Stakeholder webinar on the Novel Food Guidance

Background

Since the implementation of Regulation (EU) 2015/2283 on Novel Foods in January 2018, a centralised procedure for the authorisation of novel food applications has been in effect. This stipulates that, upon request by the European Commission, EFSA conducts risk assessments of novel foods, evaluating the evidence submitted in the respective application dossiers prepared by food business operators who intend to place their product(s) on the European Union market. EFSA developed scientific and technical guidance in 2016 for the preparation and submission of application dossiers, enabling food business operators to prepare a structured application dossier that includes information to substantiate the safety of their product.

The guidance document, last updated in 2021 solely in the context of the Transparency Regulation, is now undergoing the first revision of its scientific content following a mandate from the European Commission. The update aims to reflect recent EU regulatory updates in the novel food area, consider advances in food research and innovation, and capitalise on EFSA's increased experience in assessing novel food applications since the centralisation of the process in January 2018. The update touches upon various scientific areas pertinent to the risk assessment of novel foods, including compositional data, production process, toxicological information, exposure, nutritional information and allergenicity.

The goal is that the guidance remains a practical and updated tool for applicants and a reference document for risk assessors.

A preliminary draft version of the revised guidance document was finalised and made available for public consultation, with the aim to gather input and feedback from stakeholders interested in its refinement and finalisation.
As part of the engagement activities related to the update of the guidance document, on 4 March 2024, EFSA also hosted an ad-hoc meeting with Member States and Observer Countries, during which the main elements of the revised guidance proposal were presented and discussed. Further details about the content and presentations of the meeting can be found on the dedicated page. 

Objectives of the webinar

Concurrently with the public consultation process on the draft guidance document, EFSA is organising a webinar with the following objectives:

• Explaining the main elements of novelty in the updated guidance document
• Illustrating the ongoing public consultation and providing guidance on how stakeholders can contribute input
• Starting to address questions and requests for clarification received from stakeholders regarding the draft guidance document.

For this purpose, the webinar was tailored to align with the questions and clarification needs submitted by registrants. 

Structure of the webinar

Documents

• Presentation - Stakeholder webinar on the Novel Food Guidance update
• The draft version of the revised guidance document is available for public consultation on EFSA’s Connect platform