Order of the Ministry of Agriculture of the People's Republic of China

No. 2 of 2014

The "Administrative Measures for the Registration of Imported Feed and Feed Additives", which were deliberated and adopted at the 11th executive meeting of the Ministry of Agriculture on December 27, 2013, are hereby promulgated and shall come into force on July 1, 2014. The Administrative Measures for the Registration of Imported Feed and Feed Additives promulgated by the Ministry of Agriculture on August 17, 2000 and revised on July 1, 2004 shall be abolished at the same time.

Minister Han Changfu

January 13, 2014

Measures for the Administration of Registration of Imported Feed and Feed Additives

Article 1 In order to strengthen the supervision and management of imported feed and feed additives and ensure the quality and safety of animal products, these Measures are formulated in accordance with the Regulations on the Administration of Feed and Feed Additives.

Article 2 The term "feed" as mentioned in these Measures refers to the industrially processed and manufactured products for animal consumption, including single feed, pre-mixed feed with additives, concentrated feed, compound feed and concentrate supplements.

The term "feed additives" as mentioned in these Measures refers to small or trace amounts of substances added in the process of feed processing, production and use, including nutritional feed additives and general feed additives.

Article 3 An overseas enterprise that exports feed and feed additives to China for the first time shall apply to the Ministry of Agriculture for import registration and obtain an import registration certificate for feed and feed additives; those without an import registration certificate shall not be sold or used in China.

Article 4 When an overseas enterprise applies for import registration, it shall entrust an agency within China to handle it.

Article 5 The feed and feed additives applied for import registration shall meet the requirements of the relevant laws, regulations and technical specifications of the place of production and China.

The feed and feed additives that are not approved for production, use or are prohibited from being produced or used by the place of production shall not be registered.

Article 6 To apply for the import registration of feed and feed additives, one shall submit true, complete and standardized application materials (both in Chinese and English, in duplicate) and samples to the Ministry of Agriculture.

Article 7 The application materials include:

(1) Application form for import registration of feed and feed additives.

(2) Power of Attorney and Qualification Certificate of Domestic Agency: If an overseas enterprise entrusts its resident representative office in China to act as an agent for registration, it shall provide the original power of attorney and a copy of the "Registration Certificate of Foreign Enterprise's Resident Representative Office in China"; For registration, the original power of attorney and a copy of the legal person business license of the agency shall be provided.

(3) The certificate of approval of production and use by the place of production, the registration information of other countries and regions other than the place of production, and the promotion and application of the product.

(4) Product name, composition, physical and chemical properties, scope of application, and method of use of imported feed; product name, main ingredients, physical and chemical properties, source of product, purpose of use, scope of application, and method of use of imported feed additives.

(5) Production technology, quality standards, testing methods and inspection reports.

(6) The labels, trademarks and Chinese label styles used in the place of production.

(7) For microbial products or fermented products, a strain preservation certificate issued by an authoritative institution shall also be provided.

To export the feed and feed additives specified in Article 13 of these Measures to China, the following application materials shall also be submitted:

(1) The chemical structure identification report of the active components or the classification identification report of animals, plants and microorganisms.

(2) Product effectiveness evaluation test report and safety evaluation test report (including target animal tolerance evaluation report, toxicology safety evaluation report, metabolism and residue evaluation report, etc.) issued by the testing agency designated by the Ministry of Agriculture; application for feed additives For import registration, an analysis and evaluation report of the possible impact on human health caused by the residues of the feed additive in aquaculture products shall also be provided.

(3) Stability test report and environmental impact report.

(4) If there is a maximum limit requirement in the feed product, the maximum limit value and the detection method of the active ingredient in the feed product shall also be provided.

Article 8 Product samples shall meet the following requirements:

(1) Each product shall be provided with 3 batches and 2 samples of each batch, and each sample shall be no less than 5 times of the testing requirement;

(2) Provide relevant standards or chemical reference substances when necessary.

Article 9 The Ministry of Agriculture shall review the application materials within 10 working days from the date of accepting the application; if the review is qualified, the applicant shall be notified to submit the samples to the inspection agency designated by the Ministry of Agriculture for review and testing.

Article 10 Review testing includes quality standard review and sample testing. If there are national standards and industry standards for the detection methods, the national standards or industry standards shall be adopted preferentially; if there are no national standards and industry standards, the detection methods provided by the applicant shall be adopted; when necessary, the inspection agency may adjust the detection methods according to the actual situation.

The inspection agency shall complete the review and testing work within 3 months, and submit the review and testing report to the Ministry of Agriculture, with a copy to the applicant at the same time.

Article 11 If an overseas enterprise has any objection to the re-inspection test results, it shall apply for re-inspection within 15 working days from the date of receipt of the re-inspection test report.

Article 12 For those who pass the review and test, the Ministry of Agriculture will issue a feed and feed additive import registration certificate within 10 working days, and make an announcement.

Article 13 If the feed or feed additive applied for import registration falls under any of the following circumstances, the Ministry of Agriculture shall organize a review in accordance with the review procedures for new feed and new feed additives:

(1) Exporting to China feed and feed additives that have not been used in China but have been approved for production and use in the place of production;

(2) Expanding the scope of application of feed additives;

(3) The content and specifications of feed additives are lower than the requirements of the safe use of feed additives, except for those prepared by feed additives and carriers or diluents in a certain proportion;

(4) Significant changes have occurred in the production process of feed additives;

(5) Products for which the Ministry of Agriculture has issued new feed and new feed additive certificates have not been put into production for more than 3 years from the date of obtaining the certificate;

(6) Other situations where there are quality and safety risks.

Article 14 The validity period of the import registration certificate for feed and feed additives is 5 years.

If the feed and feed additive import registration certificate expires and needs to continue to export feed and feed additives to China, it shall apply for renewal 6 months before the expiration of the validity period.

Article 15 To apply for renewal, the following materials shall be provided:

(1) Application form for renewal registration of imported feed and feed additives;

(2) A copy of the import registration certificate;

(3) Power of attorney and domestic agency qualification certificate;

(4) Certificates of production and use approved by the place of production;

(5) Quality standards, testing methods and testing reports;

(6) The labels, trademarks and Chinese label styles used in the place of production.

Article 16 Under any of the following circumstances, samples shall be submitted for re-examination when applying for renewal:

(1) In accordance with relevant laws, regulations and technical specifications, it is necessary to adjust the product quality and safety inspection items;

(2) The product testing method has changed;

(3) There are unqualified records in the supervision and random inspection.

Article 17 Within the validity period of the import registration certificate, if the production site of the imported feed or feed additive is relocated, or the product quality standard, production process, application scope, etc. change, the registration shall be re-applied.

Article 18 Where any of the following circumstances occurs within the validity period of the import registration certificate for imported feed and feed additives, an application for modification registration shall be applied:

(1) The product name in Chinese or foreign language is changed;

(2) applying for a change in the name of the enterprise;

(3) The name of the manufacturer is changed;

(4) The name of the production address is changed.

Article 19 To apply for modification registration, the following materials shall be provided:

(1) Application form for registration of imported feed and feed additives;

(2) Power of attorney and domestic agency qualification certificate;

(3) The original copy of the import registration certificate;

(4) Change description and relevant supporting documents.

The Ministry of Agriculture will make a decision on whether to approve the change within 10 working days after accepting the application for change registration.

Article 20 The relevant units and personnel engaged in the registration of imported feed and feed additives shall keep confidential the technical information submitted by the applicant that needs to be kept confidential.

Article 21 An overseas enterprise shall establish a sales agency within the territory of China according to law or entrust a qualified agency within the territory of China to sell imported feed and feed additives.

Foreign enterprises are not allowed to directly sell imported feed and feed additives in China.

Article 22 An overseas enterprise shall, within 6 months from the date of obtaining the feed and feed additive import registration certificate, set up a sales agency or entrust a sales agency within the territory of China and report to the Ministry of Agriculture for the record.

If the sales agency or sales agency specified in the preceding paragraph is changed, it shall be reported to the Ministry of Agriculture for a new record within one month.

Article 23 Imported feed and feed additives shall be packaged, and the packaging shall comply with China's regulations on safety and hygiene, and shall be accompanied by Chinese labels that comply with the regulations.

Article 24 If the imported feed and feed additives are proved to be harmful to the breeding animals, human health or the environment in the process of use, the Ministry of Agriculture shall announce the ban and the import registration certificate shall be revoked.

During the validity period of the feed and feed additive import registration certificate, if the production place prohibits the use of the feed or feed additive product or revokes its production or use license, the overseas enterprise shall immediately report to the Ministry of Agriculture, and the Ministry of Agriculture will revoke the import registration certificate and make an announcement.

Article 25 If an overseas enterprise finds that the feed and feed additives it exports to China are harmful to the health of farmed animals and human beings, or there are other potential safety hazards, it shall immediately notify its sales organization or sales agency in China, and report to the Ministry of Agriculture. Report.

The sales organization or sales agency of an overseas enterprise in China shall voluntarily recall the products specified in the preceding paragraph, record the recall, and report to the feed management department of the place of sale.

The recalled products shall be harmlessly disposed of or destroyed under the supervision of the feed management department of the local people's government at or above the county level.

Article 26 The Ministry of Agriculture and the feed management departments of the local people's governments at or above the county level shall organize and conduct supervision and spot checks on imported feed and feed additives on a regular or irregular basis as needed; Institutions with corresponding technical conditions designated by the feed management departments of the people's governments of autonomous regions and municipalities directly under the Central Government shall undertake the responsibility.

The supervision and random inspection of imported feed and feed additives shall be carried out according to the quality standards determined by the review and inspection during the import registration process.

Article 27 The Ministry of Agriculture and the feed management department of the provincial people's government shall publish the results of supervision and spot checks in a timely manner, and may publish the list of overseas enterprises with bad records and their sales agencies and sales agencies.

Article 28 The relevant personnel engaged in the registration of imported feed and feed additives, who fail to perform their duties as prescribed in these Measures, or abuse their powers, neglect their duties, or engage in malpractices for personal gain, shall be punished according to law; if a crime is constituted, they shall be investigated for criminal responsibility according to law.

Article 29 Where an application for import registration is provided by providing false information or samples or by other deceptive means, the Ministry of Agriculture shall not accept or approve the application, and will no longer accept the application for import registration by the overseas enterprise and registration agency within one year.

Those who provide false information, samples or obtain the import registration certificate of feed and feed additives by other deceptive methods, the Ministry of Agriculture shall revoke the import registration certificate, impose a fine of RMB 50,000 but less than RMB 100,000 on the registration agency, and will no longer accept the overseas registration within 3 years. Import registration applications for businesses and registration agencies.

Article 30 Other acts in violation of these Measures shall be punished in accordance with the relevant provisions of the Regulations on the Administration of Feed and Feed Additives.

Article 31 These Measures shall come into force on July 1, 2014. The Administrative Measures for the Registration of Imported Feed and Feed Additives promulgated by the Ministry of Agriculture on August 17, 2000 and revised on July 1, 2004 shall be abolished at the same time.