Published on

December 30, 2025

Last updated on

January 27, 2026

China’s National Health Commission Approved 14 New “Three New Foods”

On November 27, 2025, the National Health Commission of the People’s Republic of China (NHC) issued the “Announcement on 14 ‘Three New Foods’ Including Fusarium venenatum Protein” (“Announcement No. 7 of 2025”). Following formal safety evaluations and technical reviews, the NHC approved 14 substances for use in China’s food sector, granting legal eligibility for production, sale, and application nationwide.

The newly approved items cover multiple regulatory categories, reflecting the continued diversification of China’s food innovation pipeline. Specifically, the announcement authorizes:

3 new food raw materials
8 new varieties of food additives
3 new varieties of food-related products

For international food manufacturers and importers, the announcement expands market access while introducing clearer and more enforceable compliance obligations under China’s food safety framework.

At a Glance: 14 Newly Approved “Three New Foods”

China approved 14 new “Three New Foods,” including 3 food ingredients, 8 food additives, and 3 food-related products (see the full list).
Each substance is approved with defined use conditions, dosage limits, and unsuitable populations.
Several approvals reference overseas safety assessments, signaling closer alignment with international evaluations.
Early, precise compliance execution will determine who captures market opportunity — contact Cisema for expert support with regulatory interpretation and market access services.

Regulatory Background and Policy Context

The announcement forms part of the NHC’s ongoing administration of the “Three New Foods” system under the “Food Safety Law of the People’s Republic of China.” This framework governs market entry for new food raw materials, new food additives, and new food-related products not yet covered by national standards.

As innovation driven by fermentation, synthetic biology, and advanced plant extraction accelerates, application volumes have increased steadily. In response, the NHC has issued multiple approvals in 2025 with noticeably shorter review timelines. This reflects improved administrative efficiency while maintaining strict dietary safety oversight.

At the policy level, the announcement aligns with the “14th Five-Year Plan for Bioeconomy Development,” which promotes food biomanufacturing while emphasizing defined regulatory boundaries to balance innovation and risk control.

Key Regulatory Developments

Within this regulatory and policy context, the Announcement sends two clear signals to international stakeholders.

Greater Reliance on International Safety Assessments

The NHC is placing greater weight on international safety assessments during domestic reviews. Several approved substances, including Fusarium venenatum protein and olive fruit polyphenols, already hold approvals in the European Union, the United States, and Canada.

Fusarium venenatum protein, for example, has GRAS status in the United States and is permitted as a food ingredient in both the EU and Canada. In its review, the NHC explicitly referenced overseas evaluations, facilitating the transfer of mature international technologies into the Chinese market.

For foreign applicants, this highlights the strategic value of robust international compliance documentation when preparing China submissions.

More Granular and Explicit Risk Control Requirements

At the same time, the Announcement adopts a more detailed and prescriptive approach to risk management. For each approved substance, the NHC specifies clear technical parameters, including:

Conditions of use
Unsuitable populations
Intake calculation methods
Conversion standards for active components

Elderberry anthocyanins, for instance, are clearly designated as “not suitable for infants and young children, pregnant women, or lactating women,” with intake calculated based on total anthocyanin content. These provisions leave little room for interpretive error.

Core Compliance Criteria

While the approvals expand market access, they also introduce strict compliance thresholds. Failure to meet criteria may lead to product recalls, administrative penalties, or market bans.

Scope and Permitted Use Are Strictly Defined

The Announcement’s approvals are both substance- and category-specific. Key examples include:

2’-fucosyllactose is permitted for use in the following food categories:
- Formulated milk powder for children (children’s milk powder only)
- Infant formula
- Follow-up formula
- Young-child formula
- Formula for special medical purposes intended for infants
Branching enzyme is approved for use as a processing aid in food production and processing, in accordance with the principles set out in GB 2760, including its use in the production of maltodextrin from starch processing
Beta-alanine is restricted to sports nutrition foods under Category 13.05 in GB 14880.

Even if compliant overseas, use beyond the approved Chinese scope constitutes non-compliance.

Mandatory Labeling and Consumer Disclosure Requirements

The announcement also strengthens labeling obligations. Products containing approved substances must clearly disclose:

Unsuitable populations
Recommended intake levels
content conversion calculation methods

For example, foods containing Fusarium venenatum protein must disclose unsuitability for infants, young children, pregnant or lactating women, or individuals with fungal allergies. Additionally, where conversion standards apply, they must be followed precisely. For olive fruit polyphenols, a ≤600 mg/day intake based on 10.0 g/100 g total polyphenols requires proportional adjustment when concentrations differ.

Import Inspection, Filing, and Customs Clearance

For imported foods, compliance extends to border procedures. Importers must submit the relevant NHC announcement, safety evaluation materials, and supporting documentation to China Customs.

Products lacking proper filing or documentation may be detained or returned, regardless of overseas market acceptance.

Where Commercial Opportunities Are Emerging

This announcement creates clear opportunities for food companies that act early and operate within regulatory boundaries.

Growth Potential for Novel Proteins and Functional Ingredients

China’s plant-based food sector continues to grow rapidly, driven by demand for high-protein and lower-burden diets, In this market landscape, Fusarium venenatum protein is a prime example of market potential. With a protein content of at least 50.0 g/100 g on a dry basis and characteristics such as zero antibiotics, zero pesticide residues, and zero hormones, it is well suited for plant-based meat, protein beverages, baked goods, and pet food.

Olive fruit polyphenols, approved as antioxidant ingredients, also offer growth potential in health foods and sports nutrition products when dosage limits and intake calculations are precisely managed.

Clearer Entry Pathways for International Companies

For overseas companies, this announcement provides valuable regulatory precedents. By leveraging existing safety data from Europe or North America and supplementing it with China-specific materials, companies can potentially shorten approval timelines.

Notably, the approval history of Fusarium venenatum protein illustrates how an “international certification plus domestic application” strategy can support efficient market entry in China.

Practical Compliance Strategies for Food Companies

To capitalize on these opportunities, food sector companies should adopt a structured compliance approach encompassing assessment, adjustment, and implementation.

Review Products and R&D Pipelines Early.

Companies should systematically review existing formulations and R&D pipelines against the approved uses, dosage limits, and unsuitable populations specified for the 14 substances. This helps identify both application opportunities and potential compliance risks.

For example, sports nutrition manufacturers may assess the feasibility of incorporating beta-alanine or (6S)-5-methyltetrahydrofolate salts, while bakery companies may explore compliant inclusion levels of Fusarium venenatum protein for high-protein bread or pastry products.

Importers should also verify whether overseas parent company products contain any of the approved substances and confirm that their intended domestic use aligns with the Chinese approval conditions.

Align Formulations and Labels Before Launch.

Ensure that additive levels strictly comply with the use conditions and technical parameters specified in the announcement. This should be completed before product finalization to prevent downstream compliance risks.

In parallel, address labeling requirements at an early stage. Clearly disclose unsuitable populations and recommended intake levels in accordance with Chinese food safety regulations. For example, where elderberry anthocyanins are used, clearly state that the product is “not suitable for infants and young children, pregnant women, or lactating women.”

For imported products, accurately translate and adapt all relevant foreign-language labeling content to meet the requirements of the “General Standard for the Labeling of Prepackaged Foods” (GB 7718).

Strengthen Filing and Supply Chain Controls.

Manufacturers should integrate approved substances into supplier audit and qualification systems, requiring suppliers to provide documentation demonstrating compliance with announced specifications. Establishing traceability systems covering procurement, use, and sales records is also essential to support regulatory inspections when required.

Final Thoughts

The approval of 14 new “Three New Foods” substances reflects China’s continued effort to encourage food innovation while maintaining strict and disciplined risk control. These approvals broaden the scope for product development and ingredient adoption across multiple categories.

For international food companies, success will depend on the speed of interpretation and precision of execution. Those that act early and manage compliance rigorously will be best positioned to capture opportunity and build lasting trust in China’s food market. However, capitalizing on these approvals requires navigating a regulatory framework that is becoming both faster and more exacting.

Against this backdrop, experienced regulatory support becomes critical. With more than 20 years of on-the-ground experience in China, Cisema assists international food companies by translating regulatory developments into actionable guidance and supporting compliant market entry.

For international companies in the food sector pursuing compliant market entry in China, engage with Cisema for expert regulatory guidance and execution support.

Further Information

Learn more about Cisema’s China health food and dietary supplement regulatory services.

The 14 Newly Approved “Three New Foods”

New Food IngredientsNew Food AdditivesNew Food-related ProductsMycoprotein from Fusarium venenatumElderberry AnthocyaninsOlive Fruit PolyphenolsBranching Enzymeβ-Alanine(6S)-5-Methyltetrahydrofolate, Glucosamine Salt(6S)-5-Methyltetrahydrofolate CalciumSteviol Glycosides (Enzymatically Produced)Steviol Glycosides from Fermentation2’-FucosyllactoseCalcium Carbonate (Calcified Lithothamnion tophiforme source)C.I. Pigment White 21 (Barium sulfate)TalcPentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)