REGULATORY INSIGHT
On 31 July 2026, the Department of Crop Production (Department of Agrochemical Management) of the Ministry of Agriculture and Rural Affairs invited public comments on proposed revisions to the Data Requirements for Pesticide Registration. Compared with the requirements currently in force since 2017, the draft revisions adjust the data requirements for birds, aquatic organisms, sediment-dwelling organisms and soil organisms applicable to new chemical pesticide technical materials, and place greater weight on reproduction and chronic-effect data in long-term risk assessment. The published document remains a consultation draft. The final text and its implementation are subject to subsequent official documents issued by the Ministry of Agriculture and Rural Affairs and further clarification from the Institute for the Control of Agrochemicals, Ministry of Agriculture and Rural Affairs (ICAMA).
China's pesticide registration framework groups ecotoxicology and environmental fate under "environmental impact" data. This article focuses on ecotoxicology and compares the previous and revised requirements for new chemical pesticide technical materials with the current data frameworks in China, the EU and the United States. Environmental fate parameters are discussed only where they are used to determine whether an ecotoxicological study is triggered.
Table 1. Major Changes to China's Ecotoxicological Data Requirements for New Chemical Pesticide Technical Materials
| Data category | 2017 requirements currently in force | 2026 draft revisions |
|---|---|---|
| Birds | In principle, acute oral toxicity testing starts with one species, with a second species added where necessary; separate short-term dietary and reproduction studies are also required | Acute oral toxicity testing is expanded to two avian species; the short-term dietary study is deleted; the reproduction study is retained, with the selection of the more sensitive species clarified |
| Aquatic organisms | Basic and long-term studies are specified for fish, daphnids, algae and other aquatic organisms; the fish life-cycle study is triggered by a combination of PEC, NOEC, bioaccumulation or persistence criteria | The trigger conditions for the fish life-cycle study are adjusted; the rules for additional testing of major metabolites, waivers for the parent compound and selection of the sensitive taxonomic group are further specified |
| Sediment-dwelling organisms | No separate data requirement is specified | A conditionally triggered chronic toxicity data requirement for sediment-dwelling organisms is added |
| Earthworms | An acute study is required; the reproduction study is triggered by the relationship between PEC and the acute LC50 or by other indications of chronic risk | The acute study and the previous reproduction-study triggers are deleted; earthworm reproduction data are required in principle |
Note: Earthworm reproduction data do not apply to rodenticides. Where the potential for exposure is extremely low and adequately justified, a waiver may be requested under the general note. The activated sludge respiration inhibition test newly added by the draft revisions applies only to technical materials for indoor-use public health pesticides and repellents.
Changes to Avian and Earthworm Testing
The draft revisions expand the avian acute oral toxicity study to two avian species and delete the short-term dietary study. Where the acute toxicity values for the two species differ by more than twofold, the more sensitive species is selected for the reproduction study.
Regulation (EU) No 283/2013 requires short-term dietary toxicity data for birds only where the mode of action or results from mammalian studies indicate that the dietary LD50 from the short-term dietary study may be lower than the LD50 from the acute oral study. The European Commission's 2025 draft amendment proposes that no new study should be conducted solely to satisfy this data requirement; the draft has not yet entered into force. Part 158 in the United States continues to list this study. However, EPA's 2020 case-by-case waiver guidance reports that, among 119 chemicals for which a quantitative comparison was possible, 118 had a lower risk quotient from the short-term dietary study than from the acute oral study.
Under the 2017 requirements, the need for an earthworm reproduction study was determined from the relationship between PEC and the acute earthworm LC50 or from other indications of chronic risk. The draft revisions delete the acute study and the preceding trigger conditions. Except for rodenticides and cases in which a low-exposure waiver is adequately justified, earthworm reproduction data are required in principle. The current EU data requirements likewise rely primarily on the earthworm reproduction study. Although the United States has issued an earthworm subchronic toxicity test guideline, earthworms are not listed as a basic requirement in the routine ecotoxicological data table under Part 158.
The avian reproduction study can evaluate egg production, eggshell parameters, embryo viability, hatchability and chick survival. The earthworm reproduction study evaluates adult survival and growth as well as the number of juveniles. Compared with short-term dietary or acute mortality data, these endpoints are more directly relevant to long-term risk assessment. The two types of data nevertheless address different questions: acute studies provide lethal toxicity endpoints under short-term exposure, whereas reproduction studies evaluate the effects of prolonged exposure on reproductive processes and population recruitment.
Following the deletion of the avian short-term dietary and earthworm acute data requirements, the information previously available from those studies for selecting test concentrations is correspondingly reduced, making range-finding studies more important in the design of reproduction studies. For birds, a range-finding study of approximately six weeks may be conducted with reference to U.S. EPA OCSPP 850.2300 (formerly OPPTS 850.2300) where the range of sensitive reproductive endpoints is unknown, in order to select concentrations for the definitive study and estimate the highest nonlethal concentration. For earthworms, a two-week range-finding study may be conducted with reference to OECD TG 222, using widely spaced concentrations to observe mortality and define the concentration range for the definitive study. A range-finding study should not be treated as a simple preliminary check. Its concentrations should be selected in light of existing toxicity data, expected exposure and the objectives of the definitive study, so that all definitive-study concentrations do not fall entirely within either a no-effect range or an excessively lethal range. Because reproduction studies are lengthy, applicants need personnel with experience in ecotoxicology and risk assessment to coordinate the range-finding study, the definitive study and data relevant to trigger determinations from an early stage of the project.
New Chronic Toxicity Data Requirement for Sediment-Dwelling Organisms
For the first time, the draft revisions list "chronic toxicity study data for sediment-dwelling organisms" as a separate requirement. The requirement applies to an insecticide or fungicide when both of the following conditions are met: first, in a water-sediment metabolism study, more than 50% of the initially applied radioactivity is present in the sediment phase in at least one system on or after Day 14; and second, available data indicate a chronic EC10 or NOEC below 0.1 mg/L for Daphnia magna, chironomids or Lumbriculus. A chironomid larval toxicity study is conducted for insecticides, whereas a Lumbriculus study is conducted for fungicides.
Regulation (EU) No 283/2013 requires the chronic risk to sediment-dwelling organisms such as chironomids or Lumbriculus to be assessed where environmental fate studies indicate or predict that the active substance may accumulate in aquatic sediment. In the United States, 40 CFR § 158.630 establishes separate acute and chronic whole-sediment data requirements for freshwater and estuarine/marine environments, with testing triggered on the basis of sediment partitioning, persistence, estimated environmental concentrations and toxicity results. The Chinese draft revisions use both the proportion associated with sediment and a chronic toxicity threshold as triggers, establishing a clear pathway from water-sediment metabolism results to the long-term assessment of sediment-dwelling organisms.
Comparison of Ecotoxicological Data Frameworks in China, the EU and the United States
Table 2. Comparison of Ecotoxicological Data Frameworks in China, the EU and the United States
| Data category | China's 2026 draft revisions | Current EU framework | Current U.S. framework |
|---|---|---|---|
| Birds | Acute oral toxicity in two species; short-term dietary study deleted; reproduction study retained | Acute and reproduction studies are the principal requirements; the short-term dietary study is triggered under specified conditions | Both waterfowl and upland game bird species are covered; short-term dietary studies remain listed in the data table, with case-by-case waivers available |
| Freshwater organisms | Acute data and conditionally triggered long-term data are required in parallel; requirements for major metabolites are further specified | Acute, long-term and, where necessary, supplementary-species data are required | A relatively comprehensive combination of freshwater acute and chronic data is specified |
| Sediment-dwelling organisms | A chronic study is required for an insecticide or fungicide when both trigger conditions are met | Chronic risk is assessed where accumulation in sediment is possible | Acute and chronic sediment data for freshwater and estuarine/marine environments are triggered separately |
| Bees | Honey bees are used as the assessment organism: acute oral and contact studies in adults; larval chronic testing only for insect growth regulators; a semi-field study is triggered where risk is unacceptable | Regulation (EU) No 283/2013 requires acute oral, acute contact and chronic data for bees, with developmental or supplementary studies added according to larval exposure and sublethal effects; the EFSA 2023 framework covers bumblebees and solitary bees, but the implementing legislation has not yet been revised | Part 158 routinely lists acute contact toxicity to adult honey bees, while residual toxicity on foliage and field studies are conditionally triggered; EPA's 2016 documents allow adult and larval acute, chronic and higher-tier data to be requested case by case, but do not establish a routine separate data requirement for bumblebees |
| Earthworms and other soil organisms | Earthworm reproduction and soil microorganism data are required in principle | Earthworm reproduction is the principal requirement, with data on collembolans, predatory mites and other organisms triggered where necessary | Earthworms are not listed as a basic requirement in the routine Part 158 data table, but supplementary data may be requested case by case |
| Estuarine and marine organisms | No independent, systematic data package has yet been established | Relevant aquatic species may be added under specified conditions | Acute data for estuarine/marine fish, mollusks and invertebrates are expressly required for general outdoor uses |
For bees, the Chinese draft revisions continue to use the honey bee as the assessment organism and specify acute oral and contact studies in adults, larval chronic testing under specified circumstances, and a semi-field study triggered by risk. Current Regulation (EU) No 283/2013 requires acute oral, acute contact and chronic data where bees may be exposed, with developmental or supplementary studies added on the basis of larval exposure and sublethal effects. The EFSA 2023 guidance includes bumblebees and solitary bees within the assessment framework, although the corresponding legislation has not yet been revised. EPA's 2016 documents further developed a tiered data framework under which EPA may request acute and chronic studies in adult and larval honey bees on a case-by-case basis. Where lower-tier risks cannot be excluded, EPA may proceed to colony-level feeding studies, pollen and nectar residue studies, semi-field studies or field studies. Current routine U.S. data requirements continue to focus on honey bees and do not include a separate data requirement for bumblebees.
Estuarine and marine organisms remain a clear point of difference among the three data frameworks. For general outdoor uses, the basic U.S. data package includes estuarine or marine fish, mollusks and invertebrates; test organisms may include saltwater fish, mysids and oysters. Higher-tier aquatic plant testing may also include a marine diatom. The Chinese draft revisions do not currently establish a corresponding freshwater/saltwater data package. Nor do they establish EU-style data groups for other soil fauna, such as collembolans and predatory mites, or a separate data group for non-target terrestrial plants.
Key Challenges in Pesticide Registration
5.1. Changes to the Trigger Conditions for the Fish Life-Cycle Study
The fish life-cycle study demonstrates the linkage between ecotoxicological data, environmental fate and exposure assessment. Under the requirements currently in force since 2017, fish life-cycle study data must be submitted when both of the following conditions are met:
Time-weighted average predicted environmental concentration (PECtwa) > 0.1 × the no-observed-effect concentration (NOEC) from the fish early-life stage study; and
Bioconcentration factor (BCF) > 1,000, or the substance is stable in water or sediment (DegT90 > 100 days in a water-sediment system).
The draft revisions instead require submission when either of the following conditions is met:
Bioconcentration factor (BCF) > 1,000; or
The technical material is stable in water or sediment (DegT90 > 100 days in a water-sediment system) and the NOEC from the fish early-life stage study is < 0.1 mg/L.
These changes show that, before the revision, the trigger for a fish life-cycle study required simultaneous consideration of risk assessment, integrating the results of exposure and hazard assessment, environmental persistence and bioaccumulation potential. Under the draft revisions, the threshold for triggering the study is further lowered. First, the previous requirement to satisfy both conditions is replaced by two alternative trigger pathways, under which either condition is sufficient. Second, for a technical material with DegT90 > 100 days, the study can be triggered by the hazard endpoint alone—an NOEC below 0.1 mg/L in the fish early-life stage study—without first meeting the PEC-based risk criterion. Applicants therefore need to coordinate bioconcentration, environmental fate and chronic fish toxicity studies early in the project in order to determine the subsequent testing program.
5.2. Further Refinement of Data Requirements for Major Metabolites
Major-metabolite data for aquatic organisms are also subject to clearly defined screening rules. Whether supplementary testing of major metabolites is required for fish, daphnids and aquatic plants depends on the toxicity of the metabolite relative to the parent compound, the applicable acute toxicity threshold and the stability of the parent compound in water. Where the parent compound hydrolyzes rapidly under the specified conditions and the corresponding study has been completed for the major metabolite, a waiver may be requested for the parent-compound data. Where fish, daphnids or algae are more than 100-fold more sensitive to the parent compound than the other taxonomic groups, major-metabolite testing may be focused on that sensitive group.
On 16 April 2026, ICAMA invited public comments on the proposed agricultural industry standard, Pesticide Registration—Guidelines for Environmental Risk Assessment—Part 11: Pesticide Metabolites. The draft covers aquatic ecosystems, honey bees, silkworms and groundwater. It establishes a tiered assessment pathway comprising the screening of metabolites of concern, exposure and effects analysis, risk characterization based on risk quotients and any necessary supplementary testing, thereby providing clearer assessment criteria for the refined major-metabolite data requirements in the draft revisions.
5.3. Greater Emphasis on Scientific Judgment in Preparing Registration Data
As the number of triggers and waiver conditions in the data requirements increases, applicants need to conduct a data gap analysis, determine which requirements are triggered and design the study sequence before testing begins. They must also prepare adequate justification for studies proposed to be waived or otherwise omitted. Under the regulatory approach reflected in the draft revisions, preparation of the registration data package will no longer be limited to completing studies item by item against a checklist. Instead, product characteristics, proposed uses, environmental exposure and existing toxicity results must be considered in determining whether a study is triggered, whether a waiver is available and how the individual studies should be linked.
Accordingly, the focus of dossier review will extend beyond whether the individual data items are complete to whether study selection is scientifically justified, the study sequence is reasonable, waiver rationales are adequate, and the overall body of evidence can support scientifically sound risk assessment conclusions. This requires professionals with experience in ecotoxicology, environmental fate and risk assessment to coordinate the registration strategy and study program from an early stage of the project.
Implications and Outlook
The revisions bring China's ecotoxicological data requirements for new chemical pesticide technical materials significantly closer to the current frameworks in the EU and the United States. The draft revisions streamline the data requirements by deleting the avian short-term dietary and earthworm acute studies, place greater weight on reproduction and chronic-effect data, add chronic toxicity data for sediment-dwelling organisms, and further specify major-metabolite requirements and triggers for long-term studies. At the same time, an increasing number of data requirements must be assessed for applicability or waiver in light of the proposed uses, exposure and available toxicity results. For applicants, completeness is only the foundation of a registration data package. The ability to identify triggered requirements, sequence studies and develop adequate waiver rationales will directly affect the scientific rigor of the submission.
In 2025, China issued 17 newly developed or revised standards in the GB/T 31270 series, Test Guidelines on Environmental Safety Assessment for Chemical Pesticides, several of which concern ecotoxicology. The accompanying drafting explanations indicate that the technical content of the avian acute oral toxicity, daphnid acute immobilization and soil microorganism methods is equivalent or closely aligned with the corresponding OECD Test Guidelines, providing a stronger technical basis for coordinating study programs for registrations in China and overseas.
Although China does not currently participate in the OECD Mutual Acceptance of Data (MAD) system, the continuing development of domestic test methods and quality management systems provides an appropriate basis for China to assess participation and work progressively toward joining OECD MAD. While retaining the supplementary data necessary for individual markets, applicants could adopt a global registration strategy based on "one core set of studies with market-specific supplements", reducing duplicate testing and creating better conditions for new pesticides developed in China to enter international markets.
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Key References
Department of Crop Production (Department of Agrochemical Management), Ministry of Agriculture and Rural Affairs. Notice Inviting Comments on Proposed Revisions to the Data Requirements for Pesticide Registration.
Ministry of Agriculture Announcement No. 2569 and the 2017 Data Requirements for Pesticide Registration.
Regulation (EU) No 283/2013, consolidated version of 21 November 2022.
Commission Communication 2023/C 344/02.
EFSA Guidance on the Risk Assessment for Birds and Mammals (2023).
U.S. 40 CFR § 158.630.
EPA Final Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective Analysis (2020).
EPA OCSPP 850.2300, Avian Reproduction Test.
OECD TG 222, Earthworm Reproduction Test.
Official database entries for China's GB/T 31270 series of national standards.
OECD official information on the Mutual Acceptance of Data (MAD).
OECD Chemical Safety and Biosafety Progress Report (February 2026).
European Commission status page for the 2025 draft amendment to Regulation (EU) No 283/2013.
EFSA Revised Guidance on the Risk Assessment of Plant Protection Products on Bees (2023).
European Commission, Protection of Bees.
EPA Guidance on Exposure and Effects Testing for Assessing Risks to Bees (2016).
EPA Process for Requiring Exposure and Effects Testing for Assessing Risks to Bees during Registration and Registration Review (2016).
EPA Pollinator Risk Assessment Guidance.
ICAMA Letter Inviting Comments on the Proposed Standards, Including Pesticide Registration—Guidelines for Environmental Risk Assessment—Part 11: Pesticide Metabolites.
