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As revealed by an official notice issued on February 19, 2025, Vietnam’s Ministry of Health is consulting on a draft amendment to Decree No. 15/2018/ND-CP: Detailing the Implementation of a Number of Articles of the Law on Food Safety.
Key revisions are summarized below. Please send any feedback to [email protected] or submit it via the MOH page before February 28, 2025.
1. Revisions Concerning Product Declarations
The draft proposes significant changes to product declaration requirements for foods. Currently, food enterprises must complete product declarations before placing their goods on the market. There are two primary declaration modes based on product type: self-declaration and product declaration registration.
The draft mainly revises the following aspects of the product declaration requirements:
1) The Vietnamese company responsible for the products on the market applying for product declarations for imported foods must obtain an authorization letter from overseas stakeholder.
The draft strengthens control over food enterprises applying for product declarations and emphasizes their responsibilities for their products. The applicant must obtain a letter of authorization from the oversea product owner or manufacturer to take full responsibility for the food on the market. The authorization letter will be required as part of the product declaration dossier.
2) Applicable product scope for the two declaration modes are revised.
Changes to the product scope are compared in the table below. Proposed revisions are marked in red compared to the current regulations:
Self-declaration mode: Now includes prepackaged unprocessed foods and food ingredients.
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 |
|
3) Dossiers for the two declaration modes are subject to stricter requirements, and more documentation is required to ensure food safety.
The draft introduces the following key changes regarding declaration dossiers:
English documents are exempt from notarized translation. Documents in other languages must be translated into Vietnamese and notarized.
More materials are required, and some materials now have higher standards. For example, both declaration modes require the submission of product specifications (SPEC). For registration declarations, a legalized Free Sale Certificate/Health Certificate or Certificate of Exportation or other relevant Exporting Documents from the exporting/origin country must contain specific mandatory contents. Explanations for certain certificates can be found in the table below.
The draft revises requirements for test results under product registration declaration mode, eliminating the need for facilities that meet Good Manufacturing Practices (GMP) to send samples for testing at designated laboratories, reducing costs.
The changes to dossiers required in two modes are as follows.
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 | The original copy or certified true copy of the food safety data sheet, issued by a designated laboratory or a laboratory complying with ISO 17025 within 12 months before the self-declaration is made | |
3 | [New] Authorization from the manufacturing facility or product owner (if applicable) | Refer to Form No. 16 in the Appendix issued with this Decree |
4 | [New] Product label sample (a copy verified/certified by the organization/individual) | |
5 | [New] Product specifications (SPEC) | Including testing methods for safety and quality criteria of the product, issued by the manufacturing facility; original or a copy certified by the organization/individual |
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) | |
2 | A legalized Certificate of Free Sale/Certificate of Exportation/Health Certificate issued by the authority of the exporting country | |
3 | Certificate of Free Sale or Certificate of Exportation or Health Certificate or other relevant exporting document issued by the competent authority of the country of origin/export as prescribed in Clause 3 of this Article | When preparing the legalized certificate issued by the competent authority in the exporting country, the certificate must have at least the following mandatory contents:
|
4 | Food safety test results of the product within 12 months from the date of submission of the application from a designated testing laboratory or a testing laboratory accredited to ISO 17025 or a manufacturing facility that meets Good Manufacturing Practices (GMP) or includes safety indicators issued by the Ministry of Health according to the risk management principles in accordance with international regulations or safety indicators according to corresponding regulations and standards announced by organizations and individuals in cases where there are no regulations of the Ministry of Health | The test results must have a conclusion on meeting the safety indicators (original or certified copy) |
5 | Scientific evidence proving the effectiveness of the product or the ingredients that create the declared effectiveness (original or certified copy by the organization or individual). When using scientific evidence of the ingredients that create the effectiveness of the product, the daily dose of the product or the ingredients that create the effectiveness of the product must be at least 15% greater than or equal to the amount of use of that ingredient stated in the document | Scientific evidence proving the effectiveness used based on citations of scientific evidence to demonstrate the effectiveness of the product or the ingredients that contribute to the product's efficacy in the product declaration dossier (which includes content related to research conclusions proving effectiveness, target users, recommended dosage, precautions, warnings regarding the ingredients contributing to the product's efficacy, and the reliability of the research). |
6 | Certificate of food safety facility meeting Good Manufacturing Practice (GMP) requirements or equivalent certificate in case the imported product is a health protection food (copy certified by the organization or individual) | |
7 | [New] Authorization letter from the manufacturing facility or product owner (if any) | Refer to form No. 16 of the Appendix issued with this Decree |
8 | Product label sample (copy certified by the organization or individual) | |
9 | [New] Product specifications (SPEC) | Including testing methods for safety indicators and quality indicators of the product of the manufacturing facility; comply with Good Manufacturing Practice (GMP) requirements for health supplement product declaration registration dossiers, or comply with Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000 Food Safety Management System, International Food Standards (IFS), Global Food Safety Standards (BRC), Food Safety System Certification (FSSC 22000) that is still valid for medical nutritional foods, foods for special diets, nutritional products for children up to 36 months old (original or certified copy by the organization or individual) |
10 | [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 according to biomedical research related to humans according to regulations of the Ministry of Health. | Functional foods introduced into circulation on the market for the first time are functional foods containing a new ingredient that contributes to their efficacy or an ingredient being used as food in Vietnam for the first time; foods with a novel combination of ingredients that create product efficacy, which have already been circulated or previously used as food in Vietnam.
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4) Enterprises are subject to more specific responsibilities.
Product Information File (PIF) is required for all products before being placed on the market.
The draft introduces a new requirement stating that organizations and individuals responsible for bringing products to market must, before market introduction, maintain a Product Information File (PIF) at the facility. This file must be available for post-inspection and presented to competent authorities upon request.
Clearly introducing changes that need new declaration/registration of declaration
Organizations or individuals must re-declare the product in case of changes to the party responsible for bringing the product to market, changes in the manufacturing facility; product origin; ingredients; concentration or content of product ingredients, 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 noncompliant cases that may lead to the withdrawal of product declaration/registration
To strengthen post-registration supervision, the draft introduces provisions for revoking product declaration registration certificates in non-compliant cases, as outlined in Article 8a, and halting application reception as per Article 8b. For instance, the authority will revoke the registration certificate if two product batches are recalled due to poor quality within 36 months. The registration process will be halted if the applicant is found to be producing or trading smuggled, counterfeit, or unregistered products.
5) Adding new verification for self-declaration process
The draft introduces a review process for self-declared product dossiers three months after the self-declaration is made. This process includes checking product classification, functions, intended users, and ingredients to ensure accurate and compliant self-declarations. It aims to address cases where businesses misclassify products or exaggerate their benefits. For example, some companies self-declare products as supplemented foods when their ingredients actually classify them as health-protecting foods, which requires registration of declaration.
2. Revisions Regarding Definition of Functional Foods
The following definitions regarding functional foods are to be revised:
Health supplements/Dietary supplements are proposed to include fungi as a natural source, and these products can now be in powdered form.
Table 4 Comparison of the definition of health supplement
Definition in the current regulation | Definition proposed in this draft |
Substances of natural origin, including animals, minerals and plants in the form of extracts, isolations, concentrates and transformations; | Substances of natural origin, including animals, minerals, plants and fungi meeting food standards in the form of powders, extracts, isolations, concentrates and transformations; |
Supplemented foods will be subject to restricted claims. The draft proposes that no health claims or efficacy statements related to the supplemented components are allowed. These foods are intended to supplement daily dietary intake and can only declare the supplemented components. The purpose of this is to distinguish supplemented foods (basic fortified foods) from health supplements.
3. Revisions Regarding Advertising Content Confirmation
The draft deletes 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 a video file (mp4 format) and an audio file (mp3 format). For advertisements on other media, a mockup (content sample) of the proposed advertisement, certified by the organization or individual, must be submitted.
Moreover, the draft introduces a provision allowing the revocation of the advertising content confirmation certificate, for instance, when the product’s Certificate of Registration for Product Declaration is revoked.
4. Other Revisions
In addition to the above content, the draft updates the following appendixes:
Status | Corresponding appendixes |
Revision | Form 01 Product self-declaration copy Form 02 Product declaration registration copy Form 10 Application for confirmation of advertising content Form 11 Certificate of advertising content |
Addition | Form 15 Product Information File (PIF) Form 16 Power of attorney Form 17-24 regarding testing |
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.
For dossiers that were granted or posted on the receiving management agency’s electronic information page prior to the effective date, the manufacturing facility must update the dossier to meet the new provisions within two years, unless the organization voluntarily complies.
If the dossier fails to meet the new provisions and falls under revocation conditions as specified in the Decree, the competent authority will revoke relevant certificates (product declaration registration, advertising content confirmation, and GMP facility certificates) and remove the product information from the electronic page.
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 significantly impacted by the new declaration registration requirements. For instance, the legalized 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 and health supplement ingredient sources. Additionally, facilities that meet Good Manufacturing Practices (GMP) will no longer need to send samples to designated laboratories for testing, reducing costs. Lastly, Vietnam’s restricted claims for supplemented foods will help standardize the functional food industry.
For further translation, registration, or consulting service, please email [email protected].
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