China National Agricultural Technology Extension and Service Center (NATESC) recently warned of outbreaks of rice stem borer in southern paddy regions. Rice crops would be threatened due to the elevated insect population and resistance to insecticides including chlorantraniliprole, chlorpyrifos, triazophos and abamectin, etc.

On 29 April 2017, Chinese Ministry of Commerce (MOFCOM) released Announcement 25 of 2017 regarding the merger of Dow Chemical and Dupont. MOFCOM started the anti-monopoly probe in March 2016 and has deemed that the merger would result in a monopoly and impact competition in China’s paddy insecticide and selective herbicide sector, as well as the global acid copolymers and ionomers market. Despite this result, the government can still approve this merger provided the two MNCs fulfill major obligations

On 27th Apr 2017, China MoA issued an announcement opening up a 30-day public comment period on 5 draft supporting rules for China’s new pesticide regulation.

On 1 April, China MoA released the drafts of 5 supporting regulations for the newly promulgated pesticide regulation, which were currently under internal consultation among governmental departments including NDRC, MIIT, MPS, MEP, MOFCOM, NHFPC, SAIC, AQSIQ, SAWS, SFDA, SFB (State Forestry Bureau), SGB (State Grain Bureau), GSMC (General Supply and Marketing Cooperative) and all provincial agricultural departments. The 5 supporting drafts will be issued under ministerial regulation, which reflects the regulatory prospects of pesticide regulation, production, marketing, label and manual, as well as the accreditation of pesticide labs: Administrative Measures for the Registration of Pesticide; Administrative Measures for the Production of Pesticide; Administrative Measures for the Marketing of Pesticide; Administrative Measures for the label and Manual of Pesticide; Administrative Measures for the Experimentation of Pesticide Registration; Risk Assessment and Benefit Evaluation as a prerequisite for pesticide registration applications The “Risk Assessment Report” and the” Benefit Evaluation Report” are now required during application. The reports should be fully supported by the product chemical, toxicological, efficacy, ecotoxicological and environmental properties and should help demonstrate the safety, efficacy and economic advantages over registered product.  On the basis of hazard and toxicity of inert ingredient, MoA will maintain updates on the “List of Restricted/Prohibited Inert Ingredients(Adjuvant)”. If the inert ingredient was exclusively used for formulation, additional testing report on the inert ingredient will be required. All registered pesticides are subject to a safety risk surveillance system. Pesticide active ingredients which have been registered for over 15 years will be periodically revaluated by MoA. The number of registrations will be furt

“Decree 677-Regulation on the Administration of Pesticides” was a prelude to more far reaching regulatory/legislative/administrative reform in the Chinese pesticide sector. Comparing current regulations with pending regulations and the drafts of the 5 supporting rules, the impact on pesticide production is foreseeable. Clearer Division of Labor, Centralized Management and Fewer Certificates Under the new system enterprises wishing to engage in pesticide production should firstly notify the MIIT. Depending on the corresponding product quality standard, an enterprise should either apply to the AQSIQ for the production license or apply to the MIIT for the single product production approval. In the past multiple authorities were involved which lead to administrative overlap, redundancy and overall inefficiency. Pesticide Production Management under Chinese Current and New Regulations

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

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