Labeling Requirements of Foods for Special Medical Purpose (FSMP) in China

The manuscript of product label and instruction book is one of the required dossiers for FSMP registration. In order to help applicants better understand the labeling requirements during the FSMP registration, CFDA issued the Label and Instruction Book Manuscript Requirements of FSMP (Trial). There are 12 aspects required to indicate in total.

1. Product Name

The product name consists of general name and trade name. For imported FSMP products, the English name is also available.

Examples

• XXX特殊醫學用途嬰兒配方粉氨基酸配方 (XXX amino acid formula of infant formula powder for special medical purpose);
• XXX特殊醫學用途嬰兒配方粉苯丙酮尿癥配方 (XXX phenylketonuria formula of infant formula powder for special medical purpose)

Note:XXX refers to the trade name.

2. Product Category

Product Category shall be indicated in accordance with the categories in GB 29922 and GB 25596, including,

• Full nutritional formula food
• Specific full nutritional formula food
• Incomplete nutritional formula food
• Lactose free formula or low lactose formula food
• Partially hydrolyzed milk protein formula food
• Extensively hydrolyzed milk protein formula food or amino acid formula food
• Premature or low birth weight infant formula food
• Breast milk nutrition food
• Amino acid metabolism disorder formula food

3. Ingredients List

It shall be indicated in accordance with GB 7718 General Rules for Labeling of Prepackaged Food.

*Basic requirement:All ingredients shall be listed in descending order of their weights added; those ingredients constituting less than 2% of the food may not be listed in descending order.

4. Nutrition Information

The nutrient values in each 100g and/or 100ml, and each 100kJ shall be indicated in a box table. It is optional to indicate the nutrient values in each serving. Here is an example for your reference.

Nutrition Information

5.Formulation Characteristics

Including the description of the disease or medical condition of the product and the suitable crowd, characterization of energy and nutrients in products, interpretation of formula principles, etc.

6. Suitable Crowds

It shall be indicated in accordance with the GB 29922 and GB 25596. For example,

• For “Amino acid metabolism disorder formula food”, it is suitable for “Abnormal amino acid metabolism infant”.
  

7. Direction

8. Warning

The following warnings shall be indicated in the prominent location,

1) Please use under the guidance of a doctor or clinical nutritionist

2) It is not applicable to non-target groups

3) This product is prohibited for parenteral nutrition or intravenous nutrition

In addition, the applicant shall indicate additional warnings based on the food category and actual needs.

Except the above 8 aspects, theorganization status,net weight and specification,expiry date, andstorageshall be indicated as well.

Conclusions

The 12 aspects are mandatory to indicate on the manuscripts of product label and instruction book when applying for FSMP registration. CFDA will carry out the technical review on the contents of these 12 aspects.

On the other hand, for the final labels and instruction books that used for the products on the market, they shall be further designed according to relevant laws and regulations in China. For examples, adding the registration number, indicating the importer information, etc. Relevant applicants shall pay attention to the whole FSMP labeling regulations at that time, not only for the registration.

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