China
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Revised Data Requirement for Pesticide Registration in China
To enhance the sustained and healthy development of bio-pesticide, and protect the quality and safety of agricultural products, the MOA decided to revise the data requirement on pesticide registration (MOA Decree 10, 2007) on April 28, 2011. The main changes are listed as below:
- Add on article 3.1.3:
- The Article 3.1.3 will be changed into 3.1.4.
- Add one article in 4.3.2.1.3 and 4.3.3.1.3:
- Add one article in 4.3.2.1.5:
- The Article 4.3.2.2.5 C and 4.4.2.2.5 C shall be revised as:
- Add one article in 4.3.2.2.6 and 4.3.3.2.6:
- Article 4.4 shall be revised as microbial pesticide.
- Article 4.4.1.3.2 revised as:
- Add one article in 4.4.2.1.5、4.4.3.1.5、4.5.2.1.5 and 4.5.3.1.5:
- Add one article in 4.4.2.2.6 and 4.4.3.2.6:
- Add one article in 4.5:
- Article 4.5.1 revised as:
- Article 4.5.2.1.4 and 4.5.3.1.4 revised as:
- Article 4.5.2.2 A revised as:
- Add one article in 4.5.2.2 and 4.5.3.2:
The exemption of full composition analysis reports (five batch analysis reports) for agricultural antibiotic pesticides can be applied if that relative analysis can’t be carried out because of exceptional cases, but the relative certification issued by the pesticide registration test units approved by MOA shall be supplied. The exemption of residue tests and environmental fate test data can be applied for the low-toxic and slightly-toxic agricultural antibiotic pesticides which are produced through bio-fermentation technology and have been proven as safe through long-term application in agriculture. The environmental fate test reports related to beneficial organisms shall be supported when the pesticides are highly-toxic to the beneficial organisms.
The exemption of full composition analysis report (five batch analysis report) can be applied if that relative analysis can’t be carried out because of Exceptional cases.
The environmental toxicity data of formulated products can be used in the registrations of technical Products (technical concentration) when the applications of the technical products (technical concentration) and formulated products are raised simultaneously.
The environmental toxicity data shall be exempted for pheromone, hormone and enzyme.
The insecticides and fungicides shall supply field efficacy test reports conducted at different provincial districts of four points during two years or eight points during one year.
The herbicides and plant growth regulators shall supply filed efficacy test reports conducted at different provincial districts of five points during two years or ten points during one year.
The filed efficacy test reports conducted for the crops planted at particular zones ( such as flax, beet, sunflower, ginseng, rubber tree, lychee, longan tree, banana, mango etc.) or the products used to control diseases, pests, weeds occurring in particle zones, can be carried out at different provincial districts of three points during two years or six points during one year.
For the above pesticide used in places where the environmental conditions are relatively stable, such as storage, preservative, fresh-keeping, the filed efficacy test reports conducted at different provincial districts shall be carried out at two points during two years or at four points during one year.
The filed efficacy tests shall be conducted on the controlled targets and the crops shall be the main host plants of that controlled targets when the controlled targets are single.
The residue test data shall be exempted for low-toxic-or slightly-toxic bio-chemical pesticides
The registration of technical products (technical concentration) can be exempted for the microbial pesticides for which producing of the technical products ( technical concentrations ) are really unnecessary or the producing of the technical products (technical concentrations) is difficult, but, the product manufacturing process , the description reports and the necessary testing data for the technical products (technical concentrations ) conducted by the formulated products shall be supplied.
The registration of microbial technical products (technical concentration) is encouraged.
Laboratory activity assay reports ( For the microbial pesticide exempted from the registrations of technical products (technical concentrations), the laboratory activity assay shall be conducted on the formulated products).
When applying for the registration of technical product (technical concentration) and formulated products simultaneously, the environmental toxicity data of the formulated products can be used on the registration of technical products (technical concentrations)
The residue test data for low-toxic or slightly –toxic microbial pesticides can be exempted.
The registration of technical product (technical concentration) can be exempted for botanical pesticides for which producing of the technical products ( technical concentrations ) are really unnecessary or the producing of the technical products (technical concentrations) is difficult, but the product manufacturing process , the description reports and the necessary testing data for the technical products (technical concentrations ) conducted by the formulated products shall be supplied.
The registration of botanical technical products (technical concentration) is encouraged.
Same as the general new pesticide. See 3.3.1.
The action mechanism or predictive analysis of the action mechanism can be exempted with support of the description data for the product’s mode of action.
The laboratory activity essay can be conducted on the formulation products for the product which the registrations of technical products (technical concentrations) are exempted.
Same as the genera new pesticide. See 3.2.1.4.
However, for those botanical pesticides which have been registered by the competent government departments as food additives, health foods or drugs, toxicity data, except the six pack, can be exempted with support of the approval certificates issued by the relative departments and the literatures of studies.
The action mechanism or predictive analysis of the action mechanism can be exempted with support of the description data for the product’s mode of action.
The laboratory activity assay can be conducted on the formulation products for the product which the registrations of technical products (technical concentrations) are exempted (the report copies can be supplied if the reports have been supported at the stage of filed efficacy tests).
The insecticides and fungicides shall supply filed efficacy test reports conducted at different provincial districts of four points during two years or eight points during one year.
The herbicides and plant growth regulators shall supply filed efficacy test reports conducted at different provincial districts of five points during two years or ten points during one year.
The filed efficacy test reports conducted for the crops planted at particular zones ( such as flax, beet, sunflower, ginseng, rubber tree, lychee, longan tree, banana, mango etc.) or the products used to control diseases, pests, weeds occurring in particle zones, can be carried out at different provincial districts of three points during two years or six points during one year.
For the above pesticides which are used in places where the environmental conditions are relative stable, such as storage, preservative, fresh-keeping, the filed efficacy test reports conducted at different provincial districts shall be carried out at two points during two years or at four points during one year.
The residue test data can be exempted for low-toxic or slightly-toxic botanical pesticide.
Our Services
We provide free initial consultation regarding your obligations under this legislation. We will provide pre-service assistance with regard to compiling a registration strategy and estimating the registration costs. If registration is required, we can then prepare a detailed registration schedule with cost estimation included, registration strategy analysis, study monitoring, report collection and dossier preparation.
Our expert team have many years experience with pesticide registration in China and we are confident that we can help you register your products in China in a cost-efficient manner. Click the following picture to view our comprehensive pesticide registration services for China.
About Us
Initially set up by China Inspection and Quarantine(CIQ) Bureau in 2007 to provide REACH compliance services to Chinese chemical industry, CIRS has grown to be a leading provider of comprehensive chemical compliance services for companies doing businesses in/with China.
Our services cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment of industrial chemicals, pesticides, food additives and cosmetic ingredients. We provide one-stop solutions to your regulatory issues in China. We also deliver the most up-to-date regulatory information about chemical control laws in China.
- Mr. David Wan, China Office
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Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533
Email: david@cirs-reach.com
