China New Food Raw Material Registration | NHC Approval

What Is a New Food Raw Material in China?

Under China's regulatory framework, established by the Administrative Measures for Safety Review of New Food Raw Materials (NHC, 2017), a new food raw material refers to any food ingredient that does not have a traditional consumption history in China and falls into one of the following categories:

• Animals, plants, or microorganisms;

• Ingredients isolated from animals, plants, or microorganisms;

• Food ingredients with altered original structures;

• Other newly developed food raw materials.

A new food raw material must have the characteristics of a food raw material, meet applicable nutritional requirements, and must not cause acute, sub-acute, chronic, or other potential health hazards. Before being used in food production and distribution in China, new food raw materials must pass NHC safety review.

For overseas companies, this means that an ingredient already used in the United States, the European Union, Japan, Australia, or other markets may still require a separate regulatory assessment in China.

Who Needs NHC New Food Raw Material Registration?

China's new food raw material registration is relevant for any overseas organization that:

• An overseas manufacturer of an innovative food ingredient;

• A food ingredient supplier planning to export to China;

• A food brand intending to use a novel ingredient in products sold in China;

• A distributor or importer introducing a new ingredient into the Chinese market;

• A company with U.S. GRAS, EU Novel Food, or other overseas authorizations seeking China market access;

• An R&D team developing synthetic biology-derived, microbial fermentation-derived, plant-derived, or functional ingredients for food use.

If your company is also exporting finished food products to China, you may need to consider GACC Registration for Food Export to China or China Prepackaged Food Regulatory Compliance Service.

When Is NHC Registration Required?

NHC registration may be required when an ingredient:

• Has no traditional consumption history in China;

• Is newly developed for food use;

• Is isolated from animals, plants, or microorganisms and has not been approved for food use in China;

• Has an altered original structure compared with existing food ingredients;

• Is intended for import, production, or use in food products in China.

What Is Not Covered by This Route?

The new food raw material route in China does not apply to all innovative food-related products. According to China’s official rules, the following products are not regulated as new food raw materials under this route:

• Genetically modified foods;

• Health foods;

• New varieties of food additives.

These products are subject to other applicable Chinese laws and regulations.

In addition, the following situations are not within the application scope for new food raw material registration:

• The material does not have the characteristics of a food raw material;

• The material is already listed in China’s GB 2760 Food Additive Use Standard;

• The material is already listed in China’s GB 14880 Food Nutrition Fortifier Use Standard;

• NHC has already made a non-approval decision for the material;

• Other circumstances that do not comply with relevant Chinese laws, regulations, or new food raw material management requirements.

Because the regulatory boundary between new food raw materials, food additives, nutrition fortifiers, health foods, FSMP ingredients, infant formula ingredients, and imported finished food can be complex, REACH24H can help companies confirm the correct China market access pathway before starting dossier preparation or testing.

China New Food Raw Material Registration Process

The China new food raw material approval process involves seven stages. The overall timeline typically averages 18 months from acceptance, though plant-based extracts may be processed in 1–2 years, while complex or high-risk ingredients can take considerably longer. Understanding each stage helps companies plan their China market entry timeline accurately.

Stage 1: Ingredient Status Check and Feasibility Assessment

REACH24H reviews the ingredient's source, production process, composition, intended use, history of consumption, overseas approvals, and existing NHC announcements. This stage determines whether full NHC registration is required, whether the substantial equivalence pathway applies, or whether an alternative compliance route is more appropriate.

Stage 2: Regulatory Gap Analysis

We identify data gaps against China's specific application requirements, covering safety data, toxicology studies, quality specifications, production processes, intended use, target population, consumption levels, and overseas use history. We also assess which elements of your existing EU or US data package can be leveraged for China.

Stage 3: Testing Strategy and Safety Assessment Planning

Based on the ingredient's type and risk profile, REACH24H develops a testing strategy and coordinates with certified Chinese laboratories to generate the required safety data. This stage is particularly critical for overseas companies unfamiliar with China's specific testing standards.

Stage 4: Dossier Preparation

Application materials are compiled in accordance with NHC requirements. All foreign-language materials must be translated into standardized Chinese. The dossier must be complete, internally consistent, and properly organized. REACH24H prepares and reviews all components, including the research and development report, safety assessment report, production process description, quality standards, and labeling materials.

Stage 5: Application Submission and Acceptance

The application is submitted through the NHC's official service portal. REACH24H manages all submission logistics and communications during the acceptance review phase.

Stage 6: Technical Review and Public Consultation

The CFSA organizes an expert panel review of the submitted safety assessment materials. The NHC may request supplementary materials, require the applicant to address technical questions, or organize on-site verification of the production process. Accepted applications are also subject to a public consultation period. REACH24H provides full support throughout this phase.

Stage 7: Approval Announcement and Post-Approval Compliance

Upon successful review, the NHC publishes an official approval announcement. The approved ingredient must be used strictly according to the approved scope, specifications, recommended intake, target population restrictions, and labeling requirements stated in the announcement.

How REACH24H Supports Your China Market Entry

REACH24H provides end-to-end China new food raw material registration support, from early-stage regulatory assessment to dossier preparation and review follow-up.

1. Registration Need Assessment

• Determine whether the ingredient falls under China’s new food raw material scope;

• Check whether the ingredient is already approved, substantially equivalent, or covered by existing standards;

• Evaluate whether an alternative pathway may be more appropriate;

• Provide a feasibility assessment, estimated project timeline, cost factors, and key regulatory risks.

2. Regulatory Gap Analysis

• Review existing safety, quality, toxicology, production, and overseas use data;

• Identify missing information against NHC application requirements;

• Assess whether overseas approval data can be leveraged for China;

• Develop a practical China registration strategy.

3. Dossier Preparation and Submission Support

• Prepare and organize application materials;

• Draft or review research reports, safety assessment summaries, production process descriptions, quality standards, labels, and instructions;

• Support translation, formatting, notarization, or certification needs where applicable;

• Assist with sample and testing coordination.

4. Technical Review Follow-up and Supplementary Response

• Track application status;

• Support communication during acceptance and technical review;

• Prepare responses to supplementary material requests;

• Assist with expert question responses and technical clarification;

• Follow up on public consultation and approval announcements.

5. Post-Approval Compliance Support

• Interpret approved use scope, specifications, intake levels, target population restrictions, and labeling requirements;

• Support downstream food product compliance review;

• Assist with China label, formula, import, and customs compliance where needed.

Why Choose REACH24H?

With more than a decade of experience in food regulatory compliance, REACH24H has supported thousands of food companies worldwide in entering target markets, including Fortune Global 500 companies. We also work with embassies, consulates, business associations, and industry organizations as a trusted market access service provider.

Decades of Food Compliance Expertise

Our food compliance team combines expertise in food science, toxicology, chemistry, biology, nutrition, and regulatory affairs. REACH24H also has toxicology professionals with credentials such as DABT, ERT, and DCST, enabling us to support safety assessment, dossier preparation, and technical responses during the NHC review process.

Global Service Network

With 9 global branches and over 300 in-house specialists, we have served over 15,000 enterprises including 103 Fortune Global 500 firms, delivering prompt cross-border regulatory support.

Trusted Technical Communication Channel

We keep regular professional communications with China’s competent regulators and technical institutes such as NHC and CFSA review panels. We help clients draft technical briefs, respond to supplementary document requirements and resolve scientific & regulatory queries in the review process.

FAQ: China New Food Raw Material Registration

Access Your Free Resource: Regulatory Pathways for Novel Food Ingredients Worldwide

We are pleased to introduce our Regulatory Pathways for Novel Food Ingredients Worldwide. This guide provides a systematic overview of the regulatory frameworks for novel food ingredients in key markets, including China, the USA, the EU, Australia-New Zealand, Japan, South Korea, and Southeast Asia.

Key sections include:

• Regulatory Frameworks & Authorities

• Approval Processes & Documentation

• Key Compliance Strategies

  

Relevant Regulations and Official References

• Administrative Measures for Safety Review of New Food Raw Materials

• Provisions on Application and Acceptance of New Food Raw Materials

• NHC Explanation on Application and Safety Review Procedures for New Food Raw Materials

Related services:

• China Prepackaged Food Regulatory Compliance Service

• GACC Overseas Manufacturers Registration

• China Health Food Registration and Filing

• China New Food Additive Registration

• China Special Medical Purpose Food Registration

• EU Novel Food (NF) Application

• U.S. FDA GRAS Certification

• U.S. FDA New Dietary Ingredient (NDI) Notification