The term "new feed additives" as mentioned in these Measures refers to the newly developed feed additives used in China without approval. Article 3 Under any of the following circumstances, an application shall be submitted to the Ministry of Agriculture and Rural Affairs for review with reference to the examination and approval procedures for new feed and new feed additives as stipulated in these Measures. After examination and approval, the Ministry of Agriculture and Rural Affairs will announce the production and use of feed and feed additives, but will no longer issue certificates of new feed and new feed additives:
(a) feed additives to expand the scope of application;
(2) The content specification of feed additives is lower than the requirements for the safe use of feed additives, except that it is prepared with carriers or diluents in a certain proportion;
(three) the production process of feed additives has undergone major changes;
(four) new feed and new feed additives have not been put into production for more than 3 years since the date of obtaining the certificate, and other enterprises apply for production;
(5) Other circumstances stipulated by the Ministry of Agriculture and Rural Affairs. Article 4 The development of new feeds and new feed additives shall follow the principles of science, safety, effectiveness and environmental protection, and ensure the quality and safety of new feeds and new feed additives. Article 5 The Ministry of Agriculture and Rural Affairs shall be responsible for the examination and approval of new feeds and new feed additives.
The National Feed Review Committee (hereinafter referred to as the Review Committee) organizes the review of the safety, effectiveness and environmental impact of new feeds and new feed additives. Article 6 Before new feed and new feed additives are put into production, the developer or production enterprise (hereinafter referred to as the applicant) shall apply to the Ministry of Agriculture and Rural Affairs for examination and approval, and submit the application materials and samples of new feed and new feed additives. Article 7 The application materials include:
(a) the application form for examination and approval of new feed and new feed additives;
(two) the product name and naming basis, product development purposes;
(3) Identification report of effective components, physical and chemical properties and chemical structure of effective components, or classification (strain) identification report of animals, plants and microorganisms, and strain identification report of strains used in the production of microbial fermentation products;
(four) the scope of application, the method of use and the recommended dosage in the compound feed or the total mixed diet, and provide the maximum limit value when necessary;
(five) production technology, manufacturing methods and product stability test report;
(six) the draft quality standard and its preparation instructions and product inspection report; If there is a maximum limit requirement, the detection method of effective components in compound feed, concentrated feed, concentrate supplement and additive premix feed should also be provided;
(seven) the product effectiveness evaluation test report and safety evaluation test report issued by the testing institution designated by the Ministry of Agriculture and Rural Affairs (including the target animal tolerance evaluation report, toxicology safety evaluation report, metabolism and residue evaluation report, etc.). ); To apply for examination and approval of new feed additives, it shall also provide an analysis and evaluation report on the possible impact of the residues of new feed additives in aquaculture products on human health;
(eight) label style, packaging requirements, storage conditions, shelf life and matters needing attention;
(nine) pilot production summary and "three wastes" treatment report;
(10) A statement that another person's patent does not constitute infringement. Article 8 Product samples shall meet the following requirements:
(a) from the pilot or industrial production line;
(2) Each product shall be provided with 3 consecutive batches of samples, with 4 samples in each batch, and each sample shall not be less than 5 times the amount required for testing;
(3) Provide relevant standards or chemical reference materials when necessary. Article 9 The effectiveness evaluation and testing institutions and safety evaluation and testing institutions shall conduct experiments scientifically, objectively and fairly in accordance with the technical guidance documents formulated by the Ministry of Agriculture and Rural Affairs or the technical standards recognized by the industry, and shall not have any interest relationship with the developers or production enterprises.
Experts undertaking the test shall not participate in the evaluation of new feed and new feed additives. Article 10 The Ministry of Agriculture and Rural Affairs shall, within 5 working days from the date of accepting the application, submit the application materials and samples to the review committee for review. Eleventh new feed, new feed additives review in the form of a review meeting. The review meeting shall be attended by more than 9 experts from the review committee, and when necessary, experts other than 1 2 experts from the review committee may be invited. Experts participating in the review have the right to vote on the review matters.
The review meeting shall form review opinions and meeting minutes, which shall be reviewed and signed by the experts participating in the review; If there are different opinions, it shall be indicated. Twelfth experts participating in the review shall perform their duties according to law and put forward the review opinions scientifically, objectively and fairly.
If the evaluation experts are interested in the developers and production enterprises, they should be avoided. Thirteenth after the principle of the review meeting is passed, the review committee will submit the samples to the feed quality inspection institution designated by the Ministry of Agriculture and Rural Affairs for quality review. The quality evaluation institution shall complete the quality evaluation within 3 months from the date of receiving the sample, and report the quality evaluation report and evaluation opinions to the evaluation committee and serve them on the applicant. If special methods are needed for testing, the quality review time can be extended by 1 month.
Quality review includes standard review and sample testing. If there is a maximum limit requirement, the detection method of the effective components of the declared products in feed products should also be verified.
If the applicant disagrees with the quality review results, he may apply for reinspection within 15 working days after receiving the quality review report.