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On June 30 and July 1, 2025, Vietnam notified the World Trade Organization (WTO) of a new draft decree to amend Decree No. 15/2018/ND-CP, which implements the country's Law on Food Safety. This latest draft introduces substantial revisions to product declaration registration, state inspection requirements, and post-marketing surveillance rules.
Compared to previous drafts circulated in February and March 2025, this version focuses on different requirements for product declaration and inspection, while other proposals remain largely unchanged. Interested parties have 20 days from the notification's publication date to submit comments.
Key Content
The following sections summarize the key changes proposed in the new draft regarding product declaration and product inspection compared to the current regulations.
1. Revisions to Self-Declaration Requirements
1.1 Applicant Definition
The responsibility for product self-declaration is shifting. Currently, the "organization or individual producing or trading food" is responsible. The new draft broadens this to "Organizations and individuals responsible for placing products on the market", which includes:
The manufacturer or the product owner; OR
The organization or individual authorized by the manufacturer or the product owner to be applicant of self-declaration
1.2 Products subject to self-declaration mode
The draft adds micronutrients to the list of products requiring self-declaration. The complete list is as below:
No. | Applicable food products |
1 | Prepackaged processed foods |
2 | Food additives; food processing aids |
3 | Containers in direct contact with food; primary packaging materials |
4 | [New] Micronutrients |
Notes | This excludes products specified in Clause 2 of Article 4 and Article 6 of this Decree |
1.3 Required dossiers
The required documents for self-declaration have been updated. The "certificate of food safety testing results" is now termed "Product CoA (Certificate of Analysis)". Additionally, a power of attorney is now required if an authorized party is submitting the declaration.
No. | Required dossiers | Notes (if any) |
1 | The self-declaration form (Form No. 01 in Appendix I of Decree No. 15/2018) | / |
2 | [Updated] Product CoA (certificate of Analysis)
[Previously called the certificate of food safety testing results of the product] | At the time of self-declaration, CoA is issued within 12 months by an accredited laboratory in conformity with ISO/IEC 17025 and shall include quality criteria and safety criteria (a copy affixed with the organization/ individual seal, or certified electronic copy) |
3 | [New] A power of attorney issued by the manufacturer or the owner of the food product for the applicant of the product self-declaration | It should contain all of the information specified in Article 8a of this Decree (in case of authorization) (a copy affixed with the organization/individual seal; or certified electronic copies) |
[Updated] When preparing the dossiers, English documents are exempt from authenticated translation. Enterprises may self-translate but are responsible for accuracy. Other languages must be translated into Vietnamese and authenticated with the translator's signature. For multilingual labels (but not in English), only the country of origin/export language must be translated. Documents must be valid at submission.
1.4 Application procedure
The applicant must post the self-declaration through mass media, on their website, or at their premises and submit one copy to the provincial regulatory authority. [New] The competent authority has 21 days to review the dossier. If there is no written objection within that time, the authority will post the dossier on its website, and the organization can begin production and trade.
[New] However, if an imported food product is already licensed by a Stringent Regulatory Authority (SRA), the company may begin trading immediately after submitting the self-declaration, and the competent authority will post the dossier online within 10 days. The applicant bears full responsibility for the legality of the dossier and the safety of the product.
2. Revisions to Product Declaration Registration Requirements
2.1 Applicant Definition
Similar to the self-declaration process, the applicant for product declaration registration is defined as the "Organizations and individuals responsible for placing products on the market", which can be the manufacturer, product owner, or an authorized party.
2.2 Foods subject to product deceleration registration
The new draft now includes "supplemented food" within the scope of registration and removes "novel food additive". The affected products are as below:
No. | Applicable food products |
1 | Health supplement, medical nutrition foods, and foods for special dietary uses, [New] supplemented foods |
2 | Nutritional products for children up to 36 months |
3 | [Deleted] Novel food additives |
Notes | Except for foods stipulated in Clause 2, Article 6 of this Decree |
2.3 Required dossiers
Compared to the current effective version of Decree 15/2018 and the previous two drafts thereof, this new Draft proposes quite different management measures, namely, affected products shall first prepare the dossiers for general cases in Table 1 and then prepare the additional dossiers for different food categories in Table 2. The language requirement of dossiers goes align with the proposal for self-declared products.
Required dossiers for different cases are summarized as below.
Table 1: Registration dossier of Product Declaration for imported food products
No. | Required dossiers | Notes (if any) |
1 | Declaration form (Form No. 02 in Appendix I of Decree No. 15/2018) | |
2 | Certificate of Free Sale or Certificate of Exportation or Health Certificate [New] or other relevant certificates for exported food issued by a competent authority of the country of origin or exporting country as prescribed in Clause 3 of this Article
| [Updated] Consular legalization or electronic copy enclosed with the results of self-search from the website or English database of the issuing authority or competent authority and stamped with the applicant’s seal
[New] These certificates must contain at least the following information:
|
3 | [Updated] CoA including quality and safety criteria
[Previously called the “Certificate of food safety testing results of the product”] | [Updated] At the submission time, CoA is issued within 12 months (copy affixed with the applicant’s seal and the original copy to be presented for comparison when submitting or receiving the result of administrative procedures; or a certified electronic copy) by:
|
4 | [Updated] Scientific evidence supporting the contents related to the intended use and dosage or documents evaluated and published by domestic and foreign competent authorities proving the intended use and effect of the product or of the ingredients constituting the declared intended use (a copy affixed with applicant’s seal) | When using scientific evidence on the use of ingredients of the product to make uses of the product, the daily dose of the product must be higher than or equal to 15% of the amount of use of such ingredient stated in the document.
[Updated] Scientific evidence means scientific information, scientific data and scientific documents that support the claims on intended use and effect on health of a product or its components from scientific research works published in national journals, internationally, prestigious journals ISI (Institute of Scientific Information), SCOPUS; or documents on traditional medicine, medicinal plants, herbal medicine, medical, pharmaceutical and food literature published in scientific publications. |
5 | [New] The power of attorney, issued the manufacturer or the owner of the food product for registration of the Product Declaration (a copy affixed with applicant’s seal and the original copy will be provided for comparison when submitting or receiving results of administrative procedures; or certified electronic copies) |
|
[Updated] Table 2: Registration dossier of Product Declaration for different food categories
| No. | Product category | Dossiers for health supplement |
1 | Health supplement |
Detailed instructions for the above documents and the dossier are specified in Form No. 15; Appendix I of this Decree. |
2 | Medical nutritional foods, foods used for special diets, supplemented food, and nutritional products for children up to 36 months of age |
Detailed instructions for the above documents and the dossier are specified in Form No. 16, Appendix I of this Decree. |
2.4 Application procedure
[Updated] Applicants shall submit registration dossiers of product declarations via the online public service system or postal services or directly to the competent authority as prescribed below:
Submit to the Ministry of Health for Health Supplement.
Submit to competent state management agencies designated by provincial level People's Committees for medical nutritional foods, foods used for special diets, supplemented food and nutritional products for children up to 36 months of age.
Within 90 days from the date of receiving a complete registration dossier of product declaration, the competent authority shall appraise the dossier and issue a receipt of product declaration registration according to Form No. 03, Appendix I of this Decree.
3. Revision to State Inspection of Imported Foods
The draft proposes removing the exemption from state inspection for products that have a "certificate of registered product declaration". It also updates the name of the "Ministry of Agriculture and Rural Development" to the "Ministry of Agriculture and Environment".
In addition, inspection measures and frequency for the current three inspection methods are revised as summarized in the table below. The application for inspection and inspection procedures thereof are revised accordingly.
No. | Inspection method | Current inspection measures | Proposed inspection measures |
1 | Reduced inspection |
|
|
2 | Normal inspection | Document inspection only | Examination of dossiers and taking representative samples to check the appearance, labeling, packaging status, and special storage conditions (if any) |
3 | Tightened inspection | Both document inspection and sampling | Examine the dossier and take sufficient or all samples for needed testing (with 3 detailed situations) |
4. New Post-inspection Requirements
The draft introduces two new articles establishing post-marketing surveillance: "Article 41a. Planned post-marketing inspection" and "Article 41b. Unexpected post-marketing inspection". Vietnam will develop annual inspection plans based on risk levels.
Inspection Frequency:
Once a year: For medical nutritional foods, foods for special diets, nutritional products for children under 36 months, and supplemented foods.
At least once every three years: For Health Supplements.
Inspection Items:
Inspect the conformity of products with technical regulations, declared standards, goods labels and the enclosed documents;
Inspect the traceability of products as prescribed by regulations;
Inspect other contents related to product quality and safety;
During the inspection, if the product shows signs of failure to ensure quality and safety, take samples as prescribed by regulations;
For food products traded in e-commerce, besides the inspection as prescribed at the previous four points, the consistency of information on websites versus the ones on actual products shall be inspected.
For situations specified by Article 41b (e.g., when food safety incidents occur), an irregular post-marketing inspection shall be conducted.
Transitional Provisions
For product declaration registrations submitted or granted before the new decree takes effect, organizations have 18 months to amend their dossiers to comply with the new rules. After this period, non-compliant registrations will become invalid, though products manufactured during this 18-month window can be circulated until their shelf life ends.
For products self-declared before the effective date, organizations have 6 months to update their dossiers. After this deadline, non-compliant self-declarations will no longer be valid for production or import.
For further translation, registration, or consulting service, please email [email protected].
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