Pre-market Authorisation

This chapter provides an overview of the market authorisation procedures in the EU. It outlines the essential steps involved in gaining authorisation to place food products on the EU market, specifically focusing on the authorisation processes governed by the Novel Food Regulation and the legal acts governing Genetically Modified Food and Feed. Both of these authorisation pathways impose rigorous regulatory requirements, which can present significant challenges for the growth of the precision fermentation sector, particularly for start-ups and small to medium-sized enterprises. While accurately categorising products can be a complex task, it is imperative for food business operators to gain a comprehensive understanding of the relevant legal framework early in the product development process, as the authorisation pathways differ in their standards.