As the food industry grows and consumer demands diversify, innovation in new food ingredients becomes crucial for product differentiation and market strategy in China.

This article summarizes China's new food ingredient acceptance, approval, and regulatory trends in H1 2025 (data up to June 30), offering practical compliance insights for food companies.

Application Trends and Review Progress

In H1 2025, China had received 34 new food ingredient applications, marking a significant year-on-year increase. Among them, 27 were domestic and 7 were imported. Compared with the same period in 2024, the number of applications more than doubled—already surpassing the full-year totals of any of the past five years, reaching a record high. This surge reflects not only the industry's growing interest in innovation but also its ability to act quickly on regulatory opportunities.

Probiotic strains continue to dominate applications, underscoring the deepening trend in microbiome research and application. Notable strains include Bifidobacterium longum subsp. infantis YLGB-1496, Lacticaseibacillus paracasei N1115, Bacillus subtilis subsp.natto)VB205, Bifidobacterium bifidum BGN4, and Streptococcus salivarius K-12 and M18.

Functional ingredients also saw active submissions, including L-theanine, L-ergothioneine, β-lactoglobulin, N-Acetylneuraminic Acid (NANA), and N-acetylglucosamine (NAG). Meanwhile, plant-based extracts such as Cyclocarya paliurus leaf extract and Ampelopsis grossedentata polyphenols remain in focus, reflecting continued consumer interest in natural ingredients.

In terms of review progress, 2 ingredients (Hericium erinaceus BCRC35669 mycelium and tauroursodeoxycholic acid complex) have received review comments; 26 ingredients are currently under extended review, highlighting the dual challenges of growing review pressure and the need for caution.

Approved New Food Ingredients in H1 2025

In H1 2025, the National Health Commission (NHC) issued Notices No. 1 and 3 under the so-called "Three New Foods" announcements (covering new food ingredients, additives, and food-related products), approving 6 new food ingredients and revising the usage level for rye pollen (overriding the provisions of 2023 Notice No. 3).

1. More Diverse Ingredient Categories

The newly approved ingredients span microbial strains, plant extracts, and functional compounds. Notably, D-allulose produced via synthetic biology was approved—the first of its kind—marking a major regulatory breakthrough for synthetic biology in China's food sector.

2. Varying Review Timelines

The average review period was around 18 months, ranging from as short as 10 months (e.g., Lemon myrtle leaf, Sakura polyphenols, and B. longum subsp. infantis LMG11588) to as long as 4 years and 8 months (e.g., Calciumβ-hydroxy-β-methylbutyrate(CaHMB)). In general, plant-based ingredients tend to have shorter approval timelines, typically between 1 to 2 years.

These approvals reflect more efficient regulatory execution and offer companies greater predictability in product development timelines.

*Data source: National Health Commission Service Platform. Acceptance dates are indicative only.

Alternative Regulatory Outcomes: Termination

In addition to standard reviews, some new food ingredients were concluded through "review termination", forming a flexible alternative regulatory pathway.

As of June 30, 2025, the NHC had listed 88 ingredients on its public platform as terminated from review. Most of them were determined to be "substantially equivalent" to already approved ingredients. These ingredients can be managed as general food, local specialty food, or substances traditionally used in both food and medicine—allowing for market access.

In 2025 alone, 6 new ingredients received termination conclusions (4 in January, 2 in May), highlighting the growing use of this mechanism to accelerate commercialization. Companies are encouraged to systematically assess the potential for substantial equivalence when planning new product applications, especially where similar ingredients already exist.

Public Consultations: More Approvals Expected

The CFSA conducted three rounds of public consultation in H1 2025, covering eight ingredients. Of these, four ingredients were officially approved as of July 2 (under Notice No. 4):

Saccharomyces cerevisiae CNCMI-3799, D-allulose/D-psicose, Bifidobacterium animalis subsp.lactis BLa80, and Bifidobacterium longum subsp. infantis LMG11588.

The remaining four are still under review. If approved, they are expected to boost confidence in innovation and regulatory clarity for similar products.

Outlook and Recommendations

Over recent years, the average time from acceptance to approval of new food ingredients has gradually decreased, suggesting faster regulatory processing. This provides a positive signal for companies pursuing ingredient innovation and market entry. ZMUni Compliance Centre offers the following recommendations:

1. Leverage the Synthetic Biology Regulatory Window

Since September 2024, China has opened the regulatory channel for food ingredients produced using genetically modified microorganisms (GMMs). The CFSA is now responsible for conducting Class I and II GMO safety assessments. This policy shift has streamlined the approval process and created a more favorable environment for synthetic biology innovations. Companies should align their regulatory strategy with this opportunity.

2. Explore the "Substantial Equivalence" Pathway

For ingredients substantially equivalent in composition and safety to existing approved ingredients, the NHC often recommends review termination and provides management suggestions. This mechanism not only reduces review burdens but also enables faster market entry. Businesses should understand its implications and assess the feasibility of applying it, especially when using differentiated processes (e.g., via GMM production).

3. Prioritize Compliance and Dossier Quality

While review timelines are improving, regulatory standards remain high. Companies should keep a close eye on policy updates and complete full safety assessments covering toxicology, physicochemical properties, production processes, and nutritional data. A clear, well-structured dossier is key to success. Partnering with a professional compliance agency can further increase success rates and reduce uncertainties.