On July 18. 2024, Vietnam’s Ministry of Health issued Circular No. 12/2024/TT-BYT promulgating National Technical Regulation QCVN 20-1:2024/BYT on the limits of contaminants for health supplements (“Circular 12”). The new national technical regulation is the very first relating to health supplements, and is expected to have a great impact on the control of health supplement quality in Vietnam. Circular 12 will take effect on August 1, 2025.
Contents of Circular 12
The new circular prescribes limits of contaminants (heavy metals and microorganisms), testing samples and testing methods, management requirements, and responsibilities of entities manufacturing and trading in health supplements.
Supplemented alcohol products which are declared as health supplements are notably excluded from the scope of the regulation.
Transitional Provisions
Health supplements which (i) have been granted a declaration registration certificate, and (ii) are manufactured before August 1, 2025, are allowed to continue to be imported, traded, and circulated until the expiry date of the product, even if it is not aligned with Circular 12, except when there is food safety warning.
Declaration registration dossiers for health supplements submitted before August 1, 2025, will continue to be handled in accordance with the prevailing regulations at the time of submission.
From August 1, 2025, if a health supplement with a granted declaration registration certificate has a manufacturer’s standard that does not comply with Circular 12, the party manufacturing/trading in the product must adjust the product standard to conform to Circular 12 and notify the authority of this adjustment.
