The State Administration for Market Regulation further strengthens the supervision of special medical purpose formula foods.
The State Administration for Market Regulation recently revised and issued the "Regulations on the Review of Production Licenses for Special Medical Purpose Formula Foods". The "Regulations" have a total of 7 chapters and 43 articles, with strict requirements in terms of production sites, equipment and facilities, technological processes, personnel management, and system management. The main revisions include: adjusting and refining the detailed list of production license varieties according to the 2025 version of the special medical food standard; further clarifying the requirements for environmental hygiene control in operational areas and key equipment monitoring according to the 2023 version of the good manufacturing practices for special medical food; specifying the responsibilities of key personnel positions according to the newly revised "Regulations on the Supervision and Management of Food Production and Business Enterprises in Implementing the Main Responsibility for Food Safety"; strengthening the management of allergen risks for products based on the needs of the target population and their allergen risk management requirements; and further strict material management based on emerging food safety risks and the latest requirements for storage and transportation.
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