Supporting bespoke human safety testing for a first-in-class red food dye

The recent U.S. Food and Drug Administration (FDA) ban on red dye No. 3 and announcement to phase out six petroleum-based food colorants by the end of 2026 has heightened focus on new alternatives in food coloring. Addressing this growing market need, a Danish pre-revenue startup company in the food additive sector has developed an innovative red food coloring. Produced using precision fermentation, this food improvement agent is the first vegan, heat-resistant and pH-stable red food dye, poised to enter a market saturated with dyes that are either synthetic or originate from traditional agricultural products or insects. 

Introducing this novel product to the market presents significant testing challenges, especially when it comes to the regulatory landscape for new food additives. To navigate these complex challenges, the biotech company needed a highly experienced laboratory partner with the capabilities and agility to advance the food improvement agent’s journey from discovery to regulatory submission.