Agrochemical Regulatory News&Database
China to Approve 7 New Pesticide Active Ingredients
On November 30 2021, China ICAMA opened a 7-day consultation of 13 pesticides containing 7 new active ingredients that have passed through the expert review at the 9th session of the 9th National Committee of Pesticide Registration, and 5 of them are chemical pesticides of Isofetamid and Tembotrione.
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
A Brief Retrospective on the Investments in China’s Agrochemical Production
From 2016 to 2020, China invested 68.76 billion overall in new agrochemical facilities, capable of producing 653,000 tons of active ingredients, 918,000 tons of intermediates, 531,000 tons of formulations, and 9,700 tons of other products including adjuvants, antidotes, and synergists. As a result of China’s environmental and safety rectification and industrial upgrading, 17.66% and 25.07% of the capital went into northwestern or northern regions, and the East China region has access to 22.83% of the investments, owing to its diverse supply chain, advantageous infrastructure and human resource. As the top agrochemical production province, Jiangsu had put forward a provincial plan to rectify chemical industry as early as 2007, but the concrete measures were enforced since 2016 aimed to merger and upgrade or cancel the existing chemical industrial park/zone, as well as eliminate chemical factories outside the designated chemical industrial park/zone, which were and especially accelerated after the explosion in March 2019. By the end of October 2020, 14 chemical parks and 15 chemical concentration zones have been designated, but only 50% to 60% of chemical producers have moved in and the rest of producers would be forced to relocate or shut down. As for Shandong , the second-largest producing province, 85 chemical industry parks were announced and 34% of chemical producers were moved in and the number of chemical producers decreased from 6,094 in 2018 to 4,580 in 2020. Currently, over 20 provinces have enforced similar measures and it has become an unavoidable tendency that chemical producers to relocate to industrial parks. Since China has not yet established environmental protection regulations specific to Yellow River basin, upstream areas have become perfect destinations for migratory producers. Looking back on the annual investment, the growth in 2019 and 2020 was remarkable, mainly because increasing relocation/investment plans had been announced a
China Enacted Fertilizer Standard to Define Biostimulants
On November 1, 2021, China began to enact the agricultural standard “NY/T 3831-2021 Organic Water-Soluble Fertilizers-General Regulations”. In addition to the definition, classification and general rules on the raw materials, nutrient/harmful contents and label, NY/T 3831 first defined that this category of agricultural input is the result of organic raw materials and contains biostimulant, resolving the ambiguous legal status and offering conceptual ideas for the pre-marketing procedures for biostimulants.
Brazilian Pesticide Treated Area Rose by 8.7% in Q3 2021
According to the statistic from the Brazilian National Union of Plant Protection Products Industry(Sindveg) released on November 25, 2021, 209.3 million hectares were treated with pesticides in the third quarter of 2021, an increase of 8.7% compared to the same period last year.
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
South Korea NIER Proposed Minor Refinement on Data Requirements for Biocide Approval
On November 1, 2021, the South Korean National Institute of Environmental Research(NIER) invited a 20-day consultation on the amendment to the department rules, “Regulation on the Scope and Method for Preparing Application Data on Biocidal Substance and Product Approvals”. The current version was published on January 26, 2021, in the form of NEIR Notice 2021-7, which specified all the endpoints of test data and items of general data in the form of mandatory or conditional required data, criteria for exemption, additional test data, acceptance of testing methodology and testing institutes, as well as methods for preparing this data.
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
China MoARA Clarifies the Jurisdiction Scope of Body-use Mosquito Repellents
On September 23, 2021, the Chinese Ministry of Agricultural and Rural Affairs released a positioning paper regarding the regulatory definition of body-use mosquito repellents, which were increasingly circulated on the market in different forms such as repelling patches, lotion, liquid, and wristbands containing botanical ingredients.
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