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Shauni FitzgeraldMay 22, 2024 11:35:40 AM6 min read

Understanding EFSA Health Claim Validation Changes

Understanding EFSA Health Claim Validation Changes

The process for validating and reviewing EU health claim dossiers has undergone significant changes in the last three years, coinciding with the introduction of the transparency regulation in 2021. This blog explores the impact of these changes on the timelines faced by potential applicants, delving into the various stages of the process and the challenges encountered along the way.

Table of Contents

The Changing Landscape of Health Claim Submissions

The process for health claim submissions has evolved significantly over recent years. This evolution has been both a boon and a challenge for applicants.

Introduction of the Transparency Regulation

The transparency regulation, introduced in 2021, aimed to bring more clarity to the process. It has indeed achieved greater transparency, but it also brought along some complexities.

Increased Timelines

One of the most notable changes is the increased timelines for dossier submissions. Previously, the process could be completed in a shorter timeframe. Now, it often takes up to 24 months.

Impact on Applicants

These extended timelines can be problematic for applicants. Many may not be aware of the prolonged duration, which can affect their planning and operations.

The Completeness Check: A Longer Wait Than Expected

One of the initial stages of the health claim submission process is the completeness check. This step, although seemingly straightforward, can take longer than anticipated.

Purpose of the Completeness Check

The completeness check is designed to verify that all necessary parts of the dossier are present. This includes the core six elements and supporting documentation.

Components Verified

  • Core six elements
  • Covering letter
  • Appendices
  • Clear health claim

Expected Duration

While this step is intended to be a simple verification, it can take around two months. This delay can be unexpected for applicants, adding to the overall timeline.

In conclusion, understanding these changes and preparing for extended timelines can help applicants navigate the process more efficiently. Awareness is key to managing expectations and planning accordingly.

The Validation Stage: The Crux of the Matter

The validation stage is where the real nuances of the process come to light. This is a critical juncture in the health claim submission journey.

What Does the Validation Step Involve?

During this stage, the dossier undergoes a detailed pre-check. This is not yet the scientific review, but an intensive look at the content.

Detailed Pre-Checks

The validation step involves multiple rounds of pre-checks to ensure the dossier meets all requirements. This stage can take up to twelve months.

Challenges Faced

  • Multiple rounds of requests for information
  • Documents not in the right format
  • Missing cited publications
  • Improperly redacted confidential data

These issues often lead to delays, adding to the overall timeline and making the process more cumbersome for applicants.

Understanding the common pitfalls and challenges during the validation stage can help applicants better prepare and navigate this phase more effectively.

Impact of the Covid-19 Pandemic

The Covid-19 pandemic has significantly impacted the number of applications. Restrictions on human studies and research have contributed to fewer submissions.

Learning Curve for Applicants

Both EFSA and applicants are still adapting to the new process. As familiarity with the system grows, timelines may improve.

Common Mistakes to Avoid

Many delays during the validation stage are due to common mistakes. Avoiding these can help streamline the process.

Format and Searchability

Ensure all documents are in the correct format and are word-searchable PDFs. This small detail can prevent unnecessary delays.

Complete Documentation

Include all cited publications and ensure that confidential and non-confidential data are properly redacted.

Importance of Experience

Experience plays a crucial role in navigating the validation stage. Experienced applicants are better equipped to avoid common pitfalls.

Potential for Timeline Improvement

With increased familiarity and experience, both EFSA and applicants can work towards shortening the validation timeline.

Understanding and preparing for these challenges can help applicants better manage their expectations and navigate the validation stage more efficiently.

The Scientific Review: A Familiar Process

Once the health claim dossier passes the validation stage, it moves on to the scientific review. This stage has remained relatively unchanged over the years.

Regulation and Timelines

The scientific review process is governed by VC Regulation 1924/2006. EFSA has a legislative window of five to six months to complete this review and provide their opinion.

Consistency in Timelines

Despite changes in other parts of the process, the timeline for the scientific review has remained consistent. EFSA generally adheres to the stipulated review period.

Clock Stops and Their Impact

During the review, EFSA may issue questions, leading to clock stops. These pauses can extend the timeline, especially if applicants take longer to respond.

  • EFSA issues questions
  • Clock stops initiated
  • Response time impacts overall duration

Applicants who respond promptly can minimize delays, keeping the process within the expected timeframe.

The Evolving Digital Landscape

The digital tools and platforms used in the submission process have seen significant changes. These tools aim to streamline the process but come with their own set of challenges.

EFSA Connect Portal

The EFSA Connect portal allows companies and individuals to interact with EFSA. This platform has improved understanding and communication.

E-Submission Food Chain Platform

The e-Submission Food Chain platform is where dossiers are built and submitted. While it aims to simplify submissions, it can be time-consuming.

Challenges with Digital Tools

Despite their potential to enhance efficiency, these platforms can be challenging to navigate. Proper understanding and use are crucial for smooth submissions.

  • Time-consuming process
  • Complex navigation
  • Requires thorough understanding

Explaining these platforms to clients is essential for ensuring they can use them effectively, reducing potential delays in the submission process.

Key Takeaways

1. Extended Timelines: Health claim dossier filings now take longer, frequently up to 24 months, due to the introduction of the transparency legislation in 2021.
2. Completeness Check Delays: This stage, which involves confirming all relevant dossier components, may take up to two months.
3. Validation Challenges: Often involving incorrect formatting and missing documentation, the validation stage entails thorough pre-checks and might take up to a year.
4. Consistent Scientific Review: This phase, which may involve clock stoppage, usually takes five to six months and is governed by VC Regulation 1924/2006.
5. Digital Tools: Although very helpful, sites like EFSA Connect and e-Submission Food Chain can be difficult to use and take a lot of time to get the hang of.



How do dossier submissions get affected by the transparency regulation?
A: The deadline for submitting a dossier has been extended by the transparency rule, and it now takes up to 24 months to complete.

What is the duration of the completion verification process?
A completeness check, which confirms that the dossier contains all required parts, may take up to two months.

What typical problems arise throughout the validation phase?
A: Common problems include poorly redacted confidential material, missing papers, and faulty formatting.

What is the duration of the scientific review procedure?
A: The duration of the scientific review process is often five to six months, though it may take longer if EFSA raises concerns.

What difficulties do digital venues for submissions pose?
A deep comprehension is necessary for the efficient use of platforms such as EFSA Connect and e-Submission Food Chain, which can be difficult to use and take a lot of time.


Shauni Fitzgerald

Shauni Fitzgerald, a seasoned Regulatory Affairs & Research Manager at Atlantia Clinical Trials, excels in clinical study design, regulatory submissions, and quality management. With a master's in Nutritional Sciences, she brings expertise and leadership to the field.