Health

The release of the "Detailed Rules for the Review of Production Licenses for Special Medical Formula Foods (2026 Edition)" is related to the quality and safety of special medical food

2026-03-05   

The reporter learned from the State Administration for Market Regulation that in order to further strengthen the safety supervision of special medical use formula foods (hereinafter referred to as "special medical food"), the State Administration for Market Regulation recently revised and released the "Detailed Rules for the Review of Production Licenses for Special Medical Use Formula Foods (2026 Edition)" (hereinafter referred to as the "Detailed Rules"). According to the State Administration for Market Regulation, the detailed rules are important technical documents for the market supervision department to organize the production license review of special medical food enterprises. There are 7 chapters and 43 articles in total, which strictly require production sites, equipment and facilities, process flow, personnel management, and system management, and mainly revise five aspects. One is to adjust and refine the production license variety details according to the product classification of the 2025 version of the special medical food standard; Secondly, in accordance with the 2023 version of the Good Manufacturing Practice for Special Medical Food, further clarify the requirements for environmental hygiene control and key equipment monitoring in the work area; Thirdly, in accordance with the newly revised "Regulations on the Supervision and Management of the Implementation of Main Responsibility for Food Safety in Food Production and Operation Enterprises", the job responsibilities of key personnel will be refined; Fourthly, strengthen the management of product allergy risks based on the target audience and their allergy risk management needs; Fifth, in combination with the latest requirements for food safety risks and storage and transportation, we will further strengthen the management of raw materials. It is reported that the detailed rules will be implemented from the date of publication. The "Detailed Rules for the Examination of Production Licenses for Special Medical Formula Foods" issued by the State Administration for Market Regulation on January 29, 2019 are simultaneously abolished. (New Society)

Edit:Luoyu Responsible editor:Jiajia

Source:xinhuanet.com

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