New regulations for the review of special medical food production permits seek opinions on stricter requirements for raw material safety.

date
04/11/2025
Special medical use formula foods, also known as specialty medical foods, are processed and formulated specifically to meet the special nutritional needs of people with limited food intake, digestive absorption disorders, metabolic disorders, or specific disease states. Currently, in China, there are 32 rare disease patients who rely on specialty medical foods. Yesterday, it was learned that the State Administration for Market Regulation has organized the revision of the regulations for the production permit review of specialty medical foods and is seeking public opinions. The new regulations greatly refine the product classification. In the past, specialty medical foods were divided into two major categories with a total of 27 varieties, but the new rules have increased the product variety to 46. The new regulations require companies to establish a mechanism for monitoring raw material risk substances and ensure that the transportation of bulk liquid raw materials meets the latest national standard requirements to prevent contamination loopholes in the logistics process and ensure the safety of raw materials in transit. At the same time, companies need to screen for potential pollutants such as plasticizers in packaging materials, and conduct batch inspections on purchased dairy ingredients to meet the requirements of national standards for melamine and other substances.