Archive | 2019
Regulation of functional foods in European Union
Abstract
Abstract Within the European Union, a regulation on nutrition and health claims came into force in 2007. Under the regulation, health claims are subject to preapproval, involving scientific assessment by the European Food Safety Authority (EFSA). Although the EFSA assesses scientific dossiers supporting potential health claims, the final decision to accept or reject a claim lies with the European Commission. By definition, functional foods have additional health benefits and are likely to carry an approved nutrition or health claim. The water-soluble extract of tomato (later marketed as Fruitflow) became the first product in Europe to obtain an approved, proprietary health claim under Article 13(5) of European Health Claims Regulation 1924/2006 regarding nutrition and health claims made on foods. Potent antiplatelet factors were identified in Fruitflow that significantly inhibited platelet aggregation and lowered blood pressure. Several human volunteer studies demonstrated the potency and bioavailability of active compounds in Fruitflow. This chapter describes the development of Fruitflow and subsequent documentation processes that led to the approval of the health claim by the EFSA.