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Moolec Science achieves USDA-APHIS 'Regulatory Status Review' clearance for molecular farming product

April 5, 2023

Moolec Science, a molecular faming food-ingredient company, has today announced that the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture (USDA) has concluded that Moolec's GLA safflower plants pose no greater plant pest risk than non-genetically engineered safflower plants according to regulation found at 7 CFR part 340. To access the Regulatory Status Review (RSR) response from USDA-APHIS, click here.

Moolec is a science-based food ingredient company focused on producing animal proteins in plants through molecular farming, a disruptive technology in the alternative proteins landscape. Its purpose is to upgrade taste, nutrition, and affordability of alternative protein products while building a more sustainable and equitable food system. Moolec's technological approach aims to have the cost structure of plant-based solutions with the organoleptic properties and functionality of animal-based ones. Its technology has been under development for more than a decade and is known for pioneering the production of a bovine protein in a crop for the food industry. The company's product portfolio and pipeline leverage the agronomic efficiency of broadly used target crops, like safflower, soybean, and pea.

"This important milestone reinforces our go-to-market path and validates our proposed regulatory strategy," enthused Gastón Paladini, Moolec's CEO & Co-founder. "Also, it complements the FDA's food safety reviews and approvals already obtained for our GLA safflower oil (GLASO). The green light from USDA-APHIS bolsters the idea of the safe use of molecular farming technology to improve nutritional profile for end food products. Moolec is very excited that its innovative food ingredients are a key part of the bioeconomy."

"This will greatly increase the efficiency of our operations, including raw material procurement, downstream crushing, and processing," added Martin Salinas, Chief of Technology & Co-founder of Moolec. "We will no longer need USDA-APHIS permits to import, move interstate or grow these plants in the field in the USA. We are positive that this achievement paves the way for our upcoming regulatory reviews in our pipeline."

According to USDA-APHIS regulation found at 7 CFR part 340, developers may submit a request for a RSR when they believe a genetically engineered (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.

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