New requirements for Functional Foods, including Food Supplements and Supplemented Food products

    Earlier this year, the Vietnam Food Administration (VFA) published a draft amending the Government Decree No. 15/2018/ND-CP on Food Safety. These amendments introduce new requirements for Functional Foods, including Food Supplements and Supplemented Food products.

    The revised decree is expected to take effect in July 2026.

    According to the proposed Decree:

        • Circulation numbers (currently known as the “Registration of Product Declaration” procedure) will be assigned to specific food categories, including Food Supplements, Medical Nutrition Foods, Nutritional Products for children up to 36 months, and Supplemented Foods.

        • Currently, Supplemented Foods are subject to self-declaration, but will be classified as high-risk and will require Circulation Registration as outlined above. Both self-declaration and circulation registration will have a validity period of five years, ending the present system of perpetual declarations.

        • Certain food additives, including blended food additives with new functions, additives not on the Ministry of Health’s permitted list, or those used for incorrect purposes, will no longer require the product declaration procedure. However, the registration method for these products remains unspecified; future regulations on food additive management may be anticipated.

        • Quality criteria:

              – Facilities producing products classified as high-risk must be certified under GMP, HACCP, ISO 22000, BRCGS, IFS or FSSC 22000 standards (or equivalent);

              – Certificates of Analysis must now be issued by an ISO/IEC 17025-accredited laboratory or a GMP-compliant facility;

              – Submission of in-house specifications, along with a dossier detailing the development of those specification, will be required.

        • Approval timelines: the review process will take 90 days from the date of submission. However, only one revision will be permitted (today, an unlimited number of revisions is allowed).

    Transitional provisions: Companies will have 18 months to align existing product registrations with the new rules, and six months to update self-declared dossiers. After these timeframes, any prior product declaration documents or certificates will no longer be valid for production or importation. However, existing stock may be sold through its shelf life. 

    The draft decree does not specify a transitional period for the Supplemented Food products that will transition from the self-declaration procedure to the Registration of Product Declaration procedure.