You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

August 8, 2025

New Draft Regulatory Framework for Food Product Declaration and Registration in Vietnam

Subscribe to Updates

In response to persistent challenges in food safety management and recent high-profile incidents involving counterfeit supplemented foods, infant formula, and health supplements, the Ministry of Health of Vietnam is initiating comprehensive regulatory reforms. These reforms include proposed amendments to the Law on Food Safety and its implementing Decree No. 15/2018/ND-CP (Decree 15), introducing significant changes to the registration procedures for food products, especially supplemented food products and health supplements.

While awaiting public consultation and approval of the amended Law on Food Safety, the Ministry of Health is developing an interim mechanism, which includes a draft decree to replace Decree 15 and a draft resolution to address urgent issues until the amended law becomes effective, expected in July 2026.

To align with the new Law on Quality of Products and Goods, the draft resolution stipulates that the declaration and registration of food products will follow the following procedures:

  • Declaration of applied standards for food products, which is currently known as the “self-declaration” procedure, applies to processed packaged foods, food additives, food processing aids, containers or utensils that come into direct contact with food, packaging materials in direct contact with food, and micronutrients.
  • Granting of circulation numbers, which is the current “registration of product declaration” procedure, applies to specific categories of food including health supplements, medical nutrition foods, special dietary foods, nutritional products for children up to 36 months, and, especially, supplemented foods, which are currently subject to self-declaration but will be shifted to this registration procedure.

In addition, the following new procedure is introduced in the draft decree:

  • Registration of declaration of conformity, which applies to the same product category as in “declaration of applied standards” above, but is for products that are already subject to technical regulations covering both safety indicators and quality indicators.

Changes to the Food Product Declaration and Registration Procedures

Details of the procedures for declaration of applied standards and granting of circulation numbers are stipulated in the draft resolution, while details of the procedure for registration of declaration of conformity are stipulated in the draft decree. These procedures will see some key changes compared to the current regulations, as highlighted below:

  • Letter of authorization: A letter of authorization (LOA) from the manufacturer or product owner to the entity conducting the declaration of applied standard or registration is a new requirement applicable to both procedures. Information that must be included in the LOA is detailed in the draft resolution.
  • Quality criteria: It is newly required to test quality criteria in a Certificate of Analysis (COA), in addition to safety criteria, for both procedures. The COA will need to follow the format set out in the draft resolution.
  • Declaration of conformity with internal standards: In addition to the declaration of compliance with food safety requirements, both product declaration and registration procedures have a new requirement that the declaring or registering entity must confirm that the product complies with its internal standards. This conformity is substantiated by submitting the in-house specification along with a dossier detailing the development of the specification.
  • Timeline for declaration of applied standards: The draft resolution introduces a defined principal evaluation timeline of 21 days from the date of submission—an element not specified under current regulations. It also clarifies that entities may begin manufacturing and trading declared products once the declaration, including the entity name and product name, is published on the authority’s official website.
  • Required documents: The required documents applicable to products subject to the registration of product declaration procedure are much more stringent than in current practice. The registration dossier will cover two parts: (i) administrative and (ii) technical. More technical documents will be required for the technical part, such as a manufacturer’s certificate (GMP, HACCP, etc.), report on product research and development process, documentation on quality and safety standards, documentation of manufacturing process, long-term stability report, and other technical explanation (if necessary).
  • Timeline for registration of product declaration: The estimated principal approval timeline is specifically set as 90 days from the date of submission. Compared to the current regulation, the timeline for submitting a supplemental dossier will be reduced from 90 working days to 60 working days from the date of receiving an official notice of deficiency. Notably, instead of an unlimited number of revisions, the draft resolution only permits a one-time revision.
  • Exclusion of certain products from the registration of product declaration procedure: Certain food additives—including blended food additives with new functions, those not on the Ministry of Health’s permitted list, or those used for incorrect purposes—are no longer subject to the registration of product declaration procedure under the draft resolution. Neither the draft resolution nor the draft decree specify how these products should be registered, suggesting that future regulations on food additive management may address this gap.

Suspension of Product Declaration Registration

The draft resolution introduces a new provision allowing competent authorities to temporarily suspend the receipt and processing of product declaration dossiers from entities who have violated food safety regulations. Processing will resume once the violations are fully remedied and a compliance report is submitted.

Transitional Provision

Under the draft decree, for food products that are registered or self-declared before the effective date of the decree, product owners must complete the procedures for re-registering or re-declaring product standards in accordance with the draft resolution (after it is enacted), within the following timeframes:

  • 18 months from the effective date of the decree for products that already have a Certificate of Receipt for Product Declaration.
  • 6 months from the effective date of the decree for products that are self-declared.

After these deadlines, any previous product declaration documents or certificates will no longer be valid for production or importation. However, products with a certificate that were produced within 18 months of the decree’s effective date and products that were self-declared and produced within 6 months of the decree’s effective date may continue to be circulated until their expiration date, and the product owner remains fully responsible for those products.

The draft decree does not specify a transitional period for the supplemented food products that will be shifted from the self-declaration procedure to the registration of product declaration procedure.

The draft resolution and draft decree will be discussed and approved under the fast-track procedure. However, no expected effective date has been provided. It remains possible that further revisions to the draft decree may be introduced.

Impact for Businesses and Next Steps

Businesses will be required to prepare additional documentation for declaration and registration processes to comply with the new regulations once they are enacted. Stricter documentation will be required for products subject to registration of declaration procedure, especially for supplemented foods, which are shifted from self-declaration procedure to registration of product declaration procedure.

Businesses should review their product portfolios to determine applicable registration pathways, develop plans to update the declaration and registration dossiers, and monitor for further amendment, official issuance, and implementation guidance.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

December 9, 2024
Cambodia’s Law on Seed Management and Plant Breeder’s Rights was enacted in 2008, but it was not until recently that new plant varieties could successfully be registered for protection in the country. Although the law has been in place for some time, recent developments confirmed the application process and a schedule of charges for the registration of new plant varieties. With these developments, breeders have been able to register their new plant varieties in Cambodia since March 1, 2024. Applicants for new plant variety protection must be Cambodian nationals, foreign nationals domiciled in Cambodia, or permanent residents of either a country that is a contracting party to the International Union for the Protection of New Varieties of Plants (UPOV) Convention or a country with which Cambodia has signed a memorandum of understanding on plant variety protection. Applicants can also claim a priority date from the first application for the same plant variety filed in any contracting party of the UPOV Convention within 12 months of the earliest application’s filing date. To be eligible for protection, new plant varieties must satisfy the following criteria: Novelty: A variety is considered “new” if, at the date of filing the application for new plant variety protection, it has not been sold, marketed, or otherwise disposed of others—by or with the consent of the breeder—for more than: One year for any plant variety in Cambodia; Six years for trees and vines or four years for all other plant varieties in countries besides Cambodia. Distinctiveness: A variety must be clearly distinguishable from any other existing varieties. Uniformity: A variety must be sufficiently uniform in its relevant characteristics. Stability: A variety must remain unchanged in its essential characteristics at the end of each cycle of propagation and in each generation. The last three criteria are often
Read More
December 4, 2024
On October 28, 2024, Indonesia officially amended its existing Patent Law when the president ratified Law Number 65 of 2024. This comprehensive update—the third such amendment in the history of Indonesia’s Patent Law—introduces several key changes that will significantly impact patent protection and application processes in Indonesia. Key highlights and changes are outlined below. Definition of Invention The new law broadens the definition of “invention” to explicitly include systems, methods, and uses. Additionally, the law introduces formal definitions for traditional knowledge and genetic resources. Patentability Criteria Notable changes include: Computer programs are now excluded, with an exception for computer-implemented inventions. Theories and methods in science and mathematics are added to the list of excluded inventions. Previous restrictions on new uses of existing products are removed. Grace Periods The grace periods for some patent-related actions have been adjusted: The grace period for disclosures has been extended to 12 months (from 6 months previously), providing inventors with more flexibility in filing patent applications after initial disclosure. A newly introduced item is the grace period for a conventional patent application claiming priority rights, which is 4 months after the 12-month filing deadline under the Paris Convention. The grace period for annuity payments is 6 months (from 12 months previously) with a fine for late payments of 100% of the annual fee payable. Patent Holder Rights and Obligations Patent holders can now grant permissions to enforce patents. There is a new requirement for patent holders to submit annual statements on patent implementation in Indonesia. Compulsory Licensing Significant changes to compulsory licensing include: Establishment of licenses based on the principle of expediency. Limitations on license scope and transferability. Prioritization of domestic market needs. New provisions for technical improvements and economic significance. Government Patent Exploitation The new law contains specific provisions for the government’s implementation
Read More
December 4, 2024
Thailand Legal Basics, a valuable primer for foreign investors, explores all aspects of living and doing business in Thailand. Written by specialists at Tilleke & Gibbins in Bangkok, it is the only comprehensive English-language guide to the Thai legal system with a focus on the concerns of foreign business and investment.
Read More
December 2, 2024
Kratom (Mitragyna speciosa) was once listed as a prohibited substance under the Narcotics Act. Kratom was then removed from the narcotics list in 2021 and is now regulated under the Kratom Plant Act B.E. 2565 (2022), which allows the trading, use, import, and export of kratom. Furthermore, the Ministry of Public Health has allowed the use of kratom in food and drink, food supplements, and herbal products. Anyone who wishes to launch kratom food or herbal products must first obtain a product license from the Thai Food and Drug Administration (FDA). On September 4, 2024, the Thai FDA announced guidelines specifically for powdered kratom leaves and kratom leaf extracts (using water or ethanol as solvents) as ingredients in food supplements. These guidelines aim to provide business operators with a clear framework for launching kratom-based food products in Thailand. Key points from these guidelines include: Raw material specifications and standards: Powdered kratom leaves and kratom leaf extracts must contain at least the prescribed amount of mitragynine (one of the primary active compounds in kratom) as a marker of quality. For example, mitragynine must account for at least 1% by mass for powdered kratom leaves. Food supplement specification and standards: Food supplements containing powdered kratom leaves or kratom leaf extracts must not have a dosage of over 0.2 mg/day of mitragynine (including 7-hydroxymitraglynine, which may occur naturally), or 1 mg/day for food supplements containing kratom extracts that use water as a solvent. Addition of 7-hydroxymitraglynine to food supplements is prohibited. Mitragynine content in food supplement products must not exceed the specified dosage limit. Additionally, the food supplement product must be in a ready-to-eat form (e.g., liquid, gel, tablet, or capsule). If powdered kratom leaves or kratom leaf extracts are to be used as ingredients in food categories other than food supplements,
Read More