Experimenting with new foods when visiting a faraway country is an evergreen must that cannot be missed. It tells you about the local environment, climate ecosystem, and culture. It is a piece of history of that place. That’s not all! Globalization, however, can get your exotic meals meal seen in that travel magazine directly on your sofa.
How can these foods be marketed in the European Union?
First, it is essential to define these foods and see how they are regulated at the EU level.
Regulation No. 2015/2283 on Novel Food defines the so-called traditional Food from a third country as food consumed in an extra-EU country for at least 25 years, from a significant (many!) number of people. Hence, these foods have a well-established history of consumption in that country.
Before their marketization in the European market, the safety of traditional food from a third country needs to be evaluated and assessed by the European Food Safety Authority (EFSA). At this scope, the Regulation has introduced a smother safety assessment procedure, mainly based on the consumption data provided by the Applicant.
Is this procedure similar to the one for Novel Food?
Novel Food and traditional foods from third-country applications share the same submission process (e.g., submission of a dossier that undergoes suitability checks and assessment). Still, the data that must be provided within the dossiers varies.
The main difference is the ground upon which the safety of the food relies. For Novel Foods, toxicological data need to be newly generated to substantiate the safety of the new ingredient. Instead, traditional food from a third country is supposed to be safe as it is already largely consumed elsewhere. So, more are the consumption data submitted, and smother will be the authorization process.
Not for nothing, the novel food application is a procedure, while the traditional Food from third country application is a notification.
So, what is the content of the dossier?
The dossier content should be summarized as the following:
- Administrative information (name and address of the Applicant)
- Characterization (e.g., physic-chemical properties, impurities, 5-batch analysis, stability data) and detailed composition of the traditional Food (e.g., quali-quantitative information)
- Information on country/ies of origin of the traditional Food
- Documented data demonstrating the history of safe food use in a third country;
- A proposal for the conditions of intended use and for specific labelling requirements, which do not mislead the consumer, or a verifiable justification why those elements are not necessary.
How does the authorization procedure work?
The notification dossier has to be sent to the European Commission which forwards it to all the Member States and the EFSA (the Authority). Within 4 months of receiving the notification, a Member State or the EFSA may submit duly reasoned safety objections on the notified Food. If this is the case, the Applicant is requested to submit an application and generate new scientific evidence to support food safety.
If no objection is moved, the EC takes 1 month to authorize the traditional Food and update the novel food union list. The procedure scheme is represented below.
For more information, ask Chemsafe 😊
