On May 7, 2023, the second meeting of the 10th Fertilizer Registration and Evaluation Committee of the Ministry of Agriculture and Rural Affairs (China MARA) was held in Beijing.
The meeting was divided into a chemical fertilizer group and a microbial fertilizer group for review. A total of 26 members attended the meeting, who reviewed 270 fertilizer products, discussed the relevant issues related to fertilizer registration management in China, and put forward opinions and suggestions on strengthening fertilizer management work. The meeting also contained the latest fertilizer registration and review statistics and new regulatory policies for fertilizer registration in China.
I. Fertilizer Registration and Review Statistics
A total of 270 fertilizer products were reviewed at this meeting, including 233 chemical fertilizer products and 37 microbial fertilizer products. After the voting by the members of the review committee, 159 products passed the review, including 141 chemical fertilizers and 18 microbial fertilizers, and 111 products failed, including 92 chemical fertilizers and 19 microbial fertilizers. The pass rate for chemical fertilizers was 60.5%, and for microbial fertilizers, it was 48.6%.
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II. Other Decisions Made at the Meeting
(1) Adjust the scope of toxicological tests for chemical fertilizer products. Under the Minutes of the First Meeting of the Tenth Ministry of Agriculture and Rural Affairs Fertilizer Registration Review Committee, the Review Committee once again had a full discussion on the scope of chemical fertilizer products for acute oral toxicity tests, insisting on the principle of safety first, based on the requirements of the national mandatory standard "Limits of toxic and hazardous substances in fertilizers" (GB 38400-2019), fully considering factors such as product implementation standards, raw materials, production processes, field trials, historical testing results, etc.
The following three types of products were identified to continue to carry out acute oral toxicity tests:
1. Soil conditioning agent products;
2. Organic water-soluble fertilizer products; and
3. Other fertilizer products assessed by the Review Committee as having acute oral toxicity risks.
(2) The toxicology test of microbial fertilizer registration products should be linked with the General Guidelines for Quality and Safety Evaluation of Microbial Fertilizers. On May 1, 2023, the national standard - General Guidelines for Quality and Safety Evaluation of Microbial Fertilizers (GB/T 41728-2022) (hereinafter referred to as the "General Guidelines") - was officially implemented. It is required that the toxicology test of microbial fertilizer registration products should be linked with the "General Guidelines," and the safety evaluation of bacterial strains and acute oral toxicity tests of products should be carried out in a graded manner in combination with the general requirements, evaluation procedures, evaluation requirements, and results evaluation of the four aspects of microbial fertilizer product safety evaluation and the classification catalog of bacterial strain safety.
(3) The function of fertilizer products applying for registration of agricultural microbial agents should be linked with the "Technical Specifications for Functional Evaluation of Agricultural Microbial Agents." On May 1, 2023, the national standard "Technical Specifications for Functional Evaluation of Agricultural Microbial Agents" (GB/T 41727-2022) (hereinafter referred to as the "Technical Specifications") was officially implemented. The "Technical Specifications" divide the functions of agricultural microbial agents into five categories: providing and activating nutrients, promoting crop growth, improving crop yield, quality, stress resistance, soil improvement, soil remediation, and organic material maturation, and stipulate the evaluation procedures, evaluation items, measurement methods, and result determination requirements. If the labels of the fertilizer products applying for registration of agricultural microbial agents indicate the five functions specified in the "Technical Specifications," the relevant enterprises should carry out a functional evaluation following the standard requirements and submit evaluation reports. If the evaluation confirms that the product has the corresponding functions, it can be marked on the label.
(4) Chemical fertilizer products with a deviation of more than 50% between the application index and the test result will not be reviewed. The "Minutes of the First Meeting of the Ninth Agriculture and Rural Affairs Fertilizer Registration Review Committee" clearly states that "production enterprises should strictly control product quality to ensure that the fertilizer quality is qualified and stable; the deviation between the test results and the applied technical indicators should not be too large, and in principle should not exceed 50%." The summary of this meeting clearly states that chemical fertilizer products with a deviation of more than 50% between test results and applied technical indicators, which is considered too large, will not be reviewed, and the review committee will review them only after the test results meet the requirements.
(5) Standardize the registration of specific microbial strains of fertilizer products such as Golden Tortoise Green Zombie and Ball Spore White Zombie. Studies have shown that certain specific microbial strains, such as Golden Tortoise Green Zombie and Ball Spore White Zombie, have both fertilizer and bio-control effects. The Review Committee believes that when applying for registration of fertilizer products containing such specific microbial strains, detailed product development materials should be submitted, and the fertilizing function of the strains used should be clarified and differentiated from the registered microbial pesticides' strains.
III. Relevant Suggestions
(1) Further standardize the requirements for continuous non-compliance of product quality inspection. The Review Committee suggests that the revision of the "Fertilizer Registration Service Guide" and "Fertilizer Registration Material Requirements" be accelerated to clarify the relevant requirements for continuous non-compliance of product quality inspection. For fertilizer products applying for initial registration, if they fail the inspection twice in a row (including product quality inspection, toxicology testing, bacterial strain identification, coating degradation testing, explosion resistance testing, etc.), the business registration application qualification will be considered for suspension for one year from the date of completion.
(2) Further standardize the rules for fertilizer registration review. To promote the standardization of fertilizer registration review and improve the efficiency and service level of administrative approval, the Secretariat of the Fertilizer Registration Review Committee will take the lead in researching and formulating the "Fertilizer Registration Technical Review Specification" and the "Fertilizer Registration Expert Review Work Rules" and compile a Q&A manual for frequently asked questions on fertilizer registration review.
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