Procedures for the registration of the product declaration

1. Products that are required to register for the product declaration

According to Article 6 of Decree 15/2018/ND-CP, organizations and individuals producing and trading food must register the announcement for the following products:

• 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 compiled by the Ministry of Health (hereinafter referred to as “unregistered food additives”). 

2. Procedures for registration of product declaration

Step 1: Submit the application for registration of the product declaration

Organizations and individuals producing and trading food shall submit dossiers for registration of product declarations via the online public service system or by post or directly to the application-receiving agency.

Agencies receiving dossiers include:

• Submit to the Ministry of Health for health foods, mixed food additives with new uses, and food additives that are not included in the list of additives permitted for use in food prescribed by the Minister of Health. determined.

• Submit to the competent state management agency designated by the People's Committee of the province for medical nutrition food, food for special diets, nutritional products for children up to 36 months old.

• In case organizations or individuals producing many types of food fall under the competence of receiving dossiers of registration of product declarations from both the Ministry of Health and the competent state management agencies approved by the provincial People's Committees. If designated, organizations or individuals have the right to choose whether to submit dossiers to the Ministry of Health or products under the authority to receive registration dossiers of which agencies shall submit registration dossiers to such receiving agencies.

Step 2: Processing registration documents

Competent agencies shall appraise registration dossiers within a specific time limit.

Dossier for registration of product declaration for mixed food additives with new uses, food additives not included in the list of additives permitted to be used or not for the right users in food, approved by the Minister The Ministry of Health stipulates that medical nutrition food, food for special diets, and nutritional products for children up to 36 months old must be made within 07 working days from the date of receipt of a complete application. valid profile.

Dossier for registration of product declaration for health foods shall be made within 21 working days from the date of receipt of complete and valid dossiers.

Applications for registration of product declaration

Applications for registration of product declaration for imported products includes:

• The product declaration according to the form.

• Certificate of Free Sale or Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/export content that is safe for users or freely sold in the market of the producing/exporting country (consular legalization).

• The product's food safety test result sheet (original or certified true copy).

• Scientific evidence proving the use of the product or the ingredients creating the announced use (the original or a copy certified by the organization or individual). When using scientific evidence about the use of a product's ingredient for the product's use, the daily dose of the product must be at least 15% greater than or equal to 15% of the use of that ingredient stated in the brochure.

• Certificate of food safety eligibility, Good Manufacturing Practice (GMP) or equivalent certificate in case imported products are health foods, applied from July 1, 2019 (copy certified by the organization or individual).

Applications for registration of product declaration for domestically produced products includes:

• The product declaration according to the form.

• The product's food safety test result sheet (original or certified copy).

• Scientific evidence proving the use of the product or the ingredients creating the announced use (the original or a copy certified by the organization or individual). When using scientific evidence on the use of a product's ingredient for the product's use, the daily dose of the product must be at least 15% greater than or equal to 15% of the use of that ingredient stated in the brochure.

• Certificate of eligibility for food safety in case the establishment is subject to the issuance of a certificate of eligibility for food safety as prescribed (a copy certified by the organization or individual).

• Certificate of eligibility for food safety and Good Manufacturing Practice (GMP) in case domestically produced products are health protection foods, applicable from July 1, 2019 (certified copy of the organization or individual).

This is the entire order and procedures for registering the product declaration. Individuals, organizations need to clearly grasp the above order and procedures to ensure the legitimate interests of their business.