Biostimulants under China’s Fertilizer Regulations

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Biostimulant includes diverse substances and microorganisms that are utilized for plant enhancement or stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and/or crop quality apart from its “nutrient content”. Although the term “biostimulant” has not yet been defined under any specific regulation in China, these types of products are most frequently marketed as two types of novel fertilizer: microbial fertilizers and water soluble fertilizers. As stipulated under the MoA Order 32 “Measures for the Registration Management on Fertilizer”, products fall into both categories have to be registered with the MoA prior to placement on the market.

 

Product under Fertilizer Registration

Depending on the nature, nutrient element, origin, production process, mechanism, function and availability of official product specification, analytical method of nutrient/functional ingredient, criterion for efficacy evaluation and other considerations, products subject to fertilizer registration should be registered, labeled and marketed under 29 mandatorily generic names(AgroPedia:China Fertlizer Registration Overview):

Types

Mandatorily Generic Name

Macronutrient

Water-soluble fertilizer containing nitrogen, phosphorus and potassium*

Urea ammonium nitrate solution*

Potassium nitrate for agricultural use

Modified ammonium nitrate for agriculture*

Calcium ammonium nitrate for agriculture use*

Magnesium-potassium sulfate for agriculture use

Magnesium-potassium chloride for agriculture use

Slow-release fertilizer*

Synergized nitrogen fertilizer

Secondary Element

Water-soluble fertilizer containing calcium and magnesium*

Fertilizer containing calcium and magnesium

Calcium nitrate for agricultural use

Magnesium sulfate for agricultural use

Micronutrient

Water-soluble fertilizer containing micronutrients*

Micronutrient fertilizer*

Soil Conditioner

Soil conditioner

Agro-forestry absorbent polymer*

Synergist

Fertilizer synergist

Organic water soluble  Fertilizer

Water-soluble fertilizer containing amino-acids*

Water-soluble fertilizer containing humic -acids*

Organic water soluble fertilizer (alginic acid, chitin, polyaspartic acid and other organic matters )

Microbial Fertilizers

Inoculant of photosynthetic bacteria

Organic matter-decomposing inoculant

Rhizobia inoculant

Endomycorrhiza inoculant

Bio-remediating inoculant

Microbial inoculant (azotobacteria inoculant, plant growth-promoting rhizosphere microorganism and silicate bacteria inoculant etc.)

Compounded microbial fertilizer

Microbial organic fertilizer

Products marked with “*” compulsorily require compliance with the agricultural standard (product specification). Five water soluble products are directly reviewed and approved by the MoA and the remaining products are reviewed through the National Expert Committee of Fertilizer Registration.

Policy Variation

MoA used to commission two subordinate institutions to accept registration application and provide technical assistance during registration review: the Center for Quality Supervision and Testing of Microbial Fertilizers and Edible Fungus Spawn, Ministry of Agriculture (hereinafter as Microbial Fertilizer Center)and the National Center for Quality Supervision and Testing of Chemical Fertilizers(hereinafter as Chemical Fertilizer Center). Both institutions also engaged in the establishment of national/agricultural standards of fertilizer within their respective expertise. In August 2015, MoA issued the Announcement 2287 and 2291. The former standardized the registration review and approval procedures and the latter centralize the competence of accepting registration application from the two institutions.  Residue study and pilot-scale field trial are exempted and requirements on laboratory eligibility and product sampling were also loosened. However, the remaining data requirements were emphasized in a MoA circular:

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