Based on the comprehensive data package submitted and scientific exchanges conducted throughout the evaluation process, the Fermentalg received from EFSA a “no safety concern” for its use in food applications.
This opinion represents a decisive milestone toward formal authorisation by the European Commission in the coming months.
Galdieria Blue is the first naturally derived blue colorant combining high stability with acid resistance — a breakthrough innovation that enables performance in applications historically reserved for synthetic dyes.
Produced through precision fermentation, it offers a 100% natural, traceable and petroleum-free alternative designed for clean label reformulation at global scale.
A rigorous scientific evaluation securing commercialisation
Following a strict, science-driven assessment process, EFSA’s positive conclusion validates the robustness of Fermentalg’s R&D, regulatory strategy and pilot platform — from strain selection and process optimisation to advanced analytical characterisation and scale-up.
Hywel Griffith, Scientific Director at Fermentalg, said: "The EFSA's positive conclusions perfectly illustrate Fermentalg's strengths and the quality of our R&D and regulatory teams who have contributed fully to the completion of this project. From strain selection to process development and production, and thanks in particular to the cutting-edge expertise of our analytical team, each step has provided the data needed to prove the efficacy and safety of this product."
The expected European authorisation would complement the approval granted in May 2025 by the Food and Drug Administration (FDA), enabling commercialisation in the United States as a bio-based alternative to synthetic Blue Brilliant #1. Together, these regulatory milestones provide food and beverage manufacturers with a clear pathway for global product roll-out.
Industrial production has already started at Huvepharma, Fermentalg’s industrial partner and main shareholder, ensuring supply readiness upon European approval.
Accelerating global deployment through strategic partnership with Givaudan
Commercialization of Galdieria Blue is conducted in partnership with Givaudan, which markets the ingredient under the EverzureTM brand. This alliance combines Fermentalg’s proprietary microalgae fermentation platform and European production capabilities with
Givaudan’s global commercial reach, formulation expertise, and strong relationships with leading food and beverage brands.
The unique acid stability of Galdieria Blue removes one of the most persistent technical barriers in natural coloration. It enables vibrant and stable blue, purple and green shades in acidic beverages, confectionery, fruit preparations and other demanding matrices — unlocking previously untapped market segments where synthetic dyes have long dominated.
For manufacturers, this translates into:
• A breakthrough natural blue compatible with low-pH applications
• Dual US and forthcoming EU regulatory alignment to support global launches
• Secure, scalable European production
• End-to-end commercial and application support from a world-leading ingredient partner
Europe represents nearly one-third of the global natural food colorants market, where natural blue solutions are projected to grow strongly while compliant, stable alternatives remain scarce. In the context of increasing regulatory scrutiny of synthetic dyes, Galdieria Blue is positioned as a strategic enabler for brands accelerating the transition toward sustainable, clean-label portfolios.
This anticipated European milestone, combined with US commercialisation and industrial readiness, demonstrates Fermentalg’s ability to transform advanced biotech innovation into globally commercialised BioSolutions — delivering tangible competitive advantage to its partners and opening new growth opportunities in food, nutrition and beyond.