China has always been a major exporter of pesticide technical materials. The most convenient way for pesticide technical materials to enter the European market is to apply for Technical Equivalence (TE) Assessments. REACH24H, based on our experience in assisting companies with TE applications, found that many companies are still not familiar with how technical specifications are determined in TE. Hence, this article summarizes some common questions for companies interested in TE applications.

Pesticide enterprise standards (QB) are standards prepared by enterprises on product quality specifications and testing methods, which play a very important role in China’s pesticide registration. Therefore, storage stability tests and product quality tests in pesticide registration should be carried out according to such product enterprise standards. We sorted out and summarized the matters of concern in the process of compiling enterprise standards, to help the enterprises compile qualified stability tests and product quality test reports, and to successfully complete the pesticide registration..

Enterprises usually have to spend a huge amount of cost to complete a pesticide registration under the US EPA, but are subject to registration amendments afterward due to various reasons, such as trade market demands, formula changes, active ingredient source changes, label changes, etc. What’s the difference between the pesticide registration amendments and new registration? Is the registration amendments easier than new registration? In this article, REACH24H will give a detailed introduction to pesticide registration amendments under the US EPA.

In China’s pesticide system, the definition of biological pesticides includes microbial pesticides, biochemical pesticides and botanical pesticides. In recent years, the Chinese government has also encouraged enterprises to develop and use biopesticides, and the registration of biopesticides also enjoys preferential policies.

Product chemical data is the most basic part among the pesticide registration dossier. In addition to identity information, it also includes the 5 batch analysis of the technical materials, phys-chem properties and physical hazards for both technical materials and preparations, and technical properties for preparations. Generally, tests are needed to generate data for the four parts. This article will compare the product chemistry requirements for pesticide registration in China, the US and Europe, hoping to help companies in pesticide registration in various countries.  

China is the fourth largest soybean producer in the world and the area and output have been increasing steadily from 8.5 million hectares and 15.15 million in 1998 to 9.86 million hectares and 19.6 million tons in 2020. The plantation has been widespread across China, from Heilongjiang to Hainan and from Shandong to Xinjiang and the Top 6 production provinces account for 80% of the total output. Chinese Soybean Production in 2018   Area (Hectare m.) Output (Ton m.) Heilongjiang 3.57 6.58 Inner Mongolia 1.10 1.79 Anhui 0.65 0.97 Henan 0.39 0.96 Sichuan 0.38 0.89 Jilin 0.28 0.55 Other provinces 1.63 4.23 China has abundant and high-quality soybean germplasm and all soybean planted are homegrown non-GM varieties developed by public research institutes, notably the Chinese Academy of Agricultural Sciences and provincial agricultural academies of Shandong, Heilongjiang, Henan, etc. China has a large geological span and complex climate and the seeding stage usually extends from September to November and the harvest concludes between March and April next year. However, the output drags far behind domestic demand and 80% of the soybean consumed in China are imported, mainly used for crushing and feed purposes. A total of 50 diseases have been reported and 10 of them are severe and frequent diseases and 20 of them occur sporadically. Over 100 weeds have been reported in China and 87 of them are frequent ones. 404 insects have been detected and 10 of them are widespread, 150 of them are sporadic ones. Some of these weeds and insects are also the

Minor use pesticides are crop protection products targeting value specialty crops with small acreage, as well as controlling minor pests on major crops. Due to the low financial incentive for agrochemical companies to register their products alone, the lack of available pesticides led to illegal uses and crop loss in China until the regulatory reform. In 2017, China MoARA issued the ministry regulation, “Administrative Measures for the Registration of Pesticides”, constituting a characteristic mechanism consists of cost-sharing among multiple applicants, and an extrapolation scheme to use residue and efficacy data from crop groups, as well as the fast-track process introduced last year. In this article, we will introduce the scope, extrapolation, field trial and application procedures for minor-use pesticide registration. Dynamic Scope and Crop Grouping MoARA adopts constant readjustment to the pesticide, crop, and pests for minor uses and 3 lists were issued to help applicants to determine the scope: List of Minor Crops with Low Availability of Crop Protection Solution; List of Crop Groups for Extrapolated Use of Residue Data; List of Crop Groups for Extrapolated Use of Efficacy Data; The “List of Crop Grouping for Extrapolated Use of Residue Data” consists of crop group/sub-group, specific crops, and representative crops of the group. If the applicant completed the residue test of the representative crop and 1 or 2 specific crops with the same GAP (Good Agriculture Practice) condition, the data can be extrapolated to support the whole group. The number and test sites and selection of their locations shall conform to Annex 6 and Annex 9 of the “MoARA Announcement 2569- Data Requirements on Pesticide Registration” and the extrapolated use of residue data is inapplicable to post-harvest solutions. The “List of Crop Grouping for Extrapolated Use of Efficacy Data” specifies the representative crop/

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