Chinese New Pesticide Regulation: A Comparative Overview of Current and Pending Regulatory Framework
China’s new pesticide regulation will take effect on on 1 June 2017 and 5 draft supporting rules have been released for departmental consultation, all of which support the pending new regulation. An analysis on the context, alternation and timeline of the new license requirements and regulations specified in the new pesticide regulation and supporting documents will provide important data to help minimize compliance failures.
Pesticide Registration
Existing
Regulation(old)
Data Requirement on Pesticide Registration (MoA order 10)
New Regulation(draft)
Administrative Measures for the Registration of Pesticide
Alternation
To be abolished with the effectiveness of new regulation
Transitional Term
Applications accepted prior to the new regulation will be reviewed under old regulation;
Temporary registration issued prior to the new regulation will not be renewed;
Note: Detail guidance on the administrative and technical requirements is still needed and MoA would release the supporting document separately
Pesticide Production
Existing Regulation(old)
Rules for implementing the Production license on Pesticide (AQSIQ rules);
Measures for the Administration on the Manufacturing of Pesticide-(order 23 of NDRC, being implemented by MIIT)
New Regulation(draft)
Administrative Measures for the Production of Pesticide;
Transitional Term
Enterprises that obtained the production license/manufacturing approval prior to the effectiveness of new regulation may continue to produce pesticide before the expiry;
Enterprises that want to continue the production after the expiry of
Analysis of New Data Requirements for Chinese Pesticide Registration: Risk Assessment Report
Following the release of the new "Regulations on pesticide administration" in April 1, 2017, the general office of the Chinese Ministry of Agriculture (MOA) released the drafts of 5 supporting regulations for the newly promulgated pesticide regulation. Among them, the data requirements for pesticide registration application have undergone significant changes.
Provisions of “Administrative Measures for the Registration of Pesticide (Draft for comment)”:
Article 19th The following application materials and data should be included in the application: test report, risk assessment report, benefit evaluation report, label or manual sample, product safety data sheets, related documents, qualification certificate of the applicant, statement of authenticity of the data.
The documents or data cited in the application materials should be marked with the name of the study work, the name of the publication, the volume, the period, the page as well as the number of years, etc. Unpublished documents can be used as support data with the permission of the author. Foreign language materials should be translated into simplified Chinese. Paper documents and electronic documents shall be submitted at the same time.
According to Article 19th of “Administrative Measures for the Registration of Pesticide (Draft for comment)”, the new requirements for pesticide registration not only covers traditional test data such as toxicological, efficacy, eco-toxicological and environmental impact, but also increases the data requirements of the risk assessment report and evaluation report for evaluation of pesticide products. This is to ensure conformity with Chinese national standards and uphold the ultimate goal of efficient pesticide management, ensure the quality of pesticides, protection of the quality and safety of agricultural products and the safety of human beings and livestock, as well as protection of agriculture, forestry and the ecosystem.
Risk
2017-04-08
Analysis of Chinese New Pesticide Regulation: Risk Assessment and Benefit Evaluation Firstly Required
2017-04-06
Chinese New Pesticide Regulation: Inter-Departmental Comments on 5 Draft Supporting Rules
2017-04-05
China Promulgates New Pesticide Regulation
On 1 April 2017, Chinese Prime Minister Li Keqiang issued State Council Decree 677 promulgating the revised pesticide regulation, “Regulation for the control of Agrochemicals(aka: Regulation on Pesticide Administration)”, which will take effect on 1 June 2017. The move is part of an overall regulatory/legislative/administrative reform in China in which authority is being centralized replacing China’s historical predilection of dividing labor between several different regulatory authorities.
2017-03-29
China MoA to Form 9th National Pesticide Registration Expert Committee
On 20 Mar 2017, China MoA circulated an official letter concerning the formation of the 9th National Committee on Pesticide Registration. In response to the newly revised pesticide regulation and the expiration of the 8th Committee, MoA plans to assemble a new group of experts to conduct technical review of pesticide registration. The new committee will be composed of about 130 experts recommended by MIIT, MEP, NHFPC, AQSIQ, SAWS and CFDA. MoA is responsible for the committee organizational structure, personnel and verification of the qualifications of experts.
Biopesticides in China
Biopesticides are certain types of pesticides derived from such natural materials such as animals, plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. From the legislative/regulatory perspective, in China Biopesticide is considered as a type of pesticide category which belongs to biological pest control (kill or inhibit harmful organisms by biological measures). Different countries or regions have different definition and scope of biopesticides. Please refer to the table below for the scope of biopesticide in different countries or regions.
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