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Vivici Attains Self-Affirmed GRAS Status, Paving the Way for Animal-Free Whey Protein in the US Market.

Vivici, a Dutch precision fermentation startup and a joint venture between DSM-Firmenich Venturing and Fonterra, has achieved a significant milestone by obtaining self-affirmed Generally Recognized as Safe (GRAS) certification for its animal-free beta-lactoglobulin in the United States. This makes Vivici the first European startup to secure such certification for precision-fermented dairy proteins, positioning itself as a pioneer in the emerging market.

The self-affirmed GRAS status enables Vivici to commercialize its whey protein for its business-to-business (B2B) customers, making it the sixth producer authorized to sell animal-free dairy proteins in the US. While Vivici is in the process of submitting a dossier to the FDA, it has plans to seek approval in the European Union and Singapore in the coming months.

Vivici CEO Stephan van Sint Fiet told Green Queen that the company’s plans for 2024 are twofold: being a “partner of choice” to customers by supporting them with product development and a stable supply of its sustainable protein, and raising funds via a Series A round to “make precision fermentation a commercial reality” (it closed a seed round for an undisclosed sum in August).

Vivici’s journey began in 2022 as a collaborative effort between DSM-Firmenich Venturing and Fonterra, utilizing their extensive experience, knowledge, and intellectual property to accelerate the commercialization of fermentation-derived dairy ingredients. The startup is set to launch its first whey protein, with beta-lactoglobulin constituting approximately 65% of all whey proteins in dairy.

Beta-lactoglobulin is known for its properties such as gelling, foaming, and emulsification, enhancing mouthfeel and texture in various food and drink applications. Vivici’s beta-lactoglobulin boasts essential amino acids required by the human body, with rapid absorption in the blood plasma. Notably, it has 16% leucine and 29% branched-chain amino acids (BCAAs), crucial for muscle growth and recovery.

CTO Marcel Wubbolts emphasized the nutritional superiority of Vivici’s beta-lactoglobulin isolate compared to plant protein isolates and even traditional whey protein isolates in specific applications. The protein, clear in color and neutral in flavor, maintains taste, performance, and nutrition integrity, making it suitable for applications like ready-to-mix protein powders, ready-to-drink protein beverages, and protein bars.

Van Sint Fiet highlighted that Vivici’s whey protein from fermentation adds value to a wide range of products, catering to diverse consumers, including those following a vegan diet. The startup is working towards obtaining vegan certification, acknowledging the growing interest in plant-based and sustainable alternatives.

As a B2B operator, Vivici is collaborating with partners in Europe and the US for commercial manufacturing. While it will not bring its own consumer products to market, the company has ongoing development projects with other businesses, ensuring the debut of products containing its beta-lactoglobulin later this year. A partnership with Gingko Bioworks in October further expanded Vivici’s range of dairy proteins, with plans to introduce a second whey protein to the market in late 2025.

Vivici’s self-affirmed GRAS certification aligns with the industry trend of companies independently assessing the safety of their products. This approach, while faster and more cost-effective, requires businesses to conduct safety approvals through scientific panels without full FDA review. Despite this, Vivici remains committed to transparency, expecting a ‘no questions’ letter from the FDA within the year.

The accomplishment comes in the wake of growing interest and investment in precision-fermented dairy proteins, signaling a transformative shift in the dairy industry towards sustainable and eco-friendly practices. Vivici’s success underscores the industry’s commitment to providing innovative and ethically sourced protein alternatives that meet the demands of a rapidly evolving market.

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