EFSA webinar on novel food applications: an overview

Sep 30, 2021
Sébastien Bouley

The webinar aimed at pointing out how the Transparency Regulation impacts the novel food sector in terms of application procedures and confidentiality

On 23 September 2021 the EFSA held a webinar aiming at outlining the developments in novel food application procedures following the implementation of the “Transparency Regulation”. This designation refers to Regulation (EU) 2019/1381, concerning the transparency and sustainability of the EU risk assessment in the food chain, in application since 27 March 2021. The regulation, that applies to the whole framework of general food law, defines transparency as the norm and confidentiality as an exception of it; therefore, it stresses important points, as the possibility for the public to access, as much as possible, the information used by the EFSA in its risk assessment tasks.

Under the lead of Margherita Guidi (communication officer of the EFSA Application Desk Unit) as a moderator, three speakers intervened during the webinar: Karine Lheureux (head of the Application Desk Unit), Anastasia Livaniou (scientific officer of the Application Desk Unit), and Simone Gabbi (team leader of the Transparency and Confidentiality Team).

The structure of the meeting followed the main steps of novel food application procedures, pointing out, for each stage, the changes that took place since last March.

One of the innovations will be the possibility to ask to the EFSA a pre-application advice prior to the submission of a novel food dossier (using such a possibility is highly recommended by the EFSA); the submitted data will be published in a second step, when the application will be considered as valid.

Subjects submitting applications will have to notify to the EFSA the studies that are mentioned in the application dossier. Throughout this process, it will be important to specify whether the applicant possesses intellectual property over the presented data (if that is not the case, the rights for application to public authority will have to be acquired). The applicant will also need to indicate if it wishes to request confidentiality on some domains. In this case, it will need to justify the request by indicating the reason motivating it, its legal basis, and an estimation of the harm that could potentially derive from the disclosure of the information; the EFSA will conduct an assessment on the confidentiality demand. All non-confidential data will be published, under the instructions of the Transparency Regulation. It means that two files should be prepared and submitted: one with the public information and one including the confidential data identified as such.

For more details on the whole subject, it is possible to consult online, on the EFSA website, the replay of the webinar.

Orchidali can help you to assess whether a novel food application is needed, and can guide you in preparing and submitting a novel food dossier.