The introduction of GLP (Good Laboratory Practice) to China’s pesticide registration dates back to the 1980s and toxicological laboratories began to follow the principles. Between 1982 and 1986, a safety evaluation center funded by the United Nations Industrial Development Organization (UNIDO) was established and a series of GLP documents in the form of agricultural standards, targeting specific areas such as residue test, physical and chemical analysis, and environmental safety evaluation. In late 2003, MoA(now known as MoARA) issued the ministerial regulation, “MoA Announcement 739-Measures for the GLP Compliant Accreditation of Pesticide Laboratories’”, marked MoA a GLP monitoring authority in pesticide area and 29 pesticide laboratories were accredited between 2010 and 206. But at the same time, MoA also accepted test data from GLP/GEP institutes accredited by CNAS, CMA CAL and other authorities can also be allowed for pesticide registration until the pesticide regulatory reform since 2017. China has been an active participant in global exchange and cooperation. Since 2005, many government officers have participated in the OECD GLP working group meetings and inspector training course. China and the US signed a cooperative agreement on the “sustainable GLP compliance monitoring program” in 2005, which has been renewed biannually until 2017. China also participated in various accreditation events initiated by monitoring authorities from OECD members such as Belgium, Germany, Netherlands, and Poland, etc. By 2020, 16 out 27 Chinese testing facilities accredited by OECD members are pesticide laboratories. With the promulgation of new pesticide regulation in 2017, GLP accreditation became a requisite for the registration process: only data from MoA-recognized testing facilities or overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement wit

As of December 31, 2020, 41885 pesticides of 714 active ingredients have been registered in China, consisting of 39299 agricultural pesticides and 2576 public health pesticides. Since 2013, the number of pesticides newly registered each year has grown by an average rate of 5%. As China introduced new data requirements in 2018, the number of pesticides newly approved plumbed a new depth of only 205 in 2019. Although 805 pesticides were approved in 2020, the number is still far below the level years ago. Apart from the elevated registration requirements, the increasing M&A events and elimination of SMEs lead by industrial consolidation and environmental rectification is another cause of the decreasing number, which will be a chronic condition and beneficial to China’s “quantity reduction and efficiency increasing” towards pesticide use. Green Development In recent 8 years, over 90% of the pesticides approved were slightly or low toxic and the figure has risen to 100% in recent 4 years. Emulsifiable Concentrates (EC) is the most registered formulation type and contributes the most VOCs, but its percentage has continued to drop. Wettable powder has had the same situation. Meanwhile, Suspension Concentrate(SC), Water Dispersible Granules and Oil Dispersion have maintained annual growth of 9.1%, 6.7% and 17% respectively. In addition to the rapid growth of Flowable Concentrate for Seed Coating (FS), Capsule Suspension (CS) and other environmentally friendly formulations, a novel formulation type, Dispensor(DR) has also been increasingly registered. Product Category Insecticides take up the highest proportion of all products and have been the most registered category before 2016, but that is set to change with the rapid growth of herbicides and fungicides. These three categories now have a relatively equal percentage in newly registered products. The number of public health pesticides has maintained at around 2500 owing to the stag

According to China's customs statistics, in 2020 China imported 100.33 million tons of soybean, exceeding the historical level of 95.53 million tons in 2017. It took China only 25 years to increase hundred-fold its imports and take over 60% of global soybean trade. The total arable land area fell to the lowest registered level at 120 million hectares, while its protein feed demand continued exploding, forcing China to allow its long-standing stranglehold on domestic soybean oil and soybean meal supply to be covered by a number of foreign grain giants in order to save its farmlands for cereal production. Over the years, China’s trade supply has been affected by specific government policies and the agricultural reality in some of its trading countries, especially the Sino-US trade conflict and Covid-19 supply chain issues. To stabilize soybean supply, China has begun exploring new trade partners, including Russia, Ukraine and other African “Belt and Road” countries, well-known for their non-GM soybean plantations. These partners have now become an important part of China’s high-value edible bean market. With the longest history of soybean plantation and the highest diversity of germplasm in the world, China expects to see a difference in the global non-GM soybean market by accelerating crop variety research and by taking advantage of scale advantages and financial tools. Non-GM Market: Overall Self-Sufficient but Rapidly Growing China addresses imported soybeans (mostly GM) and homegrown soybeans (All non-GM) differently: GM soybeans are imported through state-back dealers and can only be sold to bean crushers. About 97% of the soybean oil and soybean meal produced in China comes from imported GM soybeans. Only non-GM soybeans are allowed for direct consumption and for bean products/condiments production. About 80% of homegrown soybeans are for edible purposes. In recent years, China has taken proactive

In 2017 China NHFPC (now knowns as NHC) promulgated the “WS 575-2017 Hygiene Requirements for Hygienic Wet Wipes”. Since its implementation in March 2018, the mandatory standard has played an active role in market regulation, but some of its contents were also misinterpreted/wrongly enforced by manufacturers, law enforcers and users. In a recent scholarly journal, NHC officials reiterated the background and significance and outlined the key technical requirements, as well as clarified the scope, legal positioning and intersection with other disinfection products, in the hope of safety and effective use of health-related products, particularly under the circumstance of Covid-19 pandemic. Background Hygienic Wet Wipes are a category of disposable sanitary products widely used in households, schools, catering and tourism service and medical institutions, etc., for the cleaning and bactericidal treatment of hand, skin and mucosa, as well as ordinary object surface. Hygienic wet wipes have been piecemeal mentioned in several regulation and standards: Catalog of Disinfectant Products GB/T 27728-2011 Wet Wipes GB 15979-2002 Hygienic Standard for Disposable Sanitary Products None of them had offered specific technical requirements targeting hygienic wet wipes. Compared GB/T 27728-2011 and GB 15979-2002 that respectively apply to general wet wipes (with no biocidal effect) and all sanitary products, WS 575-2017 put forward comprehensive requirements on raw materials, germicidal performance, product safety, labeling and manual specific to hygienic wet wipes. offering greater operability in postmortem surveillance. Hygienic wipes are Class III disinfection products which can be directly placed on the market without completing any evaluation and record-filing formality with the health authorities whenever the following conditions are met: The manufacturer has obtained the hygienic license of disinfection products (only homemade products

Organic fertilizer is a category of fermented fertilizers obtained from animal manure and plant/animal residue and the use of organic fertilizers has a long history in China. But in recent decades, the percentage of organic fertilizer in total nutrient input has steadily reduced from 99.9% in 1949 to 20% in 2010 and bottomed at 5% to 10% today. China’s per-unit-area rate of chemical fertilizer is 443.5 kg per hectare, almost 3 times the global average level of 120 kg per hectare and twice the internationally-accepted safety limit of 225 kg per hectare. This gives China an ever-increasing agricultural output at the expense of soil fertility: 26% and 44% of the farmland has the fewest organic matter and organic carbon of less than 1%. 64%, 53% and 40% of the farmland are in serious deficiency of Calcium, Magnesium and Sulphur. Since China launched the “Action Plan for Zero-growth of Chemical Fertilizer and Pesticide Use” in 2015, as well as other agricultural development policies thereafter, this reviving sector has witnessed a double-digital increase for the past few years and the demand would reach 227 Billion Yuan by 2023. In the course of China’s agricultural revitalization of quality enhancement and green development, it is vital for agribusiness enterprises to have a better understanding of the industrial actuality, key driving force and the developing tendency of China’s organic fertilizer market. Industry Characteristics Organic fertilizers can be conceptually classified into 3 commercialized categories: refined organic fertilizer, organic-inorganic compound fertilizers and microbial organic fertilizers and their market percentage were 43.5%, 17.6% and 38.9% respectively: Refined organic fertilizer- Obtained thought the fermentation or decomposition of organic materials and typically formulated into powdery, granular, or liquid form. organic-inorganic compound fertilizer-blended or compounded products of inorganic fe

On October 14, 2019, China MoARA issued the announcement 222 to update the service guide for the administrative approval of 30 agricultural-related matters. The announcement streamlines the legal basis, scope, process, data requirements, timeframe and fee for the new application and renewal of fertilizer registration, amid a minor change on registration renewal. After a period of enforcement, the Ministry has formed tacit practices for the handling and review of registration applications. This article will offer a brief introduction to the procedures, and comparative analysis of the data requirements, as well as the recent lessons learned by REACH24H experts, who successfully helped many overseas enterprises to obtain fertilizer registration in China. Categorized Registration Management Based on the level of risk, fertilizers subject to registration management need to be registered with MoARA or provincial agricultural authority. Fertilizers not yet established with national or industrial standards are reviewed by the technical committee on a case-by-case basis will other fertilizers that satisfy the quality indicators in the national or industrial standards are reviewed and approved directly. The Classification and Quality Standardization Status of Fertilizer in China Category Generic Name Standard Fertilizers Registered at Ministerial Level Macronutrient Fertilizers Water-soluble fertilizer containing nitrogen, phosphorus and potassium NY 1007-2010 Urea ammonium nitrate solution NY 2670-2015 Modified ammonium nitrate for agriculture use NY 2268-2012 Calcium ammonium nitrate for agriculture use NY 2269-2002 Magnesium-potassium for agriculture use / Magnesium-potassium chloride

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 April 20, the Chinese Standardization Administration (SAC) released the full contents of 14 national standards for disinfectants, disinfecting instruments, medical electrical equipment including critical care ventilators, of which the most notable one is “GB 388750-2020 Lists of Material and Restricted Substances in Disinfectants”, a mandatory standard without prior consultation, but due to take effect starting from November 1, 2020. Mandatory National Standards Issued under the SAC Announcement 7 of 2020 No. Code and Name Replacement Effective Date 1 GB 9706.1-2020 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance 医用电气设备 第1部分:基本安全和基本性能的通用要求 GB 9706.1-2007, GB9706.15-2008 2023/5/1 2 GB 9706.212-2020 Medical Electrical Equipment—Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators 医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求 GB 9706.28-2006 2023/5/1 3 GB 9706.237-2020 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment 医用电气设备 第2-37部分:超声诊断和监护设备的基本安全和基本性能专用要求 GB 9706.9-2008 2023/5/1 4 GB 27948-2020 General Requirements for Air Disinfectant 空气消毒剂通用要求 GB 27948-2011 2020/11/1 5 GB 27949-2020 General Requirements of Disinfectant of Medical Instruments 医疗器械消毒剂通用要求 GB/T 27949-2011 2020/11/1 6 GB 27950-2020 General Requirements for Hand Disinfectant 手消毒剂通用要求 GB 27950-201

The latest overhaul of China’s disinfection product regulation goes back as far as 2002, when all related technical matters were simultaneously compiled into the "Technical Standard for Disinfection (version 2002)". The 200-page document offered great value to authorities and testing institutes in assessing product quality, safety, and efficacy, the precondition for entering China's market. After years of regulatory reform, the premarketing surveillance of non-new disinfection products has been delegated to the health department at the provincial level, and regulatory studies can be conducted either by enterprises or third-party testing institutes (CMA-accredited). To improve compliance, help enterprises and testing facility comply and align with international practices, some of the product specifications, testing methods, and technical practice were revised, supplemented, and released in the form of national/industrial standards. Early this year, the Chinese Standardization Administration (SAC) announced seven disinfectant-related standards to be implemented on October 1. Two of these standards related to efficacy evaluation in the most common scenarios. This article explains the enforceability, product scope, and other elements affecting product qualification, etc. to keep overseas enterprises up-to-date with best practices. GB/T 38502-2020 Test Method of Bactericidal Effect of Disinfectant in laboratory GB/T 38504-2020 Evaluation Method of Disinfection Effect of Spray Disinfection PREMARKETING ASSESSMENT AND RECORDING FILING OF DISINFECTION PRODUCTS Currently, enterprises of Class I and Class II disinfection products need to complete a comprehensive evaluation on the product label, manual, test data, product standard/enterprise standard, hygienic license (homemade product)/documentary evidence & customs declaration (imported product), product formula(disinfectants, anti-microbial agents and sterilization indicators) or comp