How to Apply the Novel Foods Regulation

Abstract

The European Union (EU) Novel Foods Regulation 258/97 was adopted in 1997 and is applicable still today until the revision currently undertaken will be adopted. Over time the scope and application of this legislation have evolved. This report gives a detailed insight into the way this legislation has been implemented and applied in practice. It provides background and guidance for a number of issues companies are likely to encounter when they intend to submit an application. It covers the scope of the law and helps to clarify when a food or food ingredient would be covered and when not, and which elements should be considered when collecting evidence for the non-novel status (Chapter 1). It guides the reader through the process of how to submit an application in either of the two procedures for authorization (Chapter 2) and provides guidance on the scientific elements that need to be considered when compiling a novel food application (Chapter 3). The report also addresses the revision of the law currently being undertaken, and highlights the main changes that are expected and the consequences that will arise from these modifications for current and future submissions (Chapter 4). Finally, the report provides answers to some of the most frequently asked questions relating to novel food applications (Chapter 5). The report has been on sale from 2009-2012. It has now been made available for general reference.