Scientific research has identified potential health benefits of many food ingredients. These health-promoting (bioactive) food ingredients may be naturally present in a food, or may be added by manufacturers into foods that do not naturally contain such components. These bioactives have challenged traditional concepts of food fortification and consequently food regulations. Dairy foods and ingredients have significant potential as vehicles for the delivery of such bioactives and health-promoting physiological effects, if regulatory hurdles can be overcome. The regulatory landscape on the addition of bioactive ingredients (from dairy streams and non-dairy sources) into foods is rapidly evolving, and the industry will need to be aware of the potential regulatory challenges within the countries they wish to market their products.