On 10 Nov 2017, China ICAMA opened a 30-day consultation on the “Guideline on Pesticide Residue Trials on Crop”. As a vital component of pesticide management, residue trial provides scientific justification for MRL development and good agricultural practice for pesticide application, which is of great significance in ensuring food safety.
In 2004, the residue trial guideline was initially released in the form of NY/T2004. It specified the nomenclature, definition and the general requirement for the experiment design, performance of study, sampling, sample storage, residue analysis, recording and report of study. China refined the trial site distribution/selection requirements in 2016 and promulgated a new pesticide regulation in 2017. In the new “Data requirement for pesticide registration”, the duration for residue study has been reduced from 2 years to one year but minimum number of sites almost doubled, varying from different crop/commodity group. ICAMA consolidates these new requirements and technical adjustment in this updates.
Exemption on Environmental Sample-Tests on environmental samples (soil and water) will no longer be required and only edible/feeding parts of treated crop will be tested;
Test Dosage-In the 2004 version, both the maximum recommended application rate and its 1.5-2 doses were required for final residue study. If the pesticide was applied after the formation of edible part, a residue dissipation study will be additionally required and the 1.5-2 doses are utilized for dissipation test. The draft requires only the maximum recommended application rate for final residue study and dissipation study. The soil and paddy field dissipation study will no longer be required;
Site Selection and Plot Size-The number and regional distribution of trial sites should comply with the Annex IX of the Data Requirement for Pesticide Registration and the “Interim Guideline on Crop/Area Distribution for the Residue Study of Pesticide Registration”. The minimal plot sizes for are also elevated:
Plot Size | 2004 version | Draft |
Food crops | No less than 30 square meters | No less than 100 square meters |
leafy vegetables | No less than 15 square meters | No less than 50 square meters |
Fruit trees | No less than 2 plants | No less than 4 plants |
Grape(individually planted ) | / | No less than 8 plants |
Grape(Greenhouse ) | / | No less than 50 square meters |
Sampling-The number of Independent samples from each plot has been increased from 1 to 2 per plot and freezing treatment will be mandatorily required after sampling and during transportation
Residue Determination-The draft emphasized that utilized test method should be capable of quantifying all compound/metabolites/ degraded products identified during metabolite study or defined during dietary risk assessment, as well as distinguishing their isomeric or analogous compounds and method validation report will be particularly required in the final report.
Informative Annexes-Crops are regrouped in Annex A. Crop sampling part, number and quantity of sampling are also revised. A template of method validation report is newly provided in Annex C.
