Navigating EFSA Confidentiality Requirements: Atova Tips and Tricks
By Evangelia Padenoglou, Regulatory Scientist at Atova
When preparing an application for a regulated product in the EU, confidentiality can sometimes feel like an administrative task to address once the scientific dossier is complete. In reality, it is much more than that.
Whether you are preparing an application for a Novel Food, food or feed additive, food enzyme, flavouring, health claim or another regulated product subject to European Food Safety Authority (EFSA) assessment, understanding how confidentiality works in practice can save time, avoid unnecessary complications during the assessment process and help ensure that confidential business information is adequately protected.
In the latest article in our Atova Regulatory Insights series, Regulatory Scientist Evangelia Padenoglou explores the practical side of navigating EFSA confidentiality requirements and shares seven key steps to help applicants approach confidentiality more effectively.
Why does confidentiality matter?
Since the EU Transparency Regulation became applicable in 2021, transparency has become a central part of the EU food regulatory framework. EFSA’s approach aims to increase public access to the scientific information underpinning its risk assessments, while still recognising that certain commercially sensitive information may require protection.
For companies preparing a regulated product application, this creates an important balance between what needs to be made publicly available, and what can legitimately remain confidential.
Getting this balance right requires careful planning, a good understanding of the applicable legal framework and, importantly, clear and well-supported confidentiality justifications.
As Evangelia highlights:
“Commercially sensitive information can still be protected, but confidentiality is not something to consider only immediately before submission. It needs to be built into the regulatory strategy from the outset and managed throughout the post-submission process.”
Evangelia also highlights common pitfalls to avoid and provides a practical confidentiality checklist to help applicants prepare their dossiers more effectively.
A perspective informed by experience
The article also draws on Evangelia’s own experience working as a trainee within EFSA’s Legal Affairs team, where she supported the assessment of confidentiality requests.
This provided a valuable perspective on the interaction between legal and scientific considerations when determining whether information may be granted confidential treatment.
Her experience reinforces an important message for all applicants submitting regulated product dossiers, including novel foods to EFSA: confidentiality is most effective when it is planned as part of the regulatory strategy, rather than treated as a separate administrative exercise at the point of submission.
Each confidentiality request is assessed individually, making it particularly important to understand the legal basis for each request and clearly explain why disclosure could result in significant commercial harm.
A useful final question to ask is:
“Would I be comfortable if this version appeared on the OpenEFSA Portal tomorrow?”
If the answer is no, it may be time to revisit your confidentiality strategy.
Read the full article
For companies preparing an EU Novel Food application or other regulated product application, understanding confidentiality requirements early can help reduce avoidable work, better protect commercially sensitive information and support a more robust regulatory strategy throughout the assessment process.
Read Evangelia Padenoglou’s full article, Navigating EFSA Confidentiality Requirements: Atova Tips and Tricks, for a practical guide to the seven steps, common pitfalls and confidentiality checklist.
About Evangelia Padenoglou
Evangelia Padenoglou is a Regulatory Scientist at Atova, specialising in global food regulatory affairs including EU novel food and food additive applications. Her experience includes working within EFSA’s Legal Affairs team, providing a valuable perspective on the practical application of confidentiality requirements.
Through the Atova Regulatory Insights series, our team shares practical regulatory knowledge and perspectives from across the evolving food-tech landscape, helping companies better understand the regulatory considerations involved in bringing new food products to market.
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