Moolec Science SA (NASDAQ:MLEC) ("the Company"), a leader in Molecular Farming technology, announced today that the U.S. Department of Agriculture's ("USDA") Animal and Plant Health Inspection Service ("APHIS") has completed its Regulatory Status Review ("RSR") for the Company's genetically engineered ("GE") peas which produce iron through bovine meat proteins. This is the third regulatory clearance from USDA-APHIS achieved by Moolec in an 18-month window, alongside its genetically engineered safflower and soybean for GLASO™ and Piggy Sooy™ products, respectively. Access the official USDA-APHIS publication here.
"With USDA approval for our GE pea, Moolec has now secured regulatory clearance for all of our key crops in the US: safflower, soybean, and pea," said Gastón Paladini, CEO and Co-Founder of Moolec. "We are proud to be the only Molecular Farming company with three US regulatory approvals and a major commercial contract. This milestone underscores our leadership in the landscape with tangible, science-backed results."
Moolec's genetically engineered peas produce high yields of bovine myoglobin, a protein that boosts iron content, making it an ideal alternative for consumers seeking plant-based sources of iron. This product has the potential to revolutionize both the food ingredient market and the $65 billion pea industry by offering a nutritious, iron-rich alternative to traditional meat products.
Amit Dhingra, Chief Science Officer for the Company, stated, "The USDA-APHIS Regulatory Status Review for pea marks a significant milestone for Moolec. As the first review for GE pea, it represents a historic development. It validates Moolec's strategic approach and exemplifies our commitment advancing sustainable food production through science and innovation. This approval is a critical step toward enhancing global food supply and meeting the growing demand for innovative, nutritious food solutions for the world."
This approval not only showcases Moolec's innovation in Molecular Farming but also highlights the company's commitment to meeting the highest regulatory and safety standards. Moolec has also developed an Identity Preservation Program to ensure sustainable farming practices, promote stewardship for its crops and product quality for partners, clients and consumers alike.
According to USDA-APHIS regulation found at 7 CFR part 340, developers may submit a request for a RSR when they believe a GE plant is not subject to the regulation. APHIS reviews the GE plant and considers whether it might pose an increased plant pest risk compared to its non-GE comparator. If APHIS does not identify a greater pest risk relative to the comparator, the GE plant is not subject to this regulation. Regulation 7 CFR part 340 governs the importation, interstate movement, and the environmental release of certain organisms that have been modified or produced by genetic engineering.
The USDA-APHIS review process is a critical component of ensuring that genetically engineered crops can be grown safely, and this approval opens the floor for expanded field trials, seed scaling, and eventual commercialization. With increasing interest in science-based ingredients, this approval positions the company to lead a new wave of innovation in the food and agriculture sectors.