Novel foods are regulated under Regulation 2015/2283 which repeals and replaces Regulation 258/97 and Regulation 1852/2001. The latter were in force until 31 December 2017.

The current regulation stipulates that foods 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 must provide such proof in their application.

The new regulation established the Union list of novel foods compiling all the authorized novel foods in the European Union up to date.

However, it must not be mistaken with the EU Novel Food Catalogue which solely 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. Note that for botanical extracts, the novel food status is particularly complex. This is because in some cases the novel status of an extract only coincides with a specific part of the plant.

Food Compliance Int. has extensive expertise in the field of novel foods. We advise our clients on the novel food status of ingredients and we prepare application dossiers for full authorizations and substantial equivalence authorizations

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