When applying for changes in pesticide registration, enterprises can apply for registration to expand the scope of pesticide use. This application takes a relatively short time and costs less than completing a formal registration. Below we have sorted out the list of registration materials for enterprises to expand the scope of pesticide use to non-small crops.
1. General materials
❖ Application form
❖ Declaration of the Applicant
Copy of registration certificate
❖ Explanation and reasons for the change
❖ Labels and instructions
❖ Other materials related to registration changes
2. Toxicological data
❖ Health risk assessment report
3. Drug efficacy data
❖ Laboratory biological activity test data (this information is required when new control objects are involved)
❖ Laboratory crop safety test data (required when new crops are involved)
❖ Field plot efficacy test report (For products that do not involve new application scope and new application method, 1-year field efficacy test report can be provided.)
❖ Resistance risk assessment information (this information is required when new control targets are involved)
❖ Comprehensive Assessment report
4, residual information (for non-food crops and non-feed crops, sanitary insecticide and rodenticide products do not need to provide this information)
❖ Test data on pesticide residues in crops (for expanded use of crops, provide this information. For products that have passed the protection period of new pesticides, when applying for registration of expanded scope of use, if the crops applied for expansion have the same active ingredient and content, and the same dosage form of products registered on the crops, the residue test data may not be submitted. If the residual risk may increase, the relevant residual test data shall be submitted, that is, the residual test data shall be submitted with the number of points halved, but the number of points shall not be less than 2 points.)
For expanded control objects (i.e., unchanged crops), if the risk of residue is likely to increase according to the application period, application frequency, dosage and application interval, residue test data of half of the points are required to be submitted, but the points shall not be less than 2 points.
❖ Storage stability test data of pesticide residues (provided when expanding the range of crops used)
❖ Residue analysis method information (provided when expanding the use of crops)
❖ Test data on pesticide residues in processed agricultural products (Provide test data or query materials for crops such as soybeans, peanuts, rapeseed, citrus and apples)
❖ Dietary Risk Assessment Report
5. Environmental impact information (as required)
❖ Supplement environmental impact information
Environmental Risk Assessment Report
What are the requirements and precautions for registration of pesticide products?
2023 11/13