Vietnam to Regulate the Maximum Levels for Contaminants in Health Supplements

According to Vietnam Food Administration (VFA), Vietnam is soliciting opinions on the draft of a new regulation “National Technical Regulation — Maximum Levels for Contaminants in Health Supplements” (hereinafter “this Regulation”). Opinions can be sent to [email protected] prior to September 30, 2022.

Background to develop this Regulation

At present, health supplement in Vietnam is subject to the regulations as follows:

• 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, none of the regulations above have proposed safety criteria for health supplements, which means manufacturers have to develop their own product standards. In this context, it is necessary for Vietnam to develop a national technical regulation (abbreviated as QCVN in Vietnam) to set food safety regulatory limits for health supplements.

When drafting this Regulation, Vietnam mainly takes Annex III — ASEAN Guidelines on Limits of Contaminants for Health Supplements as a basis in combination with the test methods for specific indicators from the Association of Official Analytical Chemists (AOAC), national standards in Vietnam, etc.

Major content of this Regulation

This Regulation consists of five chapters, stipulating contaminant limits, test methods, management requirements, and responsibilities for organizations and individuals producing and trading safe health supplements.

The five chapters are:

• Chapter 1 General provision, which specifies the application scope as well as terms and explanations.

• Chapter 2 Technical requirements. It stipulates the requirements for microorganisms and heavy metals, including arsenic, cadmium, lead and mercury levels.

• Chapter 3 Requirements for sampling and test method

• Chapter 4 Management requirements. The requirements for the registration of health supplements remain the same as what is regulated in “Circular No. 43/2014/TT-BYT Regulating the Management of Functional Foods”. In addition, the test result of the health supplement product shall be issued by a laboratory designated or recognized by Vietnam’s Ministry of Health.

• Chapter 5 Responsibilities of organizations and individuals. It details the stakeholder’s responsibility for product safety and compliance.

For further translation or regulation monitoring services, please email [email protected].