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EFSA Health Claims: Atlantia’s Regulatory Officer, Steve Morrison offers a detailed analysis of the systematic errors seen in applications over the past decade, along with insights as to how he guided the first successful Article 13.5 Health Claim.

Health claims within the EU is a well discussed and well researched topic. However, the articles and research alike tend to focus on a specific claim or health area   

If you are a health and nutrition professional looking to expand your knowledge on EFSA Health Claims, our Regulatory Officer, Steve Morrison can guide you through the key challenges and success factors of any health claim across a multitude of health areas. Furthermore, Steve will also discuss his experience with assisting in the construct of the first successful EFSA Article 13.5 Health Claim in this online presentation.

When and why was EFSA created? 

EFSA is funded by The European Union, but it is overseen Independent of European legislative and executive institutions. This is because EFSA offer scientific advice on food related risks whereas The European Union introduce legislation regarding food safety.

 During the late 1990’s there was a series of food crises in the EU such as Salmonella and E. coli. As a result, new legislation was introduced with the primary purpose to protect consumers, to ensure claims are truthful, clear & reliable and to facilitate choice.

The key piece of legislation covering health claims in Europe is Regulation No: 1924/2006, commonly known as NHCR or Nutrition and Health Claims Regulation. It was fully Introduced in 2007 by the European Food Safety Authority (EFSA). 

First Successful EFSA Article 13.5 Health Claim

There are three core subsections of the NHCR, however, article 13.5 is the most relevant in functional foods as it is concerned with proprietary, new developed scientific data from the applicant. 

Atlantia’s Regulatory Officer Steve Morrison helped construct and acted as the main contact person for the first successful EFSA Health Claim back in 2009. The product was outlined as a water-soluble tomato concentrate which helps maintain normal platelet aggregation, contributing to healthy blood flow.

The concentrate contained a diverse group of more than 30 polyphenolic compounds which contributed significantly to its overall cardiovascular health. One of the more interesting facts about this functional food ingredient is that it has a similar antiplatelet effect to aspirin, with the crucial difference being that the effect is more subtle, making it suitable for the general population. The product is now found in a range of 50 or more functional foods across Europe from beverages and foods to supplements and cereal bars.

Challenges and Success Factors in EFSA Health Claims

The challenge was the nature of this particular claim and the benefits regarding platelet function and blood flow is not the easiest of claims for a level of consumer understanding.

Steve Morrison notes that in his experience the consistency of experimental findings, particularly in human studies appears to be a key success factor in any EFSA Health Claim. These findings must effectively demonstrate clear cause and effect. 

This particular study consisted of 250 human subjects, showing success isn’t about absolute numbers. Similarly, the overall study consisted of 8 small human studies (with mostly 20-30 subjects).

The Study

Firstly, the sponsor company showed an effect on the unprocessed food ingredient i.e. the tomato juice, which only showed a sub optimal effect. 

The extract was then created and semi-purified and put into a capsule to be studied. The time, cause and effect of that capsule in a single dose and acute setting was looked at before putting it into other product forms and more chronic consumption of a period up to one month.

Multiple presentations of the end product and final consumer presentations were tested in these trials. An objective result from an ex vivo blood sample was then measured, which was taken from samples before and after dosing and using a method of testing and aggregation that has been the Gold Standard since the 1950’s.

This study sequentially answered a series of logical questions with strong consistency of outcome measures findings across the smaller studies. Similarly, the company fixed the product specification before running the key human trials which is something companies tend not to do, they run trial on products that don’t resemble the final specification.

What are the most influential factors according to EFSA?

Within EFSA’s General Scientific Guidance for Health Claim applications (2016) it is stated “human intervention studies are at the top of the hierarchy that informs decisions on substantiation of health claims”. Atlantia conduct trials at ICH-GCP which is the gold standard for human clinical studies. Visit our clinical expertise areas and our research services to learn more.

EFSA consistently talk about weighing the evidence in their published opinions, which again shows that quality is of more importance that quantity.

it is important to outline that company size does not play a factor as successful applicants range from small companies to multinationals. Similarly, the health benefit area isn’t significant as gut health, cardiovascular health, sports nutrition, blood sugar etc. have been successful.

Drawback of EFSA’s Guidance Notes

These notes are reactive, meaning they are purely based on historical applications to EFSA in a particular health area and focus on what applicants didn’t do right. Half of the guidance notes have not been updated since 2012, technology moves fast in this industry and has developed drastically over the past number of years. 

This suggests the guidance is less useful in areas where there has been fewer claims, in contrast to this cognitive health benefits in foods has a higher number of applications making the guidance more useful. This shows that experience in conducting human clinical trials at the highest standard is paramount in a successful health claim, which will be illustrated further in the following sections.

Pattern over the last decade

The headline we see most often reported in this sector is the lack of success with applications and EFSA’s apparent unreasonable approach to these scientific assessments, as there have been roughly 10 successful claims during this 10-year period.

There was a surge in applications in the early years of Article 13.5 which consisted of a largely historical or bibliographical approach to making the applications, relying on very old published studies which ultimately were not up to modern standards and good clinical practice which illustrates a hoping for the best approach. 

Characteristics of failed EFSA claims

The conditions of use have to be practical as they have an effect on commercial usability and success, these are the conditions of which the applicant proves cause and effect i.e. the dose, dosing regimen, population studied and choice of comparator. Steve analyses a specific example of a claim that fails to address these requirements in the EFSA Health Claims webinar.

A recent study in January of 2020 regarding a vitamin K2 claim included 3 human studies, but none were relevant and acceptable by EFSA, showing that studies are looked at and critiqued individually before weighing any overall evidence: in this case one study was uncontrolled and performed in a patient population which is not the target of the EFSA Health Claim legislation – meaning this study could only ever be supportive rather than confirmatory. To learn more about this study and five more examples, along with some common questions such as “how many studies are enough?”, tune in to Steve’s webinar.

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