The European Food Safety Authority (EFSA) has updated the guidelines for applications for novel foods in the EU. The updates include both scientific and administrative guidance that will apply to all new novel food applications from February 2025.
The pre-announced changes to the framework are intended to ensure that the safety assessment of novel foods keeps pace with current developments in food research and legal requirements. Not only will the latest scientific findings be taken into account, but the experience gained from the previous evaluation of applications will also be used to create clarity and improve the quality of applications. The aim is to establish a more efficient procedure that continues to prioritise consumer safety.
The following Q&A with Ermolaos Ververis, scientific officer in EFSA’s Nutrition and Food Innovation Unit, is here reproduced with the permission of the EFSA.
What was EFSA’s task?
Ermolaos Ververis: The European Commission asked EFSA to update the guidelines for the preparation and submission of applications for the marketing of novel foods in the EU. This update consists of two important documents.
Firstly, the scientific guidelines outline the scientific information to be provided by applicants. Secondly, the administrative guidelines explain the application process that will be handled by our front desk support team.
These updates will apply to all novel food applications submitted to the European Commission from February 2025.
Why have the guidelines been updated?
Ermolaos Ververis: We have made these updates to reflect changes to the EU regulatory framework for novel foods and recent advances in food research and innovation. The novel food industry is evolving rapidly and it is important that our safety assessment procedures are up to date. Novel food applications have become more diverse and this is also reflected in the update.
We have also learned a lot from assessing novel food applications since the Novel Food Regulation came into force in 2018. This experience has helped us to clarify definitions and data requirements to enable higher quality applications, which in turn should lead to a more efficient risk assessment process.
Overall, the new guidelines contain more detailed information, particularly on the scientific requirements, where we have identified gaps over the past six years.
What information do applicants have to provide?
Ermolaos Ververis: Our scientific guidelines explain how to describe and identify the novel food and provide details on the manufacturing process, composition, specifications and proposed uses.
Applicants must also provide information on the expected consumption, use history and safety data of the food, including information on how the food is processed by the body, toxicology, nutritional value and potential allergens.
In addition, the administrative guidelines outline the practical steps for preparing and submitting an application.
Will the update speed up the assessment process?
Ermolaos Ververis: We have a deadline of nine months to finalise a risk assessment, but if we need more information from the applicant, we will pause the process. The updated guidelines should help to streamline the application process by clarifying the requirements and reducing the likelihood of missing information.
However, thoroughness always comes first. Consumer safety is our top priority and the time needed for the assessment depends on the complexity and quality of the data submitted. The European Commission and national authorities in the EU are responsible for the final authorisation and marketing rules.
How were the stakeholders involved?
Ermolaos Ververis: As part of 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. In total, we received more than 700 responses. All feedback, together with our responses, is publicly available as an annex to the guidelines.
We also organised a scientific colloquium in May 2023 to discuss current trends in food research and ensure that our risk assessment methods remain effective. Once the guidelines are published, we will present them at workshops, conferences and other events. Use our channels to stay up to date!
Do these guidelines also cover foods derived from cell cultures?
Ermolaos Ververis: Yes, the guidelines apply to all applications for novel foods, including those for foods and food ingredients derived from cell cultures.
Will fewer animal tests be carried out as a result of the update?
Will the update reduce animal testing?
Ermolaos Ververis: Our aim is to minimise animal testing in line with the EU’s wider strategy to phase out animal testing. We recommend that applicants use validated alternative methods whenever possible. If animal testing is required, it must comply with EU standards and applicants must first conduct a thorough literature review before testing on animals.
How does this protect consumers?
Ermolaos Ververis: The EU’s food safety standards are among the highest in the world. EFSA’s role is to ensure that novel foods are safe to consume within the proposed uses. Once our assessment is complete, it is up to the European Commission and national authorities in the EU to make decisions on authorisation and placing on the market, including labelling requirements. Our aim is to ensure that all novel foods on the market are safe and non-detrimental in terms of nutrition.
Further information: efsa.europa.eu/en
