Guidance for detailed Regulatory Food Additive Labeling

Regulations food additive labeling must be controlled carefully in Vietnam because labeling errors may trigger customs delays, compulsory recalls, and administrative fines of up to VND 200,000,000. Foreign enterprises must ensure product labels match statutory requirements, including the “Food Additive” designation, complete ingredient information, and expiry dates, while remaining consistent with declared product dossiers. Any mismatch between technical documents and actual packaging can disrupt import, distribution, or repackaging plans.

Businesses should review Legal Updates and work with Long Phan Consulting to manage food additive compliance risks before market entry.

Mandatory information system required by regulations for food additive labeling

Food additive packaging functions as a critical compliance document rather than a mere commercial identifier. Every data point on the label must enable regulatory authorities, distribution partners, and end-users to accurately trace the product. Consequently, enterprises must exercise strict control over labeling from the initial design and printing file stages.

List of 10 core criteria for product packaging

The QA/QC and Legal departments should consider label checklists as a prerequisite before mass printing. Missing any required information can result in product rejection, corrective action required, or penalties for labeling violations.

• Product name: State the correct legal name of the additive, followed by the phrase “Food additive” or “Food processing aid” depending on the product group.
• Composition: Accurately list each ingredient, avoiding omitting any substances that contribute to the product’s effectiveness.
• Quantitative: Clearly state the net weight or actual volume so that the distribution partner can monitor the shipment.
• Date of manufacture: Display the production date (day, month, year) for traceability purposes.
• Expiry: Record in accordance with the product’s technical specifications and stability characteristics.
• Storage conditions: Specify temperature, humidity, or storage conditions if they affect the quality of the additive.
• Instructions for use: Describe the appropriate usage, dosage, or application limits for the intended technological purpose.
• Information about the responsible organization: Include the name, address, and contact information of the business responsible for the goods.
• Origin of goods: Accurately state the country or territory of origin to avoid conflicts with import documents.
• Safety warning: Include warnings when the product has usage conditions, restricted users, or safety risks that require attention.

For small-sized packaging, the letters and numbers on food additive labels must meet minimum size requirements.0,9 mm. According to Clause 4, Article 37 of Decree No. 37/2026/ND-CP, in the case of additives sold loose or simply packaged, businesses must still publicly display the product name, expiration date, warnings, and information of the responsible unit at the point of sale, as stipulated in Article 51 of Decree No. 37/2026/ND-CP.

Principles for Identifying Food Additives and Healthcare-Standard INS Code Declaration

Product names must not convey misleading impressions regarding the additive’s function or inherent nature. When determining nomenclature, International Numbering System (INS) codes, and technological functions, enterprises must verify their data directly against the “List of food additives permitted for use in food” as stipulated in Article 5 of Consolidated Document 09/VBHN-BYT (2024).

Consistency across labels, product declaration dossiers, and technical documentation is mandatory. Discrepancies regarding substance names, concentrations, or technological functions may result in the product being deemed non-compliant with its declared standards.

• Composition Sequencing: Additive components must be listed in descending order of weight to accurately reflect the product structure.
• Substance Identification: Enterprises must clearly state the substance group name, specific additive name, or international INS code pursuant to Clause 3, Article 48 of Decree 37/2026/NĐ-CP.
• National vs. International Codes: If a domestic additive code matches the international INS code, the enterprise may utilize the national code as an alternative (Point a, Clause 3, Article 48, Decree 37/2026/NĐ-CP).
• Coloring and Sweetening Agents: Labels must explicitly clarify whether the agents are natural, synthetic, or artificial to prevent technological misinterpretation.
• Genetically Modified Ingredients: If GMO content exceeds 5% of total production materials, the label must include the notation “genetically modified” (Section 5, Appendix I, Decree 37/2026/NĐ-CP).
• Declaration Exceptions: Additives incorporated through raw materials that serve no technological function in the final product are not required to be listed on the label (Clause 4, Article 9, Consolidated Document 09/VBHN-BYT (2024)).

Legal Requirements for Imported and Repackaged Food Additive Labels

Imported and repackaged food additives are high-risk categories concerning origin accuracy, original label integrity, and quality liability. Minor translation errors or a lack of proper authorization can lead to customs clearance delays, distribution failures, or mandatory product recalls. Enterprises must implement a dual-layer control system. Imported goods must satisfy Vietnamese secondary label requirements before circulation, while repackaged items must provide evidence of authorization for repackaging and guarantee the retention of the original product quality, pursuant to Articles 40, 42, 44, and 46 of Decree 37/2026/NĐ-CP, and Article 10 of Consolidated Document 09/VBHN-BYT (2024).

Timing and Translation Principles for Secondary Labels

Upon customs clearance, the original foreign-language label must at least contain the product name, origin, and manufacturer information. This serves as the foundational data for customs authorities, importers, and legal departments to verify against import dossiers. Before circulation in Vietnam, enterprises must finalize the Vietnamese secondary label. This label must be affixed directly to the packaging, provide an accurate translation of the original label, include missing legal information, and not obscure mandatory content on the original label, in accordance with Clauses 1 and 3, Article 40 of Decree 37/2026/NĐ-CP.

The primary risk remains discrepancies between original labels, secondary labels, and customs declarations. Enterprises should pre-verify product names, origins, and manufacturer data to prevent cargo from being trapped at warehouses, ports, or within distribution systems.

Quality Control Conditions for Splitting and Repackaging

Repackaging food additives is not merely a logistical task. It triggers specific liabilities concerning quality, labeling, and traceability for each product batch.

• Authorization: Repackaging activities are only lawful if accompanied by a written consent document from the organization responsible for the product (Point a, Clause 1, Article 10, Consolidated Document 09/VBHN-BYT (2024)).
• Maintenance of Original Quality: Enterprises must ensure that repackaging does not alter the initial quality of the additive (Point b, Clause 1, Article 10, Consolidated Document 09/VBHN-BYT (2024)).
• Repackager Identification: Labels for repackaged goods must display the name and address of the repackaging unit alongside the original manufacturer (Clause 8, Article 44, Decree 37/2026/NĐ-CP).
• Expiry Date Calculation: Expiry dates for repackaged goods must be calculated from the production date specified on the original manufacturer’s label (Point c, Clause 1, Article 10, Consolidated Document 09/VBHN-BYT (2024)).
• Traceability Management: Enterprises must ensure the identification of individual product units or batches throughout each stage of the supply chain (Clause 20, Article 3, Decree 37/2026/NĐ-CP).

For F&B raw material importers, the critical control point is maintaining the link between the new label and the original technical dossier. Each batch division must include a batch record, defined storage conditions, and clear documentation justifying the expiration date.

QA/QC Protocols for Aligning Labels with Product Declaration Dossiers

Consistency between labeling and product declaration dossiers is the definitive requirement for the legal circulation of food additives. Minor discrepancies regarding product names, concentrations, or origins can trigger recalls, administrative fines, or supply chain disruptions.

Most standard food additives utilize the Product Self-Declaration mechanism. However, blended additives with new functions or those absent from the approved list require the registration of a Product Declaration dossier with the Vietnam Food Administration (VFA), pursuant to Clause 2, Article 11, Consolidated Document 09/VBHN-BYT (2024).

Data Reconciliation: From COA and Specifications to Test Reports

The QA/QC department must treat the label as the nexus connecting legal, technical, and import documentation. Circulating goods must conform to the applicable declared standards and labeling regulations.

Enterprises must perform a 100% reconciliation of critical data fields across the product label, Self-Declaration dossier, Product Declaration, COA, Specification, Test Report, and import documentation:

• Product Name: Must remain consistent across the label, import declaration, and declaration dossier to avoid commercial identification errors.
• Composition: Substance names, additive groups, and INS codes must align with the official Specification and the “List of food additives permitted for use in food.”
• Concentration: Ingredient ratios must match the COA, Specification, and declaration dossier, particularly for blended additives.
• Functionality: Technological functions stated on the label must not exceed those officially declared or permitted for use.
• Manufacturer: Information regarding the manufacturer on original labels, secondary labels, and import dossiers must be uniform.
• Origin: The country or territory of manufacture must correspond across labels, import documents, and batch records.

Note: The COA is the Certificate of Analysis issued by the manufacturer; the Test Report is the result sheet from a testing laboratory; and the Specification is the technical standard used to control parameters before product declaration and label printing.

8 Mandatory Internal Audit Steps Before Product Circulation

Enterprises should implement a standard operating procedure (SOP) to audit internal processes before releasing goods into distribution. This facilitates the early detection of discrepancies between physical labels and declaration dossiers.

• Audit Additive Legality: Compare substance names, INS codes, and functions against the permitted additive list.
• Verify Declaration Dossier: Confirm whether the product falls under Self-Declaration or formal VFA registration.
• Audit Original Label: Review the product name, origin, manufacturer, composition, and expiry date on original packaging.
• Review Vietnamese Secondary Label: Assess translation accuracy, supplementary data, and ensure mandatory original labels remain unobscured.
• Audit Technical Documentation: Compare Specifications, COAs, and Test Reports against the product label.
• Verify Import Documentation: Reconcile customs declarations, invoices, packing lists, and Certificates of Origin.
• Sample Retention: Retain samples of labels, packaging, and products per batch to facilitate post-market surveillance.
• Audit Traceability Records: Ensure batch identification remains intact through production, import, repackaging, storage, and distribution stages.

Effective QA/QC is only achieved when conducted prior to mass printing. Once products enter circulation, any deviation manifests as costly recall expenses, formal explanation requests, and legal liability.

Identifying Commercial Risks and Penalties for Labeling Violations

Labeling non-compliance for food additives is not merely a packaging error. It represents a substantial commercial risk that can result in customs detention, distributor rejection, and the obligation to issue formal explanations to regulatory authorities.

The maximum administrative fine in the food safety sector is 100,000,000 VND for individuals and 200,000,000 VND for organizations, pursuant to Clause 1, Article 3 of Decree 115/2018/NĐ-CP (amended by Decree 124/2021/NĐ-CP). Enterprises must systematically review label discrepancies based on operational risk groups.

Enterprises should prioritize the control of three data pillars: product names, ingredient compositions, and origins. These specific fields are the most frequent causes of punitive sanctions, product recalls, and commercial disputes with distribution partners.

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Transitional Roadmap for Existing Packaging and Quality Documentation

Businesses are not required to immediately discard all existing packaging if the labels were printed or the products were manufactured, imported, or circulated before the transitional deadline. These transitional provisions help optimize inventory costs but do not exempt businesses from complying with the new labeling requirements for subsequent production and imported batches.

Products bearing labels that complied with the previous regulations and were manufactured, imported, or circulated before January 23, 2026, may continue to be marketed until the expiration date stated on the label. Commercial labels and packaging printed before this date may continue to be used for up to two years from January 23, 2026, in accordance with Clauses 3 and 4, Article 98 of Decree No. 37/2026/ND-CP.

• Packaging printed under the previous regulations: Businesses may continue using existing packaging during the transitional period but should maintain an inventory register to ensure it is not used beyond the two-year transitional limit.
• Products labeled in compliance before January 23, 2026: These products may continue to be marketed until the expiration date shown on the label, pursuant to Clause 3, Article 98 of Decree No. 37/2026/ND-CP.
• Completed food additive declaration dossiers: Products may continue to be marketed until their expiration date, provided no food safety warnings arise, in accordance with Clauses 1 and 2, Article 14 of Consolidated Document No. 09/VBHN-BYT (2024).
• Pending cases involving previous violations: Businesses may request the application of the more favorable legal provisions if the new regulations exempt liability or impose lighter penalties, pursuant to Clause 2, Article 4 of Decree No. 124/2021/ND-CP.

Compliance Advisory for Food Additive Labeling at Long Phan Consulting

Ensuring regulatory compliance for food additives requires seamless coordination between legal, QA/QC, R&D, import, and packaging design departments. Long Phan Consulting supports enterprises in mitigating risks arising from product declaration dossiers, original labeling, Vietnamese secondary labels, and batch traceability. Our service methodology emphasizes practical document audits, gap identification, and the proposal of operational-ready remediation strategies to minimize the risks of cargo detention, product recalls, and administrative sanctions.

• Due Diligence: Comprehensive legal audits of food additive labeling prior to printing, import, or market release.
• Gap Analysis: Evaluating the alignment between original labels, Vietnamese secondary labels, COAs, and Specifications to identify discrepancies in naming, composition, concentration, functionality, and origin.
• Regulatory Review: Auditing additive lists and INS codes against current legal standards, particularly for blended or technologically specialized additives.
• Administrative Representation: Managing product self-declaration procedures for imported additives or providing consultation on formal VFA registration dossiers.
• Legal Due Diligence: Assessing import documentation and raw material labeling before contract execution, customs declaration, or distribution.
• Technical Translation: Standardizing specialized food industry terminology for Vietnamese secondary labels to ensure precision.
• Traceability Consultation: Structuring batch management, expiry calculation, and origin identification protocols for repackaging units.
• Defense & Mediation: Representing enterprises in formal explanations and administrative violation procedures before market management or food safety authorities.

For a preliminary evaluation of your labels, product declarations, COAs, Specifications, or import documents, please forward them to our team via Email: info@longphanpmt.com or Zalo/WhatsApp: +84 906 735 386.

Frequently Asked Questions about the Business Guide to Closely Reviewing Food Additive Labeling Regulations

Synchronizing information between self-declared records and actual product labels is a mandatory requirement for businesses to avoid serious legal risks. Any discrepancies in ingredients, quantities, or origin on the packaging can lead to administrative penalties or forced product destruction by authorities. Businesses need to thoroughly understand the current “Regulations on Food Additive Labeling” to ensure transparency, safety, and protect their brand reputation in the eyes of consumers.

Conclusion

Food additive labeling compliance is a critical legal control point that precedes the import, repackaging, distribution, or utilization of ingredients within the F&B supply chain. Enterprises must ensure absolute consistency across original labels, Vietnamese secondary labels, COAs, Specifications, Test Reports, and Product Declaration dossiers. Discrepancies regarding additive names, INS codes, composition, functionality, origin, or expiry dates can lead to customs detention, product recalls, administrative fines, and the loss of distribution rights. For expert review of your documentation and labeling before market circulation, contact the hotline at 1900636389 or reach out to Long Phan Consulting for professional support.