03.01.08
European Advisory Services (EAS), Brussels, Belgium, has put together a proposal to revise the European Union Novel Foods Regulation. Pieter Lagae, a regulatory adviser to EAS, said while the current procedure links authorized use of a novel food to the specific applicant, the revision would allow for more general use of approved novel foods. “At the moment only the applicant can benefit from the approval as others must put forward a separate novel foods dossier before they can market similar products,” Mr. Lagae said. “The new proposal abolishes the current exclusivity right, so all food companies can market approved novel foods.” Mr. Lagae added, however, that while the proposal is for the majority of authorizations to be generic, there is still a provision for data protection for a limited period of time. He said, “Data protection could be granted only in justified cases for newly developed scientific evidence and/or proprietary data, with a five-year exclusivity period.”