Pesticides are essential substances used in agriculture and forestry to prevent or control the spread of diseases, insects, weeds, rodents, and other harmful organisms. They regulate plant growth and insect behavior, helping to maintain the integrity of crops and forests.
However, the use of pesticides also carries potential risks and hazards to human health and the environment. Therefore, China implements a rigorous pesticide registration management system. Under the Regulation on the Administration of Pesticide, all pesticides are required to be registered before they can be produced, sold, or used.
To help companies navigate the complex and demanding process of pesticide registration in China, REACH24H launched a step-by-step guide for successful pesticide registration in China. This guide aims to address three main questions:
- What are the requirements for applicants?
- Before applying for pesticide registration, what preparations are required?
- What is the application process?
The registration process is divided into five stages, with detailed breakdowns and summaries of key points and strategies for each stage.
Stage 1: Applicant Qualification Review
Overseas companies that produce pesticides and export to China must have a domestic office or a qualified agency to assist with the application. This requirement is essential to ensure that companies comply with China’s pesticide registration laws and regulations.
Stage 2: Determination of the Registration Type
Different pesticide types and registration types have different data requirements. The pesticide types include chemical pesticides, biochemical pesticides, microbial pesticides, and botanical pesticides. The registration types include registration of the active ingredient*, the formulation*, or others*.
*Active ingredient: This includes new TC/TK registration, me-too TC/TK registration, and other TC/TK registration
*Formulation: This category covers new pesticide formulation registration, new dosage formulation registration, new active ingredient content registration, new pesticide ready-mixture registration, new application scope registration, new application method registration, me-too formulation, and similar formulation registration.
*Other registration types: This category covers change of registration (including expansion of use scope, change of dosage, change of toxicity, etc.), renewal of registration, and export (only) pesticide registration.
Stage 3: Data Gap Analysis
The third stage involves gathering existing data and information to assess the feasibility and risk of registration. This analysis helps to determine which tests are required and which can be exempted, as well as the registration period and testing costs.
Stage 4: Experimental Filing and Testing
The fourth stage is experimental filing and testing, where pesticide samples should be sealed by the provincial authority before testing can be conducted. Testing must be conducted by qualified laboratories in China, and testing plans and reports must be confirmed and controlled to ensure compliance with requirements. This stage is essential to ensure that the pesticide is safe and effective for use in China.
Stage 5: Preparation, Submission, and Acceptance of the Registration Dossier
The dossier must be comprehensive, scientific, and meet the standards required for registration. The dossier is submitted through the “Ministry of Agriculture and Rural Affairs (MOARA) Government Service Platform” and undergoes evaluation by regulatory agencies. This stage is essential for gaining approval to sell and use the pesticide in China.
To ensure that your company’s pesticide registration in China is successful, it is crucial to meet all the requirements and follow the registration process carefully. By following the detailed guidance and information provided, companies can successfully navigate the complex registration process and gain approval to sell and use their pesticides in the Chinese market.
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