Crop Biotech Update

US FDA Favorably Concludes HB4® Wheat Food and Feed Safety Evaluation

June 29, 2022

Bioceres Crop Solutions has announced that the U.S. Food and Drug Administration (FDA) has concluded its evaluation of the company´s proprietary drought tolerant HB4® Wheat.

According to Bioceres, after reviewing all the safety and regulatory information submitted, the FDA has concluded that it has no further questions regarding the safety of HB4® Wheat and that it does not raise issues that would require premarket review or approval by FDA. This conclusion is a key step toward commercial enablement in the United States, which is awaiting approval from the U.S. Department of Agriculture (USDA).

The FDA's conclusion follows recent approvals for HB4® Wheat by Brazil, Colombia, Australia, and New Zealand for use in food and feed. HB4® Wheat is commercially authorized for production and consumption in Argentina, where five varieties have been cleared for registration in the current crop season. HB4® drought tolerance technology has been shown to increase wheat yields by an average of 20% in water-limited conditions.

For more details, read the news release from Bioceres.

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