Agrochemical Regulatory News&Database
EU Technical Equivalence Assessment (TE): About Specifications
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.
Analysis of Disinfection Products Classification in China
What’s the difference between China’s disinfection products, EU biocides, and antimicrobial pesticides in the U.S.? To help enterprises better understand China’s disinfection products classification system, today we will introduce the detailed definitions and types of disinfection products in China.
Concerns in Preparation of Enterprise Standards for Pesticide Products in China
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..
How to Amend a Registered Pesticide Product under the U.S. EPA?
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.
China Biological Pesticides: Compliance Suggestions and Market Analysis
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.
Comparison of Product Chemistry Requirements and Key Points Analysis for Pesticide Registration in China, the US and Europe
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 Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)
On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements on raw materials, technical criteria, testing methods, labeling and instruction of these body-use disinfecting products, which would provide scientific foundations for the quality evaluation, correct product claim and consumer choice and promote the standardization process of China’s antimicrobial industry. Product Scope Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim. Raw Materials and Banned Substances All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as other quality specifications for food grade, medicine grade and cosmetic-grade, etc. The productive water shall satisfy the requirements in the “Hygienic Practice for Producers of Disinfection Products (2009)”. Pharmaceutical active ingredients listed in the Chinese Pharmacopoeia,animal/human-derived and biologically obtained materials that used for disease prevention, treatment and diagnosis, and banned ingredients listed in the “Safety and Technical Standards for Cosmetics”(excluding iodine), as well as other ingredients banned by the health department are prohibited from the formula of antibacterial/ bacteriostatic lotion. Technical Requirements Antibacterial/bacteriostatic lotion shall comply with a series of technical indicators through physicochemical property, efficacy an
Registration State Quo of Soybean-use Pesticides in China
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
An Insight into China’s New Pesticide MRL Regulation (GB 2763-2021)
On September 3, 2021, China began enforcing its new pesticide MRL regulation, “GB 2763-2021”, consisting of 10092 MRLs for 564 pesticides in 13 main food categories. The transformation from GB 2763-2019 to GB 2763-2021 represents by far the greatest variance compare to previous updates since 2012m, as 81 pesticides and 2985 MRLs were newly added. Besides, 16 banned/ restricted pesticides have their MRLs developed/amended in line with the detecting limit covering all plant-derived food/prohibited crops, which brings greater influence on the food supply chain. By combining the ideas and comments from MoARA drafters and food quality inspectors, this paper tries to characterize the main features of GB 2763-2021 and offer practical advice to the food-related sectors. Broader Coverage but Highlighted Priorities Of all the 564 pesticides established with MRLs, 428 pesticides have been registered with MoARA, 49 pesticides have been banned or restricted and 87 pesticides have not yet been registered in China but widely used overseas, as well as other 44 low-risk pesticides exempted from MRL developing. the number of pesticides established with MRLs has already exceeded that of the CAC standard or the US regulation and approach to the EU regulation. 792 MRLs have been developed for 29 banned pesticides and 345 MRLs have been developed for 20 restricted pesticides. 16 pesticides have had MRL developed/revised down following the detecting limits referenced testing methods and universally applied on 12 categories of plant-derived food or prohibited crops. 1742 CAC MRLs for 87 unregistered pesticides have been evaluated and transformed into national MRLs in response to the increasing demand for imported food. Excess pesticide residue in vegetables and fruits has long been a worldwide puzzle for the low availability of residue data due to the poor profitability for agrochemical companies. Since the reform of pesticide
Overview of the Minor-use Pesticides Registration in China
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/
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