New Feed And Feed Additives Management Approach

Original Language Title: 新饲料和新饲料添加剂管理办法

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New feed and feed additives management approach

    (May 2, 2012 the Ministry of Agriculture announced on July 1, 2012, 2012 4th promulgation) first to strengthen the new feed, feed additives, protect animal product quality and safety, in accordance with the regulation of feed and feed additives, these measures are formulated.

New feed in these measures in article, refers to the new development in my country has not yet been approved for use in a single feed.

    New feed additives in these measures refers to newly developed in the country that have not yet ratified the use of feed additives.

Article one of the following circumstances, an application shall be submitted to the Ministry of agriculture, in accordance with the measures under the new feed, feed additives of new validation procedures for review, review, announcement by the Ministry of agriculture as the production and use of feed and feed additives, but does not issue the certificate of new feed, feed additives:

(A) extension of feed additives;

(B) the content of feed additives specifications below the feed additive safety specification for requirements, from feed additives with the carrier or diluent according to the certain proportion of except;

(C) significant changes in the production of feed additives;

(D) the new feeds, new feed additives for more than 3 years from the date of certification was not put into production, others in production;

    (E) other circumstances as stipulated by the Ministry of agriculture.

    Article fourth developed new feed, feed additives, should follow scientific, safe, effective and environmentally-friendly principles, guarantee the quality and safety of the new feed, feed additives.

Fifth Ministry of agriculture is responsible for the validation of new feed, feed additives.

    National feed Audit Committee (hereinafter referred to as jury) Organization to new feed, feed additives safety and effectiveness review and its impact on the environment.

    Article before the new feed, feed additives in production, development or production enterprise (hereinafter the applicant) an application shall be submitted to the Ministry of agriculture approval and submit new feed, feed additives applications and samples.

Article seventh application materials include:

(A) the application form for validation of new feed, feed additives;

(B) the product name and named basis, product development purposes;

(C) identification of the active ingredients, chemical structure and physico-chemical properties, or the animal, plant, microorganism classification report; microbial products or fermentation products, and shall provide the designated by the Ministry of agriculture issued by national culture collection organizations strain preservation number;

(D) the scope, method of use, feed or a total mixed ration in the recommended dosage, if necessary, provide the highest limit values;

(E) production processes, manufacturing methods and products [0] stability test report;

(F) quality standards and the preparation of the draft statement and product test reports has the highest limits, should also provide an effective component in feed, concentrated feed, concentrate supplement and additives in premixed feed detection methods;

(G) specified test certificate issued by the Ministry of agriculture product evaluation test reports, test reports for safety evaluation (including target animal tolerance evaluation reports, toxicological safety evaluation report, metabolism and residue evaluation reports, etc), application for validation of new feed additives, should also be provided of the new feed additives in aquaculture products residues analysis of the potential impact on human health of evaluation reports;

(H) the label design, packaging requirements, storage conditions, shelf life and notes;

(I) pilot production summary and "three wastes" treatment reporting;

    (J) the statement does not constitute an infringement of a patent to others.

Eighth product samples shall conform to the following requirements:

(A) from a pilot or industrial production, (ii) provide 3 consecutive batches of samples of each product, each batch of 4 samples, each sample of not less than 5 times of testing requirements;

    (C) when necessary, provides standard products or chemical control sample.

Nineth validation test bodies and experiment for security evaluation of institution shall, according to the Ministry of agriculture to develop technical guidance documents or industry-recognized technical standards, scientific, objective and fair trials, and may not, production companies have a stake in the development.

    Take test expert shall not participate in the new feeds, new evaluation of feed additives.

    Tenth Department of agriculture within 5 working days from the day of acceptance of the application, review the application materials and sample to the jury. 11th new fodder, feed additives of new assessment takes the form of review meetings. Review meeting should have 9 or more jury experts, as needed 1 to 2 members of the Review Committee of experts can be invited outside experts to participate in.

Experts participating in the review to review the matter has the right to vote.

    Review meeting should form review comments and the minutes, signed and approved by the experts participating in the review; there are different views, should be indicated.

12th experts participating in the review should perform their duties according to law, scientific, objective and fair review comments.

    Reviewers have a stake in development, production and business, and should be avoided. 13th meeting approved in principle, samples from the jury designated by the Ministry of agriculture feed quality inspection authority for quality review. Quality review organization shall, within 3 months from the date of receipt of the samples quality review and quality review and review comments on the report Review Committee, and served on the applicant.

Requires special methods for detection, the quality of review time can be extended by 1 month.

Quality review including standard review and sample testing, there are maximum limits should also be valid for registration validated detection method in the component in animal feed products.

    The applicant disagrees with the results of the quality review, you can receive quality review report within 15 working days after the application for review.

    14th in the assessment process, the Department of agriculture can be organized on-site verification of applicant's test or production conditions or test data verification or validation.

    15th-jury shall receive the new feed, feed additives of new applications and submitted to the Ministry of agriculture within 9 months from the date of the sample results; however, jury decisions relevant tests are carried out by the applicant, by the Department of Agriculture agreed to review time can be extended by 3 months.

16th Ministry of agriculture from the date of receiving the results within 10 business days whether or not to issue a new feed, feed additives of new certificate of decision. Decided to issue a new feed, feed additives of new certificates by the Ministry of agriculture shall be announced, while releasing the product quality standards.

Put into production new feed, feed additives, in accordance with the quality standard in the bulletin for monitoring and supervision.

    Decided not to issue, notify the applicant in writing and state the reasons. Article 17th before new feed, feed additives in production, producers production permits shall be obtained in accordance with the relevant provisions of the Ministry of agriculture.

    Production of new feed additives, and shall obtain the corresponding product approval number.

18th new feeds, feed additives of new monitoring for a period of 5 years, since the new feed additives for feed, calculated from the date of issue of the certificate.

    Monitoring period will not be accepted in respect of the new feeds, new applications for production and imports of feed additives applications for registration, but the new feeds, new feed additives except for over 3 years was not put into production.

19th new feed and feed additive production enterprises should be collected in the monitoring phase of the new product quality, target animal safety and animal product quality and safety and other relevant information, and report to the Department of agriculture.

    Department of agriculture to the new feed, feed additives of new security organizations to track the quality of monitoring and, if necessary, re-evaluation, proves its security issues, certificate revocation of new feed, feed additives and make an announcement.

    20th in the new feed, feed additives of new audited work units and personnel, confidential technical information submitted by the applicant should be kept confidential.

    Article 21st new feed, feed additives authorized working personnel, fails to perform the duties as provided herein, or abuse of power, negligence, malpractice, shall be subject to punishment constitutes a crime, criminal responsibility shall be investigated according to law.

22nd the applicant to hide relevant information or provides false information to apply for validation of new feed, feed additives, inadmissible or not to permit the Ministry of agriculture, and give a warning; within 1 year of the applicant may not apply again for a new feed, feed additives of new validation.

    To cheat, and bribery, not due means made new feed, and new feed additives certificate of, by Ministry of agriculture revoked new feed, and new feed additives certificate, applicants in 3 years within shall not again application new feed, and new feed additives validation; to cheat way made new feed, and new feed additives certificate of, and at 50,000 yuan above 100,000 yuan following fine; constitute crime of, law transferred judicial organ held criminal.

    Article 23rd other contravention of this regulation, in accordance with the relevant provisions of the regulations on feed and feed additives management for punishment. 24th article this way come into force on July 1, 2012. Department of agriculture released on August 17, 2000, the new feed and feed additives of new regulation abolished at the same time.

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