Which products are required a product declaration in Vietnam? What documents are included in the Application for a product declaration in Vietnam?
Which products are required a product declaration in Vietnam?
Based on Article 6 of Decree 15/2018/ND-CP regarding the registration of product declarations:
Article 6. Registration of Product Declarations
Organizations and individuals engaged in food production and trading must register a product declaration for the following products:
- Health supplements, medical nutritional foods, foods for special dietary uses.
- Nutritional products for children up to 36 months old.
- Mixed food additives with new uses, food additives not on the list of additives allowed for use in food or not intended for use as prescribed by the Ministry of Health.
Thus, the following products must register a product declaration:
- Health supplements, medical nutritional foods, foods for special dietary uses
- Nutritional products for children up to 36 months old.
- Mixed food additives with new uses, food additives not on the list of additives allowed for use in food or not intended for use as prescribed by the Ministry of Health.
Which products are required a product declaration in Vietnam? What documents are included in the Application for a product declaration in Vietnam? (Image from the Internet)
What documents are included in the Application for a product declaration in Vietnam?
Based on Article 7 of Decree 15/2018/ND-CP prescribing the documents required in the Application for a product declaration:
[1] For imported products
- Product declaration form
- Certificate of Free Sale or Export Certificate or Health Certificate from the competent authority of the country of origin/export with content ensuring safety for users or allowing free sale in the market of the producing/exporting country (with consular legalization)
- Food safety testing result certificate of the product within 12 months up to the submission date issued by a designated testing laboratory or a laboratory accredited with ISO 17025 including safety indicators issued by the Ministry of Health according to risk management principles following international regulations or the safety indicators according to the relevant standards declared by the organization/individual in case there are no regulations by the Ministry of Health (original or certified copy)
- Scientific evidence proving the effectiveness of the product or its ingredients creating the declared effectiveness (original or copy certified by the organization/individual). When using scientific evidence of the ingredient's effectiveness to state the product's efficacy, the daily usage of the product must be at least equal to or greater than 15% of the ingredient’s usage mentioned in the documentation
- Certification of a facility meeting food safety conditions achieving Good Manufacturing Practice (GMP) standards or equivalent certification in the case of imported products being health supplements effective from July 1, 2019 (copy certified by the organization/individual)
[2] For domestically produced products
- Product declaration form
- Food safety testing result certificate of the product within 12 months up to the submission date issued by a designated testing laboratory or a laboratory accredited with ISO 17025 including safety indicators issued by the Ministry of Health according to risk management principles following international regulations or the safety indicators according to the relevant standards declared by the organization/individual in case there are no regulations by the Ministry of Health (original or certified copy)
- Scientific evidence proving the effectiveness of the product or its ingredients creating the declared effectiveness (original or copy certified by the organization/individual). When using scientific evidence of the ingredient's effectiveness to state the product's efficacy, the daily usage of the product must be at least equal to or greater than 15% of the ingredient’s usage mentioned in the documentation
- Certification of a facility meeting food safety conditions in cases where the facility is subject to certification of food safety conditions as prescribed (copy certified by the organization/individual)
- Certification of a facility meeting food safety conditions achieving Good Manufacturing Practice (GMP) standards in the case of domestically produced products being health supplements effective from July 1, 2019 (copy certified by the organization/individual).
Note: Documents in the Application for a product declaration must be presented in Vietnamese; in cases where documents are in a foreign language, they must be translated into Vietnamese and notarized. Documents must be valid at the time of submission of the Application for a product declaration.
What is the latest Form for product declaration in 2024 in Vietnam?
According to Form No. 02 issued together with Decree 15/2018/ND-CP prescribing the Form for product declaration:
Download the latest Form for product declaration in 2024
