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| Regulations on Administration of Animal Feed and Feed Additives | | 饲料和饲料添加剂管理条例 |
(Promulgated by Decree No. 266 of the State Council of the People's Republic of China on May 29, 1999, and revised in accordance with the Decision of the State Council on Amending the Regulations on Administration of Animal Feed and Feed Additives on November 29, 2001) | |
（１９９９年５月２９日中华人民共和国国务院令第２６６号发布 根据２００１年１１月２９日《国务院关于修改〈饲料和饲料添加剂管理条例〉的决定》修订） |
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| Chapter I General Provisions | | 第一章 总则 |
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| Article 1 These Regulations are formulated for the purpose of enhancing the administration of animal feed and feed additives, improving the quality of animal feed and feed additives, accelerating the development of the feed industry and breeding industry and maintaining the health of the people. | | 第一条 为了加强对饲料、饲料添加剂的管理，提高饲料、饲料添加剂的质量，促进饲料工业和养殖业的发展，维护人民身体健康，制定本条例。 |
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| Article 2 The term "animal feed" as used in these Regulations refers to the industrially processed and manufactured feed used by animals for food, including single feed, feed additive premixes, concentrated feed, assorted feed and concentrated supplementary feed. | | 第二条 本条例所称饲料，是指经工业化加工、制作的供动物食用的饲料，包括单一饲料、添加剂预混合饲料、浓缩饲料、配合饲料和精料补充料。 |
The term "feed additives" as used in these Regulations refers to the small or tiny quantities of substances that are added in the course of processing, manufacturing or using animal feed, including nutritional feed additives and ordinary feed additives. The competent agricultural administrative department of the State Council shall formulate and promulgate the catalogue of feed additive varieties. | |
本条例所称饲料添加剂，是指在饲料加工、制作、使用过程中添加的少量或者微量物质，包括营养性饲料添加剂和一般饲料添加剂。饲料添加剂的品种目录由国务院农业行政主管部门制定并公布。 |
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| Article 3 The competent agricultural administrative department of the State Council is responsible for the administration of animal feed and feed additives throughout the country. | | 第三条 国务院农业行政主管部门负责全国饲料、饲料添加剂的管理工作。 |
The departments responsible for the administration of animal feed and feed additives of the local people's governments at or above the county level (hereinafter referred to as the animal feed administrative departments) are responsible for the administration of animal feed and feed additives in their respective areas. | |
县级以上地方人民政府负责饲料、饲料添加剂管理的部门（以下简称饲料管理部门），负责本行政区域内的饲料、饲料添加剂的管理工作。 |
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| Chapter II Evaluation and Import Administration | | 第二章 审定与进口管理 |
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| Article 4 The State encourages the research in and innovative manufacture of new animal feed and new feed additives. | | 第四条 国家鼓励研究、创制新饲料、新饲料添加剂。 |
The developers and producers (hereinafter referred to as the applicants) of the newly developed and manufactured animal feed and feed additives shall, prior to the actual production thereof, submit to the competent agricultural administrative department of the State Council written applications for new product evaluation, and after testing and feeding experiments carried out by an agency designated by the competent agricultural administrative department of the State Council, the national animal feed assessing board shall, on the basis of the results of testing and feeding experiments, assess the safety and effectiveness of the new products and their impact on the environment; certificates for new animal feed and feed additives shall be issued by the competent agricultural administrative department of the State Council and be made public if the new products are confirmed as qualified through the assessment. | |
新研制的饲料、饲料添加剂，在投入生产前，研制者、生产者（以下简称申请人）必须向国务院农业行政主管部门提出新产品审定申请，经国务院农业行政主管部门指定的机构检测和饲喂试验后，由全国饲料评审委员会根据检测和饲喂试验结果，对该新产品的安全性、有效性及其对环境的影响进行评审；评审合格的，由国务院农业行政主管部门发给新饲料、新饲料添加剂证书，并予以公布。 |
The national animal feed assessing board shall be composed of experts in the fields of animal breeding, animal feed processing, animal nutrition, toxicology, pharmacology, metabolism, hygiene, chemical synthesis, biotechnology, quality standards and environmental protection, etc. | |
全国饲料评审委员会由养殖、饲料加工、动物营养、毒理、药理、代谢、卫生、化工合成、生物技术、质量标准和环境保护等方面的专家组成。 |
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| Article 5 The applicants shall, in addition to the provision of samples of the new products, provide the following information when they apply for the evaluation of their new products of animal feed and feed additives: | | 第五条 申请人提出饲料、饲料添加剂新产品审定申请时，除应当提供新产品的样品外，还应当提供下列资料： |
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| (1) the names, main components and physical and chemical properties of the new products; | | （一）该新产品的名称、主要成分和理化性质； |
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| (2) the methods of development and manufacture, production process, quality standards and methods of testing of the new products; | | （二）该新产品的研制方法、生产工艺、质量标准和检测方法； |
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| (3) the feeding effect, dynamic status of degrading residues, and toxicology of the new products; and | | （三）该新产品的饲喂效果、残留消解动态和毒理； |
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| (4) the environmental impact report and pollution prevention measures. | | （四）环境影响报告和污染防治措施。 |
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| Article 6 The quality standards of animal feed and feed additives promulgated by the competent agricultural administrative department of the State Council are trade standards; where there is a need to formulate national standards, the matter shall be handled in accordance with the relevant provisions of the Standardization Law. | | 第六条 国务院农业行政主管部门公布的新饲料、新饲料添加剂的产品质量标准，为行业标准；需要制定国家标准的，依照标准化法的有关规定办理。 |
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| Article 7 Anyone who intends to import animal feed or feed additives for the first time shall apply for registration to the competent agricultural administrative department of the State Council and provide the samples of the animal feed or feed additives to be imported together with the following information: | | 第七条 首次进口饲料、饲料添加剂的，应当向国务院农业行政主管部门申请登记，并提供该饲料、饲料添加剂的样品和下列资料： |
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| (1) the trademarks, labels and status of popularizing and application; | | （一）商标、标签和推广应用情况； |
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| (2) the certificates of approval for production and marketing in the producer's country, and the registration documents issued by countries other than the producer's country; | | （二）生产国批准生产、销售的证明和生产国以外的其他国家的登记资料； |
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| (3) the information as prescribed in Article 5 of these Regulations. | | （三）本条例第五条规定的资料。 |
Product registration certificates shall be issued for the animal feed and feed additives as contained in the preceding paragraph by the competent agricultural administrative department of the State Council if these products are confirmed, through examination, as safe, effective and environmentally non-contaminating. | |
前款饲料、饲料添加剂经审查确认安全、有效、不污染环境的，由国务院农业行政主管部门颁发产品登记证。 |
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| Article 8 The State offers protection to undisclosed test or other data acquired and submitted by the applicant of animal feed or feed additive that has been granted approval or registration and contains new chemical entities. | | 第八条 国家对获得审定或者登记的、含有新化合物的饲料、饲料添加剂的申请人提交的其自己所取得且未披露的试验数据和其他数据实施保护。 |
For a period of six years from the date of approval or registration, if any second applicant applies for approval or registration of animal feed or feed additive by relying on the data provided in the preceding paragraph without the permission of the applicant who has been granted approval or registration, the approval or registration department shall grant no approval or registration, unless the second applicant has his own the data. | |
自审定或者登记之日起６年内，对其他申请人未经已获得审定或者登记的申请人同意，使用前款数据申请饲料、饲料添加剂审定或者登记的，审定或者登记机关不予审定或者登记；但是，其他申请人提交其自己所取得的数据的除外。 |
Except for the following circumstances, the registration department shall not disclose the data provided in the first paragraph: | |
除下列情况外，审定或者登记机关不得披露第一款规定的数据： |
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| (1) the disclosure of such data is necessary to protect the public; | | （一）公共利益需要； |
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| (2) steps have been taken to ensure that the data are protected against unfair commercial use. | | （二）已采取措施确保该类信息不会被不正当地进行商业使用。 |
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| Chapter III Administration of Production, Operation and Use | | 第三章 生产、经营和使用管理 |
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| Article 9 The establishment of enterprises producing animal feed or feed additives shall, in addition to conforming to the requirements for the establishment of enterprises prescribed in the provisions of the relevant laws and administrative regulations, meet the following conditions: | | 第九条 设立饲料、饲料添加剂生产企业，除应当符合有关法律、行政法规规定的企业设立条件外，还应当具备下列条件： |
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| (1) having the plant, equipment, processing technology and storage facilities which are compatible with the production of animal feed and feed additives; | | （一）有与生产饲料、饲料添加剂相适应的厂房、设备、工艺及仓储设施； |
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| (2) having the full time technical personnel compatible with the production of animal feed and feed additives; | | （二）有与生产饲料、饲料添加剂相适应的专职技术人员； |
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| (3) having the necessary product quality inspection unit, inspectors and inspection and testing facilities; | | （三）有必要的产品质量检验机构、检验人员和检验设施； |
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| (4) having a production environment which meets the requirements set by the State for safety and hygiene; and | | （四）生产环境符合国家规定的安全、卫生要求； |
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| (5) having the facilities for pollution prevention and control that satisfy the State environmental protection requirements. | | （五）污染防治措施符合国家环境保护要求。 |
Enterprise registration procedures shall be undertaken only for those enterprises that have been confirmed as meeting the conditions as prescribed in the preceding paragraph through the examination by the competent agricultural administrative department of the State Council or by the animal feed administrative departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government in keeping with the division of their responsibilities. | |
经国务院农业行政主管部门或者省、自治区、直辖市人民政府饲料管理部门按照权限审查，符合前款规定条件的，方可办理企业登记手续。 |
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| Article 10 Upon verification by the animal feed administrative departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government, enterprises producing feed additives or feed additive premixes shall be issued production licenses by the competent agricultural administrative department of the State Council. | | 第十条 生产饲料添加剂、添加剂预混合饲料的企业，经省、自治区、直辖市人民政府饲料管理部门审核后，由国务院农业行政主管部门颁发生产许可证。 |
The animal feed administrative departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government shall issue, through verification, the serial numbers of the approval documents for the products of feed additives or feed additive premixes to the enterprises mentioned in the preceding paragraph after they have obtained the production licenses. | |
前款企业取得生产许可证后，由省、自治区、直辖市人民政府饲料管理部门核发饲料添加剂、添加剂预混合饲料产品批准文号。 |
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