China Pesticide Risk Assessment - China - Agrochemicals

Pesticide risk assessment evaluates the chance and magnitude of harmful effects caused by pesticides to humans and ecological systems under specific use conditions by using scientific data and assessment models. Pesticide risk assessment report is an important part of pesticide registration data requirement, including a human health risk assessment report, an ecological risk assessment report and a dietary risk assessment report. The Data Requirements on Pesticide Registration, which came into effect in 2017, clearly specifies different risk assessment requirements for different product registration types (please refer to the annex of this article).

Human Health Risk Assessment

Depending on exposed human popultions, human health risk assessment can be divided into operator health risk assessment and resident health risk assessment. Operator health risk assessment is the process to determine if the use of a pesticide product poses unacceptable health risks to pesticide operators when they mix, load and apply pesticides. Resident risk assessment is the process to determine if the use of aerosol or repellent etc poses unacceptable health risks to residents.

Assessment Basis:

NY/T 3153-2017 Guidance on health risk assessment of pesticide operators;
Backpacker sprayer operator unit exposure - ICAMA;
NY/T 3154.1-2017 Guidance on health risk assessment of public health pesticides Part 1 - mosquito coil, vaporizing mat and liquid vaporizer；
NY/T 3154.2-2017Guidance on health risk assessment of public health pesticides Part 2 - aerosols；
NY/T 3154.3-2017 Guidance on health risk assessment of public health pesticides Part 3 - repellent.

Environmental Risk Assessment

Pesticide environmental risk assessment refers to the use of science, technology and available information to assess the potential risks and adverse effects of pesticide use on the environment under specific conditions. At present, protection targets considered in enviromental risk assessment include aquatic ecosystem, birds, bees, silkworm, groundwater, non-target arthropods and soil organisms.

Assessment Basis:

NY/T 2882.1-2016 Guidance on environmental risk assessment for pesticide registration –Part 1: General principles
NY/T 2882.2-2016 Guidance on environmental risk assessment for pesticide registration –Part 2: Aquatic ecosystem
NY/T 2882.3-2016 Guidance on environmental risk assessment for pesticide registration –Part 3: Birds
NY/T 2882.4-2016 Guidance on environmental risk assessment for pesticide registration –Part 4: Honeybee
NY/T 2882.5-2016 Guidance on environmental risk assessment for pesticide registration –Part 5: Silkworm
NY/T 2882.6-2016 Guidance on environmental risk assessment for pesticide registration –Part 6: Groundwater
NY/T 2882.7-2016 Guidance on environmental risk assessment for pesticide registration –Part 7: Non-target arthropods
NY/T 2882.8-2017 Guidance on environmental risk assessment for pesticide registration –Part 8: Soil organism

Dietary Risk Assessment

Dietary risk assessment refers to the scientific assessment of the likelihood and extent of health risks arising from the dietary intake of pesticide residues according to the dietary structure of consumers by analyzing the toxicology data and residual study results of pesticides. It includes toxicology assessment, residual chemistry assessment, dietary intake assessment and risk characterization.

Assessment Basis:

Guidance on pesticide residue risk assessment
Guidance on setting pesticide acceptable daily intake
Guidance on setting pesticide acute reference dose
NY/T 3096-2017 Guideline for the testing of pesticide metabolism in crops
NY/T 3095-2017 Guideline for the processing test on pesticide residue in commodities
NY/T 3094-2017 Guideline for the Stability Testing of Pesticide Residue in Stored Commodities
NY/T 788 - Guideline on pesticide residue trials

Our Services and Advantages

The agrochemical division of CRIS group is located in Beijing. All team members have master's degree or above. The core members of this team are senior regulatory experts and risk assessment technical experts that have worked in top multinational agrochemical companies for many years.

We can provide bilingual and high-quality health risk assessment reports, environmental risk assessment reports and dietary risk assessment reports, reducing the risks that a pesticide cannot be registered due to the problems of risk assessment reports in the process of pesticide registration. We can also provide high-tier risk assessment strategies when tier 1 risk assessment fails.

Annex - Requirements on Risk Assessment Reports

Pesticide		Health risk assessment		Dietary risk assessment	Ecological risk assessment
Pesticide		Resident health risk assessment	Operator health risk assessment	Dietary risk assessment	Ecological risk assessment
TC (TK)		/	/	/	/
Pesticide formulation①	Chemical formulation	/	√	√	√
	Biochemical-formulation	/	If biochemical pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.	√	/
	Microbial-formulation	/	If microbial pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.	/	/
	Botanical-formulation	/	If botanical pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.	/	/
Public health formulation ②	Public health chemical formulation	√		/	√
	Public health biochemical-formulation	If biochemical pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.		/	/
	Public health microbial-formulation	If microbial pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.		/	/
	Public health botanical formulation	If botanical pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.		/	/
Rodenticide③	Rodenticide chemical formulation	√		/	√
	Rodenticide biochemical-formulation	If pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.		/	/
	Rodenticide microbial-formulation	If pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.		/	/
	Rodenticide botanical-formulation	If pesticide TC requires submission of supplementary toxicological data, this data (pesticide operator health risk assessment report) should be provided in general.		/	/
Change of registration ④	Expand application scope	√		Whether it is required depends on residue test data.	Whether to submit a risk assessment report or not depends on the registration category of the product.
	Change of application method	√		Whether it is required depends on residue test data.	It is required when the change of application method might result in increased environmental risk.
	Increase app rate	√		√	√
	Reduce dosage	/	/	/	/
	Change of TC (TK) specification & composition	/	/	/	/
	Change of formulation specification & composition	/	/	/	/
	Change of toxicity level	/	/	/	/
Note: ①Dietary risk assessment: Not required for a product for use on non-food crops or non-feed crops, and low-toxic or slightly-toxic seed treatment product (including seed mixing, coating and soaking formulations). ②Health risk assessment：For household health pesticides, resident health risk assessment report shall be submitted. For environmental health pesticides, pesticide operator health risk assessment report shall be submitted. ③Health risk assessment: According to pesticide data requirement, operator risk assessment and ecological risk assessment abstracts are required for chemical rodenticides. ④Risk assessment: A resident health risk assessment report or an operator health risk assessment shall be submitted.