11 Apr Is it Novel Food?
Today it is almost impossible to find someone who does not know, even roughly, what we refer to when we talk about Novel Foods. In the last years, there has been a boom in the discussion over the topic.
What has changed?
To better understand what is happening in the food industry, we need to start with what is considered a Novel Food and what is not. A new whole food (e.g. an apple), which has never been consumed in Europe and is imported from countries outside Europe, is a Novel Food. Insects, in the last years, have been an exceptional example of new whole foods.
However, this is a small part of what is considered Novel Food.
Under the umbrella of the definition of Novel Foods, there are food ingredients that are produced with new processes (innovation), that have a new compositional profile (e.g., new nutritional discoveries), or that come from a material never used before in the food industry (e.g., unique plant species).
If we think about the wideness of these three scenarios -there are many more- we can start to understand the high number of products that may fall into the definition of Novel food. Let’s think about new ingredients for Food supplements, for instance.
A few months ago, we talked about the difficulties the food sector has to face with the Novel Food Regulation; -and whether a food is a Novel food; today, we want to discuss the EU procedure to authorise a new food and which are the critical aspects.
Requirements for the technical dossier
To obtain authorisation for Novel Foods, an application – a technical dossier- must be presented to the European Commission (COM). The COM later passes on the dossier to the European Food Safety Authority (EFSA), which is in charge of scientifically assessing the new product. In order to do that, the submitted technical dossier must include all the necessary material (data, studies, specifications) and support the new product’s safety to allow a scientific evaluation by a competent Panel of the EFSA (European Food Safety Authority).
The technical dossier is composed roughly of 1) a part which describes the novel food, where the specifications are detailed; 2) a part describing the intended use (whole food, food ingredients, food supplement, dosages); 3) a part of scientific evidence (toxicological studies) to support the safety profile.
Integrating these three parts allows the Authority to issue a scientific opinion on the Novel Food. The COM, if the opinion concludes that there are grounds for considering the Novel Food safe in its use, authorise the Novel Food in the European Union, adding it to the Novel Food list.
Procedure and timing
The picture here shows the process the Novel Food must go through. Since 2021, however, with the introduction of the Transparency Regulation (EFSA talks about it here), we must consider a pre-submission phase before the submission of the dossier, which is done through the EFSA website. In this phase, each product is given a pre-application ID. The food business operator (or his representative) must notify studies and inform the Authority about the future application.
Chemsafe has been involved in Novel Food for four years and continues to do so in its Food Business Unit. Please do not hesitate to contact us at firstname.lastname@example.org for more information or to arrange a non-binding preliminary call.