The National Health Commission (NHC), formerly the National Health and Family Planning Commission (NHFPC), continues to publish updated lists of approved food additives through its regular “Three New Foods” announcements. For food importers, manufacturers, and ingredient suppliers, staying current with these approved additions is essential for product innovation, regulatory compliance, and market access. This guide provides a comprehensive overview of the latest approved food additives, key trends in China‘s food additive regulatory landscape, and practical steps for compliance.
1. Understanding the “Three New Foods” Approval System
In China, “Three New Foods” refers to three categories of substances that require pre-market safety assessment and approval before they can be legally used in food production: new food raw materials (novel foods), new food additives, and new food-related products (food contact materials)[reference:0]. This system is established under Article 37 of the Food Safety Law of China, which requires that anyone producing or importing food with new food raw materials, new food additives, or new food-related products must submit safety assessment materials to the National Health Commission. The Commission then organizes expert review and issues approval announcements for substances that meet safety requirements[reference:1]. Food additives approved through this process are subsequently incorporated into GB 2760 (Standards for the Use of Food Additives) after a transition period, at which point the original announcement is automatically superseded[reference:2].
2. Key Regulatory Framework for Food Additive Approvals
Food additive approvals in China are governed by the Food Additive New Varieties Management Measures, which define “new food additives” as additives not yet listed in GB 2760 or not yet approved by the NHC, as well as existing additives with expanded usage scope or dosage[reference:3]. The approval process mandates two core criteria: the additive must be technically necessary and scientifically proven safe through risk assessment[reference:4]. The National Health Commission is responsible for reviewing and licensing new additives, while the National Food Safety Risk Assessment Center handles technical evaluations[reference:5]. Under the Food Safety Law, the Commission must complete its review within 60 days of receiving a complete application[reference:6]. The assessment covers food safety and technical necessity, with safety review based on risk assessment outcomes. Comprehensive evaluation materials include production sources, chemical and physical properties, manufacturing processes, toxicological safety data, and test reports[reference:7]. A dynamic adjustment mechanism has also been established to allow ongoing additions and revisions to the approved additive list based on industry development, technological advances, and emerging research[reference:8].
3. Approved Food Additives – 2025 to 2026
The NHC has issued multiple announcements approving new food additives and expanding the scope of existing ones. Below is a consolidated summary of key approvals announced in 2025 and 2026, with direct links to source documentation where available.
3.1 2025 Approvals – NHC Announcement (2025 No. 1)
In its first 2025 announcement, the NHC approved eight food additive varieties. The full list includes[reference:9]:
Butylated Hydroxytoluene (BHT), Branch Enzyme, β-Alanine, (6S)-5-Methyltetrahydrofolic Acid Glucosamine Salt, 6S-5-Methyltetrahydrofolic Acid Calcium, Enzyme-Conversion Method Steviol Glycosides, 2‘-Fucosyllactose (2’-FL), and Calcium Carbonate (Algae Source). The approved additives will be systematically incorporated into GB 2760-2024, which serves as China‘s unified standard for food additive usage.
3.2 2026 Approvals – NHC Announcement (No.1 of 2026)
On February 5, 2026, the NHC issued its first 2026 “Three New Foods” announcement (No.1 of 2026), approving 11 new food additive varieties. The approved additives include[reference:10][reference:11]:
D-Psicose 3-Epimerase (D-allulose 3-epimerase) – Food Industry Enzyme Preparation
3‘-Sialyllactose Sodium Salt (3’-SL) – Food Nutrition Fortifier
2‘-Fucosyllactose (2’-FL) – Food Nutrition Fortifier
Lacto-N-neotetraose (LNnT) – Food Nutrition Fortifier
Deaminase – Food Industry Enzyme Preparation
Glucose Isomerase (Xylose Isomerase) – Enzyme Preparation
Sucrose 1-Fructosyltransferase – Food Industry Enzyme Preparation
Anethole (trans-1-methoxy-4-(prop-1-enyl)benzene) – Expansion of Usage Scope
Gellan Gum – Expansion of Usage Scope
Carbon Dioxide – Expansion of Usage Scope
Bentonite (Expanded Usage)
In addition to the 11 food additive approvals, the announcement also approved five new food raw materials (Gardenia Oil, XiangYu Peony Flower, Alginate Oligosaccharide, Bifidobacterium longum subsp. Infantis YLGB-1496, Camelina Seed Oil) and six food-related products, bringing the total number of substances approved under this announcement to 22[reference:12]. Notably, the approval of 3‘-SL as a food nutrition fortifier makes it the third approved Human Milk Oligosaccharide (HMO) type in China, following 2’-FL and LNnT[reference:13].
4. Key Approved Additives in Detail
4.1 D-Allulose 3-Epimerase (D-Psicose 3-Epimerase)
Approved as a new enzyme preparation, D-psicose 3-epimerase is produced through microbial fermentation using a newly sourced production strain[reference:14][reference:15]. It catalyzes the conversion of D-fructose to D-psicose (D-allulose)[reference:16]. Since D-psicose functions as a low-calorie sweetener, this approval supports the production of rare sugars, with expanding applications in the food industry. This newly approved enzyme expands production technology pathways in China and will be integrated into GB 2760.
4.2 Human Milk Oligosaccharides (HMOs) Breakthrough
In a significant development for infant nutrition, the NHC approved 3‘-Sialyllactose Sodium Salt (3’-SL) as a new food nutrition fortifier in 2026, making it China‘s third approved HMO type (after 2’-FL and LNnT)[reference:17]. This milestone substantially expands formulation options for infant formula and functional foods.
Alongside 3‘-SL, the approvals of 2’-FL and Lacto-N-neotetraose (LNnT) were also included in the 2026 announcement[reference:18]. Each HMO approval specifies production strains, manufacturing processes, quality specifications, and scope of use. Market access for products containing these HMOs in infant formulas requires formula registration with the State Administration for Market Regulation (SAMR), in accordance with the new GB 29922 standards for Special Dietary Use Foods.
4.3 Additional Key Additives by Category
Enzyme Preparations: The 2026 announcement approved multiple new food industry enzyme preparations, including deaminase, glucose isomerase (xylose isomerase), and sucrose 1-fructosyltransferase[reference:19]. These enzymes play critical roles in the production of flavor enhancers, sweeteners, and prebiotics, supporting advanced food processing applications.
Food Nutrition Fortifiers: In 2025, the approved list of nutrition fortifiers included (6S)-5-methyltetrahydrofolic acid glucosamine salt and its calcium salt[reference:20], offering expanded folate fortification options for a variety of foods.
Sweetener Development: The approval of enzyme-conversion steviol glycosides in 2025 and 2’-FL in 2026 reflects China‘s ongoing focus on natural low-calorie sweeteners. These are key ingredients driving sugar reduction initiatives and meeting growing consumer demand for healthier products.
5. GB 2760-2024 Standard Update
In 2025, the National Health Commission and the State Administration for Market Regulation jointly released the updated Food Safety National Standard for the Use of Food Additives (GB 2760-2024), which replaced the 2014 version (which had been in effect for 10 years) and came into force on February 8, 2025[reference:21][reference:22]. The new standard integrates 28 previous supplementary announcements and comprehensively revises the scope and limits of food additive usage. This milestone standard serves as the primary reference document for determining which additives are permitted and how they may be used, superseding previous announcements after a transition period.
The new standard includes three major changes for food manufacturing: it deleted certain food additives that are no longer considered safe or necessary, established stricter usage limits for many categories, and imposed new restrictions on preservatives and colorings in certain foods[reference:23]. For importers and food producers, the key takeaway is that the additive must be permitted under GB 2760 for the specific food category in question, with the correct usage level, and no “zero added” or “no artificial flavors” claims are permitted on labels. Non‑compliance can result in detention at customs, fines, and product recalls. Therefore, staying informed about updates to the GB 2760 standard and the list of food additives approved through “Three New Food” announcements is essential for maintaining compliance in the Chinese market.
6. Application & Approval Process for Food Additives
The approval process for new food additives in China is multi-stage and thorough. Applicants must submit a comprehensive application package to the NHC, including a completed application form, the additive‘s technical name and functional classification, proposed usage amount and applicable food categories, documentation demonstrating its technical necessity and efficacy, detailed quality specifications, production and processing methods, as well as information on testing methods[reference:24]. Comprehensive safety assessment data must also be submitted, covering production sources, chemical and physical properties, the manufacturing process, toxicological safety data, quality specification test reports, and product labels and samples[reference:25]. For import applications, additional documentation is required, including proof from the relevant authorities in the country of origin that the additive may be legally produced or sold there, as well as evidence of facility audits or certifications from the relevant institutions in the country of origin[reference:26]. After submission, the NHC solicits public input, conducts expert technical assessments, and processes the approval. From application acceptance to formal approval, the timeline ranges from a minimum of 7 months to a maximum of 30 months for food additives[reference:27].
7. Post-Approval Compliance & Ongoing Responsibilities
Once a food additive is approved, manufacturers and importers must adhere to several ongoing responsibilities. First, they must only use the additive according to its approved scope, limits, and functional category. No deviation is allowed. Second, food safety risk monitoring and post-market surveillance are required for new additives. The industry should also be aware that with the establishment of the Food Additives Dynamic Adjustment Mechanism, previously approved additives may be deleted from the permitted list if new evidence emerges indicating safety concerns, or if their technical necessity is no longer justified[reference:28].
For companies looking to add newly approved additives to their products, this typically requires amending product formulations, updating internal quality control procedures, and potentially modifying product labels and registration filings. For example, incorporating HMOs into infant formula will require formula registration with the SAMR, a process that involves a thorough review of the product‘s nutritional composition, safety data, and manufacturing processes. Conversely, where new additive expansions broaden the permitted categories of use, producers should verify whether their specific product type is now allowed to use the additive, and ensure that new labeling and advertising materials are accurate and do not contain any prohibited claims (such as “zero added” or “no artificial flavors”) as stipulated by the new GB 7718 labeling standard[reference:29]. It is essential for companies to fully understand the specific details and the scope of use as described in the official approval announcements before making any changes to product formulations or labels.
8. Future Outlook & Industry Trends
Analysis of approval patterns reveals that the NHC is prioritizing several categories: Human Milk Oligosaccharides (HMOs) – The approval of 2‘-FL, LNnT, and now 3’-SL marks significant progress, with additional HMO approvals likely coming in the future, expanding infant formula innovation opportunities. Low-Calorie Sweeteners and Sugar Reduction – Approvals of D-allulose-related enzymes and enzyme-conversion steviol glycosides align with the national sugar reduction strategy and industry demand, supporting healthier product development. Enzyme Preparations – New approvals for deaminase, glucose isomerase, and fructosyltransferase enable more efficient production of functional food ingredients. Natural Food Additives – The inclusion of algae-source calcium carbonate reflects growing interest in naturally derived, sustainable additive sources. Fortification Advances – Expanded folate fortification options signal broader opportunities for nutritional enhancement across multiple food categories. With the establishment of the dynamic adjustment mechanism and harmonization with GB 2760-2024, China’s food additive regulatory framework continues to improve. It is anticipated that innovation will accelerate in the fields of functional foods, sugar reduction, infant nutrition, and natural additives in the years ahead.
9. Practical Compliance Guidance for Importers & Manufacturers
For companies seeking to use newly approved food additives in products destined for the Chinese market, the following steps are essential. First, verify the official approval announcement and ensure the additive is listed in the most recent NHC bulletin. Second, confirm the specific scope of use – the approved food categories, maximum permitted dosage, and conditions of use, as each additive has specific restrictions. The most current information is maintained in the GB 2760-2024 database and the ChinaFoodDB. Before proceeding with product development or import, importers should commission laboratory testing to ensure that the final product‘s additive levels are within the approved limits, with particular attention to newly approved additives where the appropriate testing methods may still be evolving. For infant formula and special dietary products, incorporating a newly approved additive (such as an HMO) will likely require a separate product formula registration with the SAMR, including the additive in the product’s compositional dossier. Finally, it is crucial to update product labels in accordance with GB 7718-2025, and to never use banned claims such as “zero added” or “no artificial flavors.” The GB 7718-2025 labeling standard is now in effect, and non‑compliant labeling can result in detention at the port of entry.
Importers should also be aware of the customs clearance process. Customs officials will check imported food products for compliance with the relevant GB standards and will verify that any additive used is permitted for the specific food category. It is essential to have the correct documentation, including a certificate of analysis (COA) and, for certain additives, a health certificate from the country of origin. Failure to comply with these additive regulations can result in the consignment being refused entry, leading to costly delays, destruction, or re‑export of the goods.
10. Comparison to International Standards
Many newly approved additives correspond to those already in use in other major jurisdictions. For example, the HMOs approved in China are also permitted in the EU, US, and other major markets. For companies familiar with Codex Alimentarius, EU, or US regulations, this alignment allows for more consistent global product formulations. However, it is essential to review China‘s specific usage restrictions, as they may differ from those in other markets. For instance, while an additive may be permitted in the EU for a broad range of food categories, the Chinese approval might restrict its use to a more limited set. Therefore, reliance on international approvals alone for targeting the Chinese market is insufficient; a specific verification against GB 2760 is required.
Summary: The NHC (formerly NHFPC) has published several new food additive approvals in 2025 and 2026, including D-allulose 3-epimerase, 2‘-FL, 3’-SL, LNnT, and other enzyme preparations and nutrition fortifiers. These approvals, along with the implementation of GB 2760-2024, expand opportunities for product innovation while imposing stricter usage limits and labeling requirements. Importers must conduct due diligence by verifying additive scope, performing laboratory testing, and updating labels in accordance with GB 7718-2025 before placing products on the Chinese market. Early action on compliance is essential for maintaining seamless market access.