New recommendations could streamline European health claims procedure

The guidelines aim to clarify the European Commission legislative framework on functional food health claims, and are the outcome of a recent study published in Trends in Food Science & Technology​.

The key objective of the recommendations is to facilitate the successful substantiation of health claims on functional foods.

The study is part of the REDICLAIM (REduction of DIsease risk CLAIMs on food and drinks) project, coordinated by  the University of Surrey in collaboration with researchers at the Slovenian Nutrition Institute (NUTRIS), Aarhus University (Denmark) and the University of Ljubljana (Slovenia).

Although a set of European Commission procedures already exists regarding the approval of novel foods, their complexity has made the submission of new claims a highly time- and labour-intensive process.

“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,”​ explained Monique Raats, Professor and Director of the Food, Consumer Behaviour and Health Research Centre at the University of Surrey.

“Implementing the regulation has involved a steep learning curve for stakeholders, resulting in many health claims being rejected,”​ said study first author Dr Igor Pravst of the Nutrition Institute, Ljubljana, Slovenia

Recognising that these factors presented a potential barrier to innovation, the European Union funded the REDICLAIM project. One of the project work streams examined the interaction between the legislation and the claim substantiation process. The realisation that the process was too complex and too arduous led to the in-depth investigation in this study.

Basis of recommendations​

The researchers conducted a literature review of EFSA’s (European food Safety Authority) Opinions, of health food claims, together with interviewing experts in the field. By analysing the basis on which past claims had been accepted or rejected, they were able to develop a set of recommendations which provide important guidance as to how to satisfy approval procedure requirements.

“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 specialised in the health claim authorisation process,”​ commented Pravst.

The recommendations should enable companies to ensure that they are providing the relevant scientific evidence for their claim and should make it easier to follow the cumbersome set of procedures in the approval process, suggest the researchers.

“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,”​ explained Raats.

“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,”​ added Pravst.  ​

List of recommendations​

• 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 characterised.
• A health claim's wording must reflect the scientific evidence and should be (where applicable) comparable with already authorised 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 authorised. 

Source:  Trends in Food Science & Technology​
Published online, doi: 10.1016/j.tifs.2017.10.015​​
“Recommendations for successful substantiation of new health claims in the European Union”​
Authors: Igor Pravst, Monique M. Raats, the REDICLAIM Consortium et al​