Roadmap: Researchers publish recommendations for successful EU health food claims

14 Nov 2017 --- Researchers have developed recommendations to help food companies successfully substantiate new health claims in the EU. During this study, published in the highly regarded Trends in Food Science & Technology, researchers from the University of Surrey worked with investigators in Slovenia and Denmark as part of the REDICLAIM project. Together, they clarified the process of attaining approval for new health claims on food products.

A common framework for the use of health claims – any public association linking a food product to human wellbeing – was established by the European regulation. However, its implementation, despite providing legal certainty to the use of authorized health claims, was found to be too complex and arduous, which led to this in-depth investigation.

Examining past decisions, both favorable and unfavorable, by the European Food Safety Authority (EFSA) and conducting interviews with specialists in the field, researchers identified a number of areas that those working in food and nutrition should consider when seeking to implement a new health claim.

The researchers' recommendations include:

Consider the EFSA's extensive guidance documents on the submission and substantiation of health claims.
Consider the EFSA's previous opinions, particularly those published since the last revision of specific guidance concerning the health outcome in question.
Consider the novelty of the food (constituent) and the science providing the evidence.
Consider the results of key EU-funded research projects dealing with health claims.
Evaluation time can be cut considerably if the health claim application (dossier) contains details of all pertinent data.
Data protection is possible when the scientific substantiation is primarily based on companies’ own data.
In the process of scientifically evaluating a health claim, the safety of a food (constituent) is not systematically assessed.
Assure that the food (constituent) can be sufficiently characterized.
A health claim's wording must reflect the scientific evidence and should be (where applicable) comparable with already authorized claims.
The claim should be clearly defined and relevant for human health.
For all claims other than those based on the essentiality of nutrients, the substantiation of a health claim should primarily be based on good-quality human efficacy studies.
The proposed conditions of use should reflect the conditions in which the studies used for substantiating the claim were conducted.
The application should provide the totality of the available scientific data.
Successful scientific substantiation of a health claim does not ensure that it will be authorized.

Monique Raats, Professor and Director of the Food, Consumer Behavior and Health Research Center at the University of Surrey, says: “Getting a successful food claim from the European Union is often a resource-intensive process, costing companies time and a lot of money, which means some have stopped trying to highlight the potential health benefits of their products.”

“Where health benefits of food are being communicated, it is important to ensure they are backed by appropriate evidence, and we have developed this evidence-based list of recommendations that will provide guidance on navigating the journey to secure successful health claims,” she adds.

“Recommendations should be seen as a starting point for researchers in the area of nutrition and food technology, and for those dealing with functional foods, particularly in the food industry,” says Dr. Igor Pravst of the Nutrition Institute, Ljubljana, Slovenia. “Our proposals were prepared on the basis of an analysis of the EFSA’s Opinions and interviews with experts that were participating in preparing health claim dossiers, mostly from the food industry and research consultancy service providers specialized in the health claim authorization process.”

A recent story showing the difficulty of getting an EFSA health claim was the rejection of a dental health claim for Cargill’s erythritol. EFSA experts said they could not substantiate the claim “in the absence of evidence for an effect on the incidence of dental caries in vivo in humans.” In other EFSA work, it has also recently set updated dietary reference numbers for riboflavin (vitamin B2) as part of its review of scientific advice on nutrient intakes.