What was EFSA asked to do?
The European Commission tasked EFSA with updating the guidance on how to prepare and submit applications to market novel foods in the EU. This update consists of two key documents:
First, the scientific guidance outlines the scientific information applicants must provide.
Second, the administrative guidance clarifies the process for applying, which is handled by our front-desk support team.
These updates will apply to all novel food applications submitted to the European Commission starting in February 2025.
Why was the guidance updated?
We made these updates to reflect changes in the EU legal framework for novel foods and recent advances in food research and innovation. The novel food industry is evolving quickly, and it’s important that our safety assessment processes keep up. We’ve seen a growing variety of novel food applications, and the update takes this into account too.
We’ve also learned a lot from assessing novel food applications since the 2018 novel food regulation came into effect. This experience helped us clarify definitions and data requirements, so applicants can submit higher-quality applications, which in turn should lead to a more efficient RISK ASSESSMENT A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation process.
Overall, the new guidance provides more detail, especially on scientific requirements where we’ve noticed gaps in the past six years.
What information do applicants need to provide?
Our scientific guidance explains how to describe and identify the novel food, along with details on the production process, composition, specifications, and proposed uses.
Applicants also need to provide information on the food’s expected consumption, history of use, and safety data, including how the body processes the food, toxicology, nutrition, and potential allergens.
The administrative guidance complements this by outlining the practical steps for preparing and submitting an application.
Will the update speed up the assessment process?
We have a nine-month deadline to complete each risk assessment, but if we need more information from the applicant, we pause the process. The updated guidance should help streamline the application process by making the requirements clearer and reducing the chances of missing information.
That said, thoroughness always comes first. Consumer safety is our top priority, and the time needed for assessment depends on the complexity and quality of the data submitted. The European Commission and the EU national authorities handle the final approval and marketing rules.
How were stakeholders involved?
During the update, we launched a public consultation and received feedback from a wide range of stakeholders, including academia, consumer groups, industry, NGOs, and the public — over 700 comments in total. All feedback, along with our responses, is publicly available as an annex to the guidance document.
We also hosted a scientific colloquium in May 2023 to discuss current trends in food research and ensure our risk assessment methods remain effective. Now that the guidance is published, we’ll be presenting it at workshops, conferences, and other events. Stay tuned to our channels for updates!
Does this guidance cover cell culture-derived foods?
Yes, the guidance applies to all novel food applications, including those for cell culture-derived foods and food ingredients.
Will the update reduce animal testing?
Our goal is to minimise animal testing in line with the EU’s broader strategy to phase it out. We recommend applicants use validated alternative methods whenever possible. If animal studies are necessary, they must comply with EU standards, and applicants must first conduct a thorough literature review before proceeding with any IN VIVO Research method which involves testing individual live animals or populations of live animals studies.
How does this protect consumers?
The EU has some of the highest food safety standards in the world. EFSA’s role is to ensure any novel food is safe to eat under its proposed uses. Once our assessment is complete, it’s up to the European Commission and the EU national authorities to make decisions on approval and marketing, including labelling requirements. Our goal is to ensure all novel foods on the market are safe and not nutritionally disadvantageous.
O artigo foi publicado originalmente em EFSA.
