Luxembourg-based molecular farming company Moolec has announced that the US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has concluded its Regulatory Status Review (RSR) for Moolec's genetically engineered soybean, Piggy Sooy.

The USDA-APHIS RSR has determined that Moolec's soybean, genetically engineered to produce animal meat protein, is unlikely to pose an increased plant pest risk relative to non-engineered soybeans. Therefore, it is not subject to the APHIS regulation that governs the movement of organisms modified or produced through genetic engineering.

Gastón Paladini, Moolec Science's CEO and co-founder, said: “We achieved an unprecedented milestone in biotechnology with the first-ever USDA-APHIS approval of this kind. We are unlocking the power of plants by leveraging science to overcome climate change and global food security concerns. I am very proud of the Moolec team, creating value for shareholders and the planet at the same time."

This milestone reinforces Moolec's B2B go-to-market strategy for its Piggy Sooy product, a functional and nutritious ingredient. By adding animal meat protein – porcine myoglobin – to the standard soybean proteins, the company expects to provide food manufacturers with a unique ingredient with positive eco-credentials.

Martin Salinas, chief of technology and co-founder at Moolec, added: "We believe this milestone sets the stage for a revolution in the food-industrial biotech landscape, paving the way for expedited adoption of molecular farming technology by other industry players. Also, this compelling advancement signifies a stride in enhancing our operational efficiency, transforming our methods of raw material sourcing and optimising our downstream crushing and processing operations."

In June last year, the company announced that Piggy Sooy seeds had achieved high levels of expression of pork protein – up to 26.6% of the total soluble protein – and had patented its technology.

The company clarifies that Piggy Sooy development is set to keep moving forward completing the necessary consultation with the US Food and Drug Administration (FDA). Moolec said it is engaged in the consultation process with the FDA, representing the next pivotal regulatory milestone preceding the commercial availability of Piggy Sooy ingredient.

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