In the EU, proteins derived by fermentation fall under category II of the novel food regulation.
To sell proteins derived from fermentation using bacteria, fungi &/or yeast, you will need to obtain pre-market authorisation as a novel food.
You will need to demonstrate the safety of the production strain & the final product.
We can help you to determine which studies you need to support the safety of the microorganism & the final product. We can also help you to design the studies to ensure regulatory compliance & guide you through the entire regulatory process.
We can also help you to understand the requirements for GM microorgansims.
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