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Until now, totally 81 FSMP products have been approved in China, including 52 domestic products and 29 foreign products. Among the 81 approved products, the dosage forms of 62 products are powder, and only 19 products are liquid. In terms of product type, as shown in the figure below, 36 of them are infant formula for special medical purposes, 25 are nutritionally incomplete food, and 20 are nutritionally complete food. While specific nutritionally complete food have not been approved until now.
In recent years, Human milk oligosaccharides (HMOs) has become the new aristocrat in milk and been well known by the public. HMOs are the third largest solid component in breast milk after lactose and fat. The importance of HMOs in the field of food nutrition has been constantly confirmed. Its typical ingredient 2'-FL has successively won the "pass" in the several countries. Although 2'-FL has not been officially approved for use in China, many 2'-FL applications have been reviewed and draft for public comments by the China National Center for Food Safety Risk Assessment (CFSA), including synthetic sources and modified E.coli sources, which indicates that the approval of 2'-FL in China is near.
CFDA released the Administrative Measures of FSMP Registration (trial)on March 7, 2016, and it was implemented on July 1, 2016. Now the CIRS provide the detailed explanation.