Melt&Marble clears US path with GRAS status for fermented fat ingredient

Swedish biotechnology company Melt&Marble has secured self-affirmed GRAS (Generally Recognised as Safe) status for its precision fermentation-derived fat ingredient, MeltyMarble, opening the door for commercial sales in the USA.

Melt&Marble achieved self-affirmed GRAS status for its fermentation-derived fat ingredient MeltyMarble, enabling the company to begin commercial sales in the United States.

The ingredient is produced using engineered yeast and designed to replicate the melting behavior and mouthfeel of animal fats across multiple food applications.

The regulatory milestone followed a US$7.7 million Series A funding round that supported the company’s transition from development to commercial scale production.

The regulatory milestone marked a significant step for the Gothenburg-based company as it moved from technology development toward commercial launches in the food sector.

MeltyMarble is produced through precision microbial fermentation using engineered yeast that converts sugars into tailored lipids with specific functional properties. The ingredient has been designed to mimic the melting behavior, flavor delivery and mouthfeel associated with animal fats, allowing it to be used in products ranging from alternative meat and dairy to confectionery, bakery and snack formulations.

Melt&Marble previously referred to the ingredient as MeatyMarble, but the company later adopted the name MeltyMarble to reflect its broader applicability beyond meat alternatives.

According to the company, the ingredient has been developed as an alternative to fats derived from petrochemical sources, animals or certain plant oils that can present sustainability or supply chain challenges.

Anastasia Krivoruchko, Co-founder & CEO of Melt&Marble, said the GRAS determination represented a key step in the company’s commercial progress. “This milestone represents a significant step forward for Melt&Marble and underscores our progress across product development, regulatory readiness and scale-up. With self-GRAS achieved, we're well positioned to advance our food focussed pipeline and pursue a 'no questions' letter from the FDA for MeltyMarble, bringing us closer to delivering better and more sustainable fats to the market,” Krivoruchko said.

The company said the next regulatory objective would be to obtain a “no questions” letter from the US Food and Drug Administration, which would provide additional regulatory assurance for food manufacturers seeking to incorporate the ingredient into commercial products.

The GRAS milestone followed a Series A funding round announced in December 2025, when Melt&Marble secured €7.3 million (US$7.7 million) to scale production of its precision-fermented fats and prepare its first ingredients for commercial launch. The financing formed part of €10 million (US$10.6 million) raised over the past year, including support from the European Innovation Council.

The round was led by Swedish deeptech investor Industrifonden, with participation from the European Innovation Council Fund, Beiersdorf and Valio, alongside Chalmers Ventures and Catalyze Capital.

At the time, Krivoruchko said the investment marked a turning point as the company prepared to move from research and development into commercial operations.

“This investment marks a major milestone for Melt&Marble as we transition from R&D to commercialization,” Krivoruchko said. “With key scalability milestones already achieved and strategic partners onboard, we’re entering the market with the capabilities and confidence to deliver real impact. Our vision has always been to deliver more sustainable, high-performance ingredients, and this round brings us significantly closer to that goal.”

Melt&Marble’s technology platform draws on more than a decade of research and development focused on engineering lipid structures through microbial fermentation. The company has built an intellectual property portfolio covering fermentation processes and lipid design to support applications across multiple industries.

Its platform targets a global fats and lipids market valued at more than US$100 billion, spanning sectors including food, cosmetics and personal care. While the company has been preparing food-market entry in the USA, it has also been developing ingredients for beauty and personal care applications.

Strategic investors involved in the funding round highlighted the potential for precision-fermented fats to address challenges associated with conventional sources such as palm oil, coconut oil and animal fats.

With regulatory clearance now secured for MeltyMarble in the USA, Melt&Marble is moving closer to bringing its designer fat ingredients to commercial food manufacturers as it continues scaling production and pursuing additional regulatory approvals.