09/11/2011: "How much science do you need? - Overview on current legal challenges in the marketing of functional foodstuffs"

Keynote speech at the “End-to-end CDM efficiency – from eCRF set-up to submission and archiving”, Workshop organised by the Xclinical GmbH, Munich (further information available at www.xclinical.com).

Any food business operator that wants to make health claims in relation to its product must be in the position to prove that the respective claims "are based on and substantiated by generally accepted data". But what does that mean in practice? The lecture will provide an overview on the current stringent requirements that have been established by the EU Health Claims Regulation on the use of health and nutrition claims, will show examples of positive and negative assessed health claims by the European Food Safety Authority and, finally, will give guidance on recommended study designs for new health claims applications