As the largest user and producer of fertilizer on the global stage, China’s chemical and organic fertilizer utilization reached 50 million tons in 2023 respectively. To ensure market regulation and agricultural safety, China has established a robust fertilizer registration system, characterized by product categorization, rigorous procedures, and stringent data review. This article will introduce the legal basis, mechanism, and procedure of fertilizer regulation in China, as well as the data requirements, current challenges, and future trends.
Mechanism and Organization
China’s fertilizer registration system was established under the ministerial regulation “Measures for the Administration of Fertilizer Registration” in 2000 and has since undergone four revisions. The measures specify that fertilizer refers to any organic, inorganic, or microbial materials or mixtures used to provide, maintain, or improve plant nutrition and soil physical, chemical properties, and biological activity. These materials can increase agricultural product yield, improve agricultural product quality, or enhance plant stress resistance. Fertilizers cannot be imported, produced, sold, or used in China until the registration and filing processes are completed.
The Chinese Ministry of Agricultural and Rural Affairs (MARA) is responsible for the registration, filing, and supervision of fertilizers nationwide. The ministry also formulates data requirements guidance, accepts applications, reviews dossiers, issues and announces approvals, and organizes the National Review Committee of Fertilizer Registration (NRCFR). The agricultural and rural authorities at the provincial level are responsible for assisting MARA with registering or filing fertilizer within their jurisdiction, or approving the registration/filing for certain fertilizers. In addition, they may outsource to soil or fertilizer institutions to carry out significant tasks related to fertilizer registration or filing. The agricultural and rural authorities at or above the county level are responsible for overseeing fertilizer within their jurisdictions. They do so by conducting regular or irregular inspections of fertilizer producers, wholesalers, retailers, and end users. They also investigate and address any illegal activities.
Differentiated Management
Depending on the product’s features, technologies, intended uses, and potential risks, the premarketing processes can be classified into three categories: registration, filing, and exempted from registration.
China is continuously developing and updating executive product standards for each type of fertilizer. These standards are formalized in the form of agricultural and national standards, which specify product definition, raw material, manufacturing process, and quality specifications.
Producers of functional fertilizers that are technically sophisticated but not yet subject to official standards must compile their enterprise standards and register their products with MARA. If the products are deemed to be of significant importance to agricultural production or the environment, their dossiers are often reviewed and discussed at the annual or semi-annual NRCFR plenary sessions. Others risk-controllable fertilizer can be directly approved by the NRCFR secretariat or only need to be filed at MARA, while some basic fertilizers or products for regional uses are registered or filed at the provincial authorities. Seventeen low-risk fertilizers that have been in use for a long time or that meet national or industrial standards are exempt from registration or filing requirements. However, their domestic producers are required to obtain a production license from the Ministry of Industry and Information Technology (MIIT) before commencing production activities. The table below provides a comprehensive overview of the standardization status and compliance process for various fertilizer types.
| Fertilizer Generic Name | Code of Standard | Registration/Filing | ||
| Registration/Filing at MARA | ||||
| Macro-element fertilizers | ||||
| Water-soluble marco-nutrient fertilizers | NY 1107-2020 | File at MARA | ||
| Urea ammonium nitrate solution | NY 2670-2020 | Registration (NRCFR reviewed) | ||
| Modified ammonium nitrate for agriculture | NY 2268-2020 | Registration (directly approved) | ||
| Calcium ammonium nitrate for agriculture | NY 2269-2020 | Registration (partly NRCFR reviewed) | ||
| Potassium magnesium sulphate for agriculture | NY/T 3620-2020 | File at MARA | ||
| Potassium magnesium chloride for agriculture | Enterprise standard | File at MARA | ||
| Slow-release fertilizer | Enterprise standard | Registration (NRCFR reviewed) | ||
| Secondary element Fertilizers | ||||
| Water-soluble fertilizer containing calcium and magnesium | NY 2266-2010 | File at MARA | ||
| Non-water-soluble secondary element fertilizer | NY/T 3830-2021 | Registration (directly approved) | ||
| Water soluble silicon fertilizer | NY/T 3829-2021 | Registration (directly approved) | ||
| Calcium nitrate for agriculture use | Enterprise standard | Registration (NRCFR reviewed) | ||
| Micronutrient fertilizers | ||||
| Water-soluble fertilizer containing micronutrients | NY 1428-2010 | File at MARA | ||
| Micronutrient fertilizer | Enterprise standard | Registration (NRCFR reviewed) | ||
| Organic fertilizers | ||||
| Water-soluble fertilizer containing amino-acids | NY 1429-2010 | Registration (directly approved) | ||
| Water-soluble fertilizer containing humic-acids | NY 1106-2010 | Registration (directly approved) | ||
| Organic water-soluble fertilizer | Enterprise standard | Registration (NRCFR reviewed) | ||
| Soil conditioners | ||||
| Soil conditioner | Enterprise standard | Registration (NRCFR reviewed) | ||
| Agro-forestry absorbent polymer | NY/T 886-2022 | Registration (NRCFR reviewed) | ||
| Soil remediation inoculant | Enterprise standard | Registration (NRCFR reviewed) | ||
| Microbial fertilizers | ||||
| Microbial inoculant in agriculture | GB 20287-2006 | Registration (directly approved) | ||
| Concentrated inoculant of agriculture Microorganism | NY/T 3083-2017 | Registration (NRCFR reviewed) | ||
| Microbial organic fertilizer | NY 884-2012 | Registration (directly approved) | ||
| Compound microbial fertilizer | NY/T 798-2015 | Registration (directly approved) | ||
| Organic matter-decomposing inoculant | NY 609-2002 | Registration (directly approved) | ||
| Rhizobium fertilizer | NY 410-2000 | Registration (directly approved) | ||
| Inoculant of Endophytic mycorrhizal bacteria | GB 20287-2006 | Registration (directly approved) | ||
| Microbial inoculant in agriculture | GB 20287-2006 | Registration (NRCFR reviewed) | ||
| Inoculant of photosynthetic bacteria | NY/T 527-2002 | Registration (directly approved) | ||
| Others | ||||
| Fertilizer Synergist | Enterprise standard | Registration (NRCFR reviewed) | ||
| Registration/Filing at provincial authorities | ||||
| Compound fertilizer | GB/T 15063-2020 | Filing | ||
| Organic fertilizer | NY/T 525-2021 | Registration | ||
| Organic-inorganic compound fertilizer | GB/T 18877-2020 | Registration | ||
| Rice nursery soil conditioner | NY 526-2002 | Registration | ||
| Bulk blending fertilizer | GB/T 21633-2020 | Filing | ||
| Fertilizer Exempted from Registration | ||||
| Generic Name | Standard Code | Generic Name | Standard Code | |
| Ammonium sulphate | GB/T535-2020 | Potassium sulfate | GB/T 20406-2017 | |
| Urea | GB/T 2440-2017 | Potassium nitrate | GB/T 20784-2018 | |
| Ammonium nitrate | GB/T 2945-2017 | Ammonium chloride | GB/T 2946-2018 | |
| Calcium cyanamide | HG/T 2427-2021 | Ammonium bicarbonate | GB/T 3559-2001 | |
| Monoammonium phosphate and diammonium phosphate | GB/T 10205-2009 | Fused calcium magnesium phosphate fertilizer | GB/T20412-2021 | |
| Nitrophosphate | GB/T 10510-2023 | Potassium dihydrogen phosphate | HG/T2321-2016 | |
| Single superphosphate | GB/T 20413-2017 | Straight fertilizer containing micronutrient | / | |
| Potassium chloride | GB/T 37918-2019 | high-concentration compound fertilizer | / | |
Procedures
Only manufacturing companies are eligible to apply for fertilizer registration. Overseas producers may submit applications through their Chinese branch office or entrusted local agents. These agents should be held liable for any relevant legal responsibilities that arise. Provincial agricultural authorities are responsible for accepting applications and conducting field inspections on producers within their jurisdiction, as well as providing preliminary opinions. MARA’s administrative service hall will perform a completeness check on the applications and dossiers, and the NRCFR secretariat will check the fertilizer samples. The application and dossiers will then be discussed and reviewed by NRCFR or its secretariat. Once the review is complete, qualified fertilizers will be issued with registration certificates. The registration is valid for five years, and the renewal application should be submitted six months prior to the expiration date. If the registrant makes any alterations to the use scope, trade name, company name, or other non-quality relevant changes, a registration amendment should be applied. In the event of significant changes, such as alterations to the constituent or formulation type, the registrant is required to submit a new application for its product.
For fertilizers subject to filing obligations, applicants must submit the relevant data exclusively through the online systems of MARA or provincial authorities prior to commencing production activities.
Data Requirements
For the initial registration process, it is essential that the application materials be organized into nine sections. These sections should include information regarding the company and its products, safety and effectiveness data, labels, and product samples. The key points are summarized as follows:
| Title | Remark |
| 1.Application form | The document should be the original w委托and in paper form. |
| 2.Applicant Credentials | Domestic applicants should submit a copy of their company registration certificate with the official seal;
Applicants from outside the country must submit company registration certificates and production permits or product approvals issued by the government or fertilizer regulation authority from their home countries. These documents must be certified by the local Chinese Embassy; Applicants from outside the country should also submit the commission contract with the entrusted Chinese agent. This agreement should specify that the agent has been delegated to register, package, or import the fertilizer and to assume relevant legal responsibility. |
| 3. Preliminary opinions from provincial authorities | Issued after the field inspection by the provincial authorities;
Applications for imported fertilizers are directly submitted to MARA. |
| 4.Manufacturer’s review form | Domestic applicants should submit the form issued by the provincial agricultural authorities or other authorized institutions and include image data on the production facility and quality control device, including test instruments. Applicants from outside the country should submit the same image data. |
| 5.Safety data | For products considered high-risk, applicants are required to submit additional evaluation materials on its risks to soil, crop, water, and human, etc. |
| 6.Effectiveness data | |
| 6.1 Field trial report; | The applicant is required to conduct a normative field trial in China. The trial should be conducted at specific locations with a scientific study plan and standardized procedures. The trial report is to be signed and ratified by a qualified agronomist, and the name of the study director should also be indicated. The test report should also include the professional titles and certificates of relevant personnel, the name and contact information of the grower who conducted the field trial, as well as the testing record and image data for future reference.
For general fertilizers, each crop should provide a 1-year trial report at two sites or a 2-year report at one site. According to the protocol, soil remediation fertilizers (including soil remediation inoculant) should be trialed at two sites for three consecutive years. Similarly, organic matter-decomposing inoculant used exclusively for organic material should be trialed at two sites. |
| 6.2 Product executive standard | If a domestic producer chooses to self-compile the standard, the standard should be filed at the local standardization administrative department. |
| 7.Label sample | The size, format, claim, and other information must comply with the “Measures for the Administration of Fertilizer Registration,” “Data Requirements on Fertilizer Registration,” and national mandatory standards. |
| 8. General information of products and producer | |
| 8.1 Producer’s profile; | General information on the producer, staff composition, technology strength, production scale and designed capacity, etc. |
| 8.2 R&D report; | R&D background, target, process, raw material composition, technical specification, testing methods, application effect and scope, etc. Microbial fertilizer should additionally provide data on source of the origin, taxonomy, cultivation conditions, and strain safety, etc. |
| 8.3 Production Process | Raw material composition, process flow, key equipment configuration, production control measures. |
| 9.Product sample | For quality and acute oral toxicity tests, it is essential that samples are obtained from the same batch. The quantity of each sample should be a minimum of 600 grams (or 600 milliliters). For granular formulations, the amount should be no less than 1000 grams;
At least 9,000 grams of sample will be required for the anti-detonating test. This requirement applies only to fertilizers containing high levels of nitrate nitrogen; At least 1,000 grams of coating materials will be required for the degradation test, and two tubes of slant strain will be required for microbial fertilizers； It is essential that all samples be packed in without any mark. The organization that samples the product must label the producer, sample name, active ingredients and content, production date, etc. Provincial authorities or their designated testing institutions will sample domestic products. |
The field trial can be conducted by the applicants themselves or by an external entity such as an agricultural technology station or a soil fertilization station. In either case, both parties are responsible for ensuring the integrity of the trial report.
To renew registration, the registrant should provide a three-year report on quality tests, as well as a situation report on product uses, including use acreage, crops, effects, major use regions, sales volume and value, and users feedback. If the registrant alters the scope of use, product name, or company name, the amendment application must include the corresponding field trial report, label sample, and credentials.
At the provincial level, only three fertilizers are registered, and these products are often intended for regional use or specific crops. Their data requirements are more individualized. For instance, organic fertilizers derived from livestock manure should be tested for ascarid egg mortality and Escherichia coli levels. A fertilizer used on Pu’er tea was required to provide data on the accumulation of aroma substances, contribution to polyphenol level and crop resistance to cold and drought stress, etc.
Post-Registration
In addition to registration, China established a coordinated, top-down approach to market surveillance. MARA is increasing the random quality inspection with its provincial subordinates. Over the past five years, MARA has conducted over 2,000 inspections of organic fertilizers, water-soluble fertilizers, and compound fertilizers, while provincial authorities have inspected over 20,000 fertilizers.
The market supervision authorities are responsible for overseeing fertilizer transactions, cracking down on false advertising and price fraud, with MIIT promoting the optimization and upgrade of the sector by formulating development plans and industrial guidance.
Current Status and Future Trend
It is important to note that China has already enacted specific national regulations for all major agriculture inputs, including seeds, pesticides, veterinary medicines, and feeds, with the exception of fertilizers. Due to the dissemination of relevant stipulations across ministerial rules, notices, and documents, the registration process for certain novel fertilizers is currently cumbersome and inefficient. For instance, fertilizers that have been directly approved by the NRCFR secretariat generally have a higher qualification rate. This is due to the enactment of national or industrial standards and explicit review criteria. However, the NRCFR plenary session has only approved approximately 60% of the fertilizers that were reviewed. This is due to the complexity of the source of raw materials, technology, and use scopes, as well as the potential risks to agriculture and the environment, and the case-by-case basis.
To streamline the fertilizer registration process and keep pace with new innovations, NRCFR is systematically collecting common issues of faulty data. The organization periodically publishes their opinions and solutions in the form of meeting minutes. The country is also accelerating the establishment of the corresponding standard. Once a category of fertilizer is issued with national or industrial standards and its review criteria are established, the registration procedure will be delegated to NRCFR secretariat approval or provincial registration/filling office.
Meanwhile, MARA is actively engaged in the legislative process for the “Regulation for the Control of Fertilizers,” a national regulation specifically targeted at the fertilizer sector. A draft was already compiled in late 2007, but it had not yet been approved by the State Council. In 2024, the ministry has recently announced its intention to resume the process.
