Novel food services: classification, registration strategies, consultation requests, GAP analyses and applications in the EU and UK
Novel foods are foods or ingredients that have not been consumed to a significant degree in the EU and UK before 1997. They may include new plant extracts, algal ingredients, microorganisms, innovatively processed raw materials – or familiar substances with a new intended use. Before placing a novel food or new ingredient on the market, it is essential to determine whether pre-market authorisation is required. If the regulatory status of the new ingredient under Novel food regulation is unclear, an official consultation procedure may be utilised.
Each jurisdiction has its own approval processes and procedures. In the EU, novel foods are regulated under Regulation (EU) 2015/2283, while UK legislation is based on the same framework. Also traditional food from a third country may be a novel food. For those foods, a notification procedure in the EU and UK is required.
Medfiles supports you throughout the entire novel food registration process – from identifying regulatory status and preparing consultation requests to gap analyses, preclinical and clinical studies, and submission of the final application. Our experts have more than 25 years of experience with classification, consultation requests and novel food applications in both the EU and UK.
Free webinar: Is your ingredient a novel food? Understanding regulatory status and the consultation procedure in the EU
One key question for food business operators is whether an ingredient can be considered a traditional food or falls within the scope of the EU Novel Food Regulation (EU) 2015/2283. Join our webinar for a practical overview of how to assess the regulatory status of a food ingredient and how the consultation procedure can provide an official determination on whether a product is considered a novel food.
Regulatory Positioning and Registration Strategy for New Ingredients
Correct classification of a new ingredient is a crucial step for successful market entry. We help you determine whether the product can be launched as a conventional food or whether it qualifies as a novel food requiring assessment and authorisation before market entry. If applicable, we prepare the documentation to justify that a novel food registration is not needed.
If the classification is ambiguous and a formal decision is required, we prepare and submit official consultation requests on your behalf to the competent authorities in the EU and UK, or conduct equivalent discussions in other jurisdictions (e.g. Norway, Iceland). Each consultation request is built on product data, literature, history of use, legislation and our extensive regulatory experience. We can also manage all communications with the authorities during the process.
Whether your product is a traditional food or a novel food, we design the most efficient strategy for regulatory progress – also covering international markets outside the EU and UK. This enables us to create cost-efficient, harmonised registration strategies for global market access.
See also:
- Free webinar: Is your ingredient a novel food? Understanding regulatory status and the consultation procedure
- Consultation request may save you from the novel food authorisation process
- For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics
- Algiecel & Medfiles: collaborating on EU regulation for novel ingredients
Gap Analyses and Novel Food Applications in the EU and UK
Preparation of novel food applications: gap analyses, literature reviews and pre-application consulting
The preparation of a novel food application begins with assessing existing data. Through a gap analysis, we identify what information you already have and what additional data is needed to meet regulatory requirements. A comprehensive gap analysis covers the review of existing analyses, reports and other documentation. We evaluate their quality and suitability for the application and compare them against EU and/or UK regulatory requirements.
Based on this, we deliver a report specifying in detail:
- which data already complies with requirements
- what additional information is needed
- what gaps remain to be filled
We also conduct literature reviews to ensure that all relevant information is included in the application.
Before drafting the application, we provide pre-application consulting. We guide you in collecting missing information and studies. Through our extensive laboratory and research network, we identify suitable partners for generating the required results (e.g. compositional analyses and preclinical studies). EFSA requires early notification of studies for novel foods, often before drafting the application. Medfiles can manage these notifications on your behalf. We also assist in pre-submission discussions with EFSA and the UK FSA.
See also:
Clinical Studies for Novel Food Applications
Novel food applications may also require clinical studies to prove the safety of the novel food. Medfiles’ Clinical Trial Services team provides comprehensive support – from study design and ethics approvals to regulatory notifications and full implementation. We always assess which study design is most appropriate for your product. Our team has broad experience in food clinical trials evaluating the safety of new ingredients and investigating effects to support health claims.
We can manage the entire process: from study conduct and final reporting to scientific publications. Studies are conducted in collaboration with experienced research organisations, ensuring high quality and compliance.
Novel Food Applications in the EU and UK
A well-prepared novel food application dossier is the key to a smooth regulatory process. Medfiles ensures your application meets all criteria from the beginning. We draft all required sections, including product information, background, estimated intake calculations, scientific data and a comprehensive safety assessment. All documentation is prepared in line with EU legislation and the guidance of the EC and EFSA. For UK submissions, FSA guidance is followed accordingly.
We can manage the entire submission process, including communications with EFSA or FSA, as well as responses to authority questions and requests for additional information.
See also:
Novel Food Applications in Singapore, Canada and Other Countries
Singapore has become an attractive market for food innovation companies thanks to its relatively fast novel food registration process. Medfiles offers equivalent services for Singapore, and the same documentation can often be adapted across jurisdictions.
We also support novel food registrations in other countries (e.g. USA, Canada, China, Japan, Australia, South America and other Asian markets) through our network of trusted international partners. We may also prepare the US and EU dossiers parallel.
See also:
- FAP, GRAS and NDI registration applications in the USA
- Free webinar: Registering Food Ingredients and Dietary Supplements for the US Market: GRAS and NDI Explained
- Blog: GRAS – the faster regulatory pathway to food and feed market
Novel Food Team
Medfiles’ food regulatory experts have nearly 30 years of experience in food safety regulation and more than 25 years of expertise in novel foods. Our extensive know-how in food legislation, registrations, market entry, and safety and risk assessment has been gained through work in regulatory authorities across EU Member States, EFSA, the European Commission, as well as the food industry. Our dedicated team includes registration specialists, a toxicologist, a risk assessor, food and nutrition experts, and other food safety professionals.
Over 25 Years of Experience in Novel Foods:
14 novel food notifications
(under former Regulation 258/1997) – 100% success rate
15 submitted novel food applications
3 under review – 84% success rate
14 consultation requests
11 traditional foods, 3 novel foods
*Figures as of September 2025
Algiecel & Medfiles: Collaboration to shed light on the regulation of novel ingredients in the EU
”The Medfiles regulatory specialists clearly knew what they were doing and were very organised. We felt that we could trust them and that they would be honest with us. They were also able to point out the regulatory pitfalls. We felt that if we needed to ask any further questions, we would choose Medfiles again.” – Claus Rosensparre
News and insights on novel foods
Our expert team regularly writes blogs about novel foods. Topics include product classification, consultation requests and novel food applications.
Contact us
You may also be interested in:
- Free webinar: Is your ingredient a novel food? Understanding regulatory status and the consultation procedure in the EU
- UK-EU SPS Agreement: What could alignment with EU rules mean for GB market authorisations of food and feed products
- Consultation request may save you from the novel food authorisation process
- For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics
- Algiecel & Medfiles: collaborating on EU regulation for novel ingredients
- Free webinar: EFSA’s new novel food guidance – what to know?
- Free webinar: Novel food classification and route to authorisation in EU
- Novel foods in the European Union explained
- GRAS – the faster regulatory pathway to food and feed market
- Free webinar: Registering Food Ingredients and Dietary Supplements for the US Market: GRAS and NDI Explained
- Meet our people: Expertise in food and feed toxicology and risk assessment in Canada, the US and EU
- Will the algae-based new foods feed Europe’s population?