Study On The Current Registration Status,establishment Of Testing Methods And Its Applicability For Food For Special Medical Purposes In China

The research on the quality,safety,and applicability of testing methods for Food for Special Medical Purposes(hereinafter referred to as "FSMP")is currently a hot topic in food safety.In recent years,FSMP has flourished worldwide,receiving widespread attention for its quality,safety,and medical efficacy.Due to its late start and complex matrix,some of the current national food safety standards in China do not include FSMP.As of March 31,2023,104 FSMP in China have been registered,covering infant formula food for special medical purposes,whole nutrition formula food,non whole nutrition formula food,and specific whole nutrition formula food.Some special populations with chronic diseases or eating difficulties mainly obtain nutrition from FSMP,especially for infants and young children with milk protein allergies or amino acid metabolism disorders.FSMP are the most important source of nutrition for maintaining their growth,metabolism,and development.In the context of the "Healthy China","National Nutrition Plan",and "Healthy China Action",FSMP,as an important special product and means,is of great significance in meeting the nutritional and dietary needs of specific populations under special medical conditions,improving their nutritional status,and reducing patients’ medical costs.This article studied the situation of registered FSMP and established a method for detecting inositol content in FSMP.At the same time,the applicability of national standard detection methods for taurine,choline,and manganese content in different matrix FSMP was studied.(1)The analysis of the situation of 104 registered FSMP in China shows that the number of domestic products has exceeded that of imported products,but imported products still occupy an important share in the FSMP for baby.Most domestic products are consumed by people over 1 year old.FSMP for baby have covered all common product categories listed in the product standards.Only one specific full nutrient formula product is registered,and technical assistance and research and development for this type of product should be strengthened in the future.Some products have increased their content based on the specific nutritional needs of the audience and standard Q&A.In terms of adding optional ingredients,the frequency of adding nutrients varies depending on the age of the population and different types of products.(2)A gas chromatography detection method for inositol in FSMP has been established,and detailed explanations have been provided on the preparation of derivative reagents,optimization of pre-treatment,selection and optimization of gas chromatography columns,etc.The sample was extracted with acetonitrile,added with anhydrous ethanol,dried with nitrogen blowing,derivatized with silanization reagent,extracted with n-hexane,and determined on the machine.The recovery rate was validated on three special medical samples with different formulations and matrices,and the average spiked recovery rate was between 91.3% and 103.3%.The method has accurate quantification,high precision,and high recovery rate,and is suitable for the detection and analysis of inositol in FSMP.It can provide technical support for market supervision and inspection.(3)Using national standard methods,the taurine content of 8 different matrix FSMP,choline content of 5 different matrix FSMP,and manganese content of 5 different FSMP were tested.Six laboratories were invited to conduct inter laboratory comparisons to study the applicability of the national standard testing methods for different matrix FSMP,and it was found that some testing methods were not applicable.