Tiếng Việt
Product testing is a mandatory step to ensure food safety and protect consumer rights prior to the circulation of health supplements (HSPs) in the Vietnamese market. On July 18, 2024, the Ministry of Health issued Circular No. 12/2024/TT-BYT, promulgating the National Technical Regulation QCVN 20-1:2024/BYT on limits of contaminants in health supplements.
Legal Basis
- Decree No. 15/2018/ND-CP dated February 2, 2018, of the Government detailing the implementation of several articles of the Law on Food Safety.
- Circular No. 12/2024/TT-BYT dated July 18, 2024, issued by the Ministry of Health, promulgating QCVN 20-1:2024/BYT on permissible limits of contaminants in health supplements. This Circular takes effect from August 1, 2025.
Mandatory Testing Parameters
1. Organoleptic Criteria
- Evaluation of product color, odor, taste, and physical form (e.g., tablets, powders, solutions).
- Assessment of product uniformity and stability.
2. Physicochemical Criteria
- Quantitative analysis of active ingredients as declared on the label (e.g., flavonoids, polyphenols, vitamins, minerals).
- Testing for moisture content, pH, solubility, peroxide index (for oil-based formulations), etc.
3. Microbiological Criteria
As per QCVN 20-1:2024/BYT, mandatory microbiological indicators include:
- Total aerobic microbial count.
- Escherichia coli.
- Salmonella spp.
- Staphylococcus aureus.
- Yeasts and molds.
4. Heavy Metals Criteria
The regulation sets maximum allowable limits for the following heavy metals:
- Lead (Pb)
- Cadmium (Cd)
- Mercury (Hg)
- Arsenic (As)
5. Mycotoxin Criteria (If Applicable)
For products containing plant-based raw materials, especially seeds and powders, testing is required for:
- Aflatoxins B1, B2, G1, G2
- Ochratoxin A (in case of raw materials from yeast, cereals, etc.)
6. Banned Substances and Pesticide Residues (If Necessary)
For herbal-based products, testing must include:
- Pesticide residue screening
- Detection of banned substances as per current regulations
Key Updates Under QCVN 20-1:2024/BYT
- Scope of Application: This regulation applies to organizations and individuals involved in the production and trading of health supplements in Vietnam. However, it does not apply to tonic wines classified as health supplements.
- Testing Methods: The regulation specifies sampling and analytical methods to ensure accuracy and consistency in testing.
- Responsibilities: Manufacturers and traders must comply with contaminant limits to ensure product safety for consumers.
QCVN 20-1:2024/BYT is a specialized technical regulation for health supplements, replacing the use of general food standards. It sets stricter and more detailed contaminant limits, especially regarding heavy metals, microbiological content, and mycotoxins.
Important Notes for Implementation
- Effective Date: Circular 12/2024/TT-BYT is effective from August 1, 2025. Enterprises must prepare and adjust their testing protocols accordingly.
- For Products Declared Before the Effective Date: If the product does not yet meet the new regulation, it may continue to be imported, distributed, and sold until its expiry date, unless there is a food safety warning.
- For Registration Dossiers Submitted Before the Effective Date: These will be processed according to regulations in effect at the time of submission.
- After the Effective Date: Products already granted a Certificate of Product Declaration must revise their internal standards to comply with the new regulation and re-register under Article 8 of Decree 15/2018/ND-CP.
Keeping up-to-date and compliant with the new product testing regulations is critical to ensuring health supplement quality and meeting legal requirements. Enterprises should proactively adapt their production and testing procedures to ensure product safety and contribute to public health protection.
📞 For free consultation on dossiers, registration procedures for medical devices, health supplements, cosmetics, and pharmaceuticals, please contact our hotline: 098.546.1894.