Traditional Food Assessments
Last updated: 27 August 2020
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What is a Traditional Food?
A traditional food from third countries is a type of Novel Food defined by Regulation (EU) 2015/2283. It can be described as food that would be new to the EU but has a safe history of consumption within its country of origin. Under the regulation, there is a more streamlined process for getting these types of food into the EU market, providing they can be shown to be safe.
Regulation (EU) 2015/2283 introduces a special procedure for safety assessment for traditional foods from third countries, based on a history of safe food use. In this case, a notification for the placing on the market of a traditional food from a third country is sent to the Commission who forward it to all the Member States and the European Food Safety Authority (EFSA). A Member State or EFSA may submit duly reasoned safety objections on the placing on the market of the notified food. In this latter case, the applicant may transform the notification into an application, for which a safety evaluation will be requested from EFSA. In assessing the safety of these types of novel foods, EFSA shall, where appropriate, consider the following:
- whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant;
- whether the composition of the food and the conditions of its use do not pose a safety risk to human health in the Union;
- where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
The Current Application Process
Before a traditional food can be marketed in the EU, it must be subjected to a pre-market safety assessment before a decision is made on EU-wide authorisation. The aim of the assessment is to make sure the food is safe for the consumer. The process is shorter than that of a novel food being based on a history of safe use. During this:
- The Applicant must prepare a dossier on the traditional food from third country (know as a notification), providing the information needed so the European Food Standards Agency (EFSA), European Commission and all member states, including the U.K., can carry out a safety assessment. Please follow guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283.
- The applicant must submit the dossier/notification to the European Commission (EC). Submission occurs via the e-submission system for Novel Foods. Please follow the e-submission system for Novel Foods User Guide.
- The European Commission must verify the validity of the notification within 30 days.
- The notification is subject to assessment by the European Food Safety Authority, the European Commission and All member states over a four month period, giving all participants a chance to raise objections to the application.
- An opinion on the novel food is formed if no further information is needed.
- If there are no objections the traditional food is added to the Union list of Novel foods, which means it can now be market in the EU.
- If Objections are raised the applicant can submit a traditional food application through the e-portal which address the safety issues concerned.
- This would be subject to a risk assessment by EFSA. This is completed in a six month time frame but can be extended if further information is needed.
- An Opinion is formed based on the evidence
- From a positive opinion the European Commission have three months to draft an implementing decision to add the traditional food to the Union List of Novel Foods.
Please note that this notification process will be changing as of January 2021 when the EU-Exit transition period ends. The above details reflect the current position of handling notifications.