The Regulation defines “other substance” as a substance other than a vitamin or mineral that has a nutritional or physiological effect.

The addition of substances other than vitamins or minerals is permitted provided that it is possible to demonstrate that the food or food ingredient has been consumed in food, to a significant degree, in the European Union prior to 15 May 1997. Otherwise, to use this food or food ingredient it is necessary to request authorisation to place the product on the market in accordance with Regulation (UE) 2015/2283, on novel food and novel food ingredients.

The food business operators are responsible for providing safe products which satisfy the applicable food law. With respect to novel foods, the food operator is also responsible for establishing, and if necessary, providing data to prove the consumption history of the product prior to 1997.

To establish whether a food product is considered as a novel food or novel food ingredient and enters under the scope of Regulation (UE) 2015/2283, requiring, where applicable, authorisation for its marketing, please see the following link: How is a novel food or a novel food ingredient marketed in Spain?