The regulatory hurdles that exist to bring a functional food to market often prove the greatest challenge for the food industry. Different regulatory approaches exist worldwide, with the European Union having one of the tightest regimes of all. EU Regulation 1924/2006 sets out the framework for nutrition and health claims, and the system has been slow at approving claims. In recent years, the European Food Safety Authority has published Guidance Notes to aid industry with the applica-tion process. However, among other things, the fact that not one probiotic has received approval has left the food industry critical of the system. It is likely that an approval pattern will emerge in the future, and once the pathway to approval identified, the industry will emerge stronger and with more integrity than before. [ABSTRACT FROM AUTHOR]