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Collection of Frequently Asked Questions on FSMP

From the global point of view, the market capacity of FSMP in 2016 was about 64 billion RMB, the scale of European and American markets is 45 billion yuan, and the market size of Japan and South Korea is 18.5 billion yuan. The scale of China's special medical use food market is only 600 million yuan, in which China just accounted for 1% of global share, but the FSMP market in China has rapidly developed in recent years with an average annual growth rate of more than 30%.
Foodmate summarized the frequently asked questions below about FSMP.

Raw material basis and standard for infant formula milk powder for FSMP

According to the "GB 25596-2010 National Food Safety Standard for General Rules for FSMP Infant Formula", "GB 29922-2013 National Food Safety Standard for General Rules for FSMP ", "National Food Safety Standard for General Rules for FSMP Infant Formula" (GB25596-2010) Q&A and the requirements from CFDA to register the raw materials.
Please refer to our article How to Choose Raw Materials for FSMP to learn more about FSMP raw materials.
 
FSMP normally produce with food grade ingredients. Can pharmaceutical grade ingredients be used in FSMP?

 Answer: If there is a food grade ingredients, it is preferred to use food grade raw materials. If there are no food grade raw materials, use raw materials that meet Pharmacopoeia standards, such as calcium pantothenate and biotin.

The 13 FSMP covered by special medicines correspond to the nutritional and medical characteristics of the population (different medical stages)

Answer: 1. Diabetes patients, 2. Respiratory diseases, 3. Nephropathy, 4. Tumor patients, 5. Inflammatory bowel disease patients with protein allergies, 7. Obesity patients, 8. Congenital metabolic defects, 9 . Liver disease patients, 10. Muscle decay syndrome patients, 11. Trauma, infection, surgery and other patients, 12. Intractable epilepsy patients, 13. Gastrointestinal malabsorption, patients with pancreatitis, (Special medical use formula food applicable population ).
 
Specific content requirements for pollution control programs, control plans for the transfer of hazardous substances in packaging materials, nutrients, and optional component control programs 

Answer: FSMP are food in terms of the names. Therefore, from the perspective of food production risk control, the relative control standard is based on HACCP or FSSC22000. The elements of control include biological, chemical and physical hazards. The current goal of specialty foods may also be chemical hazards, including the issue of packaging contamination migration.
Contaminant control programs also include the control of harmful substances in packaging materials, nutrients, and other components. From the perspective of company operations, we need to develop a set of control system based on HACCP, establish supplier management procedures and production management procedures, and control risks through these procedures. Risk control in the production process should be determined according to the actual conditions of the process and equipment.
Safety requirements for packaging materials are included in GB4806 and GB9685.

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