Biostimulants under China’s Fertilizer Regulations

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China Fertilizer RegistrationBiostimulant 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:

Table1-Required Study Report for Fertilizer Registration

Test Report

Note

Product Quality

Applicable to all fertilizers

Acute Oral Toxicity

Applicable to all fertilizers conducted by accredited lab under the “NY 1980-2010 Fertilizer Registration-Determination and evaluation of acute oral toxicity

Coating Material Degradation

Only required for slow-release fertilizer coated with resin

Anti-detonating

Only required for high nitrate nitrogen content fertilizer such as modified ammonium nitrate for agriculture

Strain Identification

Only required for microbial fertilizers

Microbial Strain Toxicity

Applicable to microbial fertilizers and categorization required in accordance with the “NY 1109-2006 General  Technical Criteria for Biological Safety of Microbial Fertilizer”

Field trial of efficacy

Applicable to all fertilizers

 

 

Table 2-Varation Comparison of 4 Registration Types

 

Registration Type

Requirement

Former

New Policy

Temporary Registration

Field trial

Plot scale test conducted by MoA accredited testing institution

eligibility of the testing facility is not compulsorily required

Sample sealing for inspection

Required

Do not required, but enterprise should submit the product quality test report issued by an accredited lab

Annual quality test report

Required

Required

Preliminary review and approval by provincial authority(indigenous product only)

Required

Required

Full Registration

Field trial

Pilot scale test at two provincial area

Do not required, but utilization information proved by users should be submitted

Sample sealing for inspection

required

Do not required, but enterprise should submit the product quality test report issued by  accredited lab;

Annual quality test report

Required

Test on two batches

Preliminary review and approval by provincial authority(indigenous product only)

Required

Do not required

Temporary Registration Renewal

Sample sealing for inspection

Required

Do not required, but enterprise should submit the product quality test report issued by accredited lab;

Annual quality test report

Required

Test on two batches

Usage information

Required

Usage information proved by users

Preliminary review and approval by provincial authority(indigenous product only)

Required

Do not required

Full Registration Renewal

Sample sealing for inspection

Required

Do not required, but enterprise should submit the product quality test report issued by  accredited lab;

Annual quality test report

Required

Test on two batches

Usage information

Required

Utilization information proved by users should be submitted

Preliminary review and approval by provincial authority(indigenous product only)

Do not required

required

Safety Evaluation on Microbial Fertilizer/Bio fertilizer

Microbial Fertilizers (inoculant, compounded microbial fertilizer and microbial organic fertilizer) contain living microorganisms. The strain identification and strain toxicity studies on the microorganism are additionally required. The studies will be performed stepwise under two agricultural standards:” NY/T-1736-2009 Technical Specification of Strain Identification for Microbial Fertilizers” and “NY1109-2006 General Technical Guidelines on Biosafety of Microbial Fertilizer”.

The identified strains are further studied on toxicological aspect. NY1109-2006 classified microbial strains into 4 catalogue and the test items differ:

Catalogue

test item

Criterion

Class I(A.1)

Exempted from all toxicological tests

 

Class II(A.2)

Only acute oral toxicity test is required

LD50>5000mg/kg;

Class III(A.3)

  • Acute oral toxicity;
  • Abraded skin irritation test;
  • hemolytic test;
  • Antibiotics sensitivity test
  • Peritoneal injection test;
  • Acute ocular irritation test

LD50>5000mg/kg;

Nonirritating or slightly irritating;

Negative;

Sensitive to no less than 2 antibiotics;

No acute pathogenic;

Nonirritating or slightly irritating;

Class III(A.4)

Prohibited microbial strains

/

Except rhizobia and Lactobacillus, microbial strains outside these catalogues are required to conduct full microbial toxicity tests (Class III). Solid microbial inoculants except organic matter-decomposing inoculants are exempted from toxicological test and all compounded microbial fertilizers, microbial organic fertilizers and liquid inoculants are required to conduct the acute oral toxicity test.

Water Soluble Fertilizer Agriculture Standards

Currently, China has established 6 mandatory standards for 5 types of water soluble fertilizers, which specified the minimum content of nutrient elements and maximum limit of objectionable contents:

  • NY 1106-2010 Water-soluble fertilizers containing humic-acids
  • NY 1106-2010 Water-soluble fertilizers containing nitrogen, phosphorus and potassium;
  • NY 1428-2010 Water-soluble fertilizers containing micronutrients;
  • NY 1429-2010 Water-soluble fertilizers containing amino-acids;
  • NY 2266-2012 water-soluble fertilizers containing calcium and magnesium;
  • NY 1110-2010 Water-soluble fertilizers content limit of mercury, arsenic, cadmium, lead and chromium;

Organic water soluble fertilizers containing alginic acid, chitin, polyaspartic acid and other organic matters have not yet established any mandatory standard. But voluntary standards have been frequently developed in recent years and more types of organic water soluble fertilizers would be included into China’s mandatory standard system.

Registration Statistics

By the end of June 2016, 10920 products have been registered by 4020 companies, of which 482 are registered by 183 overseas companies. Approximately 60% of the bio-fertilizers and organic water soluble fertilizers are registered in the last three years. The percentages of imported product of all microbial fertilizers and water soluble fertilizers containing humic –acids and amino-acids are much lower than the percentages in other product types.

Regulatory Prospects

China’s agricultural system is characterized as high input and high consumption. Since the implementation of fertilizer registration, the consumption of chemical fertilizer has doubled, while the output has increased by only 56%. Currently, average chemical fertilizer consumption is 400 kg per hectare, which is 1.8 times the international alarm level. China has realized the grim reality of soil infertility and pollution caused by excessive but low efficacy agrochemical use. China issued the “Action Plan for Zero Growth of Chemical Fertilizer and Pesticide Use by 2020” in 2015 and the “Action Plan for the Prevention and Control of Soil Pollution” in May 2016. Both documents require reduction of chemical fertilizer use and the rational use of organic resources and water & fertilizer integrated irrigation, which are the featured advantages of microbial fertilizer and organic water soluble fertilizer over chemical fertilizers.

A draft standard for fertilizer gradation is currently under review, which would be promulgated as a mandatory standard in this year or next. According to the draft text, all commercial fertilizers will be classified into 3 grades which should be labeled on the product package. The three grades are ecological grade fertilizer, the field grade fertilizer and garden grade fertilizer, which correspond to their permitted application area of organic agriculture, ordinary agriculture and garden use respectively. All grades of fertilizers will be required to conduct the terrestrial plant test (Seedling Emergence and Seedling Growth Test) prior to the placement on the market. Fertilizers with higher grade are subject to more stringent requirements in line with maximum limits of heavy metals and other contaminants.

 

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