PROCEDURES FOR REGISTRATION OF FUNCTIONAL FOODS DECLARATION

Functional foods (Health Supplement, Dietary Supplement) are products used to supplement the daily diet in order to maintain, enhance and improve the functions of the human body, and reduce the risk of disease. All functional foods before being put into circulation on the market must go through the procedure of declaration according to the provisions of law, in order for the competent authorities to manage the products being circulated and used within Vietnam. However, the procedure for announcing imported or domestically produced functional foods is not simple, requires a lot of paperwork, goes through many stages, thus causing difficulties for individuals and organizations producing and trading this type of foods.

1. DOCUMENTS FOR DECLARATION OF FUNCTIONAL FOODS

Dossiers for registration of quality standards of functional foods include a dossier of declaration of conformity with food safety regulations and a dossier of general legal documents.

a) Dossier of general legal documents

No	Documents	Notes
1	Enterprise registration certificate with food business lines or certificate of legal entity for organizations and individuals importing food;	A copy authenticated by the supplier
2	Certificate of food safety;	A copy authenticated by the supplier
3	Certificate of conformity with HACCP or ISO 22000 or equivalent.	Notarized copy

The dossier for announcement of dietary supplements conforming to food safety regulations includes the declaration of functional foods produced domestically and imported from abroad.

b) For imported functional foods:

No	Documents	Notes
1	Product declaration;	Form No. 02 issued together with Decree 15/2018/ND-CP
2	The Certificate of Free Sale or Certificate of Exportation or Health Certificate  issued by a competent authority of the country of origin/exporting country;	The certificate must be consularly legalized
3	The food safety data sheet issued within 12 months;	Original copy or certified true copy
4	The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate;	A copy authenticated by the supplier
5	Documents about scientific evidence of the effects of the product or ingredients.	Original or authenticated copy

c) For domestically produced functional foods:

No	Documents	Notes
1	Product declaration;	Form No. 02 issued together with Decree 15/2018/ND-CP
2	The food safety data sheet issued within 12 months;	Original copy or certified true copy
3	The certificate of food safety;	If one is required (a copy authenticated by the supplier)
4	The certificate of Good Manufacturing Practice (GMP);	A copy authenticated by the supplier
5	Scientific evidence of the effects of the product or ingredients.	Original or authenticated copy

2. PROCEDURES FOR REGISTRATION OF FUNCTIONAL FOODS DECLARATION 

Implementation process

– Organizations and individuals submit documents by post or directly to the Food Safety Department..

– Within 30 working days after receiving a complete and valid dossier, a Certificate of Receipt of the announcement of conformity with food safety regulations must be issued. In case the Receipt is not granted, a written reply must be given to the reason for not granting it.

Authority: Department of Food Safety (Ministry of Health)

Time: 30 working days from the date the state agency receives the dossier

Results: The certificates of declaration of conformity or certificates of declaration of conformity with food safety regulations