According to Decree No. 15/2018 / ND-CP dated February 2, 2018, Vietnamese and foreign organizations and individuals that produce or sell foods in Vietnam; organizations and individuals whose operation involve food safety in Vietnam must carry out the Procedures for Self-Product declaration and Procedures for registration of product declaration before manufacturing or trading.
Type of food shall be made Product Declaration:
– 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
Procedures for registration of the product declaration for foods
Application for registration of the product declaration and Procedures for registration of the product declaration shall be specified at article 7 and article 8 at Decree no.15/2018/NĐ-CP.
1. An application for the declaration of imported products
- The declaration form (Form No. 02 in Appendix I hereof);
- The Certificate of Free Sale, Certificate of Exportation or Health Certificate (the certificate must be consularly legalized);
- 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;
- Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy).
- 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.Procedures for registration of the product declaration for imported foods
- The supplier shall submit the application for registration of the product declaration, whether online, by post or directly to:
+ Dietary supplements and unregistered food additives: Ministry of Health
+ Medical foods, food for special dietary uses and dietary products for children up to 36 months : A competent authority designated by the People’s Committee of the province
+ For declaration includes of the products mentioned above: the application may be submitted to either receiving authority.
- Within 07 working days (for unregistered food additives, medical foods, food for special dietary uses, dietary products for children up to 36 months) or 21 working days (for dietary supplements) from the day on which adequate documents are received.
- The time limit for document verification begins on the date of receipt according to the online public service system (if the application is submitted online) or date stamp of the receiving authority (if the application is submitted by post or directly).
- The receiving authority shall post on its website and update on the food safety database the names and products of suppliers whose product declarations have been registered.
3.Fee for document verifications ( Circular no. 117/2018/TT-BTC) :
- Medical foods, food for special dietary uses, dietary products for children up to 36 months: VND 1,500,000 / times / a product
- Mixed food additives with new uses, food additives that are not on the list of permitted food additives compiled by the Ministry of health :VND 500,000 / times / a product