Administrative Regulations on Feed and Feed Additives (Revised in 2013)
Administrative Regulations on Feed and Feed Additives (Revised in 2013)
Administrative Regulations on Feed and Feed Additives (Revised in 2013)
Order of the State Council of the People's Republic of China No.645
December 7, 2013
(Promulgated under the Order of the State Council of the People's Republic of China No.266 on May 29, 1999; revised for the first time in accordance with the Decision of the State Council on Revising the Administrative Regulations on Feed and Feed Additives issued on November 29, 2001; revised for the second time according to the 177th executive meeting of the State Council convened on October 26, 2011; and revised for the third time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations issued on December 7, 2013)
Chapter I General Provisions
Article 1 The Administrative Regulations on Feed and Feed Additives (these "Regulations") are formulated with a view to enhancing the administration of feed and feed additives, improving the quality of feed and feed additives, guaranteeing the quality safety of animal products, and maintaining the health of the public.
Article 2 For the purpose of these Regulations, the term "feed" means the industrially processed or manufactured products that are consumed by animals, including single feed, additive premixes, concentrated feeds, formula feeds and concentrate supplements.
For the purpose of these Regulations, the term "feed additives" means the small or micro quantities of substances that are added in the course of processing, manufacturing or using feed, including nutritional feed additives and general feed additives.
The competent administrative department of agriculture of the State Council shall formulate and promulgate the catalogue of feed raw materials and the catalogue of feed additive varieties.
Article 3 The competent administrative department of agriculture of the State Council is responsible for the supervision and administration of feeds and feed additives throughout the country.
The departments in charge of the administration of feed and feed additives under local people's governments at or above the county level (hereinafter referred to as the "feed administrative departments") are responsible for the supervision and administration of feed and feed additives within their respective administrative regions.
Article 4 Local people's governments at or above the county level shall exercise a uniform leadership over the supervision and administration of feeds and feed additives within their respective administrative regions, establish and improve a mechanism for supervision and administration, and guarantee the implementation of supervision and administration.
Article 5 Production enterprises and operators of feed and feed additives shall establish and improve the system of quality safety, and be responsible for the quality safety of feed and feed additives produced and operated by them.
Article 6 Any organization or individual has the right to report any behaviors in violation of these Regulations in the course of production, operation and use of feed and feed additives, and to put forward opinions and suggestions on the supervision and administration of feed and feed additives.
Chapter II Examination, Approval and Registration
Article 7 The State encourages the research and development of new feed and new feed additives.
The research and development of new feed and new feed additives shall follow the principles of science-based, safety, effectiveness and environmental protection, and the quality safety of new feed and new feed additives shall be guaranteed.
Article 8 Before a newly-developed feed or feed additive is put into production, the developer or production enterprise shall file an application for examination and approval with the competent administrative department of agriculture of the State Council and provide the samples of the new feed or new feed additive together with the following materials:
1. the 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; and
2. a report on the feeding effects, residue dissipation dynamics and toxicological safety evaluation of such new feed or new feed additive issued by a testing institution designated by the competent administrative department of agriculture of 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 competent administrative department of agriculture of the State Council shall, within five working days from the date of accepting an application, submit the samples of a new feed or new feed additive and the application materials to the National Feed Evaluation Committee ("NFEC") for evaluation of the safety, effectiveness and environmental impact of such feed or feed additive.
The NFEC consists of experts in the fields of breeding, feed processing, animal nutrition, toxicology, pharmacology, metabolism, hygiene, chemical synthesis, biotechnology, quality standards, environmental protection and food safety risk assessment and other related fields. The NFEC evaluates new feed and new feed additives by holding an evaluation meeting, which requires the participation of nine or more experts from the NFEC, and as required, one or two expert(s) other than those from the NFEC may also be invited to participate in the evaluation. Experts participating in the evaluation have the voting rights on the matters under evaluation. Evaluation opinions and meeting minutes shall be formed at the evaluation meeting and be examined and signed by participating experts, and dissenting opinions (if any) shall be indicated. Experts participating in the evaluation shall fulfill their duties in a fair and impartial manner according to the law, keep the evaluation materials confidential, and actively withdraw if there is any cause for withdrawal.
The NFEC shall, within nine months from the date of receiving the samples of a new feed or new feed additive and the application materials, issue the evaluation results and submit the same to the competent administrative department of agriculture of the State Council; however, if the NFEC makes a decision that requires the applicant to conduct the relevant tests, the evaluation period may be extended by three months upon approval of the competent administrative department of agriculture of the State Council.
The competent administrative department of agriculture of the State Council shall, within ten working days from the date of receiving the evaluation results, make a decision on whether to issue a certificate for the new feed or new feed additive; and if the said department decides not to issue the certificate, it shall notify the applicant in writing and give reasons.
Article 10 The competent administrative department of agriculture of the State Council shall, when issuing a certificate for a new feed or new feed additive, publish the product quality standards for the new feed or new feed additive according to its duties and authority.
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 new feed additive, any other applications for the production and import registration of the new feed or new feed additive shall not be accepted, unless the new feed or new feed additive has not been put into production within three years or more.
A production enterprise shall collect the information on the quality stability of new feed and new feed additives within the monitoring period and their impact on the quality safety of animal products, and report the same to the competent administrative department of agriculture of the State Council. The competent administrative department of agriculture of the State Council shall organize the follow-up and monitoring of the quality safety status of new feed and new feed additives, and if it proves that there is any safety problem in any new feed or new feed additive, the certificate for such new feed or new feed additive 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 exporting country for production and use, an applicant shall commission an agency in China to apply for registration to the competent administrative department of agriculture of the State Council, and provide samples of the feed or feed additive together with the following materials:
1. the trademark, label, and information on the promotion and application thereof;
2. approval certificates for production and use issued at the place of production and registration materials in any country or region other than the place of production;
3. the 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; and
4. a report on the feeding effects, residue dissipation dynamics and toxicological safety evaluation of such feed or feed additive issued by a testing institution designated by the competent administrative department of agriculture of 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 competent administrative department of agriculture of the State Council shall organize the evaluation according to the procedures for evaluation of new feeds or new feed additives as prescribed in Article 9 of these Regulations, and shall decide whether to issue a certificate for import registration of feed or feed additives.
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 exporting country for production and use, the applicant shall apply for registration under Paragraphs 1 and 2 of this Article.
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Order of the State Council of the People's Republic of China No.645
December 7, 2013
(Promulgated under the Order of the State Council of the People's Republic of China No.266 on May 29, 1999; revised for the first time in accordance with the Decision of the State Council on Revising the Administrative Regulations on Feed and Feed Additives issued on November 29, 2001; revised for the second time according to the 177th executive meeting of the State Council convened on October 26, 2011; and revised for the third time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations issued on December 7, 2013)
Chapter I General Provisions
Article 1 The Administrative Regulations on Feed and Feed Additives (these "Regulations") are formulated with a view to enhancing the administration of feed and feed additives, improving the quality of feed and feed additives, guaranteeing the quality safety of animal products, and maintaining the health of the public.
Article 2 For the purpose of these Regulations, the term "feed" means the industrially processed or manufactured products that are consumed by animals, including single feed, additive premixes, concentrated feeds, formula feeds and concentrate supplements.
For the purpose of these Regulations, the term "feed additives" means the small or micro quantities of substances that are added in the course of processing, manufacturing or using feed, including nutritional feed additives and general feed additives.
The competent administrative department of agriculture of the State Council shall formulate and promulgate the catalogue of feed raw materials and the catalogue of feed additive varieties.
Article 3 The competent administrative department of agriculture of the State Council is responsible for the supervision and administration of feeds and feed additives throughout the country.
The departments in charge of the administration of feed and feed additives under local people's governments at or above the county level (hereinafter referred to as the "feed administrative departments") are responsible for the supervision and administration of feed and feed additives within their respective administrative regions.
Article 4 Local people's governments at or above the county level shall exercise a uniform leadership over the supervision and administration of feeds and feed additives within their respective administrative regions, establish and improve a mechanism for supervision and administration, and guarantee the implementation of supervision and administration.
Article 5 Production enterprises and operators of feed and feed additives shall establish and improve the system of quality safety, and be responsible for the quality safety of feed and feed additives produced and operated by them.
Article 6 Any organization or individual has the right to report any behaviors in violation of these Regulations in the course of production, operation and use of feed and feed additives, and to put forward opinions and suggestions on the supervision and administration of feed and feed additives.
Chapter II Examination, Approval and Registration
Article 7 The State encourages the research and development of new feed and new feed additives.
The research and development of new feed and new feed additives shall follow the principles of science-based, safety, effectiveness and environmental protection, and the quality safety of new feed and new feed additives shall be guaranteed.
Article 8 Before a newly-developed feed or feed additive is put into production, the developer or production enterprise shall file an application for examination and approval with the competent administrative department of agriculture of the State Council and provide the samples of the new feed or new feed additive together with the following materials:
1. the 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; and
2. a report on the feeding effects, residue dissipation dynamics and toxicological safety evaluation of such new feed or new feed additive issued by a testing institution designated by the competent administrative department of agriculture of 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 competent administrative department of agriculture of the State Council shall, within five working days from the date of accepting an application, submit the samples of a new feed or new feed additive and the application materials to the National Feed Evaluation Committee ("NFEC") for evaluation of the safety, effectiveness and environmental impact of such feed or feed additive.
The NFEC consists of experts in the fields of breeding, feed processing, animal nutrition, toxicology, pharmacology, metabolism, hygiene, chemical synthesis, biotechnology, quality standards, environmental protection and food safety risk assessment and other related fields. The NFEC evaluates new feed and new feed additives by holding an evaluation meeting, which requires the participation of nine or more experts from the NFEC, and as required, one or two expert(s) other than those from the NFEC may also be invited to participate in the evaluation. Experts participating in the evaluation have the voting rights on the matters under evaluation. Evaluation opinions and meeting minutes shall be formed at the evaluation meeting and be examined and signed by participating experts, and dissenting opinions (if any) shall be indicated. Experts participating in the evaluation shall fulfill their duties in a fair and impartial manner according to the law, keep the evaluation materials confidential, and actively withdraw if there is any cause for withdrawal.
The NFEC shall, within nine months from the date of receiving the samples of a new feed or new feed additive and the application materials, issue the evaluation results and submit the same to the competent administrative department of agriculture of the State Council; however, if the NFEC makes a decision that requires the applicant to conduct the relevant tests, the evaluation period may be extended by three months upon approval of the competent administrative department of agriculture of the State Council.
The competent administrative department of agriculture of the State Council shall, within ten working days from the date of receiving the evaluation results, make a decision on whether to issue a certificate for the new feed or new feed additive; and if the said department decides not to issue the certificate, it shall notify the applicant in writing and give reasons.
Article 10 The competent administrative department of agriculture of the State Council shall, when issuing a certificate for a new feed or new feed additive, publish the product quality standards for the new feed or new feed additive according to its duties and authority.
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 new feed additive, any other applications for the production and import registration of the new feed or new feed additive shall not be accepted, unless the new feed or new feed additive has not been put into production within three years or more.
A production enterprise shall collect the information on the quality stability of new feed and new feed additives within the monitoring period and their impact on the quality safety of animal products, and report the same to the competent administrative department of agriculture of the State Council. The competent administrative department of agriculture of the State Council shall organize the follow-up and monitoring of the quality safety status of new feed and new feed additives, and if it proves that there is any safety problem in any new feed or new feed additive, the certificate for such new feed or new feed additive 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 exporting country for production and use, an applicant shall commission an agency in China to apply for registration to the competent administrative department of agriculture of the State Council, and provide samples of the feed or feed additive together with the following materials:
1. the trademark, label, and information on the promotion and application thereof;
2. approval certificates for production and use issued at the place of production and registration materials in any country or region other than the place of production;
3. the 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; and
4. a report on the feeding effects, residue dissipation dynamics and toxicological safety evaluation of such feed or feed additive issued by a testing institution designated by the competent administrative department of agriculture of 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 competent administrative department of agriculture of the State Council shall organize the evaluation according to the procedures for evaluation of new feeds or new feed additives as prescribed in Article 9 of these Regulations, and shall decide whether to issue a certificate for import registration of feed or feed additives.
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 exporting country for production and use, the applicant shall apply for registration under Paragraphs 1 and 2 of this Article.
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