Novel Food Ingredient Registration & Regulatory Compliance Services (China)

Reg-Compliance specializes in Novel Food Ingredient (New Food Resource) registration and compliance in China, providing end-to-end, one-stop regulatory solutions for both domestic and international companies.

With a deep understanding of China’s novel food regulatory framework and practical submission requirements, we support clients throughout the entire registration lifecycle—helping innovative food ingredients achieve lawful approval, compliant application, and successful market entry in China.

Definition of Novel Food Ingredients in China

Novel Food Ingredients refer to food raw materials without a history of traditional consumption in China. They fall into four main categories:

• Animal-, plant-, and microorganism-derived materials
• Components isolated from animals, plants, or microorganisms
• Food ingredients with altered original structures
• Other newly developed food raw materials

China’s Regulatory Framework & Approval Authority

Under the Food Safety Law of the People’s Republic of China, Novel Food Ingredients are subject to a mandatory pre-market approval system.

Any food produced using a novel food ingredient—or imported food containing such ingredients—must obtain national-level approval prior to commercialization. Ingredients that have not been approved are prohibited from use in food production or distribution.

Core Registration Dossier Requirements

Standard Application Materials

A complete Novel Food Ingredient registration dossier typically includes:

• Novel Food Ingredient registration application form
• Ingredient research report and safety assessment report
• Manufacturing process description and product specification/standard
• Draft labeling and product instructions
• Information on domestic and international research, use history, and safety evaluations
• Other supporting materials relevant to safety assessment
• Representative ingredient samples

Additional Requirements for Imported Ingredients

For imported Novel Food Ingredients, the following documents are also required

• Official certification demonstrating that the ingredient is legally permitted for production and sale in the country or region of origin
• Compliance, inspection, or certification documents related to the overseas manufacturing facility

Standard Registration & Approval Process in China

Novel Food Ingredient registration in China follows a standardized, centrally managed approval process overseen by the National Health Commission. Horizon Regulatory provides full-process support and professional coordination at every stage:

• Dossier Submission

  Preparation and formal submission of complete regulatory documentation to the NHC

• Technical Review

  Coordination with expert reviews organized by the China National Center for Food Safety Risk Assessment (CFSA), including responses to technical inquiries and dossier supplementation

• Public Consultation

  Monitoring official announcements and public comment procedures following successful technical review

• Administrative Approval

  Continuous tracking of regulatory decisions and administrative approval progress

• Final Announcement

  Confirmation and follow-up on official approval publication to ensure compliant market implementation

Our End-to-End Regulatory Services

Horizon Regulatory delivers full lifecycle support for Novel Food Ingredient registration, offering tailored solutions from early-stage assessment through final approval:

Regulatory Feasibility Assessment

Professional evaluation of ingredient characteristics, R&D background, and intended use to determine regulatory eligibility and define the optimal registration pathway.

Gap Analysis & Risk Identification

Comprehensive identification of dossier gaps and compliance risks, with clear recommendations for data supplementation and optimization.

Dossier Preparation & Submission

Expert support in drafting and structuring all required regulatory documents, including manufacturing processes and safety assessments, followed by official submission management.

Approval Tracking & Regulatory Communication

Real-time monitoring of review progress, professional handling of authority feedback, dossier revisions, and expert review communications to facilitate efficient approval.

Our Competitive Advantages

Experienced Regulatory Team with Global Reach

Our senior regulatory experts possess extensive hands-on experience in Novel Food Ingredient approvals across China, the United States, Taiwan, Singapore, and other jurisdictions, offering strong cross-regional regulatory insight.

Full-Process Control to Minimize Regulatory Risk

Deep familiarity with China’s review focus, technical challenges, and supplementation requirements enables proactive risk management and higher approval success rates.

Tailored Solutions for Domestic & Imported Ingredients

We design customized regulatory strategies for locally developed and imported ingredients, adapting to different ingredient types, technical characteristics, and commercial objectives.

High-Efficiency Project Management

Dedicated project teams provide responsive, one-on-one support, rapid issue resolution, and continuous progress tracking—significantly shortening approval timelines and accelerating compliant market entry.