(Promulgated by Decree No. 266 of the State Council of the People's Republic of China on 29 May 1999, and revised in accordance with the Decision of the State Council on Amending the Regulations on the Administration of Feed and Feed Additives on 29 November 2001)文章源自FOFCC-http://fofcc.org.cn/en/11221/
Chapter 1 General Provisions文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 1 These Regulations are formulated with a view to strengthening the administration of feeds and feed additives, improving the quality of feeds and feed additives, promoting the development of the feed industry and aquaculture, and safeguarding people's health.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 2 For the purposes of these Regulations, feed refers to feed that is industrially processed and produced for animal consumption, including single feed, additive premixed feed, concentrated feed, compound feed, and supplement feed.文章源自FOFCC-http://fofcc.org.cn/en/11221/
For the purposes of this Regulation, feed additives refer to substances added in small or trace amounts during the processing, manufacture and use of feed, including nutritional feed additives and general feed additives. The catalogue of feed additive varieties shall be formulated and published by the agriculture administrative department of the State Council.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 3 The administrative department for agriculture under the State Council shall be responsible for the nationwide administration of feed and feed additives.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Local people's governments at or above county level responsible for the administration of feed and feed additives (hereinafter referred to as the feed administration departments) shall be responsible for the administration of feed and feed additives within their respective administrative areas.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Chapter 2 Approval and Import Management文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 4 The State encourages the research and development of new feeds and new feed additives.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Prior to the commencement of production of newly developed feed and feed additives, the developers and manufacturers (hereinafter referred to as ‘the applicants’) must submit an application for the approval of new products to the competent agricultural administrative department of the State Council,following testing and feeding trials conducted by an institution designated by the competent agricultural administrative department of the State Council, the National Feed audit Committee shall, based on the results of such testing and feeding trials, conduct an audit assessment of the new product’s safety, efficacy and environmental impact;If the evaluation is passed, the competent agricultural authority of the State Council shall issue a certificate for the new feed or feed additive and make the approval public.文章源自FOFCC-http://fofcc.org.cn/en/11221/
The National Feed audit Committee is comprised of experts in animal husbandry, feed processing, animal nutrition, toxicology, pharmacology, metabolism, hygiene, chemical synthesis, biotechnology, quality standards, and environmental protection.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 5 When an applicant submits an application for the evaluation and approval of a new feed or feed additive product, in addition to providing samples of the new product, they shall also provide the following materials:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) the name, main ingredients, and physicochemical properties of the new product;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(2) the development method, production process, quality standards and testing methods of the new product;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(3) The feeding efficacy, residue elimination dynamics, and toxicology of the new product;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(4) Environmental impact report and pollution prevention and control measures.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 6 Product quality standards for new feeds and new feed additives published by the administrative department for agriculture under the State Council shall be industry standards; where national standards need to be formulated, matters shall be handled in accordance with the relevant provisions of the Standardization Law.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 7 Where feed or feed additives are imported for the first time, an application for registration shall be made to the agricultural administrative department of the State Council, and samples of the feed or feed additives along with the following information shall be provided:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) Trademarks, labels and promotion and application;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(2) Proof of approval for production and sale issued by the country of production, and registration data from other countries outside the country of production;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(3) The materials stipulated in Article 5 of these Regulations.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Where the feeds and feed additives referred to in the preceding paragraph are reviewed and confirmed to be safe, effective and non-polluting to the environment, product registration certificates shall be issued by the administrative department for agriculture under the State Council.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 8 The State shall protect the undisclosed test data and other data submitted by an applicant, which have been obtained by the applicant independently and relate to an approved or registered feed or feed additive containing a new chemical substance.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Within 6 years from the date of approval or registration, if another applicant applies for the approval or registration of feed or feed additives using the data referred to in the preceding paragraph without the consent of the applicant that has already obtained approval or registration, the approval or registration authority shall not grant approval or registration; however, this shall not apply where the other applicant submits data obtained by itself.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Except in the following circumstances, the approval or registration authority shall not disclose the data provided for in the first paragraph:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) public interest requirements;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(2) measures have been taken to ensure that such information will not be used improperly for commercial purposes.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Chapter 3 Production, Operation and Use Management文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 9. To establish an enterprise for the production of feed or feed additives, in addition to meeting the conditions for enterprise establishment stipulated in relevant laws and administrative regulations, the following conditions shall also be met:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) Having factory buildings, equipment, processes, and storage facilities appropriate for the production of feed and feed additives;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(2) have full-time technical personnel compatible with the production of feed and feed additives;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(3) necessary product quality inspection bodies, inspection personnel, and inspection facilities;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(4) The production environment complies with the safety and sanitary requirements stipulated by the State;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(5) Pollution prevention and control measures comply with national environmental protection requirements.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Upon review by the agricultural administrative department of the State Council or the feed administration department of the people's government of a province, autonomous region, or municipality directly under the Central Government within their respective authority, and upon finding that the conditions prescribed in the preceding paragraph are met, enterprise registration formalities may be completed.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 10 Enterprises producing feed additives or additive premixes shall, after examination and approval by the feed administrative departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government, be issued production licences by the competent department of agriculture under the State Council.文章源自FOFCC-http://fofcc.org.cn/en/11221/
After the enterprises referred to in the preceding paragraph have obtained the production licence, the feed administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall issue approval document numbers for feed additive and additive pre-mixture products.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 11 Enterprises producing feed or feed additives shall organise production in accordance with product quality standards, and implement production record and product retention sample observation systems.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 12 Enterprises producing feed and feed additives shall not directly add veterinary drugs and other prohibited substances; veterinary drugs that are permitted to be added must be made into medicinal feed additives before they can be added. In the production of medicinal feed additives, hormonal substances shall not be added.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 13 Enterprises producing feed and feed additives shall carry out product quality inspections. Those that pass inspection shall be accompanied by a product quality inspection certificate; those without a product quality inspection certificate shall not be sold.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 14 The packaging of feed and feed additives shall comply with the relevant state regulations on safety and hygiene.文章源自FOFCC-http://fofcc.org.cn/en/11221/
The packaging of flammable feed, feed additives or those with other special requirements shall bear warning marks or instructions, and indicate precautions for storage and transportation.文章源自FOFCC-http://fofcc.org.cn/en/11221/
The packaging of feed and feed additives shall not be reused; however, this shall not apply where the manufacturer and the user have agreed otherwise.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 15. Labels shall be affixed to the packaging of feed and feed additives. The labels shall indicate the product name, ingredient composition, guaranteed analysis value of product constituents, net weight, date of manufacture, shelf life, name of the factory, factory address, and product standard code in Chinese or applicable symbols.文章源自FOFCC-http://fofcc.org.cn/en/11221/
The labels of feed additives must also indicate the method of use and precautions.文章源自FOFCC-http://fofcc.org.cn/en/11221/
The labels of feed containing medicinal feed additives must also bear the words “contains medicinal feed additive”, and state its chemical name, content, method of use, and precautions.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Labels for feed additives and additive premixed feeds must also state the product approval number and production licence number.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 16 Enterprises engaging in the business of feed and feed additives shall meet the following conditions:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) having storage facilities suitable for the operation of feeds and feed additives;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(2) have technical personnel with knowledge of the use, storage, repacking, etc. of feeds and feed additives;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(3) Have the necessary product quality management systems in place.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 17 Enterprises operating feed and feed additives must check product labels and product quality certificates when purchasing goods.文章源自FOFCC-http://fofcc.org.cn/en/11221/
It is prohibited to trade feeds and feed additives that lack product quality standards, product quality qualification certificates, production licences, and product approval numbers.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 18: The production and operation of feeds and feed additives that have been suspended, banned or phased out, as well as feeds and feed additives that have not been examined, approved and published, are prohibited.文章源自FOFCC-http://fofcc.org.cn/en/11221/
It is prohibited to trade imported feed and imported feed additives that have not been registered by the administrative department for agriculture under the State Council.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 19 The use of feed additives shall comply with the safety use specifications formulated by the agricultural administrative department of the State Council.文章源自FOFCC-http://fofcc.org.cn/en/11221/
It is prohibited to use the feed and feed additives stipulated in Article 18 of these Regulations. It is prohibited to add hormone-type drugs and other prohibited drugs prescribed by the agriculture administrative department of the State Council to feed and animal drinking water.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 20 Where feeds or feed additives are proved in the course of use to be harmful to farmed animals, human health or the environment, the administrative department for agriculture under the State Council shall decide to restrict, suspend or ban their use, and shall make an announcement to that effect.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 21 It is prohibited to make claims or advertisements regarding feed and feed additives stating that they prevent or treat animal diseases; however, where medicinal feed additives are added to feed, the effects of the added medicinal feed additives may be explained.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 22: Institutions engaged in the quality inspection of feed and feed additives may only undertake product quality inspection work for feed and feed additives after passing the examinations conducted by the product quality supervision and administration department or the agricultural administrative department under the State Council, or by the product quality supervision and administration department or the feed administration department of the people's government of a province, autonomous region, or municipality directly under the Central Government.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 23. The administrative department for agriculture under the State Council may, in accordance with the national product quality supervision and spot-check work plan formulated by the product quality supervision and administration department under the State Council, carry out quality supervision and spot checks on feeds and feed additives; however, duplicate spot checks shall not be conducted.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Local people's governments at or above the county level in charge of feed administration may, in accordance with the work plans for quality supervision and spot-checking of feed and feed additives, organise supervision and spot-checks on feed and feed additives, and shall, in conjunction with the product quality supervision and administration department at the same level, publish the results of the spot-checks.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Chapter 4 Penalties文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 24: Anyone who violates the provisions of these Regulations by producing feed additives or additive premixed feeds without obtaining a production licence shall be ordered by the feed administrative department of the local people's government at or above the county level to cease production, and shall have the illegally produced products and illegal gains confiscated, together with a fine of not less than 1 time and not more than 5 times the illegal gains; where a production licence has been obtained but the product approval number has not, production shall be ordered to cease, and the product approval number shall be retroactively applied for within a specified time limit.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 25: Where, in violation of the provisions of these Regulations, feeds or feed additives are traded without attached product quality inspection certificates, product labels, production licences, approval document numbers, or product quality standards, the feed administrative department of the local people's government at or above the county level shall order the cessation of trading, confiscate the illegally traded products and illegal gains, and may impose a fine of not more than one time the illegal gains.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 26 If the packaging of feed or feed additives fails to comply with the provisions of Article 14 of these Regulations, or the attached labels fail to comply with the provisions of Article 15 of these Regulations, the feed administrative department of the local people's government at or above the county level shall order rectification within a prescribed time limit; if no rectification is made within the time limit, the sale shall be ordered to be suspended, and a fine of not more than one time the illegal gains may be imposed.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 27: Where feed or feed additives are operated without meeting the conditions stipulated in Article 16 of these Regulations, the feed administration department of the local people's government at or above the county level shall order rectification within a prescribed time limit; if no rectification is made upon the expiration of the time limit, the operation shall be ordered to cease, the illegal gains shall be confiscated, and a fine of not less than 1 time and not more than 3 times the illegal gains may be imposed concurrently.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 28 Where the provisions of these Regulations are violated by producing or operating feeds, feed additives that have been suspended from use, banned, or phased out, as well as those that have not been examined, approved, and published, criminal responsibility shall be investigated in accordance with the provisions of the Criminal Law regarding the crime of illegal business operations; if the circumstances are not serious enough for criminal punishment, the feed administrative department of the local people's government at or above the county level shall order the cessation of production and operation, confiscate the illegally produced or operated products and illegal gains, and impose a fine of not less than 1 time and not more than 5 times the illegal gains.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 29: Anyone who violates the provisions of these Regulations by failing to use feed additives in accordance with the regulations of the agricultural administrative department of the State Council shall be ordered to correct immediately by the feed administrative department of the local people's government at or above the county level, and may be fined up to 30,000 yuan.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Anyone who uses feed or feed additives as specified in Article 18 of these Regulations, or adds hormonal drugs or other prohibited drugs stipulated by the agricultural administrative department of the State Council to feed and animal drinking water, shall have the prohibited drugs confiscated by the feed administration department of the local people's government at or above the county level, and may also be concurrently fined not less than 10,000 yuan and not more than 50,000 yuan.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 30: Anyone who violates the provisions of these Regulations and commits any of the following acts shall be investigated for criminal responsibility in accordance with the provisions of the Criminal Law regarding the crime of producing and selling counterfeit or substandard products; if the circumstances are not serious enough for criminal punishment, the feed administrative department of the local people's government at or above the county level shall order the cessation of production and operation, confiscate the illegally produced or operated products and illegal gains, and impose a fine of not less than 1 time and not more than 5 times the illegal gains; if the circumstances are serious, the production licence shall be revoked by the administrative department for agriculture under the State Council:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) in the course of production or business operations, passing off non-feed or non-feed additives as feed or feed additives, or passing off one type of feed or feed additive as another type of feed or feed additive;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(2) where the types and names of the ingredients contained in the produced or traded feed or feed additives do not match the types and names of the ingredients indicated on the product label;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(3) producing or trading feed or feed additives that do not comply with the product quality standards for feed and feed additives;文章源自FOFCC-http://fofcc.org.cn/en/11221/
(4) Selling feed or feed additives that have expired, become mouldy, or exceeded their shelf life.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 31 Where imported feed or imported feed additives that have not been registered by the agriculture administrative department of the State Council are operated, criminal responsibility shall be pursued in accordance with the provisions of the Criminal Law on the crime of illegal business operations; if the circumstances are not serious enough for criminal punishment, the feed management department of the local people's government at or above the county level shall order the cessation of operations immediately, confiscate the unsold products and illegal gains, and impose a fine of not less than 1 time and not more than 5 times the illegal gains.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 32 Where anyone counterfeits, falsifies, buys or sells production licences, product approval numbers or product registration certificates for feed additives or additive premixes, criminal responsibility shall be pursued in accordance with the provisions of the Criminal Law regarding the crime of illegal business operations or the crime of falsifying, altering, buying or selling official documents, credentials or seals of state organs; if the circumstances are not serious enough for criminal punishment, the agricultural administrative department of the State Council or the feed administration department of the people's government of the relevant province, autonomous region or municipality directly under the Central Government shall, in accordance with their statutory powers and duties, confiscate or revoke the production licence, product approval number or product registration certificate, confiscate the illegal gains, and impose a fine of not less than 1 time and not more than 5 times the illegal gains.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Chapter 5 Supplementary Provisions文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 33. For the purposes of these Regulations, the meanings of the following terms are:文章源自FOFCC-http://fofcc.org.cn/en/11221/
(1) Nutritional feed additives refer to minor or trace substances used to supplement the nutritional components of feed, including feed-grade amino acids, vitamins, mineral trace elements, enzyme preparations, and non-protein nitrogen.文章源自FOFCC-http://fofcc.org.cn/en/11221/
(II) General feed additives refer to minor or trace substances mixed into feed to ensure or improve feed quality and increase the utilisation rate of feed.文章源自FOFCC-http://fofcc.org.cn/en/11221/
(3) Medicinal feed additives refer to pre-mixes of veterinary drugs mixed into carriers or diluents for the prevention and treatment of animal diseases, including anticoccidials, anthelmintics, and antibacterial growth promoters.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 34. The administration of medicinal feed additives shall be carried out in accordance with the provisions of the Regulations on the Administration of Veterinary Drugs.文章源自FOFCC-http://fofcc.org.cn/en/11221/
Article 35 These Regulations shall come into force from the date of promulgation.文章源自FOFCC-http://fofcc.org.cn/en/11221/