Dossier Tag

What is a novel food? 

Novel Food originates from plants, animals, microorganisms, cell cultures, and specific food categories (minerals, vitamins, etc.) not used or produced within the European Union before May 1997. Since Regulation 2015/2283 entered into force, a Novel Food can also come from a third country with a consolidated history of use of at least 25 years.

Examples of Novel Foods are spirulina, chia seeds, baobab fruit pulp, synthetic meat and, last but not least, insects.

 

How do you know if a food is a Novel Food? 

The Authority can help recognize Novel Food. Article 4 of the Novel Food Regulation (No 2015/2283) allows for a consultation process with the Member State (where the food wants to be introduced firstly on the market) that, in response, gives a public opinion on the food status. This way, the food operator will know whether its product needs a Novel Food application or can be directly put on the market.

 

How does Novel Food reach the market?  

Novel Food must be authorized first (a sort of pre-market approval). The food business operator submits a dossier to the European Commission that, with the assistance of EFSA (European Food Safety Authority), evaluates the safety and nutritional contribution of the Novel Food. Once it is approved, it can be introduced in the UE market. This is made public by implementing Regulation, which reports specifications, food category and corresponding maximum level use of the Novel Food, followed by updating the Union List of Novel Food.

 

It looks like a long process, doesn’t it?  

Yes, it does. Authorizing a Novel Food can take a minimum of 17 months up to some years. It comprises a first month of administrative check done by the Commission (Suitability check), followed by 9 months of scientific evaluation and 7 months to implement the Regulation. This time can be extended (stop–the–clock phase) if the applicant is asked to provide more information.

Since 2021, however, the Transparency Regulation has introduced the pre-submission phase. This phase takes place before the submission of the dossier and results in obtaining a pre-application ID that allows notification studies and informs the Authority about the future application.

 

The dossier seems a crucial part of this process. What’s its content?  

The dossier is divided into sections, each addressing specific aspects of the Novel Food. It starts with identifying novel food and describing the production process employed, proceeding with analytical data on representative batches and specifications. The central part provides information on the history of use and proposed uses of the Novel Food among the EU food categories. Most importantly, the content of the last sections includes data on kinetics, nutritional properties, and toxicological evaluation of the Novel Food. The Novel Food must be safe for consumption, of course!!

 

A lot of information! How can all data be provided?  

Literature review of components, new toxicological studies, and in-silico predictions. These are some of the strategies that can be followed to demonstrate and strengthen the safety of the Novel Food. A multidisciplinary approach implanting laboratory solutions and in-silico assessment predictions can strongly support the authorization application and lead the Novel Food to the EU market.

 

The key to success: a comprehensive dossier!   

A dossier complaint with the normative requirements and all the necessary information is fundamental for approving the Novel Food. It may save time for food companies during the authorization process.

Collecting all the data and building a solid dossier can be challenging for food companies. Chemsafe is here to help. Please send us an email to chemsafe@chemsafe-consulting.com. Our Business Unit Food will be glad to assist you!