remilk gains regulatory approval in Singapore, US FDA
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Remilk Racking Up Regulatory Approvals

Remilk Racking Up Regulatory Approvals

PR Newswire
Feb 23, 2023

Remilk Receives Regulatory Approval from SFA, Enabling Sales of its Animal-Free Protein in Singapore, and "No Questions Letter" from FDA, following the Highest Level of Scrutiny for the Safety of its Animal-Free Milk Protein

TEL AVIV, Israel, Feb. 23, 2023 /PRNewswire/ -- Remilk, a global leader in the development and production of animal-free dairy, announced today it has received both regulatory approval from the Singapore Food Authority (SFA) and a "no questions letter" from the FDA.

Singapore, a global leader in alternative protein development and investment, is also one of the world's leaders in adoption of alt-protein finished products. SFA's approval opens the Singapore market to Remilk, enabling the company to sell its proprietary animal-free milk protein in the country.

Another milestone has been reached by the company as it received FDA's "No Questions Letter". The letter indicates the FDA accepted an expert panel's unanimous conclusion that Remilk's animal-free whey protein can be safely used in food products under its GRAS (Generally Recognized as Safe) standards. In 2022, the company declared its Self-Affirmed GRAS status in compliance with the FDA's requirements, allowing it to begin sales of its protein in the US. The letter received serves as further acknowledgement of Remilk's animal-free whey protein's safety, and positions the company at the forefront of its industry.

Remilk's animal-free protein is identical to cow-derived whey protein but produced without a single animal cell via precision fermentation. Unlike plant-based dairy alternatives, these proteins are bio-equivalent to their traditional counterparts and enable the production of dairy that is indistinguishable in taste and function from traditional dairy but without lactose, cholesterol, and hormones, and with a fraction of the environmental impact.

"Both SFA's approval and the No Questions Letter we received from the FDA serve as further proof that our animal-free milk protein is bioidentical to its cow-derived counterpart and safe for consumption", said Aviv Wolff, Remilk's Co-Founder and CEO. "Humans have consumed milk proteins as a staple source of high-quality nutrition for millennia. Remilk's animal-free protein maintains these great benefits, enabling us to reinvent dairy that is kinder, and significantly more sustainable. We take pride in these regulatory approvals and look forward to a continued global focus on unlocking the future of food".

About Remilk

Remilk is a global leader in the development of animal-free dairy. The company was founded by CEO Aviv Wolff, an entrepreneur behind several business and social initiatives, and CTO Ori Cohavi, PhD in Biochemistry, who has worked in R&D at a variety of biotech firms. They founded Remilk driven by a shared dedication to reinvent the dairy industry, by removing cows from the milk-making process. Remilk produces dairy-identical milk proteins through precision fermentation and has developed a unique and patented approach to scalable manufacturing which requires a fraction of Earth's resources compared to traditional dairy, while dramatically increasing efficiency in production, and, for the first time in history, eliminates the need for dairy cows in industrial-scale dairy production without compromising on taste, functionality, or nutritional values. Remilk is real dairy, no cows.

Remilk Receives Regulatory Approval from SFA, Enabling Sales of its Animal-Free Protein in Singapore, and "No Questions Letter" from FDA, following the Highest Level of Scrutiny for the Safety of its Animal-Free Milk Protein

TEL AVIV, Israel, Feb. 23, 2023 /PRNewswire/ -- Remilk, a global leader in the development and production of animal-free dairy, announced today it has received both regulatory approval from the Singapore Food Authority (SFA) and a "no questions letter" from the FDA.

Singapore, a global leader in alternative protein development and investment, is also one of the world's leaders in adoption of alt-protein finished products. SFA's approval opens the Singapore market to Remilk, enabling the company to sell its proprietary animal-free milk protein in the country.

Another milestone has been reached by the company as it received FDA's "No Questions Letter". The letter indicates the FDA accepted an expert panel's unanimous conclusion that Remilk's animal-free whey protein can be safely used in food products under its GRAS (Generally Recognized as Safe) standards. In 2022, the company declared its Self-Affirmed GRAS status in compliance with the FDA's requirements, allowing it to begin sales of its protein in the US. The letter received serves as further acknowledgement of Remilk's animal-free whey protein's safety, and positions the company at the forefront of its industry.

Remilk's animal-free protein is identical to cow-derived whey protein but produced without a single animal cell via precision fermentation. Unlike plant-based dairy alternatives, these proteins are bio-equivalent to their traditional counterparts and enable the production of dairy that is indistinguishable in taste and function from traditional dairy but without lactose, cholesterol, and hormones, and with a fraction of the environmental impact.

"Both SFA's approval and the No Questions Letter we received from the FDA serve as further proof that our animal-free milk protein is bioidentical to its cow-derived counterpart and safe for consumption", said Aviv Wolff, Remilk's Co-Founder and CEO. "Humans have consumed milk proteins as a staple source of high-quality nutrition for millennia. Remilk's animal-free protein maintains these great benefits, enabling us to reinvent dairy that is kinder, and significantly more sustainable. We take pride in these regulatory approvals and look forward to a continued global focus on unlocking the future of food".

About Remilk

Remilk is a global leader in the development of animal-free dairy. The company was founded by CEO Aviv Wolff, an entrepreneur behind several business and social initiatives, and CTO Ori Cohavi, PhD in Biochemistry, who has worked in R&D at a variety of biotech firms. They founded Remilk driven by a shared dedication to reinvent the dairy industry, by removing cows from the milk-making process. Remilk produces dairy-identical milk proteins through precision fermentation and has developed a unique and patented approach to scalable manufacturing which requires a fraction of Earth's resources compared to traditional dairy, while dramatically increasing efficiency in production, and, for the first time in history, eliminates the need for dairy cows in industrial-scale dairy production without compromising on taste, functionality, or nutritional values. Remilk is real dairy, no cows.