TY - JOUR

T1 - 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.

AU - Skarupinski, P.

AU - Jakobs, S.

N1 - Publisher Copyright: © Georg Thieme Verlag KG Stuttgart. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - EFSA

KW - drugs

KW - foods

KW - health claims

KW - melatonin

UR - http://www.scopus.com/inward/record.url?scp=84928479298&partnerID=8YFLogxK

U2 - 10.1055/s-0034-1387324

DO - 10.1055/s-0034-1387324

M3 - Artikel

VL - 39

SP - 312

EP - 319

JO - Aktuelle Ernährungsmedizin

JF - Aktuelle Ernährungsmedizin

SN - 0341-0501

IS - 5

ER -