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

In response to the tight supply of disinfectants caused by 2019 Novel Coronavirus(2019-nCoV), on February 3, 2020, the National Health Committee released "The Emergency Product Launching Notification of Disinfectants during Prevention And Control Period of Pneumonia Outbreak Caused by 2019-nCoV". Under this emergency measure, China has opened a "Green Channel," entailing expedited and exceptional market access for four types of disinfectants, including alcohol disinfectant, chlorine-containing disinfectant, chlorine dioxide disinfectant, and peracetic acid disinfectant placing on China market (see below). According to the Notification: Disinfectants that use alcohol as the active substance can be placed on the Chinese market after completing content tests either by the manufacturers (for the domestic disinfectants) or by Chinese legal entity (for the imported disinfectants) or 3rd party laboratories. For hand-application alcohol disinfectants, the alcohol concentration in the disinfectants should be higher than 60% (V/V). The raw materials used in ethanol disinfectants shall conform to the requirements regulated in the national standard “GB26373-2010 Hygienic Standard for Alcohol Disinfectants," and ethanol concentration should be 70% - 80% (V/V); Chlorine-containing disinfectants, chlorine dioxide disinfectants, and peroxyacetic acid disinfectants can be placed on the Chinese market after completing the content test and pH test and compliant with related standards. The period of validity for “84” liquid disinfectants containing sodium hypochlorite should be limited to 3 months, with the exception that products can be distributed and used until expiration date supported by the qualified stability test data. The producers of disinfectants already on the market that has completed record filing are encouraged to expand their production by adding new production lines, new plants, and production sites. The dis

On 30 Dec 2019, the Chinese Ministry of Agricultural and Rural Affairs released 192 GM crops to be issued with GMO safety certificate, of which 3 were homegrown grain crops with herbicide-tolerant and insect-resistant traits. Since the last time China approved food GM crops was in 2009, this move was interpreted by some analysts as another attempt to promote the commercial plantation of GM grain crops. Seed companies thus became increasingly sought after by investors on the stock market as GM grain crops would be commercially planted as soon as the next 2 or 3 years. Homegrown GM Food Crops Only GM crops issued with GMO biosafety certificates can be imported and consumed in China, but there are two more administrative steps to commercializing a plantation: the crop variety examination and the seed license. In 2009, MoA (now known as MoARA) issued 3 GMO safety certificates to 2 insect-resistant rice varieties developed by HZAU( Huazhong Agricultural University) and 1 transgenic phytase maize co-developed by CAAS( Chinese Academy of Agricultural Science) and Origin Seed, but the remaining procedures were stalled due to strong public opposition after a series of GM food-related scandals. The GM grain crops announced this time are 2 maize and 1 soybean developed by indigenous institutions, and the traits and permitted planting regions are as follows: GM Food Crop Developer Trait Region DBN Maize Da Bei Nong Group Bt Cry1Ab, CP4 EPSPS Spring maize zone in Northern China Dual-resistant Maize Ruifeng Biotech and Zhejiang University Cry1Ab/Cry2Aj, G10evo EPSPS SHZD Soybean Shanghai Jiao Tong University Glyphosate-tolerant soybean zone in Southern China Analyzing Necessity Given the fact that no biosafety certi

On 15 Aug 2019, the National Health Commission, the Ministry of Agricultural and Rural Affairs and the State Administration of Market Regulation jointly issued the “GB 2763-2019 National Food Safety Standard: Maximum Residue Limits of Pesticides in Foods”, which will take effect on 15 Feb 2020. The one major new feature in this release is that the number of MRLs in GB 2763-2019 for the first time exceeds those developed by Codex Alimentarius Commission (CAC standard), the most universally recognized pesticide MRL standard in the world, marking another new step forward in food safety and agricultural trade. In this article, we will explain the evolution if this regulation and introduce its main features based on comparative analysis, sharing some prospects on the future trend of China's pesticide MRL regulation. large Numbers of MRLs for Food Categories Specified by GB 2763-2019 Recent Updates In the past, the former Ministry of Health (now referred to as NHC) was mainly responsible for developing pesticide MRLs in the form of food hygienic safety standards, while the Ministry of Agriculture (now referred to as MoARA) also developed a series of MRLs as quality standards for agricultural commodities. Until 2009, China enacted the Food Safety Law and MoA was designated to develop pesticide MRLs and relevant testing methods. The ministry began to organize the previously disparate MRLs and released the first unified MRL regulation,  GB 2763-2012, which has then been revised amost every 2 years: Development of GB 2763 Series: a Full Timeline Code year of issue Number of Pesticides Number of MRLs GB 2763-2012 2012 322 2293 GB 2763-2014 2014 387 3650 GB 2763-2016

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.

China uses 6% of the world's water resources, 9% of the world’s farmland and 30% of the world’s chemical fertilizers to produce 26% of the agricultural products in the world. China’s annual irrigation water consumption is 360 billion tons per year but there is still an input gap of 30 billion tons. The agricultural output per water consumption was only 1 kg per ton, half the efficiency that the US and Israel achieved. Despite China leading the world in agrochemical use, with an annual chemical fertilizer consumption of 54 million tons, the average utilization efficiency is merely 30%, about 20 percent lower than in developed countries. The "high consumption but low efficiency" pattern in agricultural production has brought about a huge waste of resources and increased levels of environmental pollution, not to mention the fact that it has become one of the greatest bottlenecks constraining agricultural development. In the "National Strategic Plan for Agricultural Revitalization through Quality Enhancement (2018-2022)”, China planned to improve its fertilizer utilization efficiency to 41% by 2022, which us expected to have encouraging effects on certain agricultural inputs such as water-soluble fertilizers (WSF). Imperative Fertilization and Irrigation Integration The water-saving irrigation strategy was first put forward in 2004 and has been repeatedly emphasized by the “N01 Central Document” for 12 consecutive years. In 2011, China’s NATESC (National Agricultural Technology Extension and Service Center) identified fertilization and irrigation integration as the number one agricultural practice to be deployed nationwide. In 2015, MoA (now known as the MoARA) issued its ambitious “Action Plan for the Zero-growth of Chemical Fertilizer Uses by 2020” which means 5.33 million hectares of the farmland will be treated with an integration of fertilization and irrigation systems and the

Early this year, MUJI announced a worldwide recall of its bottled water products after detecting excessive bromate contaminant, a disinfection by-product (DBP) generated during ozone disinfection. Although the products mentioned in the recall notice have never entered Chinese mainland, the news was quickly spread on social media Weibo and aroused much widespread concern over drinking water safety, whose market penetration of water purifier/disinfector is only about 20% and household water purifier market will keep a growth of over 10% until 2022. This article explains how the drinking water disinfectants and DBPs are regulated in China and the latest regulatory developments in drinking water quality standard, the GB 5749, which is closely related to the premarket approval of drinking water-related products. Health Supervision of Drinking Water Related Products The drinking water regulatory system stems from the “Law on the Prevention and Treatment of Infectious Disease” and the “Administrative Measures for the Sanitation Supervision on Domestic Drinking Water”. The production and marketing of drinking-water treatment/disinfection/delivery devices, chemical agents and protection materials should obtain the hygienic approval from health administrative departments at national or provincial level. Drinking-water-related products can be classified into existing products and new products by the “Criteria for determining water-related products using new material, new technology and new substances”, which specified the names and use scopes of 90 existing substances and treatment technologies and water-related products using these substances and technologies are approved by provincial departments. In some provinces, the review on homemade material and tubes is further delegated to city department. Table 1-Existing Substances and Processing Technologies Used in Drinking Water Related Products Type

The removal of export taxes on chemical fertilizers, the enactment of the “Soil Pollution and Control Law”, and series of new/revised fertilizer standards are bringing far-reaching effects on Chinese fertilizer market, which is invariably moving towards rationalization, high-efficient, specialization and greenization. This article offers an overall conclusion on the likeliest regulatory and market outcomes in 2019, as well as an in-depth analysis of the new tendencies. Liberalization on secondary/micronutrients claim The labeling and marking of all commercial fertilizers should conform to the national standard, “GB 18382-2001 Fertilizer Marking: Presentation and Declaration”. The mandatory standard was promulgated by AQSIQ (now known as SMAR) as early as 2001 when China has not yet developed intact and unified testing methods for secondary/micronutrients. Expedient measures were adopted to protect growers from being misled: Compound or complex fertilizers containing secondary/micronutrients are generally prohibited from claiming on their medium/micronutrient content; Secondary nutrient fertilizers should mark the name and content of each secondary nutrient as well as the total secondary nutrient. If a secondary/micronutrient in a secondary nutrient fertilizer is below 2%/0.02%, the fertilizer shall not be marked with the secondary/micronutrient; Along with the scientific development and the market penetration of secondary/micronutrient fertilizers, both the growers and fertilizer producers have realized the importance of secondary/micronutrient in agricultural production. In late 2017, MIIT and 12 other ministries drafted an amendment to GB 18382, which has been submitted for final approval. The amendment removed the restriction on secondary/micronutrient claims. Considering the time required for a compulsory standard nationwide, the revised standard is very likely to be promulgated this year. Biostimulant is r