China Fertilizer Registration Overview

  

 

REMINDER :The content in this page is no longer accruate. Please click on below link to visit our new AgroPedia:

Overview of Fertilizer Registration in China  (2018 version)

 

 

 

 

 

China is the world’s largest fertilizer manufacturer and consumer in the world.  Production and consumption reached 63.38 million tons in 2010 comprised of a staggering 55.62 million tons based on nitrogen, phosphoric anhydride and potassium oxide bases. Rapid technological development and population growth is proving fertile ground for rapid expansion in this sector. To regulate fertilizer producers and distributors, protect the environment and the interests of farmers the Ministry of Agricultural issued the “Interim Provision of Inspection and Registration on Fertilizer, Soil Conditioner and Plant Growth Regulator” in 1989. On June 12, 2000, the Ministry promulgated Order 32 the “Measures for the Registration Management on Fertilizer”, which established the registration system currently adopted in China.

China Fertilizer Regulations
Measures for the Registration Management on Fertilizer
History
12 Jun 2000MoA Order 32
Main Supporting Rule in Force
25 May 2001MoA Announcement 161(Data Requirements on Fertilizer Registration)
11 Feb 2010MoA  Office Letter 12 of 2010
28 Nov 2017MoA Order 8 of 2017(2 amendments to fertilizer registration )
29 Dec 2017MoA announcement 2636(guidance on adminstrative procedures of fertilizer registration)
Major Mandatory StandardFertlizer Management(Unversal standard)
GB 18382-2001
GB 8569-2009
NY 1979-2010
NY 1980-2010
NY 885-2004
GB 20287-2006

Contents

 

Major Mandatory Standards for Fertilizer Registration/Mananagement in China

Code and Name

Type

Publisher/Proposer/Drafter/Technical Committee

Brief Introduction

GB 18382-2001 Fertilizer Marketing-Presentation and Declaration

肥料标识,内容和要求

National Standard

Publisher

AQSIQ;

All markings of fertilizers produced in China shall conform to this Standard as of 1 Jan 2002 and all markings of commercial fertilizers marketed in China shall comply with this standard as of 1 Jul 2012.

Proposer

State Bureau of Petroleum and Chemical Industries;

Drafter

National Center for Quality Supervision and Testing of Chemical Fertilizers(Shanghai);

Technical Committee

National Technical Committee 105 on Fertilizers and soil conditioners of standardization Administration of China(SAC/TC 105)

GB 8569-2009 Packing of Solid Chemical Fertilizers

固体化学肥料包装

National Standard

Publisher

AQSIQ/Standardization Administration of the People's Republic of China(SAC)

Applicable to the packing of all solid chemical fertilizers, including, but not limited to nitrogen, phosphate, potassium, compounded fertilizers and other types of solid fertilizers.

Proposer

China Petroleum and Chemical Industries Association

Drafter

National Center for Quality Supervision and Testing of Chemical Fertilizers(Shanghai) and 3 enterprises

Technical Committee

National Technical Committee 105 on Fertilizers and soil conditioners of standardization Administration of China(SAC/TC 105)

NY 1979-2010 Fertilizer Registration Tech-regulations of Fertilizer Labels

肥料登记 标签技术要求

Agricultural Standard

Publisher

MoA

This Standard specified the text content, compulsory nutrient content and formation of fertilizer label.

All fertilizers and soil conditioners registered and marketed in China, except compounded fertilizers, organic fertilizer and microbial fertilizers shall be labeled in comply with this Standard.

Proposer

MoA

Drafter:

National Center for Quality Supervision and Testing of Chemical Fertilizers(Beijing);

Technical Committee

MoA

NY 1980-2010 Fertilizer Registration-Determination and Evaluation of Acute Oral Toxicity

肥料登记 急性经口毒性试验及评价要求

 

Agricultural Standard

Publisher

MoA

This Standard specifies the procedures and technical requirement on the acute oral toxicity test of fertilizers, as well as the toxicity classification of fertilizers.

Applicable to all fertilizers and soil conditioners registered in China

Proposer

MoA

Drafter:

National Center for Quality Supervision and Testing of Chemical Fertilizers(Beijing), National institute of Occupational Health and Poison Control of China CDC;

Technical Committee

MoA

NY 885-2004 Marking of Microbial Product in Agriculture

农用微生物产品标识要求

Agricultural Standard

Publisher:

MoA

This Standard provides the general principles, requirements and label content for the marking of microbial products in agriculture, which is applicable to the product, marketing of agricultural microbial products(a.k.a microbial fertlizer) in China.

Microbial product in agriculture use refers to living microorganism products of industrial multiplication process of functional microorganism, intended for the agriculture use, by directly or indirectly improving the soil fertility, biological system of plant rhizosphere, nutrient supply, plant growth or quality of agricultural product through the biological activity of functional microorganism.

Depending on product composition, microbial product consists of microbial inoculant, compounded microbial fertilizers(microbial inoculants compounded with nutrient substance) and microbial organic fertilizers((microbial inoculant compounded with organic fertilizers) .Microbial inoculants can be furtherly divided into rhizobia inoculant, azotobacteria inoculant, silicate bacteria inoculant, inoculant of phosphate-solubilizing microorganism, inoculant of phytosynthetic bacteria, inoculant of plant growth-promoting rhizosphere microorganism, organic matter-decomposing inoculant, mycorrhizal fungi inoculant and bioremediating inoculant.

Proposer:

MoA

Drafter:

Center for Quality Supervision and Testing of Microbial Fertilizers of MoA

Technical Committee:

MoA

NY 1109-2006 General Biosafety Standard for Microbial Fertlizers

微生物肥料生物安全通用技术准则

Agricultural Standard

Publisher

MoA

This standard provides four categorized lists of known microorganism strains for microbial fertilizers. The required items, procedures and criteria for the   toxicological evaluation of  different  microorganism strains and the microbial fertilizers were specified.

Proposer

MoA

Drafter

Center for Quality Supervision and Testing of Microbial Fertilizers of MoA

Technical Committee:

MoA

 

Scope and Applicant of Fertilizer Registration

Fertilizer usually refers to the organic, inorganic and microbial substances and mixture of substances which offer, maintain or improve the nutritional status, output, quality and stress tolerance (abiotic) of crops or the physical, chemical and biological performance of soils or plants, increase the output and quality of agricultural produce or increase stress resistance of plants. Fertilizers cannot be imported, produced, sold, or advertised without prior registration with the competent authorities of at a ministerial or provincial level. From registration prospective, fertilizers can be divided into 3 types:

  • Exempted from Registration -Fertilizers that has been used for many years domestically and have been established with national or industrial product executive standard are  exempted from registration: ammonia sulfate, urea, calcium cyanamide,  ammonium phosphate(mono and di), phosphor nitrate, superphosphate, potassium chloride; potassium sulfate, potassium nitrate ,ammonium chloride ,ammonium bicarbonate, calcium magnesium phosphate, potassium dihydrogen phosphate, single microelement fertilizer, high concentration compound fertilizer;
  • Registered with provincial agricultural department-compound fertilizer; formula fertilizer (no foliar fertilizer); refined organic fertilizer and soil acid regulating agents should be registered with provincial agricultural department and can be only sold within the administration area of the province. If the producer or distributor files a provincially registered fertilizer to the department at other province, the fertilizer can be sold in other province.
  • Fertilizers that do not fit above 2 criteria should be registered with the MoA. Fertilizer-pesticide mixtures and the homemade organic fertilizer produced by the farmers are also beyond the scope of fertilizer registration management. Homemade organic fertilizers are usually for self-use purpose and fertilizer-pesticide mixtures are controlled under China’s pesticide registration system.

Imported Fertilizers that not yet exempted from fertilizer registration should be directly registered with the MoA.

Fertilizer registration can only be applied by its indigenous producer or local entrusted agency/ branch office of overseas producer. The former should be a legal entity that registered with the Administration of Industry and Commerce (Business Registration) for corresponding business scope (fertilizer production or distribution) and the latter should be authorized and certified by the overseas producer to import or market the fertilizer. If the fertilizer is produced overseas but marketed only in China, the data requirement, testing item and approval procedure will be a little different compared with other products.

The examination and final approval of the application material, issuance and public announcement of registration certificate are MoA's responsibility. Fertilizers that established with national or industrial product executive standard can be directly reviewed and approved by the MoA. Other products are reviewed and discussed by the National Expert Committee on Fertilizer Registration and MoA issues registration certificates or required for additional data or material based on the results and opinions. MoA has gathered the suggestions previously proposed by the Committee and compiled them into the MoA Office Letter 12 of 2010, the “Agreed Matters Decided at the National Expert Committee on Fertilizer Registration”. In addition to numerous explanations and requirements targeting specific fertilizer products and techinal and administrative issues, the Letter defines the function of the Committee and product scope that needs to be reviewed by the Committee, which serves as an important addition to its previous ministerial regulations:

  • Fertilizers should be mandatorily registered with designated generic names in the “Catalogue and Specification on Generic Names for Fertilizer Registration” (Fertilizer Registration Catalogue). The amendment, removal and addition of Fertilizer Registration Catalogue should be proposed by the Committee and approved by the MoA;
  • Plenary session of the Committee are held in March and September each year. New fertilizers (using new raw material, new production technology and containing new ingredient) and other fertilizers not yet established with mandatory executive product standard are reviewed by the Committee. On a case by case basis, the Committee will propose the technical requirement for quality inspection and efficacy evaluation for each new fertilizer. Through the assessment on technical and product nature, the Committee may maintain or alter the original generic name originally proposed by the applicant while product falls outside any generic name of the Catalogue would be rejected from registration;

The latest clarification between what products can be directly approved by the MoA and what fertilizer needs to be reviewed by the National Expert Committee was made by 1st session of the 7th Committee in 2013.

Category

Mandatorily Generic Name (excluding microbial fertilizer)

National/Industrial Product Standard

Marconutrient

Water-soluble fertilizer containing nitrogen, phosphorus and potassium*

NY 1107 -2010

Urea ammonium nitrate solution*

NY 2670-2015

Potassium nitrate for agricultural use

GB/T 20784-2013

Modified ammonium nitrate for agriculture*

NY 2268-2012

Calcium ammonium nitrate for agriculture use*

NY 2269-2012

Magnesium-potassium sulfate for agriculture use

GB/T26568-2011

Magnesium-potassium chloride for agriculture use

 

Slow-release fertilizer*

GB/T23348-2009

Synergized nitrogen fertilizer

 

Secondary Element

Water-soluble fertilizer containing calcium and magnesium*

NY 2266-2012

Fertilizer containing calcium and magnesium

 

Calcium nitrate for agricultural use

 

Magnesium sulfate for agricultural use

 

Micronutrient

Water-soluble fertilizer containing micronutrients*

NY 1428-2010

Micronutrient fertilizer

 

Soil Conditioner

Soil conditioner

 

Agro-forestry absorbent polymer*

NY 886-2010

Synergist

Fertilizer synergist

 

Organic water soluble  Fertilizer

Water-soluble fertilizer containing amino-acids*

 

Water-soluble fertilizer containing humic -acids*

NY 1429-2010

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

NY 1106-2010

 

 

 

Fig.1 -Fertilizer Registration Scope

Approval Procedure and Registration Category

The registration of fertilizer products can be classified into four categories based on the novelty of the application and the validity period.

Temporary Registration-After the plot experiment, if the product requires a field trial or marketing trial, its producer should apply for the temporary registration;

Full Registration-After temporary registration and field trial or marketing trial are complete, if the product wants to be marketed as a commercial product, the producer should apply for full registration;

Registration Extension-if the registrant wants to continue marketing or producing their product after the expiry of the original temporary or full registration, the company should apply for the registration extension;

Registration Modification-If the registrant alters the uses, product name and company name which it should apply for registration modification;

Domestic applicants and overseas company go through different examination and approval procedures depending on their registration category, summarized in the table below:

Fig.2 -Fertilizer Registration Procedure

 

Data Requirement on Fertilizer Registration

To ensure the quality and safety of fertilizers, the reviewing body needs a comprehensive understanding of the producer and the product. The applicants are required to undertake a series of tests and prepare different data depending on the origin and category of product and the registration stage. The similarities and the differences of the data packages are summarized in the table below:

 

Temporary Registration

Full Registration

General Information

Credentials of the business registration(the overseas applicant should be certificated by the competent authority or authenticated by the Chinese embassy of the host country );

General introduction about the producer;

General information about the product and production process;

Certification of trademark registration;

Declaration stating no knowledge of deliberate IP infringement

The applicant should supplement material summited during temporary registration;

If a product is manufactured abroad was registered in other countries after the temporary registration, the overseas applicant should summit these information to the MoA;

Quality Standard

If the product was manufactured in China and China has established national or industrial standard for the product, the quality should meet the corresponding national or industrial standard;

If the product was manufactured abroad, the applicant should provide the physical-chemical property, quality control indicator and method of the product, as well as the quality assurance document certified by the host county/region;

Based on the material summited during the temporary registration, MoA will decide whether the applicant should further supplement new quality standard and information about test method;

Label Template

The product should be labeled in Chinese. Pinyin and foreign language can be labeled simultaneously. The product label should be labeled with the name of the active ingredient, content, quality standard number, crop, usage, precaution and other information. The label should reserve a place for fertilizer registration certificate number.

Based on the material summited during the temporary registration, MoA will decide whether the applicant should further submit other information;

Efficacy test data

The efficacy plot experiment should be taken within three years before the date of the application;

If the product was manufactured by domestic producers, the experiment should be conducted by the testing institute approved by the competent authority at provincial level or above. If the product was manufactured by overseas company, the testing institute should be approved by the MoA;

Proof that the product has been utilized in agricultural product, which should be supported by the users.

If China has established national or industrial standard for the product or the Expert committee suggested data waived on the product and the product was identified by the MoA;

If the active ingredient of the product was contained in other product and the product was fully registered by the same producer and the producer only alter s formulation type of the product;

Toxicity Data

The toxicity report should be issued by the testing institute approved by the competent authority of health administration at provincial level or above.;

Based on the material summited during the temporary registration, MoA will decide whether the applicant should further submit other information;

Optional Data

Coating Material Degradation (only required for slow released fertilizer coated with resin);

Anti-detonating-(only required for fertilizer containing high level of nitrate nitrogen such as modified ammonium nitrate for agriclutre)

Strain identification and strain toxicity(only required for microbial fertlizers)

 

Residual  data

Totally exempted after late 2015

Totally exempted after late 2015

Annual report for quality tests

 conducted by MoA recognized lab

tests on two batches

Comment of the preliminary review

only applicable for the product manufactured in China

do not required

In recent years, China has compiled a series of industrial standard for certain kinds of fertilizer products, the technical specifications of which are widely adopted in quality assurance and registration management. Currently, the specifications of 8 agricultural standards have been mandatorily adopted in fertilizer registration management:

NY 1107-2010 Water-soluble fertilizer containing nitrogen, phosphorus and potassium

Added with calcium and magnesium

Added with micronutrients

Item

Solid

Liquid

Item

Solid

Liquid

content of macronutrients a ≥                                                   

50.0

500

content of macronutrients a  ≥                                                   

50.0

500

content of calcium and magnesium b  ≥                                                   

1.0

10

content of micronutrient C ≥                                                   

0.2~3.0

2~30

water insoluble substance ≤                        

5.0

50

water insoluble substance  ≤                            

5.0

50

pH(250 times diluted )

3.0~9.0

pH(250 times diluted )

3.0~9.0

water(H2O), % ≤

3.0

/

water(H2O), % ≤

3.0

/

Hg≤

5

Hg≤

5

As≤

10

As≤

10

Cd≤

10

Cd≤

10

Pb≤

50

Pb≤

50

Cr ≤

50

Cr ≤

50

a The content of macronutrients refers to the sum of nitrogen, phosphorus pentoxide and potassium oxide. The product should contain at least two element of nitrogen, phosphorus and potassium and the content of each element should not be less than 4.0%(40 g/L);

b The content of calcium and magnesium refers to the sum of calcium and magnesium and the product should contain either calcium or magnesium at least. If the product contain no less than 0.1% (1 g/L)of calcium or magnesium, the content of the element can be counted as part of the sum of calcium and magnesium;

C The content of micronutrients refers to the sum of copper, iron, manganese, zinc, boron and molybdenum. The product should contain at least one of the above elements. If the product contain no less than 0.05% (0.5 g/L)of the above element , its content  can be counted as part of the sum of the micronutrients. The content of molybdenum should not be higher than 0.5%(5 g/L);

 

 

 

NY 2266-2012 Water-soluble fertilizer containing calcium and magnesium

Item

Solid

Liquid

content of calcium and magnesium  ≥                                                   

1.0

10

water insoluble substance ≤                        

5.0

50

pH(250 times diluted )

3.0~9.0

water(H2O), % ≤

3.0

/

Hg≤

5

As≤

10

Cd≤

10

Pb≤

50

Cr ≤

50

The content of calcium and magnesium refers to the sum of calcium and magnesium or single calcium or magnesium. If the product contain no less than 1.0% (10 g/L)of calcium or magnesium, the content of the element can be counted as part of the sum of calcium and magnesium. The content of sulfur should not be counted as the sum but it should be marked on the label of the product;

if the product was fortified with micronutrients, the content of the micronutrients should not be less than 0.1 %(1 g/)and higher than 10% of  the sum of calcium and magnesium. The content of micronutrients refers to the sum of copper, iron, manganese, zinc, boron and molybdenum. The product should contain at least one of the above elements. If the product contain no less than 0.05% (0.5 g/L)of the above element , its content can be counted as part of the sum of the micronutrients.

 

 

NY 1428-2010 water-soluble fertilizers containing micronutrients

Item

Solid

Liquid

content of micronutrients  ≥                                                   

1.0

10

water insoluble substance ≤                        

5.0

50

pH(250 times diluted )

3.0~10.0

water(H2O), % ≤

6.0

/

Hg≤

5

As≤

10

Cd≤

10

Pb≤

50

Cr ≤

50

The content of micronutrients refers to the sum of copper, iron, manganese, zinc, boron and molybdenum. The product should contain at least one of the above elements. If the product contain no less than 0.05% (0.5 g/L)of the above element , its content  can be counted as part of the sum of the micronutrients. The content of molybdenum should not be higher than 0.5%(5 g/L), except the fertilizer contains only molybdenum element.

 

 

 

NY 1429-2010 Water-soluble fertilizers containing amino-acids

Added with micronutrient

Added with calcium and magnesium

Item

Solid

Liquid

Item

Solid

Liquid

content of free-amino acids ≥                                                     

10.0

100

content of free-amino acids ≥

10.0

100

content of micronutrient a≥                                                   

2.0

20

content of calcium and magnesiumb≥                                                   

3.0

30

water insoluble substance ≤                         

5.0

50

water insoluble substance ≤                            

5.0

50

pH(250 times diluted )

3.0~9.0

pH(250 times diluted )

3.0~9.0

water(H2O), % ≤

4.0

/

water(H2O), % ≤

4.0

/

Hg≤

5

Hg≤

5

As≤

10

As≤

10

Cd≤

10

Cd≤

10

Pb≤

50

Pb≤

50

Cr ≤

50

Cr ≤

50

a The content of micronutrients refers to the sum of copper, iron, manganese, zinc, boron and molybdenum. The product should contain at least one of the above elements. If the product contain no less than 0.05% (0.5 g/L)of the above element , its content  can be counted as part of the sum of the micronutrients. The content of molybdenum should not be higher than 0.5%(5 g/L);

b The content of calcium and magnesium refers to the sum of calcium and magnesium and the product should contain either calcium or magnesium at least. If the product contain no less than 0.1% (1 g/L)of calcium or magnesium, the content of the element can be counted as part of the sum of calcium and magnesium;

 

 

NY 1106-2010 Water-soluble fertilizers containing humic-acids

Added with macronutrient

Added with micronutrient

Item

Solid

Liquid

Item

Solid

Liquid

content of  humic-acids≥                                                     

3.0

30

content of free-amino acids ≥

10.0

100

content of macronutrient a≥                                                   

20.0

200

content of micronutrient b≥                                                   

3.0

30

water insoluble substance ≤                         

5.0

50

water insoluble substance ≤                            

5.0

50

pH(250 times diluted )

4.0~10.0

pH(250 times diluted )

3.0~9.0

water(H2O), % ≤

5.0

/

water(H2O), % ≤

4.0

/

Hg≤

5

Hg≤

5

As≤

10

As≤

10

Cd≤

10

Cd≤

10

Pb≤

50

Pb≤

50

Cr ≤

50

Cr ≤

50

a The content of macronutrients refers to the sum of nitrogen, phosphorus pentoxide and potassium oxide. The product should contain at least two element of nitrogen, phosphorus and potassium and the content of each element should not be less than 2.0%(20 g/L);

b The content of micronutrients refers to the sum of copper, iron, manganese, zinc, boron and molybdenum. The product should contain at least one of the above elements. If the product contain no less than 0.05% (0.5 g/L)of the above element , its content can be counted as part of the sum of the micronutrients. The content of molybdenum should not be higher than 0.5%;

 

 

NY 886-2010 agro-forestry absorbent polymer

Item

Specification

water-absorbency, g/g                                               

100 ~ 700

saltwater –absorbency(0.9% sodium chloride), g/g                          

30

water(H2O), % ≤

8

pH(1000 times diluted )

6.0 ~ 8.0

particle size (≤0.18 mm,  or 0.18 mm ~ 2.00 mm, or 2.00 mm ~ 4.75 mm)% ≥ 

90

Hg≤

5

As≤

10

Cd≤

10

Pb≤

50

Cr ≤

50

 

 

NY 2268-2012 modified ammonium nitrate for agricultural use

Item

Specification

Total nitrogen(N),%  ≥                                  

26.0

nitrogen in nitro form (N),% ≤                 

13.5

content of calcium and magnesium ≥

5.0

pH(250 times diluted )

6.0 ~ 8.5

water(H2O), % ≤

2.0

particle size (1.00 mm ~ 4.75 mm)% ≥

90

Hg≤

5

As≤

5

Cd≤

5

Pb≤

25

Cr ≤

25

The content of calcium and magnesium refers to the sum of calcium and magnesium or single calcium or magnesium. If the product contains no less than 0.5%of calcium or magnesium, the content of the element can be counted as part of the sum of calcium and magnesium.

 

 

NY 2269-2012 calcium ammonium nitrate for agricultural use

Item

Specification

Total nitrogen(N),%  ≥                                  

15.0

nitrogen in nitro formed (N),% ≤                 

14.0

content of calcium ≥

18.0

pH(250 times diluted )

5.5 ~ 8.5

water insoluble substance ≤

0.5

water(H2O), % ≤

3.0

particle size (1.00 mm ~ 4.75 mm)% ≥

90

Hg≤

5

As≤

10

Cd≤

10

Pb≤

50

Cr≤

50

The content of calcium and magnesium refers to the sum of calcium and magnesium or single calcium or magnesium. If the product contains no less than 0.5%of calcium or magnesium, the content of the element can be counted as part of the sum of calcium and magnesium.

In order to push forwards its regulatory agendas and registration system, China’s government has compiled a series of technical guidance and supporting document for registration. China abolished the registration fee for fertilizers in 2005 and exempted the VAT on organic fertilizer product. In 2009, China provided subsidized organic fertilizer to farmers in Beijing, Shanghai Shandong and other regions.

However these efforts were not appreciated by the fertilizer industry. Most of the producers believed that registration is a waste of mon

ey and time and the management does not help to crack down on substandard products and unlawful behavior in the industry. It has been repeatedly proposed during the People's Congress that the registration system should be terminated as MoA Order 32 does not have enough supporting legislation. Most important regulatory measures are founded on the principles outlined in a higher-level law, which is usually promulgated under the State Council or the People’s Congress in as a “Law” or “Administrative Regulation”. It is claimed that Order 32 was compiled under the Agricultural Law, but the ill-defined terms of this Law are ill equipped to support the legitimacy of the registration system. Furthermore supervisory capacity issues body make it difficult to police the industry and stop circulation of illegal products.

Instead, the administrative approval systems on other two other agricultural inputs have been implemented with the promulgation of the “Regulation on Pesticide Administration” and the “Seed Law”. A draft of the “Regulation on fertilizer Administration” was proposed to the People’s Congress in 2011. We can expect promulgation of a new regulation for fertilizer management in the near future.

News and Analysis

[AgroAnalysis]Biostimulants under China’s Fertilizer Regulations