On November 11, 2020, China’s State Administration for Market Regulation (SAMR) and the State Standardization Administration jointly issued the mandatory national standard” GB38598-2020 General Requirement for Label and Instruction Book of Disinfection Products”, expected to take effect on December 1, 2021. This standard will apply not only to disinfectants, disinfecting apparatus, disinfection indicators and antibacterial/bacteriostatic agents that fall under the pre-marketing safety and efficacy evaluation and record-filing process, but also other daily necessities such as contact lenses solutions, wet wipes, hygienic wet wipes, sanitary napkins(pad), diapers, cotton swab/ball, tissues, household paper (excluding toilet paper) and papery tableware. The drafter and responsible authority, the National Health Commission (NHC) revealed that the standard is the first hygiene standard to passed the deliberation stage by over 140 WTO members. GB38598-2020 is expected to play an important role in reducing trade barriers and ensuring correct and safe uses of disinfection products by both healthcare professionals and general consumers. Significance and Coverage All disinfection-related regulations were developed under the national law “Prevention and Treatment of Infectious Diseases” and the ministerial regulation “Administration Measures for Disinfection”. In late 2005, MoH (former NHC) issued a lower level ministerial regulation, “Management Specification for Label and Instruction Book of Disinfection Products” (the “ministerial labeling regulation”), but it gradually become disconnected from the industrial and market changing conditions, especially the decentralized reform of 2013. Now, the arrival of GB38598-2020 has elevated the legal priority of labeling regulations and costs of mishandling: the breach of a national mandatory standard can now be fined up to 50,000 RMB. Not all products with

In 2020, China MoARA approved 795 pesticides, a significant recovery from 2019 of just 264. 15 pesticides were registered as TC/TK, including 14-hydroxylated brassinosteroid， Indolebutyric acid (IBA)， Benzylaminopurine，24-Epibrassinolide， Gibberellic acid， Naphthylacetic acid，L-glufosinate, Broflanilide, Teraniliprole, Allantoin, Quinotrione, Bromadiolon, Flocoumafen, Clethodim and Bacillus subtilis. 780 formulated pesticides were approved, consisting of 320 single-element formulations and 460 multi-element formulations. Of the 795 pesticides approved, 672 of them were categorized as low toxic, followed by 84 slightly toxic pesticides and 39 moderately toxic pesticides. Category and Formulation 300 pesticides were registered as herbicide (2 of them can function as both herbicide and plant growth regulator), followed by fungicide(203), insecticide(179), plant growth regulator(59), fungicidal and insecticidal seed treatment(19), acaricide(19, 6 of them can function as both insecticide and acaricide), nematicide(7), molluscicide(4), rodenticide(3), resistant inducer(3), and insect pheromone（1）. With significant environmental advantages， 300 of the pesticides were formulated as suspension concentrate. Driven by a large number of Glyphosate and Glufosinate producers, 153 pesticides were registered as solid liquid, the most compatible formulation of these non-selective and widely used herbicides. The number of formulation types rose to 29 in 2020, remarking the sustainable innovation in targeted pests and application technology. New Combination As it is becoming increasingly difficult to develop new compounds, agrochemical enterprises are paying more attention to combine different active ingredients to expand pest spectra and mitigate pest resistance: 22.17% of the fungicides approved in 2020 were new fungicide mixtures; 12% of the herbicides approved were new herbicide mixtures; 9.5% of the insecticides approved were new insecticide mixtures From 

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

On August 24, the Korean Ministry of Environment issued the Notification 2020-182 to amend the list of existing biocidal substances subject to deferred approval. South Korea enacted the “Act on the Safety Management of Household Chemical Products and Biocides(K-BPR)” in 2018, requiring manufacturers and importers of biocidal substance to obtain a substance approval from the Ministry. Biocidal substances used in biocidal products or treated articles placed in Korea before December 31, 2018, are allowed to be designated as “existing biocidal substances subject to deferred approval” and manufactured or imported without obtaining the approval within their grace period if their producers and manufacturers fulfilled reporting and submission obligations: Notify MoE the basic information on the substance before June 30, 2019, including name, trade name and use type, etc.; Submit to the MoE the plan for the application of substance approval within 1 year after the substance being designated as the existing substance. For substance manufactured or imported by multiple companies, the plan shall be submitted separately and one of the companies can be selected as the representative of data submitter for the joint submission. The data can also be used by other applicants not yet participate in the joint submission through MoE’s data compensation system. If the manufacturer or importer failed to submit the plan or application for substance approval, the notified substance will be deemed as difficult to submit the data within the grace period and manufacturer or importer will be prohibited from business activities. If all manufacturers and importers of the substance were prohibited, the designation of the substance will be canceled. On December 31, 2019, MoE issued the Notification 2019-249 and a total of 741 substances were designated as the existing substances. The chemical name, CAS number, use type, grace period, and notifying co

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