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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.

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Food Additive Registration


Service Overview

We provide professional food additive registration services aimed at helping enterprises ensure their products comply with national food safety standards and smoothly pass the approval process of the National Health Commission. Our services cover the entire process from initial consultation to obtaining the final registration certificate, ensuring your food additives enter the market safely and compliantly.

Service Content

Regulatory Consultation and Compliance Assessment  
Standard Compliance Check:Ensure the use of food additives complies with relevant national standards such as the 'Standards for the Use of Food Additives' (GB 2760).
Safety Assessment:Provide professional food safety assessment services, including the preparation of toxicology test reports and residue test reports.
Quality Specifications and Production Process Audit  
Quality Specification Standard Development:Clarify the quality specifications of food additives, including appearance, properties, identification methods, purity, impurity limits, etc.
Production Process and Flow Optimization:Provide consulting services for production processes and flows to ensure product quality and safety are traceable.
Labeling Review  
Label Compliance Check:Review the labels of food additives to ensure they comply with relevant laws, regulations, and standards.

Registration Process Management

Pre-application Preparation:Assist enterprises in collecting and organizing relevant product information and preparing samples.

Submit Application:Represent enterprises in submitting food additive registration applications to the National Health Commission or its designated agencies.

Document Review and Sample Inspection:Follow up on regulatory authorities' review of submitted application materials and inspection of product samples by nationally recognized testing institutions.

Technical Review and Approval Decision:Organize experts to conduct technical reviews of the applied food additives and follow up on approval decisions based on review results.

Certificate Management and Maintenance

Registration Certificate Management:Manage food additive registration certificates to ensure renewal applications are submitted before expiration.

 

 

Our Capabilities

Professional Knowledge:Our team consists of food regulation experts and industry consultants who have a deep understanding of the food additive registration process 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 helping clients smoothly navigate 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 receives timely and professional answers.

 

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 possess a strong industry background and professional knowledge, enabling us to provide you with precise consulting services.
Cost-effectiveness:Through our professional services, you can avoid time and cost losses caused by insufficient document preparation or unfamiliarity with processes.
Continuous Support:We not only help you complete registration but also provide ongoing supervision and management services to ensure your products remain compliant.

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

 

'Food Additive Declaration'

'Food additives are agents added during the food production process that comply with regulatory requirements, allowing new products to present diversity in color, aroma, flavor, and shelf life. They are often included in the 'Standards for the Use of Food Additives' (GB 2760) list. There are strict requirements for legality of varieties and compliance with dosage. The use of additives must be strictly approved by national management departments to ensure the safety and rationality of food production.'
'Situations requiring declaration include: new variety declaration and change declaration.'

'General Requirements'

'Compliance with Relevant Standards: The use of food additives must comply with relevant national standards such as the 'Standards for the Use of Food Additives' (GB 2760), which clearly stipulates usage scope, dosage limits, etc.'

'Safety Assessment: Production enterprises need to submit safety assessment materials for food additives, including toxicology test reports, residue test reports, etc., to prove that their products do not pose a risk to human health under specified usage conditions.'

'Quality Specification Standards: Clarify quality specifications for food additives, including appearance, properties, identification methods, purity, impurity limits, etc., to ensure consistency and stability in product quality.'

'Production Process and Flow: Provide detailed production processes and flows including raw material procurement, processing procedures, quality control measures, etc., to ensure product quality and safety are traceable.'

'Labeling Review: Labels for food additives should comply with relevant laws, regulations, and standards. They must include product name, ingredients, usage scope, dosage, production date, shelf life, storage conditions, manufacturer information, etc., so that consumers can correctly understand and use the product.'

'Registration Process'

Pre-application Preparation:'Enterprises need to collect and organize relevant product information such as product formulas, production processes, quality standards, safety assessment reports, labeling information, etc., and prepare samples.'
Submit Application:'Enterprises submit food additive registration applications to the National Health Commission or its designated agencies by filling out application forms along with relevant materials and samples.'
'Document Review:'The regulatory authority reviews the submitted application materials, including assessments of the product's safety, quality specifications, usage scope, and dosage. If necessary, the enterprise may be required to supplement or modify the materials.
Sample Inspection:Send product samples to a nationally recognized testing agency for inspection. The testing includes various quality indicators and safety indicators of the product to verify whether it meets relevant standards and requirements.
Technical Review:Organize experts to conduct a technical review of the applied food additives, considering factors such as product safety, necessity, and quality controllability, and provide review opinions.
Approval Decision:Based on the results of material review, sample inspection, and technical review, the regulatory authority makes an approval decision. If approved, a food additive registration certificate will be issued; if not approved, the enterprise can make corrections as required and reapply.
Certificate Management:The validity period of the food additive registration certificate is generally 5 years. Before the expiration date, enterprises need to apply for renewal in advance to ensure the legal production and use of the product.

Regular Steps for Food Additive Registration

Prepare Application Materials:This includes the chemical composition of the food additive, production process, intended use, usage amount, safety assessment report, etc.
Submit Application:Submit the prepared application materials to relevant regulatory agencies, such as the FDA (Food and Drug Administration) in the United States.
Defense, Assessment, and Review:The regulatory agency conducts a formal review of the application materials → acceptance receipt → expert defense meeting → review opinions.
Obtain Approval:If the application materials pass the review and assessment, the regulatory agency will officially publish a 'Notice of Solicitation for Opinions' on its website. After 1-2 months, it will announce that it is in effect and publish the official approval document for food additives.