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 | | NOVEL FOODS PROPOSAL ABOLISHES MAJORITY EXCLUSIVITY RIGHTS | | | EAS | | 21/01/2008 | | | The proposal to revise the European Union Novel Foods Regulation will allow all food companies to market approved novel foods in most cases, it has been revealed.
Pieter Lagae, Regulatory Adviser at Brussels food and nutrition policy consultancy EAS, said that while the current procedure links authorised use of a novel food to the specific applicant, the revision will allow for more general use of approved novel foods.
“At the moment only the applicant can benefit from the approval and others should 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 would be able to market approved novel foods.”
Mr Lagae added however, that while the proposal is for the majority of authorisations 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.”
Mr Lagae also highlighted that the draft explicitly states ingredients used only in food supplements before May 1997 will be regarded as novel foods if these are intended to be used in other food applications.
“Ingredients considered to be safe for use in food supplements would still need to undergo a risk assessment,” he said.
A novel food is a food or food ingredient that has not been used for human consumption to a significant degree in the European Union before 15 May 1997. The proposal to revise the Regulation was published on January 14. | |
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