From years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) applications to help you understand the current requirements in China.
Q1: Can FSMP be entrusted to other enterprises for production?
A1: No. According to the interpretation of Administrative Measures for Registration of Food for Special Medical Purposes, the applicants for FSMP shall be the manufacturers, including the manufacturers intending to produce and sell FSMP in China and the overseas manufacturers intending to export FSMP to China. In addition, the applicants should also be capable of R&D, production, and inspection. The FSMP registration certificate is non-transferable.
Q2: What about the relationship and priority order between the registration for FSMP and the application for a food production license?
A2: Manufacturers intending to produce and sell FSMP in China shall:
1. obtain the business license of the corresponding business scope according to relevant regulations；
2. register the FSMP guided by the Administrative Measures for Registration of Food for Special Medical Purposes and got the registration certificate;
3. apply for FSMP production according to the Measures for the Management of Food Production License.
Q3: How to determine whether a specific amino acid is permitted for use in FSMP?
A3: The amino acids permitted for use in FSMP should be listed in Appendix B of the General Rules of Infant Formula for Special Medical Purposes (GB 25596) and Appendix B of the General Rules of Food for Special Medical Purposes (GB 29922).
Except for the simplest stable amino acid glycine, human proteins are made up of L-amino acids, which (as well as their salts) have been approved for use in FSMP.
Q4: Are amylase and protease available to be used in FSMP as raw materials?
A4: No. Enzymes are proteins that act as biological catalysts by accelerating chemical reactions. However, according to the requirements of the application material for FSMP registration, nutrients and bioactive substances other than the permitted ingredients specified in related standard shall not be added to the product formula.
Q5: Is on-site inspection a necessary step for imported FSMP products?
A5: Yes. After being accepted by SAMR, the application materials for FSMP registration will be reviewed by CFE. CFE shall examine the application materials and organize an on-site inspection according to the actual needs. For those applying for the registration of imported FSMP, the time limit for on-site inspections and sampling tests abroad will be determined by the actual conditions of the overseas manufacturers.
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