On October 14, 2019, China MoARA issued the announcement 222 to update the service guide for the administrative approval of 30 agricultural-related matters. The announcement streamlines the legal basis, scope, process, data requirements, timeframe and fee for the new application and renewal of fertilizer registration, amid a minor change on registration renewal. After a period of enforcement, the Ministry has formed tacit practices for the handling and review of registration applications. This article will offer a brief introduction to the procedures, and comparative analysis of the data requirements, as well as the recent lessons learned by REACH24H experts, who successfully helped many overseas enterprises to obtain fertilizer registration in China.
Categorized Registration Management
Based on the level of risk, fertilizers subject to registration management need to be registered with MoARA or provincial agricultural authority. Fertilizers not yet established with national or industrial standards are reviewed by the technical committee on a case-by-case basis will other fertilizers that satisfy the quality indicators in the national or industrial standards are reviewed and approved directly.
The Classification and Quality Standardization Status of Fertilizer in China
Fertilizers Registered at Ministerial Level
Water-soluble fertilizer containing nitrogen, phosphorus and potassium
Urea ammonium nitrate solution
Modified ammonium nitrate for agriculture use
Calcium ammonium nitrate for agriculture use
Magnesium-potassium for agriculture use
Magnesium-potassium chloride for agriculture use
Synergized nitrogen fertilizers
Secondary Element Fertilizers
Water-soluble fertilizer containing Calcium and magnesium
Fertilizer containing calcium and magnesium
Calcium nitrate for agriculture use
Magnesium sulfate for agricultural use
Water-soluble fertilizer containing micronutrients
Soil conditioner/soil amendments
Ago-forestry absorbent polymer
Organic Water-soluble Fertilizers
Water-soluble fertilizer containing amino-acids
Water-soluble fertilizers containing humic-acids
Organic water-soluble fertilizer (alginic acid, chitin, polyaspartic acid and other organic materials)
Microbial organic fertilizer
Compound organic fertilizer
Fertilizers Registered at Provincial Level
Bulk blending fertilizer
Organic-inorganic compound fertilizer
Rice Nursery soil conditioner
Organic fertilizers are prohibited to be imported into China and extracts of organic materials that qualify with the national/industrial standards may be registered as water-soluble organic fertilizers.
Data Required for Fertilizer Registration
The requirements for homemade and imported fertilizers are slightly different, mainly due to the preliminary review of homemade fertilizers at provincial level and additional documents of imported fertilizers.
Comparison of the data and materials required for homemade and imported fertilizers
Application form (filled online)
Documents certifying the legal status of the manufacturer
Position on the preliminary review by the provincial authority
Documents certifying that the fertilizer is legally produced/marketed within the original country;
Business registration information of the overseas manufacturer
Evaluation form of production capacity
Business license of Chinese subsidiary/domestic agent
Entrustment agreement signed between the overseas applicant and subsidiary/agent
General information on the manufacturers, production facility and testing instruments
Product safety data
Executive product standard
Letter of quality commitment
Field trial report
Test report of product sample used for field trial(conditionally required)
Label used in its origin country
Statement of non-intellectual property infringement
There are couple of things in need of attention when preparing the dossier, most notably the imported fertilizer:
- The overseas enterprise may register a fertilizer either through its Chinese subsidiary or an appointed agent, whose business license shall indicate the manufacturing or marketing of the fertilizer proposed;
- The documents certifying the legal marketing/manufacturing overseas and the business registration of the manufacturer shall be issued from the fertilizer authority within the origin country and authenticated by the local Chinese Embassy or Consulate. All original foreign language documents shall be translated and notarization by a third party;
- The entrustment agreement shall define the duties: the subsidiary/agent is responsible for the registration formality, label preparing, packaging and importation, as well as bearing legal responsibility within China.
Important Notes for Registration Renewal
Fertilizer registration is valid for a maximum period of 5 years and the renewal application shall be submitted 90 days before the expiry. The 2 most important documents submitted are the quality inspection reports and the import declaration and customs clearance of imported fertilizers.
As the Announcement 222 increased the number of quality inspections from once a year to twice a year, the number of inspection reports of fertilizer registered/renewed after October 14, 2019, will be 10 instead of 5.
MoARA discourages the renewal of imported fertilizers without any actual import activity and customs clearance documents will be examined carefully. The “Shipper & Consignee” and the “User” appeared on the documents shall be the subsidiary or domestic agent exactly. If the subsidiary/agent was unable to manage the importation, an import and export company can be delegated to handle the importation. In this case, the delegate protocol signed between the subsidiary/agent and the import and export company shall be attached. The product name and specification that appeared on the document shall be consistent with those on the registration certificate and all customs clearance documents summited for the renewal shall be within their validity.
The latest major adjustment on fertilizer registration happened in late 2017 when temporary registration was removed and field trial can be performed either by the applicant or appointed testing facility. It was generally recognized that the product quality test will be conducted twice: one arranged by the applicant during the field trial and one arranged by the MoARA after receiving the application.
After years of enforcement, the applicants gradually found that the test during the field trial is usually at the discretionary of the test facility conducting the field trial and not compulsorily required.
The field trial report shall indicate the study director, accompanied by the professional certificate of agronomist or above title. The name and contact information of the grower who conducted the trial, and the trial record and image data must be kept available for inspection.
Technical Related Tips
During each plenary session of the technical committee, only half of the fertilizer deliberated can finally be approved, mainly due to unreasonable nutrient content and target crop claimed, backward production technology used as well as the absence of the safety data for fertilizers using new raw material or production technology. The MoARA experts have reached a tacit consensus on some particular opinions, especially the biofertilizers submitted by overseas enterprises:
- Crop use-Leafy vegetables have less demand for silicon and therefore it is inappropriate to register a silicon fertilizer on leafy vegetables. It is preferable to register calcium nitrate on tomato and apple, etc.;
- MSDS-For new fertilizers using a new material or production technology not yet previously registered in China, the applicant would be required to submitted the internationally-recognized material safety data sheet (MSDS). MoARA has a rigorous requirement on animal-derived materials and all organic water-soluble fertilizers of animal origin need to submit MSDS.
- Product category- Fertilizers made from feather and hair hydrolysates shall be registered as water-soluble fertilizer containing amino-acids and fertilizers made from weathered coal or amino acids should be registered as water-soluble fertilizer containing humic-acids and water-soluble fertilizer containing amino-acids respectively
- Nutrient content in organic water-soluble fertilizers-For fertilizers made from seaweed and chitosan, the organic matter shall be no less than 5.0% in powdery products and 50g/L in aqueous solution. For fertilizers made from fermented molasses, low-value fish and soybean meal, the organic matter shall be no less than 10.0% in powdery products and 100g/L in aqueous solution.