China’s New Pesticide Rules Change How Products Are Brought to Market

By Bo Yang, Jose Carvalho
and Xiaohua He
Dr. Knoell Consult
Shanghai Co., Ltd

China’s Ministry of Agriculture (MoA) has been implementing considerable changes regarding the use of agricultural pesticides, particularly in the field of environmental safety and defining the protection goals for risk assessment of pesticides.

The new Chinese regulations on the Management of Pesticides (State Council Decree No.677) entered into force on June 1, 2017 with a main supporting guidance document released soon after, on Aug. 1, the Pesticide Registration Management Measures (MOA Order [2017] No.3). This guidance document brings about major changes for registrants: 1) by introducing risk assessment approaches to assess the environmental safety of pesticides ahead of approval decisions; 2) encouraging companies to bring to the Chinese market more innovative and environmentally friendly products.

Another pertinent document, Data Requirements for Pesticide Registration, was released on Sept. 29, 2017 (MOA announcement No.2569; entering into force on Nov. 1, 2017), laying down the four types of pesticide registration that will require an Environmental Risk Assessment (ERA report):

1) First registration for new formulated products (including chemical pesticides, bio-chemical pesticides, microbial pesticides, botanical pesticides, and pesticides for non-crop use;

2) eRgistration to add new uses to products already approved, i.e., label expansion for an existing product;

3) Registration to change the application method of a product;

4) Registration to change the application/dose rate.

ICAMA (Institute for the Control of Agrochemicals, Ministry of Agriculture, China) started the research work leading to the new regulations and guidance documents back in 2008, in a cooperative project between China and The Netherlands on Pesticide Environmental Risk Assessment. To date, seven protection goals are defined in the technical guidance on Environmental Risk Assessment, including aquatic ecosystem (fish, daphnia, and aquatic plants), birds, honeybees, silkworms, groundwater, non-target arthropods (parasitic and predatory), and soil organisms (earthworm and soil microorganisms).

The risk characterization for each protection goal will be expressed as a Risk Quotient (RQ), calculated by dividing the Predicted Environmental Concentration (PEC) by a Predicted No Effect Concentration (PNEC).

Similar to Europe, the new China ERA will follow a tiered approach in order to minimize costs but also to encourage the use of low-risk products. Only if ERA fails at Tier I assessment, would further lab/field data be required for a higher-tier assessment.

For Tier I assessment, three environmental fate and exposure models were developed to simulate PEC values for the environmental compartments: surface water, groundwater, and soil.

The TOP-RICE is a groundwater and surface water exposure model for paddy field in South China; ChinaPEARL predicts the groundwater concentrations for dryland north of Yangtze River; and the third model PRAESS, developed by Nanjing Institute of Environmental Sciences, simulates the PEC values in all three compartments for both dryland and paddy field. The models are still being refined, as technical issues still arise when running the models for some applications, particularly when assessing microbial pesticides or non-crop uses of chemical pesticides.

In addition, more exposure scenarios are needed to model the fate of chemical pesticides, to allow for covering more crops/applications, thus reflecting the diversity of China agriculture practices and use pattern of products. This is a work in progress.

Options for higher-tier assessment are also under development. The Chinese authorities are engaged in developing guidance to support higher-tier risk assessment and its implementation for registration purposes. Guidance documents should be expected in the near future providing guidance to conduct laboratory chronic studies, semi-field and field studies on birds and honeybees, and environmental fate field studies. The goal of such effort by the Chinese authorities is to make environmental risk assessment more comprehensive, transparent and realistic.

In summary, the new approach to Environmental Risk Assessment of pesticides is likely to catalyze ongoing changes in the Chinese agchem market. This year we have seen a considerable number of regulatory documents being released, some currently under commenting phase, and much more are expected to see the light in the coming months.

 

For further information or details on China Environment Risk Assessment please contact knoell in China (Dr. Xiaohua He, [email protected], +86 21 6199 2001)

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