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Risikobewertung Von Pflanzen Und Pflanzlichen Zubereitungen

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Risikobewertung Von Pflanzen Und Pflanzlichen Zubereitungen Bundesinstitut für Risikobewertung Herausgegeben von S. Klenow, K.P. Latté, U. Wegewitz, B. Dusemund, A. Pöting, K.E. Appel, R. Großklaus, R. Schumann, A. Lampen Risikobewertung von Pflanzen und pflanzlichen Zubereitungen Impressum BfR Wissenschaft Herausgegeben von S. Klenow, K.P. Latté, U. Wegewitz, B. Dusemund, A. Pöting, K.E. Appel, R. Großklaus, R. Schumann, A. Lampen Risikobewertung von Pflanzen und pflanzlichen Zubereitungen Bundesinstitut für Risikobewertung Abteilung Risikokommunikation Fachgruppe Presse- und Öffentlichkeitsarbeit Max-Dohrn-Str. 8-10 10589 Berlin Berlin 2012 (BfR-Wissenschaft 01/2012) 310 Seiten, 2 Abbildungen, 49 Tabellen € 15,- Druck: Umschlag, Inhalt und buchbinderische Verarbeitung BfR-Hausdruckerei Dahlem ISBN 3-938163-76-3 ISSN 1614-3795 (Print), 1614-3841 (Internet) BfR-Wissenschaft 3 Inhalt Teil A – Allgemeiner Teil 7 1.1 EFSA-Leitlinie für die Bewertung von Pflanzen und pflanzlichen Zubereitungen in Nahrungsergänzungsmitteln 8 1.2 Der Markt für Pflanzen und pflanzliche Zubereitungen in Nahrungsergänzungsmitteln in Europa 9 1.3 Aktivitäten in Deutschland 10 1.3.1 Stoffliste des Bundes und der Länder – Empfehlungen zur Einstufung und Beurteilung von Pflanzen und Pflanzenteilen 10 1.3.2 Anwendung der EFSA-Leitlinie zur gesundheitlichen Bewertung von Pflanzen und pflanzlichen Zubereitungen für eine Verwendung in Lebensmitteln 11 1.3.3 Erfassung und Prüfung der Informationen auf Level A in Anlehnung an die EFSA-Leitlinie 13 1.3.4 Risikobewertung auf Level A gemäß EFSA-Leitlinie 15 1.3.5 Anwendung der Anreicherungsverordnung 16 1.4 Literatur 16 Teil B – Spezieller Teil 19 1 Lycium barbarum L. (Gojibeeren) 19 1.1 Ergebnis 19 1.2 Stellungnahme 20 1.3 Handlungsrahmen/Maßnahmen 35 1.4 Referenzen 36 2 Rhodiola rosea (L.) SCOP. (Rosenwurz) 41 2.1 Ergebnis 41 2.2 Stellungnahme 41 2.3 Handlungsrahmen/Maßnahmen 57 2.4 Referenzen 57 3 Potentilla erecta (L.) RÄUSCHEL (Tormentillwurzeln / Tormentillae rhizoma 63 3.1 Ergebnis 63 3.2 Begründung im Einzelnen 63 3.3 Handlungsrahmen/Maßnahmen 76 3.4 Referenzen 77 4 Withania somnifera (Schlafbeere) 83 4.1 Ergebnis 83 4.2 Stellungnahme 83 4.3 Handlungsrahmen/Maßnahmen 95 4.4 Referenzen 95 5 Pueraria lobata (Willdenow) Ohwi (Kudzuwurzel) 101 5.1 Ergebnis 101 4 BfR-Wissenschaft 5.2 Stellungnahme 103 5.3 Handlungsrahmen/Maßnahmen 118 5.4 Referenzen 119 6 Tribulus terrestris L. (Erdstachelnuss) 125 6.1 Ergebnis 125 6.2 Stellungnahme 126 6.3 Handlungsrahmen/Maßnahmen 146 6.4 Referenzen 146 7 Pausinystalia yohimbe L. (Yohimbe) 153 7.1 Ergebnis 153 7.2 Stellungnahme 153 7.3 Handlungsrahmen/Maßnahmen 163 7.4 Referenzen 163 8 Catha edulis (VAHL) FORSK. ex ENDL. (Khat) 167 8.1 Ergebnis 167 8.2 Stellungnahme 167 8.3 Handlungsrahmen/Maßnahmen 186 8.4 Referenzen 186 9 Aristolochia spp. (Aristolochia-Arten) 191 9.1 Ergebnis 191 9.2 Stellungnahme 191 9.3 Handlungsrahmen/Maßnahmen 201 9.4 Referenzen 201 10 Aconitum spp. ( Eisenhut-Arten ) 205 10.1 Ergebnis 205 10.2 Stellungnahme 205 10.3 Handlungsrahmen/Maßnahmen 211 10.4 Referenzen 211 11 Digitalis spp. (Fingerhut-Arten) 213 11.1 Ergebnis 213 11.2 Stellungnahme 213 11.3 Handlungsrahmen/Maßnahmen 221 11.4 Referenzen 221 12 Ephedra spp. (Meerträubel-Arten) 223 12.1 Ergebnis 223 12.2 Stellungnahme 223 12.3 Handlungsrahmen/Maßnahmen 239 12.4 Referenzen 239 BfR-Wissenschaft 5 13 Datura L. und Brugmansia L. (Datura- und Brugmansia-Arten) 243 13.1 Ergebnis 243 13.2 Stellungnahme 243 13.3 Handlungsrahmen/Maßnahmen 257 13.4 Referenzen 257 14 Dryopteris filix-mas (L.) Schott (Wurmfarn) 263 14.1 Ergebnis 263 14.2 Stellungnahme 263 14.3 Handlungsrahmen/Maßnahmen 268 14.4 Referenzen 268 15 Salvia divinorum Epling & Jativa (Aztekensalbei) 271 15.1 Ergebnis 271 15.2 Stellungnahme 271 15.3 Handlungsrahmen/Maßnahmen 279 15.4 Referenzen 279 16 Rauvolfia serpentina (L.) BENTH. ex KURZ (Schlangenwurzel) 285 16.1 Ergebnis 285 16.2 Stellungnahme 285 16.3 Handlungsrahmen/Maßnahmen 295 16.4 Referenzen 296 17 Abbildungsverzeichnis 299 18 Tabellenverzeichnis 301 BfR-Wissenschaft 7 Teil A – Allgemeiner Teil Pflanzen und Zubereitungen aus Pflanzen sind ein wesentlicher Bestandteil der menschli- chen Ernährung. Die große Auswahl pflanzlicher Lebensmittel trägt zur Vielfalt unserer Nah- rung bei. Die Menschen haben gelernt, wie man bestimmte Pflanzen so zubereitet, dass man unerwünschte Wirkungen vermeidet, und welche Pflanzenteile essbar bzw. welche giftig sind. In den letzten Jahren und Jahrzehnten kamen aber auch neue Pflanzen als Lebensmit- tel auf den Markt oder alte Kulturpflanzen wurden neu entdeckt. Neue Zubereitungen (wie z.B. industriell hergestellte Extrakte) oder Darreichungsformen (z.B. als Kapseln) bekannter oder weniger bekannter Pflanzen drängten zunehmend auf den Markt, weil diesen Produkten besondere Wirkungen zugesprochen werden. Diese Wirkungen werden häufig mit dem Ge- halt an sekundären Pflanzeninhaltsstoffen begründet. Zu diesen gehören beispielweise Po- lyphenole (z.B. Flavonoide) und Carotinoide. In Abhängigkeit von der Menge und den Be- gleitstoffen in Extrakten und Zubereitungen können diese Stoffe auch toxisch wirken. Es ist unbestritten, dass eine Ernährung, die reich an Gemüse und Obst ist, die Gesunder- haltung fördert. Welche Inhaltsstoffe hierfür verantwortlich sind, wird seit Langem erforscht, ist aber nach wie vor nicht vollständig bekannt. Auch pflanzliche Extrakte werden auf Basis entsprechender wissenschaftlicher Hypothesen vermarktet, obwohl deren Wirkung oft nur ungenügend geklärt ist. Die Frage, ob sich durch relativ unbekannte Pflanzen oder neue Zu- bereitungen Risiken für die Gesundheit der Konsumenten ergeben, bleibt oft unbeantwortet. Nach dem europäischen Lebensmittelrecht1 müssen Lebensmittel sicher sein, d.h. sie dürfen der Gesundheit nicht schaden. Die Verantwortung hierfür trägt zunächst der Hersteller. Kon- trolliert wird die Sicherheit von Lebensmitteln im Rahmen der geltenden lebensmittelrechtli- chen Vorschriften von den Behörden der Lebensmittelüberwachung. Ein Zulassungsverfah- ren wie bei Arzneimitteln gibt es nicht. Das bedeutet, dass in vielen Fällen Pflanzen bzw. pflanzliche Zubereitungen vor ihrer Vermarktung als Lebensmittel nicht ausreichend auf ihre Unbedenklichkeit geprüft sind. Eine Ausnahme stellen die sogenannten Neuartigen Lebens- mittel (Novel Food) und Lebens- und Futtermittel aus gentechnisch veränderten Organismen (GVO) dar, die beide einem Zulassungsverfahren und damit einer behördlichen gesundheitli- chen Bewertung unterliegen. Aufgrund der Vielfalt an pflanzlichen Produkten ist es für die Lebensmittelüberwachung kaum möglich, die Spreu vom Weizen zu trennen. Für die Verwendung von Vitaminen und Mine- ralstoffen in Nahrungsergänzungsmitteln gibt es in der Nahrungsergänzungsmittel-Richtlinie2 eine Positivliste, d.h. eine Liste, in der alle Stoffe aufgeführt sind, die verwendet werden dür- fen. Im Gegensatz dazu ist die Verwendung von Pflanzen in Lebensmitteln im Europäischen Wirtschaftsraum nicht einheitlich (d.h. nicht harmonisiert). Mit der Nahrungsergänzungsmit- tel-Richtlinie war die Europäische Kommission aufgefordert, bis zum 12.07.2007 einen Be- richt über die Zweckmäßigkeit spezieller Vorschriften für andere Stoffe mit ernährungsspezi- fischer oder physiologischer Wirkung, wie z.B. Positivlisten für Pflanzen und pflanzliche Zu- bereitungen, zu erstellen. Die Europäische Kommission stellte zunächst fest, dass auf der Ebene der wissenschaftlichen Informationen zwischen Stoffen pflanzlichen Ursprungs und anderen Kategorien von Stoffen, wie z.B. Aminosäuren oder Probiotika, unterschieden wer- den muss (Kommission der Europäischen Gemeinschaften, 2008). Die Europäische Kom- mission verwies auf methodische Arbeiten zur Bewertung von Stoffen pflanzlichen Ur- sprungs, die von der Europäischen Behörde für Lebensmittelsicherheit (EFSA) und dem Eu- roparat3 erstellt wurden, und vertrat die Ansicht, dass diese Arbeiten den Mitgliedstaaten neuartige Instrumente zur Verfügung stellen, mit deren Hilfe die Konsensfindung vereinfacht 1 VO (EG) Nr. 178/2002, die sogenannte „Basisverordnung“ 2 RL 2002/46/EG 3 Der Leitfaden des Europarates bezieht sich nicht auf einzelne Pflanzen, sondern auf die Anforderungen an ein fertiges Produkt (NEM), welches Pflanzen enthält. Drei Punkte müssen berücksichtigt werden: Sicherheit und Qualität der Produkte sowie die Transparenz der Informationen (Council of Europe, 2005). 8 BfR-Wissenschaft wird. Die Europäische Kommission kam zu dem Schluss, dass spezifische Vorschriften für andere Stoffe als Vitamine und Mineralstoffe nicht gerechtfertigt sind. Sie hat zudem Zweifel an der Durchführbarkeit der Einrichtung einer Positivliste für Pflanzen und pflanzliche Zube- reitungen, für die aus Sicht der Europäischen Kommission sonst keinerlei Notwendigkeit be- steht. Zum einen ist die Verwendung anderer Stoffe in den Mitgliedstaaten mit äußerst unter- schiedlichen Konsumgewohnheiten verbunden (Durchführbarkeit). Zum anderen ist die Eu- ropäische Kommission der Ansicht, dass die vorhandenen Instrumente, insbesondere die sogenannte Anreicherungsverordnung4, geeignete Verfahren einer allmählichen Harmonisie- rung bieten (Notwendigkeit). Die Europäische Kommission weist zudem ausdrücklich auf das in Artikel 8 der Anreicherungsverordnung genannte Verfahren hin: Im Falle unzureichender wissenschaftlicher Informationen kann ein Stoff während eines festgelegten Zeitraums unter Überwachung gestellt werden. Dieses Verfahren ist insbesondere im Falle von Pflanzen und Pflanzenauszügen geeignet, für die ausreichende und sachgerechte Daten nicht immer ver- fügbar sind (Kommission
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