The European Food Safety Agency (EFSA) has published its guidelines for guiding candidate companies seeking authorisation for marketing novel foods produced from biotechnology, on the EU market. These guidelines apply to products manufactured in the EU, as well as new imported foodstuffs that are considered traditional in the third countries from whence they come.
These documents were published on Thursday 10 November. They provide detailed explanations of the kind of information authorisation candidate companies have to provide in the dossier they submit, in order to help assess the level of risk and clarify the way in which this information has to be presented.
The candidate companies submitting a request for authorisation for a novel food in the EU therefore have to provide data describing the product, as well as data about the composition and nutritional, toxicological and allergen properties in the food, in addition to information about the production process, use and levels of use proposed.
Companies submitting an authorisation for novel foods considered traditional in third countries will therefore be subject to guidelines that are examined in a different dossier. These guidelines also require that those seeking authorisation submit proof demonstrating the safe historic use of the food in question in at least one country outside the EU and for a period of at least 25 years. The proof provided will be assessed by the EFSA and member state as part of parallel procedures.
These parameters were announced in February for facilitating implementation of the updated European regulation on novel foods adopted in November 2015. The latter replaces the obsolete “Novel Food” regulation dates back to1997 (see EUROPE 11494). (Original in French by Aminata Niang)