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Six Key Point in the Interpretation of the Draft of the Labeling Guidelines on FSMP

from CIRS by

On November 7, 2022, the State Administration for Market Regulation (SAMR) released a public consultation on the Draft of the Labeling Guidelines on Foods for Special Medical Purposes (FSMP). The deadline for the feedback is November 25, 2022.

Six key points in the announcement

1. An exclusive logo for FSMP

The minimum sales packaging of FSMP should be marked with an exclusive logo, which must be located in the upper left or right corner of the main display page of the label. The logo is shown below:


2. Product name: specific restrictions about the size and location of the trade name and trademark

  • The font size of the trade name should be smaller than that of the common name. In terms of single character area, the total font area of the trade name should not be greater than half of the total font area used for the common name;
  • When the registered trademark is not the trade name of the product, its total area should be no more than one-fourth of the common name, and its area also less than the trade name. Besides, such registered trademarks should not be used with the product name.

Interpretation: The product name requirements mentioned above are consistent with those for infant formula milk powder labeling.

3. The elimination of functional claims on nutrients

The draft indicates that the nutrient function of FSMP products should not be claimed.

Interpretation: According to GB 13432, content and functional claims are only prohibited for essential ingredients of infant formula from 0-6 months of age while there is no limit for people over six months of age. Now the guidelines are intended to eliminate the functional claims of all nutrients in all age groups of FSMP.

4. Specific nutritionally complete food: clear clinical trials overview requirements

The label of specific nutritionally complete food should include a general description of the relevant clinical trials, such as the objective descriptions of the study purpose, protocol, population, period, observational indicators, and results.

Interpretation: The Guidelines clearly state that the labeling of certain specific nutritionally complete food should attach an overview of relevant clinical trials.

5. Specific requirements for the special identification of some FSMP categories

1) Some categories of FSMP should be labeled with product osmotic pressure; (e.g. premature/low birth weight infant formula, protein (amino acid) block, carbohydrate components, electrolyte formulas, nutritional supplements for special medical purposes for infants, specific nutritionally complete food;)

2) Carbohydrate components shall be marked with "Blood glucose should be monitored in clinical use";

3) The electrolyte formula should be marked with "Pay attention to monitor the serum ion concentration of design elements in the product during clinical use".

Interpretation: Currently, the osmotic pressure labeling requirements are not mandatory for nutritionally complete food, fat formula, liquid formula, thickening component, and amino acid metabolic disorder formula.

6. Content requirements of the main display page

1) The content of the main display page mainly should include the product name, FSMP logo, net content (specification), registration certificate number, applicable population, product flavor, and the prompt message "Use only under the guidance of your doctor or clinical dietitian".

2) A logo area should be set up on the label and located on the upper left or upper right of the main display page of the minimum sales package. When the maximum surface area of the packaging is less than 10cm2, no logo is required.

Interpretation: The label sets the logo area, and the main display page contains the prompt message and applicable population, which highlights the fact that FSMP is different from other foods.

In addition to the major changes mentioned above, the draft also puts forward new requirements regarding nutrition information, warnings, and precautions:

  • The rounding interval of the nutrition facts information should not be less than the number of decimal places according to the corresponding state criteria for food safety.
  • There should be a corresponding relationship between the values of energy and nutrient content in products under different units in the nutrition information.
  • The font of the warnings and precautions should not be smaller than the content on the non-primary display page of the label.

What need to be noted is that according to the instructions of the draft, the guideline mainly works to standardize the label of FSMP from a guiding point of view which means non-mandatory. However, as its content is practical in combination with the requirements of review and approval, it is recommended that enterprises should abide by it.

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