PART 1. The main revised content

Compared with the current standard, the main revisions of this standard include: Firstly, the revision of product categories, including the addition and adjustment of categories of some complete nutritional formula and non-complete nutritional formula, and the refinement of the original components and formulas. Secondly, based on the latest scientific evidence, further improved the relevant technical requirements, such as adding some optional ingredients to complete nutritional formula, modifying the technical requirements for energy and nutritional components, and adjusting the minimum or maximum values of some nutrients; The technical indicators of non-complete nutrition components and formulas have been further improved in non-complete nutritional formula. Thirdly, increased the suitable people of partially modified nutrient complete formula, components and formulas, to better guide the production and use of food for special medical purpose. Fourthly, in terms of the overall content of the standard, sensory requirements, requirements for raw materials, labeling requirements and requirements for appendix of amino acids have been modified. The limits of contaminants, mycotoxin and pathogenic bacteria are referenced from the general standards, ensuring the connection and coordination between this standard and other basic food safety standards.

PART 2. Revision of category of food for special medical purpose

Compared with the current standard, the revision of product categories in this standard mainly involves three aspects: Firstly, adding product categories, such as newly adding "partially modified nutrient complete formula" under the category of complete nutritional formula, and newly adding subcategories including "dietary fiber components", "preoperative carbohydrate formula", "non-complete nutritional formula for specific disease" and "other" under the category of non-complete nutritional formula; Secondly, the catalogue of specific complete nutritional formula has been adjusted, modifying food protein allergy-specific complete nutritional formula to partially modified nutrient complete formula and adding "other"; Thirdly, further refined the original components and formulas of non-complete nutritional formula, such as refining the protein (amino acid) components in the current standard into protein components, essential amino acid components, branched chain amino acid components, arginine components, glutamine components and metabolic disorder amino acid (or peptide) components. Through the revision of these categories, on the one hand, it ensured the connection with GB 25596-2025 General Principles for Infant Formula for Special Medical Purpose applicable to the population under 1 year old, and on the other hand, it can better meet the nutritional needs of people with different disease states.

PART 3. Regarding the newly added "partially modified nutrient completeformula" under the category of complete nutritional formula

This type of food is based on a complete nutrition formula, with adjustments made to the processing method or content of energy density and macronutrients (such as fats, carbohydrates, proteins), e.g. extensively hydrolyzed milk protein formula, high-fat and low carbohydrate formula. Appendix A of the standard specifies the technical requirements for partially modified nutrient complete formula for people aged 1 to 10, such as extensively hydrolyzed milk protein formula and amino acid formula, to maintain continuity with infant formula for special medical purpose.

PART 4. Regarding the newly added "non-complete nutritional formula for specific disease" under the category of non-complete nutritional formula

This type of product is mainly targeted at patients with specific diseases, who have clear characteristic requirements for certain nutritional components. Therefore, the formula design needs to have specific nutrient composition and meet certain content requirements to provide partial nutritional support for patients with specific diseases. Its safety and clinical application (effectiveness) need to be scientifically proven. In addition, this type of product is different from complete nutritional formula for specific disease, as it only provides partial nutritional support for patients with specific diseases and needs to be used in conjunction with other foods.

PART 5. Revision of technical requirements for non-complete nutritional formula

One is the refinement and supplementation of the main technical requirements for common non-complete nutritional components and formula, such as improving the source of raw materials, application characteristics, purpose of use, fatty acid composition and other raw material usage in fat (fatty acid) components. The second is the increase of suitable people with special medical conditions of all components and formulas, to better guide the production and use of this type of food.

PART 6. The age group division of the population in the standard

This standard classifies complete nutritional formula into categories for those aged 1 to 10 and those aged 10 and above. Manufacturers can develop products suitable for different age groups within the scope of meeting standard requirements, based on clinical practical needs and scientific evidence. When the product is marked as suitable for people aged 1-3 and 3-7, its technical indicators should meet the requirements of the product for people aged 1-10 in the standard. However, the same product should not cover both the age groups of 1-10 years old and 10 years old and above at the same time, such as labeling the product as "suitable for people aged 8-16 years old".

PART 7. How to understand that "when the energy supply from other substances accounts for 5% or more of the total energy, they should be included in the total energy"

The revision of this standard takes into account the complexity of the actual formula and raw materials of food for special medical purpose. Some ingredients added to food for special medical purpose may also be energy-producing substances themselves, such as isomaltulose added as a sweetener. In order to ensure the accuracy of energy calculation and formulation, when the energy supply of such substance (as a single substance) accounts for 5% or more of the total energy, it should be included in the calculation of total energy.

Source: CFSA

Note: This article is compiled by Antion. Please indicate the source for reprint.