Request a Demo
On March 31, 2025, Vietnam’s Ministry of Health issued a draft amendment to Decree No. 15/2018/ND-CP: Detailing the Implementation of a Number of Articles of the Law on Food Safety. This follows the previous draft released on February 19, 2025, marking further progress in the regulatory update process.
Major revisions in this draft are summarized below. Noteworthy changes compared to the February draft are highlighted in red. Stakeholders may submit feedback to [email protected] or via the MOH page before May 24, 2025.
Key Revisions Compared to the Current Effective Version
1. Revisions to Product Declaration Requirements
Under current regulations, food businesses must complete product declarations before marketing their goods. The two declaration modes—self-declaration and product declaration registration—are determined by product type.
The draft focuses on amendments to product declaration requirements, primarily revising:
The applicant scope,
The product scope subject to declaration, and
The required dossiers for declaration.
Below is a summary of the key changes:
1.1 Clarification of Responsible Parties for Declarations
Currently, it is the “organization or individual producing or trading food” must complete the product declaration for foods. Now, the draft revises the applicant scope into:
The manufacturer or the product owner; OR
The organization or individual authorized by the manufacturer or the product owner (hereinafter "agent" or "third party")
If a third party submits the declaration, their name must be signed on the document, and they assume responsibility for the product in the Vietnamese market. Additionally, Vietnam requires such third parties to provide an authorization letter, which should meet the following requirements:
Language: Vietnamese, English, or bilingual (Vietnamese and English).
Mandatory details for authorization letter:
Name and address of the manufacturing facility; if the authorizing party is the product owner, then both the name and address of the product owner and the manufacturing facility must be clearly stated. The product owner is the entity listed on the Certificate of Free Sale, Certificate of Exportation, Health Certificate, or any other relevant certificate.
Name and address of the authorized third party.
Scope of authorization (e.g., responsibility for declaration and product compliance in Vietnam).
Brand/product name covered by the authorization.
Duration of authorization.
Name, title, and signature of the representative of the authorizing party.
1.2 Revised Product Scope for Two Declaration Modes
The draft adjusts the products subject to each declaration mode (see Table 1 below):
Self-declaration mode: Now includes micronutrients. Food flavorings are explicitly separated from food additives for regulatory clarity.
Product declaration registration mode: Novel food additives are removed from the product scope, as Vietnam automatically adopts international standards such as the CODEX standards for food additives, resulting in minimal applications from enterprises in practice.
Table 1 Product scope under the supervision of two product declaration modes
Declaration modes | Applicable food products |
Self-declaration mode
|
Notes: Except for products specified in Clause 2 of this Article and Article 6 of this Decree |
Product declaration registration for imported foods |
|
1.3 Stricter Dossiers Requirements
The draft introduces the following key changes regarding declaration dossiers:
English documents are exempt from notarized translation. Enterprises may self-translate but are responsible for accuracy. Other languages must be translated into Vietnamese and notarized. [NEW] For multilingual labels, only the country of origin/export language must be translated. Documents must be valid at submission.
[New] In the case where the legal documents provided are in electronic form (lacking signatures, the name of the signatory, or the seal of the competent issuing authority), the organization or individual must submit self-retrieved copies of these legal documents from the electronic portal or English-language database of the issuing authority (or the competent authority of the issuing country), bearing the institution's confirmation seal. A document specifying the retrieval path must also be provided to the receiving authority. The organization or individual assumes full legal responsibility for the authenticity, accuracy, and compliance of these documents, the submitted information, and the self-retrieval process.
The changes to dossiers required in two modes are as follows (Table 2 & 3).
Table 2 Dossiers required for self-declaration
No. | Required dossiers | Notes (if any) |
1 | The self-declaration form (Form No. 01 in Appendix I of Decree No. 15/2018) | |
2 | Certificate of food safety testing results of the product, within 12 months from the date of application submission, issued by a designated testing laboratory or a testing laboratory recognized in accordance with ISO 17025 (original or certified copy) | [New] The certificate should include
|
3 | [New] Authorization letter for self-declaration of product by the manufacturer or product owner (if any) (original) |
Table 3: Dossiers required for product declaration registration for imported foods
No. | Required dossiers | Notes (if any) |
1 | Declaration form (Form No. 02 in Appendix I of Decree No. 15/2018) (Original) | |
2 | Certificate of Free Sale or Certificate of Exportation or Health Certificate or other relevant certificates for exported food issued by the competent authority of the country of origin/export as prescribed in Clause 3 of this Article | [New] The certificate must have at least the following mandatory contents:
|
3 | Certificate of food safety testing results of the product within 12 months from the date of application submission from a designated testing laboratory or a testing laboratory accredited in accordance with ISO 17025 or a manufacturing facility that meets Good Manufacturing Practices (GMP) and has the capacity to test the indicators of the manufacturer's own products (original or certified copy) | The certificate should include
|
4 | Scientific evidence proving the effectiveness of the product or of the ingredients that create the announced effectiveness (original or certified copy by the organization or individual)
When using scientific evidence of the active ingredients of the product, the daily dose of the product or active ingredient must be at least 15% or greater than the amount of that ingredient stated in the document. | Scientific evidence of efficacy is based on citing existing scientific evidence that demonstrates the effectiveness of the product or the components responsible for its efficacy, as presented in the submission dossier. This includes details such as study results supporting the efficacy, the target user groups and dosage, as well as any precautions or warnings regarding the effective ingredients or the product itself, along with the reliability of the research.
Scientific evidence refers to the scientific information and documentation that validate the claimed health effects of a product or its components. This evidence may come from research studies approved and accepted by the state authority competent in scientific research or from publications in reputable national, international, or ISI-indexed journals, as well as from documents on traditional medicine, medicinal plants, traditional remedies, and medical, pharmaceutical, or food-related literature that have been published in scientific outlets. |
5 | Certificate of food safety qualified facility meeting Good Manufacturing Practice (GMP) requirements or certificate equivalent to Certificate of food safety qualified facility meeting GMP requirements for imported health protection foods (copy certified by the organization or individual) | |
6 | [New] Authorization letter to register the product declaration from the manufacturer or goods owner with full contents specified in Article 8a of this Decree (if any) | |
7 | [New] Report on effectiveness testing on uses if the case is a functional food that is first introduced to the market
Testing on effectiveness on human health must be conducted regarding biomedical research related to humans according to regulations of the Ministry of Health. | [New] Functional foods introduced into the market for the first time are
|
1.4 Enhanced Enterprise Responsibilities
[New] Enterprises shall keep records properly.
For enterprises under the declaration registration mode, they must retain records in accordance with provisions outlined in the Food Safety Law (point g, clause 2 of Article 7 and point e, clause 1 of Article 19). Additionally, they must comply with applicable regulations such as Good Manufacturing Practices (GMP) for health-protecting foods, the Hazard Analysis and Critical Control Points (HACCP) system, Food Safety Management System (ISO 22000), International Food Standard (IFS), Global Food Safety Initiative (BRC), Food Safety System Certification (FSSC 22000), or equivalent standards if applicable and certified. These records must be kept for inspection, verification, and submission upon request by the competent authorities.
Clearly introducing changes that need re-registration
Organizations or individuals must re-register the product in case of changes to the party responsible for bringing the product to market; product origin; ingredient composition, intended function and target users, dosage, the amount of active ingredient, etc. In other cases where the change does not affect food safety control, the organization or individual must notify the competent state management agency in writing. Production and trade can continue immediately after submitting the notification.
Introducing cases that may lead to the invalidation of declarations
To strengthen post-registration supervision, the draft introduces provisions for revoking product declaration certificates in non-compliant cases, as outlined in Article 8b, and halting application reception as per Article 8c. For instance, the authority will revoke the certificate if the declaration is made based on fake documents.
2. Revisions Regarding Advertising Content Confirmation
In addition to requirements for product declaration, the draft deletes (by annulling relevant provisions) two required application materials for advertising content confirmation, as the authority responsible for approving product declarations will also approve advertising content. The two deleted materials are:
Certificate of product declaration registration and product declaration.
Product label sample (copy certified by organization or individual).
For advertisements using images and sounds, a proposed advertising script (certified by the organization or individual) is required, along with the proposed advertising content recorded in the video and audio file. For advertisements on other media, a mockup (content sample) of the proposed advertisement, certified by the organization or individual, must be submitted.
When applying for the advertising confirmation registration, an authorization letter is required as well for agents. For advertising content other than the product's uses and features stated in the product declaration, there must be scientific documents to prove it (certified copies by the organization or individual).
Transitional Provisions
Declaration dossiers submitted before the effective date of this Decree will continue to be processed according to the provisions in place at the time of submission, unless organizations and individuals voluntarily comply with the new provisions.
Products manufactured or imported according to the declaration dossier before the effective date of this Decree but the dossier does not meet the provisions of this Decree shall continue to be circulated until the expiry date of the product.
Impact on Enterprises
The Ministry of Health had initially planned to require all food products to undergo product declaration registration, as proposed in the draft raised on August 15, 2024. The new draft is a positive development for most prepackaged foods, as they can still use the self-declaration mode, despite stricter dossier and post-registration supervision requirements.
Functional foods will be greatly impacted by the new declaration registration requirements. For instance, the needed certificate must include specific mandatory information. The draft also optimizes some requirements, such as expanding the possibility of using other exporting certificates where CFS/HC/EC are not possible, as well as the sources of scientific evidence. For functional food that is first introduced to the market, a report on effectiveness testing on uses is required.
For further translation, registration, or consulting service, please email [email protected].
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
