Issues, Advice for Fertilizer Registration in China

According to the Regulations on Fertilizer Registration Management issued by the Ministry of Agriculture and Rural Affairs of the People’s Republic of China (MARA), specialty fertilizers (new types of fertilizers) must be registered or have a filed record at MARA. Novel fertilizers mainly include water-soluble fertilizers with amino acids, water-soluble fertilizers with humic acid, organic water-soluble fertilizers, micronutrient fertilizers, water-soluble fertilizers with silicon, non-water-soluble fertilizers with secondary nutrients, soil amendments, urea ammonium nitrate solutions, fertilizer synergists, slow-release fertilizers, agroforestry absorbent polymers, biological organic fertilizers, microbial fertilizers, agents to decompose organic matter, rhizobia inoculants, agents of photosynthetic bacteria, microbial agents for soil amendment, microbial concentrates, endophytic mycorrhizal inoculants, bioremediating inoculants, and others. 

The report’s author has been working on fertilizer registration with MARA for many years. This article will highlight common issues and provide advice for applying for a specialty fertilizer registration.

Issues for the registration application

1. Applicators do not meet the requirements

When providing fertilizer registration consulting services, we have found that many clients do not meet the basic application requirements. Specifically, some registration applicators were too hasty to apply for fertilizer registration before their industrial and commercial business licenses were approved; the business scope of some applicator’s licenses does not cover the production and sale of fertilizers, making them ineligible to apply for fertilizer registration at MARA; some companies do not have a fertilizer production plant (note: only those with industrial land can be approved to build a production plant); and applicators have not updated their plant’s environmental assessment in a timely manner.

2. Applicators lack awareness of the current changes in registration policies

There were recent changes in the registration policies. In September 2015, the administrative approval for fertilizer registration was transferred to MARA’s Administrative Approval Office, which is now the MARA Government Affairs Service Hall, which processed both online and paper-based applications. In early 2018, provisional registrations were abolished. At the end of 2020, MARA replaced the registration of water-soluble fertilizers with secondary/micronutrients nutrients and some chemical fertilizers with record filing. In 2021, the registration renewal and revision process for fertilizers went online for application and approval. Some applicators are not aware of the latest policies and prepare documents based on the old checklist, resulting in many documents being invalid or missing.

3. Field trial reports do not meet registration requirements

Field trial reports play a key role in the process of fertilizer registration. Our internal data reveals that every year, around 40% of products submitted to MARA failed to meet registration requirements because of improper field trial reports. The main reasons for this include non-standard field trials, improper Analysis of Variance (ANOVA), similar data, suspected falsification of trials, and unqualified personnel conducting the trials. The field reports prior to being submitted to MARA have various errors. These common issues not only increased the workload of the auditing departments of MARA, they also lower their work efficiency.

4. Submitted samples are unqualified

Another key issue in the process of fertilizer registration is that submitted samples are unqualified. Among samples received and sent by provincial agricultural departments for testing, over 22% samples of chemical fertilizers are unqualified, as well as more than 53% samples of microbial fertilizers. The main reasons include discrepancies between the samples’ composition and indicators, significant differences between test results and indicators, excessive microbial contaminants, and unacceptable hemolysis test results.

5. Annual testing reports do not meet requirements

The most common problem affecting the registration renewal of fertilizers is the fact that annual testing reports do not meet requirements. Major reasons include unqualified testing agencies, questionable testing data, and insufficient testing items, which lead to the five-year testing reports being a waste of time. If applicators miss the renewal deadline because of this issue, there would be considerable losses. 

6. It is difficult to register some specialty fertilizers

With the rapid development of the specialty fertilizer industry, manufacturers have been constantly innovating in their R&D. While some new resources have been utilized, there is a lack of sufficient trial data before companies apply for registration.

7. Irregularities in the market

Due to insufficient knowledge of fertilizer registration policies, applicators tend to be misled by some consulting agencies with their claim of ″rapid approval with low price.″ Trusting unreliable agencies could lead to repeated modification and supplementation of application documents, unsuccessful trials, increased costs for applicators, and delayed product launches.

Advice for applicators to deal with the above issues 

1. Obtain all qualifications before applying for the fertilizer registration

Firstly, applicators should be formally registered by the Administration for Industry and Commerce, and have a legal personality and a business license that cover applied products. Secondly, the fertilizer production site must be on industrial land. Manufacturers should make sure if it is necessary build the production plant in an industrial park according to local regulations. It should also be noted that the environmental impact assessment for production may also affect the registration result. Furthermore, applicators should operate legally and credibly, otherwise, approved their fertilizer certificate will be revoked.

2. Choose a legal testing agency

Applicators should choose qualified testing agencies to conduct standardized trials and tests, as well as provide reliable field trial reports and quality inspection reports. They should also ask qualified agricultural technology promotion agencies and research institutions to conduct field trials. 

For each crop, a product should undergo trials in different regions over one year or in one region for at least two years, except for soil amendments that should undergo trials in two representative regions for at least three consecutive years. These trials should objectively and accurately demonstrate product efficacy, and are carried out according to a scientific trial design, through standardized operations supervised and approved by agricultural professionals with intermediate or higher titles issued by human resources authorities. Only genuine and standardized field trials can pass the review by MARA’s fertilizer registration authorities.

Applicators should also ask testing agencies at provincial level or above that have obtained CMA certifications to carry out product quality testing, especially annual quality testing. Testing agencies with strong technical capabilities and international credibility provide more accurate and reliable data, adding value to products. Applicators should avoid asking testing agencies who provide questionable data, in order to protect themselves from being on MARA’s ″blacklist.″

3. Professional testing and evaluation reduce risks

Before submitting samples to MARA for inspection, companies should first have the same batch of samples tested by authoritative agencies. When the samples pass the relevant tests and there are no significant differences between the test results and indicators, the samples can be submitted for official inspection, reducing unqualified risks.

For innovative products, professional organizations should be asked to evaluate risks before the registration application process is started, which will help increase the possibility of approval. For example, products derived from industrial waste, such as fly ash, steel slag and furnace slag, as raw materials are not eligible for registration. Another example is the selenium that has a narrow content range effective to crops, but is ineffective under low content or harmful under high content, therefore, products with selenium should not be registered. So far, there has been no successful case of a registration with selenium.

If the applicator fails to receive an approval, the time and cost invested in the preliminary stages would be wasted, which is a significant loss for the company.

It is essential to pay close attention to raw material sources and conduct random testing on materials in each batch. The use of unstable raw materials may lead to unstable product quality, insufficient nutrient content and the presence of harmful substances, resulting in an unqualified product. MARA refuses to renew the registration of fertilizers that have failed to pass inspections twice during the valid period of its registration certificate.

4. Stay informed about fertilizer registration policies

Applicators should stay updated on registration policies and requirements, accurately prepare for relevant application materials, and avoid multiple supplements that prolong the approval process. Applicators can find the latest policies through MARA and reputable consulting agencies.

5. Choose professional agencies

Lack of knowledge about registration policies makes it difficult for companies to apply for fertilizer approval on their own. They should ask consulting agencies to handle the registration process. To choose a reliable agency, it is necessary to check their establishment date, historical background and qualifications, as well as ensure that they have professional expertise without adverse records. These are more important than low service costs.

Conclusion

The fertilizer registration process cannot be completed overnight. Applicators should plan carefully and complete all steps, from building production plants, conducting trials, and undertaking various analyses, to ensure that their fertilizers are safe and beneficial to crops. I hope applicators gained some insights from this article.

This article was originally published in the magazine 2023 Biologicals Special.