Novel foods and ingredients are regulated under Regulation 258/97. It stipulates that foods and food ingredients belonging to certain categories which have not been used for human consumption to a significant degree within the EU before May 15, 1997 require an authorization before they can be placed on the market.
The responsibility to prove that a food has been consumed to a significant degree before May 15, 1997 lies with the food business operator. Thus, food business operators may be asked by enforcement authorities to provide such proof.
The EU Novel Food Catalogue gives an overview of the currently obtained information regarding history of use and lists mostly botanicals. The list has however no normative status and can therefore only be relied on as an informative instrument.
For botanical extracts, the novel food status is particularly complex. This is because there is no consensus among the Member States to which extent the novel food status of an extract coincides with that of the plant.
Novel foods and novel food ingredients require an authorization. This authorization can be granted solely by virtue of a positive assessment by a Member State, or may involve an assessment by EFSA. Application dossiers should contain extensive safety information about the food or ingredient.
Authorizations are currently only valid for the applicant The draft for a new novel foods Regulation, which is currently in the process of being adopted, foresees a generic system, in which authorized novel foods may be used by any food business operator, provided that the conditions are met, unless the applicant requests protection of proprietary data, which gives him an exclusive right to use the food or ingredient.
Already authorized novel foods and novel food ingredients may be placed on the market by others than the applicant, if it can be established that the food or ingredient is substantially equivalent to the food or ingredient for which an authorization has been issued. The application is done by submitting a dossier proving substantial equivalence to one of the EU Member States. The food may be marketed after a positive assessment by a Member State and a notification before the European Commission.