China Promulgates 21 Agricultural Standards for Registration and Testing of Agrochemicals

MoA newly promulgated a series of testing guidelines to support environmental and health risk assessment required during pesticide registration. China offers reduced regulatory requirements and exemptions under certain conditions for biochemical pesticides, microbial pesticides, botanical pesticides and chemical pesticides in certain formulation type, use site, scope and application method. Test endpoints for different product and registration types are specified in MoA Announcement 2569-Data Requirements on Pesticide Registration.

China Promulgates 21 Agricultural Standards for Registration and Testing of AgrochemicalsOn 10 Jan 2018, China MoA’s website released announcement 2622 to promulgate 87 agricultural standards which became effective on 1st of Jan 2018. Among them, 21 standards are for the regulatory studies required during registration of pesticides and fertilizers.

China implemented the new registration data requirements on 1 Nov 2017. Compared with previous regulations, dietary, health and environmental risk assessment reports are additionally required. A tiered approach will be utilized to assess occupational health and environmental risks: beginning with preliminary assessing using basic data and conservative assumptions. If a more refined risk assessment is needed, higher-tiered screening model (mesocosm, semi-field simulation and field study) that more reflective to actual use condition will be proceeded. In the new Data Requirements, these higher-tiered models and studies are more often referred to as “If preliminary assessment indicates unacceptable risks to human or environmental organisms. Additional tests would be required.” General criteria and conditions for risk assessment reports and higher-tier data requirements are summarized as follows:

  • For the registration of TC containing new active ingredient or generic TC which is not determined as me-too product, mescosm study on a representative formulated product will be required if the assessment indicates unacceptable risk to aquatic organisms. Other tests will be required if preliminary assess indicates unacceptable risk to certain organism. For example, if preliminary assess indicates unacceptable risk to bee, a semi-field test on bee will be additionally required;
  • Dietary (residue) risk assessment report will be required for all crop-use formulated pesticides;
  • Occupational health risk assessment report of pesticide applicators will be required for agricultural pesticide and hygienic pesticide for environmental use. If preliminary assessment indicates unacceptable risk, in-field exposure test on pesticide applicator and/or other tests will be required;
  • Health risk assessment report will be required for household pesticides. If preliminary assessment indicates unacceptable risk, simulated exposure test on residents and/or other tests will be required;
  • If the pesticide was a me-too or similar product and has similar use scope and application method compared with other pesticide, dietary and health risk reports and additional test will not be required;
  • Environmental risk assessment report will be required for agricultural pesticide and hygienic pesticide for out-door uses. If preliminary assessment indicates unacceptable risk to certain environmental organism, further in-field or simulated test on this organism will be required to support higher-tiered assessment;

The new data requirements waives testing requirements for certain product categories namely biochemical pesticides, microbial pesticides, botanical pesticides and chemical pesticides in certain formulation type, use site, scope and application method. Test endpoints for different product and registration types are detailed in the of MoA Announcement 2569.( An Introduction on China’s New Pesticide Registration Data Requirements-MoA Announcement 2569)

21 Guidelines for the Assessment and Testing of Pesticides and Fertilizers Promulgated under MoA Announcement 2622

 

1

NY/T 3148-2017 Guideline for the Outdoor Simulation(Mesocosm) Test of Pesticide
农药室外模拟水生态(中宇宙)试验准则

2

NY/T3149-2017 Guideline for the Upland Field Dissipation Test of Pesticides
化学农药 旱田田间消散试验准则

3

NY/T 2882.8-2017 Pesticide Registration-Guideline for the Risk Assessment on Pesticide: Part 8 Soil Organisms
农药登记 环境风险评估南 8部分:土壤生物

4

NY/T 3150-2017 Pesticide Registration-Guideline for the Evaluation and Calculation on Environmental Degradation Kinetics of Pesticides
农药登记 环境降解动评估及计算指南

5

NY/T 3151-2017 Pesticide Registration-Guidance on the Developing and Validation on the Analytical Method for the Determination of Chemical Pesticides in Soil and Water
农药登记 土壤和水中化学农药分析方法建立和验证指南

6

NY/T 3152.1-2017 Microbial Pesticide-Guidance on Environmental Risk Assessment: Part 1. Toxicity to Avian
微生物农药 环境风险评价试验准则:第1部分 鸟类毒性试验

7

NY/T 3152.2-2017 Microbial Pesticide-Guidance on Environmental Risk Assessment: Part 2. Toxicity to Bee
微生物农药 环境风险评价试验准则:第2部分 蜜蜂毒性试验

8

NY/T 3152.3-2017 Microbial Pesticide-Guidance on Environmental Risk Assessment: Part 3. Toxicity to Silkworm
微生物农药 环境风险评价试验准则:第3部分 家蚕毒性试验

9

NY/T 3152.4-2017 Microbial Pesticide-Guidance on Environmental Risk Assessment: Part 4. Toxicity to Fish
微生物农药 环境风险评价试验准则:第4部分 鱼类毒性试验

10

NY/T 3152.5-2017 Microbial Pesticide-Guidance on Environmental Risk Assessment: Part 5. Toxicity to Daphnia Magna
微生物农药 环境风险评价试验准则:第5部分 溞类毒性试验

11

NY/T 3152.6-2017 Microbial Pesticide-Guidance on Environmental Risk Assessment: Part 6. Growth Inhibition to Daphnia Magna
微生物农药 环境风险评价试验准则:第6部分 藻类生长影响试验

12

NY/T 3153-2017 Guideline for the Health Risk Assessment of Pesticide Applicators
农药施用人员健康风险评估指南

13

NY/T 3154.1-2017 Guideline for the Health Risk Assessment on Hygienic Pesticides: Part 1. Mosquito Coils
卫生杀虫剂健康风险评估指南 1部分:蚊香类产品 NY/T2875-2015

14

NY/T 3154.2-2017 Guideline for the Health Risk Assessment on Hygienic Pesticides: Part 2. Aerosols 
卫生杀虫剂健康风险评估指南 2部分:气雾剂

15

NY/T 3154.3-2017 Guideline for the Health Risk Assessment on Hygienic Pesticides: Part 3. Repellents
卫生杀虫剂健康风险评估指南 3部分:驱避剂

16

NY/T 3161-2017 Method for the Determination of Arsenic, Cadmium, Chromium, Plumbum, Mercury, Cuprum, Manganese, Nickel, Zinc and Strontium in Organic Fertilizers- ICP-MS Method
有机肥料中砷、镉、铬、铅、汞、铜、锰、镍、锌、锶、钴的测定 微波消解-电感耦合等离子体质谱法

17

NY/T 3162-2017 Method for the Determination of Fulvic Acid in Fertilizers
肥料中黄腐酸的测定 容量滴定法

18

NY/T 3167-2017 Method for the Determination of Sulfonamides in Organic Fertilizers
有机肥中磺胺类药物含量的测定 液相色谱-串联质谱法

19

NY/T 3174-2017 Water Soluble Fertilizers-Determination of Alginic Acid
水溶肥料 海藻酸含量的测定

20

NY/T 3175-2017 Water Soluble Fertilizers- Determination of Chitosan
水溶肥料 壳聚糖含量的测定NY/T1109-2017

21

NY/T 1109-2017 General Biosafety Standard for Microbial Fertilizers
微生物肥料生物安全通用技术准则 NY 1109-2006

Something Wrong? At Chemlinked we do our utmost to provide you with accurate information. However sometimes errors slip under the radar, we’re only human. That’s where you our vigilant reader come in! If you notice any errors contact us on: error@chemlinked.com Budding Journalist ? Send us your news on: news@chemlinked.com