Plant protection products and a majority of biocidal products are regulated by Regulations on Pesticide Administration and shall be registered with the Institute for the Control of Agrochemicals of Ministry of Agriculture and Rural Affairs (ICAMA) in China prior to their production, import or use. In this guide, we will give you a step-by-step guide on pesticide registration in China.
Note: This article is part of Free Guide on Pesticide Regulation and Registration in China. You may contact email@example.com to get a free copy.
Step 1: Determination of Registration Type
In China, pesticides are classified into chemical pesticides, biochemical pesticides, microbial pesticides, botanical pesticides and public health pesticides. Depending on product type and form (TGAI or finished formulation), data requirements vary significantly.
In this step, it is also important to know whether your product is regarded as a new pesticide or not (whether it has been registered in China before). For new pesticide, TGAI and formulation must be registered together (but not necessarily by the same applicant). For non-new-pesticides, you can choose to register TGAI or finished formulation separately.
Companies who export TGAI or finished pesticide formulation to China can also apply for pesticide registration and become pesticide registration holder. This is usually done with the assistance of a local reliable agent like CIRS Group.
Step 2: Data Gap Analysis
In this step, applicant shall identify detailed registration data requirements (product chemistry, toxicology, environment, residue and efficacy) and data gaps for specific pesticide registration type.
China currently only accepts test data generated in overseas labs that have been accredited by the Ministry of Agricutlure and Rural Affairs (MARA) or generated in GLP labs in countries/regions that have signed Mutual Acceptance of Data (MAD) agreement with China. So far, China has not signed the MAD with OECD which means that studies done in OECD GLP labs are not accepted in China for pesticide registration.
For new pesticide AI and formulation, almost all studies must be conducted in Chinese labs accredited by MARA.
Step 3: Application of China Pesticide Management Platform Account
China implements online filing and submission of pesticide registration. For manufacturers applying for pesticide registration in China for the first time, they need to submit company related info to apply for China pesticide management platform account through the administrative service hall of the MARA. Manufacturers with existing accounts can ignore this step.
Step 4: Application of Chinese Common Name for New Active Ingredient
For the new active ingredient not listed in GB 4839-2009 “Chinese common names of pesticides”, it is necessary to apply for the Chinese common name of the new active ingredient from the National Technical Committee for pesticide standardization, and obtain the naming letter and accurate Chinese common name. It is also necessary to complete the application byadding new active ingredient name information on the government service platform of MARA.
For other pesticides already assigned with common Chinese names, please ignore this step.
Step 5: Prepare Samples and Seal Them in China
The applicant needs to prepare the finalized registration test samples of the products to be registered, and submit the test samples to the local provincial agricultural and rural affairs department for sample sealing. For an overseas enterprise applying for registration in China, the sample shall be sealed by the agricultural and rural affairs department at the provincial level where the domestic office is located. This step is to ensure the samples received by labs for testing have been recorded/examined by agriculture authorities before testing starts.
Step 6: Filing of Registration Test Record
The pesticide registration test record shall be filed through the "China Pesticide digital supervision and management platform" before the test. This step is to inform authorites where the registration studies will be carried out carried out, making it more difficult/challenging for companies to provide fake test reports.
Step 7: Carry Out Pesticide Registration Tests
After the records of pesticide registration test have been filed, the applicant can arrange registration tests on pesticide technical material (technical concentration) and/or pesticide formulation in institutes accredited by MARA, and carry out product chemistry, toxicology, efficacy, residue, environmental impact and other tests in accordance with the "Data requirements for pesticide registration.
Step 8: Application for Registration
After the pesticide registration tests have been completed, the applicant shall complete the dossier (including required risk assessment reports) according to the "Data requirements for pesticide registration” published in 2017.
Domestic pesticide production enterprises and new pesticide developers apply to the local provincial agricultural and rural authorities, and enterprises exporting pesticides to China apply to the Ministry of Agriculture and Rural Affairs in Beijing. If the applicant is an enterprise exporting pesticides to China, it shall also submit supporting materials that the product has been registered in relevant countries (regions).
Step 9: Evaluation and Approval
The picture below shows you the diagram of evaluation and approval process, which typically takes about 6 months to 1 year.
Estimated Fees and Timelines
The total costs of pesticide registration consist of testing fee and consultancy fee, among which testing fee accounts for a large proportion. ICAMA does not charge administrative fees for pesticide registration applications. It takes about 4-5 years (including test time) to register a new chemical pesticide TGAI, 2-3 years to register a new biopesticide or a new formulation or label extension in China.
Estimated testing fee for various types of registration is listed as below assuming all studies are carried out in Chinese GLP labs.
|Application Type||Product Type||Estimated Testing Fee (USD)||Estimated Total Time (Year)|
|New Formulation||Public Health||25K-30K||3|
We provide one-stop solutions to help you comply with pesticide regulation in China.
Our services include:
Pesticide registration legislation and policy survey;
Registration budget, cost control and registration strategy;
Data evaluation and gap analysis;
Product safety assessment report(environment/health/dietary);
Dossier preparation and submission;
Import and export customs release certificate;
Renewal of pesticide registration certificate;
Advice and training on pesticide production permit.
Why Choose Us？
The agrochemical division of CIRS group is located in Beijing. All team members have master's degree or above. The core members of this team are senior regulatory experts and risk assessment technical experts that have worked in top mult-national agrochemical companies for many years. We can help you remove your regulatory challenges and ensure smooth pesticide product registrations in China.