UC EU Novel Food Application

What is Novel Food?

Regulation (EU) 2015/2283 defines Novel Food (NF) as any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, when the first Novel Food Regulation came into effect.

Novel Food includes newly developed revolutionary foods, those produced using new technologies or processes, and traditional foods from a third country*.

* Traditional foods from third countries refer to foods that have been consumed in at least one third country for at least 25 years as a part of the customary diet of a significant number of people.

Why apply for Novel Food?

Novel Food application primarily facilitates market access. To put in another way, companies seeking to place products containing NF on the European market must undergo the pre-market review process by applying for Novel Food.

Who can apply for Novel Food?

The applicant is defined as the Member State, the third country or the interested party who has submitted to the Commission an application in accordance with Regulation (EU)2015/2283.

Procedures for Novel Food application

NF is accepted and authorized by the European Commission (EC) and undergoes safety assessment by the European Food Safety Authority (EFSA). The specific application processes are as follows:

Stage A - Pre-dossier submission: The applicant is required to conduct pre-notification and may request submission advice from EFSA;

Stage B - Dossier submission: The applicant submits the application to EC online and waits for the applicability review results (typically available within 30 working days, excluding time for additional information submission);

Stage C - Safety assessment: If the NF passes the applicability review, the EC will formally accept the application and transfer it to EFSA for safety assessment (typically taking 9 months, excluding time for additional information submission); and

Stage D - Approval: If the NF passes the safety assessment, EFSA will release the scientific opinion. Based on EFSA’s opinion, the EC will then draft regulations and, after approval by the Standing Committee, enact the regulations, formally granting approval to the NF.

Materials required for Novel Food application

According to the Guidance on the preparation and presentation of an application for authorization of a novel food in the context of Regulation (EU) 2015/2283, the following materials are required:

Part A: Administrative data: Comprehensive table of contents of the dossier, applicant, and regulatory status outside the European Union

Part B: Characterization of the Novel Food, technical and scientific data

• Identity of the Novel Food;
• Description of the Novel Food;
• Production process;
• Specifications;
• History of use of the Novel Food and/or of its source;
• Proposed uses, use levels and anticipated intake;
• Absorption, distribution, metabolism and excretion (ADME);
• Nutritional information;
• Toxicological information;
• Allergenicity; and
• Concluding remarks

Part C: Annexes to the dossier

Our services

• EU Novel Food application feasibility analysis
• EU Novel Food application service
• Other customized compliance services

Our strength

The Food Business Division at CIRS Group boasts a professional technical team specializing in the field of “Three New Foods”. With extensive experience, we have made a track record of successful cases in the regulatory application and filing of new food raw materials, new food additives and new food contact materials. Currently, CIRS Group has carried out the application of dozens of GMM new food raw materials and additives on behalf of our clients, positioning us at the forefront of the industry. We warmly welcome inquiries or visits for a more in-depth insight into our technological capabilities.