Regulation on the Administration of Feeds and Feed Additives (2017 Revision)

Regulation on the Administration of Feeds and Feed Additives (2017 Revision) Regulation on the Administration of Feeds and Feed Additives (Issued by Order No. 266 of the State Council of the People's Republic of China on May 29, 1999; amended for the first time according to the Decision of the State Council on Amending the Regulation on the Administration of Feeds and Feed Additives as issued on November 29, 2001; revised and adopted at the 177th executive meeting of the State Council on October 26, 2011; amended for the second time according to the Decision of the State Council on Amending Some Administrative Regulations on December 7, 2013; and amended for the third time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016; and amended for the fourth time in accordance with the Decision of the State Council to Amend and Repeal Certain Administrative Regulations on March 1, 2017) Chapter I General Provisions Article 1 This Regulation is developed to strengthen the administration of feeds and feed additives, improve the quality of feeds and feed additives, guarantee the quality and safety of animal products, and maintain the health of the general public. Article 2 For the purpose of this Regulation, the term “feeds” means industrially processed or manufactured products to be fed to animals, including single feeds, additive premix feeds, concentrated feeds, formula feeds, and concentrate supplements. For the purpose of this Regulation, the term “feed additives” means the small quantities or traces of substances added in the processing, manufacturing and use of feeds, including nutritional feed additives and general feed additives. The catalogue of feed raw materials and the catalogue of feed additive varieties shall be developed and published by the agriculture administrative department under the State Council. Article 3 The agriculture administrative department under the State Council shall be responsible for the supervision and management of feeds and feed additives nationwide. The department in charge of the administration of feeds and feed additives under a local people's government at or above the county level (hereinafter referred to as the “feed administrative department”) shall be responsible for the supervision and administration of feeds and feed additives within the administrative region. Article 4 A local people's government at or above the county level shall lead the supervision and administration of feeds and feed additives within its administrative region in a unified way, establish sound regulatory mechanisms, and guarantee the implementation of regulatory work. Article 5 The production enterprises and business operators of feeds and feed additives shall establish sound quality safety rules and be responsible for the quality safety of feeds and feed additives they produce and deal. Article 6 All organizations and individuals shall be entitled to report the violations of this Regulation in the production, business operation and use of feeds and feed additives and to give opinions and suggestions on the supervision and administration of feeds and feed additives. Chapter II Approval and Registration Article 7 The state encourages the research and development of new feeds and new feed additives. In the research and development of new feeds and new feed additives, the principles of science, safety, effectiveness, and environmental protection shall be followed, and the quality safety of new feeds and new feed additives shall be guaranteed. Article 8 Before a developed new feed or new feed additive is put into production, the developer or production enterprise shall file an application for examination and approval with the agriculture administrative department under the State Council and provide samples of the new feed or new feed additive together with the following materials: (1) Name, main components, physical and chemical properties, development methods, production techniques, quality standards, testing methods, testing reports, stability test reports, environmental impact reports, and pollution prevention and control measures. (2) A report on the feeding effects, residue dissipation dynamics and toxicology safety evaluation of such new feed or new feed additive, as issued by a testing institution designated by the agriculture administrative department under the State Council. To apply for the examination and approval of a new feed additive, the applicant shall also state the purpose of adding such feed additive and the use method and provide an analysis and evaluation report on the possible impact of the residue of such feed additive on human health. Article 9 The agriculture administrative department under the State Council shall, within five working days of accepting an application, submit the samples of a new feed or feed additive and the application materials to the National Feed Evaluation Committee for evaluation of the safety, effectiveness and environmental impact of such feed or feed additive. The National Feed Evaluation Committee shall consist of experts in aspects such as breeding, feed processing, animal nutrition, toxicology, pharmacology, metabolism, health, chemical composition, biological technologies, quality standards, environmental protection and food safety risk appraisal. The National Feed Evaluation Committee shall evaluate new feeds and new feed additives by holding evaluation meetings, which shall be attended by nine or more experts from the National Feed Evaluation Committee, and as required, one or two experts other than those from the National Feed Evaluation Committee may also be invited to participate in evaluation. Experts participating in evaluation shall have voting rights on matters subject to evaluation. Evaluation opinions and minutes of meetings shall be formed at evaluation meetings and be examined and signed by participating experts, and dissents (if any) shall be indicated. Experts participating in evaluation shall fulfill their duties in a fair and impartial manner according to the law, keep the evaluation materials confidential, and voluntarily withdraw if there is any cause for withdrawal. The National Feed Evaluation Committee shall, within nine months of receiving the samples of a new feed or feed additive and the application materials, issue evaluation results and submit them to the agriculture administrative department under the State Council; however, if the National Feed Evaluation Committee decides to have the applicant conduct relevant experiments, the evaluation period may be extended by three months upon the approval of the agriculture administrative department under the State Council. The agriculture administrative department under the State Council shall, within ten working days of receiving the evaluation results, make a decision on whether to issue a new feed or feed additive certificate; and if the department decides not to issue the certificate, it shall notify the applicant in writing and give reasons. Article 10 When the agriculture administrative department under the State Council issues a new feed or feed additive certificate, it shall also publish the product quality standards for the new feed or feed additive according to its functions and powers. Article 11 New feeds and new feed additives shall be subject to a monitoring period of five years. Within the monitoring period of a new feed or feed additive, any other application for the production or import registration of the feed or feed additive shall not be accepted, unless the feed or feed additive has not been put into production for three years or more. A production enterprise shall collect information on the quality stability of new feeds and new feed additives within the monitoring period and their impact on the quality safety of animal products, and report to the agriculture administrative department under the State Council. The agriculture administrative department under the State Council shall organize the tracking and monitoring of the quality safety status of new feeds and new feed additives, and if it is verified that there is any safety problem in any new feed or new feed additive, the new feed or feed additive certificate shall be revoked and such revocation shall be announced. Article 12 To export to China any feed or feed additive that has not been used within the territory of China but has been approved by the export country for production and use, the exporter's office within the territory of China or the agency within the territory of China commissioned by it shall apply to the agricultural administrative department of the State Council for registration, and provide samples of the feed or feed additive together with the following materials: (1) Trademark, label, and the information on the promotion and application thereof. (2) Approval certificates of production and use at the place of production and the registration materials in any country or region other than the place of production. (3) Main components, physical and chemical properties, development methods, production techniques, quality standards, testing methods, testing reports, stability test reports, environmental impact reports, and pollution prevention and control measures. (4) A report on the feeding effects, residue dissipation dynamics and toxicology safety evaluation of such new feed or new feed additive, as issued by a testing institution designated by the agriculture administrative department under the State Council. To apply for the import registration of a feed additive, the applicant shall also state the purpose of adding such feed additive and the use method and provide an analysis and evaluation report on the possible impact of the residue of such feed additive on human health. The agriculture administrative department under the State Council shall organize evaluation according to the procedure for evaluation of new feeds or new feed additives as prescribed in Article 9 of this Regulation, and shall decide whether to issue a feed or feed additive import registration certificate. To export to China for the first time any feed or feed additive that has been used within the territory of China and has been approved by the export country for production and use, the applicant shall apply for registration under paragraphs 1 and 2 of this Article. The agriculture administrative department of the State Council shall, within ten working days of accepting an application, examine the application materials; deliver the samples to the designated institution for recheck and inspection if the application passes examination; and issue a feed or feed additive import registration certificate within ten working days if the feed or feed additive passes the recheck and inspection. A feed or feed additive import registration certificate shall be valid for five years. Where the export of a feed or feed additive to China needs to be continued at the expiry of the validity of the import registration certificate, the applicant shall apply for renewal six months before the date of expiry. It is prohibited to import any feed or feed additive for which a feed or feed additive import registration certificate has not been obtained. Article 13 The state shall protect the undisclosed experimental data and other data which are obtained and submitted by the applicant of any feed or feed additive containing new compounds for which a new feed or feed additive certificate or a feed or feed additive import registration certificate has been obtained. Where, within six years of issuance of a certificate, any other applicant applies for the approval of a new feed or feed additive or for the import registration of a feed or feed additive by using the data prescribed in the preceding paragraph without the consent of the applicant that has obtained a new feed or feed additive certificate or a feed or feed additive import registration certificate, the agriculture administrative department under the State Council shall not grant approval or registration, unless the data submitted by the said other applicant is separately obtained by itself. Except for the following circumstances, the agriculture administrative department under the State Council shall not disclose the data prescribed in paragraph 1 of this Article: (1) The data is needed for the public interests. (2) Measures have been taken to guarantee that such information will not be unjustly used for commercial purposes. Chapter III Production, Business Operation, and Use Article 14 To form a production enterprise of feeds or feed additives, the applicant shall conform to the development planning and policies of the feed industry and meet the following conditions: (1) Having the factory buildings, equipment, and storage facilities appropriate for the production of feeds or feed additives. (2) Having full-time technicians appropriate for the production of feeds or feed additives. (3) Having necessary product quality inspection institutions, personnel, facilities, and quality management rules. (4) Having a production environment conforming to the safety and hygienic requirements of the state. (5) Having pollution prevention and control measures that conform to the environmental protection requirements of the state. (6) Having other conditions set out in the quality safety management rules for feeds and feed additives as developed by the agriculture administrative department under the State Council. Article 15 To apply for engaging in the production of feeds or feed additives, the applicant shall apply to the feed administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government. The feed administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within ten working days of accepting the application, conduct a documentary examination; if the application passes the examination, the department shall organize an on-site examination and, within ten working days, make a decision on whether to issue the production license on the basis of the examination results. A production license shall be valid for five years. Where the production of a feed or feed additive needs to be continued at the expiry of the validity of the production license, the applicant shall apply for renewal six months before the date of expiry. Article 16 After a production enterprise of feed additives or additive premix feeds obtains a production license, the feed administrative department of the people's government of the province, autonomous region or municipality directly under the Central Governmen......