Quick Search

PHDS HEALTHCARE RESEARCH Co., Ltd. (CRO) is a CRO company serving the world, a national high-tech enterprise, and one of the leading contract research institutions (Contract Research Organization) in the industry.

搜索历史清除全部记录
最多显示8条历史搜索记录噢~
All
  • All
  • Product Management
  • News
Services and Solutions

Global standards and quality systems, one-stop drug discovery and preclinical research services and solutions.

Product Registration

Share

New food ingredient registration


Service Overview

We provide comprehensive registration services for new food ingredients, aimed at helping businesses legally introduce innovative food ingredients to the market. Our services cover the entire process from initial consultation to obtaining the final approval certificate, ensuring that your new food ingredients comply with national food safety regulations and standards.

Service Content

Consultation on Registration Requirements

Regulatory Interpretation:We provide relevant regulatory interpretations for the registration of new food ingredients to ensure you fully understand the registration requirements.

Preparation of Application Materials:Assist you in preparing a complete set of application materials, including application forms, new food ingredient development reports, safety assessment reports, etc.

Safety Assessment

Toxicology Testing:Conduct comprehensive toxicology tests to demonstrate the safety of new food ingredients.
Nutritional Evaluation:Conduct nutritional evaluations to assess the nutritional value and safety of new food ingredients.

Data Collection and Organization

Qualification Documents:Collect business licenses, production permits, and other qualification documents.

Detailed Data Preparation:Prepare detailed information such as research and development reports for raw materials, production process descriptions, quality control measures, label samples, etc.

Submit Registration Application

Fill out Application Form:Accurately and completely fill out the new food ingredient registration application form according to the format and requirements specified by the National Health Commission.

Submit Application Materials:Submit the completed application form along with relevant supporting materials to the National Health Commission or its designated acceptance agency.

Acceptance and Review

Formal Review:Assist you in passing the formal review by the acceptance agency to ensure the completeness and compliance of application materials.

Technical Review:Organize experts to conduct a technical review of the applied new food ingredients, including reviewing safety assessment reports, production processes, quality standards, etc.

On-site Verification:Cooperate with regulatory authorities for on-site verification of the production site of new food ingredients to ensure that production conditions, processes, quality control, etc., are consistent with the submitted materials.

Administrative Approval and Certificate Management

Administrative Approval:Follow up on the administrative approval decision from the National Health Commission based on comprehensive review results.

Certificate Management:Manage the approval certificate for new food ingredients to ensure that renewal registration is applied for before its expiration.

Declaration of New Food Ingredients

'New food ingredient registration' refers to applying for registration of new food ingredients with relevant regulatory authorities in order to obtain legal market access qualifications. New food ingredients typically refer to those that do not have traditional consumption habits in our country, including animal, plant, and microbial sources; components isolated from animals, plants, and microorganisms; food components with altered original structures; as well as other newly developed food ingredients.

'Key Information on New Food Ingredient Registration'

'Registration Requirements:''The registration of new food ingredients requires submitting a series of application materials, including 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. Additionally, if applying for imported new food ingredients, proof from relevant departments or institutions in the exporting country (region) allowing the product to be produced or sold in this country (region) must also be submitted, along with proof from relevant institutions or organizations in the exporting country (region) regarding audits or certifications of the producing enterprise.'

'Registration Process:''The registration process for new food ingredients includes preparing reports on component analysis, hygiene studies, toxicological safety evaluations, risk assessment opinions, etc., as well as enterprise defenses, expert reviews, supplementary data submissions even on-site verifications and public consultations. The entire process is very strict and complex; success is closely related to the standardization and compliance of submitted materials. Therefore, conducting a pre-assessment before submission is very important.'
'Announcement Requirements:''Once a new food ingredient is approved, announcements will clearly require labeling consumption amounts and unsuitable populations on labels and instructions. This means that enterprises must strictly follow announcement regulations when using new food ingredients in production and sales.'
'Technical Barriers:''Although announced new food ingredients can be used by everyone, due to limited information published in announcements, certain technical barriers are formed. Other enterprises wishing to produce the same new food ingredient must not only obtain corresponding production licenses but also consider whether they can meet production standards and technical levels equivalent to those of the applicant.'
'Substantial Equivalence:''If a new food ingredient is substantially equivalent to an already announced new food ingredient, it may lead to termination of review. This means that enterprises need to carefully assess their differences and uniqueness compared to existing food ingredients when applying for new ones.'
'Use of Special Foods:''For certain special foods such as infant probiotics, special attention must be paid to their safety assessment data regarding specific populations.'
'In summary, registering new food ingredients is a complex and strict process involving multiple aspects of preparation work and review procedures. Enterprises need to fully understand relevant regulations and requirements when registering new food ingredients, prepare necessary materials adequately, and may need to undergo a series of reviews and assessments.'

'Registration Process'

'Preparation Before Application'

'Confirm Raw Material Properties:''Clarify basic information such as source, composition, production process, consumption methods, quality standards of new food ingredients to ensure they meet the definition and scope of new food ingredients.'

'Conduct Safety Assessment:'Conduct a comprehensive safety assessment, including toxicological tests, nutritional evaluations, microbiological inspections, etc., to prove that the raw material is harmless to human health under the expected consumption conditions.

Collect relevant information:Prepare the company's business license, production license, and other qualification documents, as well as detailed information such as the raw material's research and development report, production process description, quality control measures, and label samples.

Submit Registration Application

Fill out Application Form:Fill out the new food raw material registration application form according to the format and requirements set by the National Health Commission, providing accurate and complete information.

Submit Application Materials:Submit the completed application form and relevant supporting materials to the National Health Commission's government service hall or its designated acceptance agency.

Acceptance and Review

Formal Review:After receiving the application, the acceptance agency will conduct a formal review of the completeness and compliance of the application materials. If materials are incomplete or do not meet requirements, the company will be notified to supplement or correct them within a specified time.

Technical Review:Organize experts to conduct a technical review of the applied new food raw materials or require an on-site defense. This includes reviewing safety assessment reports, production processes, quality standards, etc., to evaluate their safety, nutritional characteristics, and compliance with relevant regulations and standards.

On-site Verification:If necessary, regulatory authorities may conduct on-site inspections of the production site of new food raw materials to check whether production conditions, processes, and quality control are consistent with the submitted materials, ensuring that product quality and safety are effectively guaranteed.

Administrative Approval:Based on the results of formal reviews, technical reviews, and on-site inspections, the National Health Commission will make an administrative approval decision. If approved, a new food raw material approval certificate will be issued; if not approved, the company can make corrections as required and reapply.

Certificate Management:The validity period of the new food raw material approval certificate is generally 5 years. Before expiration, companies need to apply for renewal in advance to ensure legal production and use of products.

Precautions

Pay attention to regulatory changes:The registration management regulations for new food raw materials may be adjusted and improved based on industry development and regulatory requirements. Companies should pay attention to changes in relevant regulations in a timely manner to ensure that registration applications comply with new provisions.
Ensure that information is true and accurate:The registration application materials submitted should be true, accurate, and complete. False information or concealment of important facts is not allowed; otherwise, it will affect the registration approval results and may face corresponding legal responsibilities.
Enhance communication and coordination:During the registration process, companies should maintain good communication with regulatory authorities to understand registration progress in a timely manner, answer questions raised during the review process, and actively cooperate with regulatory authorities' work to improve registration efficiency and success rate.

 

Our capabilities

Professional knowledge:Our team consists of food regulation experts and industry consultants who have an in-depth understanding of food additive registration processes and regulatory requirements.
Efficient processes:We have optimized the registration process to quickly respond to and handle various registration matters, shortening your product's time to market.
Successful cases:We have numerous successful cases that help clients smoothly pass through the registration process and obtain food additive approval documents.
Customer service:We provide one-on-one customer service to ensure that every question you have can be answered promptly and professionally.

 

Why choose us

 

One-stop service:From consultation to registration, we provide one-stop services so you don't have to worry about complicated registration processes.
Professional team:Our team members have a strong industry background and professional knowledge that can provide you with precise consulting services.
Cost-effectiveness:Through our professional services, you can avoid time and cost losses caused by insufficient material preparation or unfamiliarity with processes.
Continuous support:We not only help you complete registration but also provide subsequent supervision and management services to ensure your products remain compliant.

By choosing us, you will gain a trustworthy partner who helps your food additive business enter the market smoothly and efficiently. We look forward to working with you to create a future of food safety.