Abstract
The regulatory aspects relevant to functional dairy products are to a large extent similar to those of functional foods in general. Functional foods, with the exception of Japan, are not officially recognized in food law as a separate entity, and consequently regulations on the crucial aspects, safety and efficacy are mostly lacking. It can be assumed that the situation would change, and formal criteria for the authorization of functional food products both at national and international level would be established. Currently, Japan has the most coherent policy regarding the health claims that can be accepted. In the US and particularly in the EU the regulations on health claims are still under development. While the distinction between foods and drugs should be kept clear, a more relaxed policy towards enhanced function claims and reduction of disease risk claims would encourage the further development of functional foods. The specific questions on the probiotic dairy products and the safety evaluation of probiotic strains are connected to the development of regulations on the general use of micro-organisms in foods, whether conventional starters or probiotics.
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