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.

On 10 Jan 2018, China MoA’s website released announcement 2622 to promulgate 87 agricultural standards which became effective on 1^st 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