Differences between product self-declaration and registration of the product declaration according to the law in Vietnam

Pre-packaged processed foods, food additives, food processing aids, food containers, primary packages of foods.

Except for following cases:

Products that are subject to registration of the product declaration

Products, raw materials that are manufactured or imported for production or processing of exports or internal production and are not sold domestically

- Dietary supplements, medical foods, food for special dietary uses.

- Dietary products for children up to 36 months.

- Mixed food additives with new uses, food additives that are not on the list of permitted food additives or not used for intended foods as prescribed by the Ministry of Health

- The self-declaration form (Form No. 01 in Appendix I of this Decree);

- Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available).

1. An application for regulations of the declaration of imported products consists of:

a) The declaration form (Form No. 02 in Appendix I hereof);

b) The Certificate of Free Sale, Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/exporting country, which assures safety of users or permit free sale of the products in the country of origin/exporting country (the certificate must be consularly legalized);

c) Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available)

d) Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of effects of the ingredients is used, the daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document;

dd) The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate if the imports are dietary supplements, applicable from July 01, 2019 (a copy authenticated by the supplier).

2. An application for regulations of the declaration of domestic products consists of:

a) The declaration form (Form No. 02 in Appendix I hereof);

b) Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available);

c) Scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of effects of the ingredients is used, the daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document;

d) The certificate of food safety if one is required (a copy authenticated by the supplier);

dd) The certificate of Good Manufacturing Practice (GMP) if the domestic products are dietary supplements, applicable from July 01, 2019 (a copy authenticated by the supplier).

3. The documents must be written in Vietnamese language; documents in other languages must be translated into Vietnamese language and notarized. The documents must be unexpired when the application is submitted.

- Organizations or individuals shall announce the product declaration through mass media or post it on their websites or publicly post it up at their offices and make public through the food safety data system;

- If such system has not been established, organizations or individuals shall send 01 application by post or in person to the regulatory agency assigned by the People's Committees of provinces and central-affiliated cities, in order for it to retain the application documents and post the self-declaration, including names of organizations or individuals and product information, on its website;

- If the organizations or individuals have more than 02 facilities which manufacture the same product, they shall only submit the application at the regulatory agency in their locality where the manufacturing facility is selected by them. After selecting the regulatory agency for submitting the application, the next self-declared documents must be submitted at the previously selected agency;

The supplier shall submit the application for registration of the product declaration, whether online, by post or directly, to the following receiving authorities:

- The Ministry of Health for declarations of dietary supplements, mixed food additives with new uses and unregistered food additives;

- A competent authority designated by the People’s Committee of the province for medical foods, food for special dietary uses and dietary products for children up to 36 months;

- In the cases where the declaration includes of the products mentioned in both Point a and Point b of this Clause, the application may be submitted to either receiving authority.

If the supplier has more than one factory that produces the same product, the declaration may be registered to the regulatory authority of one of the provinces of the supplier’s choice (except for products that have to be registered to the Ministry of Health). Once selected, the next applications for registration shall be submitted to the same authority.