The European Food Safety Authority (EFSA) published the new “General Scientific Guidance on Health Claim Applications” on Jan. 18. This document’s purpose is to aid manufacturers applying for a health claim by explaining the general scientific principles applied by the NDA Panel for the evaluation of all health claims.

The industry has eagerly awaited this guidance, as a large number of rejected health claim applications led to many questions regarding how the NDA Panel and EFSA evaluate health claims in general, and clinical trials submitted as substantiation for the desired claim in particular. During the years since the first applications were rejected, EFSA has received a number of comments from stakeholders, prompting the publication of this new guidance.

The General Guidance is not final; it is expected to be further updated when additional issues are addressed. The new guidance supersedes the existing General Guidance published in 2011 and the Pre-Submission Guidance from 2005.

Highlights
Does the new guidance live up to stakeholders’ expectations? Let’s look at some of the highlights.

For the first time, stakeholders find a summary of the various guidance documents and opinions addressing a number of common issues encountered by health claim applicants.

The guidance helps improve the transparency of necessary product characterization, characterization of the claimed physiological effect, and the evidence required to substantiate health claims. This issue has been a common pitfall for many applications.

In more detail, the new guidance provides a comprehensive summary of the legal framework for the authorization of health claims in the EU (including who does what when), and includes administrative and procedural aspects governing the life cycle of a claim application.

There is also guidance on the main application steps, the scientific requirements for applicants, and the workflow during the evaluation, which is graphically supported by flow schemes. An explicit differentiation is made between the principles applied to the evaluation of health claims based on the essentiality of nutrients (article 13.1) and those applied to other claims (articles 13.5 and 14).

The guidance also provides a compendium of molecular methods and technologies validated and suitable for the characterization of microorganisms (e.g., bacteria, yeast) that shall be the object of a health claim. Also given are considerations and suggestions concerning the validation (e.g., validity and reliability, ability to obtain consistent results) of questionnaires (which are generally considered to be rather subjective and thus generally not preferred over the use of objective measures) and their use as outcome parameters for claim substantiation.

Important Takeaways
From a&r’s perspective, the most important information for applicants given in the new publication concerns the guidance on using questionnaires. One point emphasized is that questionnaires are only appropriate if the population in which the questionnaire has been validated is representative of the study group. Also, the setting in which the questionnaire has been validated must be representative of the setting of the study in which it is to be used.

Most notably, the guidance makes it clear that validation of the questionnaires cannot be performed in the same trial in which the questionnaire is being used to show a cause-and-effect relationship between a food constituent and a health benefit. Thus, only pre-validated questionnaires can be used. Also, any modification of an existing validated questionnaire, such as translation into another language, modification, or leaving out any items requires re-validation. This part is especially valuable because no prior guidance has existed here.

This updated guidance is very welcome, as it helps clarify a substantial amount of uncertainty surrounding the general health claim application process. It does leave some issues unanswered, however, those pertain to health claims related to specific conditions such as joint health issues that are covered by specialized guidance documents, or will be covered by future publications. It also intentionally does not cover the issue of health claims that have not been evaluated yet. Clinical trial groundwork such as study design or statistical analysis is also not within the scope of the guidance.

With the publication of the new guidance, the picture of health claim applications has gained more clarity. This may entice more manufacturers to go this route and apply for proprietary health claims in the future as a means of distinguishing their products from the crowd of generic (article 13.1) health claims. With the help of experienced consultancies such as a&r that can also give advice on and conduct clinical trials, the goal of gaining a health claim is not as unattainable as it seemed in 2010. 

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: [email protected];
Website: www.analyze-realize.com.