Fermentation

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.

 

To book a free consultation: