Novel Foods proposal abolishes majority exclusivity rights

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.

For more information about the European Commission’s proposal to revise the Novel Foods Regulation download the full podcast interview with Pieter Lagae at


EAS provides strategic consulting advice on European, Asian and international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe and Asia. EAS also advises governments, trade associations and companies on the impact of European, Asian and global policy.

EAS has offices in Brussels, Italy and Singapore. EAS-Italy is a branch of EAS located in northern Italy to follow EFSA developments in Parma closely.

For more information on EAS Europe contact EAS, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0) 2 218 14 70, email [email protected] or visit For information on EAS Asia contact EAS Strategic Advice Pte Ltd, 3 Killiney Road, 07-04 Winsland House I, Singapore 239519, tel: (+65) 68 38 12 70, email: [email protected] or visit

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