Strengthen allergy risk management; the 2026 version of the special medical food production license review guidelines released

A reporter learned today (March 5) that, to further improve the quality and safety level of special medical purpose formula foods, the State Administration for Market Regulation has revised and issued the “Implementation Rules for the Examination and Approval of Production Licenses for Special Medical Purpose Formula Foods (2026 Edition)” (hereinafter referred to as the “Rules”), which have been implemented recently. The Rules adjust and refine product categories. The number of varieties of special medical purpose formula foods increased from 27 to 46.

Adjusted and refined categories; the number of product varieties has increased to 46. Special medical purpose formula foods—what we commonly call “special medical purpose foods”—are formula foods that are specially processed and prepared to meet the special needs for nutrients or diets of people with restricted feeding, digestive and absorption disorders, metabolic disorders, or specific disease conditions. The Rules adjust and refine product categories as follows: from 27 varieties to 46, they break down full-nutrition formula foods into two categories—full-nutrition formula foods for children aged 1 to 10 and full-nutrition formula foods for those aged 10 and above—as well as certain full-nutrition formula foods of the partial nutrition adjustment type. For non-full-nutrition formula foods, new categories are added, such as preoperative carbohydrate formulae and non-full-nutrition formulae for specific diseases. Protein (amino acid) components are refined into six types, including protein components, essential amino acid components, and metabolic disorder amino acid (or peptide) components. These refined measures help special medical purpose foods to be selected more purposefully for applicable patient populations, based on their own diseases and special circumstances, under the guidance of doctors. (CCTV News)