II. REGISTRATION OF FOOD SUPPLEMENTS
(i) Type of registration
Under article 3 of the Circular No. 43/2014/TT, functional foods are subject to regulation conformity announcement. This form of registration needs to be completed with the Ministry of Health (Vietnam Food Administration) before the products are marketed.
The products should at least be conform to the Articles 6 and 7 of the Government's Decree No. 38/2012/ ND-CP of 25 April 2012 detailing a number of articles of the Law on Food Safety, and Articles 4, 5, 7 and 9 of the Minister of Health's Circular No. 19/2012/TT-BYT of 9 November 2012 guiding the announcement of regulation conformity or conformity with food safety regulations.
(ii) Customs registration
Product registration is different from customs registration. For the purpose of customs clearance, imported foods must satisfy the following; (I) a certificate of free sale from the originating country must be included; (ii) the Conformity Announcement or Announcement On Conformity With Regulation on Food [Registration of functional foods], (iii) Certificate of Compliance with the Foods Import Requirements issued with every consignment by a designated inspection officer, and (iv) A Certificate of Food Hygiene and Safety.
(iii) Documentation (to obtain regulation conformity announcement)
According to article 6 (3) of Government's Decree No. 38/2012/ ND-CP of 25 April 2012, the following documentation is required for functional foods:
- Announcement of compliance (official form provided in the Decree)
- Product specifications (official form provided in the Decree)
- Certificate of free sale of originating country verifying safety and compliance (original, notarized copy or legalized copy)
- Product testing results dating back to maximum 12 months, including major quality and safety criteria. The lab must be designated by an authorized government agency or a recognized independent lab; by original or notarized copy, or accredited by an authorized agency in Vietnam.
- Periodic monitoring plan, authenticated by the organization or individual
- Sample of the product label. Both of the original label in the country of origin as well as the label in Vietnamese. Authenticated by the organization or individual.
- Sample of the finished product
- Business registration certificate. License of food business or a certificate of legal entity for food importers, authenticated by the organization or individual.
- Certificate of satisfaction of food safety requirements. For importers that are legally required to be certified for food safety requirements, copies need to be authenticated by the organization or individual.
- Certificate of conformity to HACCP standards or ISO 22000 or equivalent. A notarized copy or a copy accompanied with the original verification needs to be submitted.
- Scientific information and documents proving the effect(s) of each ingredient that helps generate the announced functions (copies authenticated by the organization or individual).
- Testing reports are required for products which include utility effects on human health (Products with announced recommendations about their disease treatment support effects and Products with announced recommendations about their disease treatment support effects)
The estimated time for registration is 3-4 weeks. The announcement of regulation conformity remains valid for 3 years. In case of refusal, the applicant has 2 months to complete the dossier as requested, otherwise the dossier will be cancelled (article 7 of Circular No. 19/2012/TT-BYT of 9 November 2012).