What documents are required to register pesticides for minor specialty crops?

Release Date:

2018-07-06

Pesticide registration for specialty minor crops offers numerous policy advantages, such as the possibility of conducting joint trials, grouping efficacy and residue studies, completing efficacy tests within one year or a single growing season, and waiving requirements for resistance‑risk assessments and field monitoring protocols. Additionally, toxicological data are not mandatory, and supplementary information on environmental impacts may be submitted only when needed. Compared with registration dossiers for major‑crop pesticides, the documentation requirements for minor‑crop products are relatively less stringent, which has attracted considerable interest from many companies. Today, we will explore how companies can proceed with registering pesticides for specialty minor crops.

　　For specialty minor crops Pesticide Registration offers numerous policy advantages, such as the ability to conduct joint trials, group‑based efficacy and residue studies, and the option to complete efficacy trials within one year or a single growing season. It also eliminates the need to submit resistance‑risk assessments or field‑based resistance‑monitoring protocols, obviates the requirement for toxicological data, and allows for the submission of environmental and other relevant information as needed.
　　Due to, compared with bulk crops, Pesticide Product, for minor crops Pesticide The registration requirements are relatively lenient, which has attracted considerable interest from many enterprises. So today, let’s take a look at how companies can register for use with specialty minor crops. Pesticide , what documents are typically required?
　　1. For specialty minor crops Pesticide What are the prerequisites for registration?
　　As specified in Announcement No. 2569 of the Ministry of Agriculture, the requirements for registration dossiers of pesticides intended for specialty minor crops are limited to those that have already been obtained. Pesticide The scope of application for registered products has been expanded. Implicitly, if a company intends to submit a registration application for the first time for a product intended for use on specialty minor crops… Pesticide The likelihood of having the required documentation rejected is nearly 100 percent. Conversely, this can be interpreted as follows: if a company seeks to register a product for the first time and the intended registration scope pertains to a minor crop, it must proceed in accordance with standard chemical‑related procedures. Pesticide Formulation, Biochemical Chemistry Pesticide Formulations, Microorganisms Pesticide Data requirements for formulations and other relevant categories shall be provided.
　　2. Regarding specialty minor crops Pesticide Registration trial
　　For specialty minor crops Pesticide Regarding registration, the relevant authorities encourage the conduct of joint trials.
　　3. Regarding the Duration of the Trial
　　Efficacy trials for the registration of pesticides on minor specialty crops can be completed within one year.
　　4. Regarding the Number of Test Points
　　In the registration of pesticides for minor specialty crops, the number of field efficacy trial sites shall be no fewer than three. For crops cultivated in multiple provinces (autonomous regions or municipalities), trials shall be conducted across provinces (autonomous regions or municipalities) representing different ecological zones. For crops grown only locally in one or two provinces (autonomous regions or municipalities), trials may be carried out in different regions within the same province (autonomous region or municipality).
　　The number of residue test sites shall be no fewer than four.
　　5. What efficacy data are required for the registration of pesticides for minor specialty crops?
　　(1) Efficacy and benefit analysis, including an overview of the crops and target organisms for which registration is sought, an assessment of socio-economic benefits, and an analysis of the substitutability of the product relative to already registered products, among other aspects;
　　(2) Efficacy trial data, including: for products targeting new pest or disease control targets, in‑vitro bioactivity data; for products intended for new crops, an in‑field crop‑safety report and a field plot efficacy trial report.
　　(3) Field efficacy trial reports may be submitted for the target crop and pest or disease being controlled, or may be prepared in accordance with the requirements for minor specialty crops. Pesticide Submit test reports for the representative crops and target pests or diseases within the same group, as required by the registered efficacy trial grouping management system.
　　6. What residue data are required for the registration of pesticides used on specialty minor crops?
　　(1) Pesticide Residual storage stability data;
　　(2) Documentation on residue analysis methods;
　　(3) In crops Pesticide Residue study data, in accordance with the “ Pesticide “Requirements for the Number of Residue Trial Sites,” submitted for the corresponding crop. Pesticide Residue study data may also be submitted for specialty minor crops. Pesticide Registration requirements for residue trial group management, submission for the representative crop of that group. Pesticide Residue study data
　　(4) Dietary Risk Assessment Report
　　7. What environmental data are required for the registration of pesticides used on minor specialty crops?
　　According to the application Pesticide , crops and targets, with environmental and other relevant data or explanations provided as needed.
　　In addition to the aforementioned materials, registration of pesticides for specialty minor crops also requires submission of a product summary, a copy of the registration certificate, an approved label, and sample labels and package inserts, among other relevant documents.