In the EU, proteins, fats & milk derived by cell culture fall under category VI of the novel food regulation.
To sell cell-cultured meat, fat or milk, you will need to obtain pre-market authorisation as a novel food.
You will need to demonstrate the safety of all components of the manufacturing process from the cell line, the culture media, the scaffolding through to the final product.
We can help you to determine which studies you need to support the safety of your cell-cultured product. We can also help you to design the studies to ensure regulatory compliance & guide you through the whole regulatory process.
We can provide regulatory advice on the requirements for GM cell-lines & help you to avoid regulatory pitfalls.
To find out more or to book a free consultation: