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Data Requirements for Registration of Imported Feed and Feed Additives

DATE:2013-05-13       SOURCE:MOA
 

Item Name: Data Requirements for Registration of Imported Feed and Feed Additives

 

Item Type: Examination prior to its Approval

Contents of Examination :
1. Whether the product conforms with the State’s regulations on feed and feed addictive;
2. Whether the product is safe, effective, controllable and environmental-friendly;
3. Whether the experiment data and documents concerned are valid and reliable;
4. Whether the results of the quality recheck up is up to the standard.

Legal Basis:
1. Regulations on Administration of Feed and Feed Additives;
2. Measures for the Registration and Administration of Feed and Feed Addictives (No.[2000] 38; No. [2004] 38 Amendment, Ministry of Agriculture);
3. Catalogue of feed additive varieties released by the Ministry of Agriculture.

Requirements:
Samples of the products and the following documents are required for application (Both Chinese and English versions are required except for special regulations, the original and a duplicate are both necessary. The original English documents should be provided by the manufacturer).
1. Application Form for Feed and Feed Additives Import;
2. Proof of approval from originating country (region) for production and sales in this country (region), and the registration information in other countries (regions) (notarization and confirmation required);
3. Authorization  from manufacturer to agent for registration on its behalf;
4. Description on the composition of raw materials, active ingredients and physiochemical properties of the product;
5. Production process flow chart and description of manufacturing method;
6. Quality standards, inspection procedures and product samples of 3 batch numbers and their test reports;
7. Product’s scope of application, applied quantity and description of usage precautions and other matters needing attention;
8. Label, packing specifications, cautions on storage and description of shelf life;
9. For the products that have been approved for use in producing countries or regions but not yet in China, expert assessment is required prior to registration. The following documents are needed (1 original and 2 duplicates):
(1) Official certification of approval from originating country (region) on the product or the application of active ingredients as feed additives;
(2) General description of the product;
(3) Test reports on the chemical structures of the product’s active ingredients and the classified identification reports of animals, plants and microorganism;
(4) Sample of product descriptions;
(5) Stability experiment report;
(6) Feeding test report and application report;
(7) Safety test report;
(8) Bibliography.

Procedure: 
1. Acceptance of documents. The applicant’s Application Form for Imported Feed and Feed Additives and related documents are submitted to the General Office of Administrative Examination and Approval of the Ministry of Agriculture for pre-examination;
2. Project examination. The National Feed Industry Office of the Ministry of Agriculture shall examine the application documents according the relevant regulations;
3. Quality recheck up. According to the results of the preliminary examination, applicants shall submit samples of 3 batch numbers for quality recheck up to the feed test institutions designated by the Ministry of Agriculture;
4. Feeding test and safety assessment test. For the products which have not obtained national or local registration, the applicant should submit the samples to the designated institutions by the Ministry of Agriculture for feeding test and safety assessment test. For the products that have been approved for use in producing countries or regions but not yet in China, the applicant should submit the samples to the designated institutions by the Ministry of Agriculture for feeding test, and if necessary, accompanied by safety assessment test;
5. Expert evaluation. The National Feed Evaluation Council shall examine and assess the feed and feed additive products, according to the results of the above-mentioned two types of tests;
6. Approval issuance. Based on the results of the quality recheck up and expert assessment, the National Feed Industry Office the Ministry of Agriculture shall work out the approval proposal, which will then be submit to the Minister for final approval.

Timeline: 20 working days (a maximum of 6 months for expert evaluation; and a maximum of 3 months for quality recheck up)

Charge: free of charge

 

Contact Information

 

Mail:    To: Livestock Production Desk

Address: Administrative Examination and Approval Office

Ministry of Agriculture

No.11 Nongzhanguan Nanli, Chaoyang District, Beijing, China

Postcode: 100125  

 

(All information posted in this website is authentic in Chinese. English version is provided for reference only.)

 

 

 

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