Stoffe wie Melatonin im rechtlichen Grenzbereich zwischen Arzneimittel, Medizinprodukt und Lebensmittel im Rahmen der Bewertung von gesundheitsbezogenen Angaben durch die EFSA. © 2014 Georg Thieme Verlag KG Stuttgart.

verfasst von

P. Skarupinski, S. Jakobs

Abstract

Introduction: According to the Nutrition and Health Claims Regulation (NHCR) health claims should exclusively be used for the labeling and advertising of foods. However, in the context of the establishment of the European Community list of permitted health claims pursuant to Article 13.1 NHCR the European Food Safety Authority (EFSA) had carried out the scientific scrutiny of health claims related to substances, which also can be used as constituents of drugs and medical devices. Seen from a legal point of view, the question arises whether these health claims can be made on food labels in accordance with applicable law. Methods: A content analysis of 341 scientific opinions, which has been published by EFSA in the period from 1

^st October 2009 to 28

^th July 2011, was used to identify the relevant borderline substances. As a next step, a consideration of the provided scientific references to substantiate several health claims related to melatonin has been conducted. Possible legal consequences for the advertising of melatonin containing products as well as an assessment of the product classification have also been elaborated. Results: Nine borderline substances have been identified, which might be used as a component in foods, drugs or medical devices. These include melatonin, activated charcoal, monacolin K from red yeast rice, chitosan, lactulose, lactase enyzme, hesperidin, troxerutin and diosmin. The inclusion of the first six borderline substances in the European Community list permits the use of certain health claims. Nonetheless this does not constitute, and cannot be construed as, an authorisation to the marketing of the food/food constituent, nor a decision on whether the food/food constituent is, or is not, classified as foodstuffs. Such an assessment is not foreseen in the framework of NHCR. Therefore, in spite of a positive EFSA evaluation, there is a risk that health claims will be classified as disease claims in the member states of the European Union due to the drug status of borderline substances. Conclusions: The authorization of a health claim made on foods excludes the simultaneous registration as a drug claim for reasons of legal system compatibility. Case reports as melatonin are authorized as health claim by the NHCR, although melatonin containing products are often classified as a drug device within the meaning of the principle of the primacy of pharmaceutical legislation.

Organisationseinheit(en)

Institut für Lebensmittelwissenschaft und Humanernährung
Abteilung Ernährungsphysiologie und Humanernährung

Typ

Artikel

Journal

Aktuelle Ernährungsmedizin

Band

Seiten

312-319

Anzahl der Seiten

ISSN

0341-0501

Publikationsdatum

2014

Publikationsstatus

Veröffentlicht

ASJC Scopus Sachgebiete

Medizin (sonstige), Ernährung und Diätetik

Elektronische Version(en)

https://doi.org/10.1055/s-0034-1387324 (Zugang: Geschlossen)