Overview
Fermentalg developed a novel natural colorant requiring authorization for the European market. As its first food additive dossier, the company needed support selecting the appropriate regulatory pathway, preparing the submission, and navigating a complex review process. Building on a partnership of more than a decade, Fermentalg relied on FoodChain ID’s regulatory expertise to support market access and approval in Europe.
Challenge
Fermentalg developed a new natural colorant that required authorization before it could be commercialized in Europe. As the ingredients were derived from species not previously used in the human food,the company needed support to determine the appropriate regulatory pathway and manage interactions with EFSA throughout the review process.
Solution
FoodChain ID provided strategic regulatory support, including regulatory pathway assessment, dossier review, scientific guidance, interpretation of regulatory requests, and support throughout the European Commission and EFSA review process.
Results
• Advanced a first food additive authorization dossier
• Successfully navigated four rounds of regulatory questions
• Reduced unnecessary testing and associated costs
• Saved valuable internal time and resources
• Supported European market access and global commercial opportunities
Customer View
“The guidance we’ve had has meant that our responses have been on point and relevant every time. The greatest testimonial is that we continue to use FoodChain ID for any new activity over multiple dossiers.”
Hywel Griffiths
Chief Scientist, Fermentalg
About Fermentalg
Fermentalg is a biotechnology company specializing in the development and production of sustainable ingredients derived from microalgae for nutrition, health, and food applications.
