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On July 18, 2024, Vietnam's Ministry of Health promulgated QCVN 20-1:2024/BYT, a National Technical Regulation that regulates the limits of contaminants in health supplements/dietary supplements, excluding wine products declared as health supplements.
The regulation will come into effect on August 1, 2025.
Importance of the regulation
Prior to the release of this Regulation, health supplements in Vietnam were subject to the following regulations:
Law No. 55/2010/QH12 on Food Safety
Decree No. 15/2018/ND-CP Detailing the Implementation of a Number of Articles of the Law on Food Safety
Circular No. 43/2014/TT-BYT Regulating the Management of Functional Foods
Circular No. 18/2019/TT-BYT Guiding Good Manufacturing Practices (GMP) in the Production and Trading of Dietary Supplements
Circular No. 10/2021/TT-BYT Stipulating the List of Substances Banned from Being Used in the Production and Trading of Dietary Supplements
Decree 111/2021/ND-CP Amending and Supplementing Some Articles in Decree No. 43/2017/ND-CP Regarding the Governance of the Label of Goods
However, at that time, there were no specific national technical regulations (QCVN) or national standards (TCVN) available to establish safety criteria limits for health supplements. In practice, manufacturers had to develop their own product standards, often referring to existing national technical regulations such as QCVN 8-2:2011/BYT and QCVN 8-3:2011/BYT, which primarily focused on regular food and certain types of foods but did not specifically address health supplements.
In light of this, Vietnam introduced this Regulation to establish national-level food safety limits for health supplements. It is crucial to emphasize that compliance with QCVN national technical regulations is mandatory in Vietnam.
Key Content
The regulation includes the following provisions:
Maximum limits for heavy metals, namely arsenic, cadmium, lead, and mercury
Maximum limits for microorganisms, including situations where products contain probiotics
Corresponding sampling and testing methods
Product management requirements. The regulation mainly cites requirements from other currently effective regulations, such as labeling requirements and product declaration registration requirements
The responsibilities of organizations and individuals involved in the production and trading of health supplements
Transitional provisions for different situations are summarized below:
No. | Situation | Corresponding requirements |
1 | Health supplements manufactured before the effective date of this Regulation, and the enterprise has obtained the certificate of product declaration registration | Products can continue to be imported, traded, and circulated in Vietnam's market before the product's expiration date, unless there is a food safety warning. |
2 | The dossiers for product declaration registration were submitted before the effective date of this Regulation | The applications will continue to be processed according to the regulations in place at the time of dossier submission. |
3 | Staring from the effective date of this regulation, if the enterprise has received a document of receipt from the authority indicating the acceptance of the declaration registration application, but the manufacturing standard does not comply with this Regulation | The enterprise shall adjust the manufacturing standards and notify the authority as per Article 8, Clause 4 of Decree No. 15/2018/ND-CP of the Government: Detailing the Implementation of a Number of Articles of the Law on Food Safety. |
For further translation and consulting service, please email [email protected].
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