Decree 46/2026/ND-CP: Stringent Regulations on Food Safety for Health Supplement Production

The Government has officially issued Decree No. 46/2026/ND-CP, providing detailed guidelines for the implementation of the Law on Food Safety. Notably, regulations regarding food safety conditions for health supplement manufacturing have been tightened to enhance market quality.

Under the new regulations, manufacturing facilities must strictly apply Good Manufacturing Practices (GMP) in accordance with Ministry of Health guidelines. The quality management system must control the entire process from raw materials to distribution, ensuring product stability throughout its shelf life.

Regarding personnel, the Decree requires the professional supervisor to hold at least a university degree in medicine, pharmacy, nutrition, food safety, or food technology, with a minimum of 3 years of practical experience. The heads of production and quality control must be official full-time employees and operate independently.

Infrastructure must adhere to the one-way flow principle, specifically designed to prevent cross-contamination and dust accumulation. Enterprises are required to maintain full traceability records for every batch. Furthermore, the quality control department must conduct necessary tests and ensure no substandard products enter the market.

For the issuance of the Certificate of Food Safety Eligibility, the Decree specifies a clear appraisal process. The receiving authority will establish an appraisal team of 03 to 05 members. In cases where results are unsatisfactory, businesses have up to 30 days to rectify issues identified in the Appraisal Minutes.

The Decree also clarifies entities exempted from the Certificate requirement, including: small-scale primary producers, mobile food businesses, unregistered communal kitchens, and street food vendors. Despite this, these establishments must still strictly comply with relevant food safety conditions.