China Released the 2024 Edition of General Rules for Food for Special Medical Purposes (Draft) - Summary of Key Revisions

Nutritionally complete food

(1) Nutritionally complete food for people aged 1 to 10;

(2) Nutritionally complete food for people above 10;

Partially adjusted nutritionally complete food has been added. For example:

1) High-fat, low-carbohydrate nutritionally complete food, with fat providing ≥40% of the energy;

2) High-protein nutritionally complete nutritional food, with protein providing ≥20% of the energy; and

3) High-energy density nutritionally complete nutritional food, with an energy density ≥1.5kcal/mL in the ready-to-eat state.

Specific nutritionally complete food

13 categories listed in Appendix A

1) Twelve current categories have been retained and food protein allergy nutritionally complete food has been reclassified into the category of partially adjusted nutritionally complete food;

2) “B.13 Others” has been added to encourage product innovation.

Nutritionally incomplete food

Nutrient module, thickening module, liquid formula, electrolyte module, and amino acid metabolism disorder formula

1) A new category of nutritionally incomplete formulas for specific diseases, and others, such as non-disease-specific nutritionally incomplete formulas have been added;

2) Dietary fiber module and preoperative carbohydrate formula have been added; and

3) The protein modules have been refined. The original standard protein (amino acid) modules have been subdivided into five categories, namely protein, essential amino acid, branched-chain amino acid, arginine, and glutamine modules.

Nutritionally complete food

1. Energy calculation. It is specified that the energy ratio of dietary fiber in FSMP is calculated at 8kJ/g. If other substances provide more than 5% of the total energy, they shall be included in the total energy calculation;

2. Alternative components and the content requirements have been added:

For nutritionally complete formula for people aged 1 to 10, Vitamin K2, 1,3-DIOLEOYL-2-PALMITOYL-GLYCEROL, lutein, lactoferrin, and casein phosphopeptide have been added;

For nutritionally complete formula for people above 10, Vitamin K2, EPA＋DHA, and CaHMB have been added;

3. The content levels of certain nutrients have been revised. For nutritionally complete food for people aged 1 to 10, the lower limit of Vitamin A has been adjusted from 75.0µgRE/100kca to 35.0µgRE/100kcal; the labeling of DHA and ARA content has been changed from “% total fatty acids” to “mg”, with the upper limit values revised accordingly;

4. The testing methods of certain nutrients have been updated. For instance, the measurements for fatty acids, Vitamin A, and Vitamin D have been revised in accordance with the updated national standards;

5. Others. Regarding the content requirement for Vitamin E, the statement of “1 mg dl-α-tocopherol = 0.74 mgα-TE (the amount of tocopherol) has been added.

Nutritionally incomplete food

1. The protein content of protein modules shall account for 70% or more of the total product (for liquid products, it shall make up 65% or more of the total dry matter); the amino acid content of the 4 amino acid modules shall constitute 70% or more of the total product, respectively;

2. Regarding the fat (fatty acid) module: Raw material sources, application solubility, fatty acid composition, the use of other raw materials, and other technical requirements have been added;

3. Regarding the carbohydrate module: Restrictions on insoluble dietary fiber have been added;

4. Regarding the thickening module: It’s stipulated that the carbohydrates added should not be intended to provide energy and nutrients, nor should additional nutrients be added;

5. Regarding electrolyte formula: Peptides-based, that is, “carbohydrates and/or peptides-based” has been added;

6. Regarding liquid formula: It’s clarified that fat should not be added for the purpose of providing energy; the sources of protein and its energy contribution requirements have also been specified;

7. Regarding the preoperative carbohydrate formula: The energy density, electrolyte, osmotic pressure, and other technical indicators have been specified.