In 2019, China MoARA approved 294 registration applications, down 95.6% from previous year of 4326. The decline was mainly due to the implementation of the elevated data requirements and the huge wave of merger and acquisition activities among the industry. Notably, of the 34 new active ingredients approved, 13 of them were developed by Chinese enterprises. Fungicide was the most registered product registered category and a total of 100 fungicides, based on 14 chemical and 8 biological active ingredients. 12 chemical and 7 biological active ingredients were firstly approved, of which 4 were exempted from TC/TK registration. ICAMA Registration Number Registrant Composition& formulation type Crop Disease Rate Method PD20190257 Syngenta AG 瑞士先正达作物保护有限公司 Pydiflumetofen 98% TC         PD20190267 Pydiflumetofen 200g/L SC wheat Fusarium head blight 50-65mL/Chinese acre spray rape Sclerotinia sclerotiorum 50-65mL/Chinese acre spray PD20.190268 Difenoconazole 125g/L+Pydiflumetofen 75g/L SC cucumber powdery mildew 40-50mL/Chinese acre spray watermelon powdery mildew 40-50mL/Chinese acre spray PD20190055 Mitsui Chemicals 日本三井化学AGRO株式会社 Penthiopyrad 99% TC         PD20190054 Penthiopyrad 20% SC cucumber powdery mildew 25-33mL

On 6 Aug 2019, the Ministry of Agricultural and Rural Affairs disclosed a response to the suggestions and proposals regarding the extension of biopesticides from the NPC deputies. The ministry publicly clarified its policy support to biopesticides and hope this product category can play an expanded role in the national action plans of chemical pesticide substitution and agricultural quality enhancement. In this article, we will introduce China’s concrete efforts toward green development, but most importantly, we hope a contrastive analysis on the data gap between conventional pesticides and 3 typical biopesticides could help agrochemical companies to determine the tactical and effective strategic implementation for the market entry of biopesticides in China.

Rice contributes to 60% of the world’s grain supply and rice growing/consumption regions tend have the largest populations and largest economies in the world. Given the likelihood of increased global demand for rice, we can expect a concomitant increase in the paddy herbicide market, which already accounts for 40% of the plant protection products used. The paddy herbicide market is characterized by diverse combinations of active ingredients and is influenced by multiple factors such as climate, agricultural practices, and agricultural development level, national food security policies and international trade. To help readers better comprehend this niche and variable market, this analysis summarizes the scale and characteristics of rice plantation, herbicide use and market conditions in the major rice growing regions globally. The global rice growing area was 160.1 million hectares in 2016, up 0.8% year-on-year. The overall plantation area has been stable in recent years. Rice is universally planted in temperate and tropical regions and the top rice-growing country is India, followed by China, Indonesia, Bangladesh and Thailand. India was second behind China in rice output due to its moderate productivity of 2.6 ton per hectare. China is the largest and the most efficient rice producer with an annual output of 144.9 million tons and boasts a per unit output of 4.8 ton per hectare. large Plantation Area, Output adn Annual Changes in Major Rice Growing Countries in 2016 Rice price, inventory, weather condition and currency exchange rate are the major factors affecting rice plantation and paddy herbicide market. In 2016, the United States, Thailand, Indonesia, Vietnam and Philippines have increased rice area while the plantation decreased in India, Japan, Pakistan and Brazil. Although rice price was low, the weather condition was conducive to high overall production volume in Asia. Self-sufficiency policies in Indonesia and Malaysia also he

Pesticide MRL establishment not only protects the integrity of the food supply, but also protects domestic agriculture. China’s response to WTO TBT/SPS notifications varies depending on the impact on trade balance, the value of the commodity, existence of established MRLs and China’s overall trade relationship with the notifying country. Member countries are required to notify other countries of any new or revised regulations which affect trade and to set up offices (official enquiry points) to answer requests for more information on new or existing measures at the WTH level. In regards to pesticide, TBT includes pesticide/chemical registration regulations and measures concerning food safety, production, environmental and labeling, etc., while SPS is more on MRL establishment/amendment/exemption/cancellation, crop grouping and other agricultural or technical practice for pesticide uses. China participated in the WTO TBT/SPS notification activities as early as 2003 and has formed a mature response system to support international trade of agricultural products, protect its domestic agricultural production and consumers. Through the introduction of official comment on MRL notification and studies of recent cases, this article aims to demystify how these WTO MRL notifications impact China's national pesticide MRL establishment. Workflow of Official Comments In the last 2 years, China has made very few WTO notifications on new enactment or amendment of pesticide regulations and the majority of these notifications involved establishment, amendment or cancellation of pesticide MRLs. An official inquiry point was established at the National Quality Standardization Center of Agricultural Product under the MoARA (Ministry of Agricultural and Rural Affair), receiving notifications from 19 countries/regions including the US, EU, Brazil, Canada and New Zealand etc. Each notification will be sent to relevant government body/institutions cover

Since the Nov 1st 2017 implementation of  "MoA Announcement 2569-Data Requirements on Pesticide Registration", subsequent registration applications have been subject to increased data requirements and elevated criteria. Other changes include but not limited to the abolishment of temporary registration and mandatory risk assessment. Compared with the previous regulation, MoA Order 10 of 2008, Announcement 2569 includes significant improvements in text structure and information transparency. A comparative analysis between the new and old version offers useful information to aid companies in adapting to new requirements. Chapter Reorganization in Regulation Text In the 2008 version, hygienic pesticides, rodenticides, biochemical pesticides, microbial pesticides, botanical pesticides, GMOs and natural enemy pesticides are defined as special pesticides and their registration requirements were incorporated in an independent chapter similar to the individual chapters  detailing requirements of new active ingredients, new formulated pesticides, me-too and technical concentrations(TKs). In the main body, each of these chapters consists of 3 sub-chapters, corresponding to the requirements for field trial application, temporary registration and full registration. In the new data requirements, three types of biopesticide have equal chapter allocation as chemical pesticides. The requirements for manufacturing “use product” (TC/TK) and end-use product (formulation) are respectively compiled in 2 sub-chapters.  Furthermore,  “atypical” products including agricultural GMOs and natural enemies have been removed from the new data requirements. GMOS are regulated under agricultural GMO regulations and natural enemies are subject to significantly decreased registration data requirements. Conditions for post registration including use scope expansion, amendment to application method and dose are refined in Chapter VI

No.1 Top-down Renewal of Pesticide Regulations in China On 8 Feb 2017, China’s State Council approved the revised draft of “Regulation on the Administration of Pesticides”, which was implemented as of 1 Apr. Thereafter, 5 administrative measures were released in the form of ministerial regulations concerning the registration experimentation, registration, production, marketing and labeling of pesticide. On September, 6 supporting documents were issued under series of MoA Announcements. These productive legislative actions constitute a comprehensive regime of product registration and 3-element licensing system of pesticide: State Council Decree Ministerial Regulation MoA Announcement Decree 677- Regulation on the Administration of Pesticide MoA Order 3 of 2017 "Administrative Measures for the Registration of Pesticide" MoA Order 4 of 2017 "Administrative Measures for the Production License of Pesticide" MoA Order 5 of 2017 "Administrative Measures for the Marketing License of Pesticide" MoA Order 6 of 2017 "Administrative Measures for the Registration Experimentation of Pesticide" MoA Order 7 of 2017 "Administrative Measures for Pesticide Labels and Manuals" MoA Announcement 2569 "Data Requirement on Pesticide Registration" MoA announcement 2567-"Catalogue of Restricted Pesticides (Version 2017)" MoA announcement 2568-" Rules for the Inspection on Pesticide Production License"; MoA announcement 2579-"Announcement concerning the Format and Generation of 2D Codes on Pesticide Labels";  MoA announcement 2570-"Rules for the Accreditation on Testing Facilities for Pesticide Registration & Good Laboratory Practice for the Experimentation of Pesticide Registration" (2 document)

  Annually, plant nematodes account for 12% of crop losses globally, amounting to some 100 billion USD in losses. It is forecasted that the global nematicide market will reach a value of 1.35 billion USD by the end of 2020 and significant growth will happen in the Asia Pacific and South America region. Currently, the value of the Chinese nematicide market is 500 million CNY, representing only 1% of the total pesticide market. With the increasing occurrence of nematode crop infestations in China, the nematicide market is expected to undergo significant growth.

On 30 Jun. 2017, China MoA invited public consultation on “Data Requirements for Pesticide Registration” and 5 other supporting rules for new pesticide regulation. The guideline for the determination of technical equivalence was included in the Annex 4 of the “Data Requirements for Pesticide Registration”. Compared with the currently enforceable requirements, “MoA Order 10-Data Requirement on Pesticide regulation (2008)”, the new requirements clearly specify the applicable scope and some of the new criteria have become as stringent as that of developed countries. All of this is expected to reduce new registration of generic pesticide 30% by 2020. A comparative analysis on the scope and criteria is provided to interpret the impacts on me-too pesticide registration. TECHNICAL GRADE ACTIVE INGREDIENT(TGAI) Applicable Scope Currently, technical equivalence determination is mainly utilized for me-too registration, which enjoys considerable data waive and fast-track preference. In the draft, 3 more conditions were added. Conditions subject to mandatory determination: Apply for TGAI(technical grade active ingredient)registration under equivalent product(me-too) category; A TGAI registrant alters the production process/production site; If a formulation alters the source of TGAI, the equivalence determination between new sourced TGAI and the original TGAI should be conducted; If an applicant is seeking registration under equivalent formulation, the equivalence between the TGAIs of the proposed formulation and referenced formulation should prior determined; Tiers and Technical Criteria

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 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