Understanding Novel Food Ingredients in China – A Comprehensive Guide

Navigating the complex regulatory landscape for Novel Food Ingredients in China can be challenging. We specialize in providing end-to-end registration and compliance services to help your products meet China’s stringent regulatory requirements. From initial assessment to final approval, we ensure a seamless process for your novel food ingredient registration.

What Are Novel Food Ingredients (NFI)?

Novel Food Ingredients refer to ingredients that do not have a history of traditional consumption in China, including:

1. Animals, plants, and microorganisms
2. Components derived from animals, plants, or microorganisms
3. Food ingredients with altered structures
4. Other newly developed food ingredients

Under the Food Safety Law of China, any production or import of food using novel ingredients requires a safety assessment and approval from the National Health Commission (NHC).

How Are Novel Food Ingredients Regulated in China?

The NHC oversees the registration process, which includes:

• Safety assessment and technical review
• Public consultation
• Final approval and announcement

Only ingredients that meet strict safety standards are approved for use in the Chinese market.

New Food Ingredient Registration Process

Pre-Application Preparation

• Assess the raw material’s characteristics, production processes, and intended consumption to ensure it qualifies as a novel food ingredient.

• Conduct thorough safety evaluations

• Compile essential documentation: application forms, new food ingredient development reports, safety assessment reports, production processes, relevant standards being followed, labels and instructions, domestic and international research utilization situations and related safety assessment data.

Application Submission

• Complete the designated application form with accurate and comprehensive information.

• Submit all supporting materials to the National Health Commission’s designated service portal or acceptance center.

Technical Review

• Expert panels conduct a detailed technical evaluation of materials like the safety assessment reports, production processes, and quality control measures, and provide review opinions.

Public Consultation

• For transparency, the ingredients that pass the technical review are publicly announced to gather feedback, further ensuring compliance and public safety.

Administrative Approval

• Based on the comprehensive reviews and any necessary follow-up actions, the National Health Commission makes a final administrative approval decision. Approved ingredients receive an official approval certificate and are publicly announced for market use. If not approved, businesses can make corrections and reapply.

Our Novel Food Ingredient Registration Services

We provide comprehensive support for your NFI registration, including:

1. Registration Feasibility Assessment
   Evaluate the potential for your ingredient to meet China’s regulatory requirements.
2. Gap Analysis & Strategy Development
   Identify gaps in your application and develop a tailored strategy for success.
3. Document Preparation & Submission
   Assist in preparing and submitting all required documents, including:
   • Application forms
   • Research and safety assessment reports
   • Production processes and standards
   • Labeling and instructions
   • Samples and additional supporting materials
4. Approval Process Tracking & Feedback
   Monitor the approval process, address regulatory queries, and ensure timely updates.
5. Post-Approval Support
   Help expand the usage scope of approved ingredients (e.g., new food categories, higher usage limits).

Why Choose Us?

• Expert Team: Our team of regulatory specialists and food scientists brings deep expertise in China’s food regulations, ensuring accurate and efficient solutions.
• Proven Client Satisfaction: We have earned high praise from global clients, including Fortune 500 companies, for successfully guiding them into the Chinese market.
• Global Network: With offices worldwide and strong ties to regulatory authorities and industry organizations, we deliver localized support with a global perspective.
• End-to-End Solutions: From initial assessment to post-approval support, we offer one-stop services to ensure your product remains compliant.

Frequently Asked Questions (FAQs)

How long does the complete registration process for new food ingredients take?
The registration timeline varies depending on several factors, including the preparation of application materials, the complexity of safety assessments, and the efficiency of the reviewing authorities. Generally, if the application materials are complete and meet the requirements, the approval process may proceed relatively quickly. However, if additional materials or further testing are required, the registration process may be extended.

How to improve the approval rate for new food ingredient registration?

1. Conduct a thorough feasibility assessment in the early stages, fully understanding the characteristics of the new food ingredient, its usage domestically and internationally, and market demand.
2. Prepare complete application materials and ensure their authenticity and accuracy.
3. Select qualified and competent institutions to conduct safety assessments.
4. Actively cooperate with the reviewing authorities by promptly providing supplementary materials or conducting further tests if required.

What policy support does the government provide for new food ingredient registration?
The government encourages food technology innovation and the research, development, and application of new food ingredients. Through a formal application process, new food ingredients undergo strict review to ensure their safety and suitability.

What are the recent trends in the approval of new food ingredient registrations?
In recent years, the number of applications for new food ingredients has been increasing, and the approval speed by the National Health Commission has significantly accelerated. However, the review thresholds and requirements have not been lowered, as regulatory authorities maintain extremely high standards for the quality and safety of new food ingredients.

How to expand the approved usage scope of an ingredient after approval?
According to the “Administrative Measures for the Safety Review of New Food Ingredients” and relevant requirements from the National Health Commission, if a company intends to expand the approved usage scope of an ingredient (e.g., adding food categories, increasing usage levels, or adjusting target populations), it must reapply and pass a new safety assessment.

Can microbial or genetically modified components be registered as new food ingredients?
Microbial or genetically modified components can be registered as new food ingredients if they meet the definition and application requirements for new food ingredients. However, they must undergo rigorous safety assessments and approval processes to ensure their safety and compliance.