On 25 Jun 2017, China MoA issued an opinion regarding a developmental program for the pesticide industry. The document proposes production plant relocation, reduction of generic product and improvent on qualification rate, as well as new management policies on pesticide registration, production approval and marketing approval. A 3-elements approval system was established under China’s new pesticide regulation, which took effect on 1 June this year. MoA expects the regulatory reform would help to promote food safety and realize safety and environmental improvements in pesticide production methods.

By May 2017, 36,433 pesticides using 672 active ingredients have been registered with China ICAMA, of which 35,408 are registered by 2,116 Chinese domestic companies, 308 are registered by 20 US companies, 189 are registered by 8 German companies, 179 are registered by 24 Japanese company, 106 are registered by 2 Swiss companies and other 243 are registered by 53 overseas companies from India, Australia, Israel, Singapore, UK, Korea and Italy, etc. Technical Grade Products 4,269 of the registrations are for manufacturing use, consisting of 3,993 TCs(technical), 230 TKs (technical material),38 TKLs (technical material in liquid) 8 TKPs (technical material powder) and 1 TFs(another form of technical material powder). 8 of the products are mixtures of complex compounds such as enadenines, brassinolides, and sodium/potassium nitrophenolates. With the patent expiry in 2011, azoxystrobin became the top registered TC in the last five years and the registration of pyraclostrobin is growing after it’s patent expiry in 2015. The development of more herbicide-resistant GMOs is driving more producers to register traditional generics such as 2,4-D and dicamba. large Fig.1-Top 20 Most Registered Technical Grade Active Ingredients (TGAI) Since 2012 Product Category and Formulation Type Around 38% of the formulations are insecticides, followed by fungicides 26%, herbicides 23% and health pesticides 7%. E Although market share of ECs has decreased each year since China MIIT begun restricting the production approval in 2009, it represents the highest proportion among all formulation types. The reason for the record high number of approved products in 2009 was the promulgation of “Data Requirement on Pesticide Registration” in 2008. Most companies had started the efficacy, residual and toxicological tests in 2007 and the applications were finally approved in 2009. It is estimated that the number of registration will be redu

On 26 May 2017, China ICAMA announced the suspension of acceptance and approval of pesticide field trial and temporary registration starting from 1 June 2017. Companies engaged in pesticide production, marketing and testing institutions may continue their operation activities prior to the effectiveness of supporting rules for the new pesticide regulation

On 12 May 2017, China MoA invited departmental consultation to ban/restrict the agricultural uses of 5 active ingredients including endosulfan, bromnomenthane, acephate, carbosulfan and dimethoate.

The Brazilian MAPA has drafted a list of products which will be subject to priority review in 2017, which was discussed with IBAMA and ANVISA during the 2nd regular meeting of CTA (Technical Advisory Committee of Pesticide). 53 pesticides were included into the list, of which 26 are insecticides, 20 are herbicides and 7 are fungicides.

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 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