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

On 20 March 2018, South Korea officially enacted its biocide regulation, “Law 15511-Act on the Safety Management of Household Chemical Products and Biocides”. This regulation comprises 60 articles organized into 7 chapters plus 5 articles in the Annex.  The new regulation establishes a fundamental framework of safety verification on household chemical products and pre-approval of biocidal substances and products. Depending on the notification and application plan of existing biocidal substances, K-BPR will offer different grace periods for biocidal substances and products. Some deadlines will be due as early as 2020 while others have been extended until 2032. All deadlines and corresponding eligibility criteria/clauses are summarized below.

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

1.[EU BPR]The First opinion on Union authorization was adopted The Biocidal Products Committee (BPC) supported applications for EU-wide access to the market  of two biocidal product families containing iodine/PVP-iodine for use in veterinary hygiene on 20 December 2017. It is the first opinion supporting applications for Union authorization which means that it is realized successfully that companies are allowed to place their biocidal products on the market throughout the entire Union with one authorization form. 2.[US EPA-FIFRA]Pesticide Registration Improvement Extension Act (PRIA 4) will recently be updated PRIA 3 is about to expire and PRIA 4 will enable after PRIA 3 is invalid. While PRIA 3 was originally set to expire December 8, 2017, now for the duration of that Continuing Resolution period, it has been extended until January 19, 2018. When PRIA 4 is expected to be enabled, a number of new registration types, such as disinfectant devices identification, will be added, as well as additional review costs. 3.[Chinese disinfectant products] The relevant standards for relevant Chinese disinfectant products are to be issued. NHFPC (National Health and Family Planning Commission) is working to formulate or revise relevant standards for disinfection products, including the classified catalogue of disinfection products, hygienic safety evaluation, test contents, disinfecting wipes, etc. These are expected to be announced in the first half year of 2018. 4.[EU BPR]Draft guidance for identifying endocrine disruptors was issued This draft guidance for identifying endocrine disruptors which will be used to evaluate pesticides and biocides has been developed by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) with the support of the Commission’s Joint Research Centre (JRC). ECHA and EFSA are inviting interested parties to comment on the draft guidance document for the identification of endocrine disruptors under EU legisl

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)

China’s pesticide MRL regulatory framework (the maximum concentrations of pesticide residues in foods) is underdeveloped compared with other major economies and fails to adequately meet food safety and international trade requirements. China plans to establish 10,000 MRLs by 2020, based on this and on historical trends it is possible to offer the following predictions with regard to future developments in China’s MRL system: Fruits and vegetables will be given priority over grains Proprietary and off-patent pesticides will have MRLs added Prohibited and high risk pesticides will be prioritized Concepts used in Japan’s positive list system which includes population based exposure scenarios and susceptible populations could be implemented As early as 1990, China started pesticide MRL development. Since then numerous MRLs have been developed by China’s various regulatory authorities in the form of national/industrial standards for agricultural produce or food safety/ standards. This multi-sector development has resulted in overlap and inconsistency in both standards, enforcement and supervision. Since 2010, China began the process of reforming it MRL regulatory framework with the aim of deleting, consolidating and updating the MRLs into a unified food safety standard for pesticide MRLs, known as GB 2763. Up to now the standard has been updated three times and the number of MRLs has increased from 873 in 2012 to 4140 in 2016. A total 433 pesticide active ingredients and 286 commodities/ commodity groups are included into GB 2763-2016, covering 70% of the active ingredients approved and most commodities currently consumed in China. Particularly, GB 2763-2016 provides MRLs for all banned/restricted pesticides in all types of commodity. prioritization of fresh edible agriculture produce. Fig.1- Number of MRLs established for Different Commodities 2014 and 2016 Edition Comparison Compa

Unilateral acceptance of test reports from overseas GLP laboratory will no longer be supported. A transitional period before the implementation of this new stipulation is being considered. On 1 Nov 2017 China begins practical implementation of new pesticide regulations. After this date all subsequent pesticide registration applications will be reviewed under new data requirements. New regulation specifies that test reports should be issued by a MoA-recognized testing facilities or overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement with China. The report from overseas OECD GLP labs (which China has recognized for decades) will no longer be usable in China. During the 9th Chemical Regulatory Annual Conference, Mr. Chen Tiechun from ICAMA introduced how GLP principles will be adopted for laboratory monitoring and shared with the audience the latest MAD achievements.   Experimentation Management under New Pesticide Regulatory System In the past transparent and clear requirements on laboratory testing have not been available, requirements were based on ICAMA’s on laboratory inspection guidance and MoA’s voluntary measures on GLP-compliance. In fact there was no strong legislative or regulatory basis managing this aspect of pesticide administration in China. Under the new legislation, a ministerial regulation (which will parallel the regulations managing registration, production, marketing and management) was promulgated and two new mandatory supporting rules on laboratory accreditation and GLP management have been issued issued under the MoA Announcement 2570. Under this new framework testing labs are regarded as other business entities such as registrant, producers and dealers:  

  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