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woman with three dossiers ready to submit for an EFSA health claim
Shauni FitzgeraldApr 8, 2024 3:34:49 PM5 min read

The Secret to EFSA Health Claims: How Many Studies do you Really need?

Navigating the complex world of EFSA health claims can be a daunting task, but our expert regulatory specialist is here to provide valuable insights. In this blog, we'll explore the key factors that contribute to a successful EFSA health claim, focusing on the importance of consistency and quality in the supporting studies.


Table of Contents


Understanding Article 13(5) Health Claims

Article 13(5) health claims under the EFSA regulation cover a unique category of claims. These claims are based on newly developed scientific evidence, setting them apart from other types of health claims.


What Article 13(5) Covers

Article 13(5) claims are distinct from Article 14 claims, which focus on disease risk reduction and children's health. The primary focus of Article 13(5) claims is on new scientific evidence. This means that the data supporting these claims must be fresh and innovative.


Proprietary Claims and Data Protection

One of the significant advantages of Article 13(5) claims is the opportunity for proprietary claims. If you can show that your health claim is based on your newly developed data, you may receive five years of data protection. This can be a substantial benefit, offering exclusive rights to the data you have developed.


Requirements for Article 13(5) Claims

To make a successful Article 13(5) claim, it is crucial to provide robust scientific evidence. This evidence should demonstrate the health benefits of the food or ingredient in question. The data must be comprehensive, reliable, and reproducible.


The Importance of Reproducible Cause and Effect

Reproducible cause and effect is a fundamental criterion for EFSA health claims. Understanding this concept can help in designing studies that meet EFSA's stringent requirements.


Human Intervention Studies

EFSA places human intervention studies at the top of its evidence hierarchy. These studies are essential for demonstrating the cause and effect relationship between a food ingredient and its health benefit.


Why Reproducibility Matters

Reproducibility is crucial because it ensures that the observed effects are not due to chance. EFSA requires that the demonstrated benefits be consistent across multiple studies. This consistency builds a stronger case for the health claim.


Challenges with Single Study Evidence

Relying on a single study, no matter how well-designed, is usually insufficient for EFSA approval. EFSA often comments negatively on applications supported by research from a single center or investigator. Multiple studies help confirm that the observed effects are universally applicable.


Successful EFSA Health Claims: How Many Studies are Enough?

The number of studies required for a successful EFSA health claim can vary. Understanding the trends in successful claims can guide your research efforts.


Minimum Number of Studies

Historically, only one health claim has been approved based on two human intervention studies. This was a unique case where the product acted locally in the gut and did not need to be absorbed into the system.


Typical Study Requirements

More commonly, successful health claims are supported by three to five human intervention studies. These studies collectively provide robust evidence of the health benefits.


When More Studies Are Needed

In some cases, even ten or more studies may not be sufficient for EFSA approval. The quality of the studies, demonstration of dose-response, and mode of action are also critical factors. It's not just the quantity but the quality and consistency of the evidence that matter.


Quality Over Quantity: The Key to EFSA Approval

When it comes to EFSA health claims, quality trumps quantity every time. Here's why focusing on quality is crucial for your application.


Consistent Methodology

EFSA highlights methodological limitations in many studies, often due to inconsistent methods. Ensuring a high-quality, consistent approach across studies is essential.

  • Standardize study design
  • Maintain consistent dosages
  • Use reliable measurement techniques


Reproducible Results

Consistent, high-quality studies produce reproducible results, which are key for EFSA approval. Reproducibility ensures observed effects aren't due to chance.

  • Conduct similar or identical studies
  • Confirm findings across multiple trials


Consistency is Key: Advice for Clients

For clients seeking EFSA approval, consistency in study design is paramount. Here are some practical tips.


Maintain Study Parameters

Once you achieve a positive study result, replicate it. Avoid altering key parameters like dose or formulation.

  • Replicate successful studies
  • Keep dosages unchanged
  • Use the same formulations


Document Everything

Thorough documentation helps maintain consistency. Keep detailed records of study designs, methodologies, and results.

  • Record study designs
  • Document methodologies
  • Track all results


Conclusion: Navigating the EFSA Health Claim Process

Navigating the EFSA health claim process can be challenging, but focusing on quality and consistency can significantly improve your chances of success.


Key Takeaways

Remember these essential points as you prepare your EFSA health claim application.

  • Prioritize high-quality studies
  • Ensure methodological consistency
  • Replicate successful study designs


Final Thoughts

By adhering to these principles, you'll be well-positioned to achieve EFSA approval. Consistency and quality are your best allies in this process.




Here are some frequently asked questions about EFSA health claims.


What is EFSA?

The European Food Safety Authority (EFSA) provides independent scientific advice on food-related risks. It ensures food safety in the European Union.


Why are human intervention studies important?

Human intervention studies are crucial as they provide the highest level of evidence for EFSA health claims. These studies demonstrate the direct effects of a food or ingredient on health.


How many studies are typically needed?

Typically, successful health claims are supported by three to five human intervention studies. However, quality and consistency of evidence are more important than quantity.


What is Article 13(5)?

Article 13(5) covers health claims based on newly developed scientific evidence. These claims can receive five years of data protection if the data is proprietary.


What are the key factors for a successful EFSA health claim?

Consistency and quality of studies are paramount. Ensure methodological consistency and reproducible results to build a strong case for your health claim.


Can a single study be sufficient?

Usually, a single study is insufficient for EFSA approval. Multiple studies are needed to confirm that observed effects are consistent and not due to chance.


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.