Lessons for startups: Navigating regulations to deliver food innovation in the EU and USA Christiaan Kalk is the founder of LSBI | life science-based innovations, a company that provides scientific and regulatory support for product innovation. Serving startup companies, established multinational firms as well as investors, LSBI supports businesses in developing healthier and more sustainable products. Global food innovation is developing at a tremendous pace. Novel products boosting consumers’ health and offering more sustainable alternatives are on the rise. However, in order to succeed, new product developers must deal with complex and costly food regulations, such as the EU novel food regulation and US GRAS. What do these mean for startups?
EU Novel Food Regulation vs US GRAS “The EU novel food regulation requires pre-market approval by governmental authorities; US GRAS does not. If a food or ingredient is not very common, its status being ‘Generally Recognised As Safe’ can be affirmed by an independent panel of recognised experts. Prior to evaluation by the panel, the pivotal studies used in risk assessment must be published in a peer-reviewed scientific journal. If the panel concludes the product is GRAS, the manufacturer may or may not consult FDA. If the administration agrees, they publish a letter stating they have ‘no further questions.’ If FDA is not consulted, we speak of a ‘self-affirmed GRAS’.” “From submission of a full application to publication in the Union List of novel foods, it takes about two years. In theory, it could be a bit quicker. In practice, interactions often take more time. The Commission’s DG SANTE and the PAFF Committee on Novel Food and Toxicological Safety in which the Member States are represented, are involved, as well as EFSA and its NDA Panel.” “Obtaining US GRAS status can be much quicker. If the data is there and the pivotal studies are published, it can be done within a few months. Consulting FDA takes a few more months. If there are no questions, the procedure can be completed within a year.” “Preparing well for a novel food registration and US GRAS affirmation pays off. Despite the regulatory differences, the data required for risk assessment is rather comparable; with the EU being a bit more demanding. If the planning is right, if decisions are taken quickly and the outcome of analyses and studies is favourable, data generation for risk assessment and dossier preparation can be done within 12 to 15 months.”
Disruptive Innovation: Reshaping the food systems of tomorrow | 19
