general food safety, labeling, and nutritional requirements.
Step 1: Sample Import and Laboratory Testing
Importers are required to conduct laboratory testing on product samples to provide the legal basis for their self-declaration. This is to prove the product is safe and meets the declared quality and nutritional standards. The test results must be retained and presented upon request during post-market inspections.
Step 2: Prepare Self-Declaration Dossier
The self-declaration dossier for formula milk includes:
| Document | Purpose / Explanation |
|---|---|
| Self-Declaration Form | A standardized form containing product details, ingredients, nutritional composition, labeling information, usage instructions, manufacturer/importer details, production date, expiry date, and country of origin. |
| Test Report | Laboratory test results verifying microbiological safety, heavy metal levels, and nutritional compliance, issued within 12 months by an accredited or designated laboratory. |
This simplified dossier does not require a Certificate of Free Sale or scientific evidence for claimed benefits, unlike formula for children under 36 months.
Step 3: Submit Dossier to the Competent Authority
The completed self-declaration dossier should be submitted through the official online service portal of the Ministry of Health or by postal service. Once submitted, the self-declaration is recorded and published in the national product declaration system, allowing the product to circulate legally in the Vietnamese market. Authorities may conduct administrative reviews or post-market inspections, but prior approval is not required.
Customs Clearance and Documentation
After successfully completing product registration or self-declaration, importers must prepare for smooth customs clearance by providing comprehensive and accurate documentation. Essential documents typically include:
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Commercial Invoice: Lists the product value, Harmonized System (HS) code, payment terms, and seller/buyer information.
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Packing List: Details the quantity, type, dimensions, and packaging specifics of the shipment.
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Certificate of Origin (CO): Verifies the country where the infant formula was manufactured.
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Import Permit: A formal license issued by local food safety or import control authorities authorizing product entry.
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Health Certificates: From competent authorities in the exporting country, validating product safety.
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Bill of Lading (B/L) or Airway Bill (AWB): Legal proof of shipment for sea or air freight.
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Customs Declaration Form: Contains declared values, tariff codes, taxes, and duties payable.
Failure to submit any required documents or discrepancies in paperwork can cause shipment delays, additional fines, or outright rejection by customs authorities, severely impacting your supply chain.
Compliance with Post-Import Regulations
After both types of infant formula enter the Vietnamese market, they are subject to post-market surveillance to ensure continuous compliance with safety, nutritional, and labeling standards. Authorities perform routine inspections and random sampling to check for pathogens, heavy metals, and verify nutrient content against declared values. They also monitor consumer complaints and any adverse reactions, taking corrective measures such as recalls, warnings, or fines if violations are found. This ongoing oversight safeguards infant health, ensures product quality, and maintains regulatory compliance for all formula products, regardless of age group.
Conclusion
Importing infant formula into Vietnam in 2025 is a delicate, highly regulated undertaking—from dossier and registration through testing, customs, and post-market checks. Mistakes or omissions can be costly. If you want to streamline your entry and reduce regulatory risk, Green NRJ offers full support: we guide you through dossier preparation, regulatory submission, testing coordination, and customs clearance. Contact us today to ensure your formula product meets Vietnam’s standards and reaches market without delay.
