The term "feed additives" as mentioned in these Measures refers to small or trace substances added in the process of feed processing, production and use, including nutritional feed additives and general feed additives. Article 3 Where the feed and feed additives produced by foreign enterprises are sold in the People's Republic of China for the first time, they shall apply to the People's Republic of China and the Ministry of Agriculture for registration and obtain the product registration certificate; Feed and feed additives that have not obtained the product registration certificate shall not be sold or used in China. Article 4 Imported feed and feed additives shall conform to the principles of safety, effectiveness and no environmental pollution. Feeds and feed additives that have been eliminated or banned from production, sale and use in the producing country (region) shall not be registered. Article 5 When applying for the registration certificate of imported feed and feed additives, foreign manufacturers or their agents shall submit the following materials and product samples to the People's Republic of China and the Ministry of Agriculture:
(1) An application form for registration of imported feed or feed additives (in duplicate, filled in both Chinese and English).
(2) The agent is required to submit the authorization letter of registration entrusted by the production enterprise.
(3) Submit application materials (in duplicate in Chinese and English), including the following contents:
1. Product name (common name, commodity name);
2. The certificate that the production country (region) has approved the production and sales in its own country and the registration information in other countries;
3. Product source, components and manufacturing method;
4. Quality standards and inspection methods;
5. Label style, instruction manual and trademark;
6. Scope of application, method of use or dosage;
7. Packaging specifications, storage precautions and shelf life;
8. Provide safety evaluation test report and stability test report when necessary;
9. Feeding test data and its popularization and application;
1. Other relevant materials.
(4) submit product samples.
1. each variety needs 3 different batch numbers, and each batch number needs 3 samples, each of which is 3-5 times the inspection requirement. At the same time, attach the quality inspection report of the batch number sample;
2. If necessary, provide the standard or reference substance corresponding to the product. Article 6 The Ministry of Agriculture shall make a decision on whether to accept or not within 15 working days after receiving all the above application materials and product samples. If it is decided to accept it, it shall be submitted to the feed quality inspection institution designated by the Ministry of Agriculture for product quality review inspection. Seventh feed quality inspection institutions shall complete the product quality review inspection within 3 months after receiving the product samples and related materials, and submit the inspection results to the National Feed Work Office of the Ministry of Agriculture. The applicant shall assist the feed quality inspection institution to review the quality inspection. Article 8 Feed and feed additives that have not obtained the registration permission of the producing country (region) must undergo feeding tests and safety evaluation tests when they are registered in China. The test fee shall be borne by the applicant. Article 9 Feed and feed additives that have not been allowed by the People's Republic of China but have been approved for production and use by the exporting country shall be fed and tested for safety if necessary. The test plan shall be reviewed by the Ministry of Agriculture, and the test undertaker shall be approved by the Ministry of Agriculture. The test fee shall be borne by the applicant. Article 1 The applicant shall be responsible for the adverse consequences caused by the application of product samples during the test. Eleventh products with complete application materials and qualified quality review inspection shall be issued with registration certificates of imported feed and feed additives after passing the examination by the Ministry of Agriculture. Under the circumstances specified in Article 8 and Article 9, the results of feeding test and safety evaluation test shall be submitted to the National Feed Evaluation Committee for examination and approval, and the Ministry of Agriculture shall issue a product registration certificate. Article 12. Once the feed and feed additives that have been registered and used in the People's Republic of China are proved to be harmful to human body, farmed animals and the environment, their use shall be restricted or their registration shall be cancelled immediately. Foreign manufacturers should compensate all economic losses. Thirteenth units and personnel engaged in the registration, evaluation, review and testing of imported feed and feed additives shall keep confidential the technical information provided by the applicant. Article 14 The registration certificate of imported feed and feed additive products shall be valid for five years. After the expiration, if it is still necessary to continue to sell in China, it shall apply for renewal of registration within six months before the expiration of the product registration certificate. Article 15 The following materials and product samples shall be provided for renewal registration:
(1) Submit an application form for renewal registration;
(2) submit a copy of the original product registration certificate;
(3) provide the latest approval documents, quality standards, product specifications and other necessary information of the producing country (region). Article 16 Imported feed and feed additives that fail to renew their registration within the prescribed time limit or fail to pass the supervision and spot check once shall be sent to product samples for re-inspection. Except for those who are punished for business suspension. Seventeenth production countries (regions) have stopped production and use of feed and feed additives, or more than two consecutive supervision and inspection of unqualified imported feed and feed additives shall not be renewed.