"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 sold. To help enterprises better understand "three new" foods, Antion sorted out the application and approval situation in June 2025 based on the information released by the National Health Commission.
In July 2025, the NHC released a total of 87 cases of acceptance and approval information for “three new” foods. There were 17 novel food ingredients, among which 5 cases were approved, 4 cases were accepted, 1 case without administrative permission, 7 cases for public opinions; There were 58 new varieties of food additives, among which 9 cases were approved, 10 cases were accepted, 4 cases had review opinions issued, 1 case without administrative permission, 24 cases were postponed, 10 cases for public opinions; including 19 cases of human milk oligosaccharides (HMOs), 1 case was approved, 2 cases were accepted, 12 cases were postponed, 4 cases for public opinions; There were 12 new varieties of food related products, among which 6 cases were approved, 5 cases were accepted, 1 case for public opinions.
In July, in the application projects of novel food ingredients, the first domestic synthetic biological novel food ingredient “D-allulose”, the first infant strain in the Chinese Mainland “Bifidobacterium animalis subsp. lactis BLa80”, “Bifidobacterium longum subsp. infantis LMG11588”, “Ascorbyl palmitate (enzymatic)” declared by Antion were successfully approved.
In the application project of new varieties of food additives, there were a total of 19 applications for human milk oligosaccharides (HMOs) in July, among which 1 case was approved, 2 cases were accepted, 12 cases were postponed, 4 cases for public opinions. The number of applications accounted for 33% 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 61 cases of HMOs have been applied. Among them, public opinions have been solicited on 2‘-fucosyllactose, 3’-fucosyllactose, 3‘-sialyllactose sodium salt, 6’-sialyllactose sodium salt, lactose-N-neotetrasaccharide and lactose-N-tetrasaccharide; At present, 19 cases have been approved, including 16 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 3 cases in the acceptance stage, 30 cases with postponed review, 2 cases with review opinions issued, and 7 cases without administrative permission.
In addition to HMOs, new varieties of food additives have a wide range of applications, covering multiple categories such as enzyme preparations, sweeteners and processing aids. Enzyme preparations such as Aminopeptidase, Xylanase and Glucoamylase have been successfully approved, and D-psicose-3-epimerase and Deaminase have also entered the stage of soliciting opinions. The approval of enzyme preparations is in line with the trend of green catalysis in food processing; Sweetener is also a hot topic for application, which is highly in line with the encouragement of healthy sugar substitutes in the “sugar reduction policy”, promoting enterprises to focus on the R&D and application of high-magnification, low-calorie sweeteners; Sulfuric acid, Deacetylated chitin (Chitosan), Ethyl acetate and other processing aids have been approved to expand their scope of use, indicating that these processing aids are considered to meet the requirements of safety and process necessity in the new scope of use after strict review.
Based on rich and successful experience in the field of food approval and registration, Antion suggests that for the “three new” foods that have already been approved, when other enterprises apply for the same products, their quality specifications should be consistent with the approval announcement. For the “three new” foods that are currently under public opinions, if other enterprises plan to apply for the same products, it is recommended that they submit the application materials after the approval announcement is issued, so as to shorten the application cycle and reduce the application cost.
Source: Antion
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