Pre-submission Consultation
Seek advice from EFSA before submitting your application. This consultation helps clarify requirements and streamline the application process.
Novel foods are foods or ingredients that have no significant history of consumption in the EU before May 15, 1997. These foods can be newly developed foods, innovative food products and foods produced using new technologies and production processes.
The Novel Food Application is a process by the European Food Safety Authority (EFSA) for approving novel foods on the EU market.
Anyone looking to market novel food products within the European Union must undergo a pre-market review process by submitting a Novel Food Application.
This requirement applies to food manufacturers, distributors, importers, and anyone involved in producing or selling new food products in the EU.
Novel Food (NF) receives authorization from the European Commission (EC) and undergoes a safety assessment by EFSA. Below are key steps:
Seek advice from EFSA before submitting your application. This consultation helps clarify requirements and streamline the application process.
Submit your application to the European Commission (EC). The dossier must include comprehensive details about the novel food, such as its composition, manufacturing process, proposed uses, and safety study data. The EC will conduct an applicability review, usually completed within 30 working days.
If your application meets the initial review criteria, the EC will officially accept it and forward it to EFSA for a detailed safety assessment.
EFSA evaluates the dossier to assess the safety of the novel food. This review involves analyzing toxicological data, potential allergenicity, nutritional information, and intended use. The safety assessment typically takes about nine months.
Upon completing the assessment, EFSA issues a scientific opinion on the safety of the novel food. If the food is deemed safe, EFSA will recommend its authorization to the European Commission.
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