China MoARA Proposes Separate Data Requirements for Herbicides Used on Herbicide-tolerant Crops

China MoARA Proposes Separate Data Requirements for Herbicides Used on Herbicide-tolerant CropsOn November 26, 2021, China MoARA opened a public consultation regarding the registration of herbicide used on herbicide-tolerant soybean and maize, aimed to regulate the regulatory study and registration of herbicide used on herbicide-tolerant crops: “Data Requirements for the Registration of Herbicides Used in Herbicide-tolerant Crops”,“Guideline on Field Efficacy Trial of Herbicides Used in Herbicide-tolerant Maize”,and “Guideline on Field Efficacy Trial of Herbicides Used in Herbicide-tolerant Soybean.

These herbicides should be only registered on crop GM crops obtaining the safety certificate of agricultural GMO (commercial production) issued from MoARA and the proposed crop will be deemed as a new crop category and the applicant shall indicate transformant(s) contained in the target crop and perform field trails in limited planting zones.

Compare to conventional herbicides, a GM crop-use herbicide needs to submit more information on resistance risk assessment, especially Glyphosate and Glufosinate, including sensitivity baseline test, cross-resistance, level of risk and acceptability, mitigation measure and method for resistance monitoring. If a new main metabolite was found in the GM crop, the applicant shall perform an additional animal metabolism test.
Furthermore, the product label shall explicitly display that the product can only be used for GM crops containing the transformant(s) and shall not be used on other crops, as well as the detailed application method and measures on how to isolate the GM crop from other crops.

Reference Link

MoARA's Conslutation Notice(in Chinese)

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