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.
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.
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.
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.
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.
To learn more, watch Steve Morrison's webinar on EFSA health claims. Morrison was in charge of obtaining the first EFSA health claim under Article 13.5.
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.
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.
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.
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.
The number of studies required for a successful EFSA health claim can vary. Understanding the trends in successful claims can guide your research efforts.
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.
More commonly, successful health claims are supported by three to five human intervention studies. These studies collectively provide robust evidence of the health benefits.
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.
When it comes to EFSA health claims, quality trumps quantity every time. Here's why focusing on quality is crucial for your application.
EFSA highlights methodological limitations in many studies, often due to inconsistent methods. Ensuring a high-quality, consistent approach across studies is essential.
Consistent, high-quality studies produce reproducible results, which are key for EFSA approval. Reproducibility ensures observed effects aren't due to chance.
For clients seeking EFSA approval, consistency in study design is paramount. Here are some practical tips.
Once you achieve a positive study result, replicate it. Avoid altering key parameters like dose or formulation.
Thorough documentation helps maintain consistency. Keep detailed records of study designs, methodologies, and results.
Navigating the EFSA health claim process can be challenging, but focusing on quality and consistency can significantly improve your chances of success.
If you're about to begin clinical trials and are curious about EFSA health claims, read our blog on the role of pre-clinical data for EFSA health claims.
Visit the official EU health claim website to find out how to register.
Remember these essential points as you prepare your EFSA health claim application.
By adhering to these principles, you'll be well-positioned to achieve EFSA approval. Consistency and quality are your best allies in this process.
If you want to get started on applying for an EFSA Heath claim, click here.
Here are some frequently asked questions about EFSA health claims.
The European Food Safety Authority (EFSA) provides independent scientific advice on food-related risks. It ensures food safety in the European Union.
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.
Typically, successful health claims are supported by three to five human intervention studies. However, quality and consistency of evidence are more important than quantity.
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.
Consistency and quality of studies are paramount. Ensure methodological consistency and reproducible results to build a strong case for your health claim.
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.