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

“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

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.

Risk assessment of pesticides has been given higher priority in recent years. Reform of Chinese pesticide regulations has seen increasing restrictions/prohibition place on many pesticides. In terms of the money an enterprise must spend during registration, registering a pesticide for use on vegetables offers no clear economic or market incentives to registrants when compared to registering a pesticide for use on grains. In addition there are no specific favorable policies afforded to pesticides registered for use on vegetables when compared to registering a pesticide for use on minor crops. An analysis of the registration status of pesticides designated for use on vegetables pesticides can help to predict which pesticides will be subject to revaluation and also help reflect the degree of competition in this niche market. Product analysis By then end of 2013, 7,473 formulations of 635 active ingredients/combinations had been registered on vegetable crops, of which 262 are single compound pesticides and 373 are multiple compound pesticides. Usage of these pesticides covers 94 crops and 123 pests/diseases. Insecticides accounted for 59% (4361) of registrations, followed by fungicides (2459), herbicides (469) and PGRs(148).

On February 8nd 2017, the State Council passed the draft of revised Regulation on Pesticide Administration. We forecast the new Regulation on Pesticide Administration will be issued in April or May, 2017. New management measures will come into effect, including Pesticide Production License, Pesticide Registration, Permission of Pesticide Experiment Institutions and Pesticide Distribution Permit. In order to ensure traceability throughout the entire pesticide supply chain, the Ministry of Agriculture will take full responsibility for pesticide production, registration, distribution and application. Our predictions for the new regulation are as follows: Old Regulation Prediction of New Regulation Chapter I General Provisions Article 2 Words like “destroying or wipe out” used in the context of pesticide efficacy were deleted in the new regulation. The aim of pesticide is to prevent or control diseases, pests etc. Pesticide with the ability of destroying or wiping out disease, pests etc. may pose unnecessarily high risk to the environment and human health. The supervision of highly toxic pesticides will be more stringent. Article 2.2 To prevent, wipe out or control storage diseases, pests, rodents and other harmful organisms. To prevent or control storage and processing places diseases, pests, rodents and other harmful organisms. Article 2.6 To prevent, wipe out or control organisms harmful to dikes and dams, railroads, airports, buildings and other facilities. To prevent or control organisms harmful to dikes and dams, railroads, dock, airports, buildings and other facilities. Chapter II Registration of Pesticide Article 7 The pesticide production (including technical material and formulated product