Infant Formula & FSMP
Infant formula and food for special medical purposes (FSMP) fall under a special category not included into Health food, called “special dietary food”, and is governed by separate regulations. Both FSMP and Infant formula require registrations in China. Foreign producers of infant formula must register their in-country manufacturer and product formula prior to exporting goods into China.
Infant formula milk powder in China includes:
- Infant formula (0-6 months)
- Older infant (6-12 months) and
- Young children (12-36 months) formula
According to the FSMP National Standards, FSMP products are classified into 4 categories (i – iv):
- Nutritionally complete FSMP – this formula can be used as s single source of nutrition for targeted population requirements
- Specific nutritionally complete FSMP – This formula can be used as a single source of nutrition to meet targeted groups’ requirements that have a particular disease or medical condition
- Nutritionally incomplete FSMP – This formula can be used to meet the targeted population requirements who have partial nutrition standards and therefore, cannot be a single source of nutrition
- FSMP for infants – this formula can be used for 0 to 12-month-old infants
The registration management of foods for special medical purpose in China, must be in accordance with The Food Safety Law of the People’s Republic of China to ensure quality and safety.
We Offer These Services for Infant Formula & FSMP
Preliminary Product Evaluation
Knudsen&CRC can provide general guidelines on the process and timeline of SAMR Registration, give a general overview on your product, and carry out product category evaluation to determine whether your product(s) qualify as FSMP or infant formula. Moreover, the process of preliminary product evaluation for special dietary foods will include a labeling check. The overall goal of product screening is to provide you with a detailed overview of ingredient and product compliance.
SAMR Filing/
Registration
For SAMR Registration, approved ingredient and intake levels should be screened before importation, including raw materials, food additives and nutrition enhancers. All food products shall comply with the relevant GB standards and shall be checked accordingly during importation. Knudsen&CRC can assist with SAMR registration by completing dossier preparation, applying for customs clearance of samples if necessary, application dossier submission, and management of the filing process with the SAMR. Note for SAMR registration, companies need a responsible agent within China to manage the process if you do not have a WFOE or hold legal entity in China.” Knudsen&CRC can assist with SAMR registration by completing dossier preparation, applying for customs clearance of samples if necessary, application dossier submission, and management of the filing process with the SAMR. Note that for SAMR registration, you need a responsible agent within China to manage the process if you do not have a WFOE or hold legal entity in China.
Includes
Application Dossier Preparation
Ingredient & Packaging Consulting
Documentation Submission
Sample Test Preparation
Frequently Asked Questions
FSMP products are classified into 4 categories:
1) Nutritionally Complete FSMP: This formula can be used as a single of nutrition for targeted population requirements
2) Specific Nutritionally Complete FSMP: This formula can be used as a single source of nutrition to meet targeted groups’ requirements that have a particular disease or medical condition
3) Nutritionally Incomplete FSMP: This formula can be used to meet the targeted population requirements who have partial nutrition standards and therefore, cannot be a single source of nutrition
4) FSMP for Infants: This formula can be used for 0 to 12 month old infants
The registration management of FSMP in China must be in accordance with the Food Safety Law of the People’s Republic of China to ensure quality and safety.
The information on the Chinese label should be compliant with GB 13432-2013. The Chinese label of imported infant formula milk powder should be printed on the retail package before entry and cannot be affixed in China.
GB Standards refers to the Chinese National Standards. All importers of General Food into China are required to adhere to Chinese National Standards. National Standards with the prefix “GB” are mandatory. National Standards with the prefix “GB/T” are recommended, but are actually obligatory for compliance.