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.

• 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.

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