(Promulgated by Decree No. 327 of the State Council of the People's Republic of China on November 29, 2001, and effective as of the date of promulgation)

The State Council decides to make the following amendments to the Regulations on Administration of Animal Feed and Feed Additives:

1. One article is added as 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.

"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.

"Except for the following circumstances, the registration department shall not disclose the data provided in the first paragraph:

(1) the disclosure of such data is necessary to protect the public;

(2) steps have been taken to ensure that the data are protected against unfair commercial use."

2. The title of Chapter III is changed to be "Administration of Production, Operation and Use".

3. One article is added as Article 19: "The use of feed additive shall abide by the norms for safe use formulated by the competent agricultural administrative department of the State Council.

"It is prohibited from using the animal feed or feed additive provided for by Article 18 of these Regulations. It is prohibited from adding any hormonal medicine or any other medicine the use of which is prohibited by the competent agricultural administrative department of the State Council to animal feed or drinking water for animals."

4. Article 23 is changed to be Article 25: "Where anyone, in violation of the provisions of these Regulations, deals in animal feed or feed additives without attaching product quality inspection certificates and product labels thereto or without the production license, number of the document of approval or the standard for product quality, the animal feed administrative department of the local people's government at or above the county level shall order him to stop operations, confiscate the products illegally dealt in and the illegal income, and may concurrently impose a fine of not more than one time the amount of the illegal income."

5. Article 26 is changed to be Article 28: "Where anyone, in violation of the provisions of these Regulations, produces or deals in animal feed or feed additives the use of which has been stopped, prohibited or eliminated or those that have not made public upon approval, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of illegal business operation, be investigated for according to law; where such acts are not serious enough for criminal punishment, the animal feed administrative department of the local people's government at or above the county level shall order him to stop production or operations, confiscate the products illegally produced or dealt in and the illegal income therefrom, and concurrently impose a fine of not less than one time but not more than five times the illegal income."

6. One article is added as Article 29: "Where, in violation of the provisions of these Regulation, the feed additive is used not in compliance with the provisions of the competent agricultural administrative department of the State Council, the animal feed administrative department of the local people's government at or above the county level shall order to make corrections promptly, and may concurrently impose a fine of not more than 30,000 yuan.

"Where the animal feed or feed additive provided for by Article 18 of these Regulations is used, or where any hormonal medicine or any other medicine the use of which is prohibited by the competent agricultural administrative department of the State Council is added to animal feed or drinking water for animals, the animal feed administrative department of the local people's government at or above the county level shall have the contraband medicine confiscated, and may concurrently impose a fine of not less than 10,000 yuan and not more than 50,000 yuan."

7. Article 27 is changed to be Article 30: "Where anyone, in violation of the provisions of these Regulations, commits any of the following acts, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of producing or selling fake or substandard commodities, be investigated for according to law; where such acts are not serious enough for criminal punishment, the animal feed administrative department of the local people's government at or above the county level shall order him to stop production or operations, confiscate the products illegally produced or dealt in and the illegal income therefrom, and concurrently impose a fine of not less than one time but not more than five times the illegal income; if the circumstances are serious, the competent agricultural administrative department of the State Council shall have his production license revoked:

(1) in the process of production and business operations, passing substances other than animal feed or feed additives off as real ones, or passing one category of animal feed or feed additives off as another category;

(2) producing or dealing in animal feed or feed additives that contain components whose categories and names differ from those as indicated on the labels of the products;

(3) producing or dealing in animal feed or feed additives that fail to conform to the product quality standards therefor; or

(4) dealing in animal feed or feed additives that have lost their efficacy, become mildewed or the quality guaranty period of which has expired."

8. Article 28 is changed to be Article 31: "Where anyone deals in imported animal feed or imported feed additives that are not registered by the competent agricultural administrative department of the State Council, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of illegal business operation, be investigated for according to law; where such acts are not serious enough for criminal punishment, the animal feed administrative department of the local people's government at or above the county level shall order business operations ceased immediately, confiscate the unsold products and illegal income, and concurrently impose a fine of not less than one time but not more than five times the illegal income."

9. Article 29 is changed to be Article 32: "Where anyone falsifies, forges, buys or sells in production licenses, serial numbers of the approval documents for the products or the product registration certificates of feed additives or feed additive premixes, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of illegal business operation or the crime of forging, altering or buying or selling official documents, credentials or seals of State organs, be investigated for according to law; where such acts are not serious enough for criminal punishment, the competent agricultural administrative department of the State Council or the animal feed administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, in accordance with their respective duties and powers, seize or revoke the production licenses, the serial numbers of the approval documents for the products or the product registration certificates, confiscate the illegal income and concurrently impose a fine of not less than one time but not more than five times the illegal income."

In addition, the order of some articles shall be adjusted correspondingly, and "Article 13" and "Article 14" referred to in Article 24 are changed to be "Article 14" and "Article 15" respectively, "Article 15" referred to in Article 25 is changed to be "Article 16".

This Decision shall be effective as of the date of promulgation.

The Regulations on Administration of Animal Feed and Feed Additives shall be amended correspondingly according to this Decision and re-promulgated.

Regulations on Administration of Animal Feed and Feed Additives

(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)

Chapter I General Provisions

Article 1These 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.

Article 2The 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.

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.

Article 3The competent agricultural administrative department of the State Council is responsible for the administration of animal feed and feed additives throughout the country.

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.

Chapter II Evaluation and Import Administration

Article 4The State encourages the research in and innovative manufacture of new animal feed and new feed additives.

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.

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.

Article 5The 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:

(1) the names, main components and physical and chemical properties of the new products;

(2) the methods of development and manufacture, production process, quality standards and methods of testing of the new products;

(3) the feeding effect, dynamic status of degrading residues, and toxicology of the new products; and

(4) the environmental impact report and pollution prevention measures.

Article 6The 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.

Article 7Anyone 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:

(1) the trademarks, labels and status of popularizing and application;

(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;

(3) the information as prescribed in Article 5 of these Regulations.

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.

Article 8The 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.

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.

Except for the following circumstances, the registration department shall not disclose the data provided in the first paragraph:

(1) the disclosure of such data is necessary to protect the public;

(2) steps have been taken to ensure that the data are protected against unfair commercial use.

Chapter III Administration of Production, Operation and Use

Article 9The 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:

(1) having the plant, equipment, processing technology and storage facilities which are compatible with the production of animal feed and feed additives;

(2) having the full time technical personnel compatible with the production of animal feed and feed additives;

(3) having the necessary product quality inspection unit, inspectors and inspection and testing facilities;

(4) having a production environment which meets the requirements set by the State for safety and hygiene; and

(5) having the facilities for pollution prevention and control that satisfy the State environmental protection requirements.

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.

Article 10Upon 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.

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.

Article 11Enterprises producing animal feed or feed additives shall organize production in accordance with the product quality standards and institute the system of keeping production records and reserving product samples for observation.

Article 12No animal drugs and other prohibited drugs shall be directly added to the products in the process of producing animal feed or feed additives; the animal drugs that are permitted to be added shall be added only after they have been turned into medical feed additives; no hormonic drugs shall be added to the medical feed additives to be produced.

Article 13Product quality inspections shall be effected when enterprises produce animal feed and feed additives. Product quality inspection certificates shall be attached to the products that have been confirmed as up to the quality standards through inspection and testing; no products without product quality inspection certificates attached shall be marketed.

Article 14The packaging of animal feed and feed additives shall conform to the relevant State provisions on safety and hygiene.

Cautions or application directions shall be indicated on the packages for inflammable animal feed or feed additives and those that require special packages, and special care and cautions relating to storage and transportation shall be clearly indicated on the packages.

Packages for animal feed or feed additives shall be used once only except where the producer and user have agreed otherwise.

Article 15Labels shall be attached to the packages of animal feed and feed additives. The product names, composition, guaranty value of the product composition's analysis, net weight, production date, quality guaranty period, plant name, plant address and standard code number of the product must be indicated on the label in Chinese or other valid symbols.

On the label of feed additives shall also be indicated the method of use and other matters to pay attention to.

For animal feed with medical feed additives, there must be "with medical feed additives" on the label, which also explains the chemical name, composition, method of use and matters to pay attention to.

On the labels for feed additives and feed additive premixes, the serial number of the approval document for the products and the production license numbers shall also be indicated.

Article 16An enterprise which deals in animal feed and feed additives shall meet the following conditions:

(1) having warehouses which are suited for the operation of animal feed and feed additives;

(2) having professional technical personnel who are equipped with knowledge about the use, storage and packaging of animal feed and feed additives; and

(3) having the necessary product quality control system.

Article 17An enterprise which deals in animal feed and feed additives must check the product labels and product quality inspection certificates when purchasing such products.

It is forbidden to deal in animal feed and feed additives without product quality standards, without a product quality inspection certificate, without a production license or the serial number of the approval document for the products.

Article 18It is forbidden to produce and deal in animal feed and feed additives the use of which has been stopped or forbidden and which have been eliminated or those that have not been evaluated and made public.

It is forbidden to deal in imported animal feed and imported feed additives that have not been registered by the competent agricultural administrative department of the State Council.

Article 19The use of feed additive shall abide by the norms for safe use formulated by the competent agricultural administrative department of the State Council.

It is prohibited from using the animal feed or feed additive provided for by Article 18 of these Regulations. It is prohibited from adding any hormonal medicine or any other medicine the use of which is prohibited by the competent agricultural administrative department of the State Council to animal feed or drinking water for animals.

Article 20If animal feed and feed additives are, through use, proved to be harmful to animals raised, human health and the environment, the competent agricultural administrative department of the State Council shall decide to restrict, cease or prohibit the use thereof and make it public.

Article 21It is forbidden to make written remarks about or publicize the efficacy of animal feed and feed additives in preventing and curing animal diseases; however, if medical feed additives are added in animal feed, written remarks may be made about the efficacy of the medical feed additives added.

Article 22The agencies that engage in quality inspection of animal feed and feed additives may undertake product quality inspection assignments of animal feed and feed additives only after their qualifications therefor have been confirmed through verification by the department of product quality supervision and administration or the competent agricultural administrative department of the State Council, or by the departments of product quality supervision and administration or the animal feed administrative departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government.

Article 23The competent agricultural administrative department of the State Council may carry out quality supervision and sample testing of animal feed and feed additives according to the national action plan for product quality supervision and sample testing formulated by the department of product quality supervision and administration of the State Council; but repeated testing is not permitted.

The animal feed administrative departments of the local people's governments at or above the county level may organize supervision and sample testing of animal feed and feed additives according to the action plan for quality supervision and sample testing of animal feed and feed additives and shall, in conjunction with the department of product quality supervision and administration at the same level,

Chapter IV Penalty Provisions

Article 24Where anyone, in violation of the provisions of these Regulations, produces feed additives or feed additive premixes without obtaining a production license, the animal feed administrative department of the local people's government at or above the county level shall order him to stop production, confiscate the illegal products and illegal income and concurrently impose a fine of not less than one time but not more than five times the illegal income; those who have obtained a production license but have not obtained the serial number of the approval document for the product shall be ordered to stop production and to acquire the serial number of the approval document for the product within a time limit.

Article 25Where anyone, in violation of the provisions of these Regulations, deals in animal feed or feed additives without attaching product quality inspection certificates and product labels thereto or without the production license, number of the document of approval or the standard for product quality, the animal feed administrative department of the local people's government at or above the county level shall order him to stop operations, confiscate the products illegally dealt in and the illegal income, and may concurrently impose a fine of not more than one time the amount of the illegal income.

Article 26Where the packaging of animal feed or feed additives fails to conform to the provisions of Article 14 of these Regulations, or the labeling fails to conform to the provisions of Article 15 of these Regulations, the animal feed administrative department of the local people's government at or above the county level shall order amends made within a time limit; if no amends are made within the given time limit, the sales shall be ordered to be stopped and a fine of not less than the amount of the illegal income may be imposed.

Article 27Where anyone, in the absence of the conditions prescribed in Article 16 of these Regulations, deals in animal feed or feed additives, the animal feed administrative department of the local people's government at or above the county level shall order amends made within a time limit; if no amends are made within the time limit, the business operations shall be ordered to be stopped, the illegal income shall be confiscated, and a fine of not less than one time but not more than three times the illegal income may be concurrently imposed.

Article 28Where anyone, in violation of the provisions of these Regulations, produces or deals in animal feed or feed additives the use of which has been stopped, prohibited or eliminated or those that have not made public upon approval, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of illegal business operation, be investigated for according to law; where such acts are not serious enough for criminal punishment, the animal feed administrative department of the local people's government at or above the county level shall order him to stop production or operations, confiscate the products illegally produced or dealt in and the illegal income therefrom, and concurrently impose a fine of not less than one time but not more than five times the illegal income.

Article 29Where, in violation of the provisions of these Regulation, the feed additive is used not in compliance with the provisions of the competent agricultural administrative department of the State Council, the animal feed administrative department of the local people's government at or above the county level shall order to make corrections promptly, and may concurrently impose a fine of not more than 30,000 yuan.

Where the animal feed or feed additive provided for by Article 18 of these Regulations is used, or where any hormonal medicine or any other medicine the use of which is prohibited by the competent agricultural administrative department of the State Council is added to animal feed or drinking water for animals, the animal feed administrative department of the local people's government at or above the county level shall have the contraband medicine confiscated, and may concurrently impose a fine of not less than 10,000 yuan and not more than 50,000 yuan.

Article 30Where anyone, in violation of the provisions of these Regulations, commits any of the following acts, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of producing or selling fake or substandard commodities, be investigated for according to law; where such acts are not serious enough for criminal punishment, the animal feed administrative department of the local people's government at or above the county level shall order him to stop production or operations, confiscate the products illegally produced or dealt in and the illegal income therefrom, and concurrently impose a fine of not less than one time but not more than five times the illegal income; if the circumstances are serious, the competent agricultural administrative department of the State Council shall have his production license revoked:

(1) in the process of production and business operations, passing substances other than animal feed or feed additives off as real ones, or passing one category of animal feed or feed additives off as another category;

(2) producing or dealing in animal feed or feed additives that contain components whose categories and names differ from those as indicated on the labels of the products;

(3) producing or dealing in animal feed or feed additives that fail to conform to the product quality standards therefor; or

(4) dealing in animal feed or feed additives that have lost their efficacy, become mildewed or the quality guaranty period of which has expired.

Article 31Where anyone deals in imported animal feed or imported feed additives that are not registered by the competent agricultural administrative department of the State Council, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of illegal business operation, be investigated for according to law; where such acts are not serious enough for criminal punishment, the animal feed administrative department of the local people's government at or above the county level shall order business operations ceased immediately, confiscate the unsold products and illegal income, and concurrently impose a fine of not less than one time but not more than five times the illegal income.

Article 32Where anyone falsifies, forges, burs or sells production licenses, serial numbers of the approval documents for the products or the product registration certificates of feed additives or feed additive premixes, criminal liability shall, in compliance with the provisions in the Criminal Law on the crime of illegal business operation or the crime of forging, altering or buying or selling official documents, credentials or seals of State organs, be investigated for according to law; where such acts are not serious enough for criminal punishment, the competent agricultural administrative department of the State Council or the animal feed administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, in accordance with their respective duties and powers, seize or revoke the production licenses, the serial numbers of the approval documents for the products or the product registration certificates, confiscate the illegal income and concurrently impose a fine of not less than one time but not more than five times the illegal income.

Chapter V Supplementary Provisions

Article 33The meanings of the following terms as used in these Regulations are:

(1) Nutritional feed additives refer to the substances of small or tiny quantities that are used to add to the nutritional components of animal feed, including animal feed class amino acids, vitamins, mineral trace elements, enzymes and non-protein nitrogen, etc.

(2) Ordinary feed additives refer to the substances of small or tiny quantities that are added to animal feed in order to ensure or improve the quality of animal feed and enhance the efficiency of the use of animal feed.

(3) Medical feed additives refer to vet-pharma premixes to which a medium or dilutor is added to prevent or cure animal diseases, including anti-coccocidiosis, vermifuges and bacteriostat growth promoters, etc.

Article 34Medical feed additives shall be administered according to the provisions of the Regulations on the Control of Animal Drugs.

Article 35These Regulations shall be effective as of the date of promulgation.