All clauses regarding temporary registration have been removed from China’s fertilizer registration system. Both fertilizers producers and testing facilities are allowed to conduct field trail and must shoulder legal liabilities for the authenticity of the final report
On 28 Nov 2017, China MoA’s Website released Order 8 of 2017 regarding the amendment and annulment of several ministerial regulations and other regulatory documents, of which 2 are amendments to fertilizer registration. The most notable changes are that temporary registrations are removed from the registration scheme and also there is a broadened acceptance scope of efficacy trail report.
Under the “Administrative Measures for the Registration of Fertilizers”, a phased system was used for fertilizer registration:
Temporary Registration-After efficacy trial, fertilizer shall go through demonstrative trial (field efficacy trial at larger scale) or trial sale and the producer shall apply for temporary registration. Temporary registrations are valid for 1 year and can be renewed 2 times
Full Registration-After demonstrative trial, the product can be fully circulated as a commercial product and the producer shall apply for full registration. Full registrations are valid for 5 years and can be renewed an unlimited number of times. Amendments to administrative information (use scope, trade name and company name, etc.) are permitted but new application will be required for technical amendment (composition or formulation type)
The Measures also specified requirements on laboratory qualification. Field trails on non-microbial fertilizers produced by Chinese domestic producers should be conducted by testing facilities designated by the agricultural department at or above provincial level. Field trails on microbial fertilizers and other non-microbial fertilizers produced by overseas producers and all demonstrative trials should be conducted by testing facilities designated by the MoA.
In the amendment, all clauses regarding temporary registration have been removed and field trail and demonstrative trail are collectively referred to as field trial. Both fertilizers producers and testing facilities are allowed to conduct field trail and will shoulder legal liabilities for the authenticity of the efficacy trial report. Furthermore, the amendment added that plant growth regulators are not subject to fertilizer registration regulations.
Corresponding adjustments on temporary registration and field trial are also reflected in the amendment to “Data requirements on Fertilizer Registration”. However, the textual removal of microbial strain safety identification report and toxicology test report are relatively ambiguous and it still isn’t entirely clear whether these tests are required for microbial fertilizer registration or have been removed to align terminology with other regulations:
- A mandatory standard for the safety evaluation of microbial fertilizer, the “General Requirements on Biosafety of Microbial Fertilizers” was promulgated in 2006. It specifies the general principles, categorization, procedures, scope, method and criteria for toxicological evaluation of microbial fertilizers;
- Announcement 2287 on the administrative procedures for fertilizers registration. The document mentioned the test scope and laboratory qualification for microbial fertilizers
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