Health Claims on Micronutrients. Regulatory Framework, Scientific Evidence and Chances for Small and Medium-Sized Enterprises

      Аннотация: In order to protect the consumer against exaggerated or misleading health claims on foods and food supplements, to enable the consumer to make informed buying decisions, and to harmonise national regulations to facilitate the free flow of food products in the European Community, a regulatory framework has been created which requires that all health claims in the EU must be evaluated by the European Food Safety Authority (EFSA) and authorised by the European Commission. In this master's thesis, the regulatory framework and procedures for health claims in both the EU and the USA are compiled, described and compared. The required body of scientific evidence for successful application for authorisation of health claims is discussed regarding regulatory requirements, design of clinical trials, and appropriate study populations. It is fathomed why claims are approved or rejected in Europe based on previous Scientific Opinions of the EFSA. Finally, the accessibility and possible benefits of health claims for food (supplement) vendors, especially small and medium-sized enterprises, are examined. The relevance of the approved health claims for public health is also shortly discussed.

Ключевые слова: clinical trials, health claims, Regulatory Framework, food supplements, Scientific Evidence, human trials, approval, financial benefit