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.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
We’ve been doing this for over 18 years, with over 2,000 happy clients!
No time to waste! We help you get to the market quickly without compromising quality.
Every ingredient is unique, and so is our approach. We tailor our services to your specific needs.
Safety is our top priority. We make sure your ingredients meet all the requirements.
Avoid costly delays, fines and potential product recalls with our expert guidance.
Regulations can change. We’ll keep you compliant for the long haul.
EFSA evaluates several safety measures for novel foods, including toxicology, potential allergenicity, and nutritional value. These assessments confirm compliance with food safety and quality assurance certification standards. Additionally, EFSA considers the manufacturing process and the food’s intended use to ensure it meets EU safety requirements.
Yes, any food additives included in a novel food must comply with Regulation (EC) No 1333/2008. These additives undergo separate evaluations for safety, efficacy, and necessity as part of the overall EFSA compliance process, ensuring adherence to EU standards.
EFSA ensures compliance with European food additive regulations by reviewing toxicology studies, exposure levels, and dietary consumption patterns. For novel foods containing additives, the submission must demonstrate that the additive adheres to EU safety guidelines and is included within permitted usage levels. GRAS Experts can help align these requirements with your novel food application.
While GRAS-certified ingredients provide valuable safety data, EFSA typically requires additional evidence tailored to EU standards, such as nutritional assessments and labeling compliance. Using GRAS-certified data as a foundation can strengthen a novel food application, but further evaluations are often needed to meet EFSA’s rigorous requirements.
The EFSA Novel Food Application process typically takes nine months to a year. This timeline can vary depending on the complexity of the food and the completeness of the provided data. Conducting thorough food testing and ensuring alignment with food safety audit standards can help streamline the review process and reduce delays.
© All Rights Reserved.
Powered by Jivaso
