Consumers’ food choices tend to vary in time and, especially in recent years, new types of foods have arrived on our tables. Possible causes can be identified in the growing ethnic variety and in an increased globalisation. This trend imposes, at regulatory level, the presence of a clear-cut, well-defined regulation allowing the marketing of food products that are safe for consumers.
The concept of “novel food” is not a novelty at all. During history, in fact, new types of foods, ingredients or food manufacturing processes have appeared all over Europe from various regions of the world.
The first European norm on novel foods goes back to Regulation (EC) 258/97 of the European Parliament and of the Council; however, the European Union has considered necessary to update this regulation in order to ensure high standards in terms of safety as well as of quality, to simplify authorisation procedures and to eliminate genetically modified organisms (GMOs) from the field of application of the norms on novel foods, one of the main class of foods that during the ’90 urged to device a community unique system to specifically assess food risks. So, the new reference is Regulation (EU) 2015/2283 on novel foods, that became effective on 1st January 2018, repealing the previous Regulation (EC) 258/97.
Definition of New Foods
The definition of novel food is rather wide and include different types of food products. According to EU legislation, in fact, any food that was consumed “to a significant degree” before 15 May 1997 (the date when the first Regulation became effective) should be considered as a novel food. The category include novel foods, foods from new sources, new substances used in food products as well as new processes and technologies for food production. “Traditional foods” are a subset of novel foods: the term refers to foods traditionally consumed outside the European Union.
Some examples of novel foods? We can mention the oils rich in fat omega-3 acids derived from krill as new food source, vegetal sterols as new substances, or the nanotechnologies as new food manufacturing processes; however, some edible insects also fall into the category of novel foods. Now that we have defined and understood what is a novel food, let’s take a look at the appropriate procedure for their marketing.
How to market Novel Food
Regulation (EU) 2015/2283 has defined a new procedure for the authorisation application, now taking place at centralised level. The request should in fact be submitted directly to the European Commission rather than to one of the Member States, as it happened according to the previous regulation. The authorisation application, to be prepared following the EFSA (European Food Safety Authority) guidelines, shall include all scientific data supporting the safety of the novel food to be authorised.
Following a positive assessment of the new ingredient by EFSA, the Commission releases the authorisation by including the authorised novel food in the Union list, a list of novel foods reporting all new authorised ingredients along with all the specifications provided for, including the type of food where it can be contained, its dose and other features.
In case of food with no consumption in the EU, but already marketed outside the EU, the Regulation is still followed, but with a different procedure. In case of “traditional foods from third countries”, i.e. foods deriving from primary production with a safe and confirmed history of consumption in an extra-EU country, the new regulation provides for a simplified procedure for its marketing in the EU.
The relevant EFSA guidelines should be considered for the preparation of the application, and this should be submitted to the European Commission, complete with use safety data of the product in the country of origin. Flavours, additives and extraction solvents are excluded from the regulation as they are already regulated by dedicated norms.
Before submitting the authorisation application for a novel food, Food Business Operators (FBO) can also verify whether the food they intend to market in the European Union is a novel food, by submitting a request to one of the Member States. This is a new procedure introduced by Regulation 2015/2283 providing for a procedure dedicated to the determination of novel food status. The procedural steps and the relevant details are defined in Regulation (EU) 2018/456.
A Food Business Operator wishing to apply for the authorisation of a novel food in 2021 can therefore count on the availability of all regulating tools for the submission of the application. However, the preparation of the application and its supporting documentation is no easy task, and requires the support of technical experts in the field.
Writter by: Federica Montozzi