"Three new" foods refer to novel food ingredients, new varieties of food additives and new varieties of food related products. Before "three new" foods enter the market, they must go through declaration and review. Only after being approved by the National Health Commission (hereinafter referred to as the NHC) can they be produced and sold. To help enterprises better understand the application and approval of "three new" foods, Antion sorted out the application and approval situation in April 2025 based on the information released by the National Health Commission and conducted an analysis and interpretation.
In April, the NHC released 27 cases of acceptance and approval for "three new" foods. There were 24 new varieties of food additives, among which 8 were accepted, 6 cases had review opinions issued, 10 cases were postponed; There were 3 new varieties of food related products accepted.
From the perspective of the application categories, the "three new" food application projects in April were mainly concentrated in the field of new food additive varieties, and no related applications for new food raw materials have been received yet.
In the application project of new varieties of food additives, there were a total of 6 applications for human milk oligosaccharides (HMOs) in April, among which 2 were accepted and 4 were extended. The number of applications accounted for 25% of the total new food additive variety applications, indicating that the research enthusiasm for HMOs in the application of food additives has not waned. Since 2021, a total of 54 cases of HMOs have been applied. Among them, 14 cases were approved (12 cases of 2'-fucosyllactose and 2 cases of lactose-N-neotetrasaccharide), all of which were derived from genetically modified microorganisms. Antion has successfully completed the application work for many of its products and has rich successful experience in the application of such projects.
In addition, 3-fucosyllactose, 3'-sialyllactose sodium, 6'-sialyllactose sodium and lactose N-tetrasaccharide have been publicly solicited for opinions. Among the remaining HMOs projects, there are 7 cases in the acceptance stage, 24 cases with postponed review, 2 cases with review opinions issued, and 7 cases without administrative permission.
Apart from HMOs, new varieties of food additives such as potassium glycyrrhizinate, potassium glycyrrhizinate monohydrate and ammonium glycyrrhizinate were accepted for review in a concentrated manner. Glycyrrhizinate salts have functions of sweetening and flavoring, which indicates from the side that the application for sweeteners in the market is showing a diversified trend. Enterprises are no longer confined to traditional sweetener categories but are actively exploring new types of sweeteners like glycyrrhizinate salts that have multiple functional characteristics.
Enterprises need time to collect and organize more complete application materials to meet the more detailed review requirements of regulatory authorities and avoid delaying the launch of new products due to incomplete materials or failure to pass the review. Based on rich and successful experience in the application for "three new" foods, Antion suggests that for the "three new" foods that have already been approved, when other enterprises apply for the same product, their quality specifications should be consistent with the approval announcement; For the "three new" foods that are currently under public opinions, if other enterprises apply for the same product, it is recommended to wait until the approval announcement is released before submitting the application materials, so as to shorten the application cycle and reduce the application cost.
Source: Antion
Note: This article is compiled by Antion. Please indicate the source for reprint.