At present, FSMP does not have an adding list of raw materials ingredients. Does that mean everything could be added into the FSMP? The answer is NO.
The “Project and Requirements for Registration of Application for Formula FSMP(Trial)” (2017 Revision) stipulates that FSMP “prohibit adding nutrients other than those specified in the standard and other biologically active substances other than the optional ingredients”. Please refer to GB 25596-2010 "Food Safety National Standard General Principles of Infant Formula for Special Medical Use" and GB 29922-2013 "National Standards for Food Safety General Principles of Formula Food for Special Medical Use" to ensure whether the nutrients and optional ingredients are within the standard requirement.
What are the main raw materials for FSMP?
FSMP experts replied: Whether it is special medical infant formula or full-nutrition or special full-nutrition special medical food for people over 1 year of age, the main raw materials are similar to infant formula, which are whey protein and/or soy protein. The main reason is that FSMP, like infant formulas, are foods that provide nutrients to specific populations. Whey protein and soy protein are currently the best sources of protein for them.
Apart from the whey protein, soy protein and the nutrients specified in the standards, what other ingredients could be added?
To clarify a principle, in order to meet the requirements of laws and standards, try to choose ingredients with single nutritional function and simple raw material nutrients.
For example:
Myogen and Serum proteins in meat can be used as proteins in FSMP, but meat cannot be directly added to FSMP.
The medium-chain and long-chain fatty acid edible oil in the new food raw materials, the quality requirements for the provisions of the long-chain fatty acids triglycerides, medium-chain triglycerides, these components are more specific, able to provide fat, can be added to the FSMP.
New food materials used by infants and young children - galacto-oligosaccharides, whose main components are anhydrous lactose, anhydrous glucose, etc., can provide carbohydrates, which can also be added to specialty foods.
The range of foods used but not including infants and young children, such as inulin, polyfructose, can be used in special medical products older than 3 years old, and can be used according to the list.
FSMP are food targeted at a special population. They are very different from normal food. Therefore, only a small portion of the raw materials used for normal food may be used for FSMP. When selecting raw materials, it is necessary to study the relevant regulations of GB25596 and GB29922. In addition, companies need to learn more about medicine, nutrition, and the raw materials selected for the products that have already been marketed.
