Circular No. 12/2024/TT-BYT dated July 18, 2024, promulgating National Technical Regulation QCVN 20-1:2024/BYT on maximum limits of contaminants in health supplements

1. Scope and Applicable Entities 

• Applies to all organizations and individuals that produce or trade health supplements within Vietnam. 

• Does not apply to tonic wines declared as health supplements. 

2. Maximum Permissible Limits of Contaminants 

• Heavy Metals: 

• Arsenic (As): 

• Total: 5.0 mg/kg or mg/L 

• Inorganic: 1.5 mg/kg or mg/L (only tested if total As > 1.5 mg/kg or mg/L) 

• Cadmium (Cd): 

• 3.0 mg/kg or mg/L (if containing seaweed or bivalve mollusks) 

• 1.0 mg/kg or mg/L (otherwise) 

• Lead (Pb): 10.0 mg/kg or mg/L 

• Mercury (Hg): 0.5 mg/kg or mg/L 

• Microorganisms: 

• Total aerobic microbial count 

• Total yeast and mold count 

3. Testing Methods 

• Testing must be carried out using internationally recognized methods, such as those by AOAC (Association of Official Analytical Collaboration). 

4. Transitional Provisions 

• Health supplements already issued with a Certificate of Product Declaration before the effective date of the Circular may continue to be imported, traded, and circulated until their expiry date, except where food safety warnings are issued. 

• Dossiers submitted before the Circular’s effective date shall be processed under the regulations in effect at the time of submission. 

• After the Circular takes effect, entities with approved Product Declarations must adjust their internal technical standards to conform with the new regulation and notify authorities in accordance with Clause 4, Article 8 of Decree 15/2018/ND-CP.