Updated:
On December 20, 2022, SAMR officially unveiled the Guidelines for the Label of Foods for Special Medical Purposes.
On November 7, 2022, State Administration for Market Regulation (SAMR) released an exposure draft of Guidelines for the Label of Foods for Special Medical Purposes (hereafter referred to as Guidelines). The authority summarizes labeling requirements in the current laws, regulations, normative documents and national food safety standards and makes them more practical with detailed explanations and instances. Comments can be sent to tsspsypzcc@samr.org.cn before November 25, 2022.
It is noteworthy that all those requirements specified in the Guidelines are voluntary. Here are key points revealed by the proposed guidelines.
1. FSMP logo is newly introduced.
l The FSMP logo is suggested to be indicated in the top left or right corner of the label on the minimum sales package of FSMP products
l The size of the logo is suggested as follows:
Package | Logo |
The major display area ＞ 100cm2 | The diameter of the logo ≥ 2cm |
The major display area ＜ 100cm2 | The diameter of the logo ≥ 1cm |
The biggest surface area ＜10cm2 | It is allowed not to display the logo |
2. The requirements for the product name of FSMP are detailed.
l Product name:
Product name includes generic name, trade name, and English name for imported products, which should correspond to the Chinese name. Product name is suggested to be in standard Chinese characters without any traditional Chinese characters, numbers, letters (except for ®), graphics or symbols.
l Generic name:
Enterprises need to refer to the Announcement on Adjusting Generic Names of Food for Special Medical Purposes Products for the use of generic name.
l Trade name:
The trade name of FSMP product is not suggested to be the same as that of the approved FSMP products, health foods or drugs. Trade name may be a registered trademark name.
l The contrast relation of generic name and trade name:
The size of the trade name is suggested to be smaller than the generic name, whose font and color is not recommended to be more prominent than that of the generic name.
In terms of single-character area, the total font area of the trade name is not suggested to be larger than one half of the total font area of the generic name.
When the trademark name is not identical to the trade name, the total area of the trademark (in rectangular form) is not advised to be larger than one quarter of the font area of the generic name and is not suggested to be smaller than the area of the trade name.
3. The information on the label should follow the laws, regulations, normative documents and GB standards.
The GB standards include GB 29922 General Rules for Foods for Special Medical Purposes, GB 25596 General Rules of Infant Formula Foods for Special Medical Use, GB 7718 General Standard for the Labeling of Prepackaged Foods, GB 2760 Standard for Uses of Food Additives.
If it is clearly defined in the GB standard, the label's information is not suggested to be described as formula characteristics. For instance, in GB 25596, it is stipulated that only pre-gelatinized starch can be added to the infant formula for special medical use. For this type of product, the description “the potato starch is pre-gelatinized” is not recommended to appear as a formula characteristic or nutritional characteristic.
4. The authority proposes specific requirements for the label of some FSMP categories.
Categories of FSMP | Specific requirements |
Premature or low birth weight infant formula, protein (amino acid) components, carbohydrate components, electrolyte formula, infant nutrition supplement and specific full nutritional formula food Note: The current GB standard only covers premature or low birth weight infant formula for special medical purposes. The other categories are newly proposed by the Guidelines. | Osmotic pressure under ready-to-eat state and other appropriate states is suggested to be labeled. |
Carbohydrate component formula foods for special medical purposes | “Blood glucose should be monitored in clinical use” or similar descriptions are suggested to be labeled |
Electrolyte formula foods for special medical purposes | “Serum ion concentration of the elements involved should be monitored in clinical use” or similar descriptions are suggested to be labeled. |
5. FSMP products are not suggested to make functional claims about the nutrients in the product
6. The Chinese label of imported FSMP for infants is suggested to be printed on the minimum sales package directly before entry to China.
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