"Three new" foods refer to novel food ingredients, new varieties of food additives and new varieties of food related products. Before entering the market, they must go through declaration and evaluation. 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 situation of "three new" foods, Antion sorted out the application and approval situation in May 2025 based on the information released by the National Health Commission and conducted an analysis and interpretation.

In May, the NHC released a total of 95 cases of acceptance and approval information for "three new" foods. There were 25 novel food ingredients, among which 2 cases were approved, 9 cases were accepted, 12 cases were postponed, 2 cases for public opinions; There were 48 new varieties of food additives, among which 6 cases were approved, 9 cases were accepted, 5 cases had review opinions issued, 18 cases were postponed, 10 cases for public opinions; including 17 cases of human milk oligosaccharides (HMOs), 2 cases were approved, 4 cases were accepted, 9 cases were postponed, 2 cases for public opinions; There were 22 new varieties of food related products, among which 3 cases were approved, 10 cases were accepted, 5 cases had review opinions issued, 4 cases were postponed.

In May, the popularity of plant extracts in novel food ingredient application projects remained high. Since 2020, 7 cases of plant extracts have been approved, 2 cases have been subject to public opinions, 5 cases had review postponed, 1 case is in the acceptance stage, and 1 case has not been granted administrative permission. As of May 28, 2025, a total of four extracts have been included in the Catalogue of Termination Review for Novel Food Ingredients, namely potato extract, Ashitaba stem and leaf extract (later renamed Ashitaba stem and leaf juice powder), mulberry leaf extract and oat green extract. For specific review opinions, please refer to the requirements of the catalogue of termination review. No further elaboration will be given here. The application of strains such as Bacillus natto VB205 and fermentation mycelium protein of Fusarium venezia TB01 demonstrates the extension of the application scenarios of probiotics and the expansion of fermentation technology in the field of food raw material development.

In the application project of new varieties of food additives, there were a total of 17 applications for human milk oligosaccharides (HMOs) in May, among which 2 cases were approved, 4 cases were accepted, 9 cases were postponed, 2 cases for public opinions. The number of applications accounted for 35% 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 58 cases of HMOs have been applied. Among them, public opinions have been solicited on 2'-fucosyllactose, 3'-fucosyllactose, 3'-sialyllactose sodium salt, lactose-N-neotetrasaccharide, 6'-sialyllactose sodium salt and lactose-N-tetrasaccharide; At present, 16 cases have been approved, including 13 cases of 2'-fucosyllactose and 3 cases of lactose-N-neotetrasaccharide, all of which are derived from genetically modified microorganisms. Antion has successfully completed the application work for two of these cases and has rich successful experience in the application of such projects. Among the remaining HMOs projects, there are 5 cases in the acceptance stage, 28 cases with postponed review, 2 cases with review opinions issued, and 7 cases without administrative permission.

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.