Botanical health claims on foods: minimising the risk of misleading consumers during the evaluation period in the EU

Health claims are an important tool when communicating health benefits of foods, particularly in specific food categories, such as food supplements. Currently the use of botanical health claims included in the EFSA's register (on hold) is tolerated, on the condition that they are used in line with the general requirements of EU regulation, not misleading for consumers, and scientifically substantiated [1, 2]. Considering the lack of pertinent controlled clinical trials on botanicals and the fact that traditional use has been in the past considered as insufficient evidence, meeting such criteria has presented a major challenge for both researchers and the food industry. However, recent successful use of data from EMA monographs for the substantiation of a health claim [3] has opened up a new chapter for botanical health claims. In accordance with this fact, the objective of our study was to compare the wordings of botanical health claims, for which the evaluation process was put on hold, with the evidence about their traditional use. Ten commonly used botanicals were included in our study, for which 64 applications for health claims have on hold status. We determined that evidence on traditional use exists for about 56% of claimed health-relationships. The presented concept can help food manufacturers avoid the risk of misleading consumers. The results will also contribute to the discussion in the scientific community and the authorities on the criteria for assessing botanical health claims.

References:

[1] Pravst I. Dietary supplement labelling and health claims. In: Berginc K, Kreft S, eds. Dietary Supplements. Cambridge: Elsevier; 2014: 3 – 24

[2] Kušar A, Pravst I. Quality and safety of botanical food products and their labelling. Agro Food Ind Hi Tec 2014; 25: 33 – 35

[3] EFSA. Scientific Opinion on the substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function. EFSA Journal 2013; 11: 3412, 1–12