Comparison on the Chemistry Data Requirements for Pesticide Registration in China, EU and the US

Comparison on the Chemistry Data Requirements for Pesticide Registration in China, EU and the USThe number of pesticides newly registered in China has plummeted from 4326 in 2018 to 294 in 2019 and one of the main causes is the elevated data requirements newly enforced. As an essential component of a dossier, product chemistry data is usually firstly reviewed by the competent authorities. In a training course organized by the Chinese Crop Protection Industry Association in June, Ms. Nancy Shen, technical supervisor of REACH24H, concluded the similarity and differences in the data requirements and exchanged her long years of experience in registering pesticides in China, EU and the United States.

Generally, Product chemistry data consists of component analysis, Physico-chemical properties, physic-chemical hazard properties and product technical indicators related to its formulation types.

Component analysis refers to the qualitative and quantitative analysis on active ingredient and impurities in TGAI (technical grade active ingredients) sampled from 5 representative batches, mainly aimed to determine the relevant impurities with toxicological and environmental significance.

China, EU and the United State have developed technical guidelines for component analysis and their similarity and differences are summarized as follows:

 

China

EU

US

Name of Data

Full-component Analysis

Analytical profile of batches

Preliminary analysis

Guideline

NY/T 2886-2016

SANCO/3030/99

OPPTS 830.1700

Samples

Representative batched sampled from a proven and stable process

Discontinuously produced in recent 5 years at large scale

Representative

Qualitative analysis

AI: UV/IR/NMR/MS spectrums

Impurity: 1 spectrum (Qualitative)

Depending on the specificity of the method used

Refer to EU

Quantitation

Contents of active ingredients, relevant impurity and significant impurity and mass balance (98-102%)

Others

Relevant impurities

Insoluble matters

Relevant impurities

Solvent/raw materials

 

 

In addition to support component/product identification, the physic-chemical properties can help to determine the possible changes in production process and whether additional tests/assessment are required, the utilization of an appropriate container and signal words as well as other measures for first-aid and agricultural practice(re-entry interval). As shown in below table, the EU has comparatively fewer requirements on TGAIs while the US has the most complicated requirements on stability study. For formulated products.

 

physic-chemical property

China

EU

US

TGAI

Appearance

 

 

 

Melting/boiling point

Both pure AI and TGAI

Only required for pure ai (below 360℃) or decomposition/ sublimation temperature

Melting point will be required for solid sample and boiling point for liquid sample

Vapor pressure

/

At 20-25℃(normal substance);

If the VP is less than 10-5Pa 20-25℃, an extrapolated data after testing at a higher temperature will be acceptable;

Henry's constant will also be required

With no need for salt compound

Dissociation constant

 

Performed at 20 ℃ and the structure of the dissociated substances should be provided;

For salt compound, pKa will be required for function group

Only required for substance containing acidic/ alkali or alcohol groups

Partition coefficient

 

Tested at 20-25℃. For substance with pKa between 2 and 12, the impact of different pH values to the coefficient should be additionally tested.

Only required for nonpolar organic substance

Spectrum

 

 

 

Solubility

In organic solvents(polar, nonpolar and aromatic)

Water: in a neutral condition. For substance with  pKa between 2 and 12, the solubility in acidic(pH 4 to 5) and alkali(pH 9 to 10) conditions should be provided;

Organic solvent: for substance with solubility below 250g/L at 15-25 ℃, the applicant should provide the solubility in aliphatic hydrocarbons, aromatic hydrocarbons, halohydrocarbon, alcohols, ketones and esters.

With no need for organic solvents

Hydrolysis/photolysis in water

 

 

 

Surface tension

 

 

 

pH and acidity

/

For liquid formulation, test the substance directly.

For non-liquid formulation, the pH value of a 1% solution.

For substances with pH value greater than 10 or less than 4, the acidity will be additionally required.

Only pH value will suffice

Density

 

 

 

Stability

 

 

 

Corrosiveness

 

 

 

viscosity

 

2 shear rates obtained at 20 ℃ and 40℃.

 

 

To predict and prevent possible explosion and combustion during the transportation, storage and handling of pesticide, the 3 economies have explicit requirements on hazard identification for both TGAI and formulated pesticides, but the EU and the US have offered considerable flexibility.  

Hazard

China

EU

US

oxidizability

 

Deducible from structure theory following the CLP rules

Only required for substance with oxidizing or reducible group

combustibility

 

Only required for flammable liquid

explosibility

 

Only required for possible explosive substance

 

Technical indicators are a series of specific requirements relevant to pesticide formulation type. Only the US has not yet required the testing of these indicators. China and the EU have established the requirements similar to the FAO specification. China developed the agricultural standard “NY 2989-2016: Guidelines on Developing the specifications of pesticide for registration” and multiple standards for each formulation type and the applicant only needs to complete the tests of indicators already established. In EU the tests are more conducted on a case-by-case basis and FAO specification is the most frequently referred guideline.

 

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