Entering the Chinese market: key regulatory considerations for novel foods and food additives

China is one of the world's largest and most dynamic food markets, offering significant opportunities for companies developing innovative ingredients, biotechnology-derived products, novel foods and food additives. At the same time, the regulatory landscape differs considerably from the regulatory landscapes in Europe and North America, making early planning and a thorough understanding of local requirements essential for successful market entry.

To help companies better understand these requirements, Biosafe recently hosted a webinar featuring Tian Xue, Co-Founder of Blotting Consultancy, who provided an overview of China's approval pathways for novel foods and food additives and shared practical insights from his experience supporting regulatory submissions in the Chinese market. Based in China, Tian and his team support food industry clients with regulatory strategies and registrations across a broad range of innovative products, including novel foods, food additives, genetically modified products and biotechnology-derived ingredients.

 

Understanding China's "Three New Foods" framework

China regulates innovative food products through a framework commonly referred to as the “Three New Foods” system. This framework covers:

• Novel Foods

• New Food Additives

• New Food-Related Products

Novel foods generally refer to substances that do not have an established history of consumption in China. This may include new microorganisms, plants, animals, isolated components or ingredients produced using innovative technologies. According to the framework presented during the webinar, a traditional consumption history is generally considered to be approximately 30 years of documented use in China.

New food additives include substances that are not already authorised under China's existing food additive standards, as well as applications seeking expanded uses or increased dosage levels for currently approved additives. New food-related products primarily concern food-contact materials and related substances.

For companies developing fermentation-derived ingredients, microbial products, sweet proteins, human milk oligosaccharides (HMOs) and other biotechnology-enabled innovations, determining which regulatory pathway applies is one of the first and most important steps in market access planning.

A regulatory system that continues to evolve

One of the key themes highlighted by Tian was the rapid evolution of China's regulatory landscape for food innovation.

Over recent years, China has seen a growing number of applications involving genetically modified production organisms, enzyme preparations, HMOs, carotenoids, sweet proteins and other biotechnology-derived products. The presentation highlighted how regulatory pathways have gradually expanded to accommodate new categories of innovative ingredients, reflecting both technological developments and increasing interest from international companies seeking access to the Chinese market.

For businesses operating in precision fermentation, industrial biotechnology and alternative protein sectors, these developments are particularly encouraging, although regulatory requirements remain rigorous and data-intensive.

Who reviews novel food applications in China?

Several authorities participate in the review and approval process.

The National Health Commission (NHC) receives applications and is ultimately responsible for granting approvals. The China National Center for Food Safety Risk Assessment (CFSA) conducts the technical review of applications, organises expert review panels and prepares scientific conclusions regarding safety and compliance. In addition, the State Administration for Market Regulation (SAMR) plays a role in market supervision and may provide comments during the review process.

Together, these authorities form a multi-stage evaluation system designed to assess both safety and regulatory compliance before products enter the market.

The approval process: more than just a dossier

A recurring message throughout the webinar was that successful approval requires much more than simply submitting a dossier. Novel food applications typically involve detailed information on product identity, manufacturing processes, specifications, compositional analysis, contaminant testing, microbiological testing, toxicological data, exposure assessments and supporting evidence from other markets where relevant.

The review process generally includes:

1. Submission of the application dossier to the NHC.

2. Technical review by the CFSA.

3. Expert panel evaluation.

4. A public consultation period.

5. Further expert review.

6. Final assessment and approval by the NHC.
   

   For some novel foods, an abbreviated route based on substantial equivalence may be available. However, as Tian emphasised, even these submissions typically require comprehensive supporting documentation and are not exempt from the need to demonstrate safety and compliance.

Toxicology requirements remain a key consideration

The topic that generated the most audience discussion was toxicological testing. Many companies developing novel ingredients already possess extensive toxicological packages generated for European, North American or other international submissions. A common question is therefore whether existing studies can also be used in China.

According to Tian, the answer is often "yes and no".

While overseas studies may theoretically be acceptable, reviewers must still determine whether the studies were performed in accordance with China’s GB standards for toxicological testing. In practice, this can create uncertainty because assessments are conducted by expert review panels whose members are selected from a larger expert pool. Different experts may have differing views regarding the suitability of foreign-generated studies, including studies conducted under GLP.

According to Tian, batch analysis reports and toxicological studies are generally expected to be generated by laboratories holding China’s CMA certification. As a result, companies planning future entry into China may benefit from considering Chinese requirements already during broader global regulatory planning.

Frequently asked questions by companies entering China

The webinar concluded with an active question-and-answer session that revealed several recurring concerns among international applicants:

Can a foreign company submit an application directly?

According to Tian, applications currently need to be submitted through a company established in China. International businesses therefore typically require a local entity or local partner to manage the submission process.

Can toxicological studies conducted outside China be used?

Potentially, yes. However, acceptance is assessed case by case. While some experts may readily accept overseas GLP studies, others may request additional information or supplementary testing to demonstrate compliance with Chinese requirements.

Does approval provide exclusivity?

Regulatory approval itself does not provide exclusive rights to a product. However, Tian noted that for certain biotechnology-derived and fermentation-based products, approval specifications may include details about production strains or microorganisms. This can create an indirect level of protection because competing products would need to meet the same specifications.

How much information becomes public?

Participants also asked about confidentiality during public consultation. According to Tian, information such as product specifications, summaries of analytical methods and intended uses may be disclosed, while detailed manufacturing information is generally not made publicly available.

Are requirements different for infant nutrition ingredients such as HMOs?

Tian explained that HMOs are currently regulated under a food additive pathway in China. For these applications, published scientific and clinical literature can often play an important role in supporting technical justification, rather than requiring new clinical studies for each individual product.

Early planning supports efficient market access

One of the strongest conclusions from the webinar was that China deserves its own regulatory strategy alongside EU and US market planning.

Although existing safety data and international approvals can provide valuable support, Chinese authorities may require additional information, alternative study designs or documentation that differs from expectations in other jurisdictions. Understanding these requirements early can help companies identify potential data gaps, reduce duplication of work and develop more efficient market access strategies.

Looking ahead

China continues to be an increasingly important destination for innovative ingredients, precision fermentation products, microbial solutions, sweet proteins, HMOs and other next-generation food technologies. At the same time, the approval process remains highly structured, with extensive scientific and regulatory requirements.

As highlighted by Tian Xue during the Biosafe webinar, companies that begin considering Chinese regulatory expectations early in product development are often better positioned to navigate the approval process efficiently and support successful global commercialisation.

Through webinars like this, Biosafe helps food and biotechnology companies understand evolving regulatory requirements across global markets and make better-informed decisions throughout product development and commercialisation.