EUROPE – The European Food Safety Authority (EFSA) has initiated a public consultation on a draft guidance outlining the requirements for applications for novel food authorizations in the EU.

Additionally, EFSA will host a public webinar in March to engage stakeholders in discussions about the draft guidance.

Regulation (EU) 2015/2283, implemented in January 2018, introduced a centralized procedure for the authorization of novel food applications in the EU.

As per the regulation, EFSA is tasked with conducting risk assessments on the safety of novel food applications upon request by the European Commission (EC).

To meet this mandate, EFSA developed scientific and technical guidance in 2016 for the preparation and submission of novel food applications. Now, EFSA is revising this guidance to update its scientific content in response to a mandate from the EC.

The updated guidance aims to incorporate recent EU regulatory changes regarding novel foods, reflect advancements in food research and innovation, and leverage EFSA’s progress in assessing novel food applications since the centralization of the process in January 2018.

It covers various scientific areas relevant to the risk assessment of novel foods, including compositional data, identity, production process, toxicological information, exposure, and allergenicity. The goal is to ensure 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 is available for public consultation until March 14, 2024.

EFSA has also scheduled a webinar for stakeholders to discuss the draft guidance, which will be conducted online in English on March 21, 2024. Interested parties must register by March 19, and questions can be submitted via the registration form until March 10. Registration may close earlier if the maximum number of participants is reached.

During the webinar, EFSA aims to elucidate the key updates in the draft guidance, provide insight into the ongoing public consultation process, offer guidance on how stakeholders can contribute input, and address queries and requests for clarification regarding the draft guidance document.

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