Registration Requirements of Herbicides for Genetically Modified Herbicide-Tolerant Crops in China
On March 25, 2022, China published the Registration Requirements of Herbicides for GM Herbicide-Tolerant Crops, which was immediately implemented.
As early as March 11, 2022, the Ministry of Agriculture and Rural Affairs issued two guidelines for the efficacy test of herbicides for the control of weeds in GM herbicide-tolerant corn and soybean. It can be seen that China is opening up the genetically modified crop market for corn and soybean, which brings the next hot topic for the pesticide market in China.
The following chart shows the data requirements of pesticides expanding to GM herbicide-tolerant crops and pesticides expanding to conventional crops.
| Data requirement | Expanding application scope on conventional crops | Expanding application scope on GM crops |
| Physical and Chemical tests | / | 1. Chemical data for technical material
2. Formulation product composition information |
| Efficacy tests | 1. Indoor biological activity test;
2. Indoor crop safety test; 3. Efficacy test in field plots; 4. Resistance risk assessment; 5. Other information; 6.Comprehensive assessment report |
1. Benefit analysis report;
2. Indoor biological activity test; 3. Indoor crop safety test (for crops involving new transformants); 4. Efficacy test in field plots; 5. Resistance risk assessment; 6. Other information; 7.Comprehensive assessment report |
| Toxicology tests | 1. Advanced test data required for health risk assessment;
2. Health Risk Assessment Report |
1. Toxicity data of major metabolites ;
2. Advanced test data required for health risk assessment; 3. Health Risk Assessment Report |
| Residual tests | 1. Pesticide residue storage stability test data;
2. Residue analysis method; 3. Test data for pesticide residues in crops; 4. Test data for pesticide residues in processed agricultural products; 5. Dietary Risk Assessment Report |
1. Metabolism test data in plants;
2. Metabolism test data in livestock; 3. Pesticide residue storage stability test data; 4. Residue analysis method; 5. Test data for pesticide residues in crops; 6. Test data for pesticide residues in processed agricultural products; 7. Dietary Risk Assessment Report |
| Environmental impact tests | 1. Supplementary environmental impact information;
2. Environmental risk assessment report |
1. Supplementary environmental impact information;
2. Environmental risk assessment report |
China pesticide manufacturers and overseas enterprises can both apply for the registration of target single-dose herbicides for GM herbicide-tolerant crops in China. As shown in the chart, compared with pesticide target conventional expansion registration, the expansion of herbicides into GM crops requires metabolism test on plant and livestock, and main metabolites toxicity test, because herbicides may have different metabolic pathways in GM crops and may further generate new metabolites.
These tests can be carried out as enterprise-joint tests. In addition, the efficacy test should be carried out on the GM herbicide-tolerant crops that have obtained the “Agricultural GMO Safety Certificate (manufacture application)”, and the transformant information should be registered for GM herbicide-tolerant crops.
New Opportunities
Herbicides can be divided into nonselective herbicides and selective herbicides according to their functions and nature. Nonselective herbicides mainly include glyphosate, glufosinate-ammonium and diquat, which are widely used in weed control in non-arable and no-tillage fields. The latest registration requirements of herbicides for GM herbicide-tolerant crops and relevant efficacy test guidelines expand the application scope of nonselective herbicide and increase its market share.
Glyphosate and glufosinate-ammonium are the most popular herbicides in the market of China. Based on the approval condition of safety certificates for GM crops, REACH24H recommends that enterprises with glyphosate registration should focus on the implementation of the registration requirements and start to apply for expansion to GM crops registration as soon as possible to occupy market shares of GM crop pesticides. However, there are many challenges in registration for the expansion.
Contact Us
REACH24H Consulting Group has been working on pesticide registration in China for many years. We have rich experience and many successful cases on current new pesticide registration and are skilled in the whole process of pesticide registration, especially the planning and implementation of key steps such as trial efficacy test design, risk assessment, metabolite identification, and experiment supervision, which support us to solve difficult problems in the process of pesticide registration in China.
If you have any questions on pesticide registration, please don’t hesitate to contact us.
Tel: +86 (0)571-87006630
Email: customer@reach24h.com
Reference Link
New Pesticide Registration in China: In-depth Analysis of Challenges and the Trend
