List of Substances of the Competent Federal Government and ...

BVL-Report · 8.8

List of Substances of the Competent Federal Government and Federal State AuthoritiesCategory “Plants and plant parts”

List of Substances of the Competent Federal Governmentand Federal State AuthoritiesCategory “Plants and plant parts”

List of Substancesof the Competent FederalGovernment andFederal State Authorities

Category “Plants and plant parts”

BVL-Reporte

IMPRINT

ISBN 978-3-319-10731-8ISBN 978-3-319-10732-5 (eBook)DOI 10.1007/978-3-319-10732-5Springer Cham Heidelberg New York Dordrecht London

Thiswork is subject to copyright. All rights are reserved, whether thewholeor part of thematerial isconcerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broad-casting, reproduction on microfilm or in any other way, and storage in data banks. Duplication ofthis publication or parts thereof is permitted only under the provisions of the German CopyrightLaw of September 9, 1965, in its current version, and permission for use must always be obtainedfrom Springer. Violations are liable to prosecution under the German Copyright Law.

Theuse of general descriptive names, registerednames, trademarks, etc. in this publicationdoes notimply, even in the absence of a specific statement, that such names are exempt from the relevantprotective laws and regulations and therefore free for general use.

While the advice and information in this book are believed to be true and accurate at the date ofpublication,neither the authors nor the editors nor the publisher can accept any legal responsibilityfor any errors or omissions thatmay bemade. The publishermakes nowarranty, express or implied,with respect to the material contained herein.

© 2014 Federal Office of Consumer Protection and Food Safety

Editor: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)Dienststelle BerlinMauerstraße 39–42D-10117 Berlin

Final editing: Herr K. Bentlage (kb-lektorat), Frau Dr. S. Dombrowski (BVL, Press office)

Editorial board: Herr F. Riedel (BVL), Herr F. Gründing (LUA Sachsen),Frau R. Maslo (LAVES Niedersachsen),Frau Dr. B. Schlagintweit (LGL Bayern), Frau Dr. R. Schumann (BfR),Frau Dr. K. Stephan (BfArM), Frau K. Woese (LAV Sachsen-Anhalt)

ViSdP: Frau N. Banspach (BVL, Press office)Cover design: deblik, BerlinCover illustration: ©Kathleen Rekowski – Fotolia.comTypesetting: le-tex publishing services GmbH

Printed on acid-free paper

Springer is part of Springer Science+Business Media (www.springer.com)

www.springer.com

Contents

1 Explanatory notes on the List of Substancesof the Competent Federal Government and Federal State Authorities –Category “Plants and plant parts” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2 Legal framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.3 Instruction on how to use the List of Substances . . . . . . . . . . . . . . . . . 2

2 Decision tree: Explanatory notes on the classification of substancesin the List of Substances of the Competent Federal Governmentand Federal State Authorities – Category “Plants and plant parts” . . . . . . . . 52.1 Classification in the lists A, B and C . . . . . . . . . . . . . . . . . . . . . . . . . . . 62.2 Decision tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3 List of Substances of the Competent Federal Governmentand Federal State Authorities – Category “Plants and plant parts” . . . . . . . . 9

Legal basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

v

1Explanatory notes on the List of Substancesof the Competent Federal Governmentand Federal State Authorities –Category “Plants and plant parts”

1.1 Introduction

The Lists of Substances of the Competent Federal Gov-ernment andFederal StateAuthorities (lists of substances)are created to facilitate the classification and assessmentof substances regarding their use as food or food ingredi-ent. They are designed to serve as a reference guide forauthorities and food distributors. The final assessmentof products containing these substances or preparationsthereof must always bemade on a case-by-case basis, giv-ing due regard to all criteria relevant to that assessment.

Lists of Substances of the Competent Federal Govern-ment and Federal State Authorities are to be created forvarious categories. To provide a uniform system for thelists of substances, the entries in the categories are re-ferred to as “substances”, although they may not alwaysbe chemically defined individual substances. A more de-tailed definition may be provided in addition to the cate-gories.

The lists of substances do not claim to be complete anddo not exempt the food business operator from the re-sponsibility to ensure that the relevant product is safe andlegally marketed as a food in Germany. They are subjectto updating in order to take account of new scientific find-ings as well as developments in the food industry.

1.2 Legal framework

Article 2 of the Regulation (EC) No. 178/2002 (GeneralFood Law Regulation)1 specifies “food” as any substanceor product, whether processed, partially processed or un-processed, intended to be, or reasonably expected to beingested by humans.

Substances used as source materials for flavourings orfoodswith flavouring properties are governed by the pro-

1 Regulation (EC) No. 178/2002 of the European Parliament and of theCouncil of 28 January 2002 laying down the general principles andrequirements of food law, establishing the European Food Safety Au-thority and laying down procedures in matters of food safety

visions of the Regulation (EC) No. 1334/2008 on flavour-ings and certain food ingredients with flavouring proper-ties for use in and on foods2.

Foods or food ingredients which have not been usedfor human consumption to a significant degree in the EUbefore 15 May 1997 are governed by the provisions of theRegulation (EC) No. 258/97 on novel foods andnovel foodingredients (Novel Food Regulation)3, if they fall into oneof the following categories: Foods and food ingredientswith a newor intentionally

modified primary molecular structure, Foods and food ingredients consisting of or isolated

frommicro-organisms, fungi or algae, Foods and food ingredients consisting of or isolated

from plants and food ingredients isolated from ani-mals, except for foods and food ingredients obtainedby traditional propagating or breeding practices andhaving a history of safe food use

Foods and food ingredients to which has been applieda production process not currently used, where thatprocess gives rise to significant changes in the com-position or structure of the foods or food ingredientswhich affect their nutritional value, metabolism orlevel of undesirable substances.Flavourings foruse in foodsdonot fallwithin the scope

of the Novel Food Regulation. However, if relevant sub-stances are used for purposes other than flavouring, theymay need to be classified as novel within the meaning ofthe Novel Food Regulation.

Article 2 (d) of the General Food Law Regulation stipu-lates that food does not include medicinal products. Thedefinition of amedicinal product is laid down in Section 2

2 Regulation (EC) No. 1334/2008 of the European Parliament and of theCouncil of 16 December 2008 on flavourings and certain food ingredi-ents with flavouring properties for use in and on foods and amendingCouncil Regulation (EEC)No. 1601/91, Regulations (EC)No. 2232/96 and(EC) No. 110/2008 and Directive 2000/13/EC3 Regulation (EC) No. 258/97 of the European Parliament and of theCouncil of 27 January 1997 concerning novel foods and novel food in-gredients

1List of Substances of the Competent Federal Government and Federal State Authorities, DOI 10.1007/978-3-319-10732-5_1,© Federal Office of Consumer Protection and Food Safety (BVL) 2014

1 Explanatory notes on the List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Clause 1 of the Law governing the Trade of MedicinalProducts (Medicinal ProductsAct –TheDrugLaw, AMG)4,with which the European definition of medicinal prod-ucts was enacted into national law in accordance withArticle 1 of the Directive 2001/83/EC (Medicinal ProductsDirective)5.

Article 2 (g) of the General Food Law Regulation stip-ulates that food also does not include narcotic and psy-chotropic substances. According to the General Food LawRegulation, this is laid down in the United Nations SingleConvention on Narcotic Drugs of 19616 as well as in theUnited Nations Convention on Psychotropic Substancesof 19717. Additionally, the Narcotic Drugs Act (BtMG) ap-plies in German law8.

1.3 Instruction on how to use theList of Substances

“Substances” within the meaning of this category areplants and plant parts. The substances are viewed andcategorised as such. Preparations of substances, such asextracts or isolates, may differ from the actual substancesregarding their composition, especially in terms of theirnutritional and toxicological properties. In each individ-ual case, it therefore needs to be determined whether theclassification of a substance can be applied to a prepara-tion thereof. The classification is made on the basis ofa decision tree developed for this category (see Chap. 2).

To understand the List of Substances in the category of“plants and plant parts”, the following should additionallybe noted:1. The sub lists have the following meanings:

List A: Substances not recommended for use infoods

List B: Substances for which restricted use in foodsis recommended

List C: Substances which cannot yet be completelyassessed due to lack of sufficient data

2. If substances are usually used in foods only to a verylimited extent, for example as spices or as ingredientsin the production of spirits, they are designated by thefollowing abbreviations in the “Food (F)” column:

4 Law governing the Trade of Medicinal Products (Medicinal ProductsAct – AMG)5 Directive 2001/83/EC of the European Parliament and of the Councilof 6November 2001on theCommunity code relating tomedicinal prod-ucts for human use6 Single Convention on Narcotic Drugs of 30 March 19617 Law approving the Convention on Psychotropic Substances of21 February 19718 Law governing the Trade of Narcotic Drugs (Narcotic Drugs Act –BtMG)

F: Known exclusively for use as a food ingredientwith flavouring properties or as a source materialfor flavourings

S: Known for use as a spice C: Known for use as a colouring agent T: Known for use as a teaSuch limitations are generally not documented by

placing a substance on List B. In exceptional cases, a sub-stance is also placedon List B if it is associatedwith effectsthat necessitate a restriction of its use.

Classification is made under the assumption that therelevant substance is used as documented in the list. Anyother use, e.g. in higher doses, can lead to effects that mayrequire a different classification.3. Substances that should be treated before consump-tion (e.g. heated) are designated by the letter “b” in the“Food (F)” column.

4. When classifying a substance as a novel food/novelfood ingredient (NF) within the meaning of the NovelFood Regulation or as not novel in food supplements(Not NFS), the Novel Food Catalogue of the Euro-pean Commission9 was taken into account. However,it should be noted that this catalogue does not haveany entries for a large number of substances from theList of Substances in the category “plants and plantparts”. Any other available information regarding usefor human consumption to a significant degree before15 May 1997 was also taken into account.

5. If any restrictions of use as a food or food ingredi-ent are recommended for a substance (List B) due toevidence of a pharmacological effect (No. 4 in the ex-planatorynotes on the decision tree), such a restrictionalways refers to the substance described in that evi-dence (e.g. dried plant or dried plant part). Evidenceof a pharmacological effect that leads to a classifica-tion as a medicinal product in accordance with Sec-tion 2 Clause 1 No. 2a AMG included court-approvedsources such as monographs, marketing authorisa-tions or classifications of competent authorities. Otherevidence (e.g. results of clinical studies) may addition-ally be relevant to the classification of a substance asa medicinal product.

6. Substances for which a pharmacological effect or ef-ficacy as a medicinal product is plausible based onuse and experience over many years (“traditional ev-idence”) in accordance with Sections 39a ff. of theMedicinal Products Act will not be placed on List Bbased on that traditional evidence alone. For a sub-stance to be placed on List B, pharmacological effects,

9 http://ec.europa.eu/food/food/biotechnology/novelfood/novel_food_catalogue_en.htm

2

http://ec.europa.eu/food/food/biotechnology/novelfood/novel_food_catalogue_en.htm

http://ec.europa.eu/food/food/biotechnology/novelfood/novel_food_catalogue_en.htm

1.3 Instruction on how to use the List of Substances

as specified above in item 5, or risks must be reporteddue to which restricted use in foods is recommended.

7. The classification of substances into this list is madeonly on the basis of their effect after oral ingestion.

Substances which, according to monographs, are in-tended for external use only are not designated asmedicinal products in the List of Substances.

3

2Decision tree: Explanatory notes on the classificationof substances in the List of Substancesof the Competent Federal Governmentand Federal State Authorities –Category “Plants and plant parts”

The decision tree serves as the basis for the classificationof substances in the category of “plants and plant parts” as“food (F)”, “medicinal product (MP)” and/or “novel food/novel food ingredient (NF)” as well as possible combina-tions thereof (ambivalent substances). It also providesinstructions for the classification of the substances in theLists A, B and C.

Classification as a medicinal product – except for am-bivalent substances (see No. 3 below) – is made based onthe definition of medicinal products by function set outin Section 2 Clause 1 No. 2a of theMedicinal Products Act(AMG). These are characterised by their pharmacological,metabolic or immunological effect. For the sake of clarity,the term “pharmacological effect” is used in the decisiontree for this definition. Classification as amedicinal prod-uct by presentation as defined in Section 2 Clause 2 No. 1AMG is not taken into account.

Based on the answers to the questions in the decisiontree, plants and plant parts are classified as follows:

No. 1: Food(Decision tree I – via question 3)Common foods without any known use as medicinalproducts. Based on their previous use, any restrictions ofuse are not required.

No. 2: Food C List B(Decision tree III – via question 3)Common foods without any known use as medicinalproducts.

Dose restrictions and restrictions of use are requireddue to risks posed by the constituents of the plant or plantpart. Such restrictions are expressed by placing the sub-stance on List B.

No. 3: Food C traditional medicinal product(Decision tree II – via question 5)For traditional herbal medicinal products, a pharmaco-logical effect is plausible based on use and experience

over many years in accordance with Sections 39a ff. ofthe Medicinal Products Act (AMG). At present, process-ing monographs for plants/plant parts that can be con-tained in traditional medicinal products are being cre-ated or revised by the EuropeanMedicines Agency (EMA).Where these monographs have been adopted and pub-lished, they are taken into account accordingly. Some ofthe plants/plant parts used therein have also long sincebeen used in food. A restriction (List B) was not recom-mended in individual cases where it would have beendone exclusively on the basis of traditional evidence ofpharmacological effect. Despite such evidence of phar-macological effect, classification as ambivalent substance(F/MP) without any restrictions is therefore made in thiscase only.

No. 4: Food Cmedicinal product C List B(Decision tree III/IV – via question 5)Common foods that are also used as medicinal products.Pharmacological effects are reported above a certain dose.If no significantpharmacological effects are identified, thesubstance can be classified as food. When reaching thepharmacologically effective dose, it is defined as a medic-inal product by function. This is expressed by placing thesubstance on List B.

No. 5: Novel food(Decision tree VIII – via question 9)The substance is not known to be used as either food ora medicinal product. The substance is also not known tobe associated with any risks that would restrict its use infood. The further assessment takes place in accordancewith the Novel Food Regulation.

No. 6: Novel food C medicinal product(Decision tree IV/V – via question 8)The substance has so far been known as amedicinal prod-uct only. However, it is not associated with any risks thatwould restrict its use in food. Its use in food would there-


2 Decision tree: Explanatory notes on the classification of substances in the List of Substances

fore be conceivable after assessment in accordance withthe Novel Food Regulation.

Medicinal products and novel foods are distinguishedon the basis of the pharmacologically effective dose (byanalogy with No. 4). The substance cannot be placed onList B as it is no common food.

No. 7: Novel food (Not NFS) C List C(Decision tree VIII – via question 9)A number of substances are classified as not novel ex-clusively when used in food supplements. When used infoods other than food supplements, these substances areusually placed on List C, since no sufficient information isavailable for their conclusive assessment.

No. 8: Novel food (Not NFS) C List BCmedicinalproduct(Decision tree IV/V – via question 8)The substance is known as amedicinal product. It is addi-tionally used in food supplements and is classified as notnovel in this case only. The necessary restriction of use inFS due to the pharmacological effect is expressed by plac-ing the substance on List B.

No. 9: Medicinal product C List A(Decision tree VI – via question 7)The substance has so far beenknown as amedicinal prod-uct only. Due to the associated risks, its use in food is notrecommended, irrespective of the dose.

No. 10: List A substance(Decision tree VII – via question 9)The substance, which is not a medicinal product, is asso-ciated with risks. Its use in food is therefore not recom-mended, irrespective of the dose.

2.1 Classification in the lists A, B and C

List ASubstances that are not recommended for use as food orfood ingredient due to known risks (No. 10) are placed onList A. These substancesmay be ormay have been used asmedicinal products (No. 9).

List BSubstances that are only used in food and forwhich a doserestriction is required due to certain constituents (No. 2)are placed on List B.

Furthermore, substances that are known as both foodsand medicinal products with a pharmacological effectdemonstrated on the basis of clinical data are placed onthis list. This is also done by strict application of the de-cision tree in respect of basic foods in usual amounts ofintake (No. 4).

Finally, substances that are used as food exclusively infood supplements (but are otherwise novel foods) and areknown as medicinal products with a demonstrable phar-macological effect are placed on list B (No. 8).

Substances that are knownasboth foods andmedicinalproducts with exclusively traditional evidence of phar-macological effect (No. 3) are not placed on List B.

List CSubstances that have so far been used exclusively in foodsupplements but are otherwise novel foods are placed onlist C (No. 7).

6

2.2 Decision tree

2.2 Decision tree

Figure1

Decisiontree

*Assessm

entofpotentialuseasfood/foodingredientaccordingtotheNovelFood

Regulation(Ifthesubstanceisclassifiedasnotnovelinfood

supplements[NotNFS],itmayneed

tobe

placed

onListB.)

**Assessm

entofpotentialuseasfood/foodingredientaccordingtotheNovelFood

Regulation(Ifthe

substanceisclassifiedasnotnovelinfood

supplements[NotNFS],itmayneed

tobe

placed

onListC.)

***SeeNo.3oftheexplanatorynotes

Abbreviations:F

Dfood,M

PDmedicinalproduct,trad.M

PDtraditionalm

edicinalproduct,NF

Dnovelfood/novelfoodingredient,FS

Dfood

supplement

7

3List of Substances of the Competent FederalGovernment and Federal State Authorities –Category “Plants and plant parts”

Status: December 2013


3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Table 1 List of Substances – Category “Plants and plant parts”

Stock plant(Latin)

Plant part F NF MP trad. MP List A List B List C

Abies spp. Shoot (tip) T

Achilleamillefolium L. Herb, flower S, T

Aconitum napellus L. all plant parts

Acorus calamus L., syn. Acorusaromaticus GARZ., Oronthiumcochinchinensis LOUR.

Rhizome F

Actinidia deliciosa (CHEV.)A.R. FERG.

Fruit

Adonis vernalis L., syn. Adonanthevernalis SPACH

Herb

Aegopodium podagraria L., syn.Aegopodium angelicaefoliumST. LAGER, Aegopodium latifoliumTURCZ.

Leaf

Aesculus hippocastanum L., syn.Aesculus castanea GILIB., Aesculusprocera SALISB., Hippocastanumvulgare GAERTNER

Leaf, flower Not NFS


Bark Not NFS

10


Remarks Risks Critical plantsubstances

Pharmacologically effectivedose

Positivemonograph, indications: loss ofappetite, digestive problems such as mild gas-trointestinal cramps, standard marketingauthorisation: 1249.99.99, ESCOPmono-graph: loss of appetite, dyspeptic disorderssuch as mild spasmodic complaints in the ab-dominal region,WHOmonograph: loss ofappetite, common cold, dyspeptic ailmentssuch as mild spastic discomfort of the gas-trointestinal tract, as a choleretic and for thetreatment of fevers,HMPCmonograph: tradi-tional use

Contraindications: hypersensitivityto yarrow or other Asteraceae species(Commission Emonograph)

Proazulenes,azulenes,monoterpenes(e.g. camphor,eucalyptol [D1,8-cineol])

Commission E: 4 g drug/day,equivalent preparationsESCOP: 2–4 g drug/3–4 timesa day, equivalent preparations,administration to children agedbetween 3 and 12 only undermedical supervisionWHO: 4.5 g drug/day or 3 gflower tea/day

Negativemonograph: due to risks, use inMP only in homeopathic doses, monks-hood (Aconitum napellus), extremely toxic Ia(Wink/Wyk), extremely toxic +++ (Roth/Daunderer)

Aconitine is a strong nerve andmusclepoison, numbness, paraesthesia, paral-ysis (Wink/Wyk), cardiac arrhythmia,sensitivity to cold, nausea, cramps,paralysis of tongue, facial and extrem-ity muscles, circulatory failure (Roth/Daunderer)

Alkaloids(e.g. aconitine)

Risks reported (in dependence on the vari-ant used), use of tetraploid subspecies assource material for flavourings and foods withflavouring properties prohibited by Reg. (EC)No. 1334/2008, maximum amount of beta-asarone in alcoholic beverages: 1mg/kg, li-censed anthroposophicmedicinal product acc.to Section 21 AMG, toxic + (Roth/Daunderer),mildly toxic II to toxic III (Wink/Wyk)

Risks reported for tetraploid variantse.g. A. calamus var. angustatus BESS.because of their high beta-asaronecontent. Beta-asarone demonstrateda mutagenic and carcinogenic ef-fect in animal experiments (Hager,Frohne/Pfänder); diploid subspeciese.g. A. calamus L. var. americanus(RAF.) WULFF. are free from beta-asarone

Beta-asarone

Positivemonograph, indications: slightlyreduced cardiac output, especially whenaccompanied by nervous symptoms, verytoxic Ib (Wink/Wyk), highly toxic ++ (Roth/Daunderer)

Nausea, vomiting, cardiac arrhythmia,contraindications and interactionsreported (Commission Emonograph),cardiac arrest, symptoms of cardiacglycoside poisoning, diuresis, digestivetract irritation (Wink/Wyk)

cardioactive gly-cosides (someprescription-only)

Commission E: 0.6–3 g standard-ised Adonis powder (DAB 9)/day,equivalent preparations

Neutral monograph

Neutral monograph, HMPCmonograph:traditional use

11


Stock plant(Latin)



Seed Not NFS

Agrimonia eupatoria L., syn.Agrimonia adherens GILIB., Agri-monia officinalis LAM., Agrimoniaparviflora SPRENG., Amonia ag-rimonoides STEUD., Aremoniaagrimonoides D.C.

Herb T

Agrimonia procera WALLR.,syn. Agrimonia odorata auct.non MILLER, Agrimonia odorataWALLR.

Herb T

Agropyron repens (L.) P. BEAUV.,syn. Elymus repens (L.) GOULD,Elytrigia repens DESV. ex NEVSKI,Triticum repens L.

Root T

Alchemilla alpina L. em. BUSER Herb Alchemilla vulgaris auct., Al-chemilla vulgaris L.

Herb T

Alkanna tuberculata (FORSSK.)MEIKLE, syn. Alkanna tinctoria(L.) TAUSCH, Alkanna tuberculataGREUTER, Lithospermum tincto-rium L.

Root

Allium cepa L., syn. Allium escu-lentum SALISB., Cepa esculentaS.F. GRAY, Cepa vulgaris RENAULT,Kepa esculenta RAFIN., Porrumcepa RCHB.

Bulb

12




Positivemonograph, indications: symp-tomatic treatment of diseases of crural veins(chronic venous insufficiency), e.g. pain andfeeling of heaviness in legs, night leg cramps,itching and swollen legs,WHOmonograph:treatment of symptoms of chronic venousinsufficiency, including pain, feeling of heavi-ness in the legs, nocturnal calf-muscle spasms,itching and oedema, ESCOPmonograph:chronic venous insufficiency, varicosis,HMPCmonograph: treatment of chronic venous in-sufficiency, which is characterised by swollenlegs, varicose veins, a feeling of heaviness,pain, tiredness, itching, tension and crampsin the calves, traditional use, slightly toxic +(Roth/Daunderer), mildly toxic III (Wink/Wyk)

Nausea, gastrointestinal complaints,hot flushes, oedemas, vomiting,diarrhoea, hypertension, loss of con-sciousness, circulatory collapse (Wink/Wyk, Roth/Daunderer)

Saponins Commission E: 100mg aescin/day, equivalent to 250–312.5 mgextract in delayed release form2 times a dayESCOP: equivalent to 50–150mgtriterpene glycosides (calculatedas aescin), no administration tochildrenWHO: 250–312.5 mg stan-dardised comminuted extract,equivalent to 100mg aescin

Positivemonograph, indications: mild, non-specific, acute forms of diarrhoea, inflam-mations of oral and pharyngeal mucosa,ESCOPmonograph: Agrimony has widelydocumented uses as a remedy to treat milddiarrhoea,HMPCmonograph: in progress,standard marketing authorisation: 2379.99.99

Commission E: 3–6 g drug/day,equivalent preparationsESCOP: 3–12 g drug, 3 timesa day, children!

Positivemonograph, indications: mild, non-specific, acute forms of diarrhoea, inflam-mations of the oral and pharyngeal mucosa,HMPCmonograph: in progress

Commission E: 3–6 g drug/day,equivalent preparations

Positivemonograph, indications: increaseof urinary output for catarrhs of the lowerurinary tract, adjuvant treatment of catar-rhs of the upper respiratory tract, standardmarketing authorisation: 1169.99.99, con-traindications reported, ESCOPmonograph:irritable bladder and other urinary tract disor-ders,HMPCmonograph: traditional use

Contraindications: irrigation therapyof oedemas associated with cardiacor renal insufficiency (Commission Emonograph)

Commission E: 6–9 g drug/day,equivalent preparationsESCOP: 5–10 g drug/day, noadministration to children underthe age of 12

Neutral monograph

Positivemonograph, indications: mild, non-specific forms of diarrhoea


Substance of concern (AMK – Drug Commis-sion of German Pharmacists), BfArM [FederalInstitute for Drugs and Medical Devices]graduated plan of 5 June 1992 concerningmedicinal products containing pyrrolizidinealkaloids, toxic II (Wink/Wyk), toxic + (Roth/Daunderer)

Pyrrolizidine alkaloids contained inthe drug are mutagenic, carcinogenic,ingestion of high doses causes di-gestive problems and CNS disorders(Wink/Wyk)

Pyrrolizidinealkaloids

Positivemonograph, indications: loss of ap-petite, prevention of age-dependent vascularchanges,WHOmonograph: the principal useof Bulbus Allii Cepae today is to prevent age-dependent changes in the blood vessels, andloss of appetite, non-toxic but irritating toskin (Roth/Daunderer), mildly toxic III (Wink/Wyk),HMPC assessment report

Ingestion of higher doses, especially inchildren, causes digestive tract irrita-tion accompanied by vomiting, nausea,colic and diarrhoea (Wink/Wyk)

Allicin, allyl sul-phide

Commission E: 50 g fresh onionsor 20 g dried drug, equivalentpreparationsWHO: 20 g drug/day, equivalentpreparations

13


Stock plant(Latin)


Allium porrum L., syn. Alliumampeloprasum ß. porrum GAY,Allium laetum SALISB.

Leaf

Allium sativum L., syn. Porrumsativum RCHB.

Bulb

Allium ursinum L., syn. AlliumlatifoliumGILIB., Allium nemoraleSALISB.

Herb S

Aloe barbadensis MILL., Aloe chi-nensis BAK.

Leaf gel

Aloe barbadensis MILL., Aloe chi-nensis BAK.

Leaf juice

14




Positivemonograph, indications: adjuvanttreatment of increased blood lipid concen-trations, prevention of age-related vascularchanges,WHOmonograph: as an adjuvantto dieteticmanagement in the treatmentof hyperlipidaemia, and in the preventionof atherosclerotic (age-dependent) vascu-lar changes. The drug may be useful in thetreatment of mild hypertension, ESCOPmonograph: prophylaxis of atherosclero-sis, treatment of elevated blood lipid levelsinsufficiently influenced by diet, also usedfor respiratory tract infections and catarrhalconditions, although clinical data to supportthis indication is not available,HMPCmono-graph: in progress, BfArM graduated plan of11 Mar 2008 concerning medicinal productscontaining plant substances or preparationsof Allium sativum (http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-allium-sativum.html), toxic for hu-mans only after overdose + (Roth/Daunderer),mildly toxic III (Wink/Wyk)

Higher doses may have a toxic effect(especially in children), digestive tractirritation accompanied by vomiting,excessive sweating, nausea, colic anddiarrhoea (Wink/Wyk)

Alliin, allicin, allylsulphide

Commission E: 4 g fresh garlic/day, equivalent preparationsESCOP: 0.5–1 g drug/dayWHO: 0.4–1.2 g powder or 2–5 gfresh garlic/day

non-toxic or hardly toxic (+) (Roth/Daunderer), mildly toxic III (Wink/Wyk)

Ingestion of higher doses, especially inchildren, causes digestive tract irrita-tion accompanied by vomiting, nausea,colic and diarrhoea (Wink/Wyk)

Allicin, allyl sul-phide

Mucilage from the parenchymatous tissue ofthe leaf interior, free from anthranoids, addi-tion of isolated aloin prohibited by Reg. (EC)No. 1334/2008,WHOmonograph: (traditionaluse, external)

WHO: 10–70% of fresh gel forexternal use

Positivemonograph, indications: con-stipation,WHOmonograph: short-termtreatment of occasional constipation, ESCOPmonograph: for short term use in cases ofoccasional constipation,HMPCmonograph:short-term use in cases of occasional consti-pation, BfArM graduated plan of 21 June 1996concerning medicinal products for humanuse containing anthranoid-containing plantgenera, toxic II (Wink/Wyk), toxic + (Roth/Daunderer)

gastrointestinal cramps observed inindividual cases, long-term use/abusecauses electrolyte loss, in particularpotassium, albuminuria and haema-turia. Loss of potassiummay causecardiac dysfunction andmuscularasthenia (Commission E processingmonograph), menstrual and uterinehaemorrhage. Long-term use observedto cause functional disorders of thegenital system accompanied by fol-licular atresia and hypertrophy ofinterstitial tissue. Abortionmay oc-cur, strong laxative effect, intestinalbleeding, tenesmus, haemorrhoids, in-creased diuresis, renal irritation (Roth/Daunderer)

Anthranoids(e.g. aloin/Aloeemodin)

Commission E, ESCOP:equivalent to 10–30mg hy-droxyanthracene derivatives(calculated as barbaloin)/day, noadministration to children underthe age of 10WHO: 0.1 g drug/day, singledose: 40–110mgHMPC: equivalent to 10–30mghydroxyanthracene derivatives(calculated as barbaloin)/day, noadministration to children underthe age on 12

15

http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-allium-sativum.html




Stock plant(Latin)


Aloe feroxMILL., syn. Aloe horridaHAW., Pachidendron ferox HAW.

Leaf juice

Alpinia galanga (L.) WILLD., syn.Maranta galanga L.

Rhizome S, T

Alpinia officinarum HANCE Rhizome S, T

Althaea officinalis L., Leaf T

Althaea officinalis L., Root T

Althaea rosea L. Flower T

Amaranthus caudatus L. Seed Amaranthus cruentus L. Seed Amaranthus tricolor L. Herb Ammi visnaga (L.) LAM., syn. Dau-cus visnaga L., Apium visnagaCRANTZ

Fruit Not NFS

Ananas comosus (L.) MERR. Fruit Anemone spp. all plant parts

AnemopaegmamirandumMART. Bark Not NFS

Anethum graveolens L. Fruit S

Anethum graveolens L. Herb S

Angelica archangelica L.,syn. Angelica archangelica ALL.

Stem T, S

16




Positivemonograph, indications: con-stipation,WHOmonograph: short-termtreatment of occasional constipation, ES-COPmonograph: for short term use in casesof occasional constipation,HMPCmono-graph: short-term use in cases of occasionalconstipation, BfArM graduated plan of 21 June1996 concerning medicinal products for hu-man use containing anthranoid-containingplant genera, toxic II (Wink/Wyk), toxic (Roth/Daunderer)

gastrointestinal cramps observed inindividual cases, strong laxative ef-fect, intestinal bleeding, tenesmus,haemorrhoids, increased diuresis, elec-trolyte loss (in particular potassium),whichmay cause cardiac dysfunctionand muscular asthenia, albumin-uria, haematuria (Commission Emonograph), menstrual and uterinehaemorrhage. Long-term use observedto cause functional disorders of thegenital system accompanied by fol-licular atresia and hypertrophy ofinterstitial tissue, abortionmay occur(Roth/Daunderer)

Anthranoids Commission E: 20–30mg hy-droxyanthracene derivatives/day, calculated as anhydrousaloinESCOP: preparations equivalentto 10–30mg hydroxyanthracenederivatives (calculated as bar-baloin)/day, no administration tochildren under the age of 10HMPC: equivalent to 10–30mghydroxyanthracene derivatives(calculated as barbaloin)/day, noadministration to children underthe age of 12

Positivemonograph, indications: digestiveproblems, loss of appetite


Positivemonograph, indications: inflam-mations of the oral and pharyngeal mucosa,dry cough, mild inflammations of the gastricmucosa, standard marketing authorisation:1469.99.99

Commission E: 5 g drug/day,equivalent preparations

Positivemonograph, indications: inflamma-tions of the oral and pharyngeal mucosa, drycough, ESCOPmonograph: dry cough, irrita-tion of the oral pharyngeal or gastric mucosa,WHOmonograph, HMPCmonograph: tradi-tional use, standard marketing authorisation:8899.99.99

Commission E: 6 g drug/day,equivalent preparationsESCOP,WHO: 0.5–3 g drug, up to15 g drug/day

Negativemonograph: due to risks,WHOmonograph: as anantispasmodic, musclerelaxant and vasodilator, non-toxic or hardlytoxic (+) (Roth/Daunderer)

slightly phototoxic, overdose and long-term use cause vertigo, nausea, con-stipation, lack of appetite, headache(Hänsel/Sticher, Roth/Daunderer)

Fura-nochromones(e.g. visnagin,khellin)

WHO: 50–150mg drug/day,administration to children onlyunder medical supervision

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Nausea and CNS disorders, digestiveand kidney problems, blistering andulceration, skin rash (Wink/Wyk)

Protoanemonin

individually or mixed with other barks desig-nated as catuaba

Positivemonograph, indications: digestiveproblems,WHOmonograph: treatment ofdyspepsia, gastritis and flatulence, and stom-ach ache

Commission E,WHO: 3 g drug/day, equivalent preparations

Neutral monograph

Negativemonograph: due to risks, slightlytoxic (+) (Roth/Daunderer)

phototoxic Coumarins, furo-coumarins

17


Stock plant(Latin)


Angelica archangelica L.,syn. Angelica archangelica ALL.

Root F

Angelica silvestris L., syn. Angelicabrachyradia FREYN

all plant parts Not NFS

Angelica sinensis (OLIV.) DIELS all plant parts Not NFS

Antennaria dioica (L.) GAERTN.,syn. Cyttarium dioicum (L.) PE-TERM., Gnaphalium dioicum L.

Flower C

Anthriscus cerefolium (L.) HOFFM.var. cerefolium [var. sativus (LAM.)ENDL.]

Herb S

Apium graveolens L., syn. Apiumcelleri GÄRTNER, Celeri graveolensBRITTON, Selinum graveolensE.H.L. KRAUSE, Seseli graveolensSCOP., Sison ruta BURM.

Leaf S


Fruit S, T


Root, stem

Aquilegia vulgaris L., syn. Aquilegiacornuta GILIB.

all plant parts

Arctium lappa L., syn. Articumma-jus BERNH., Lappa major GAERTN.

Root T

Arctostaphylos uva-ursi (L.)SPRENGEL, syn. Arbutus uva-ursi L., Arctostaphylos mediaGREENE

Leaf Not NFS

18




Positivemonograph, indications: lack ofappetite, digestive problems such as mildgastrointestinal cramps, feeling of fullness,bloating, standardmarketing authorisation:1419.99.99, ESCOPmonograph: dyspepticcomplaints such as mild gastrointestinalspasms, sluggish digestion, flatulence andfeeling of fullness, loss of appetite, anorexia,bronchitis, slightly toxic (+) (Roth/Daunderer)


Commission E: daily dose: 4.5 gdrug or 1.5–3 g fluid extract (1:1)or 1.5 g tincture (1:5), equivalentpreparationsESCOP: 3–6 g drug/day, no ad-ministration to children

WHOmonograph (root): traditional use,HMPC assessment report


WHO: 4.5–9 g drug/day, no ad-ministration to children

Neutral monograph

Estragole(Dmethyl chavi-col)

Negativemonograph: due to risks phototoxic, Commission E: celerymayinduce allergic reactions and evenanaphylactic shock (celery-carrot-mugwort syndrome)

Furocoumarins


Furocoumarins


Furocoumarins

toxic II (Wink/Wyk), toxic + (Roth/Daunderer),whole plant, especially the seeds

Vertigo, pupillary changes, dizziness,loss of consciousness, dyspnoea (Wink/Wyk), diarrhoea (Roth/Daunderer)

Isoquino-line alkaloids(e.g. mag-noflorine),cyanogenic glyco-sides

HMPCmonograph: traditional use

Positivemonograph, indications: inflam-matory diseases of the lower urinary tract,WHOmonograph, HMPCmonograph: tradi-tional use, standard marketing authorisation:8299.99.99, ESCOPmonograph: uncompli-cated infections of the lower urinary tract suchas cystitis, when antibiotic treatment is notconsidered essential, mildly toxic III (Wink/Wyk), slightly toxic (+) (Roth/Daunderer)

Nausea and vomitingmay occurin people with a weak stomach(Commission Emonograph), uteruscontractions, long-term use maycause symptoms of poisoning suchas haemolytic anaemia, cachexia,fatty liver disease and hair dis-colouration resulting from therelease of hydroquinones and/ormethylhydroquinones in the body,contraindications and interactionsreported (Roth/Daunderer)

Hydroquinones(e.g. arbutin)

Commission E,WHO: 3 g in150ml water, up to 4 times a day,no administration to childrenunder the age of 12ESCOP: equivalent to 400–800mg arbutin/day, noadministration to children

19


Stock plant(Latin)


Arctostaphylos uva-ursi (L.)SPRENGEL, syn. Arbutus uva-ursi L., Arctostaphylos mediaGREENE

Fruit

Areca catechu L. Fruit

Argyreia nervosa (BURM.f.) BOJ.,syn. Argyreia speciosa (L.f.) SWEET,Convolvulus nervosus BURM.f.

Seed

Aristolochia spp. all plant parts

Armoracia lapathifolia GILIB., syn.Armoracia rusticana G.M. SCH., Ar-moracia sativa BERNH., Cardaminearmoracia O. KTZE.

Root

Arnica montana L., syn. Doron-icum arnica DESF.

Flower

Aronia melanocarpa (MICHX.)ELLIOT

Fruit

Artemisia abrotanum L., syn.Artemisia abrotanifolium SALISB.,Artemisia angustifolia S.F. GRAY

Herb S, T

Artemisia absinthium L., syn.Absinthiummajus GEOFFR.,Absinthium officinale LAM., Ab-sinthium vulgare LAM.

Herb T

20




toxic II (Wink/Wyk), toxic + (Roth/Daunderer),psychotropic. Consumption in the form of“betel quids” consisting of areca seeds, betelleaves (Piper betle), dissolved lime as well asflavour-enhancing additives. When chewed,the alkaloid arecaidine (hydrolysis of arecol-ine) is released, which has a central stimulatingeffect. CNS-stimulant, narcotic

neurotoxic, arecoline activates mAChR,therefore psychotropic, stimulatessalivation, bradycardia, respiratory andcardiac arrest. People who regularlychew betel quids often suffer from oraltumours (Wink/Wyk). Higher doses(8–10 g seeds) may be fatal (Hager)

Alkaloids(e.g. arecoline,arecaidine)

toxic Ib to very toxic II (Wink/Wyk) psychotropic, highly psychedelic, effectsimilar to that of LSD, seeing colours(Wink/Wyk)

Ergot alkaloids(e.g. lysergic acid,ergine D lysergicacid amide, LSA)

BfArM graduated plan of 3 June 1981 concern-ing medicinal products containing aristolochicacid, including phytotherapeutic and home-opathic medicinal products, and BfArMgraduated plan of 22 June 2010 concerningmedicinal products produced using plantsof the Asarum genus of the Aristolochiaceaefamily, substance of concern (AMK), toxic II(Wink/Wyk), toxic + (Roth/Daunderer)

Vomiting, gastroenteritis, drop inblood pressure, cramps, tachycar-dia, serious damage to urinary tractand kidneys may occur, aristolochicacids have a mutagenic and carcino-genic effect, ingestion of higher dosesmay cause death in coma by apnoea(BfArM, Roth/Daunderer)

Aristolochic acids

Positivemonograph, indications: catarrhs ofthe respiratory tract, adjuvant treatment oflower urinary tract infections

gastrointestinal complaints, con-traindications reported (Commission Emonograph)

Commission E: 20 g fresh root/day, equivalent preparations

Positivemonograph for external use only,standard marketing authorisation: 5799.99.99(tincture), 8199.99.99 (flower),WHOmono-graph, ESCOPmonograph: for external useonly, toxic II (Wink/Wyk), slightly toxic (+) butoften sensitising (Roth/Daunderer),HMPCmonograph: in progress (external use)

Skin irritation, severe gastroenteritisaccompanied by diarrhoea and gastricpain, headache, vertigo, bradycardia,anxiety and agitation, strong heartbeat,abortifacient effect (Wink/Wyk), dueto its toxic side effects observed, arnicashould not be used internally (Roth/Daunderer) (AMKdA)

Sesquiterpenelactones (e.g. hele-nalin)

Commission E, ESCOP,WHO:2 g drug/day for external use

Positivemonograph, indications: loss of ap-petite, digestive problems, dyskinesia of thebiliary tract, ESCOPmonograph: Anorexia, forexample after illness, dyspeptic complaints,HMPCmonograph: traditional use, stan-dardmarketing authorisation: 1339.99.99,mildly toxic II to toxic III (Wink/Wyk), slightlytoxic (+) to toxic + (Roth/Daunderer)

Vomiting, severe diarrhoea, dizziness,headache and cramps (Wink/Wyk)

Thujone Commission E: 2–3 g drug/dayas water extractESCOP: 1–1.5 g drug in 150mlwater up to 3 times a day

21


Stock plant(Latin)


Artemisia cina O.C. BERG etC.F. SCHMIDT, syn. Artemisiacina BERG, Artemisia mogoltavicaPOLJAK.

Flower, seed

Artemisia dracunculus L., syn.Artemisia inodoraWILLD.,Artemisia redowskyi LEBED.,Oligosporus condimentarius CASS.

Leaf T, S

Artemisia vulgaris L., syn.Artemisia lactifloraWALL. ex DC.,Artemisia samamisica BESS.

Herb S, T

Arum spp. all plant parts

Asarum europaeum L., syn.Asarum officinale MOENCH.

all plant parts

Aspalathus linearis (BURM.F.)DAHLG., syn. Aspalathus contami-nata (THUNB.) DRUCE, Aspalathuscognata PRESL., Borbonia pinifoliaMARL., Lebeckia linearis (BURM.F.)DC., Psoralea linearis BURM.F.

Herb T

Asparagus officinalis L., syn.Asparagus altilis ASCHERS., As-paragus hortensis MILL.

Rhizome

Aspidosperma quebracho-blancoSCHLECHT., syn. Aspidospermachakensis SPEG., Macaglia quebra-cho O. KTZE.

Bark, wood

Astragalus membranaceus (FISCH)BGE., syn. Phaca membranaceaFISCH. INDC.

Root Not NFS

22




very toxic Ib (Wink/Wyk), highly toxic ++(Roth/Daunderer)

Loss of consciousness, epileptic fits,visual disturbances, excessive gall pro-duction, icterus, diarrhoea, nausea,vomiting, cold spells, hypersalivation,excessive lacrimation, dyspnoea, facialmuscle cramps, haematuria resultingfrom kidney damage, crural paralysis,delirium, coma, death by respiratoryarrest (Wink/Wyk)

Sesquiterpenelactones (e.g. san-tonin, artemisin)

concerning estragole content, s. BfRstatement: http://www.bfr.bund.de/cm/208/minimierung_von_estragol_und_methyleugenol_gehalten_in_lebensmitteln.pdf

Estragole and methyl eugenol demon-strated a genotoxic effect in in-vitroand in-vivo animal experiments (SCF,BfR)

Estragole(Dmethyl chav-icol), methyleugenol

Negativemonograph: due to risks abortifacient effect reported, allergicreactions may be induced after pre-vious sensitisation (Commission Emonograph), belongs to themost po-tent plant allergens (Schilcher)

Thujone, cam-phor, eucalyptol(D1,8-cineol)

extremely toxic Ia (Wink/Wyk), extremelytoxic +++ (Roth/Daunderer)

Irritating to skin, burning in themouth and throat, cardiac arrhyth-mia, cramps, internal haemorrhage,CNS disorders, digestive problems(Wink/Wyk), hypersalivation, gingival,gastrointestinal and uterine bleeding(Roth/Daunderer)

Aroin, saponins,cyanogenic glyco-sides

toxic II (Wink/Wyk), toxic + (Roth/Daunderer),substance of concern (AMK), due to detectionof aristolochic acids, BfArM graduated planprocedure resulted in recall of medicinal prod-ucts containing Asarum species: http://www.bfarm.de/cae/servlet/contentblob/1207042/publicationFile/

Ingestion of high doses causes di-gestive problems and CNS disorders,burning in the mouth and throat,nausea, vomiting, gastric pain, gas-troenteritis accompanied by diarrhoeaand uterine haemorrhage, in extremecases death by central apnoea (Wink/Wyk, Roth/Daunderer)

Asarone, aris-tolochic acids

Positivemonograph, indications: irrigationtherapy of inflammatory diseases of the lowerurinary tract and prevention of kidney gravel

Commission E: 45–60 g drug,equivalent preparations

highly toxic ++ (Roth/Daunderer), toxic Ib tovery toxic II (Wink/Wyk)

affects vessels (vasoconstrictive), affectsrespiratory activity, local anaestheticaction, emetic in high doses (Roth/Daunderer, Wink/Wyk)

Indole alkaloids(e.g. aspidosper-mine, yohimbine)

WHOmonograph: traditional use WHO: 9–30 g/day

23

http://www.bfr.bund.de/cm/208/minimierung_von_estragol_und_methyleugenol_gehalten_in_lebensmitteln.pdf




http://www.bfarm.de/cae/servlet/contentblob/1207042/publicationFile/




Stock plant(Latin)


Atropa belladonna L. all plant parts

Avena sativa L., syn. Avena cinereaROEM. et SCHULT.

Herb

Avena sativa L., syn. Avena cinereaROEM. et SCHULT.

Fruit

Backhousia citriodora F. MUELL. Leaf S

Banisteriopsis caapi (SPRUCE exGRISEB.)MORTON, syn. Banisteri-opsis inebrians MORTON

Bark, wood

Barosma betulina (THUNB.)BARTL. etWENDL., syn. Agath-osma betulina (BERG.) PILLANS

Leaf F

Bellis perennis L. Flower T

Berberis vulgaris L. Fruit

Berberis vulgaris L. Bark

Berberis vulgaris L. Root, root cortex

Beta vulgaris L. ssp. vulgaris var.Conditiva ALEF.

Tuber

Betula pendula ROTH and Betulapubescens EHRH.

Leaf T

24




Positivemonograph: cramps and colic-likepain in the gastrointestinal and biliary tract,extremely toxic Ia (Wink/Wyk), extremelytoxic +++ (Roth/Daunderer), isolated tropanealkaloids contained in the drug prescription-only, deadly nightshade pharmacy-only

psychotropic, all plant parts extremelytoxic, dry mouth, accommodationdifficulties, reddened and dry skin,hyperthermia, tachycardia, hallucina-tions, cramps, micturition difficulties,delirium, fever, cardiac arrest, apnoea,death, contraindications and interac-tions withmedicinal products reported(Frohne, Commission Emonograph)

Tropane alkaloids(e.g. atropine,L-hyoscyamine,scopolamine)

Commission E: Belladonnaepulvis normatus: average singledose 0.05–0.1 g, max. single dose:0.2 g equivalent to 0.6mg totalalkaloids, max. daily dose: 0.6 gequivalent to 1.8mg total alka-loids; Belladonnae radix: averagesingle dose: 0.05 g, max. dailydose: 0.3 g equivalent to 1.5mgtotal alkaloids



highly toxic ++ (Roth/Daunderer), toxic II(Wink/Wyk), used to produce ayahuasca, yagéor caapi

Beta-carboline alkaloids contained inthe drug are strong monoamine oxi-dase (MAO) inhibitors, hallucinations,mydriasis, hypersalivation, vomiting,sweating, nausea, tremor, abdominalpain, rectal tenesmus (Wink/Wyk)

Beta-carbolinealkaloids (e.g. har-mala, harmaline)

Neutral monograph gastric irritation (Schilcher) Diosphenol andpulegone

Neutral monograph: toxic II (Wink/Wyk),slightly toxic (+) (Roth/Daunderer). Ripeberries are edible (Roth/Daunderer), alkaloidcontent decreases with increasing maturity(Hager)

Isoquino-line alkaloids(e.g. berberine)

Negativemonograph: due to risks, toxic II(Wink/Wyk), slightly toxic (+) (Roth/Daunderer),WHOmonograph: used orallyfor the treatment of digestive complaints, suchas dyspepsia, diarrhoea, gastritis, feelings ofdistention and flatulence

Dizziness, nasal bleeding, vomiting,diarrhoea, renal irritation, nephri-tis, ingestion of higher doses causespoisoning by respiratory arrest andhaemorrhagic nephritis (Wink/Wyk)


WHO: 0.5–1 g drug, 3 times a day,no administration to childrenunder the age of 12

Negativemonograph: due to risks, toxic II(Wink/Wyk), slightly toxic (+) (Roth/Daunderer)

Dizziness, nasal bleeding, vomiting,diarrhoea, renal irritation, nephri-tis, ingestion of higher doses causespoisoning by respiratory arrest andhaemorrhagic nephritis (Wink/Wyk)


Positivemonograph, indications: irrigationtherapy of bacterial, inflammatory and otherdiseases of the lower urinary tract and kid-ney gravel, adjuvant treatment of rheumaticsymptoms, standard marketing authori-sation: 8399.99.99, ESCOPmonograph:irrigation of the urinary tract, especially incases of inflammation and renal gravel andas an adjuvant in the treatment of bacterialinfections,HMPCmonograph: traditionaluse

Contraindications: irrigation therapyof oedemas associated with cardiacor renal insufficiency (Commission Emonograph)

Commission E: 6–10 g drug/day,equivalent preparations, aver-age daily dose: 2.0–3.0 g drug,several times a day, equivalentpreparationsESCOP: 2–3 g drug, 2–3 timesa day, equivalent preparations

25


Stock plant(Latin)


Bixa orellana L., syn. Bixa POIR.,Bixa platycarpa RUIZ et PAV.

Seed S

Borago officinalis L. Herb S

Borago officinalis L. Seed

Boswellia serrata ROXB. exCOLEBR., syn. Boswellia glabraROXB., Boswellia thurifera ROXB.ex FLEM., Libanus thuriferusCOLEBR.

Resin Not NFS

Brassica nigra (L.) KOCH, syn. Bras-sica bracteoloata FISCH et MEY.,Crucifera sinapis E.H.L. KRAUSE,Erysimum glabrum PRESL.,Melanosinapis communis SCHIMP.et SPENN., Mutarda nigra BERNH.,Sinapis nigra L.

Seed S

Brassica oleracea L. Inflorescence, stem Brassica oleracea L. var. suttoni-ana LEV., syn. Crucifera brassicaE.H.L. KRAUSE

Leaf

Brassica oleracea var. sabellica L. Leaf Brugmansia spp. all plant parts

Bryonia spp. Root

26




used as spice or colouring (Teuscher, Gewürz-drogen), extracts of it as additive E160b,colouring, restrictions of use as additive acc.to Annexes 1b, 1c of the ZZulV [Regulationon the Authorisation of Food Additives], asfrom 1 June 2012 use acc. to Reg. (EU) No.1129/2011, specification acc. to Reg. (EU) No.231/2012

Negativemonograph: due to risks, toxic II(Wink/Wyk), non-toxic to hardly toxic (+)(Roth/Daunderer), borage is a substance ofconcern as it contains pyrrolizidine (AMK),due to this pyrrolizidine content, it shouldonly be used sparingly (Teuscher), BfArMgraduated plan of 5 June 1992 concerningmedicinal products containing pyrrolizidine

contains varying amounts of toxicpyrrolizidine alkaloids (PA), whichare known to have an organotoxic,in particular hepatotoxic effect. PAdemonstrated a carcinogenic effectwith a genotoxic mechanism of actionin animal experiments (Hager). Allplant parts contain varying amounts ofpyrrolizidine alkaloids.


toxic II (Wink/Wyk), licensed anthroposophicmedicinal product, indications: haemorrhoids,varicose syndrome, borage is a substance ofconcern as it contains pyrrolizidine (AMK),BfArM graduated plan of 5 June 1992 con-cerning medicinal products containingpyrrolizidine, the cold-pressed oil of borageseeds is usually used as food

contains varying amounts of toxicpyrrolizidine alkaloids (PA), whichare known to have an organotoxic,in particular hepatotoxic effect. PAdemonstrated a carcinogenic effectwith a genotoxic mechanism of actionin animal experiments (Hager). Allplant parts contain varying amounts ofpyrrolizidine alkaloids. Cold-pressedborage oil contains no or only tracesof pyrrolizidine alkaloids. (Frohne/Pfänder)


WHOmonograph: orally for the managementof arthritis, bronchial asthma, Crohn’s diseaseand ulcerative colitis, ESCOPmonograph:relief of painful osteoarthritis, symptomatictreatment of inflammatory bowel disease

ESCOP: 250–3,600mg/dayWHO: 1–3 g drug/day

Harmful in high doses (+) (Roth/Daunderer),toxic II–III (in high doses) (Wink/Wyk)

Ingestion of high doses causes gas-trointestinal complaints, nausea,vomiting, diarrhoea, severe poisoningcauses central paralysis, bradycardiaand bradypnoea, even coma and death(Roth/Daunderer, Wink/Wyk)

Glucosinolates

formerly belonged to the genus of Datura,extremely toxic +++ (Roth/Daunderer), ex-tremely toxic Ia (Wink/Wyk)

psychotropic, CNS-inhibitor and seda-tive in low concentrations, ingestionof high doses causes hallucinations,euphoria, disorientation, insomniaand even death by respiratory arrest(Wink/Wyk)

Alkaloids (tropanealkaloids, e.g. L-hyoscyamine,L-scopolamine,atropine)

Negativemonograph: due to risks, use asdrastic laxative and emetic obsolete, verytoxic Ib (Wink/Wyk), highly toxic ++ ( Roth/Daunderer)

Vertigo, vomiting, intense colic, severewatery, sometimes also bloody diar-rhoea, gastroenteritis, kidney damage,abortion, cramps, death by respiratoryarrest (Wink/Wyk, Roth/Daunderer)

Cucurbitacins

27


Stock plant(Latin)


Buxus sempervirens L. all plant parts

Calendula officinalis L., syn. Calen-dula officinalis var. anemonaefloraHORT., Calendula officinalis var.hortensis FIORI, Calendula san-tamaria FONT-QUER, Calthaofficinalis MOENCH

Flower T

Calluna vulgaris (L.) HULL, syn.Calluna sagittaefolia GRAY, Ericavulgaris L.

Herb T

Camellia sinensis (L.) O. KUNTZE,syn. Camellia assamica (J.W. MAS-TERS)W. WIGHT, Camelliachinensis (SIMS) KUNTZE, Theabohea L., Thea viridis RAF.

Leaf, leaf bud T

Cannabis sativa L. Seed

Capparis spinosa L. Bud S

Capsella bursa-pastoris (L.)MEDIK., syn. Bursa pastorisWIGG.,Capsella polymorpha CAV., Iberisbursa-pastoris CRANTZ

Herb T

Capsicum annuum L. convar.grossum

Fruit

Capsicum frutescens L. Fruit S

Carica papaya L., syn. Caricahermaphrodita , Papaya caricaGAERTN., Papaya vulgaris DC.

Leaf Not NFS

Carica papaya L., syn. Caricahermaphrodita , Papaya caricaGAERTN., Papaya vulgaris DC.

Fruit

Carthamus tinctorius L. Flower C

28





Contact dermatitis, ingestion causesfirst excitement then paralysis anddrop in blood pressure, nausea, vom-iting, diarrhoea, vertigo, crampscirculatory collapse, death by respi-ratory arrest (Wink/Wyk)

steroidal alkaloids

Positivemonograph: for external use,WHOmonograph, HMPCmonograph: traditionaluse, ESCOPmonograph: for external use only,standard marketing authorisation: 1209.99.99

ESCOP: external use onlyWHO: external use onlyCommission E: 1–2 g/150ml forexternal, local use

Neutral monograph

HMPCmonograph: in progress (unfermentedleaves)

Cannabis sativa as well as the cannabionid9-tetrahydrocannabinol (THC) are subject to theprovisions of the BtMG [Narcotic Drugs Act].According to Annex I to Section I Clause 1BtMG, the seeds of C. sativa are exemptedfrom this, unless they are intended for illegalcultivation. Processing in food productionas well as distribution of products producedusing Cannabis seeds is thus permitted underthe Narcotic Drugs Act. Mildly toxic III (Wink/Wyk), toxic + (Roth/Daunderer)

euphorigenic and hallucinogenic ef-fect, aphrodisiac, overdose causescardiac complaints and CNS disorders,state of intoxication, illusion,mydria-sis, impaired reactions, loss of sense oftime, incorrect estimation of distanceand speed, impaired concentration andattention, disorientation, impaired co-ordination, accelerated pulse, suddenblackout may occur after 1–3 months(Roth/Daunderer)

Cannabinoids(e.g. THC)

irritating, skin irritationmay oc-cur on contact with the plant (Roth/Daunderer)

Leek oils, glucosi-nolates

Positivemonograph, indications: mildmen-orrhagia, nasal bleeding,HMPCmonograph:traditional use, standard marketing authori-sation: 1539.99.99

Commission E: 10–15 g drug/day, equivalent preparations

HMPCmonograph: in progress

Positivemonograph: for external use, ES-COPmonograph: for external use, mildlytoxic III (Wink/Wyk), slightly toxic + (Roth/Daunderer),HMPCmonograph: in progress

chronic poisoning resulting fromabuse (e.g. overdose as spice) is ac-companied by lack of appetite, chronicgastritis, kidney and liver damage(Roth/Daunderer)

Capsaicin

Neutral monograph

WHOmonograph: treatment of amenor-rhoea, dysmenorrhoea and wounds or soreswith pain and swelling, and prevention ofatherosclerosis, used as colouring and colour-ing food (safflower)

WHO: 3–9 g drug/day

29


Stock plant(Latin)


Carum carvi L., syn. Apium carvi(L.) CRANTZ, Seseli carvi LAM.,Ligusticum carvi ROTH.

Fruit T, S

Cassia fistula L., syn. Bactyrilobiumfistula WILLD., Cassia bonplan-diana DC., Cassia excelsa H.B.K.,Cassia fistuloides COLL., Catharto-carpus excelsus G. DON

Fruit F

Cassia senna L. syn. Cassia acuti-folia DEL., Senna acutifolia LINKand Cassia angustifolia VAHL. syn.Cassia lanceolataWIGHT et ARN.,Senna alexandrina MILL., Sennaangustifolia BATKA

Leaf, fruit

Catha edulis FORSK., syn. Cathaedulis (VAHL.) FORSK. ex ENDL,Celastrus edulis VAHL.

all plant parts

Catharanthus roseus (L.) G. DON,syn.Vinca rosea L., Lochnera rosea(L.) RCHB., Ammocallis SMALL

all plant parts

Caulophyllum thalictroides (L.)MICHX., syn. Leontice thalic-troides L.

all plant parts

Centaurea cyanus L., syn. Cyanusarvensis MOENCH, Cyanus sege-tum LAM.

Flower T

30




Positivemonograph, indications: diges-tive problems such as mild gastrointestinalcramps, bloating and feeling of fullness, stan-dardmarketing authorisation: 1109.99.99,ESCOPmonograph: spasmodic gastro-in-testinal complaints, flatulence, bloating.Flatulent colic of infants,HMPCmonograph:in progress

Commission E: 1.5–6 g drug/day,equivalent preparationsESCOP: 1.5–6 g drug/day

used to produce spirits

Positivemonograph, indications: short-term treatment of constipation, standardmarketing authorisation: 7399.99.99 (sennaleaves), 1259.99.99 (senna fruits, Alexandrian),1269.99.99 (senna fruits, Tinnevelly),WHOmonograph (leaves and fruits): short-termuse in occasional constipation, ESCOPmono-graph (leaves and fruits): for short-term usein cases of occasional constipation,HMPCmonograph (leaves and fruits): short-termtreatment of occasional constipation; BfArMgraduated plan of 21 June 1996 concerningmedicinal products for human use containinganthranoid-containing plant genera, slightlytoxic (+) (Roth/Daunderer), mildly toxic III(Wink/Wyk)

Electrolyte loss (in particular potas-sium) may be accompanied bymuscular asthenia and cardiac dys-function, albuminuria, haematuria,pseudomelanosis coli, aggravation ofcolonic inertia (development of laxa-tive addiction) resulting from paralysisof intestinal muscles due to loss ofpotassium, contraindications and in-teractions reported (Commission Emonograph), damage to intestinalnerves due to stimulation of uterinemuscles, risk of abortion in pregnantwomen (Hager)

Anthranoids Commission E: 20–30mg hy-droxyanthracene derivatives/day, calculated as sennoside BESCOP: preparations equivalentto 15–30mg hydroxyanthracenederivatives (calculated as sen-noside B), no administration tochildren under the age of 10WHO: 1–2 g drug/day equivalentto 10–30mg sennosides, no ad-ministration to children underthe age of 10HMPC: equivalent to 15–30mghydroxyanthracene derivatives/day (calculated as sennoside B),no administration to childrenunder the age of 12

Some plant substances are prescription-only and/or are subject to the provisionsof the Narcotic Drugs Act (BtMG), mildlytoxic II to toxic III (Wink/Wyk), toxic + (Roth/Daunderer)

psychotropic, effect similar to am-phetamines, excitement, constipation,circulatory distress (Wink/Wyk, Roth/Daunderer)

Alkaloids(e.g. cathi-none, cathine[DD-norpseudo-ephedrine])

highly toxic ++ (Roth/Daunderer), toxic Ib tovery toxic II (Wink/Wyk), BfArM graduatedplan of 20 July 1987 concerning medicinalproducts containing Madagascar rosy periwin-kle

mitotic inhibition, neurological dis-orders, nausea, vomiting, paraesthesiaof hands and feet, visual disturbancesand hearing, fever, inhibition of leu-cocytopoiesis, loss of hair, impairmentof intestinal mucosa, constipation,diarrhoea, neuromuscular vegeta-tive disorders, affects CNS andmentalstate, apoplexy (Wink/Wyk, Roth/Daunderer)

Indole alkaloids(Vinca alkaloids)

toxic Ib to very toxic II (Wink/Wyk), toxic +(Roth/Daunderer)

causes diarrhoea, vomiting and gas-troenteritis in low doses, ingestionof high doses causes burning in themouth, hypersalivation, sweating, my-driasis, uterus contractions, nausea,paralysis, also hallucinations, delirium,respiratory arrest (Wink/Wyk), risk ofabortion during pregnancy reported,oestrogenic and antispasmodic effectsreported (Roth/Daunderer)

Quinolizidine al-kaloids, saponins

Neutral monograph

31


Stock plant(Latin)


Centaurium erythraea RAFN, syn.Centauriumminus GARSAULT,Centauriumminus MOENCH P.P.,Centaurium umbellatumGILIB-ERT, Erythraea centauriumBORKH.

Herb T

Cephaelis asiatica (L.) URBAN,syn. Centella asiatica (L.) NANNF.,Centella triflora (R. et P.) NANNF.,Hydrocotyle asiatica L.

Herb

Cephaelis ipecacuanha (BROT.)A. RICH., syn. Uragoga ipecacuanha(WILLD.) BAILL., Psychotriaipecacuanha (BROT.) MUELL. ARG.(auch STOKES)

Root

Ceratonia siliqua L., syn. Ceratoniacoriacea SALISB., Ceratonia inermisSTOKES

Fruit

Chamaemelum nobile (L.) ALL.,syn. Anthemis nobilis L.

Flower T

Chelidoniummajus L., syn. Che-lidonium grandiflorumDC.,Chelidonium japonicum THUNB.,Chelidonium luteum GILIB., Cheli-donium umbelliferum STOCK.

Herb

Chenopodium ambrosioidesL. var. Anthelminticum A. GRAY,syn. Chenopodium ambrosioidesL. ssp. eu-ambrosioides AELLENvar. anthelminticumAELLEN

all plant parts

Chondrodendron tomentosumRUIZ et PAV., syn. Botryopsis platy-phylla BENTH.

all plant parts

Cicer arietinum L. Seed

32




Positivemonograph, indications: lack of ap-petite, digestive problems standard marketingauthorisation: 1319.99.99, ESCOPmono-graph: dyspeptic complaints, lack of appetite,HMPCmonograph: traditional use

Commission E: average dailydose: 6 g drug, equivalent prepa-rationsESCOP: 1–4 g drug/150ml water,up to 3 times a day

WHOmonograph, indications: extracts havebeen administered orally to treat stressin-duced stomach and duodenal ulcers, toxic II(Wink/Wyk), toxic + (Roth/Daunderer), ESCOPmonograph, indications: chron. venous in-sufficiency, varicosis, wound healing,HMPCassessment report

Irritation of skin andmucous mem-branes, ingestion of higher doses maycause digestive problems (Wink/Wyk)

Triterpenesaponins, hydro-cotyline (alkaloid)

WHO: 0.33–0.68 g drug, 3 timesa day, equivalent preparationsESCOP: 0.6 g drug, up to 4 timesa day

WHOmonograph, indications: a syrup madefrom the roots is used as an emetic, to emptythe stomach in cases of poison ingestion, ex-tremely toxic +++ (Roth/Daunderer), emetinesprescription-only, Cephaelis ipecacuana andCephaelis acuminata pharmacy-only, used inmedicinal products as an ingredient of expec-torants and emetics

Pneumonia, nausea, vomiting, bloodydiarrhoea, pain, exhaustion, brady-cardia, myoplegia, anuria (Roth/Daunderer)

Alkaloids(e.g. cephaeline,emetine)

WHO: 21–42mg total alkaloidcontent (special doses for chil-dren)

Carob bean gum additive E 410

Negativemonograph: due to risks,HMPCmonograph: traditional use

Allergic reactions may occur (Commis-sion Emonograph)

Positivemonograph, indications: cramps inthe biliary and gastrointestinal tract,WHOmonograph: used for the symptomatic treat-ment of mild to moderate spasms of the uppergastrointestinal tract, minor gallbladder dis-orders, and dyspeptic complaints such asbloating and flatulence, ESCOPmonograph:symptomatic treatment of mild to moderatespasms of the upper gastrointestinal tract,minor gall bladder disorders, dyspeptic com-plaints such as bloating and flatulence; BfArMgraduated plan of 9 Apr 2008 concerningmedicinal products for internal use con-taining celandine, http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-schoellkraut.html, highly toxic ++(Roth/Daunderer), toxic II (Wink/Wyk),HMPCassessment report

Inflammations and burning in themouth, vomiting, paralysis, vesicaltenesmus, dizziness, arrhythmia, gas-trointestinal complaints accompaniedby bloody diarrhoea, bradycardia, dropin blood pressure, finally death by cir-culatory collapse, hepatotoxic (Wink/Wyk, Roth/Daunderer)

Isoquino-line alkaloids(e.g. chelidonine,sanguinarine,berberine)

Commission E: 2–5 g drug/dayWHO: 2–5 g drug/dayESCOP: 1.2–3.6 g/day

toxic + (plant), highly toxic ++ (oil) (Roth/Daunderer), very toxic, Ib (Wink/Wyk), in-formation: oil prescription-only (Chenopodiianthelminithici oleum)

Ingestion of higher doses causesCNS disorders, loss of consciousness,paralysis, drop in blood pressure, in-creased tendency to haemorrhage,cerebral haemorrhage, damage tothe cochlear nerve, impaired hearing,digestive tract inflammations accom-panied by cramps, abortifacient (Roth/Daunderer)

Terpenes(monoterpenese.g. ascaridole)

extremely toxic Ia (Wink/Wyk), pareira andpreparations thereof prescription-only

strong muscle relaxant, hypotensive,circulatory collapse, bronchospasm,death by cardiac arrest or respiratoryarrest (Wink/Wyk)

Alkaloids(e.g. tubocurarine)

33

http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-schoellkraut.html




Stock plant(Latin)


Cichorium intybus L. var. foliosumHEGI

Leaf bud

Cichorium intybus L. var. inty-busD ssp. intybus var. sylvestreVISIANI D C. sylvestre G. BANK

Herb, root T

Cichorium intybus L. var. sativumLAM. et DC.D ssp. sativum (DC.)JANCHEN var. radicosumALEF.

Root

Cicuta virosa L., syn. Cicuta an-gustifolia KIT., Cicuta aquaticaDUMORT., Selinum virosum (L.)E.H. KRAUSE

all plant parts

Cimicifuga racemosa (L.) NUTT.,syn. Actaea racemosa L., Botrophisactaeoides RAFIN.

Rhizome

Cinchona pubescens VAHL,Cinchona succirubra PAVON exKLOTSCH

Bark F

Cinnamomum cassia NEES ex BL.,syn. Cinnamomum aromaticumNEES, Laurus cassia NEES

Flower S

Cinnamomum cassia NEES ex BL.,syn. Cinnamomum aromaticumNEES, Laurus cassia NEES

Bark S

Cinnamomum ceylanicumBL., syn. Cinnamomum verumJ.S. PRESL, Laurus cassia BURM.

Bark S

34




Positivemonograph, indications: lack of ap-petite, digestive problems,HMPCmonograph:traditional use


Pharmacy-only (only homeopathic drugson themarket), very toxic Ib (Wink/Wyk),extremely toxic +++ (Roth/Daunderer)

Burning in mouth and throat, nau-sea, vomiting, gastric pain, mydriasis,headache, tremor, bradycardia, epilep-tic fits, delirium, coma, paralysis, deathby respiratory arrest (Wink/Wyk,Roth/Daunderer)

Polyacetylenes(e.g. cicutoxin,cicutol)

Positivemonograph, indications: pre-menstrual and dysmenorrhoeal as well asclimacteric neurovegetative symptoms,WHOmonograph: treatment of climacteric symp-toms such as hot flushes, profuse sweating,sleeping disorders and nervous irritability,ESCOPmonograph: climacteric symptomssuch as hot flushes, profuse sweating, sleepdisorders and nervous irritability, BfArMgraduated plan of 9 June 2009 concerningmedicinal products containing Cimicifuga,HMPCmonograph: herbal medicinal productfor the relief of menopausal complaints suchas hot flushes and profuse sweating

hepatotoxic, s. HMPC statement:http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/cimicifuga_hmpc_assessment.pdf?__blob=publicationFile,s. BfArM notification: http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/cimicifuga_bescheid.pdf?__blob=publicationFile

Triterpeneglycosides,isoquinoline alka-loids (e.g. cytisine)

Commission E,WHO: 40–60 %alcoholic extract, equivalent to40mg drug

Positivemonograph, indications: lack of ap-petite, digestive problems such as feeling offullness and bloating, standardmarketingauthorisation: 1459.99.99, toxic II (Wink/Wyk), toxic + (Roth/Daunderer), source ma-terial for quinine, dose restriction for quinineacc. to the Flavouring Regulation, BfR state-ment on quinine: http://www.bfr.bund.de/cm/208/chininhaltige_getraenke_koennen_gesundheitliich_problematisch_sein.pdf

Overdose may cause fever, icterus,haematuria, vomiting, diarrhoea, shiv-ering, dyspnoea, internal haemorrhageand respiratory arrest (Wink/Wyk,Roth/Daunderer)

Alkaloids (e.g. qui-nine, quinidine)

Commission E: 1–3 g drug/day

Negativemonograph: due to risks, use as tasteimprover is considered to be safe (Commis-sion Emonograph)

frequently induces allergic reactionsof skin and mucousmembranes, con-traindications reported (Commission Emonograph)

Cinnamic alde-hyde

Positivemonograph, indications: lack ofappetite, digestive problems such as mild gas-trointestinal cramps, feeling of fullness orbloating, s. BfR statement: http://www.bfr.bund.de/cm/343/neue-erkenntnisse-zu-cumarin-in-zimt.pdf

Cinnamic alde-hyde, coumarin

Commission E,WHO: 2–4 gdrug/day, equivalent prepara-tions

Positivemonograph, indications: lack ofappetite, digestive problems such as mildgastrointestinal cramps, feeling of fullnessor bloating, ESCOPmonograph: dyspepticcomplaints such as gastrointestinal spasms,bloating and flatulence, loss of appetite,diarrhoea,WHOmonograph, HMPCmono-graph: traditional use, standard marketingauthorisation: 1709.99.99, s. BfR statement:http://www.bfr.bund.de/cm/343/neue-erkenntnisse-zu-cumarin-in-zimt.pdf

Cinnamic alde-hyde, coumarin


35

http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/cimicifuga_hmpc_assessment.pdf?__blob=publicationFile




http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/cimicifuga_bescheid.pdf?__blob=publicationFile





http://www.bfr.bund.de/cm/208/chininhaltige_getraenke_koennen_gesundheitliich_problematisch_sein.pdf



http://www.bfr.bund.de/cm/343/neue-erkenntnisse-zu-cumarin-in-zimt.pdf






Stock plant(Latin)


Cistus x incanus L. all plant parts Not NFS

Citrullus colocynthis (L.) SCHRAD.,syn. Cucumis colocynthis L., Colo-cynthis officinalis SCHRAD.

all plant parts

Citrus aurantifolia (CHRISTM.)SWINGLE and Citrus latifoliaTANAKA

Peel T

Citrus aurantifolia (CHRISTM.)SWINGLE, syn. Citrus aurantiifolia(CHRISTM. et PANZ.) SWINGLE,Limonia acidissimaHOUTT. (nonL.), Limonia aurantifolia CHRISTM.

Fruit

Citrus aurantium L. ssp. auran-tium, syn. Citrus aurantium L. ssp.amara (L.) ENGL, Citrus commu-nis LEMAOUT. & DECAISN., Citrusflorida SALISB.

Leaf T


Flower C


Fruit


Peel

Citrus latifolia TANAKA Fruit Citrus limon (L.) BURM.f., syn.Citrus limonumRISSO, Limonvulgaris MILL.

Fruit

Citrus limon (L.) BURM.f., syn.Citrus limonumRISSO, Limonvulgaris MILL.

Peel S, T

Citrus paradisi MACF., syn. Citrusdecumana var. patoniaca RICCOB.,Citrus decumana var. racemosaROEM.

Fruit

36




Notification of the Federal Institute forDrugs and Medical Devices acc. to Section 21Clause 4 AMG [Medicinal Products Act] of4 Mar 2008 and decision of the North-RhineWestphalia Higher Administrative Court of15 Mar 2010 (file ref: 13 A 2612/09) on the clas-sification of products containing preparationsof Cistus incanus as medicinal products

Negativemonograph: due to risks, highlytoxic ++ (Roth/Daunderer), very toxic Ib(Wink/Wyk)

cytotoxic, irritating to gastrointestinalmucosa up to bloody diarrhoea, kid-ney damage, haemorrhagic cystitis,cramps, abortifacient effect (Wink/Wyk, Roth/Daunderer)

Cucurbitacins

concerning synephrine s. BfRstatement: http://www.bfr.bund.de/cm/343/gesundheitliche-bewertung-von-synephrin-und-koffeinhaltigen-sportlerprodukten-und-schlankheitsmitteln.pdf

Synephrine

Positivemonograph, indications: lack ofappetite, digestive problems, standard mar-keting authorisation: 1629.99.99, hardly toxic(Roth/Daunderer)

phototoxic, concerning synephrines. BfR statement: http://www.bfr.bund.de/cm/343/gesundheitliche-bewertung-von-synephrin-und-koffeinhaltigen-sportlerprodukten-und-schlankheitsmitteln.pdf

Furocoumarins Commission E: 4–6 g drug/day,equivalent preparations

37

http://www.bfr.bund.de/cm/343/gesundheitliche-bewertung-von-synephrin-und-koffeinhaltigen-sportlerprodukten-und-schlankheitsmitteln.pdf











Stock plant(Latin)


Citrus paradisi MACF., syn. Citrusdecumana var. patoniaca RICCOB.,Citrus decumana var. racemosaROEM.

Peel F

Citrus reticulata BLANCO, syn.Citrus deliciosa TEN., Citrus nobilisANDR. (non LOUR.), Citrus no-bilis var. genuina TANAKA, Citrusnobilis var. major KERR.

Fruit

Citrus reticulata BLANCO, syn.Citrus deliciosa TEN., Citrus nobilisANDR. (non LOUR.), Citrus no-bilis var. genuina TANAKA, Citrusnobilis var. major KERR.

Peel T

Citrus sinensis (L.) OSBECK, syn.Aurantium sinensis MILL., Citrusaurantium LOUR. (non L.)

Leaf T


Flower C


Fruit


Peel T, S

Cnicus benedictus L., syn. Calci-trapa benedicta LAM., Carbeniabenedicta BENTH. et HOOK.

Herb T

Cocos nucifera L., syn. Calappa nu-cifera KUNTZE, Cocos mamillarisBLANCO

Seed

Coffea arabica L., syn. Coffea lauri-folia SALISB., Jasminum arabicumlaurifolia DEJUSS.

Seed

Cola nitida (VENT.) SCHOTT etENDL., syn. Cola acuminata ENDL.

Seed

Colchicum autumnale L., syn.Colchicum commune NECK.,Colchicum crociflorum ANDERS

all plant parts

Colutea arborescens L., syn. Co-lutea vesicaria SEGUIER

all plant parts

38




Positivemonograph, indications: lack ofappetite


Positivemonograph, indications: lack ofappetite, digestive problems, hardly toxic butsensitising (Roth/Daunderer)

Cnicin contained in the drug causesheat and burning in the throat and theoesophagus, nausea, colic and diar-rhoea in low doses (Roth/Daunderer),allergic reactionsmay occur (Commis-sion Emonograph)

Sesquiterpenelactones(e.g. cnicin)


Positivemonograph, indications: mentaland physical fatigue,HMPCmonograph:traditional use, mildly toxic III (Wink/Wyk),slightly toxic (Roth/Daunderer)

Ingestion of higher doses causesheadache, vertigo, sleep disturbances,agitation and tachycardia (Wink/Wyk)

Purine alkaloids(e.g. caffeine,theobromine)


Positivemonograph, indications: acute at-tacks of gout, familial Mediterranean fever,cytotoxic, extremely toxic Ia (Wink/vanWyk),extremely toxic +++ (Roth/Daunderer)

Nausea, vomiting, watery and bloodydiarrhoea, intense abdominal pain,haematuria, drop in blood pressure,convulsions, paralysis, overdose causesdeath by respiratory and circulatoryarrest (Wink/Wyk), contraindicationsand interactions reported (Commis-sion Emonograph)

Colchicumalkaloids(e.g. colchicine)

Commission E: 0.5–1.5mgcolchicine/day,max. doseD8mg colchicine

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Diarrhoea, sometimes vomiting(Wink/Wyk)

L-canavanine,lectins

39


Stock plant(Latin)


Conium spp. all plant parts

Consolida regalis S.F. GRAY, syn.Delphinium consolida L.

Flower C

Convallaria majalis L., syn. Conva-llaria fragrans SALISB., Convallarialatifolia MILL., PolygonatummajaleALL.

Herb

Convolvulus scammonia L., syn.Convolvulus syriacus MORIS,Convolvulus pseudoscammoniaC. KOCH

all plant parts

Coriandrum sativum L., syn.Coriandrummaius GOUAN, Co-riandrum diversifoliumGILIB.

Herb S, T

Coriandrum sativum L., syn.Coriandrummaius GOUAN, Co-riandrum diversifoliumGILIB.

Fruit S

Corylus avellana L., syn. Corylussilverstris SALISB.

Leaf T

Corylus avellana L., syn. Corylussilverstris SALISB.

Seed

Crataegus laevigata (POIRET) D.C.,syn. Crataegus oxyacantha L.P.P. etAUCT.

Leaf, flower T

Crataegus laevigata (POIRET) D.C.,syn. Crataegus oxyacantha L.P.P. etAUCT.

Fruit

40




extremely toxic +++ (Roth/Daunderer), ex-tremely toxic Ia (Wink/Wyk), used only inhomeopathic drugs

all plant parts extremely toxic, paral-ysis of motor nerve ends involvingthe following symptoms: burning inmouth and throat, paralysis of tongue,vomiting, hypersalivation, diarrhoea,tachycardia, dyspnoea, disorientation,ascending paralysis, cold spills andnumbness, death by apnoea usuallywhile the patient is fully conscious(Wink/Wyk, Roth/Daunderer)

Piperidine alka-loids (e.g. coniine)

Neutral monograph (for use as colouring inamounts of up to 1%): poisonous plant, toxic +(Roth/Daunderer), extremely toxic Ia (Wink/Wyk), the (toxic) alkaloids are found in theunderground parts, the tops and the seeds(Rimpler). Reliable information about the al-kaloid content in the flowers is not available;according to the literature, their use as colour-ing in tea blends, i.e. in amounts of <1%, isconsidered to be safe (BGAmonograph)

Nausea, excitement, cardiac ar-rhythmia, cramps, gastroenteritis,respiratory arrest (Roth/Daunderer,Wink/Wyk), relevant diterpene alka-loids are found especially in seeds androots (Hager)

Alkaloids (e.g. del-phinine)

Positivemonograph, indications: mild exer-cise insufficiency, senile heart disease, chronicpulmonary heart disease, lily-of-the-val-ley plant itself pharmacy-only, extremelytoxic +++ (Roth/Daunderer), very toxic Ib(Wink/Wyk)

Nausea, vomiting, diarrhoea, arrhyth-mia, hypertension, coma, cardiacarrest, interactions with medici-nal products (Wink/Wyk, Roth/Daunderer, Schilcher)

cardioactiveglycosides(e.g. convalla-toxin)

Commission E: 0.6 g/day stan-dardised lily-of-the-valleypowder, equivalent preparations

drastic laxative Glycoretins

Positivemonograph, indications: digestiveproblems, lack of appetite, standard market-ing authorisation: 1079.99.99


Positivemonograph for combination only(Crataegi folium cumflore), indications: de-creasing cardiac output equivalent to stage IIacc. to NYHA, active ingredients: flavonoids(e.g. hyperoside, rutin and OPC), effect demon-strated for standardised extracts from leaveswith flowers, ESCOPmonograph andWHOmonograph for combinations (Crataegifolium cum flore): declining cardiac perfor-mance corresponding to Functional CapacityClass II as defined by the NYHA, nervous heartcomplaints, support of cardiac and circulatoryfunctions,HMPCmonograph: in progress

Commission E: 160–900mgnative, water-alcohol extract(ethanol 45% or methanol70%; DER 4–7:1 with definedflavonoid or procyanidincontent) equivalent to 30–168.7mg oligomer procyanidinscalculated as epicatechin or 3.5–19.8mg flavonoids calculated ashyperoside in 2 or 3 single dosesESCOP,WHO: 1–1.5 g drug, 3–4 times a day

Neutral monograph, ESCOPmonograph:cardiac complaints, support of cardiac andcirculatory functions, standard marketing au-thorisation: 1349.99.99, HMPCmonograph:in progress

ESCOP: 0.3–1 g drug, 3 timesa day

41


Stock plant(Latin)


Crocus sativus L., syn. Crocus au-tumnalis SM., Crocus officinalisMARTYN.

Stigma, style S

Croton spp. all plant parts

Cucumis melo L., syn. Cucumisacidus JACQ., Cucumis deliciosusSALISB., Melo agrestis PANG., var.reticulata and var. cantalupa andvar. inodorus

Fruit

Cucurbita pepo L., syn. Cucurbitacourgero SER., Pepo melopepoMOENCH

Seed

Cuminum cyminum L., syn.Cuminia cyminum J.F. GMELIN

Fruit S

Curcuma longa L., syn.Curcumadomestica VAL.

Rhizome S

42




Negativemonograph: due to risks,WHOmonograph: tonic, sedative, emmenagogue,prevention of arteriosclerosis, also used asfood, psychotropic, toxic II (Wink/Wyk),toxic + (Roth/Daunderer)

As much as 5 g of stigmamay cause se-vere symptoms. Ingestion of as muchas 10 g per day causes abortion anduterine haemorrhage, whereas a doseof 20 g is lethal. In low doses typicallyused in cuisine, saffron is harmless.Ingestion of higher doses causes uter-ine haemorrhage, bloody diarrhoea,haematuria and bleeding eyelids,effects on CNS such as excitement ac-companied by fits of laughter, followedby vomiting, delirium, visual distur-bances, lethargy, tachycardia, cardiacpalpitation, central paralysis and death.Skin and mucousmembranes take ona yellowish colour (Wink/Wyk)

Pinenes, eucalyp-tol (D1,8-cineol),safranal

WHO: 3–9 g drug/day, dosesbelow 5 g/day recommended dueto toxicity

extremely toxic +++ (Roth/Daunderer), ex-tremely toxic Ia (Wink/Wyk), use of seed oil asa medicinal product, e.g. as a drastic laxative,obsolete, Croton cascarilla, Croton eleuteriaand Croton tiglium pharmacy-only, substanceof concern (AMK)

very toxic seeds, drastic laxative ef-fect due to their croton oil content. Asmany as 4 seeds or approx. 20 drops ofoil are fatal to humans, burning andtickle in the mouth, vomiting, oppres-sion and agitation, watery, sometimesbloody diarrhoea, dizziness, vertigo,circulatory collapse, arrhythmia,nephritis, delirium, cocarcinogeniceffect (Wink/Wyk, Roth/Daunderer)

Phorbol ester,tiglic acid

Positivemonograph, indications: irritablebladder, micturition difficulties resultingfrom stage I–II prostatic adenoma, activeingredients: amongst others cucurbitin, phy-tosterol,WHOmonograph: for symptomatictreatment of difficulties with micturition as-sociated with stage I–II prostatic adenoma andirritable bladder, ESCOPmonograph: symp-tomatic treatment of micturition disorders(such as dysuria, pollakisuria, nocturia, urineretention and hesitancy) in benign prostatichyperplasia at stages I and II as defined byAlken or stage II and III as defined by Vahlen-sieck, irritable bladder,HMPCmonograph:traditional use

Commission E,WHO: 10 g drug/day, equivalent preparationsESCOP: 10–20 g drug/day

Positivemonograph, indications: digestiveproblems,WHOmonograph: the principaluse of Rhizoma Curcumae Longae is for thetreatment of acid, flatulent, or atonic dys-pepsia, ESCOPmonograph: symptomatictreatment of mild digestive disturbances andminor biliary dysfunction,HMPCmono-graph: traditional use, standard marketingauthorisation: 2339.99.99

Commission E, ESCOP,WHO:1.5–3 g drug/day, equivalentpreparations

43


Stock plant(Latin)


Curcuma xanthorrhiza ROXB., syn.Curcuma zanthorrhiza ROXB.

Root S

Curcuma zedoaria (BERG) ROSC.,syn. Amomum latifolium LAM.,Amomum zedoaria WILLD., Amo-mum zerumbeth KOEN. non L.,Curcuma speciosa HORT. ex LINK.,Curcuma zerumbeth (KOEN.)ROXB.

Rhizome S

Cyclamen spp. Root tuber

Cyclopia genistoides (THUNB.)R. BR.

Herb T

Cydonia oblongaMILLER, syn.Cydonia communis POIRET exDUHAMEL, Cydonia vulgaris DE-LARBRE, Pyrus cydonia L., Sorbuscydonia CRANTZ

Fruit

Cymbopogon citratus (DC.) STAPF,syn. Andropogon citratus DC.,Andropogon ceriferus HACK.,Andropogon citriodorumDESF.,Andropogon roxburghii NEES exSTEUD.

Herb S, T

Cynara scolymus L., syn. Cynaracardunculus L. ssp. Scolymus (L.)HAY

Foliage leaf Not NFS

Cynara scolymus L., syn. Cynaracardunculus L. ssp. Scolymus (L.)HAY

Receptacle, scaleleaf

(buds)

Cynodon dactylon (L.) PERS.,syn. Capriola dactylon (L.) KTZE.,Panicum dactylon L., Digitariastolonifera SCHRAD., Dactylon of-ficinale VILL., Tibichia umbellataKOELER

Rhizome Not NFS

Cynoglossum officinale L., syn.Cynoglossum clandestinumDESF.

Herb

44




Positivemonograph, indications: digestiveproblems, ESCOPmonograph: symptomatictreatment of mild digestive disturbances andminor biliary dysfunction,HMPCmono-graph: in progress

Long-term use causes gastric com-plaints, contraindications reported(Commission Emonograph)

Curcuminoids,xanthorrhizol

Commission E, ESCOP: 2 g drug/day, equivalent preparations

Neutral monograph

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Nausea, vomiting, gastric pain, di-arrhoea, sweats, circulatory distress,cramps, symptoms of paralysis,haemolysis Local irritations also re-ported (Roth/Daunderer)

Saponins (e.g. cy-clamine)

Neutral monograph

Positivemonograph, indications: digestiveproblems,WHOmonograph: treatment ofdigestive complaints (e.g. dyspepsia, feelingof fullness, flatulence, nausea, stomach acheand vomiting). Adjunct treatment of mildto moderate hypercholesterolaemia,ESCOPmonograph: digestive complaints (e.g. stom-ach ache, nausea, vomiting, feeling of fullness,flatulence) and hepatobiliary disturbance,adjuvant to a low fat diet in the treatment ofmild to moderate hyperlipidaemia,HMPCmonograph: traditional use

Commission E: 6 g drug/day,equivalent preparationsESCOP: 5–10 g dried drug/day(no administration to children)WHO: 1–10 g drug/day,equivalent preparations, notrecommended to children underthe age of 12

Negativemonograph: due to risks, substanceof concern (AMK), BfArM graduated plan of5 June 1992 concerning medicinal productscontaining pyrrolizidine alkaloids

contains pyrrolizidine alkaloids withhepatotoxic, carcinogenic, partly alsomutagenic and teratogenic properties(Frohne/Pfänder)


45


Stock plant(Latin)


Cytisus scoparius (L.) LINK,syn. Genista angulata POIRET,Sarothamnus scoparius (L.)WIMMER ex. KOCH, Spartiumscoparium L.

all plant parts

Daphne spp. all plant parts

Datura spp. all plant parts

Daucus carota L. ssp. sativus(HOFFM.) ARCANG.

Root

Delphinium elatum L., syn. Del-phinium intermediumAIT.

all plant parts

Delphinium staphisagria L., syn.Delphinium officinale WENDER.,Staphydis agria

all plant parts

Dendranthema grandifloraTZVELEV, syn. ChrysanthemummorifoliumRAMAT., Dendran-thema grandiflora (RAMAT.)KITAM., Dendranthemamorifo-lia (RAMAT.) TZVELEV

Flower

Dendrocalamus asper (SCHULTESf.) HEYNE and Dendrocalamuslatiflorus MUNRO, syn, Bambusalatiflora (MUNRO) KURZ

Sprout b

Digitalis spp. all plant parts

46




Negativemonograph: due to risks associ-ated with Scotch broom flowers, Positivemonograph: for Scotch broom, indications:functional cardiovascular disorders, standardmarketing authorisation: 1439.99.99, toxic II(Wink/Wyk), toxic + (all plant parts), (Roth/Daunderer)

circulatory collapse, arrhythmia,tachycardia, sweating, vomiting, diar-rhoea, dizziness, vertigo, convulsions,headache, ascending paralysis, deathby apnoea, hypertonia in pregnancy,contraindications reported (Wink/Wyk)

Alkaloids(e.g. sparteine)

Commission E: 1–1.5 g drug/day,water-ethanol extract

poisonous plant, extremely toxic +++ (Roth/Daunderer), extremely toxic Ia (Wink/Wyk)

Burning, swelling, blistering and red-ness in the mouth, hypersalivation,swallowing difficulties, nausea, bloodyvomiting and bloody diarrhoea, distur-bance of consciousness, fever, cramps,paralysis, kidney damage, tachycardia,circulatory collapse and death. Afterskin contact, there is a risk of swellingand blistering preceded by itching andredness (Wink/Wyk, Roth/Daunderer)

Phorbol ester(e.g. mezerein),cumaroyl glyco-side (e.g. daphnin)

Negativemonograph: due to risks associatedwith the leaves and seeds of Datura stramo-nium, isolated alkaloids prescription-only,Datura species pharmacy-only, extremelytoxic +++ (Roth/Daunderer), extremely toxic Ia(Wink/Wyk)

psychotropic, calmative and seda-tive in low doses, ingestion of higherdoses causes intense hallucinations,excitement, facial blush, dry mouth,euphoria, mydriasis, disorientation,insomnia, respiratory arrest and death(Wink/Wyk)


sometimes irritating, phototoxic Furocoumarins

poisonous plant, extremely toxic +++ (Roth/Daunderer), extremely toxic Ia (Wink/Wyk)

Nausea, excitement, cardiac arrhyth-mia, cramps, gastrointestinal tractinflammations, muscular asthenia, car-diac arrest, central paralysis, dyspnoea,death bymyoplegia and cardioplegia(Wink/Wyk)

Terpene alkaloids(e.g. delphinine)

Negativemonograph: due to risks, extremelytoxic +++ (Roth/Daunderer), extremelytoxic Ia (Wink/Wyk), Delphinium staphisagria(stavesacre) pharmacy-only

Nausea, excitement, cardiac arrhyth-mia, cramps, gastroenteritis, respirato-ry arrest (Roth/Daunderer, Wink/Wyk),relevant diterpene alkaloids are foundespecially in seeds and roots (Hager)

Terpene alkaloids(e.g. delphinine,staphisine)

toxic II (Wink/Wyk), cook before consumption When injured, the sprouts release hy-drocyanic acid (HCN). HCN inhibitscellular respiration in mitochondria.Symptoms of HCN poisoning. HCNmust be eliminated before consump-tion (by cooking) (Wink/Wyk)

cyanogenic glyco-sides

extremely toxic Ia (Wink/Wyk), extremelytoxic +++ (Roth/Daunderer)

typical cardiac glycoside poison-ing, very narrow therapeutic range,bradycardia, cardiac arrest, cardiacarrhythmia, nausea accompaniedby constant retching, diarrhoea,gastroenteritis, visual disturbances,agitation, headache, convulsions, CNSdisorders, disorientation, delirium,hallucinations, drop in blood pressure,disturbance of consciousness, suddendeath (Wink/Wyk, Roth/Daunderer)

cardioactiveglycosides(e.g. digoxin, digi-toxin)

47


Stock plant(Latin)


Dipteryx odorata (AUBL.) WILLD.,syn. Coumarouna odorata AUBL.,Baryosma tongo GAERTN.

Seed F

Dracocephalummoldavica L. Herb S

Drosera spp. Herb T

Dryopteris filix-mas (L.) SCHOTT,syn. Aspidium filix-mas (L.) SW.,Lastrea filix-mas (L.) PRESL., Poly-podium filix-mas L.

all plant parts

Ecballium elaterium (L.) A. RICH.,syn. Ecballium officinale NEES,Momordica elaterium L.

all plant parts

Echinacea angustifolia DC.,syn. Brauneria angustifolia (DC.)A. HELLER, Echinacea pallida var.angustifolia (DC.) CRONQ.

Herb T

Echinacea angustifolia DC.,syn. Brauneria angustifolia (DC.)A. HELLER, Echinacea pallida var.angustifolia (DC.) CRONQ.

Root T

Echinacea pallida (NUTT.) NUTT.,syn. Brauneria pallida BRITTON,Echinacea angustifolia HOOKER,Echinacea pallida (NUTT.) NUTT.f. albida STEYERM., Rudbeckiapallida NUTT.

Herb Not NFS

Echinacea pallida (NUTT.) NUTT.,syn. Brauneria pallida BRITTON,Echinacea angustifolia HOOKER,Echinacea pallida (NUTT.) NUTT.f. albida STEYERM., Rudbeckiapallida NUTT.

Root Not NFS

48




contains coumarin, s. BgVV state-ment: http://www.bfr.bund.de/cm/343/gehalte_an_cumarin_safrol_methyleugenol_und_estragol_in_lebensmitteln.pdf

Coumarin

Positivemonograph, indications: paroxysmaland dry cough

Overdose causes inflammations in themouth and throat, vomiting, ulcers inthe digestive tract, bloody diarrhoea(Roth/Daunderer)


Negativemonograph: due to risks, toxic II(Wink/Wyk), toxic + (Roth/Daunderer)

Nausea, vomiting, abdominal pain, di-arrhoea, cramps, cardiac insufficiency,fainting fits, dyspnoea, respiratoryarrest, fatal poisoning (Wink/Wyk,Roth/Daunderer), Commission E: dueto the risks (many cases of poisoning,also with fatal outcome), internal usecannot be justified

Acylphlorogluci-nols, flavaspidicacid

highly toxic ++ (Roth/Daunderer), very toxic Ib(Wink/Wyk)

Hypersalivation, vomiting, headache,severe, bloody diarrhoea, kidney dam-age, ingestion of higher doses causesconvulsions, death by respiratory ar-rest (Wink/Wyk)

Cucurbitacins

Negativemonograph: due to risks associatedwith parenteral use

allergic reactions ESCOP: 3 times 1ml extract,equivalent preparations

Negativemonograph: due to risks associatedwith parenteral use,WHOmonograph: Sup-portive therapy for colds and infections ofthe respiratory and urinary tract. Beneficialeffects in the treatment of these infectionsare generally thought to be brought aboutby stimulation of the immune response,ESCOPmonograph: adjuvant therapy andprophylaxis of recurrent infections of the up-per respiratory tract (common cold),HMPCmonograph: traditional use

allergic reactions

Negativemonograph: due to risks associatedwith parenteral use

allergic reactions

Positivemonograph, indications: adjuvanttreatment of influenza,WHOmonograph:supportive therapy for colds and infections ofthe respiratory and urinary tract. Beneficialeffects in the treatment of these infectionsare generally thought to be brought aboutby stimulation of the immune response,ESCOPmonograph: adjuvant therapy andprophylaxis of recurrent infections of the up-per respiratory tract (common cold),HMPCmonograph: traditional use

allergic reactions Commission E: tincture equiva-lent to 900mg drug/dayESCOP: 900mg drug/day, equiv-alent preparationsWHO: 0.5 tsp. (approx. 1 g) in150ml water, 3 times a day

49

http://www.bfr.bund.de/cm/343/gehalte_an_cumarin_safrol_methyleugenol_und_estragol_in_lebensmitteln.pdf





Stock plant(Latin)


Echinacea purpurea (L.) MOENCH,syn. Brauneria purpurea (L.)BRITTON, Echinacea intermediaLINDLEY, Echinacea purpurea (L.)MOENCH f. ligettii STEYERM.,Rudbeckia hispida HOFFMGG.,Rudbeckia purpurea L.

Herb Not NFS

Echinacea purpurea (L.) MOENCH,syn. Brauneria purpurea (L.)BRITTON, Echinacea intermediaLINDLEY, Echinacea purpurea (L.)MOENCH f. ligettii STEYERM.,Rudbeckia hispida HOFFMGG.,Rudbeckia purpurea L.

Root Not NFS

Echinopsis peruviana (BRIT-TON et ROSE) H.FRIEDRICH etG.D.ROWLEY, syn. Trichocereusperuviana

all plant parts

Elettaria cardamomum (L.) MA-TON, syn. Alpinia cardamomumROXB.

Fruit S, T

Eleutherococcus senticosus(RUPR. etMAXIM.) MAXIM., syn.Acanthopanax senticosus (RUPR. etMAXIM.) HARMS, Hedera senticosaRUPR. et MAXIM.

Root Not NFS

50




Positivemonograph, indications: adjuvanttreatment of recurrent infections of the respi-ratory tract and the lower urinary tract,WHOmonograph: supportive therapy for coldsand infections of the respiratory and urinarytract, beneficial effects in the treatment ofthese infections are generally thought to bebrought about by stimulation of the immuneresponse, ESCOPmonograph: adjuvant ther-apy and prophylaxis of recurrent infectionsof the upper respiratory tract (common cold)and also of the urogenital tract,HMPCmono-graph: short-term prevention and treatmentof coughs and colds

Immediate allergic reactions may oc-cur in individual cases (Commission Emonograph)

Commission E, ESCOP,WHO:6–9ml pressed juice, equivalentpreparationsHMPC: 6–9ml pressed juice, noadministration to children underthe age of 12

Negativemonograph: due to risks associatedAdjuvant therapy and prophylaxis of recurrentinfections of the upper respiratory tract (com-mon cold),HMPCmonograph: traditionaluse

allergic reactions ESCOP: 3 times 300mg, equiva-lent preparations

very toxic Ib (Wink/Wyk), mescaline con-tained in the drug is a non-marketablenarcotic acc. to Annex 1 of the Narcotic DrugsAct (BtMG)

psychotropic, ingestion of higher dosescauses gastrointestinal complaints,drop in blood pressure, bradycardia,apnoea, vasodilation, paralysis (Wink/Wyk)

Mescaline

Positivemonograph, indications: digestiveproblems,WHOmonograph (seeds): treat-ment of dyspepsia

Contraindications: in case of gall-stones, use only after consultation witha physician (Commission Emono-graph)

Commission E,WHO: 1.5 gdrug/day, equivalent prepara-tions

Positivemonograph, indications: tonic forstrengthening and invigoration in case offatigue and faintness, decreasing physicalperformance and powers of concentrationas well as in convalescence,WHOmono-graph: prophylactic and restorative tonic forenhancement of mental and physical capac-ities in cases of weakness, exhaustion andtiredness, and during convalescence, ESCOPmonograph: decreased mental and physi-cal capacities such as weakness, exhaustion,tiredness and loss of concentration, as well asduring convalescence,HMPCmonograph:traditional use

Contraindications: hypertension(Commission Emonograph)

Commission E, ESCOP,WHO:2–3 g drug/day, equivalentpreparations

51


Stock plant(Latin)


Ephedra spp. all plant parts

Epilobium angustifolium L., syn.Chamaenerion angustifoliumSCOP., Epilobium gesneri VILLAIN,EpilobiumpersicifoliumVILL.

Herb T

Epilobium parviflorum SCHRE-BER, syn. Epilobiummolle LAM.,Epilobiumpubescens ROTH, Epi-lobium rivulare HEGETSCHW.,Epilobium villosum CURT.

Herb T

Epimedium grandiflorumMORR.,syn. EpimediummacranthumMORR. et DECNE

Herb

Epimedium sagittatum (SIEB. etZUCC.) MAXIM.

Herb

Equisetum arvense L., syn. Equise-tum boreala (L.) BÖRNER, Allositesarvense BRONGN.

Herb T

Erysimum cheiri (L.) CRANTZ, syn.Cheiranthus cheiri L., Cheiranthuscorinthius BOISS.

all plant parts

Erythroxylum catuaba A.J. SILVAex RAYM.-HAMET

Bark

Erythroxylum coca LAM., syn.Erythroxylon coca LAM.

Leaf

52




Positivemonograph, indications: respira-tory diseases accompanied bymild bronchialspasm in adults and schoolchildren,WHOmonograph: treatment of nasal conges-tion due to hay fever, allergic rhinitis, acutecoryza, common cold, and sinusitis. The drugis further used as a bronchodilator in the treat-ment of bronchial asthma (4, 8, 10, 21–23).,toxic II (Wink/Wyk), toxic + (Roth/Daunderer),some of the alkaloids contained in the drugare subject to the provisions of the BtMG(e.g. cathine), Ephedra species and prepara-tions prescription-only, alkaloids containedin the drug (e.g. ephedrine) prescription-only,Ephedra species pharmacy-only. Ephedra is a“scheduled substance” of category 1 acc. to Ar-ticle 2a of Regulations (EC) No. 273/2004 andNo. 111/2005 and is thus subject to the provi-sions of the Precursors Control Act (GÜG).

sympathomimetic properties similarto amphetamines (Wink/Wyk), insom-nia, agitation, irritability, headache,vomiting, micturition difficulties,tachycardia, ingestion of higherdoses causes drastic increase in bloodpressure, cardiac arrhythmia, develop-ment of addiction (Roth/Daunderer),deaths in the USA due to consump-tion of food supplements containingEphedra: http://www.bfr.bund.de/de/presseinformation/2002/09/bgvv_und_bfarm_warnen__schwere_gesundheitsschaeden_durch_ephedra_kraut-1007.html

Alkaloids(Ephedraalkaloids,e.g. ephedrine,norpseu-doephedrine,cathine)

Commission E: 300mg totalalkaloids/day, calculated asephedrine (special doses forchildren)WHO: 1–6 g drug/day, no ad-ministration to children underthe age of 6

Positivemonograph, indications: posttrau-matic and static oedema, irrigation therapyof bacterial or inflammatory diseases of thelower urinary tract and kidney gravel,WHOmonograph: used internally for kidney andbladder diseases, oedema and as an adjuvant inslimming diets. It is applied as irrigation ther-apy for infectious and inflammatory diseasesof the genitourinary tract, and kidney stones,HMPCmonograph: traditional use, standardmarketing authorisation: 1239.99.99

Contraindications: oedemas associatedwith cardiac or renal insufficiency(Commission Emonograph)

Commission E,WHO: 6 g drug/day, equivalent preparations

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Symptoms of cardiac glycoside poi-soning accompanied by pronounceddigestive problems (Wink/Wyk)

Cardenolides(e.g. cheirotoxin),glucosinolates


very toxic Ib (Wink/Wyk), highly toxic ++(Roth/Daunderer), psychotropic, subject to theprovisions of the Narcotic Drugs Act (BtMG)

psychotropic, strong CNS-stimulant,tachycardia, overdose causes deathby respiratory arrest, episodes ofschizophrenia, strong psychologicaladdiction (Wink/Wyk)

Alkaloids (e.g. co-caine)

53

http://www.bfr.bund.de/de/presseinformation/2002/09/bgvv_und_bfarm_warnen__schwere_gesundheitsschaeden_durch_ephedra_kraut-1007.html






Stock plant(Latin)


Eucalyptus globulus LABILL., syn.Eucalyptus cordata MIQ., Eucalyp-tus diversifoliaMIQ., Eucalyptusgigantea DEHNH.

Leaf T

Eucommia ulmoides OLIV. Bark Not NFS Euphorbia spp. all plant parts

Euphrasia officinalis L. Herb T

Fagopyrum esculentumMOENCH,syn. Fagopyrum cereale (SALISB.)RAFIN.

Fruit

Fagopyrum esculentumMOENCH,syn. Fagopyrum cereale (SALISB.)RAFIN.

Herb T

Feijoa sellowiana BERG, syn. Accasellowiana (BERG) BURRET, Or-thostemon sellowianus BERG

Fruit

Ficus carica L., syn. Caprificus in-sectifera GASP., Ficus communisLAM., Ficus latifolia SALISB.

Fruit

Filipendula ulmaria (L.) MAXIM,syn. Spiraea ulmaria L., UlmariapalustrisMOENCH, Ulmaria pen-tapetala GILIB.

Flower, herb T

54




Positivemonograph, indications: coughsand colds of the respiratory tract, standardmarketing authorisation: 9299.99.99,WHOmonograph (leaves, oil): traditional use, ES-COPmonograph (oil): adjuvant treatment ofchronic obstructive respiratory complaintsincluding bronchitis and bronchial asthma,symptomatic relief of colds and catarrh ofthe upper respiratory tract, mildly toxic II totoxic III (Wink/Wyk), slightly toxic + (Roth/Daunderer),HMPCmonograph: traditionaluse

Higher doses of the essential oil causeCNS disorders and gastrointestinalcomplaints (Wink/Wyk), ingestionof higher doses causes drop in bloodpressure and bradypnoea, dyspepsia,vomiting, diarrhoea, circulatory dis-tress, cardiac insufficiency, circulatorycollapse (Roth/Daunderer), ingestionof Eucalyptus preparationsmay causenausea, vomiting and diarrhoea inrare cases, contraindications reported(Commission Emonograph)

Eucalyptol (D1,8-cineol)

ESCOP: 100–200mg, 2–5 timesa dayWHO: 4–6 g drug/day, no ad-ministration to children


Irritation of skin andmucous mem-branes, allergic reactions, gastric pain,nausea and retching, laxative, bloodydiarrhoea, arrhythmia, hepatic and re-nal dysfunction, coma, cocarcinogenic(Wink/Wyk)

Phorbol ester,triterpenes

Neutral monograph, HMPC assessment re-port

peel fruits before consumption The red hull surrounding the grainscontains naphthodianthrones(e.g. fagopyrin). Fagopyrin may inducephotodermatitis (fagopyrism) (Ternes)

Naphthodi-anthrones(e.g. fagopyrin)

mildly toxic III (Wink/Wyk), slightly toxic (+)(Roth/Daunderer), licensedmedicinal product

contains naphthodianthrones(e.g. fagopyrin), whichmay inducephotodermatitis. Fagopyrin notdetected in aqueous preparations(Frohne), ingestion of high dosescauses digestive problems (Wink/Wyk).

Naphthodi-anthrones(e.g. fagopyrin)

Neutral monograph

Positivemonograph, indications: adjuvanttreatment of coughs and colds, standard mar-keting authorisation: 1609.99.99, ESCOPmonograph: supportive therapy for the com-mon cold,HMPCmonograph: traditionaluse

Contraindications: known hyper-sensitivity to salicylates (due to thesalicylates contained in the drug)(Commission Emonograph)

Commission E: 2.5–3.5 g floweror 4–5 g herb/day, equivalentpreparationsESCOP: 2–6 g drug/day

55


Stock plant(Latin)


Foeniculum vulgare MILLERssp. vulgare var. dulce (MILLER)THEULLUNG, syn. Anethumfoeniculum dulce SCHKUHR

Fruit T, S

Foeniculum vulgare MILLER ssp.vulgare var. vulgare (MILLER)THELLUNG, syn. Anethumfoeniculum vulgare SCHKUHR

Fruit T, S

Fragaria ananassa DUCHESNE exROZIER

Leaf T

Fragaria ananassa DUCHESNE exROZIER

Fruit

Fragaria vesca L., syn. Fragariabotryformis E. KÖNIG, Fragariahortensis DUCH.

Leaf T

Fragaria vesca L., syn. Fragariabotryformis E. KÖNIG, Fragariahortensis DUCH.

Fruit

Fraxinus ornus L., syn. Fraxinusmannifera STEUD., Fraxinus ro-tundifolia MILL., Ornus europaeaPERS.

Resin Not NFS

Fumaria officinalis L., syn. Fumariamedia LOIS., Fumaria sturmii OPIZ,Fumaria vulgaris BUB.

Herb Not NFS

Galeopsis segetumNECK., syn.Galeopsis ochroleuca LAM.

Herb T

56




Positivemonograph, indications: diges-tive problems such as mild gastrointestinalcramps, feeling of fullness, bloating, catar-rhs of the upper respiratory tract, standardmarketing authorisation: 5199.99.99,WHOmonograph: symptomatic treatment ofdyspepsia, bloating and flatulence, as an ex-pectorant for mild inflammation of the upperrespiratory tract, treatment of pain in scrotalhernia, and dysmenorrhoea, ESCOPmono-graph: dyspeptic complaints such as mild,spasmotic gastrointestinal ailments, bloatingand flatulence, catarrh of the upper respira-tory tract, included in Annex 1 of Reg. 2001/83(s. Commission Decision 2008/911/EC), HMPCmonograph: traditional use

Side effects: allergic reactions of theskin and the respiratory tract observedin individual cases (Commission Emonograph)

Trans-anethole,estragole(Dmethyl chavi-col)

Commission E: 5–7 g drug/day,equivalent preparationsWHO, ESCOP: 5–7 g drug/day

Positivemonograph, indications: diges-tive problems such as mild gastrointestinalcramps, feeling of fullness, bloating, catar-rhs of the upper respiratory tract, standardmarketing authorisation: 5199.99.99,WHOmonograph: symptomatic treatment ofdyspepsia, bloating and flatulence, as an ex-pectorant for mild inflammation of the upperrespiratory tract, treatment of pain in scrotalhernia, and dysmenorrhoea, ESCOPmono-graph: dyspeptic complaints such as mild,spasmotic gastrointestinal ailments, bloatingand flatulence, catarrh of the upper respira-tory tract, included in Annex 1 of Reg. 2001/83(s. Commission Decision 2008/911/EC), HMPCmonograph: traditional use

Side effects: allergic reactions of skinand respiratory tract observed inindividual cases (Commission Emono-graph)

Trans-anethole,estragole(Dmethyl chavi-col)

Commission E: 5–7 g drug/day,equivalent preparationsWHO, ESCOP: 5–7 g drug/day

Neutral monograph Hypersensitivity reactionsmay oc-cur in patients with a predisposition(Schilcher)

HMPCmonograph: in progress

Positivemonograph, indications: constipa-tion, conditions in which easy defaecationwith a soft stool is desirable, e.g. anal fissures,haemorrhoids and after rectal-anal surgicalprocedures

Sensitive patients may experience nau-sea and bloating, contraindications:intestinal occlusion (Commission Emonograph)


Positivemonograph, indications: crampsin the gall bladder, the biliary tract and thegastrointestinal tract, standard marketing au-thorisation: 1479.99.99, ESCOPmonograph:digestive complaints (e.g. stomach ache, nau-sea, vomiting, feeling of fullness, flatulence)due to hepatobiliary disturbance,HMPCmonograph: traditional use, toxic II (Wink/Wyk), toxic + (Roth/Daunderer)

slightly psychotropic, calmative, nar-cotic, ingestion of high doses causesburning in the mouth and throat, nau-sea, vomiting, diarrhoea, drop in bloodpressure (Wink/Wyk)

Commission E: 6 g drug/day,equivalent preparationsESCOP: 4–6 g drug/day, equiva-lent preparations

Positivemonograph, indications: mild catar-rhs of the respiratory tract

Commission E: 6 g drug, equiva-lent preparations

57


Stock plant(Latin)


Galium odoratum (L.) SCOP., syn.Asperula odorata L., Asperula odoraSALISB., Chlorostemma odoratumFOURR.

Herb T

Galium verum L., syn. Galiumluteum LAM.

Herb T

Garcinia cambogia DESROUSS.,syn. Cambogia gutta L.

Fruit S

Gelsemium sempervirens (L.)JAUME ST.-HIL., Syn. GelsemiumnitidumMICHX., Anonymos sem-pervirens L.

Rhizome

Genista tinctoria L., syn. Cystisustinctorius VIS., Genista depressaBIEB.

Flower

Gentiana lutea L., syn. Asteriaslutea BORKH., Swertia lutea VEST.

Root T

Geumurbanum L., syn. Caryophyl-lata officinalis MOENCH,Caryophyllata urbana SCOP.,Caryophyllata vulgaris LAM., Geumcaryophyllata GILIB.

Herb Not NFS

Geumurbanum L., syn. Caryophyl-lata officinalis MOENCH,Caryophyllata urbana SCOP.,Caryophyllata vulgaris LAM., Geumcaryophyllata GILIB.

Root T

58




Neutral monograph: BfArM graduated plan of23 May 1997 concerning coumarin-contain-ing phytopharmaceuticals and homeopathicdrugs up to potency D2 containing sweetclover (Meliloti herba) or sweet woodruff(Gallii odorati herba) (for internal use), slightlytoxic (+) (Roth/Daunderer), maximum amountof coumarin when adding coumarin-con-taining foods/food ingredients to foods asflavouring specified in Reg. (EC) No. 1334/2008

Consumption of sweet woodruffpreparationsmay cause headache(Roth/Daunderer)

Coumarin

Negativemonograph: extremely toxic Ia(Wink/Wyk), extremely toxic +++ (Roth/Daunderer)

excessive sweating, central paralysis,faintness, convulsions, drop in bloodpressure and cardiac activity, visualdisturbances, convulsions similar tothose induced by strychnine, death byrespiratory arrest (Wink/Wyk, Roth/Daunderer)

Indole alkaloids,steroids, iridoidglycosides


slightly psychotropic, hallucino-genic, diuretic, uterus contractions,abdominal pain, tachycardia, cardiacarrhythmia, vomiting, diarrhoea, ver-tigo (Wink/Wyk)

Quinolizidinealkaloids (e.g. cyti-sine, anagyrine)

Positivemonograph, indications: lack of ap-petite, digestive problems such as feeling offullness and bloating, standardmarketingauthorisation: 9199.99.99,WHOmonograph:treatment of digestive complaints, such asloss of appetite, feeling of distension andflatulence. As an appetite stimulant duringconvalescence, ESCOPmonograph: Anorexiae.g after illness, dyspeptic complaints,HMPCmonograph: traditional use

Headache may occasionally occurin patients with a particular predis-position, contraindications reported(Commission Emonograph)

Commission E: 2–4 g drug/dayESCOP: 0.1–2 g drug/day, specialdosage instructions for childrenWHO: 0.1–2 g drug, up to 3 timesa day, no administration to chil-dren

59


Stock plant(Latin)


Ginkgo biloba L., syn. Pterophyllussalisburiensis NELSON, Salisburiaadiantifolia SMITH

Leaf T

Glechoma hederacea L., syn.Calamintha hederacea SCOP.

Leaf T

Gloriosa superba L., syn. Methon-ica superba LAM. and GloriosarothschildianaO’BRIEN. and Glo-riosa simplex L., syn. Gloriosavirescens LINDL., Gloriosa plan-tii LOUD.

all plant parts

60




Negativemonograph: due to risks associatedwith ginkgo leaves as well as various alcoholicextracts due to inadequate evidence of phar-macological effect and risks that cannot beruled out, Positivemonograph for standard-ised acetone/water dry extract, indications:psycho-organic performance disorders, de-mentia, impaired memory, concentrationdifficulties, depression, vertigo, tinnitus,headache,HMPCmonograph: in progress,WHOmonograph: extracts have been usedfor symptomatic treatment of mild to moder-ate cerebrovascular insufficiency (dementialsyndromes in primary degenerative demen-tia, vascular dementia, and mixed forms ofboth) with the following symptoms: mem-ory deficit, disturbance in concentration,depressive emotional condition, dizziness,tinnitus, and headache. Such extracts are alsoused to improve pain-free walking distancein people with peripheral arterial occlusivedisease such as intermittent claudication,Raynaud disease, acrocyanosis, and post-phlebitis syndrome, and to treat inner eardisorders such as tinnitus and vertigo of vas-cular and involutive origine. Extracts anddoses other than those described in Dosageforms and Posology are used for similar butmilder indications, ESCOPmonograph:preparations based on standardized extracts:Symptomatic treatment of: mild to moder-ate demetia symptoms including primarydegenerative demtia, vascular dementia andmixed forms; cerebral insufficiency, neurosen-sory disturbances such as: dizziness/vertigoand tinnitus, enhancement of cognitiveperformance, symptomatic treatment of pe-ripheral arterial occlusive disease (intermittentclaudication), BfArM graduated plan of 27May 1997 concerning medicinal productscontaining Ginkgo biloba leaves, BfR state-ment: http://www.bfr.bund.de/cm/343/die_sicherheit_von_ginkgoblaetter_haltigen_tees_kann_wegen_mangelnder_daten_nicht_beurteilt_werden.pdf

Contact allergies may be induced bythe ginkgolic acids contained in thedrug (Commission Emonograph)

Diterpene lac-tones, ginkgolicacids

Commission E, ESCOP,WHO:120–240mg extract/day

slightly toxic (+) (Roth/Daunderer) toxic to animals, cases of poisoning inhumans not known (Hager)

extremely toxic Ia (Wink/Wyk), highly toxic ++(Roth/Daunderer)

Spindle poison, abortifacient effect,nausea, pain in the throat and oesoph-agus, cramps, arrhythmia, internalhaemorrhage, peripheral neuropathy,abdominal pain, cold extremities, greyskin, tachycardia, respiratory arrest re-ported (Wink/Wyk, Roth/Daunderer)

Colchicine

61

http://www.bfr.bund.de/cm/343/die_sicherheit_von_ginkgoblaetter_haltigen_tees_kann_wegen_mangelnder_daten_nicht_beurteilt_werden.pdf


Stock plant(Latin)


Glycyrrhiza glabra L., syn. Gly-cyrrhiza echinata LEPECH.,Glycyrrhiza glanduliferaWALDST.et KIT., Glycyrrhiza hirsuta L.,Liquiritia officinalis MOENCH

Root T, S

Gratiola officinalis L. all plant parts

Grindelia robusta NUTT. andGrindelia squarrosa PURSH(DUN.), syn. Donia squarrosaPURSH, Grindelia squarrosa DUN.

Herb Not NFS

Guaiacum officinale L. and Gua-iacum sanctum L., syn. Guaiacumverticale ORTEGA

Wood F

Gymnema silvestre (WILLD.) R.BR., syn. Gymnema parviflorumROXB., Asclepias geminata ROXB.

Leaf

Gypsophila paniculata L., syn.Arrostia paniculata (L.) RAF., Gyp-sophila parviflora MOENCH,Saponaria paniculata (L.) NEU-MAYER

Root Not NFS

Hamamelis virginiana L., syn.Hamamelis androgyna WALT.

Leaf T

62




Positivemonograph, indications: catar-rhs of the upper respiratory tract, gastriculcers, standardmarketing authorisation:1309.99.99,WHOmonograph, HMPCmono-graph: traditional use, ESCOPmonograph:adjuvant therapy of gastric and duodenalulcers and gastritis, coughs and bronchialcatarrh, as an expectorant, special precautionsas specified in the LMKV [Food Labelling Reg-ulation], as from 13 Dec 2014 as specified inReg. (EC) No. 1169/2011

Long-term use and higher dosesmay cause mineral corticoid effectsmanifesting in sodium and waterretention, loss of potassium accom-panied by hypertension, oedemas andhypokalaemia, in rare cases also myo-globinurina, contraindications andinteractions reported (Commission Emonograph)

Glycyrrhizic acid Commission E: liquorice from5 g/day, Succus Liquiritiae from0.5 g/dayESCOP: 1.5–15 g drug/dayWHO: 5–15 g drug/day, equiva-lent preparations


strong laxative effect, ingestion of highdoses may cause digestive problemsaccompanied by nausea, vomiting,hypersalivation, bloody diarrhoea,nephritis, dyspnoea and cardiac dys-function, death by respiratory arrest,abortifacient effect (Wink/Wyk)

Cucurbitacins

Positivemonograph, indications: catarrhsof the upper respiratory tract, ESCOPmono-graph: productive cough, catarrhs of the upperrespiratory tract,HMPCmonograph: tradi-tional use

Side effects: irritation of gastricmucosa observed in rare cases (Com-mission Emonograph)

Commission E, ESCOP: 4–6 gdrug/day, equivalent prepara-tions

Positivemonograph, indications: adjuvanttreatment of rheumatic conditions, mildlytoxic II to toxic III (Wink/Wyk), toxic + (Roth/Daunderer)

Ingestion of higher doses causes gas-troenteritis accompanied by nauseaand diarrhoea, cardiac palpitation,vertigo (Wink/Wyk)

Commission E: 4.5 g drug, equiv-alent preparations

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Lack of appetite, faintness, fever, diar-rhoea, death by apnoea, irritation ofcardiovascular system, polyuria, irrita-tion of uterus, hypoglycaemia (Roth/Daunderer) (Wink/Wyk)

Gymnemic acid

Positivemonograph, indications: catarrhs ofthe upper respiratory tract

Irritation of gastric mucosa observedin rare cases (Commission Emono-graph)

Commission E: 30–150mg drug/day, equivalent preparations

Positivemonograph, indications: superficialskin lesions, local inflammations of skin andmucosa, haemorrhoids, varicose veins, stan-dardmarketing authorisation: 9699.99.99(witch hazel leaves), 9799.99.99 (witch hazelbark),WHOmonograph: external use only,ESCOPmonograph: symptomatic treatmentof complaints related to varicose veins such aspainful and heavy legs and of haemorrhoids,HMPCmonograph: traditional use

Tanning agents(tannins)

Commission E: 0.1–1 g drug,several times a day, equivalentpreparationsESCOP: 2–3 g drug 2–3 timesa day, equivalent preparationsWHO: 0.1–1 g drug/day, equiva-lent preparations

63


Stock plant(Latin)


Hamamelis virginiana L., syn.Hamamelis androgyna WALT.

Bark Not NFS

Harpagophytum procumbens(BURCH.) DC., syn. Harpagophy-tum burcherllii DECNE

Root T

Harungana madagascariensisLAM. ex POIR., syn. Harongamadagascariensis (LAM. ex POIR.)CHOISY

Leaf, bark Not NFS

64




Positivemonograph, indications: superficialskin lesions, local inflammations of skin andmucosa, haemorrhoids, varicose veins, stan-dardmarketing authorisation: 9699.99.99(witch hazel leaves), 9799.99.99 (witch hazelbark),WHOmonograph: external use only,ESCOPmonograph: inflammation of mu-cous membranes of the oral cavity, short-termsymptomatic treatment of diarrhoea,HMPCmonograph: traditional use

Tanning agents(tannins)

Commission E: 0.1–1 g drug,several times a day, equivalentpreparationsESCOP: 2–3 g drug 2–3 timesa day, equivalent preparationsWHO: 0.1–1 g drug/day, equiva-lent preparations

Positivemonograph, indications: lack of ap-petite, digestive problems, adjuvant treatmentof degenerative diseases of the locomotorsystem,WHOmonograph: treatment ofpain associated with rheumatic conditions,treatment of loss of appetite and dyspepticcomplaints, supportive treatment of degen-erative rheumatism, painful arthrosis andtendonitis, ESCOPmonograph: symptomatictreatment of painful osteoarthritis, relief oflow back pain, loss of appetite and dyspepsia,HMPCmonograph: traditional use

Contraindications: gastric and duo-denal ulcers, in case of gallstones, useonly after consultation with a physi-cian (Commission E monograph)

Commission E: 1.5 g/day, prepa-rations of equivalent bittervalue (lack of appetite), other-wise 4.5 g drug/day, equivalentpreparations, standardised ex-tracts equivalent to 30–100mgharpagosideESCOP: 2–5 g drug/day, equiva-lent preparationsWHO: 1–3 g drug/day, equivalentpreparations

Positivemonograph, indications: digestiveproblems,mild exocrine pancreatic insuffi-ciency

Photosensitisation especially in light-skinned patients due to the hypericinand pseudohypericin contained inthe drug, contraindications reported(Schilcher)

Naphtho-dianthronederivatives(leaves: hypericin,pseudohypericin),anthraquinones(bark: mada-gascin)

Commission E: 25–50mg drug/day, equivalent preparations

65


Stock plant(Latin)


Hedera helix L., syn. Hederacaucasigena POJARK, HederachrysocarpaWALSH

Leaf

Helianthus annuus L., syn.Helianthus cultus VENTSL., He-lianthus erythrocarpus BARTL.,Helianthus indicus L., Helianthuspumilus PERS.

Petal T

Helianthus annuus L., syn.Helianthus cultus VENTSL., He-lianthus erythrocarpus BARTL.,Helianthus indicus L., Helianthuspumilus PERS.

Seed

Helianthus tuberosus L., syn. He-lianthusmollissimus E.E. WATSON

Stem tuber

Helichrysum arenarium (L.)MOENCH, syn. Gnaphalium are-narium L.

Flower T

66




Positivemonograph, indications: catarrhsof the upper respiratory tract, symptomatictreatment of chronic bronchitis, ESCOPmonograph: coughs, particularlywhen associ-ated with hypersecretion of viscousmucus, asadjuvant treatment of inflammatory bronchialdiseases, toxic II (Wink/Wyk), toxic + (Roth/Daunderer), toxic + (Roth/Daunderer),HMPCmonograph: expectorant for productivecough

Local irritations of mucousmem-branes, digestive tract irritation,dizziness, tachycardia, headache, nau-sea, vomiting, skin rash, CNS disorders,hyperthermia and cardiac palpitationobserved in individual cases, especiallyin higher doses, overdose may causedeath by respiratory arrest (Wink/Wyk,Roth/Daunderer)

Saponins Commission E: average dailydose: 0.3 g drug, equivalentpreparationsESCOP: ethanolic preparations:250–420mg drug/day, deviatingdoses for children, ethanol-freepreparations: 300–945mg drug/day, deviating doses for childrenHMPC: adults and adolescents:a) single dose: 15–65mg,1–3 times a day up to a daily doseof 45–105mg (note: max. dailydose for ethanolic ready-to-useproducts: 67mg equivalent to420mg drug)b) single dose: 14–18mg, 3 timesa dayc) single dose: 33mg, 2 timesa dayd) single dose: 100mg, 3 timesa daychildren aged between 6 and 12:a) single dose: 11–33mg,2–3 times a day up to a max.daily dose of 33–70mg (note:max. daily dose for ethanolicready-to-use products: 34mgequivalent to 210mg drug)b) single dose: 9–18mg,2–3 times a day up to a max.daily dose of 15–40mgc) single dose 25mg, 2 timesa dayd) single dose: 75mg 3 timesa daychildren aged between 2 and 5:a) single dose: 8–18mg 2–3 timesa day up to a max. daily doseof 24–36mg (note: max. dailydose for ethanolic ready-to-useproducts: 24mg equivalent to150mg drug)No administration to childrenunder the age of 2

Positivemonograph, indications: digestiveproblems,WHOmonograph: treatment ofdyspeptic disorders, standard marketing au-thorisation: 1649.99.99

Contraindications: occlusion of biliarytract, in case of gallstones, use onlyafter consultation with a physician(Commission Emonograph)


67


Stock plant(Latin)


Heliotropium arborescens L., syn.Heliotropium corymbosum RUIZet PAV, Heliotropium odoratumMOENCH, Heliotropiumperu-vianum L.

all plant parts

Helleborus spp. all plant parts

Herniaria glabra L. Herb T Herniaria hirsuta L. Herb T Hibiscus sabdariffa L., syn. Sab-dariffa rubra KOSTEL., Sidasabdariffa L.

Flower T

Hibiscus sabdariffa L., syn. Sab-dariffa rubra KOSTEL., Sidasabdariffa L.

Seed Not NFS

Hippophae rhamnoides L. ssp.rhamnoides, Hippophae rham-noides L. ssp. fluviatilis, syn.Hippophae angustifolia “LODD.”ex DIPPEL, Hippophae fasciculataWALL ex STEUDEL, Hippophaelittoralis SALISB.

Fruit

Hoodia gordonii (MASS.) SWEET all plant parts Hordeum vulgare L., syn. Hordeumsativum JESS.

Fruit

Humulus lupulus L., syn. HumuluscordifoliusMIQ.

Flower

Hydrastis canadensis L., syn.Warneria canadensis LILL., Warne-ria diphylla RAF.

Rhizome

Hyoscyamus spp. all plant parts

68




toxic II (Wink/Wyk), toxic + (Roth/Daunderer),substance of concern (AMK), BfArM graduatedplan of 5 June 1992 concerning medicinalproducts containing pyrrolizidine alkaloids

Pyrrolizidine alkaloids contained inthe drug may cause liver damage(Wink/Wyk, Frohne), tachycardia,mydriasis, central apnoea and cardiacarrest (Wink/Wyk).


Helleborus viridis, Helleborus niger andvarious species pharmacy-only, extremelytoxic +++ (Roth/Daunderer), extremely toxic Ia(Wink/Wyk)

tickle in mouth and throat, nausea,hypersalivation,mydriasis, ragingthirst, abdominal pain and colic, gas-trointestinal complaints, diarrhoea,exhaustion, symptoms of cardiacglycoside poisoning, coma, death bycardiac or respiratory arrest (Wink/Wyk)

Alkaloids(e.g. celliamine,sprintillamine),cardioactiveglycosides(e.g. bufa-dienolides),steroidal saponins(e.g. helleborine)

Neutral monograph

Neutral monograph

Neutral monograph

WHOmonograph: treatment of cirrhosis ofthe liver , used to relieve cough with profuseexpectoration, to promote digestion in peoplewith prolonged gastrointestinal transit withabdominal pain, and for treatment of amenor-rhoea

WHOmonograph: 40–50 g freshfruit in 1 litre water, 2–3 cupsa day

Positivemonograph, indications: emotionalsymptoms such as agitation and states of anx-iety, sleep disturbances, standard marketingauthorisation: 1029.99.99,WHOmonograph:as a sedative for the treatment of nervoustension and insomnia. Treatment of dyspep-sia and lack of appetite, ESCOPmonograph:tenseness, restlessness and sleep disorders,HMPCmonograph: traditional use

fresh hop cones: dermatitis on skincontact, conjunctivitis, in severe casesvomiting, fever, dyspnoea, bradycardiaand sweats (Roth/Daunderer)

Commission E, ESCOP,WHO:single dose: 0.5 g drug, equivalentpreparations, no administrationto children under the age of 12

WHOmonograph: treatment of digestivecomplaints, such as dyspepsia, gastritis, feelingof distension and flatulence, toxic Ib to verytoxic II (Wink/Wyk), highly toxic ++ (Roth/Daunderer)

Ingestion of higher doses causes vom-iting, gastrointestinal complaints,uterus contractions, vasoconstrictive,CNS-depressor, spasmogenic, maycause myoplegia, hallucinations, delir-ium and cyanosis (Wink/Wyk)

Isoquino-line alkaloids(e.g. hydrastine,berberine)

WHO: 0.5–1 g drug, 3 times a day

Positivemonograph for Hyoscyamus niger,indications: gastrointestinal cramps, ex-tremely toxic Ia (Wink/Wyk), extremelytoxic +++ (Roth/Daunderer)

psychotropic, calmative and sedativein low doses, ingestion of higher dosescauses hallucinations, euphoria, dis-orientation, insomnia, fits of rage, lossof consciousness and death by respi-ratory arrest, facial blush, dry mouth,mydriasis, accelerated pulse (Wink/Wyk)

Tropane al-kaloids (e.g.L-hyoscyamine,L-scopolamine,atropine)

Commission E: 0.5 g standard-ised powder (single dose), 3.0 gstandardised powder (maximumdaily dose)

69


Stock plant(Latin)


Hypericum perforatum L., syn.Hypericum officinarum CRANTZ,Hypericum officinale GATER exSTEUD., Hypericum vulgare LAM.

Herb, flower F

Hyssopus officinalis L., syn. Hys-sopus arisatus GODR., Hyssopuscanascens (DC.) NYM.

all plant parts S, T

Iberis amara L., syn. Biauriculaamara BUBANI, Crucifera iberisKRAUSE, Thlaspi amarum CRANTZ

all plant parts

Ilex aquifolium L. Fruit, leaf

Ilex paraguariensis ST. HIL., syn.Ilex bonplandiana MÜNTER, Ilexdomestica REISS.

Leaf T

Illicium verumHOOK. FIL., syn. Il-licium anisatum GAERTN. NON. L.,Illicium stellatum L.

Fruit T, S

Inula helenium L., syn. Aster he-lenium (L.) SCOP., Corvisartiahelenium (L.) MÉRAT, HeleniumgrandiflorumGILIB.

Root S, T

Ipomoea purga (WENDER.)HAYNE, syn. Exogonium purga(WENDER.) BENTH.

all plant parts

70




Positivemonograph, indications: psychoveg-etative disorders, depression, anxiety and/ornervous agitation. Oily Hypericum prepa-rations for digestive problems, standardmarketing authorisation: 1059.99.99,WHOmonograph: symptomatic treatment of mildandmoderate depressive episodes (classifiedas F32.0 and F32.1, respectively, in the Inter-national statistical classification of diseasesand related health problems, Tenth revision(ICD-10), ESCOPmonograph: episodes ofmild depressive disorders or mild to moder-ate depressive episodes in accordance withICD-10 categories F32.0, F32.1, F33.0 and F33.1,HMPCmonograph: herbal medicinal prod-uct for the treatment of mild to moderatedepressive episodes (according to ICD-10).short term treatment of symptoms in milddepressive disorders, BfArM graduated planof 10 Oct 2005 concerning medicinal productsfor internal use containing St. John’s wort (Hy-pericum): http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/Johanniskraut-Bescheid-051010.pdf?_

Photosensitiser, enzyme inductor(suppression of effect of concomitantmedication), toxic increase of sero-tonin concentration in CNS (Wink/Wyk)

Naphthodi-anthrones(e.g. hypericin,pseudohyper-icin), xanthonederivatives

Commission E: 2–4 g drug/dayESCOP,WHO: 2–4 g drug/day,administration to children onlyunder medical supervision

Neutral monograph: use of hyssop as tasteimprover in tea blends in amounts of up to5% is considered to be safe (Commission Emonograph)

Consumption of oil reported to causeclonic and/or tonic-clonic cramps(Commission Emonograph)

Pinocamphone,esopinocam-phone

Ingredient of licensedmedicinal products,toxic + (Roth/Daunderer), mildly toxic II totoxic III (Wink/Wyk)

Ingestion of higher doses causes vom-iting, gastroenteritis, bloody diarrhoea,abdominal pain, respiratory depres-sion, arrhythmia (Wink/Wyk)

Cucurbitacins

highly toxic ++ (Roth/Daunderer), toxic Ib tovery toxic II (Wink/Wyk)

gastrointestinal complaints, gas-tritis, vomiting, diarrhoea, cardiacarrhythmia, paralysis, kidney dam-age, drowsiness, possibly death (Wink/Wyk)

Triterpenes,nitrile (menes-daurin)

Positivemonograph, indications: mentaland physical fatigue,HMPCmonograph:traditional use


Positivemonograph, indications: catarrhsof the respiratory tract, digestive problems,standard marketing authorisation: 2419.99.99

Commission E: 3 g drug or 0.3 gessential oil/day, equivalentpreparations

Negativemonograph: due to risks, practicallynon-toxic but allergenic (Roth/Daunderer)

Sesquiterpene lactones contained inelecampane are irritating to mucousmembranes, sensitising and induceallergic contact dermatitis (Com-mission Emonograph), ingestion ofhigher doses causes vomiting, diar-rhoea, cramps, symptoms of paralysis(Roth/Daunderer)

Sesquiterpenelactones (alan-tolactones,isoalantolactones)

toxic II (Wink/Wyk), toxic (Roth/Daunderer),resin and root tuber as MP prescription-only,whole plant pharmacy-only

drastic laxative, gastric pain, vomiting,diarrhoea, tenesmus, nausea (Wink/Wyk, Roth/Daunderer)

Convolvulin,jalapin, glycoretin

71

http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/Johanniskraut-Bescheid-051010.pdf?_





Stock plant(Latin)


Ipomoea violacea L., syn. Ipomoeatricolor CAV.

Seed

Iris germanica L. and Iris pallidaLAM. and Iris florentina L.

Rhizome F

Iris versicolor L., syn. Iris virginicaJACQ., PURSH (non L.)

Root

Jasminum grandiflorum L. Flower T

Jasminum officinale L., Flower T

Juglans regia L., syn. Nux juglansDUHAM.

Flower C


Seed


Peel F

Juniperus communis L. Fruit S, T

Juniperus communis L. Wood T

Juniperus sabina L., syn. Sabinaofficinalis GARCKE

all plant parts

Krameria triandra RUIZ et PAVON,syn. Krameria lappacea (DOMBEY)BURDET et SIMPSON, Krameriacanascens WILLD. ex SCHULTES

Root T

Laburnum anagyroides MEDICUS,syn. Cytisus laburnum L., GenistalaburnumKRAUSE

all plant parts

72




highly toxic ++ (Roth/Daunderer), very toxic Ib(Wink/Wyk), narcotic

psychotropic, hallucinogenic effect,nausea, vomiting and faintness, in-gestion of high doses causes death byapnoea (Roth/Daunderer, Wink/Wyk)

Indole alkaloids(e.g. ergometrine,ergine, chan-oclavin, lysergicacid and lysergicacid derivatives

Neutral monograph: used to produce spirits

Positivemonograph: for external use, stan-dardmarketing authorisation: 2429.99.99,HMPCmonograph: traditional use (externaluse)

The high tannin content may causeirritation of gastric mucosa. Sincea mutagenic effect is demonstratedfor juglone, internal use of the drug iscontraindicated in pregnancy (Hager)

Juglone

Negativemonograph: due to risks, as flavour-ing in spirits production

Local daily use of preparations con-taining juglone is associated witha high incidence of tongue cancerand leucoplakia (Commission Emono-graph)

Juglone

Positivemonograph, indications: digestiveproblems, standard marketing authorisation:1369.99.99, ESCOPmonograph: traditionaluse, non-toxic to slightly toxic (+) (Roth/Daunderer), mildly toxic II to toxic III (Wink/Wyk),HMPCmonograph: traditional use

Long-term use or overdose (more than150mg of essential juniper oil per day,note by Schilcher)may cause kidneydamage (Schilcher), contraindicationsreported (Commission Emonograph)

Mono- andsesquiterpenes(e.g. alpha-pinene)

Commission E: 2–10 g/dayequivalent to 20–100mg es-sential oilESCOP: 2–3 g drug in 150mlwater, 3–4 times a day

Terpene, tanningagents, lignans

extremely toxic +++ (Roth/Daunderer), ex-tremely toxic Ia (Wink/Wyk), substance ofconcern (AMK)

Ingestion causes nausea, vomiting, ab-dominal pain, excitement, arrhythmia,tachycardia, convulsions, respiratoryarrest, serious kidney and liver dam-age, profuse internal haemorrhage,haematuria, uterus contractions, abor-tion, death as a result of central apnoeain coma (Wink/Wyk). Essential oil hasa strong irritating effect on the skin,whichmay even cause necrosis anddamage to deeper skin layers.

Monoterpenes(e.g. thujone,sabinene)

Positivemonograph: for external use, stan-dardmarketing authorisation: 1179.99.99(root), 7199.99.99 for external or local use only,ESCOPmonograph: for external or local use

allergic reactions of mucousmem-branes observed in very rare cases(Commission Emonograph)

ESCOP, Commission E: externaluse only

very toxic Ib (Wink/Wyk), extremely toxic +++(Roth/Daunderer)

slightly psychotropic and hallucino-genic, diuretic, uterus contractions,abdominal pain, tachycardia, drop inblood pressure, cardiac arrhythmia,vomiting, diarrhoea, vertigo, cramps,headache, delirium, nicotinergic effect(Wink/Wyk)

Quinolizidinealkaloids (e.g. cyti-sine)

73


Stock plant(Latin)


Lactuca virosa L., syn. LactucaaltissimaM.B., Lactuca lactucariiLAMOTTE, Lactuca sylvestris LAM.

all plant parts

Lamium album L., syn. Lamiumcapitatum SM., Lamium vulgatumvar. album BENTH

Flower T

Lamium album L., syn. Lamiumcapitatum SM., Lamium vulgatumvar. album BENTH

Herb T

Laurus nobilis L. Leaf S

Lavandula angustifolia MILL.,syn. Lavandula officinalis CHAIXex VILL., Lavandula angustifoliaMUCH, Lavandula spica L.

Leaf T

Ledum palustre L., syn. Rhododen-dron tomentosumHARMAJA

Herb

Leonurus cardiaca L., syn. Cardiacatrilobata LAM., Cardiaca vulgarisMOENCH

Herb T

Lepidium peruvianum CHACON,syn. Lepidiummeyenii WALP.

Root

Lespedeza capitata MICHX. all plant parts Not NFS Levisticum officinale KOCH, syn.Angelica levisticumALL., Hip-poselinum levisticumBRITTONet ROSE, Levisticum levisticumKARSTEN

Fruit S

74





persistent irritation of skin and mu-cous membranes, calmative propertiessimilar to opium, visual disturbances,headache, sweats, vertigo, drowsiness,tachypnoea and tachycardia (Wink/Wyk, Roth/Daunderer)

Sesquiterpenelactones

Positivemonograph, indications: catarrhs ofthe upper respiratory tract, mild infections ofthe oral and pharyngeal mucosa


Neutral monograph

irritating to skin, allergenic (Roth/Daunderer)

Eucalyptol(D1,8-cineol),sesquiterpenelactones

Positivemonograph, indications: emo-tional symptoms such as agitation, sleepdisturbances, functional epigastric disor-ders (nervous irritable stomach, ROEMHELDsyndrome, meteorism, nervous intestinal dis-orders), standard marketing authorisation:1119.99.99,WHOmonograph: symptomatictreatment of restlessness, insomnia, and asa carminative and antispasmodic for gastroin-testinal disorders of nervous origin, ESCOPmonograph: symptoms of mood disturbancesuch as restlessness, agitation of insomnia,functional abdominal complaints, mildlytoxic III (Wink/Wyk),HMPCmonograph:traditional use

Overdose may induce hepatic andrenal dysfunction (Wink/Wyk)

Monoterpenes,coumarins

Commission E, ESCOP,WHO:1–2 tsp. Drug, 0.8–1.6 g/cup(150ml), 3 times a day

Negativemonograph: due to risks, toxic(Roth/Daunderer), toxic II (Wink/Wyk)

gastrointestinal irritation accompaniedby vomiting and diarrhoea, irritationand damage of kidneys and lower uri-nary tract, sweats, pain in muscles andjoints, CNS excitement accompaniedby states of intoxication, cramps andsubsequent paralysis (Commission Emonograph)

Sesquiterpenes(e.g. ledol, palus-trol), arbutin

Positivemonograph, indications: nervouscardiac disorders, adjuvant treatment ofhyperthyroidism,WHOmonograph: usedagainst cerebral ischaemia, it is also used fortreatment of heart palpitations occurring withanxiety attacks or other nervous disorders,HMPCmonograph: traditional use, mildlytoxic III (Wink/Wyk)

slightly anaesthetic, calmative (Wink/Wyk)

Iridoids, diter-penes, triterpenes

Commission E: 4.5 g drug, equiv-alent preparationsWHO: 2–4.5 g drug, equivalentpreparations

Statement of the Federal Institute for RiskAssessment (BfR): http://www.bfr.bund.de/cm/343/risikobewertung_macahaltiger_nahrungsergaenzungsmittel.pdf

Glucosinolates,imidazole alka-loids

phototoxic Furocoumarins

75

http://www.bfr.bund.de/cm/343/risikobewertung_macahaltiger_nahrungsergaenzungsmittel.pdf




Stock plant(Latin)


Levisticum officinale KOCH, syn.Angelica levisticumALL., Hip-poselinum levisticumBRITTONet ROSE, Levisticum levisticumKARSTEN

Herb S

Levisticum officinale KOCH, syn.Angelica levisticumALL., Hip-poselinum levisticumBRITTONet ROSE, Levisticum levisticumKARSTEN

Root S, T

Linaria vulgaris MILL., syn. Antir-rhinum linaria L.

Herb Not NFS

Linumusitatissimum L. Seed

Lippia triphylla (L’HÉR.) KUNTZE,syn. Aloysia citrodora PALAU,Aloysia citriodora ORTEGA exPERS., Aloysia sleumeriMOLD-ENKE, Aloysia triphylla (L’HÉR.)KUNTZE, Verbena citriodora CAV.,Verbena triphylla L’HÉR., Zapaniacitrodora LAM.

Herb S, T

Lobelia spp. all plant parts

Lophophorawilliamsii (LEM.ex SALM-DYCK) COULT., syn.Anhaloniumwilliamsii (LEM. exSALM-DYCK) LEM., Anhaloniumlewinii HENN., Ariocarpus william-sii VOSS., Echinocactus lewinii(HENN.) SCHUM.

all plant parts

Lupinus spp. Seed

76




phototoxic Furocoumarins

Positivemonograph, indications: irrigationtherapy of inflammatory diseases of the lowerurinary tract, irrigation therapy to preventof kidney gravel,HMPCmonograph: tradi-tional use, standard marketing authorisation:1569.99.99

phototoxic Furocoumarins Commission E: 4–8 g drug/day,equivalent preparations

Positivemonograph, indications: habitualconstipation, colon affected by laxatives,irritable colon, diverticulitis, as gruel prepa-ration for gastritis and enteritis, standardmarketing authorisation: 1099.99.99, ESCOPmonograph: constipation, irritable bowelsyndrome, diverticular disease, symptomaticshort-term treatment of gastritis and enteri-tis,HMPCmonograph: treatment of habitualconstipation or in conditions in which easydefaecation with soft stool is desirable, tradi-tional use, toxic II (Wink/Wyk)

Cases of poisoning in humans causedby cyanogenic glycosides in flaxnot known to date (Hager, Frohne/Pfänder)

cyanogenic glyco-sides, lignans

Commission E: 1 tbsp./150mlliquid, 2–3 times a dayESCOP: 5–10 g drug/dayHMPC: 10–15 g, 2–3 times a day,no administration to childrenunder the age of 12

Lobelia inflata prescription-only, Lobeliaspecies in general pharmacy-only, Lobeliainflata: highly toxic ++ (Roth/Daunderer), verytoxic Ib (Wink/Wyk)

nicotinergic effect, vomiting, di-arrhoea accompanied by colic andcramps, stimulates respiration in lowdoses, causes apnoea in higher doses,bradycardia, drop in blood pressure,convulsions, death by respiratory ar-rest (Wink/Wyk, Roth/Daunderer)

Piperidine alka-loids (e.g. lobeline)

narcotic, highly toxic ++ (Roth/Daunderer),very toxic Ib (Wink/Wyk), mescaline con-tained in the drug is a non-marketablenarcotic acc. to Annex 1 of the Narcotic DrugsAct (BtMG)

psychotropic, hallucinogenic, visualdisturbances and distorted thinkingpatterns, intense, even schizophrenicsymptoms, loss of perception, insom-nia, drop in blood pressure, mydriasis,pain, respiratory depression, vasodi-lation, faintness, liver damage andvomiting, ascending paralysis in highdoses (Wink/Wyk, Roth/Daunderer)

Alkaloids(e.g. mescaline)

low-alkaloid/alkaloid-free types are used infoods (sweet lupine or leached, ripe seeds ofbitter lupines) (vanWyk), other types moder-ately to highly toxic (Roth/Daunderer), toxic(Wink/Wyk), subject to labelling requirementacc. to Food Labelling Regulation, statement ofthe Federal Institute for Risk Assessment (BfR)on the allergenicity of lupine proteins: http://www.bfr.bund.de/cm/343/allergie-durch-lupineneiweiss-in-lebensmitteln.pdf

Lupine poisoning (caused by alkaloids)may cause hypersalivation, vomiting,swallowing difficulties, arrhythmia,convulsions and death by respiratoryarrest (Wink/Wyk)

Quinolizidinealkaloids

77

http://www.bfr.bund.de/cm/343/allergie-durch-lupineneiweiss-in-lebensmitteln.pdf




Stock plant(Latin)


Lycium barbarum L., syn. LyciumhalimifoliumMILLER, Lyciumflaccidum (VEILLARD) K. KOCH

Fruit

Lycopodium clavatum L., syn.Lepidotis clavata (L.) PAL. BEAUV.

Herb

Lycopus europaeus L., syn. Lyco-pus aquaticus MOENCH, Lycopuspalustris LAM., Lycopus vulgarisPERS. and Lycopus virginicusL., syn. Lycopus macrophyl-lus BENTH., Lycopus uniflorusMICHX., Lycopus virginicusMICHX.

Herb

Macadamia ternifolia F. v. MUELL. Seed

Malpighia punicifolia L., syn.Malpighia glabra L.

Fruit

Malus domestica BORKH. Fruit Malus sylvestris (L) MILL. Fruit Malva sylvestris L., syn. Malvaambigua GUSS., Malva erectaC. PRESL., Malva mauritiana L.

Leaf, flower T

Mandragora officinarum L. Root

Mangifera indica L. Fruit Marrubium vulgare L., MarrubiumalbumGILIB.

Herb

Marsdenia condurango REICHB.F., syn. Gonolobus condurango(REICHB. F.) TRIANA

Bark T

78




mildly toxic III (Wink/Wyk), highly toxic ++(Roth/Daunderer), the presence of toxicamounts of tropane alkaloids, which isthe basis of the above assessment, is notconfirmed in a recent BfR statement onL. barbarum: http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) neurotoxic, symptoms of poisoningsimilar to those induced by curare,excessive sweating, nausea, vertigo,psychotropic, causes impaired sensoryperception, impaired speech, cramps,vomiting, diarrhoea (Wink/Wyk)

Quinolizidinealkaloids (e.g. ly-copodine,clavatin)

Positivemonograph, indications: mild formsof hyperthyroidism accompanied by vegeta-tive-nervous disorders, mastalgia

Long-term use and high doses maycause enlargement of the thyroidgland, sudden discontinuation oftreatment intensifies the symptoms,interactions and contraindicationsreported (Commission Emonograph)

Coumarins Commission E: 1–2 g drug/day (tea), water-ethanol extractequivalent to 20mg drug

Positivemonograph, indications: irritationof oral and pharyngeal mucosa accompaniedby dry cough, standardmarketing autho-risation: 1579.99.99 (mallow leaves), ESCOPmonograph for flowers: dry cough, irritationof the oral, pharyngeal or gastric mucosa

Commission E: 5 g drug/day,equivalent preparationsESCOP: 1.5–2 g drug/day

psychotropic, root and preparations thereofprescription-only, mandrake pharmacy-only,very toxic Ib (Wink/Wyk), highly toxic ++

calmative and sedative in low doses,ingestion of higher doses causes hal-lucinations, euphoria, disorientation,insomnia, vertigo, tremor, impairedspeech, excitement, nausea, vomiting,mydriasis and death by central paraly-sis (Wink/Wyk)

Tropanealkaloids (e.g. L-hyoscyamine,D,L-scopolamine,atropine)

Positivemonograph, indications: lack of ap-petite, digestive problems such as feeling offullness and bloating, catarrhs of the respira-tory tract, slightly toxic (+) (Roth/Daunderer),HMPCmonograph: traditional use

Ingestion of high doses causes cardiacarrhythmia (Roth/Daunderer)

Diterpenes(e.g. marrubiin)

Commission E: 4.5 g drug/day,2–6 tbsp. pressed juice, equiva-lent preparations

Positivemonograph, indications: lack ofappetite, mildly toxic II to toxic III (Wink/Wyk), slightly toxic (+) (Roth/Daunderer)

Ingestion of high doses may cause di-gestive problems and CNS disorders(Wink/Wyk), hypersalivation, vomit-ing, stiffness of extremities, convulsivefits accompanied by twitching of fa-cial muscles, central apnoea (Roth/Daunderer)

steroidalglycosides(e.g. conduran-gins)


79

http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf




Stock plant(Latin)


Matricaria recutita L., syn.Chamomilla recutita (L.)RAUSCHERT, Matricariachamomilla L. PROPARTE

Flower T

Matricaria recutita L., syn.Chamomilla recutita (L.)RAUSCHERT, Matricariachamomilla L. PROPARTE

Seed Not NFS

Medicago sativa L. Sprout Melaleuca alternifolia (MAIDENand BETCH) CHEEL., syn.Melaleuca linariifolia var. alternifo-lia MAIDEN et BETCHE.

Leaf

Melilotus officinalis (L.) PALLAS,syn. Melilotus arvensis WALLR.,Melilotusmelilotus-officinalis AS-CHERS. et GRAEBN., Melilotusofficinalis DESR. and Melilotusaltissima THUILL., syn. Melilo-tus giganteaWENDER., Melilotusmacrorrhiza PERS.

Herb T

Melissa officinalis L., Melissaaltissima SM. INSIBTH. et SM.,Thymus melissa E.H.L. KRAUSE

Leaf S, T

Mentha aquatica L., syn. Menthahirsuta HUDS.

Herb S, T

80




Positivemonograph, indications: gastroin-testinal cramps and inflammatory diseases ofthe gastrointestinal tract, standardmarketingauthorisation: 7999.99.99,WHOmonograph:symptomatic treatment of digestive ailmentssuch as dyspepsia, epigastric bloating, im-paired digestion, and flatulence, infusionsof camomile flowers have been used in thetreatment of restlessness and in mild casesof insomnia due to nervous disorders, ES-COPmonograph: symptomatic treatmentof gastrointestinal complaints such as minorspasms, epigastric distension, flatulence andbelching,HMPCmonograph: in progress

Commission E: 1 tbsp. (approx.3 g), 3–4 times a dayESCOP: 3 g drug, 3–4 times a day,special dosage instructions forchildrenWHO: 2–8 g, 3 times a day, spe-cial dosage instructions forchildren, no administration tochildren under the age of 3

Positivemonograph: for external use, theessential oil is used mostly, whichmay in-duce contact allergies when used externally(s. BfR statement: http://www.bfr.bund.de/cm/206/verwendung_von_unverduenntem_teebaumoel_als_kosmetisches_mittel.pdf),WHOmonograph and ESCOPmonograph(oil): for external use

Terpenes(e.g. eucalyptol[D1,8-cineol])

ESCOP,WHO, Commission E:for external use

Positivemonograph, indications: chronicvenous insufficiency (especially pain and feel-ing of heaviness in legs, night leg cramps,itching, swelling), adjuvant treatment ofthrombophlebitis, postthrombotic syndrome,haemorrhoids, lymphatic blockage, ESCOPmonograph: symptomatic treatment of prob-lems related to varicose veins, such as painfuland heavy legs, nocturnal cramps in the legs,itching and swelling,HMPCmonograph: tra-ditional use, BfArM graduated plan of 23 May1997 concerning coumarin-containing phy-topharmaceuticals and homeopathic drugsup to potency D2 containing sweet clover(Meliloti herba) or sweet woodruff (Galliiodorati herba) (for internal use)

Nausea, vomiting, headache (Roth/Daunderer), contains coumarin, s.BgVV statement: http://www.bfr.bund.de/cm/208/gehalte_an_cumarin_safrol_methyleugenol_und_estragol_in_lebensmitteln.pdf+O245

Coumarin Commission E, ESCOP: equiv-alent to 3–30mg coumarin perday, equivalent preparations

Positivemonograph, indications: nervoussleep disturbances, functional gastrointestinaldisorders, standardmarketing authorisation:1149.99.99,WHOmonograph, HMPCmono-graph: traditional use,WHOmonograph:external use, ESCOPmonograph: tenseness,restlessness and irritability, symptomatictreatment of digestive disorders such as mi-nor spasms

Commission E,WHO: 1.5–4.5 gdrug, several times a dayESCOP: 2–3 g drug, 2–3 timesa day, equivalent preparations

Menthofuran,eucalyptol (D1,8-cineol)

81

http://www.bfr.bund.de/cm/206/verwendung_von_unverduenntem_teebaumoel_als_kosmetisches_mittel.pdf



http://www.bfr.bund.de/cm/208/gehalte_an_cumarin_safrol_methyleugenol_und_estragol_in_lebensmitteln.pdf+O245





Stock plant(Latin)


Mentha pulegium L., syn. MenthagibraltaricaWILLD., Mentha hir-tiflora OPIZ ex TOPIZ, PulegiumerectumMILL.

Herb S

Mentha spicata L. emend. L. var.crispa BENTH.

Leaf T, S

Mentha suaveolens EHRH. Herb T, S

Mentha x piperita L., syn. Menthapiperita (L.) HUDS.

Leaf T, S

Menyanthes trifoliata L., syn.Menyanthes palustris TOURN,Trifolium castoris THAL

Leaf T

Momordica charantia L. Fruit

Monarda didyma L., syn. Monardapurpurea LAM., Monarda coccineaMICHX.

Flower T

Morus alba L., syn. Morusbombycis KOIDZ., Morus constanti-nopolitana POIR., Morus indica L.

Leaf Not NFS

Morus alba L., syn. Morusbombycis KOIDZ., Morus constanti-nopolitana POIR., Morus indica L.

Fruit

Morus nigra L. Leaf Not NFS Morus nigra L. Fruit Mucuna pruriens (L.) DC., syn.Dolichos pruriens L.

all plant parts

Murraya koenigii (L.) SPRENG. Leaf S

Musa acuminata XMusa bal-bisiana, syn. Musa paradisiaca L.

Fruit

Myrciaria dubia (KUNTH) Mc-VAUGH, syn. Psidium dubiumKUNTH

Fruit Not NFS

Myristica fragrans HOUTT., syn.Myristica americana ROTTB.,Myristica aromatica SWARTZ,Myristica officinalis L.

Dried aril S

82




slightly toxic to toxic (Roth/Daunderer),toxic II (Wink/Wyk) contains pulegone (doserestriction acc. to Reg. (EC) No. 1334/2008)

Ingestion of higher doses causesretching, vomiting, increase in bloodpressure, central anaesthesia-likeparalysis, death by central apnoea,cases of poisoning after abuse as abor-ticide known (Roth/Daunderer)

Monoterpenes(e.g. pulegone)

L-carvone,limonene,eucalyptol (D1,8-cineol)

Positivemonograph, indications: cramps inthe gastrointestinal tract, the gall bladder andthe biliary tract, standard marketing authori-sation: 1499.99.99,WHOmonograph (leaves,oil), HMPCmonograph: traditional use, ES-COPmonograph: symptomatic treatment ofdigestive disorders, such as flatulence, irritablebowel syndrome, symptomatic treatment ofcoughs and colds

Menthol, men-thone, eucalyptol(D1,8-cineol)

Commission E: 3–6 g drug/day,equivalent preparationsESCOP: 1.5–3 g drug in 150mlwater 3 times a dayWHO: 1–3 g drug 3 times a day

Positivemonograph, indications: lack ofappetite, digestive problems, hardly toxic (+)(Roth/Daunderer)

unpleasant headache, ingestion of highdoses causes vomiting and diarrhoea(Roth/Daunderer)

Commission E: 1.5–3 g drug/day,equivalent preparations

Seeds and pericarp of ripe fruits very toxic Ib(Wink/Wyk), therefore only young fruitsshould be used in food,WHOmonograph:emetic, laxative and tonic

Seeds and pericarp of ripe fruits causesevere vomiting and diarrhoea, inhibi-tion of ribosomal biosynthesis (Wink/Wyk)

Cucurbitacins WHO: 2–15 g drug/day

Carvacrol, thymol

toxic + (Roth/Daunderer), toxic II (Wink/Wyk) hallucinogenic, psychotropic (Wink/Wyk)

Indole alkaloids,levodopa, sero-tonin

toxic when abused + (Roth/Daunderer) Ingestion of high doses causesheadache, dizziness, changes in con-sciousness up to hallucinations,ventricular tachycardia, vertigo, my-driasis, vomiting, abortifacient effect.Safrole contained in the essential oilhas a mutagenic effect and demon-strated a carcinogenic effect in animalexperiments (Wink/Wyk)

Myristicin, safrole

83


Stock plant(Latin)


Myristica fragrans HOUTT., syn.Myristica americana ROTTB.,Myristica aromatica SWARTZ,Myristica officinalis L.

Seed S

Nasturtium officinale R. BR., Syn.Baeumerta nasturtiumGAERTN.,MEY., SCHERB.

Herb

Nelumbo nucifera GAERTN., syn.Nelumbiumnelumbo (L.) DRUCE

Flower C

Nepeta cataria L., syn. Nepeta mi-nor MILL., Nepeta vulgaris LAM.,Cataria vulgaris MOENCH

Herb S, T

Nerium oleander L., syn. Neriumlaurifolium LAM.

Leaf

Ocimumbasilicum L. syn.Basilicum Indicum et citratumRUMPH., Ocimum album L., Oci-mummenthaefoliumHOCHST. exBENTH.

Herb S

Ocimum tenuiflorum L, Oci-mum sanctum L., syn. Ocimumalbum BLANCO, Ocimum virgatumBLANCO

Herb S

Olea europaea L., syn. Olea of-ficinarum CRANTZ, Olea pallidaSALISB.

Leaf T

Ononis spinosa L., syn. Ononisarvensis L., Ononis campestrisKOCH et ZIZ.

Root T

84




Negativemonograph: due to risks, toxic whenabused + (Roth/Daunderer), toxic II (Wink/Wyk)

Ingestion of high doses causesheadache, dizziness, changes in con-sciousness up to hallucinations,ventricular tachycardia, vertigo, my-driasis, vomiting, abortifacient effect.Safrole contained in the essential oilhas a mutagenic effect and demon-strated a carcinogenic effect in animalexperiments (Wink/Wyk). Ingestionof approx. 5 g of nutmeg seeds causesa series of mental disorders, whichmaymanifest themselves in slight changesin consciousness up to intense hallu-cinations. Ingestion of 9 teaspoons ofnutmeg powder per day observed toproduce an effect similar to that of at-ropine. The drug has an abortifacienteffect in high doses (Commission Emonograph)

Myristicin, safrole

Positivemonograph, indications: catarrhsof the respiratory tract, slightly toxic only inlarger amounts (+) (Roth/Daunderer)

Contraindications: gastrointestinalcomplaints observed in rare casesContraindications: gastrointestinalulcers, inflammatory kidney diseases(Commission Emonograph)

Glucosinolates Commission E: daily dose: 4–6 gdrug or 20–30 g fresh herb or60–150 g freshly pressed juice,equivalent preparations

Negativemonograph: due to risks, oleanderglycosides prescription-only, oleander phar-macy-only, highly toxic ++ (Roth/Daunderer),extremely toxic Ia (Wink/Wyk)

Numbness of tongue and throat, nau-sea, vomiting, cramps, disorientation,visual disturbances, diarrhoea, cardiacarrhythmia, apnoea, shock, brady-cardia, deathmay occur 2–5 hoursafter ingestion (Wink/Wyk, Roth/Daunderer)

cardioactive gly-cosides

Negativemonograph: due to risks contains estragole. After metabolicactivation, isolated estragole has a mu-tagenic effect. Animal experimentsprovide indications of carcinogeniceffect. Risks during pregnancy and lac-tation, for infants and young childrenas well as during long-term use cannotbe ruled out (Schilcher)

Estragole(Dmethyl chavi-col)

WHOmonograph: traditional use WHO: 6–12 g drug/day


Positivemonograph, indications: irriga-tion therapy of inflammatory diseases of thelower urinary tract, prevention of kidneygravel, standard marketing authorisation:9899.99.99, ESCOPmonograph: irrigation ofthe urinary tract, especially in cases of inflam-mation and renal gravel, and as an adjuvant intreatment of bacterial infections of the urinarytract,HMPCmonograph: in progress

Contraindications reported (Commis-sion Emonograph)

Commission E: 6–12 g drug/day,equivalent preparationsESCOP: 2–3 g drug, 2 times a day

85


Stock plant(Latin)


Origanummajorana L., syn. Ama-racus majorana (L.) SCHINZ etTHELLUNG, Majorana hortensisMOENCH

Herb S

Origanummajorana L., syn. Ama-racus majorana (L.) SCHINZ etTHELLUNG, Majorana hortensisMOENCH

Fruit Not NFS

Origanum vulgare L., syn. Orig-anum anglicumHILL., Origanumcreticum L., Origanum latifoliumMILL., Origanum venosumWILLD.ex BENTH.

Herb S

Orthosiphon aristatus (BLUME)MIQUEL, syn. Orthosiphonstamineus BENTH., Orthosiphonspicatus (THUNB.) BAK., Ocimumgrandiflorum BOLD

Leaf T

Oryza sativa L. Fruit, seed Osmanthus fragrans (THUN.)LOUR.

Flower

Paeonia officinalis (L.) emend.WILLD., syn. Paeonia femineaMILL., Paeonia foemina GARS.

Flower C

Panax ginseng C.A. MEY., syn. Ar-alia ginseng (C.A. MEY.) BAILL.,Panax quinquefolius L. var. coreen-sis LIEB.

Root T

Panax notoginseng CHEN. Root Not NFS Panax pseudoginsengWALL. Root Not NFS Panax quinquefolius L., syn.Aralia canadensis TOURN., Au-reliana canadensis LAFIT., GinsengquinquefoliumWOOD., PanaxamericanumRAF.

Root Not NFS

Panicummiliaceum L., syn. Pan-icum PERS.

Seed

86




Negativemonograph: due to risks Hydroquinone contained in the drugdemonstrates a carcinogenic effect inanimal experiments (Commission Emonograph)

Hydroquinonesand hydro-quinonederivatives(e.g. arbutin)

Neutral monograph,WHOmonograph: tra-ditional use

Positivemonograph, indications: irrigationtherapy of bacterial and inflammatory dis-eases of the lower urinary tract and kidneygravel, ESCOPmonograph: irrigation of theurinary tract, especially in cases of inflam-mation and renal gravel, and as an adjuvantin the treatment of bacterial infections ofthe urinary tract,HMPCmonograph: tradi-tional use, standard marketing authorisation:1159.99.99

Contraindications: oedemas associatedwith cardiac and renal insufficiency(Commission Emonograph)

Commission E: 6 to 12 g drug,equivalent preparationsESCOP: 2–3 g in 150ml water,2–3 times a day, equivalentpreparations

Neutral monograph: slightly toxic (+) (Roth/Daunderer)

Flowers and seedsmay induce gas-troenteritis accompanied by vomiting,colic and diarrhoea (Roth/Daunderer)

Positivemonograph, indications: tonic forstrengthening and invigoration in case offatigue and faintness, decreasing physicalperformance and powers of concentration aswell as in convalescence,WHOmonograph:used as a prophylactic and restorative agentfor enhancement of mental and physical ca-pacities, in cases of weakness, exhaustion,tiredness, and loss of concentration, andduring convalescence, ESCOPmonograph:decreased mental and physical capacities suchas weakness, exhaustion, tiredness and lossof concentration, as well as during convales-cence,HMPCmonograph: in progress, hardlyor only slightly toxic (+) (Roth, Daunderer)

Long-term use in higher doses causesdiarrhoea, insomnia, euphoria, hyper-tension and oedemas. “ginseng abuse”syndrome (Roth/Daunderer, Frohne)

Ginsenosides Commission E: 1–2 g drug/day,equivalent preparationsWHO: 0.5–2 g/day, equivalentpreparations, no administrationto children

WHOmonograph: traditional use WHO: 3–9 g drug/day

87


Stock plant(Latin)


Papaver rhoeas L. Petal Not NFS Papaver somniferum L., syn.Papaver amplexicaule STOKES,Papaver nigrum CRANTZ, Papaverofficinale GMD., Papaver opiiferumFORSK.

Dried latex

Papaver somniferum L., syn.Papaver amplexicaule STOKES,Papaver nigrum CRANTZ, Papaverofficinale GMD., Papaver opiiferumFORSK.

Seed

Passiflora edulis (AUBL.) SCHUM. Fruit Passiflora incarnata L., syn.Granadilla incarnata MEDIK.

Herb T

Passiflora incarnata L., syn.Granadilla incarnata MEDIK.

Flower C

Pastinaca sativa L., syn. Pastinacaopaca BERNH., Pastinaca pratensisH. MART., Pastinaca sativa var.edulis DC., Pastinaca sativa var.longa ALEF., SelinumpastinacaeCRANTZ

Root

Paullinia cupana KUNTH exH.B.K., syn. Paullinia cupana H.B.K.,Paullinia sorbilis (L.) MART.

Seed

88




Neutral monograph

the clottedmilky sap (Ddried latex) of plantsbelonging to the Papaver somniferum speciesreferred to as opium is subject to the provi-sions of the Narcotic Drugs Act (BtMG) highlytoxic ++ ( Roth/Daunderer), very toxic Ib(Wink/Wyk)

reduced mental performance, sopor,irregular respiration, anaesthetic mus-cular relaxation, nausea, vomiting,bradycardia, dizziness, vertigo, tonic-clonic cramps, central paralysis, pul-monary oedema, cerebral oedema,anaphylaxis, acute bilateral loss ofhearing, colonic inertia, death by ap-noea (Hager, Roth/Daunderer)

Opium alkaloids(e.g. morphine,codeine, papaver-ine)

s. BfR statement on opium poppy: http://www.bfr.bund.de/cd/6279, http://www.bfr.bund.de/cd/7409

Positivemonograph, indications: nervousagitation, standard marketing authorisation:1619.99.99,WHOmonograph: mild seda-tive for nervous restlessness, insomnia andanxiety. Treatment of gastrointestinal disor-ders of nervous origin, ESCOPmonograph:tenseness, restlessness and irritabilitywithdifficulty in falling asleep,HMPCmonograph:traditional use; information provided in theliterature stating that passion flower containsharmala alkaloids not confirmed inmore re-cent studies. Only traces of harmala alkaloids(below 1ppm) detected in individual samples.Whether these amounts are sufficient for CNSactivity needs to be investigated in in-vivostudies. (Hänsel/Sticher, Hager)

HCN release due to cyanogenic gly-cosides (Passiflora incarnata containsat most traces of these compounds(Hager)), release of harmala alkaloids islikely to cause hallucinogenic effects(Wink/Wyk)

cyanogenic gly-cosides, harmalaalkaloids

Commission E: 4–8 g drug/day,equivalent preparationsESCOP,WHO: 0.5–2 g drug, 3–4 times a day

Information provided in the literature statingthat passion flower contains harmala alkaloidsnot confirmed in more recent studies. Onlytraces of harmala alkaloids (below 1ppm)detected in individual samples. Whether theseamounts are sufficient for CNS activity needsto be investigated in in-vivo studies. (Hänsel/Sticher, Hager)

Release of harmala alkaloids is likelyto cause hallucinogenic effects (Wink/Wyk)

Harmala alkaloids

Myristicin, furo-coumarin

mildly toxic III (Wink/Wyk), toxic only whenabused + (Roth/Daunderer), ESCOPmono-graph: tonic in cases of fatigue, exhaustion orconvalescence,HMPCmonograph: traditionaluse

CNS stimulant, ingestion of higherdoses causes poisoning accompaniedby headache, vertigo, cardiac palpi-tation, sleep disturbances, agitation,vomiting, diarrhoea, severe diuresis(Wink/Wyk)

Caffeine, saponins ESCOP: 1–3 g drug/day, equiva-lent preparations

89

http://www.bfr.bund.de/cd/6279





Stock plant(Latin)


Pausinystalia yohimbe(K. SCHUM.) PIERRE ex BEILLE,syn. Corynanthe yohimbeK. SCHUM.

all plant parts

Peganum harmala L. all plant parts

Petasites spp., e.g. Petasites hy-bridus (L.) GAERTN., MEY. etSCHERB.

all plant parts

Petroselinum crispum (MILL.)NYM. ex A.W. HILL., syn. Apiumhortense E.H.L. KRAUSE, Apiumpetroselinum L., Apium vulgareLAM., Carum petroselinum BENTH.et HOOK.

Seed T


Herb S


Root

90




Negativemonograph: due to risks associ-ated with Yohimbe bark, Yohimbe pharmacy-only, yohimbic acid and its esters pre-scription-only, very toxic Ib (Wink/Wyk),highly toxic ++ (Roth/Daunderer) s. BfRstatement: http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf

Vertigo, hypersalivation, faintness,cold spills, sweats, nervous excitement,cardiac palpitation, insomnia, gastriccomplaints, headache, gastrointestinalcomplaints, increase in blood pressureand tachycardia, tremor, irritability(Hager)

Alkaloids(e.g. yohimbine)

WHOmonograph: treatment of differentforms of myasthenia, myopathy and atony ofthe bowels, highly toxic ++ (Roth/Daunderer),very toxic Ib (Wink/Wyk)

psychotropic, hallucinogenic, hyper-salivation, vomiting, muscular tremor(Hager, Wink/Wyk, Roth/Daunderer)

Indole alkaloids(e.g. harmine,harmaline),quinazoline al-kaloids

WHOmonograph: a teaspoonof the preparation of a teaspoonof drug in one cup of water, 3–4 times a day

Positivemonograph: for Petasites hybridusrhizoma (butterbur rootstock), indications:adjuvant treatment of acute cramps in thelower urinary tract,Negativemonograph:due to risks associated with Petasites hybridusfolium (butterbur leaves), classification ofPetasitidis folium as substance of concern(AMK), BfArM graduated plan of 5 June 1992concerning medicinal products contain-ing pyrrolizidine alkaloids, toxic + (Roth/Daunderer), mildly toxic II to toxic III (Wink/Wyk)

All plant parts of butterbur containvarying amounts of hepatotoxicpyrrolizidine alkaloids, whichdemonstrated a mutagenic and car-cinogenic effect in animal experiments(Schilcher)


Commission E: 4.5–7 g drug/day

Negativemonograph: due to risks, Roth/Daunderer: hardly toxic (+), mildly toxic III(Wink/Wyk)

In high doses, the essential oil in pars-ley seeds and the phenyl propanoidderivative apiol contained in it inducevascular congestions and enhance thecontractility of the smoothmusclesof the bladder, the intestines and es-pecially the uterus. Parsley seeds andparsley oil therefore formerly used asaborticide; irritation, damage to renalepithelial tissues and cardiac arrhyth-mia reported, higher doses of apiolin parsley may cause fatty liver dis-ease, emaciation, bloody stool, profusehaemorrhage of mucousmembranesand haemorrhagic-inflammatory in-filtrations in the gastrointestinal tract,haemolysis, methaemoglobinuria andanuria (Commission Emonograph).Toxic effects are not expected in usualdoses (Roth/Daunderer), phototoxic

Furocoumarins,phenylpropanoids(e.g. myristicin,apiol)

Positivemonograph, indications: irrigationtherapy of diseases of the lower urinary tractand kidney gravel, Roth/Daunderer: hardlytoxic (+), mildly toxic III (Wink/Wyk)

like seeds, but lower essential oil con-tent, phototoxic



Positivemonograph, indications: irrigationtherapy of diseases of the lower urinary tractand kidney gravel, Roth/Daunderer: hardlytoxic (+), mildly toxic III (Wink/Wyk)

like seeds, but lower essential oil con-tent, phototoxic



91





Stock plant(Latin)


Peumus boldusMOL., syn. Peumusfragrans PERS., Boldea fragransJUSS., Boldea fragrans C. GAY

Leaf

Pfaffia paniculata (MART.)KUNTZE

Root Not NFS

Phaseolus vulgaris L., syn. Phaseo-lus nanus L.

Pod b

Phaseolus vulgaris L., syn. Phaseo-lus nanus L.

Seed b

Phoenix dactylifera L. Fruit Phyllanthus emblica L., Emblicaofficinalis GAERTN., Phyllanthusmairei LÉV.

Fruit Not NFS

Physostigma venenosumBAL-FOUR

Seed

Phytolacca americana L., syn. Phy-tolacca decandra L., Phytolaccavulgaris CRANTZ.

Fruit

Picea abies (L.) KARSTEN, syn.Abies excelsa LAM. et DC., AbiespiceaMILLER, Pinus abies L.

Shoot (tip) T

92




Positivemonograph, indications: mildgastrointestinal cramps, digestive prob-lems, standard marketing authorisation:2329.99.99, ESCOPmonograph: minor hepa-tobiliary dysfunction, symptomatic treatmentof mild digestive disturbances,HMPCmono-graph: traditional use, toxic II (Wink/Wyk),toxic + (Roth/Daunderer)

neurotoxic effect observed, ingestionof higher doses causes paralysis, hal-lucinations and CNS disorders (Wink/Wyk), contraindications: occlusionof biliary tract, severe liver diseases,pregnancy (because of ascaridole con-tent). In case of gallstones, use onlyafter consultation with a physician.(Commission Emonograph)

Alkaloids(e.g. boldine),monoterpenes(e.g. ascaridole)

Commission E: average dailydose: 3.0 g drug, equivalentpreparationsESCOP: 2–5 g drug/day

Positivemonograph, indications: slightlydiuretic, standard marketing authorisation:8499.99.99; in unprocessed formmildly toxic IIto toxic III (Wink/Wyk), highly toxic ++ (Roth/Daunderer), heat thoroughly before consump-tion,HMPCmonograph: traditional use

Seeds and pods contain lectin(“phasin”). Since phasin is a protein,it is destroyed by cooking, but not bydrying. Symptoms usually occur after2 to 3 hours. The severity of the diseasevaries from case to case. Symptomsinclude nausea, abdominal pain andvomiting, gastroenteritis and cramps.May be accompanied by bloody di-arrhoea. Besides fever, shivering andsweats, convulsive fits and shockmayoccur. (Bonn Poison Control Centre)

Lectin (“phasin”) Commission E: 5–15 g drug/day,equivalent preparations

in unprocessed formmildly toxic II to toxic III,highly toxic ++ (Roth/Daunderer), heat thor-oughly before consumption

Seeds and pods contain lectin(“phasin”). Since phasin is a protein,it is destroyed by cooking, but not bydrying. Symptoms usually occur after2 to 3 hours. The severity of the diseasevaries from case to case. Symptomsinclude nausea, abdominal pain andvomiting, gastroenteritis and cramps.May be accompanied by bloody di-arrhoea. Besides fever, shivering andsweats, convulsive fits and shockmayoccur. (Bonn Poison Control Centre)

Lectin (“phasin”)

poisonous plant, extremely toxic (Roth/Daunderer), extremely toxic (Wink/Wyk),physostigmine prescription-only, Physostigmaspecies pharmacy-only

Paraesthesia, inflammation of mucousmembranes, tremor, tachycardia, per-sistent vertigo, death by cardioplegiaand respiratory arrest (Wink/Wyk)

Alkaloids(e.g. physostig-mine)

toxic + (Roth/Daunderer), toxic II (Wink/Wyk) Nausea, vomiting, diarrhoea, abdom-inal pain, colic, headache, circulatorydistress, abortionmay occur, fatal poi-soning possible (Wink/Wyk, Roth/Daunderer)

Lectins, triterpenesaponins

Positivemonograph, indications: catarrhs ofthe respiratory tract


93


Stock plant(Latin)


Pilocarpus jaborandi HOLMES,syn. Pilocarpus cearensis RIZZINI,Pilocarpus officinalis POEHL

Leaf

Pimenta officinalis LINDL., syn.Pimenta officinalis BERG, Pimentavulgaris LINDL., Eugenia pimentaDC., Myrtus pimenta L., Pimentadioica (L.) MERR.

Fruit S

Pimpinella anisum L., syn. Anisumvulgare GAERTN.

Fruit T, S

Pimpinella major (L.) HUDS., syn.Apium pimpinella CARUEL

Herb S

Pimpinella major (L.) HUDS., syn.Apium pimpinella CARUEL

Root T,S

Pimpinella saxifraga L., syn.Pimpinella alpestris SPRENG.

Herb S

Pimpinella saxifraga L., syn.Pimpinella alpestris SPRENG.

Root T,S

Pinus mugo TURRA, syn. Pinusechinata HORT., Pinus montanaMILLER

Shoot (tip) T

Pinus sylvestris L., syn. Pinus nigraMILL.

Shoot (tip) T

Piper cubeba L.f., syn. Cubebaofficinalis RAF.

Fruit S

94




Pilocarpine prescription-only, Pilocarpusspecies pharmacy-only, extremely toxic (Roth/Daunderer), very toxic (Wink/Wyk), substanceof concern (AMK)

parasympathomimetic effect,hypersalivation, sweating, visual dis-turbances, vomiting, diarrhoea, uteruscontractions, abortion, bradycar-dia, cardiac palpitation, convulsions,tremor, dyspnoea, arrhythmia, vesicaltenesmus, headache, vertigo, deathby cardiac arrest, leucocytosis (Wink/Wyk, Roth/Daunderer)

Imidazolealkaloids (e.g. pi-locarpine)

Positivemonograph, indications: diges-tive problems, catarrhs of the respiratorytract, standard marketing authorisation:8099.99.99,WHOmonograph (fruit andoil): treatment of dyspepsia and mild in-flammation of the respiratory tract, ESCOPmonograph: dyspeptic complaints such asmild spasmodic gastrointestinal complaints,bloating, flatulence, catarrh of the upper res-piratory tract,HMPCmonograph: traditionaluse

allergic reactions of skin, respiratorytract and gastrointestinal tract occuroccasionally (Commission Emono-graph)

Trans-anethole,furocoumarins,estragole(Dmethyl chavi-col)

Commission E, ESCOP,WHO:3 g drug/day, equivalent prepara-tions

Neutral monograph phototoxic (Hager) Furocoumarins


phototoxic (Hager) Furocoumarins Commission E: 6–12 g drug/day,equivalent preparations

Neutral monograph phototoxic (Hager) Furocoumarins


phototoxic (Hager) Furocoumarins Commission E: 6–12 g drug/day,equivalent preparations



toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Ingestion of higher doses causespainful urinary tract inflammations,pain in kidneys and bladder, albumin-uria, tachycardia, nausea, vomiting,diarrhoea, CNS disorders, spasmodicurinary retention, accelerated pulse,cardialgia, diarrhoea and skin rash(Wink/Wyk, Roth/Daunderer)

Cubebin, cubebicacid

95


Stock plant(Latin)


Piper methysticumG. FORST., syn.Macropiper latifoliumMIQ.

Rhizome

Piper nigrum L., syn. MulderamultinervisMIQ., Piper aro-maticum LAM., Piper trioicumROXB.

Fruit S

Piscidia erythrina L., syn. Comp-tosema pinnatum BENTH., Piscidiapiscipula (L.) SARG.

Root cortex

Pistacia vera L., syn. Pistacia nar-bonensis L., Pistacia nigricansCRANTZ, Pistacia officinarumAITON

Seed

Pisum sativum L. Seed Plantago lanceolata L., Arnoglos-sum lanceolatum (L.) GRAY,Plantago flexuosa GAUD ex RAPIN,Plantago lanceofolia SALISB.

Herb T

Plantagomajor L., syn. Plantagoasiata L., Plantago latifolia SALISB.

Herb Not NFS

96




withdrawal of marketing authorisationdue to risks following the graduatedplan procedure (BfArM notificationof 21 Dec 2007: http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-kavakava.html;jsessionid=7AF6D40DED621345B74BFDC9AD594B34.1_cid332), Positivemonograph, indications:states of nervous anxiety, stress and agitation,WHOmonograph: short-term symptomatictreatment of mild states of anxiety or insom-nia, due to nervousness, stress or tension,ESCOPmonograph: anxiety, tension andrestlessness arising from various causes ofnon-psychotic origin, substance of concern(AMK): kava-kava and kavain, toxic + (Roth/Daunderer), mildly toxic (Wink/Wyk)

severe hepatotoxic reactions (Wink/Wyk, Roth/Daunderer, BfArM notifica-tion on graduated plan)

Kavapyrones(e.g. kavain)

ESCOP: equivalent to 60–120mgkavalactones/day, (no data avail-able for children)WHO: 60–210mg kavapyrones/day

Black pepper: dried, unripe fruit White pep-per: ripe fruit without fruit pulp Green pepper:air-dried, freeze-dried, deep-frozen or pick-led unripe fruit Pink pepper: fully ripe fruit(Teuscher)

toxic + (Roth/Daunderer), very toxic Ib (Wink/Wyk)

Vomiting, hypersalivation, sweats,dizziness and tremor, first enhancedthen depressed respiration, centralparalysis, cardioplegia, used as fish andarrow poison (Wink/Wyk)

Isoflavones(jamaicin, mune-tone, ichthynone,rotenone)

Positivemonograph, indications: catarrhs ofthe respiratory tract, inflammatory changesof the oral and pharyngeal mucosa, standardmarketing authorisation: 1289.99.99, ESCOPmonograph: catarrhs of the respiratory tract,temporary, mild inflammations of the oraland pharyngeal mucosa,HMPCmonograph:traditional use

ESCOP, Commission E: 3–6 gdrug/day, equivalent prepara-tionsWHOmonograph: 2–4 g drug,3 times a day

WHOmonograph, indications: catarrh ofthe respiratory tract, cough, bronchitis, in-flammatory alterations of the oral mucosa,phlegm congestion, nephritis, cystitis, urinaryretention, dysentery, epistaxis (nosebleed) andexcessive diaphoresis (49, 50). It is also used forthe treatment of diarrhoea and constipation

97

http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-kavakava.html;jsessionid=7AF6D40DED621345B74BFDC9AD594B34.1_cid332






Stock plant(Latin)


Plantago ovata FORSSKAL, syn.Plantago isphagula ROXB. exFLEMMING, Plantago brunneaMORRIS

Seed husk

98




higher swelling number than psyllium seeds,risk of intestinal occlusion after overdose,Positive monograph, indications: habit-ual constipation, conditions in which easydefaecation is desirable, e.g. anal fissures,haemorrhoids, after rectal-anal surgicalprocedures and during pregnancy, adjuvanttreatment of diarrhoea of various origins aswell as irritable bowel,WHOmonograph:a bulk-forming laxative used therapeuti-cally for restoring and maintaining bowelregularity, treatment of chronic constipa-tion, temporary constipation due to illnessor pregnancy, irritable bowel syndrome andconstipation related to duodenal ulcer or di-verticulitis, also indicated for stool softeningin the case of haemorrhoids, or after anorectalsurgery, short-term use for the symptomatictreatment of diarrhoea of various etiologies,ESCOPmonograph: treatment of occasionalconstipation, conditions in which easy defi-cation with soft stools desireable, e.g. in casesof anal fissures or haemorrhoids, after rectalor anal surgery, and during pregnancy; condi-tions which need an increased daily intake offibre, e.g. irritable bowel syndrome, adjuvantsymptomatic therapy in cases of diarrhoeafrom various causes, as an adjunct to a lowfat diet in the treatment of mild to moderatehypercholesterolaemia,HMPCmonograph:habitual constipation; in conditions in whicheasy defaecation with soft stool is desirable,e.g. in cases of painful defaecation after rectalor anal surgery, anal fissures and haemor-rhoids; in patients to whom an increased dailyfibre intake may be advisable e.g. as an adju-vant in constipation predominant irritablebowel syndrome, as adjuvant to diet in hyper-cholesterolemia

Side effects: hypersensitivity reactionsmay occur in individual cases, con-traindications: pathologic stenosis ofgastrointestinal tract, imminent orexisting intestinal occlusion (ileus),difficult-to-control diabetes mel-litus (Commission Emonograph),oesophageal occlusion or obstructionup to intestinal occlusionmay occuron improper use (HMPCmonograph)

Commission E, ESCOP: 4–20 gdrug/day, equivalent prepara-tions (children!)HMPC: 7–20 g drug/day, equiv-alent preparations, special dosesfor children

99


Stock plant(Latin)


Plantago ovata FORSSKAL,syn.Plantago isphagula ROXB. exFLEMMING, Plantago brunneaMORRIS

Seed

Plantago psyllium L., syn. Plantagoafra L., Plantago (L.) MIRB.

Seed

Podophyllum peltatum L. Root, resin

100




Positivemonograph, indications: habit-ual constipation, conditions in which easydefaecation is desirable, e.g. anal fissures,haemorrhoids, after rectal-anal surgicalprocedures and during pregnancy, adjuvanttreatment of diarrhoea of various origins aswell as irritable bowel, standard marketingauthorisation: 1549.99.99,WHOmonograph:as a bulk-forming laxative used to restoreand maintain regularity, Semen Plantagi-nis is indicated in the treatment of chronicconstipation, temporary constipation due toillness or pregnancy, irritable bowel syndrome,constipation related to duodenal ulcer or di-verticulitis. It is also used to soften the stoolsof those with haemorrhoids, or after anorectalsurgery, traditional use, ESCOPmonograph:treatment of occasional constipation, con-ditions in which easy defication with softstools desireable, e.g. in cases of anal fissuresor haemorrhoids, after rectal or anal surgery,and during pregnancy; conditions which needan increased daily intake of fibre, e.g. irritablebowel syndrome, adjuvant symptomatic ther-apy in cases of diarrhoea from various causes,HMPCmonograph: treatment of habitualconstipation. In conditions in which easy de-faecation with soft stool is desirable, e.g. incases of painful defaecation after rectal or analsurgery, anal fissures and haemorrhoids.

allergic reactions observed in rarecases, especially with comminuteddrug and liquid preparations (Com-mission Emonograph), oesophagealocclusion or obstruction up to intesti-nal occlusionmay occur on improperuse (HMPCmonograph)

Commission E: 12–40 g drug/day, equivalent preparationsESCOP: 7–30 g/day, equivalentpreparations, special doses forchildren and for the indication ofhypercholesterolaemiaWHO: 7.5 g drug in 240ml water,1–3 times a day, special doses forchildrenHMPC: 8–40 g drug/day, equiv-alent preparations, special dosesfor children

Positivemonograph, indications: habit-ual constipation, irritable colon, standardmarketing authorisation: 1509.99.99,WHOmonograph: as a bulk-forming laxative usedto restore and maintain regularity, SemenPlantaginis is indicated in the treatment ofchronic constipation, temporary constipationdue to illness or pregnancy, irritable bowelsyndrome, constipation related to duodenalulcer or diverticulitis, it is also used to softenthe stools of those with haemorrhoids, or af-ter anorectal surgery, ESCOPmonograph:treatment of occasional constipation, con-ditions in which easy defication with softstools desireable, e.g. in cases of anal fissuresor haemorrhoids, after rectal or anal surgery,and during pregnancy, adjuvant symptomatictherapy in cases of diarrhoea from variouscauses,HMPCmonograph: treatment of ha-bitual constipation, in conditions in whicheasy defecation with soft stool is desirable,e.g. in cases of painful defecation after rectal oranal surgery, anal fissures and haemorrhoids.

Contraindications: oesophageal andgastrointestinal stenosis, side effects:allergic reactions observed in rarecases, especially with comminuteddrug (Commission Emonograph),oesophageal occlusion or obstructionup to intestinal occlusionmay occuron improper use (HMPCmonograph)

Commission E, ESCOP: 10–30 gdrug/day, equivalent prepara-tions (special doses for children)WHO: 7.5 g drug in 240ml water,1–3 times a day, special doses forchildrenHMPC: 25–40 g drug/day, equiv-alent preparations, special dosesfor children

Positivemonograph for external use, alsotoxic when used externally, root and prepa-rations thereof as well as various substancesof P. peltatum prescription-only, use as ver-mifuge, laxative and diuretic reported (Roth/Daunderer), very toxic Ib (Wink/Wyk), toxic +to highly toxic ++ (Roth/Daunderer)

Plant cytostatic, strong mitotic poison,haemorrhagic gastroenteritis, bloody-watery diarrhoea, impaired coordina-tion, cramps, tachycardiac arrhythmia,paraesthesia, nephritis, coma, death byapnoea (Roth/Daunderer)

Podophyllin,lignans(e.g. podophyl-lotoxin, peltatin)

101


Stock plant(Latin)


Pogostemon patchouly PELLET.,syn. Pogostemon cablin (BLANCO)BENTH., Pogostemon intermediumBENTH.

Leaf Not NFS

Polygala senega L. Root T

Polygonatummultiflorum (L.)ALL., syn Convallaria multiflora L.

all plant parts

Polygonum aviculare L., syn. Poly-gonum heterophyllum LINDM.

Herb T

Potentilla anserina L., syn. Ar-gentina anserina RYDBERG,Argentina vulgaris LAM., Dacty-lophyllum anserina SPENNER

Herb T

Potentilla erecta (L.) RÄUSCHEL,syn. Potentilla tormentillaNECKER, Potentilla tormentillaSCHRANK, Potentilla tormentillaSTOKES, Tormentilla erecta L., Tor-mentilla officinalis CURT.

Rhizome F

Primula elatior (L.) HILL, Primulaveris L.

Flower C

Primula veris L., syn. Primula coro-naria SALISB. PrimulamontanaREUT., Primula odorata GILIB. andPrimula elatior (L.) HILL

Root T

Prunus amydalus var. sativa (L.)FOCKE, syn. Amygdalus communisL. var. dulcis DC.

Flower Not NFS

Prunus amydalus var. sativa (L.)FOCKE, syn. Amygdalus communisL. var. dulcis DC.

Seed

Prunus amygdalus BATSCH var.amara (DC.) FOCKE

Seed F

Prunus armeniaca L., syn. Armeni-aca vulgaris LAM.

Fruit

102




Positivemonograph, indications: catar-rhs of the upper respiratory tract, ESCOPmonograph: productive cough, catarrh of therespiratory tract, chronic bronchitis,WHOmonograph: traditional use

contains saponins, long-term usecauses gastrointestinal irritation (Com-mission Emonograph)

Commission E, ESCOP,WHO:1.5–3 g drug/day, equivalentpreparations, administrationto children only under medicalsupervision

toxic + (Roth/Daunderer), mildly toxic II totoxic III (Wink/Wyk)

Nausea, diarrhoea, vomiting, used asemetic in traditional Russianmedicine(Roth/Daunderer)

steroidal saponins

Positivemonograph, indications: mild catar-rhs of the respiratory tract, inflammatorychanges of the oral and pharyngeal mucosa,WHOmonograph: supportive treatment ofgingivitis, used for the relief of cough and coldsymptoms

Commission E,WHOmono-graph: 4–6 g drug/day,equivalent preparations

Positivemonograph, indications: mild dys-menorrhoea, adjuvant treatment of mild, non-specific, acute forms of diarrhoea, mild inflam-mations of the oral and pharyngeal mucosa,standard marketing authorisation: 9599.99.99

Symptoms of irritable stomach maybe aggravated (Commission Emono-graph)


Positivemonograph, indications: non-specific, acute forms of diarrhoea, mild inflam-mations of the oral and pharyngeal mucosa,HMPCmonograph: traditional use, s. BfRstatement: http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf

Sensitive patients may experiencegastric complaints (Commission Emonograph)


Positivemonograph, indications: catarrhs ofthe respiratory tract,WHOmonograph: tradi-tional use, standard marketing authorisation:1659.99.99, HMPCmonograph: traditional use

gastric complaints and nausea ob-served in rare cases, contraindicationsreported (Commission Emonograph)


Positivemonograph, indications: catarrhs ofthe respiratory tract, standard marketing au-thorisation: 2389.99.99, ESCOPmonograph:productive cough, catarrh of the respiratorytract, chronic bronchitis,HMPCmonograph:traditional use, mildly toxic III (Wink/Wyk)

Side effects: gastric complaints andnausea observed in rare cases, con-traindications reported (Commission Emonograph)

Saponins Commission E, ESCOP: 0.5–1 g(5–10 g) drug/day, equivalentpreparations

Guidelines for oils seeds as well as mixturesand sweets produced thereof laid down in theGerman Food Code

Guidelines for oils seeds as well as mixturesand sweets produced thereof laid down inthe German Food Code: Almonds may con-tain up to 5 wt% bitter almonds, very toxic Ib(Wink/Wyk), toxic + to highly toxic ++ (Roth/Daunderer)

Hydrocyanic acid (HCN) may be re-leased on ingestion, HCN is a strongrespiratory inhibitor, ingestion ofhigher doses causes burning in thethroat, sweating, abdominal pain,vomiting, facial blush, hypersalivation,convulsions, respiratory and cardiacarrest (Wink/Wyk)

cyanogenicglycosides(e.g. amygdalin)

103





Stock plant(Latin)


Prunus armeniaca L., syn. Armeni-aca vulgaris LAM.

Seed

Prunus avium L. Fruit Prunus avium L. Stalk Not NFS Prunus cerasus L., Cerasus vul-garis MILL., Cerasus capronianaDC., Prunus caproniana GAUD.,Druparia cerasus CLAIRV.

Fruit

Prunus cerasus L., Cerasus vul-garis MILL., Cerasus capronianaDC., Prunus caproniana GAUD.,Druparia cerasus CLAIRV.

Stalk Not NFS

Prunus domestica L., syn. Prunuscommunis HUDS. Non ARCANG.,Prunus sativa ROUY et CAMUS

Fruit

Prunus persica (L.) SIEB. et ZUCC.,syn. Persica vulgaris MILL., Amyg-dalus persica L.

Fruit

Prunus spinosa L., syn. Drupariaspinosa CLAIRV.

Flower T

Prunus spinosa L., syn. Drupariaspinosa CLAIRV.

Fruit

Psidium guajava L. Fruit Psidium guajava L. Leaf Not NFS

Psychotria viridis RUIZ et PAV. all plant parts

Pteridium aquilinum (L.) KUHN,syn. Pteris aquilina L., Aspleniumaquilinum (L.) BERNH.

all plant parts

Pterocarpus santalinus L.f.,syn. Lingoum santalinum (L.f.)KUNTZE.

Wood S, T

Ptychopetalum olacoides BENTH. Wood Not NFS

Pueraria lobata (WILLD.) OHWI,syn. Pueraria thunbergiana (SIEB.et ZUCC.) BENTH., Pueraria hirsuta(THUNB.) SCHNEID. non KURZ,Dolichos japonicus HORT.

Root

104




WHOmonograph: symptomatic treatmentof asthma, cough with profuse expecto-ration and fever. The seed oil is used fortreatment of constipation; Guidelines foroils seeds as well as mixtures and sweetsproduced thereof: http://www.bmelv.de/SharedDocs/Downloads/Ernaehrung/Lebensmittelbuch/LeitsaetzeOelsamen.pdf?__blob=publicationFile

Bitter apricot kernels have a highcyanogenic glycoside content,e.g. amygdalin, which breaks downto hydrogen cyanide during digestion,symptoms of acute poisoning includee.g. cramps, vomiting, dyspnoea, cul-minating in death by apnoea (BfR, FSA)

cyanogenic glyco-sides

WHO: 3–9 g drug/day, no ad-ministration to children

Neutral monograph

Positivemonograph: for external use (mouth-wash)


WHOmonograph: acute diarrhoea, gingivitis,rotaviral enteritis

WHO: 500mg drug, 3–4 timesa day, no administration to chil-dren under the age of 12

mildly toxic III (Wink/Wyk), used to-gether with Banisteriopsis caapi to produceayahuasca, a narcotic, DMT is subject to theprovisions of the BtMG

psychotropic, hallucinogenic (Wink/Wyk)

Tryptamine alka-loids (e.g. N,N-dimethyl-tryptamine=DMT)

all plant parts very toxic Ib (Wink/Wyk),toxic + (Roth/Daunderer)

Increased incidence of gastric andoesophageal carcinoma reported(Frohne/Pfänder), ptaquiloside con-tained in the drug is highlymutagenicand causes stomach and bladder can-cer, thiaminase contained in the drugdestroys vitamin B1 (Wink/Wyk)

Ptaquiloside,thiaminase,cyanogenic glyco-sides

Neutral monograph

Neutral monograph

Isoflavones

105

http://www.bmelv.de/SharedDocs/Downloads/Ernaehrung/Lebensmittelbuch/LeitsaetzeOelsamen.pdf?__blob=publicationFile





Stock plant(Latin)


Pulsatilla pratensis (L.) MILL., syn.Anemone intermedia SCHULT.,Anemona pratensis L., Pulsatillabreynii RUPR.

all plant parts

Pulsatilla vulgaris MILL., syn.Anemona pulsatilla L.

all plant parts

Punica granatum L., syn. Grana-tum punicum ST. LAG., Punicaflorida SALISB.

Fruit


Peel Not NFS


Bark

Pyrus communis L. Fruit Quassia amara L., syn. Quassia alat-ifolia STOKES, Quassia cocea VAHL,Quassia gujanensis D. DIETR.

Wood F

Quercus robur L., syn. Quercusfemina MILL., Quercus fruc-tipendula SCHRANK, Quercusgermanica LASCH

Bark T

Quillaja saponaria MOLINA, syn.Quillaja molinae DC.

Bark Not NFS

Raphanus sativus L., syn. Raphanusofficinalis CRANTZ, Raphanusraphanistrum var. sativus BECK

Root

Rauvolfia serpentina (L.) BENTH.ex KURZ, syn. Ophioxylon ob-versumMIQ., Rauvolfia observa(MIQ.) BAILL., Rauvolfia trifoliata(GAERTN.) BAILL.

Root

106




Negativemonograph: due to risks, Pulsatillaeherba and preparations thereof prescription-only, pasque flower pharmacy-only, toxic +(Roth/Daunderer) toxic Ib to very toxic II(Wink/Wyk)

central paralysis, gastrointestinal com-plaints (nausea, vomiting, diarrhoea),irritation of mucousmembranes, ir-ritation of kidneys and lower urinarytract (Wink/Wyk, Roth/Daunderer),protoanemonin contained in the drughas an abortifacient and teratogeniceffect (Schilcher)

Protoanemonin,saponins

Negativemonograph: due to risks, Pulsatillaeherba and preparations thereof prescription-only, pasque flower pharmacy-only, toxic +(Roth/Daunderer) toxic Ib to very toxic II(Wink/Wyk)

central paralysis, gastrointestinal com-plaints (nausea, vomiting, diarrhoea),irritation of mucousmembranes, ir-ritation of kidneys and lower urinarytract (Wink/Wyk, Roth/Daunderer),protoanemonin contained in the drughas an abortifacient and teratogeniceffect (Schilcher)

Protoanemonin,saponins

WHOmonograph for bark and pericarp:chronic diarrhoea, dysentery, gingivitis andintestinal parasites

WHO: pericarp 2.5–4.6 g/day, noadministration to children underthe age of 12

WHOmonograph for bark and pericarp: diar-rhoea, intestinal parasites

Ingestion of higher doses (more than80 g) may cause nausea, diarrhoea,haemorrhage, vertigo, fever, tremor,circulatory collapse, visual distur-bances (WHOmonograph)

WHO: cortex (3–9 g drug/day),no administration to childrenunder the age of 12

mildly toxic II to toxic III (Wink/Wyk), slightlytoxic + (Roth/Daunderer), use as flavouringgoverned by Reg. (EC) No. 1334/2008

Ingestion of high doses causes di-gestive problems and CNS disorders(Wink/Wyk), gastric irritation, vom-iting, contraindicated in pregnancy(Roth/Daunderer)

Quassin

Positivemonograph, indications: externaluse: inflammatory skin diseases, internal use:non-specific, acute forms of diarrhoea, lo-cal treatment of mild inflammations in themouth and throat as well as in the genitaland anal region,HMPCmonograph: tradi-tional use, standard marketing authorisation:9099.99.99, mildly toxic (Wink/Wyk), non-toxic or hardly toxic (+) (Roth/Daunderer)

Interactions: absorption of alkaloidsand other alkaline medicinal productsmay be reduced or inhibited (Commis-sion Emonograph)


may be slightly toxic (Roth/Daunderer) Overdose causes gastrointestinal com-plaints accompanied by gastric painand diarrhoea, irritating to mucousmembranes (Roth/Daunderer)

Triterpenesaponins

Positivemonograph, indications: digestiveproblems, especially as a result of dyskine-sia of the biliary tract, catarrhs of the upperrespiratory tract

Commission E: 50–100mlpressed juice/day

Positivemonograph, indications: mild, es-sential hypertension,WHOmonograph:treatment of mild essential hypertension,Rauwolfia alkaloids prescription-only, R.serpentina, R. tetraphylla and R. vomito-ria pharmacy-only, highly toxic ++ (Roth/Daunderer), very toxic Ib (Wink/Wyk)

Depression, fatigue, temporary im-potence, contraindications andinteractions withmedicinal productsreported (Commission Emonograph),arrhythmia, bradycardia up to car-diac arrest, acidosis, shock (Roth/Daunderer)

Indole alkaloids(e.g. reserpine,ajmalin, yohim-bine)

Commission E: 600mg drug,equivalent to 6mg total alka-loids/dayWHO: 200mg powder/day, aver-age doseD 50–300mg/day

107


Stock plant(Latin)


Rhamnus catharticus L., syn.Cervispina cathartica (L.) MOENCH,R. wicklia TEN., Rhamnus wikkorLUCÉ, Rhamnus willdenowianaHORT. ex K. KOCH

Fruit

Rhamnus frangula L., syn. Fran-gula alnus MILL., Frangula frangula(L.) KARST., Frangula vulgarisBORGH.

Bark

Rhamnus purshiana DC. syn. Fran-gula purshiana (DC.) COOP.

Bark

108




Positivemonograph, indications: short-termtreatment of constipation, standardmar-keting authorisation: 1089.99.99, buckthornberries and preparations thereof pharmacy-only, BfArM graduated plan of 21 June 1996concerning medicinal products for human usecontaining anthranoid-containing plant gen-era, toxic (Roth/Daunderer), toxic II (Wink/Wyk)

strong laxative, gastrointestinal com-plaints observed in individual cases,long-term use/abuse causes electrolyteloss (in particular potassium), may beaccompanied bymuscular astheniaand cardiac dysfunction, albuminuria,haematuria, pseudomelanosis coli,aggravation of colonic inertia (devel-opment of laxative addiction) resultingfrom paralysis of intestinal musclesdue to loss of potassium, nausea, vom-iting, diarrhoea, renal irritation (Roth/Daunderer), contraindications andinteractions reported (Commission Emonograph)

Anthranoids Commission E: 20–30mg hy-droxyanthracene derivatives/day, no administration to chil-dren under the age of 12

Positivemonograph for Rhamnus frangula,indications: conditions in which easy defae-cation with a soft stool is desirable, e.g. analfissures, haemorrhoids, after rectal-analsurgical procedures, constipation, standardmarketing authorisation: 9399.99.99,WHOmonograph: short-term treatment of occa-cional constipation, as a single dose, for totalintestinal evacuation before X-rays and otherdiagnostic examinations when electrolytesolutions alone are insufficient for adequateevacuation or the use of electrolyte solutionsis not possible, ESCOPmonograph: short-term treatment of occasional constipation,HMPCmonograph: short-term use in casesof occasional constipation, toxic II (Wink/Wyk), BfArM graduated plan of 21 June 1996concerning medicinal products for humanuse containing anthranoid-containing plantgenera, toxic + (Roth/Daunderer)

gastrointestinal complaints observedin individual cases, long-term use/abuse causes electrolyte loss (in partic-ular potassium), may be accompaniedbymuscular asthenia and cardiac dys-function, albuminuria, haematuria,pseudomelanosis coli, aggravation ofcolonic inertia (development of laxa-tive addiction) resulting from paralysisof intestinal muscles due to loss ofpotassium, contraindications and in-teractions reported, nausea, vomiting,bloody diarrhoea, abdominal pain,nephritis, circulatory collapse, as-sumed to be mutagenic (Commission Emonograph)

Anthranoids Commission E, ESCOP: 20–30mg hydroxyanthracenederivatives/day, calculated asglucofrangulin AWHO: 0.5–2.5 g drug/day, theindividually correct dose isthe smallest dose required tomaintain a soft stool. No admin-istration to children under theage of 10HMPC: equivalent to 10–30mghydroxyanthracene derivatives/day (calculated as glucofrangulin)no administration to childrenunder the age of 12

Positivemonograph, indications: consti-pation, colonic inertia, standardmarketingauthorisation: 8699.99.99,WHOmonograph:short-term treatment of occasional consti-pation, ESCOPmonograph: short-term usein cases of occasional constipation,HMPCmonograph: short-term use in cases of oc-casional constipation, toxic II (Wink/Wyk),toxic + (Roth/Daunderer), BfArM graduatedplan of 21 June 1996 concerning medicinalproducts for human use containing anthra-noid-containing plant genera

strong laxative, nausea, vomiting,bloody diarrhoea, abdominal pain,nephritis, circulatory collapse, as-sumed to be mutagenic (Wink/Wyk),gastrointestinal complaints observedin individual cases, long-term abusecauses electrolyte loss, in particularpotassium, albuminuria and haema-turia, pigment implantation into theintestinal mucosa (pseudomelanosiscoli), aggravation of colonic inertia(development of laxative addiction)resulting from paralysis of intesti-nal muscles due to loss of potassium,contraindications and interactionsreported (Commission E processingmonograph)

Anthranoids,saponins

Commission E: 20–30mg hy-droxyanthracene derivatives/daycalculated as cascaroside AESCOP: 1.5–2 g drug/day, prepa-rations equivalent to 20–30mghydroxyanthracene derivates(calculated as cascaroside A), noadministration to children underthe age of 10WHO: 0.3–1 g drug/dayHMPC: equivalent to 10–30mghydroxyanthracene derivatives/day (calculated as cascaroside A),no administration to childrenunder the age of 12

109


Stock plant(Latin)


Rheum officinale BAILLON Root F

Rheum palmatum L., syn. Rhabar-barum palmatum (L.) MOENCH,Rheum laciniatum PRAIN

Root F

Rheum rhabarbarum L., syn.Rheum franzenbachii MÜNT.,Rheummuricatum BLANCO,Rheum undulatum L.

Stem

Rhodiola rosea L. Herb Not NFS Rhodiola rosea L. Root Not NFS

Rhododendron spp., (medicinalplant: Rhododendron ferrugineumL, syn. Chamaerhododendron fer-rugineum BUBANI)

all plant parts

Rhus aromatica AIT., syn. Rhuscanadensis MARSH. non MILL.

Bark

110




Positivemonograph, indications: consti-pation, standard marketing authorisation:1189.99.99,WHOmonograph: short-termtreatment of occasional constipation, ESCOPmonograph: short-term use in cases of oc-casional constipation,HMPCmonograph:short-term use in cases of occasional consti-pation, BfArM graduated plan of 21 June 1996concerning medicinal products for humanuse containing anthranoid-containing plantgenera

contains anthranoids, disturbanceof electrolyte balance (in particularpotassium), albuminuria, haema-turia, reflectory activation of uterusduring pregnancy, transfer of agly-cones into breast milk, gastrointestinalcramps observed in individual cases,contraindications and interactionsreported (Schilcher)

Oxalic acid, an-thranoids

Commission E: 20–30mg hy-droxyanthracene derivatives/day, calculated as rhein, 30–120mg hydroxyanthracenederivatives equivalent to 1.2 to4.8 g drugESCOP: equivalent to 15–50mghydroxyanthracene derivatives/day (calculated as rhein), noadministration to children underthe age of 10WHO: 0.5–1.5 g drug/day,equivalent to 10–30mg hydrox-yanthracene derivativesHMPC: equivalent to 20–30mghydroxyanthracene derivatives/day (calculated as rhein), noadministration to children underthe age of 12

Positivemonograph, indications: consti-pation standardmarketing authorisation:1189.99.99,WHOmonograph (rhizoma):short-term treatment of occasional consti-pation, ESCOPmonograph: short-term usein cases of occasional constipation,HMPCmonograph: short-term use in cases of occa-sional constipation, BfArM graduated plan of21 June 1996 concerning medicinal productsfor human use containing anthranoid-con-taining plant genera, mildly toxic III (Wink/Wyk)

Disturbance of electrolyte balance (inparticular potassium), albuminuria,haematuria, reflectory activation ofuterus during pregnancy, transfer ofaglycones into breast milk, gastroin-testinal cramps observed in individualcases, contraindications and interac-tions reported (Schilcher)


Commission E: 20–30mg hy-droxyanthracene derivatives/day, calculated as rhein, 30–120mg hydroxyanthracenederivatives, equivalent to 1.2to 4.8 g drugESCOP: equivalent to 15–50mghydroxyanthracene derivatives/day (calculated as rhein), noadministration to children underthe age of 10WHO: 0.5–1.5 g drug/day,equivalent to 10–30mg hydrox-yanthracene derivativesHMPC: equivalent to 20–30mghydroxyanthracene derivatives/day (calculated as rhein), noadministration to children underthe age of 12

slightly toxic (+) (Roth/Daunderer), mildlytoxic III (Wink/Wyk)

Cases of poisoning in children ob-served after consumption of largeamounts of raw and unripe rhubarbstalks (Roth/Daunderer)


s. BfR statement: http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf,HMPCmonograph: (Rhodiolae roseae rhizoma etradix): traditional use

Negativemonograph: due to risks associatedwith Rhododendron ferrugineum, toxic Ibto very toxic II (Wink/Wyk), toxic + to highlytoxic ++ (Roth/Daunderer)

Burning in mouth and throat, hy-persalivation, vomiting, cramps,diarrhoea, also affects CNS: headache,faintness, convulsions, death by respi-ratory arrest (Wink/Wyk)

Triterpenes(e.g. ursolic acid),hydroquinones(e.g. arbutin), an-dromedotoxin(grayanotoxin I)

111





Stock plant(Latin)


Rhus aromatica AIT., syn. Rhuscanadensis MARSH. non MILL.

Root cortex Not NFS

Rhus coriaria L., Toxicodendroncoriaria KUNTZE.

Fruit S

Rhus toxicodendron L., syn. Toxi-codendron quercifolium (MICHX.)GREENE, Toxicodendron toxico-dendron (L.) BRITT

all plant parts

Ribes nigrum L., syn. Ribes olidumMOENCH

Leaf T

Ribes nigrum L., syn. Ribes olidumMOENCH

Fruit

Ribes rubrum L., syn. Ribes do-mesticum JANCZ., Ribes sativum(RCHB.) SYME

Fruit

Ricinus communis L., syn. Cro-ton spinosus L., Ricinus africanusMILL., Ricinus. inermis JACQ., Rici-nus. vulgaris MILL.

Seed

Robinia pseudoacacia L., syn. Pseu-doacacia odorata MOENCH

Flower T, S b

Rosa canina L., syn. Rosa armataSTEV. ex BESSER, Rosa caucasicaPALL.

Fruit

Rosa gallica L., syn. Rosa grandi-flora SALISB., Rosa provincialisAIT., Rosa provincialis HERRM.,Rosa pumila JACQ., Rosa rubraLAM.

Petal T

Rosa x centifolia, syn. Rosa centifo-lia x vulgaris SERINGE ex DC., Rosagallica x centifolia REGEL

Petal T

112




extremely toxic Ia (Wink/Wyk) strong irritation of mucousmem-branes in mouth, throat andgastrointestinal tract, nausea, vom-iting, gastroenteritis accompanied bybloody diarrhoea and colic, vertigo,dizziness, excitement and serious kid-ney damage (Wink/Wyk)

Pyrocatecholderivatives(urushiols, tox-icondendrine)

ESCOPmonograph: adjuvant in the treatmentof rheumatic conditions,HMPCmonograph:traditional use

ESCOP: 20–50 g leaves/litre,250–500ml/day, equivalentpreparations

extremely toxic +++ ( Roth/Daunderer),extremely toxic Ia (Wink/Wyk),WHOmono-graph (oil): short-term treatment (3–5 days)for acute constipation when other dietarymethods or bulk-forming laxatives have notprovided adequate relief. As a cathartic for usein bowel evacuation prior to surgery

Nausea, bloody diarrhoea, vomitingaccompanied by haemorrhage, acutegastroenteritis, nephritis, liver damage,convulsions, tachycardia, circulatoryarrest, death by cardiac or circulatoryfailure or uraemia, consumption of6 seeds fatal to children, 10–20 seedsfatal to adults (Wink/Wyk)

Lectins (e.g. ricin),alkaloids(e.g. ricinin)

WHO: 1–10ml, no administra-tion to children under the age of12

highly toxic ++ (Roth/Daunderer), very toxic Ib(Wink/Wyk),

all plant parts toxic, in particular seedsand fruits, contains the lectins phasinand robin, haemagglutinating prop-erties, cytotoxic, nausea, vomiting,diarrhoea, drowsiness, mydriasis, con-vulsive fits, abdominal pain (Wink/Wyk), toxicity of robin is eliminated byheating (Roth/Daunderer)

Lectins (e.g. robin,phasin)

Neutral monograph, ESCOPmonograph:adjuvant treatment of pain and joint stiffnessassociated with osteoarthritis

ESCOP: 2–5 g drug, several timesa day

Positivemonograph: for external use Commission E: 1–2 g drug/day,equivalent preparations

Positivemonograph: for external use,HMPCmonograph: in progress (external use)

113


Stock plant(Latin)


Rosmarinus officinalis L., syn.Rosmarinus angustifolius MILL.,Rosmarinus flexuosus JORD. etFOURR., Rosmarinus laxiflorusDENOÉ, Salvia rosmarinus SCHLEI-DEN

Leaf S, T

Rubia tinctorum L., syn. Rubiatinctoria SALISB.

Root

Rubus fructicosus L. Leaf T

Rubus fructicosus L. Fruit Rubus fructicosus L. Root Rubus idaeus L., syn. Rubusframboesianus LAMK., Rubusrosaefolius SM.

Leaf T

Rubus idaeus L., syn. Rubusframboesianus LAMK., Rubusrosaefolius SM.

Fruit

Rubus suavissimus S. LEE, syn.Rubus chingii var. Suavissimus S.LEE

Leaf T

Rumex acetosa L., syn. Lapathumacetosa SCOP., Lapathum pratenseLAM.

Herb

Ruscus aculeatus L. Rhizome Not NFS

114




Positivemonograph, indications: digestiveproblems, standard marketing authorisation:1219.99.99,WHOmonograph: carminativeand spasmolytic to treat dyspepsia, traditionaluse, ESCOPmonograph: improvement ofhepatic and biliary function and in dyspepticcomplaints,HMPCmonograph: traditionaluse, slightly toxic (+) (Roth/Daunderer)

Ingestion of high doses causes coma,tonic-clonic cramps, impaired patel-lar reflex, reduced pupillary reflex,vomiting, gastroenteritis, uterinehaemorrhage, leucocytosis, renal ir-ritation, albuminuria, in severe casesdeath by pulmonary oedema (Roth/Daunderer), specific case reports onthis are not available (Hager); prepara-tions, predominantly in combinationwith a complex composition, formerlyused for abortion; however, case re-ports indicating a causal connectionbetween ingestion of rosemary andabortion are not known. Experimentalstudies allowing for assessing the riskare not available either (Hager)

Eucalyptol (D1,8-cineol), camphor,alpha-pinene

Commission E: 4–6 g drug/dayESCOP: 2–4 g drug/dayWHO: 4–6 g drug/day or as in-fusion 2–4 g in 150ml water,3 times a day

Negativemonograph: due to risks, BfArMgraduated plan of 15 Mar 1993 concerningmedicinal products containing Rubia tinc-torum, substance of concern (AMK) mildlytoxic II to toxic III (Wink/Wyk)

Ingestion of high doses causes di-gestive problems, nausea, vomiting,bloody diarrhoea, abdominal pain,nephritis, assumed to be mutagenic(Wink/Wyk)

Hydroxyan-thraquinones(e.g. lucidin)

Positivemonograph, indications: non-specific, acute forms of diarrhoea, mild inflam-mations of the oral and pharyngeal mucosa,standard marketing authorisation: 1449.99.99

Commission E: 4.5 g drug/day,equivalent preparations

Neutral monograph

Neutral monograph, HMPCmonograph: inprogress

slightly toxic (Roth/Daunderer) Due to the oxalic acid content, careshould be taken when consuming freshsorrel (Frohne)

Oxalic acid

Positivemonograph, indications: adjuvanttreatment of chronic venous insufficiency (es-pecially pain and feeling of heaviness in legs,night leg cramps, itching, swelling), adjuvanttreatment of symptoms associated with haem-orrhoids such as itching and burning,HMPCmonograph: traditional use, ESCOPmono-graph: supportive therapy for symptoms ofchronic venous insuffiency, such as painful,tired and heavy legs, tingling and swelling,supportive therapy for symptoms of haemor-rhoids, such as itching and burning, slightlytoxic (+) to toxic + (Roth/Daunderer), mildlytoxic III (Wink/Wyk)

Gastric complaints and nausea mayoccur in rare cases (Commission Emonograph)

Commission E, ESCOP: extractequivalent to 7–11mg rusco-genin/day

115


Stock plant(Latin)


Ruta graveolens L., syn. Ruta grave-olens L. var. vulgarisWILLK., Rutahortensis MILL.

Leaf, herb

Salix alba L. Bark T

Salvia divinorum EPLING etJÁTIVA

all plant parts

Salvia officinalis L., syn. Salviachromatica et papillosa HOFFMG.,Salviamaior et minor GMELI,Salvia tomentosa MILL.

Leaf S, T

Salvia sclarea L., syn. Aethiopissclarea (L.) FOURR., Salvia vulgarisMILL.

Leaf S

Salvia sclarea L., syn. Aethiopissclarea (L.) FOURR., Salvia vulgarisMILL.

Flower Not NFS

Salvia triloba L. FIL., syn. SalviafruticosaMILL., Salvia lobryanaAZNAV.

Leaf S, T

Sambucus ebulus L., syn. Ebulumhumile GARCKE

Fruit

Sambucus nigra L., syn. Sambucusarborescens GILIB., Sambucusmedullina GILIB.

Leaf Not NFS


Flower

116




Negativemonograph: due to risks, toxic +(Roth/Daunderer), toxic Ib to very toxic II(Wink/Wyk)

Contact dermatitis, swelling of tongue,hypersalivation, severe gastroenteritis,diuresis, mydriasis, visual disturbances,haematuria, even death, uterus con-tractions, therefore formerly used asaborticide (Wink/Wyk)

Furocoumarins,quinoline alka-loids

Positivemonograph, indications: febrile dis-eases, rheumatic conditions, headache,WHOmonograph: symptomatic treatment of feverand pain, and symptomatic treatment of mildrheumatic conditions, treatment of the com-mon cold, traditional use, ESCOPmonograph:relief of low back pain, symptomatic relief ofmild osteoarthritc and rheumatic complaints,HMPCmonograph: short-term treatment oflow back pain, traditional use

gastrointestinal complaints, allergicor pseudoallergic reactions to the sali-cylates contained in the drug (Wichtl,Schilcher), Reye’s syndrome

Salicylates Commission E: 60–120mg totalsalicin/dayESCOP,WHO: equivalent to120–240mg salicinHMPC: 1572mg extract/day onindication of well-establisheduse, 260–500mg comminuteddrug, 3 times a day on indicationof traditional use

toxic II, psychotropic (Wink/Wyk), non-marketable narcotic acc. to Annex 1 of theNarcotic Drugs Act (BtMG)

Psychotropic, hallucinogenic (Wink/Wyk), sweats, headache, disorientation,psychosis, anxiety and panic attacksreported (www.erowid.org)

Diterpenes (e.g.salvinorin A)

Positivemonograph, indications: digestiveproblems, excessive sweat secretion, ESCOPmonograph: inflammations and infections ofthe mouth and throat such as stomatitis, gin-givitis and pharyngitis, hyperhidrosis,HMPCmonograph: traditional use,WHOmono-graph: treatment of influenza, bronchitis,sinusitis, meningitis and neuritis, standardmarketing authorisation: 1229.99.99, slightlyor hardly toxic (Roth/Daunderer)

Long-term use of alcoholic extractsand pure essential oil may causeepileptiform cramps (Commission Emonograph)

Thujone, eucalyp-tol (D1,8-cineol),camphor

Commission E: 4–6 g drug/day,equivalent preparationsESCOP: 1–1.5 g drug in 150mlwater, also several times a dayWHO: 4 g/day

Eucalyptol(D1,8-cineol),camphor, es-tragole (Dmethylchavicol)

Eucalyptol(D1,8-cineol),camphor, es-tragole (Dmethylchavicol)

Thujone, eucalyp-tol (D1,8-cineol),camphor

mildly toxic III (Wink/Wyk), toxic + (Roth/Daunderer)

Nausea, vomiting, diarrhoea, ticklein the throat, vertigo, headache, vi-sual disturbances, cardiac complaints,bloody diarrhoea, cases of fatal poison-ing also known (Wink/Wyk)

Iridoid glycosides(e.g. ebuloside),lectins

mildly toxic III (Wink/Wyk), hardly toxic (+) Ingestion of higher doses causes vom-iting and diarrhoea (Wink/Wyk)

cyanogenicglycosides(e.g. sambunigrin),lectins

Positivemonograph, indications: coughsand colds, standard marketing authorisation:1019.99.99,WHOmonograph: traditional use,HMPCmonograph: traditional use

Commission E: 10–15 g drug/day, equivalent preparationsWHO: 3–5 g drug, 3 times a day

117

www.erowid.org


Stock plant(Latin)



Fruit b

Sanicula europaea L., syn. Astrantiadiapensia SCOP., Caucalis capi-tata SALISB., Sanicula officinalisGOUAN, Sanicula trilobata GILIB.,Sanicula vulgaris (KOCH) LANDOZ.

Herb Not NFS

Santalum album L., syn. San-dalum album RUMPH., Santalummyrtifolium (L.) ROXB., Siriummyrtifolium L.

Wood Not NFS

Saponaria officinalis L., syn. Bootianervosa GILIB., Lychnis officinalis(L.) SCOP., Saponaria hybridaMILL.,Saponaria nervosa GILIB., Silene of-ficinarum RUPR., Silene saponariaFRIES.

Root

Sassafras spp. all plant parts

Satureja biflora (Buch.-Ham. ex D.Don) Briq.

Herb

Satureja hortensis L., syn.Clinopodium hortense O. KUNTZE,Satureja brachiata STOKES, Saturejaofficinarum CRANTZ,

Herb S

Schinusmolle L., syn. Schi-nus molle var. areira (L.) DC.,Schinus areira L. and Schinus tere-binthifolius RADDI, syn. SchinusantiarthriticusMART. ex MARCH,Schinusmellisii ENGL., SchinusmucronulataMART.

Fruit S

Schisandra chinensis (TURCZ.)BAILL., syn. Idesia polycarpaMORR. et DEVOS, Kadsura chi-nensis TURCZ., Maximowicziaamurensis RUPR.

Fruit

118




Use ripe fruits, heat sufficiently (cook) beforeconsumption,HMPCmonograph: in progress

Unripe fruits, seeds and green plantparts contain sambunigrin and lectinwhich can be deactivated by thermalexposure (Ternes), ingestion of higherdoses of unripe, unheated fruits causesvomiting and diarrhoea (Wink/Wyk)

cyanogenicglycosides(e.g. sambunigrin),lectins

Positivemonograph, indications: catarrhs ofthe respiratory tract


Positivemonograph, indications: adjuvanttreatment of lower urinary tract infections,toxic + (Roth/Daunderer), toxic II (Wink/Wyk)

Ingestion of high doses may causenephritis, digestive problems, heart-burn, dyspepsia and haematuria,irritating to skin (Wink/Wyk)

Santalol Commission E: 1.0–1.5 g es-sential oil/day, 10–20 g drug,equivalent preparations

use in foods only known as an ingredient of“halva” recipes Positive monograph, indica-tions: catarrhs of the upper respiratory tract

Irritation of gastric mucosa observedin rare cases (Commission Emono-graph)

Triterpenesaponins

poisonous plant, toxic + (Roth/Daunderer),toxic II (Wink/Wyk), BfArM graduated plansof 19 Jan 1995 and 13 Aug 1997 concerningmedicinal products containing Sassafras,sassafras oil is a “scheduled substance” of cat-egory 1 acc. to Article 2 a of Regulations (EC)No. 273/2004 and No. 111/2005 and is thussubject to the provisions of the PrecursorsControl Act (GÜG).

The toxicity is basically attributed tosafrole contained in the drug, which isa genotoxic carcinogen (Hager), inges-tion of higher doses causes nephritis,loss of consciousness, faintness andliver damage, irritating to skin (Wink/Wyk)

Safrole

Carvacrol

Both species are commercially available.(s. Guidelines for spices and other season-ing ingredients), Schinus terebinthifolius:highly toxic (Roth/Daunderer), toxic II (Wink/Wyk). After consumption of small amounts ofS. terebinthifolius as spice, the reported un-desirable effects were, however, not detectedwith fruits imported from the Réunion Island

Schinus terebinthifolius: headache,swollen eyelids, digestive problems(Wink/Wyk)

WHOmonograph: treatment of chroniccough and asthma, diabetes, urinary tract dis-orders, as a general tonic for treating fatigueassociated with illness

WHO: 1.5–6 g drug/day

119


Stock plant(Latin)


Schoenocaulon officinale(SCHLECHTEND. et CHAM.)A. GRAY, syn. Sabadilla officinarumBRANDT, Veratrum officinaleSCHLECHTEND. et CHAM.,Asagraea officinalis LINDL.

Seed

Scopolia spp. all plant parts

Scutellaria baicalensis GEORGI,syn. Scutellaria macrantha FISCH.

Leaf Not NFS

Scutellaria baicalensis GEORGI,syn. Scutellaria macrantha FISCH.

Root Not NFS

Senecio spp. all plant parts

Serenoa repens (BARTR.) SMALL,Sabal serrulata (MICH.) NUTALL exSCHULT., Sabal serrulata ROEM.et SCHULT., Brahea serrulata(MICHX.) H. WENDL., ChamaeropsserrulataMICHX., Serenoa serrulataHOOK.

Fruit Not NFS

Sideritis scardica GRISEB. Herb T

120




poisonous plant, Veratrum alkaloids prescrip-tion-only, highly toxic ++ (Roth/Daunderer),extremely toxic Ia (Wink/Wyk)

The alkaloids contained in the drugact as nerve and muscle poison, burn-ing in the mouth and throat, nausea,diarrhoea, fits of rage, bradycardia,dyspnoea, convulsions, even death,highly irritating to skin (Wink/Wyk),affects CNS, mental excitement,cramps, uncontrolled rage, paraly-sis of the myelencephalic centres, inlow doses vertigo, darkened vision,marasmus, hypothermia, bradycardia,dyspnoea and gastrointestinal irrita-tion, damage to striatedmuscles (Roth/Daunderer)

steroidal alkaloids(e.g. veratridine,cevadine, saba-dine)

Positivemonograph (rhizome of Scopoliacarniolica JACQ.), indications: cramps in thegastrointestinal, biliary and lower urinary tractin adults and schoolchildren, isolated alka-loids and rhizome prescription-only, highlytoxic Ib (Wink/Wyk) extremely toxic +++(Roth/Daunderer)

psychotropic, facial blush, dry mucosa,tachycardia, mydriasis, hallucinations,euphoria, disorientation,micturi-tion difficulties, insomnia, death byrespiratory arrest (Wink/Wyk, Roth/Daunderer)


Commission E: 0.25–3.0mgtotal alkaloids/day, calculated ashyoscyamine

assumed to be hepatotoxic (Parker S.Herbal medicines, adverse reactions.The Regulatory Affairs Journal, 1994,5:29)

WHOmonograph: treatment of fever, nau-sea and vomiting, acute dysentery, jaundice,coughs, carbuncles and sores, and threatenedabortion

assumed to be hepatotoxic (Parker S.Herbal medicines, adverse reactions.The Regulatory Affairs Journal, 1994,5:29)

WHO: 3–9 g drug/day, no ad-ministration to children underthe age of 12

Negativemonograph: due to risks associatedwith wood ragwort (Senecio fucsii), substanceof concern (AMK), toxic + (Roth/Daunderer)toxic II (Wink, Wyk)

hepatotoxic, withdrawal of marketingauthorisations in 1992 for drugs con-taining pyrrolizidine alkaloids due torisks, s. Federal Gazette of 17 June 1992


Positivemonograph, indications: micturi-tion difficulties resulting from benign stageI–II prostatic hyperplasia,WHOmonograph:treatment of lower urinary tract symptoms(nocturia, polyuria, urinary retention) sec-ondary to BPH stages I and II, as defined byAlken, in cases where diagnosis of prostatecancer is negative, ESCOPmonograph: symp-tomatic treatment of micturition disorders(dysuria, pollakisuria, nocturia, urinary re-tention) in mild to moderate benign prostatichyperplasia (BPH), i.e. stages I and II as definedby Alken, stages II and II as defined by Vahlen-sieck, or a comparable severity of symptoms asevaluated by the International Prostate Symp-tom Score and associated diagnostic tests,HMPCmonograph: in progress

Side effects: gastric complaints ob-served in rare cases (Commission Emonograph)

Commission E,WHO: 1–2 g drugor 320mg extract/day, equivalentpreparations

121


Stock plant(Latin)


Silybummarianum (L.) GAERTN.,syn. Carduus marianus L.,Carthamusmaculatus LAM., Cri-sium, maculatum SCOP., Marianamariana (L.) HILL., Silybummacu-latumMOENCH

Fruit T

Sinapis alba L., syn. Bonnaniaofficinalis PRESL., Brassica albaRABENH., Crucifera lampsanaE.H.L. KRAUSE, Eruca alba NOUL.,Sinapis hispida TEN.

Seed S

Smilax officinalis KUNTH inH.B.K.

Root

Solanum dulcamara L., syn. Dulca-mara flexuosa MOENCH, SolanumlaxumROYLE, Solanum lyratumTHUNB.

Stem

Solanumnigrum L. emend. MILL.,syn. Solanum alpinum ZOLL. etMOR., Solanum americanumMILL.,Solanum vulgare PARKINS.

all plant parts

Solidago virgaurea L., syn. Am-phiraphis leiocarpa DC., Dectisdecurrens RAF. var. leiocarpaBENTH., Solidago cantonensisLOUR.

Herb T

Sorbus aucuparia L., syn. Aucu-paria silvestrisMED.

Fruit b

Spartium junceum L., syn.Sarothamnus junceus LINK, Spar-tianthus junceus (L.) LINK

all plant parts

Spinacia oleracea L. Leaf Stachys officinalis (L.) TREVISAN,syn. Betonia officinalis L.

Herb Not NFS

122




Positivemonograph, indications: digestiveproblems, toxic liver damage, adjuvant treat-ment of chronic inflammatory liver diseasesand liver cirrhosis, standard marketing au-thorisation: 1589.99.99,WHOmonograph:supportive treatment of acute or chronic hep-atitis and cirrhosis induced by alcohol, drugsor toxins,HMPCmonograph: in progress,ESCOPmonograph: toxic liver damage, sup-portive treatment in patients with chronicinflammatory liver conditions and hepaticcirrhosis

Commission E,WHO: 12–15 gdrug/day, equivalent prepara-tionsESCOP: equivalent to 154–324mg silymarin/day

Positivemonograph: for external use,harmful in high doses (+) (Roth/Daunderer),toxic II–III (in high doses) (Wink/Wyk)

Ingestion of high doses causes gas-trointestinal complaints, nausea,vomiting, diarrhoea, severe poisoningcauses central paralysis, bradycardiaand bradypnoea, even coma and death(Roth/Daunderer, Wink/Wyk)

Glucosinolates

Negativemonograph: due to risks, slightlytoxic (+) (Roth/Daunderer)

gastric irritation, temporary liverdamage (Commission E monograph),diarrhoea accompanied by vomiting,central paralysis (Roth/Daunderer)

steroidal saponins

Positivemonograph: for external use,HMPCmonograph: (traditional use, external use),BfArM only accepted external use in the post-authorisation procedure, highly toxic ++(Roth/Daunderer), toxic Ib to very toxic II(Wink/Wyk)

Nausea, vomiting, mydriasis, paraly-sis of tongue and loss of speech, fever,visual snow, painful diarrhoea, al-ternating pulse, dyspnoea, cramps,apnoea (Roth/Daunderer)

steroidal alkaloidglycosides


highly toxic ++ ( Roth/Daunderer), toxic Ib tovery toxic II (Wink/Wyk)

all plant parts toxic, including un-ripe berries, nausea, severe vomiting,mydriasis, paralysis of tongue, loss ofspeech, fever, visual snow, painful di-arrhoea, alternating pulse, dyspnoea,cramps, leg cramps, finally apnoea(Roth/Daunderer)

steroidal alkaloidglycosides

Positivemonograph, indications: irrigationtherapy of inflammatory diseases of the lowerurinary tract, prevention of urinary stonesand kidney gravel, ESCOPmonograph: irri-gation of the urinary tract, especially in casesof inflammation and renal gravel, and as anadjuvant in the treatment of bacterial infec-tions of the urinary tract,HMPCmonograph:traditional use

abdominal complaints, contact al-lergies (Hager), contraindications:oedemas associated with cardiac orrenal insufficiency (Commission Emonograph)

Sesquiterpenelactones

Commission E: 6–12 g drug/day,equivalent preparationsESCOP: 2–3 g drug, 2–3 timesa day, equivalent preparations,special dosage instructions forchildren

Neutral monograph: mildly toxic III (Wink/Wyk), slightly toxic (+), only ripe (mealy) fruitsshould be consumed. Heat/dry before con-sumption.

Freshmountain ash berries containparasorbic acid, whichmay cause localirritations, nausea, vomiting, diarrhoeaand kidney damage. Parasorbic acidis largely destroyed or eliminated bydrying or cooking the berries (Frohne/Pfänder).

Parasorbic acid,prunasin, amyg-dalin


Cases of poisoning accompanied byvomiting, kidney damage and apnoeareported (Roth/Daunderer), slightlypsychotropic and hallucinogenic(Wink/Wyk)

Quinolizidinealkaloids (e.g. cyti-sine)

Neutral monograph

123


Stock plant(Latin)


Stevia rebaudiana (BERTONI)HEMSL., syn. Eupatorium rebaudi-anum BERTONI

Herb

Strophantus spp. all plant parts

Strychnos ignatii BERG., syn.Ignatia amara L. FIL., Ignatia philip-pinensis BLUME

Seed

Strychnos nux vomica L., syn.Strychnos lucidaWALL., StrychnoscolubrinaWIGHT

Seed

Swertia chirata BUCH.-HAMILT.,syn. Agathodes chirata (DON.)GRISEB.

Herb, root Not NFS

Symphytum officinale L. Herb, root

Syzygium aromaticum (L.) MERR.et L.M. PERRY, syn. Caryophyllusaromaticus L., Eugenia aromaticaBAILL.

Flower bud S

Syzygium cumini (L.) SKEELS, syn.Eugenia cumini (L.) DRUCE, Myrtuscumini L.

Leaf, fruit Not NFS


Bark Not NFS


Seed Not NFS

Tabebuia impetigenosa (MAR-TIUS ex DC.) STANDLEY, syn.Bignonia heptaphylla sensuauct., Gelseminum avellanedae(LORENTZ ex GRISEB.) KUNTZE

Bark T

Tabernanthe iboga BAILL. Root

Tamarindus indica L., syn. Siliquaarabica BAUH., Tamarindus offici-nalis HOOK.

Fruit

Tamus communis L. all plant parts

124




Steviol glycosides licensed as additive (E 960)

extremely toxic +++ (Roth/Daunderer), ex-tremely toxic Ia (Wink/Wyk), seeds andstrophanthins prescription-only, Strophan-tus species pharmacy-only

positive inotropic effect, bradycardiaup to cardiac arrest, bloody diar-rhoea, nausea, vomiting, oppression,headache and neck pain, loss of con-sciousness, convulsions (Wink/Wyk,Roth/Daunderer)

Cardenolides(strophanthin,strophanthidin,ouabain)

extremely toxic +++ (Roth/Daunderer), ex-tremely toxic Ia (Wink/Wyk) strychnineprescription-only, Ignatius bean pharmacy-only

Cramps, epileptic fits, states of anxiety,hypersalivation, death by respiratoryarrest (Wink/Wyk)

Indole alkaloids(e.g. strychnine,brucine)

Negativemonograph: due to risks, extremelytoxic Ia (Wink/Wyk), extremely toxic +++(Roth/Daunderer)

Cramps, epileptic fits, states ofanxiety, hypersalivation, death byrespiratory arrest (Wink/Wyk), faint-ness, exhaustion, mental disorders,icterus, permanent blindness (Roth/Daunderer)

Alkaloids(e.g. strychnine,brucine, colubrin)

Positivemonograph: for external use only,toxic II–III (Wink/Wyk), slightly toxic (+)(Roth/Daunderer), ESCOPmonograph: forexternal use, BfArM graduated plan of 5 June1992 concerning medicinal products contain-ing pyrrolizidine alkaloids

Pyrrolizidine alkaloids contained inthe drug are hepatotoxic, mutagenicand carcinogenic. High doses inhibitperipheral nerves and may inducedigestive problems. (Wink/Wyk)


Commission E, ESCOP: externaluse only, equivalent preparationswith 35% root extract

Positivemonograph for external use,WHOmonograph: for external use,HMPC assess-ment report

Positivemonograph, indications: non-spe-cific forms of diarrhoea


Negativemonograph: due to risks In view of safe therapeutic alternatives,use for the treatment of diabetes melli-tus cannot be justified. (Commission Emonograph)

mildly toxic (Wink/Wyk) Naphthoquinones are irritating to skinand mucousmembranes, ingestion ofhigh doses causes cytotoxic effects anddigestive problems (Wink/Wyk)

Naphthoquinones(e.g. lapachol)


anaesthetic, psychotropic, hallucino-genic, motor disturbances, paralysis,death by cardiac failure (Wink/Wyk,Roth/Daunderer)

Indole alkaloids(e.g. ibogaine)

toxic + (Roth/Daunderer), mildly toxic III(Wink/Wyk)

Burning in the mouth, vomiting, diar-rhoea, gastroenteritis, overdose may befatal (Wink/Wyk)

steroidalsaponins, oxalateraphides

125


Stock plant(Latin)


Tanacetum vulgare L., syn.Chrysanthemumvulgare (L.)BERNH., non Leucanthemum vul-gare L.

Flower, herb

Taraxacum officinaleWEB. exWIGG., syn. Taraxacum officinale(WITH.) WIGGERS, Leontodonofficinale WITH., Leontodon tarax-acum L.

Herb, root

Taraxacum officinaleWEB. exWIGG., syn. Taraxacum officinale(WITH.) WIGGERS, Leontodonofficinale WITH., Leontodon tarax-acum L.

Flower T

Teucrium chamaedrys L., syn.Chamaedrys officinalis MOENCH,Teucrium officinale LAM.

all plant parts F

Theobroma cacao L., syn. Cacaoguianensis AUBL., Cacao minusGAERTN.

Seed

Theobroma cacao L., syn. Cacaoguianensis AUBL., Cacao minusGAERTN.

Seed husk T

Thevetia peruviana (PERS.)K. SCHUM., syn. Thevetia neriifoliaJUSS. ex STEUD., Cerbera thevetia

all plant parts

126




Negativemonograph: due to risks, toxic +(Roth/Daunderer), toxic II (Wink/Wyk), sub-stance of concern (AMK), tansy pharmacy-only

neurotoxic properties, tonic-cloniccramps, strong tachypnoea, irregularcardiac activity, liver and kidney dam-age, vomiting, severe gastroenteritis,mydriasis, abortifacient effect, loss ofconsciousness, death (Roth/Daunderer,Wink/Wyk)

Monoterpenes(e.g. eucalyptol[D1,8-cineol],thujone, cam-phor)

Taraxici herba: positivemonograph, indi-cations: lack of appetite, digestive problemssuch as feeling of fullness and bloating,Taraxici radix cum herba: positivemono-graph, indications: disturbance of biliary flow,stimulation of diuresis, lack of appetite, diges-tive problems such as feeling of fullness andbloating, standardmarketing authorisation:1139.99.99 (Taraxici radix cum herba),WHOmonograph (Taraxaci radix cum herba): tostimulate diuresis, increase bile flow and stim-ulate appetite, and for treatment of dyspepsia,ESCOPmonograph (Taraxaci radix): restora-tion of hepatic and biliary function, dyspepsia,loss of appetite, (Taraxaci folium): as an ad-junct to treatments where enhanced urinaryoutput is desireable, for example, rheumatismand the prevention of renal gravel,HMPCmonograph (Taraxici radix cum herba andTaraxaci folium): traditional use

Latex: vomiting, abdominal pain, di-arrhoea, superacid gastric complaints,contraindications reported (Roth/Daunderer, Commission E mono-graph)

Sesquiter-pene lactones(e.g. taraxinic acidglycosides)

Taraxaci herba:Commission E: 4–10 g drug,3 times a dayESCOP: 4–10 g, 3 times a dayWHO: 3–4 g comminuted drug,3 times a day, 0.75–1 g extractTaraxaci radix cum herba:Commission E: 1 tbsp. cut drugin 1 cup of water as tea or 3–4 gcut or comminuted drug in 1 cupof waterESCOP: 3–5 g, 3 times a dayWHO: 3–4 g comminuted drug,3 times a day, 0.75–1 g extract

Flavourings and food ingredients with flavour-ing properties produced using wall germandermay only be used to produce alcoholic bev-erages (Reg. (EC) No. 1334/2008), maximumamount of teucrin A in bitter spirits (5mg/kg)specified in Reg. (EC) No. 1334/2008, BfArMgraduated plan of 10 Aug 1992 concerningmedicinal products containing Teucriumchamaedris (wall germander)

Hepatotoxic effect reported (Hager)

Neutral monograph

Neutral monograph

highly toxic ++ ( Roth/Daunderer), verytoxic Ib (Wink/Wyk)

Approx. 4 seeds may be fatal to chil-dren, 8–10 seeds fatal to adults,numbness of tongue and throat,nausea, vomiting, faintness, cramps,disorientation, visual disturbances,very slow, fading heartbeat, bradycar-dia, AV block, ventricular fibrillation,death (Wink/Wyk)


127


Stock plant(Latin)


Thuja spp. all plant parts

Thymus serpyllum L.s.I. Herb S

Thymus vulgaris L., syn. Thymusaestivus REUTER exWILLK. etLANGE, Thymus durius DOD.

Herb S, T

Thymus x citriodorus (PERS.)SCHREB., syn. Thymus comptusHORT., Thymus jankae HORT.,Thymus lanuginosusMILL. var.citriodorumPERS., Thymus serpyl-lum L. var. vulgaris BENTH.

Herb S

Tilia cordata MILL., syn. Tiliaeuropaea L. ulmifolia L., Tiliaulmiflora SCOP. and Tilia platy-phyllos SCOP., syn. Tilia europaeaL. p.p., Tilia grandiflora EHRH. exW.D.J. KOCH

Leaf T

Tilia cordata MILL., syn. Tiliaeuropaea L. ulmifolia L., Tiliaulmiflora SCOP. and Tilia platy-phyllos SCOP., syn. Tilia europaeaL. p.p., Tilia grandiflora EHRH. exW.D.J. KOCH

Flower T

Tilia tomentosa MOENCH., syn.Tilia argentea DESF.

Leaf T

Tilia tomentosa MOENCH., syn.Tilia argentea DESF.

Flower T

Tribulus terrestris L. Fruit Not NFS

Trichilia catigua A. JUSS. Bark Not NFS

Trichocereus pachanoi BRITT. etROSE, syn. Echinopsis pachanoi,Cereus peruvianus

all plant parts

Trifolium pratense L., syn. Tri-folium purpureumGILIB. nonLOISEL

Flower T

128




Tree of life pharmacy-only, extremelytoxic +++ (Roth/Daunderer), very toxic Ib(Wink/Wyk)

Mydriasis, fever, visual disturbances,headache, gastroenteritis accompa-nied by severe vomiting and diarrhoea,tachycardia, very intense cramps, de-generative kidney, cardiac and liverdamage, death by respiratory and cir-culatory arrest (Wink/Wyk)

Monoterpenes(e.g. thujone)


Carvacrol Commission E: 4–6 g drug/day,equivalent preparations

Positivemonograph, indications: symp-tomatic treatment of bronchitis and whoopingcough, catarrhs of the upper respiratorytract, standard marketing authorisation:1329.99.99,WHOmonograph: traditional use,HMPCmonograph: traditional use, ESCOPmonograph: catarrh of the upper respiratorytract, bronchial catarrh and supportive treat-ment of pertussis, stomatitis and halitosis

Monoterpenes(e.g. camphor, car-vacrol, eucalyptol[D1,8-cineol])

Commission E, ESCOP,WHO:1–2 g drug/day, equivalentpreparations

Neutral monograph

Positivemonograph, indications: coughs andcolds, dry cough,WHOmonograph: use forcolds and cold-related coughs, dry cough, di-aphoretic, antispasmodic,HMPCmonograph:traditional use, standard marketing authori-sation: 1129.99.99


Neutral monograph, HMPC assessment re-port

WHOmonograph: treatment of cough,headache andmastitis, traditional use, toxic II(Wink/Wyk), s. BfR statement: http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf

contains cytotoxic saponins andalkaloids. Harmala alkaloids may inter-calate DNA and are particularly activeafter exposure to sunlight, photosen-sitivity accompanied by pronouncedswelling of lips and ears (Wink/Wyk)

Furostanol andspirostanolsaponins,beta-carbolinealkaloids (e.g. har-mala)

WHO: 3–6 g drug/day, no ad-ministration to children underthe age of 12


very toxic Ib (Wink/Wyk), mescaline con-tained in the drug is subject to the provisionsof Annex I of the Narcotic Drugs Act (BtMG)

psychotropic, hallucinogenic, in-gestion of higher doses causesgastrointestinal complaints, drop inblood pressure, bradycardia, respira-tory depression, vasodilation, paralysis(Wink/Wyk)

Alkaloids(e.g. mescaline)

WHOmonograph: traditional use WHO: 240–480mg extract/day

129





Stock plant(Latin)


Trifolium pratense L., syn. Tri-folium purpureumGILIB. nonLOISEL

Leaf Not NFS

Trigonella caerulea (L.) SER. var.caerulea, syn. Trigonella melilotus-caerulea (L.) A. et GR.

Herb S

Trigonella foenum-graecum L.,syn. Buceras foenum-graecum (L.)ALL.

Seed S

Triticum aestivum L., syn. Triticumcereale SCHRANK, Triticumsativum LAM.

Fruit

Triticum aestivum ssp. spelta L. Fruit Tropaeolummajus L., syn. Tropae-olum elatum SALISB.

Herb

Turnera diffusaWILLD. etSCHULTES (TurneramicrophyllaDESV.) and Turnera aphrodisiaca(LESTER f.) WARD, [Turnera diffusaWILLD. var. aphrodisiaca (WARD)URBAN]

Leaf

Tussilago farfara L. Leaf

Tussilago farfara L. Flower, root

Uncaria tomentosa (WILLD.) DC.,syn. Nauclea cinchoneae DC.

Bark Not NFS

Uncaria tomentosa (WILLD.) DC.,syn. Nauclea cinchoneae DC.

Root Not NFS

130




slight nausea and urticaria observedin very rare cases, concerning risks ofisoflavones isolated from red clover s.BfR statement: http://www.bfr.bund.de/cm/343/isolierte_isoflavone_sind_nicht_ohne_risiko.pdf

Positivemonograph, indications: lack of ap-petite,WHOmonograph: as an adjunct forthe management of hypercholesterolaemia,and hyperglycaemia in cases of diabetes mel-litus. Prevention and treatment of mountainsickness, loss of appetite, Treatment of pain,and weakness and oedema of the legs, tra-ditional use, ESCOPmonograph: adjuvanttherapy in diabetes mellitus, anorexia, as anadjunct to a low fat diet in the treatment ofmild to moderate hypercholesterolaemia,HMPCmonograph: traditional use, standardmarketing authorisation: 2319.99.99

Commission E,WHO: 6 g drug/day

slightly toxic (+) (Roth/Daunderer)

Neutral monograph: mildly toxic III (Wink/Wyk)

Eucalyptol (D1,8-cineol), arbutin

Positivemonograph, indications: acutecatarrhs of the respiratory tract accompa-nied by cough and hoarseness, acute, mildinflammations of the oral and pharyngealmucosa, BfArM graduated plan of 5 June 1992concerning medicinal products containingpyrrolizidine alkaloids

contains pyrrolizidine alkaloids withhepatotoxic, carcinogenic, partly alsomutagenic and teratogenic properties(Frohne/Pfänder)


Negativemonograph: due to risks contains pyrrolizidine alkaloids withhepatotoxic, carcinogenic, partly alsomutagenic and teratogenic properties(Frohne/Pfänder)


WHOmonograph, indications: symptomatictreatment of arthritis, rheumatism and gastriculcers, traditional use,HMPCmonograph: inprogress

WHO: 20–350mg extract/day, noadministration to children underthe age of 12

Side effects: constipation, increase inuric acid, cardiovascular complaints(Frohne, Schilcher)

pentacyclic alka-loids

131

http://www.bfr.bund.de/cm/343/isolierte_isoflavone_sind_nicht_ohne_risiko.pdf




Stock plant(Latin)


Urgineamaritima (L) BAKER, syn.Scilla maritima L., Drimiamaritima(L.) STEARN., Ornithogalummar-itimum (L.) LAM., Stellaris scillaMOENCH.

Bulb

Urtica dioica L., syn. UrticamajorKANITZ, Urtica urens maximaBLACKW.

Root Not NFS (wholeplant)


Fruit T, S


Herb, leaf

Urtica urens L. syn.Urtica minorFUCHS, Urticaminor MOENCH,Urtica urens minima DOD.

Herb, leaf

Urtica urens L. syn.Urtica minorFUCHS, Urticaminor MOENCH,Urtica urens minima DOD.

Root Not NFS

Vacciniummacrocarpon AITON Fruit

132




Positivemonograph, indications: mild formsof cardiac insufficiency, also when accompa-nied by renal insufficiency, Scilla glycosidesprescription-only, sea onion itself pharmacy-only, highly toxic ++ (Roth/Daunderer), verytoxic Ib (Wink/Wyk)

Nausea, vomiting, gastric complaints,diarrhoea, irregular pulse, arrhythmia,hypertension, coma, cardiac arrest,contraindications and interactionsreported, narrow therapeutic range ofcardioactive glycosides (Wink/Wyk,Roth/Daunderer)


Commission E: 0.1–0.5 g/day,standardised sea onion powder,equivalent preparations

Positivemonograph, indications: micturitiondifficulties resulting from prostatic adenoma(stage I–II),WHOmonograph: symptomatictreatment of lower urinary tract disorders(nocturia, polyuria, urinary retention) result-ing from BPH stages I and II, as defined byAlken, in cases where diagnosis of prostatecancer is negative, ESCOPmonograph: symp-tomatic treatment of micturition disorders(dysuria, pollakisuria, nocturia, urine reten-tion) in benign prostatic hyperplasia (BPH) atstages I and II as defined by Alken or stagesII and III as defined by Vahlensiek,HMPCmonograph: traditional use

occasionally causes mild gastroin-testinal complaints (Commission Emonograph)

ESCOP,WHO: 4–6 g drug/day,equivalent preparations, no ad-ministration to children underthe age of 12

Positivemonograph, indications: adjuvanttreatment of rheumatic conditions, irrigationtherapy of inflammatory diseases of the lowerurinary tract, prevention and treatment ofkidney gravel, standardmarketing authorisa-tion: 8599.99.99, ESCOPmonograph: adjuvantin the symptomatic treatment of arthritis,arthrosis and/or rheumatic conditions,HMPCmonograph: traditional use

painful itching accompanied by urtica-tion of skin areas that come in contactwith stinging hairs (Wink/Wyk)


Positivemonograph, indications: adjuvanttreatment of rheumatic conditions, irrigationtherapy of inflammatory diseases of the lowerurinary tract, prevention and treatment ofkidney gravel, standardmarketing authorisa-tion: 8599.99.99, ESCOPmonograph: adjuvantin the symptomatic treatment of arthritis,arthrosis and/or rheumatic conditions,HMPCmonograph: traditional use

painful itching accompanied by urtica-tion of skin areas that come in contactwith stinging hairs (Wink/Wyk)


Positivemonograph, indications: micturitiondifficulties resulting from prostatic adenoma(stage I–II),WHOmonograph: symptomatictreatment of lower urinary tract disorders(nocturia, polyuria, urinary retention) result-ing from BPH stages I and II, as defined byAlken, in cases where diagnosis of prostatecancer is negative, ESCOPmonograph: symp-tomatic treatment of micturition disorders(dysuria, pollakisuria, nocturia, urine reten-tion) in benign prostatic hyperplasia (BPH) atstages I and II as defined by Alken or stagesII and III as defined by Vahlensiek,HMPCmonograph: traditional use

occasionally causes mild gastroin-testinal complaints (Commission Emonograph)

Commission E: 4–6 g drug/day,equivalent preparationsESCOP: 4–6 g drug/day, equiva-lent preparationsWHO: 4–6 g drug/day, no ad-ministration to children underthe age of 12

WHOmonograph: traditional use, ESCOPmonograph: prevention of urinary tract infec-tions

ESCOP: 300–750ml juice, 200–500mg dry extract, 2 times a day,equivalent preparations, no ad-ministration to childrenWHO: 400–450mg drug

133


Stock plant(Latin)


Vacciniummyrtillus L., syn.Myrtillus niger GILIB., Myrtillussylvatica BUBANI

Leaf T

Vacciniummyrtillus L., syn.Myrtillus niger GILIB., Myrtillussylvatica BUBANI

Fruit

Vaccinium vitis-idaea L., syn.Myrtillus exigua BUBANI, Vac-cinium rubrumDULAC, Vitis idaeapunctata MOENCH, Vitis-idaeapunctifolia S.F. GRAY

Leaf T

Vaccinium vitis-idaea L., syn.Myrtillus exigua BUBANI, Vac-cinium rubrumDULAC, Vitis idaeapunctata MOENCH, Vitis-idaeapunctifolia S.F. GRAY

Fruit

Valeriana edulis NUTT. ex TORR.et GRAY ssp. Procera (H.B.K.)F.G.MEYER, syn. Valeriana mexi-cana DC

Root

Valeriana officinalis L. Root F

Vanilla planifolia ANDR., syn.Vanilla fragrans (SALISB.) AMES.,Myrobroma fragrans SALISB.,Vanilla aromatica S.W.

Fruit S

Veratrum album L., syn. Helleborusalbus GÜLDENST., Melanthiumalbum THUNB.

Rhizome

134




Negativemonograph: due to risks, slightlytoxic (+),HMPCmonograph: in progress

Long-term use in very high doses(more than 20 g/day) causes chronicpoisoning (Schilcher)

Positivemonograph, indications: non-spe-cific, acute diarrhoea, local treatment of mildinflammations of the oral and pharyngealmucosa, standard marketing authorisation:1009.99.99,WHOmonograph: use for thesymptomatic treatment of dysmenorrhoeaassociated with premenstrual syndrome, cir-culatory disorders in patients with capillaryleakage or peripheral vascular insufficiencyand ophthalmic disorders, treatment of acutediarrhoea and local irritation or inflammationof themucous membranes of themouth andthroat, ESCOPmonograph: (Extracts): symp-tomatic treatement of problems related tovaricose veins, such as painful and heavy legs,(dried fruit): supportive treatment of acute,non-specific diarrhoea,HMPCmonograph: inprogress

Commission E: 30 g drug/day,equivalent preparationsWHO: 20–60 g drug/day

mildly toxic III (Wink/Wyk) contains 5–8% valepotriates, vale-potriates are suspected to have analkyleting, cytotoxic and mutageniceffect (Hager)

Valepotriates

Positivemonograph, indications: agita-tion, nervous sleep disturbances, standardmarketing authorisation: 6199.99.99 (root),6099.99.99 (tincture),WHOmonograph: mildsedative and sleep-promoting agent, used inthe treatment of states of nervous excitationand anxiety-induced sleep disturbances, ES-COPmonograph: relief of temporary mildnervous tension and/or difficulty in fallingasleep,HMPCmonograph: relief of mild ner-vous tension and sleep disorders, traditionaluse, hardly toxic (+) (Roth/Daunderer), mildlytoxic III (Wink/Wyk), used to produce spirits

sedative properties, ingestion of higherdoses causes headache, agitation,sleep disturbances, arrhythmia, cen-tral paralysis, cardiac arrest, contains0.1–2% valepotriates (Wichtl)

Valepotriates Commission E,WHO: 2–3 gdrug, several times a day,equivalent preparations, no ad-ministration to children underthe age of 12ESCOP: 1–3 g drug/day, no ad-ministration to children underthe age of 12HMPC: 2–3 g drug, up to 4 timesa day, equivalent preparations,no administration to childrenunder the age of 12

poisonous plant, extremely toxic Ia (Wink/Wyk), highly toxic ++ (Roth/Daunderer)

Hypersalivation, sneezing, burningbitter taste in themouth, vomiting,bloody diarrhoea, bradycardia, dropin blood pressure, vertigo, headache,tremor, hallucinations, pain, itching,anaesthesia, myoplegia, death by car-diac or respiratory arrest (Wink/Wyk)

steroidal alkaloids(protoveratrineA and protovera-trine B)

135


Stock plant(Latin)


Verbascum spp. Flower T

Verbascum spp. Leaf Not NFS Veronica officinalis L. Herb T, S

Viburnum lantana L. all plant parts

Viburnum opulus L., syn. OpulusglandulosusMÖNCH, Opulus vul-garis BORKH., Viburnum lobatumLAM.

all plant parts

Vincaminor L., syn. Pervincaminor (L.) SCOPOLI, Vinca ellip-ticifolia STOKES

Herb

Viola odorata L. Flower C

Viola odorata L. Herb, rhizome Not NFS Viola tricolor L., syn. Viola tricolorL. ssp. tricolor, Viola tricolor L. ssp.vulgaris (KOCH) OBORNY.

Herb C

Viscum album L., syn. ViscumstellatumD. DON.

Fruit

Viscum album L., syn. ViscumstellatumD. DON.

Herb

136




Positivemonograph, indications: catarrhsof the respiratory tract,HMPCmonograph:traditional use, standard marketing authori-sation: 2449.99.99


Neutral monograph


Nausea, clouded consciousness,vomiting, diarrhoea, digestive tractinflammations, cardiac arrhythmia,cramps, dyspnoea, kidney damage(Wink/Wyk, Roth/Daunderer)

Viburnin, oxalates


Nausea, clouded consciousness,vomiting, diarrhoea, digestive tractinflammations, cardiac arrhythmia,cramps, dyspnoea, kidney damage(Wink/Wyk, Roth/Daunderer)

Viburnin, oxalates

Negativemonograph: due to risks, toxic +(Roth/Daunderer), toxic II (Wink/Wyk), sub-stance of concern (AMK), BfArM graduatedplan of 20 July 1987 concerning medicinalproducts containing lesser periwinkle

strong drop in blood pressure, may beaccompanied by cardiac complaints,circulatory distress and dyspnoea,gastrointestinal complaints observedin individual cases, temporary rednessof skin (Roth/Daunderer), changesin blood picture such as leucopenia,lymphopenia, drop in ˛1-, ˛2- and -globulin levels demonstrated in animalexperiments (Schilcher)

Indole alkaloids(e.g. vincamine)

Neutral monograph

Neutral monograph

Positivemonograph: for external use only,ESCOPmonograph (internal and externaluse): skin disorders such as exzema, sebor-rhoea, impetigo and acne, as well as cradle capand nappy rash of infants,HMPCmonograph:traditional use

ESCOP: 1.5–4 g, 3 times a day

Negativemonograph: due to risks, slightlytoxic to toxic + (Roth/Daunderer), toxic II(Wink/Wyk)

Retching, raging thirst, tenesmus,bloody stool, convulsions, gastric com-plaints, nausea, vomiting, diarrhoea(Wink/Wyk)

Viscotoxins,lectins

Positivemonograph: homeopathic or anthro-posophicmedicinal product for parenteral useonly,HMPC assessment report: slightly toxicto toxic (Roth/Daunderer), toxic (Wink/Wyk)

Shivering, hyperthermia, headache,anginal complaints, orthostatic cir-culatory distress, allergic reactions(Commission E, Roth/Daunderer)

Viscotoxins,lectins

137


Stock plant(Latin)


Vitex agnus-castus L., syn. Agnus-castus vulgaris CARR., Vitex verti-cillata LAM.

Fruit Not NFS

Vitis vinifera L. Leaf

Vitis vinifera L. Fruit Voacanga africana STAPF. andVoacanga thuarsii Roem-Schu

all plant parts

Wisteria spp., e.g. Wisteria sinensis(SIMS) SWEET

all plant parts

Withania somnifera (L.) DUN., syn.Physalis somnifera L.

Root

138




Positivemonograph, indications: menstrualcycle irregularities, premenstrual symptoms,mastalgia,WHOmonograph: symptomatictreatment of gynaecological disorders in-cluding corpus luteum insufficiency andhyperprolactinaemia, premenstrual syndrome,menstrual irregularities, cyclic mastalgiaand also to treat hormonally-induced acne,treatment of endometrial hyperplasia andsecondary amenorrhoea, endocrine-depen-dent dermatoses (dermatitis symmetricadysmenorrhoica (Matzenauer-Polland syn-drome)) acne vulgaris, eczema, acne rosacea),hypermenorrhoea, infertility due to hyper-prolactinaemia and luteal phase defect. Usedto treat fibroid cysts and infertility, to stopmiscarriages due to progesterone insuffi-ciency, to help expel the placenta after birthand also as a digestive aid, sedative, anti-in-fective and for the treatment of hot flushes,ESCOPmonograph: premenstrual syndrome(PMS) including symptoms such as mastody-nia or mastalgia, menstrual cycle disorderssuch as polymenorrhoea, oligomenorrhoea oramenorrhoea,HMPCmonograph: treatmentof premenstrual syndrome, traditional use,slightly toxic (Roth/Daunderer)

Ingestion of high doses causes dizzi-ness, vertigo, soporific effect (Roth/Daunderer), occasionally itching andurticaria, contraindicated during preg-nancy and lactation (Commission Emonograph)

Commission E,WHO: 30–40mgdrug/day as water-alcohol ex-tract, no administration tochildren under the age of 12ESCOP: equivalent to 30–40mg(240mg) drug/dayHMPC: 180mg drug/day,equivalent preparations, no ad-ministration to children andadolescents under the age of 18

ESCOPmonograph: (aqueous dry extract):treatment of symptoms of chronic venousinsufficiency (CVI) at stages I–II as defined byWidmer, (other preparations): symptomatictreatment of problems related to varicosissuch as painful and heavy legs,HMPCmono-graph: traditional use

ESCOP: 10 g drug in 250ml waterper day

contains psychotropic alkaloids, alkaloidscontained in the drug toxic Ib to very toxic II(Wink/Wyk)

Indole alkaloids are cell and nervepoison, psychotropic effect, supraven-tricular tachycardia, Adam-Stokessyndrome, ventricular fibrillation, dropin blood pressure, cerebral cramps,coma, cardiac arrest (Wink/Wyk)

Indole alkaloids(e.g. voacangine,voacamine)

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) gastric complaints accompanied byvomiting, diarrhoea, circulatory dis-tress, facial pallor and drowsiness,headache, vertigo and circulatory col-lapse (Wink/Wyk) (Roth/Daunderer)

Wistarin, lectins

mildly toxic III (Wink/Wyk),WHOmono-graph: as an antistress agent to improvereaction time, tonic to increase energy,improve overall health and prevent dis-ease in athletes and the elderly,HMPCmonograph: final public statement, s. BfRstatement: http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf

Nausea, vomiting, diarrhoea (WHOmonograph)

steroidal lactones(withanolides),alkaloids

WHO: 3–6 g drug/day or 250mg,2 times a day (depending on theindication)

139





Stock plant(Latin)


Xysmalobium undulatum (L.) R.BR., syn. Asclepias undulata L., Xys-malobium amplifoliumWEIM.,Xysmalobium dispar N. E. BR., Xys-malobium lapathifoliumDECNE.

Root

Yucca filamentosa L., syn. Yuccaangustifolia hort. non PURSH,Yucca smalliana FERN.

all plant parts Not NFS

Zeamays L. Style T

Zeamays L. Seed Zingiber officinale ROSC., syn.Amomum zingiber L.

Rhizome

140




Positivemonograph, indications: non-specific, acute forms of diarrhoea, licensedmedicinal product, medicinal plant, verytoxic Ib (Wink/Wyk), highly toxic ++ (Roth/Daunderer)

Since besides tannins the uzara rootcontains cardioactive glycosides,the specified dosage must be strictlyobserved. For this reason, only stan-dardised ready-to-use medicinalproducts should be administered(Schilcher). The effect of high doseson the heart is similar to that of digi-talis (Commission Emonograph)

Glycosides withcardenolide struc-ture

Commission E: preparationsequivalent to 1 g drug or 75mgtotal glycosides, daily dose equiv-alent to 4–90mg total glycosides,calculated as uzarin

WHOmonograph: supportive treatment ofchronic nephritis, treatment of cholangitis,hepatitis and cholecystitis, and of acute andchronic cystitis and urethritis. Also used in thetreatment of heart disease (as a diuretic), hy-pertension, rheumatism and diabetes mellitus

Carvacrol WHO: 4–8 g/day

Positivemonograph, indications: diges-tive problems, prevention of symptoms oftravel sickness,WHOmonograph: prophy-laxis of nausea and vomiting associated withmotion sickness, postoperative nausea, perni-cious vomiting in pregnancy, and seasickness,ESCOPmonograph: prophylaxis of the nau-sea and vomiting of motion sickness, and asa postoperative antiemetic for minor day-case surgical procedures,HMPCmonograph:prevention of nausea and vomiting in motionsickness, traditional use

irritating to mucousmembranes(Roth/Daunderer), contraindications:vomiting in pregnancy (Commission Emonograph)

Commission E: 2–4 g drug/day,equivalent preparationsESCOP,WHO: 0.5–2 g drug/day,no administration to childrenunder the age of 6HMPC: 1–2 g drug, 1 hour beforestart of journey, no administra-tion to children and adolescentsunder the age of 18

141

Legal basis

Regulation (EC) No. 178/2002 of the European Parliamentand of the Council of 28 January 2002 laying down thegeneral principles and requirements of food law, estab-lishing the European Food Safety Authority and layingdown procedures in matters of foods safety

Regulation (EC) No. 258/97 of the European Parliamentand of the Council of 27 January 1997 concerning novelfoods and novel food ingredients

Regulation (EC) No. 1925/2006 of the European Parlia-ment and of the Council of 20 December 2006 on theaddition of vitamins and minerals and certain other sub-stances to food

Regulation (EU) No. 609/2013 of the European Parlia-ment and of the Council of 12 June 2013 on food in-tended for infants and young children, food for specialmedical purposes, and total diet replacement for weightcontrol and repealingCouncilDirective 92/52/EEC,Com-mission Directives 96/8/EC, 1999/21/EC, 2006/125/ECand 2006/141/EC, Directive 2009/39/EC of the EuropeanParliament and of the Council and Commission Regula-tions (EC) No. 41/2009 and (EC) No. 953/2009

Commission Regulation (EC) No. 953/2009 of 13 October2009 on substances that may be added for specific nutri-tional purposes in foods for particular nutritional uses

Regulation (EC) No. 1334/2008 of the European Parlia-ment and of the Council of 16 December 2008 on flavour-ings and certain food ingredients with flavouring proper-ties for use in and on foods and amending Council Reg-ulation (EEC) No. 1601/91, Regulations (EC) No. 2232/96and (EC) No. 110/2008 and Directive 2000/13/EC

Directive 2002/46/EC of the European Parliament and ofthe Council of 10 June 2002 on the approximation of thelaws of the Member States relating to food supplements

Ordinance on Food Supplements of 24May 2004 (BAnz1 Ip. 1011), last amended by Article 8 of the Regulation of

1 BAnz D Bundesanzeiger (Federal Law Gazette)

13 December 2011 (BAnz I p. 2720) (Ordinance on FoodSupplements [NemV])

Food and Feed Code in the version published on 3 June2013 (BAnz I p. 1426), amended by Article 4 Section 20of the Law of 7 August 2013 (BAnz I p. 3154) (Foodstuffs,Consumer Goods and Feed Code [Food and Feed Code –LFGB])

Directive 2001/83/EC of the European Parliament and ofthe Council of 6 November 2001 on the Community coderelating to medicinal products for human use

Medicinal ProductsAct in the versionpublishedon12De-cember 2005 (BAnz I p. 3394), amended by Article 4 Sec-tion 11 of the Law of 7 August 2013 (BAnz I p. 3154) (Acton the Trade in Medicinal Products [Medicinal ProductsAct – AMG])

Ordinance on the Prescription of Medicinal Products of21 December 2005 (BAnz I p. 3632), last amended by Ar-ticle 1 of the Regulation of 19 February 2013 (BAnz Ip. 312) (Ordinance on the Prescription of Medicinal Prod-ucts [AMVV])

Ordinance on Pharmacy-Only and OTC Drugs of24 November 1988 (BAnz I p. 2150), last amended byArticle 1 of the Regulation of 21 February 2011 (BAnz Ip. 314) (Ordinance on Pharmacy-Only and OTC Drugs[AMVerkRV])

Ordinance on Standard Marketing Authorisations of3 December 1982 (BAnz I p. 1601), last amended by Ar-ticle 1 of the Regulation of 19 October 2006 (BAnz Ip. 2287) (Ordinance on Standard Marketing Authorisa-tions [StandZV])

Single Convention of 1961 onNarcotic Drugs of 30March1961 (BAnz 1973 II p. 1354) (SuchtstÜbk)

Law of 30 August 1976 approving the Convention on Psy-chotropic Substances of 21 February 1971 (BAnz 1976 IIp. 1477) (PsychotrStÜbkG)

143List of Substances of the Competent Federal Government and Federal State Authorities, DOI 10.1007/978-3-319-10732-5,© Federal Office of Consumer Protection and Food Safety (BVL) 2014

Legal basis

Narcotic Drugs Act in the version published on 1 March1994 (BAnz I p. 358), amended by Article 4 Section 7 of theLaw of 7 August 2013 (BAnz I p. 3154) (Act on the Trade inNarcotic Drugs [Narcotic Drugs Act – BtMG])

Regulation (EC) No. 273/2004 of the European Parliamentandof theCouncil of 11 February 2004 ondrugprecursors

Council Regulation (EC) No. 111/2005 of 22 December2004 laying down rules for the monitoring of trade be-

tween the Community and third countries in drug pre-cursors

Precursors Control Act of 11 March 2008 (BAnz I p. 306),amended by Article 4 Section 9 of the Law of 7 August2013 (BAnz I p. 3154) (Act on the Monitoring of the Tradein Precursors that can be misused for the Illicit Manufac-ture of Narcotic Drugs [Precursors Control Act – GÜG])

144

References

Arzneimittelkommission der deutschen Ärzteschaft2 (2013). Be-denkliche Rezepturarzneimittel (Unsafe compounded drugs),http://www.akdae.de/Arzneimittelsicherheit/Weitere/Bedenkliche-Rezepturarzneimittel.pdf.

Arzneimittelkommission der Deutschen Apotheker3, Warnung vonArnikatee innerlich (Warning about ingestion of arnica tea), Pharm.Ztg., 1981, 726, 2082.

Bäumler, S. (2006). HeilpflanzenpraxisHeute. Portraits – Rezepturen –An-wendung (1st ed.). Amsterdam: Urban & Fischer Verlag Elsevier.

Blaschek, W., Ebel, S., Hackenthal, E., Holzgrabe, U., Keller, K., Reichling,J. & Schulz, V. (2007). Hagers Enzyklopädie der Arzneistoffe und Drogen(6th ed.). Stuttgart: Wissenschaftliche Verlagsgesellschaft.

Bundesinstitut für Arzneimittel und Medizinprodukte4 (2000).BfArM warnt vor Aristolochia in Zubereitungen aus chinesischenHeilkräutern (BfArM warns about Aristolochia in preparations ofChinese herbal remedies), http://www.bfarm.de/DE/BfArM/Presse/mitteil_alt/pm01-2000.html.

Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Bescheiddes BfArMgem. §21 Abs. 4 AMGvom04.03.2008 zur Einstufung einesCistus-incanus-haltigen Produktes als Arzneimittel (BfArM notifica-tion in accordance with Section 21 Clause 4 AMG of 4 Mar 2008 onthe classification of a product containing Cistus incanus as a medici-nal product).

Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Ab-wehr von Risiken durch Arzneimittel, Stufe II, Hier: Arzneimittel,die Bestandteile oder Zubereitungen aus Allium sativum enthal-ten, Bescheid vom 11.03.2008 (Prevention of drug-associated risks,stage II, here: Medicinal products containing constituents or prepa-rations of Allium sativum, notification of 11 Mar 2008), http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-allium-sativum.html.

Bundesinstitut für Arzneimittel und Medizinprodukte (2010). Ab-wehr von Risiken durch Arzneimittel, Stufe II, Hier: Arzneimittel,die unter Verwendung von Pflanzen der Familie der Aristolochi-aceae mit den Gattungen Asarum, Aristolochia, Saruma undThottea hergestellt werden, Bescheid vom 22.07.2010 (Preven-tion of drug-associated risks, stage II, here: Medicinal productsmanufactured using plants of the Aristolochiaceae family withthe genera Asarum, Aristolochia, Saruma and Thottea, notifica-tion of 22 July 2010), http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-aristolochiaceae.html;jsessionid=38873A056B112E06417AC2A6120ACBEE.1_cid322.

Bundesinstitut für Arzneimittel und Medizinprodukte (2009). Abwehrvon Gefahren durch Arzneimittel, Stufe II hier: Cimicifuga-haltigeArzneimittel einschließlich homöopathischer Zubereitungen miteiner Endkonzentration bis einschließlich D2/Leberschädigungen,Bescheid vom 09.06.2009 (Prevention of drug-associated risks,stage II, here: Medicinal products containing Cimicifuga, includ-ing homeopathic preparations with a final concentration of up to

2 Drug Commission of the GermanMedical Association3 Drug Commission of German Pharmacists4 Federal Institute for Drugs and Medical Devices

and including D2/liver damage, notification of 9 June 2009), http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/cimicifuga_bescheid.pdf?__blob=publicationFile.

Bundesinstitut für Arzneimittel und Medizinprodukte (1987). AbwehrvonArzneimittelrisiken, Stufe II, Immergrünkrauthaltige Arzneimit-tel, Bescheid vom 20.07.1987 (Prevention of drug-associated risks,stage II, medicinal products containing Vinca minor, notification of20 July 1987).

Bundesinstitut für Arzneimittel und Medizinprodukte (2005). Ab-wehr von Gefahren durch Arzneimittel, Stufe II hier: Johanniskraut(Hypericum)-haltige Humanarzneimittel zur innerlichen Anwen-dung, Bescheid vom 10.10.2005 (Prevention of drug-associatedrisks, stage II, here: Medicinal products for internal use in hu-mans containing St. John’s wort (Hypericum), notification of10 Oct 2005), http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/Johanniskraut-Bescheid-051010.pdf?__blob=publicationFile.

Bundesinstitut für Arzneimittel und Medizinprodukte (2007). Ab-wehr von Gefahren durch Arzneimittel, Stufe II, hier: Kava-Kava(Piper methysticum)-haltige und Kavain-haltige Arzneimitteleinschließlich homöopathischer Zubereitungen mit einer End-konzentration bis einschließlich D4, Bescheid vom 21.12.2007(Prevention of drug-associated risks, stage II, here: Medicinal prod-ucts containingkava-kava (Pipermethysticum) andkavain, includinghomeopathic preparations with a final concentration of up to andincludingD4, notification of 21 Dec 2007), http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-kavakava.html.

Bundesinstitut für Arzneimittel und Medizinprodukte (1992). Abwehrvon Arzneimittelrisiken, Stufe II. Pyrrolizidin-Alkaloide, Bekannt-machung über die Zulassung und Registrierung von Arzneimitteln,vom 5. Juni 1992, Bescheid. BAnz. Nr.: 111, S. 4805 vom 17.6.1992(Prevention of drug-associated risks, stage II, pyrrolizidine alkaloids,notice of the authorisation and registration of medicinal products,notification of 5 June 1992, Federal GazetteNo. 111, p. 4805 of 17 June1992).

Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Ab-wehr von Gefahren durch Arzneimittel, Stufe II, hier: Schöllkraut-haltige Arzneimittel zur innerlichen Anwendung, Bescheid vom08.04.2008 (Prevention of drug-associated risks, stage II, here: Medic-inal products for internal use containing Chelidonium, notifica-tion of 8 April 2008), http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-schoellkraut.html.

Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Hu-manarzneimittel zur innerlichen Anwendung ausgenommen nachHAB 1 hergestellte homöopathische Arzneimittel, welche Drogen,Drogenzubereitungen oder isolierte Inhaltsstoffe der Anthranoid-(Hydroxyanthracenderivat-)haltigen Pflanzengattungen Andira,Cassia, Rhamnus, Rheum oder Aloe enthalten (Medicinal prod-ucts for internal use in humans, excluding homeopathic medicinalproducts manufactured according to HAB 1 which contain drugs,drug preparations or isolated ingredients of the anthranoid- (hy-droxyanthracene derivative) containing plant genera Andira, Cassia,

145

http://www.akdae.de/Arzneimittelsicherheit/Weitere/Bedenkliche-Rezepturarzneimittel.pdf

http://www.akdae.de/Arzneimittelsicherheit/Weitere/Bedenkliche-Rezepturarzneimittel.pdf

http://www.bfarm.de/DE/BfArM/Presse/mitteil_alt/pm01-2000.html

http://www.bfarm.de/DE/BfArM/Presse/mitteil_alt/pm01-2000.html




http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-aristolochiaceae.html;jsessionid=38873A056B112E06417AC2A6120ACBEE.1_cid322






http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/Johanniskraut-Bescheid-051010.pdf?__blob=publicationFile



http://www.bfarm.de/DE/Pharmakovigilanz/risikoinfo/stufenplanverf/Liste/stp-kavakava.html





References

Rhamnus, Rheum or Aloe notification of 21 June 1996), Bescheidvom 21.6.1996: BAnz Nr. 123, 5.7.1996.

Bundesinstitut für Risikobewertung (2011). Allergie durch Lupinenei-weiß, Aktualisierte Stellungnahme Nr. 039/2011 des BfR vom 26.August 2011 (Allergens caused by lupine protein, updated BfR state-mentno. 039/2011of 26Aug2011), http://www.bfr.bund.de/cm/343/allergie-durch-lupineneiweiss-in-lebensmitteln.pdf.

Bundesinstitut für Risikobewertung (2005). Backmohn ist keinSchlafmittel für Säuglinge 12/2005, 29.04.2005 (Poppy seed for bak-ing is not a soporific for infants, 12/2005, 29 Apr 2005), http://www.bfr.bund.de/de/presseinformation/2005/12/backmohn_ist_kein_schlafmittel_fuer_saeuglinge-6279.html.

Bundesinstitut für Risikobewertung (2002). BgVV und BfArM war-nen: Schwere Gesundheitsschäden durch Ephedra-Kraut (BgVV andBfArM warn: Ephedra causes serious health issues), http://www.bfr.bund.de/de/presseinformation/2002/09/bgvv_und_bfarm_warnen__schwere_gesundheitsschaeden_durch_ephedra_kraut-1007.html.

Bundesinstitut für Risikobewertung (2005). Chininhaltige Getränkekönnen gesundheitlich problematisch sein, Aktualisierte Gesund-heitliche Bewertung Nr. 020/2008 des BfR vom 17. Februar 2005(Quinine-containing beverages may cause health problems, Up-dated BfR Health Assessment No 020/2008, 17 Feb 2005), http://www.bfr.bund.de/cm/343/chininhaltige_getraenke_koennen_gesundheitliich_problematisch_sein.pdf.

Bundesinstitut für Risikobewertung (2009). Die Sicherheit vonGinkgoblätter-haltigen Tees kann wegen mangelnder Daten nichtbeurteilt werden (The safety of herbal teas containing ginkgo leavescannot be evaluated due to insufficient data), http://www.bfr.bund.de/cm/343/die_sicherheit_von_ginkgoblaetter_haltigen_tees_kann_wegen_mangelnder_daten_nicht_beurteilt_werden.pdf.

Bundesinstitut für Risikobewertung (2006). Erhöhte Morphingehaltein Mohnsamen: Gesundheitsrisiko nicht ausgeschlossen 05/2006,20.02.2006 (Elevated morphine levels in poppy seeds: Risk tohealth not ruled out, 05/2006, 20 Feb 2006), http://www.bfr.bund.de/de/presseinformation/2006/05/erhoehte_morphingehalte_in_mohnsamen__gesundheitsrisiko_nicht_ausgeschlossen-7409.html.

Bundesinstitut für Risikobewertung (1999). Gehalte an Cumarin,Safrol, Methyleugenol und Estragol in Lebensmitteln (insbeson-dere teeähnlichen Erzeugnissen), Stellungnahme des BgVV vom 27.April 1999 (Coumarin, safrole, methyl eugenol and estragole lev-els in food (especially tea-like products), BgVV statement of 27 Apr1999), http://www.bfr.bund.de/cm/343/gehalte_an_cumarin_safrol_methyleugenol_und_estragol_in_lebensmitteln.pdf.

Bundesinstitut für Risikobewertung (2012). Gesundheitliche Bewer-tung von synephrin- und koffeinhaltigen Sportlerprodukten undSchlankheitsmitteln (Health assessment of sports and weight lossproducts containing synephrine and caffeine), http://www.bfr.bund.de/cm/343/gesundheitliche-bewertung-von-synephrin-und-koffeinhaltigen-sportlerprodukten-und-schlankheitsmitteln.pdf.

Bundesinstitut für Risikobewertung (2007). Isolierte Isoflavone sindnicht ohne Risiko, aktualisierte StellungnahmeNr. 039/2007 des BfRvom 3. April 2007 (Isolated isoflavones are not without risk, updatedBfR statement No. 039/2007 of 3 Apr 2007), http://www.bfr.bund.de/cm/343/isolierte_isoflavone_sind_nicht_ohne_risiko.pdf.

Bundesinstitut für Risikobewertung (2002). Minimierung von Estragol-und Methyleugenol-Gehalten in Lebensmitteln, Hintergrundpapiervom 15. Januar 2002 (Minimisation of estragole and methyl eugenollevels in foods, background paper of 15 Jan 2002), http://www.bfr.bund.de/cm/343/minimierung_von_estragol_und_methyleugenol_gehalten_in_lebensmitteln.pdf.

Bundesinstitut für Risikobewertung (2012). Neue Erkenntnisse zuCumarin in Zimt, Stellungnahme Nr. 036/2012 des BfR vom 27.September 2012 (New insights into coumarin contained in cinna-mon, BfR statement no. 036/2012 of 27 Sept 2012), http://www.bfr.bund.de/cm/343/neue-erkenntnisse-zu-cumarin-in-zimt.pdf.

Bundesinstitut für Risikobewertung (2007). Risikobewertung maca-haltiger Nahrungsergänzungsmittel, Stellungnahme Nr. 024/2007des BfR vom 3. April 2007 (Risk assessment of maca-containingfood supplements, BfR statement no. 024/2007 of 3 April 2007),http://www.bfr.bund.de/cm/343/risikobewertung_macahaltiger_nahrungsergaenzungsmittel.pdf.

Bundesinstitut für Risikobewertung (2003). Verwendung von unver-dünntemTeebaumöl als kosmetischesMittel, StellungnahmedesBfRvom 1. September 2003 (Use of undiluted tea-tree oil as a cosmetic,BfR statement of 1 Sept 2003), http://www.bfr.bund.de/cm/343/verwendung_von_unverduenntem_teebaumoel_als_kosmetisches_mittel.pdf.

Bundesinstitut für Risikobewertung (2007). Verzehr von bitterenAprikosenkernen ist gesundheitlich bedenklich, StellungnahmeNr. 014/2007des BfR vom 03. Mai 2007 (Consumption of bit-ter apricot kernels presents a health risk, BfR statement no.014/2007 of 3 May 2007), http://www.bfr.bund.de/cm/343/verzehr_von_bitteren_aprikosenkernen_ist_gesundheitlich_bedenklich.pdf.

Burger, A. & Wachter, H. (1998). Hunnius’ pharmazeutisches Wörterbuch(8th ed.). Berlin: de Gruyter.

Committee on Toxicity of Chemicals in Food, Consumer Productsand the Environment (2006). Statement on cyanogenic glycosidesin bitter apricot kernels, December 2006, http://www.food.gov.uk/multimedia/pdfs/cotstatementapricot200615.pdf.

Deutschmann, F., Hohmann, B., Sprecher, E., Stahl, E., Reinhard, E. &Wagner, H. (1992). Pharmazeutische Biologie/Drogenanalyse I: Mor-phologie und Anatomie 3rd ed., Amsterdam: Urban & Fischer VerlagElsevier.

Erowid: Documenting the Complex Relationship between Humans &Psychoactives, http://www.erowid.org/.

Europäisches Arzneibuch5 (2011). Europäisches Arzneibuch 7th ed. 2011incl. Addenda 1–4. Amtliche deutsche Ausgabe (Official German Edi-tion) (7th ed.). Stuttgart: Deutscher Apotheker Verlag.

European Food Safety Authority (2012). Compendium of botanicals re-ported to contain naturally occurring substances of possible concernfor human health when used in food or food supplements.

European Herbal Infusions Association (EHIA) (2013). Inventory list ofHerbals considered as Food.

Fintelmann, V.&Weiss, R. F. (2009). Lehrbuchder Phytotherapie (12th ed.).Stuttgart: Hippokrates (Georg Thieme).

Fleischhauer, S. G. (2008). Enzyklopädie der essbaren Wildpflanzen(5th ed.). Aarau: AT Verlag AZ Fachverlage.

Franke, W. (1992). Nutzpflanzenkunde. Nutzbare Gewächse dergemäßigten Breiten, Subtropen und Tropen (5th ed.). Stuttgart: GeorgThieme.

Frohne, D. (2006). Heilpflanzenlexikon. Ein Leitfaden auf wis-senschaftlicher Grundlage (8th ed.). Stuttgart: Wissenschaftliche Ver-lagsgesellschaft.

Frohne, D. & Pfänder, H. J. (2004). Giftpflanzen. Ein Handbuch fürApotheker, Ärzte, Toxikologen und Biologen (5th ed.). Stuttgart: Wis-senschaftliche Verlagsgesellschaft.

Gerhardt, U. (1994). Gewürze in der Lebensmittelindustrie. Eigen-schaften – Technologien – Verwendung (2nd ed.). Hamburg: Behr’s.

Giftzentrale Bonn6 (2013). Informationen über Pflanzen (Informationon plants), http://www.gizbonn.de/index.php?id=284.

Hänsel, R. & Sticher, O. (2010). Pharmakognosie – Phytopharmazie(9th ed.). Berlin: Springer.

Herrmann, K. (1983). Exotische Lebensmittel. Inhaltsstoffe und Verwen-dung, Für Biologen, Chemiker, Mediziner und Hobby-Köche (1st ed.).Berlin: Springer.

Hiller, K. & Melzig, M. (2003). Lexikon der Arzneipflanzen und Drogen(1st ed.). SpektrumAkademischer Verlag Heidelberg.

5 European Pharmacopoeia6 Poison Control Centre, Bonn

146



http://www.bfr.bund.de/de/presseinformation/2005/12/backmohn_ist_kein_schlafmittel_fuer_saeuglinge-6279.html













http://www.bfr.bund.de/de/presseinformation/2006/05/erhoehte_morphingehalte_in_mohnsamen__gesundheitsrisiko_nicht_ausgeschlossen-7409.html




















http://www.bfr.bund.de/cm/343/verzehr_von_bitteren_aprikosenkernen_ist_gesundheitlich_bedenklich.pdf

http://www.bfr.bund.de/cm/343/verzehr_von_bitteren_aprikosenkernen_ist_gesundheitlich_bedenklich.pdf

http://www.food.gov.uk/multimedia/pdfs/cotstatementapricot200615.pdf

http://www.food.gov.uk/multimedia/pdfs/cotstatementapricot200615.pdf

http://www.erowid.org/

http://www.gizbonn.de/index.php?id=284

References

Jänicke, C., Grünwald, J. & Brendler, T. (2003). Handbuch Phytotherapie(1st ed.). Stuttgart: Wissenschaftliche Verlagsgesellschaft.

Klenow, S., Latté KP,Wegewitz, U., Dusemund, B., Pöting, A., Appel, K. E.,Großklaus, R., Schumann, R. & Lampen, A. (2012). Risikobewertungvon Pflanzen und pflanzlichen Zubereitungen, BfR Wissenschaft(1/2012), http://www.bfr.bund.de/cm/350/risikobewertung-von-pflanzen-und-pflanzlichen-zubereitungen.pdf.

Leistner, E., Breckle, S.W., Drewke, G., Krippeit-Drews, P. & Keusgen, M.(2008). Pharmazeutische Biologie kompakt. Grundlagen – Systematik –Humanbiologie (7th ed.). Stuttgart: Wissenschaftliche Verlagsge-sellschaft.

Leitsätze für Fruchtsäfte (Guidelines for fruit juices), Neufassung (revisedversion) vom27.11.2002 (BeilageNr. 46b zumBAnz vom7. März 2003,GMBl Nr. 8–10 S. 151 vom 20. Februar 2003).

Leitsätze für Gemüseerzeugnisse (Guidelines for vegetable products),Neufassung (revised version) vom8.01.2008 (Beilage zumBAnzNr. 89vom 18.06.2008, GMBl Nr. 23–25 S. 451 ff. vom 19.06.2008.

Leitsätze für Obsterzeugnisse (Guidelines for fruit products), Neufas-sung (revised version) vom 8.01.2008 (Beilage zum BAnz Nr. 89 vom18.06.2008, GMBl Nr. 23–25 S. 451 ff. vom 19.06.2008).

Leitsätze für Ölsamen und daraus hergestellte Massen und Süßwaren(Guidelines for oilseeds as well as mixtures and sweets producedthereof), vom 27.01.1965 (Beilage [Supplement] zum BAnz. 101 vom2.6.1965, GMBl Nr. 17 S. 165 vom 23.06.1965, zuletzt geändert am08.01.2010, BAnz. Nr. 16 vom 29.01.2010, GMBl. Nr. 5/6, S. 120 ff. vom04.02.2010).

Leitsätze für Tee, teeähnliche Erzeugnisse, deren Extrakte und Zu-bereitungen (Guidelines for tea, tea-like products, extracts thereofand preparations) (Neufassung [revised version] vom 2.12.1998 [BAnzNr. 66a vom 9.04.1999, GMBl Nr. 11 S. 228 vom 26.04.1999]).

Lieberei, R. & Reisdorff, C. (2007). Nutzpflanzenkunde (7th ed.). GeorgThieme Verlag Stuttgart.

Lück, E. (2004). Von Abalone bis Zuckerwurz, Exotisches für Gourmets,Hobbyköche und Weltenbummler (2nd ed.). Berlin: Springer.

Mueller, M. S. & Mechler, E. (2005). Medicinal Plants in Tropical Coun-tries: Traditional Use – Experience Facts, Stuttgart: Georg Thieme.

Oetker, A. (1967). Dr. Oetker Warenkunde Lexikon (9th ed.). Bielefeld:Ceres.

Oetker, A. (1989). Dr. Oetker Lexikon Lebensmittel undErnährung (3rd ed.)Bielefeld: Ceres.

Oetker, A. (2004). Lebensmittel Lexikon (4th ed.). Bielefeld: Dr. OetkerVerlag.

Pilegaard, K., Eriksen, F. D., Soerensen, M. & Gry, J. (2007). EuroFIR-NETTOX Plant List, European Food Information Resource Consor-tium (EuroFIR).

Pschyrembel (2006). Pschyrembel. Naturheilkunde und alternative Ver-fahren (3rd ed.) Berlin: de Gruyter.

Rätsch, C. (1998). Enzyklopädie der psychoaktiven SubstanzenBotanik, Ethnopharmakologie und Anwendungen. Stuttgart: Wis-senschaftliche Verlagsgesellschaft.

Rätsch, C. (1999). Enzyklopädie der psychoaktiven Pflanzen. Botanik,Ethnopharmakologie und Anwendungen (4th ed.). Aarau: AT VerlagAZ Fachverlage.

Rätsch, C. & Müller-Ebeling, C. (2003). Lexikon der Liebesmittel. Pflanz-liche,mineralische, tierischeund synthetischeAphrodisiaka, Lizenzaus-gabe (1st ed.). Stuttgart: Deutscher Apotheker Verlag/Aarau: ATVerlag AZ Fachverlage.

Reinhard, E., Dingermann, T., Kreis, W., Rimpler, H. & Zündorf, I.(2008). Reinhard Pharmazeutische Biologie 1 (7th ed.). Stuttgart: Wis-senschaftliche Verlagsgesellschaft.

Roth, L., Daunderer,M. &Kormann, K. (2006). Giftpflanzen-Pflanzengifte.Vorkommen – Wirkung – Therapie – Allergische und phototoxischeReaktionen (4th ed.). Hamburg: Nikol.

Schenk, E. G. & Naundorf, J. (1966). Manualia Nicolai. Lexikon der tro-pischen, subtropischen undmediterranen Nahrungs- und GenussmittelHerford: Nicolaische Verlagsbuchhandlung.

Schilcher,H., Kammerer, S. &Wegener, T. (2010). Leitfaden Phytotherapie(3rd ed.). Amsterdam: Urban & Fischer Verlag Elsevier.

Schneider, G., Dingermann, T., Hiller, K. & Zündorf, I. (2004). SchneiderArzneidrogen (5th ed.). Heidelberg: Spektrum.

Schrott, E., Hermann, P. & Ammon, T. (2011). Heilpflanzen der ayurvedi-schen und westlichenMedizin. Eine Gegenüberstellung (1st ed.). Berlin:Springer.

Schulz, V. & Hänsel, R. (2004). Rationale Phytotherapie. Ratgeber für Ärzteund Apotheker (5th ed.). Berlin: Springer.

Scientific Committee on Food (2001 a). Opinion of the Scientific Com-mittee on Food on Methyleugenol (4-Allyl-1,2-dimethoxybenzene).Scientific Committee on Food SCF/CS/FLAV/FLAVOUR/6 ADD2 FI-NAL (adopted on 26 September 2001) http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.html#opinions.

Scientific Committee on Food (2001 b). Opinion of the Scientific Com-mittee on Food on Estragole (1-Allyl-4-methoxybenzene). Scien-tific Committee on Food SCF/CS/FLAVOUR/4ADD1 FINAL (adoptedon 26 September 2001) http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.html#opinions.

Seidemann, J. (1993).Würzmittel-Lexikon (1st ed.). Hamburg: Behr’s.Siewek, F. (1990). Exotische Gewürze. Herkunft, Verwendung, Inhaltstoffe.

Basel: Birkhäuser.Ternes, W., Täufel, A., Tunger, L. & Zobel, M. (1993). Lebensmittel-Lexikon

(3rd ed.). Hamburg: Behr’s.Ternes, W., Täufel, A., Tunger, L. & Zobel, M. (2005). Lexikon der

Lebensmittel und der Lebensmittelchemie (4th ed.). Stuttgart: Wis-senschaftliche Verlagsgesellschaft.

Teuscher, E. (2003): Gewürzdrogen. Handbuch der Gewürze, Gewürz-kräuter, ihrer ätherische Öle und der Gewürzmischungen. Stuttgart:Wissenschaftliche Verlagsgesellschaft.

Teuscher, E., Melzig, M. F. & Lindequist, U. (2004). Biogene Arzneimittel.Ein Lehrbuch der Pharmazeutischen Biologie (6th ed.). Stuttgart: Wis-senschaftliche Verlagsgesellschaft.

The European Botanical Forum (2009). Review and consolidation ofEuropean Negative List, Prohibited plants in selected EU and Candi-date Countries, http://www.botanicalforum.eu/uploads/EBF.TFG4.EU%20neg.list.version.2.pdf.

vanWyk, B. E.,Wink, C. &Wink,M. (2004). Handbuch der Arzneipflanzen(1st ed.). Stuttgart: WissenschaftlicheVerlagsgesellschaft.

van Wyk, B. E. (2005). Handbuch der Nahrungspflanzen (1st ed.).Stuttgart: Wissenschaftliche Verlagsgesellschaft.

von Bruchhausen, F., Ebel, S., Frahm, A.W., Hackenthal, S., Hänsel, R.,Holzgrabe, U., Keller, K., Nürnberg, E., Rimpler,H., Schneider, G., Sur-mann, P., Wolf, H.U. & Wurm, G. (1992–1998). Hagers Handbuch derpharmazeutischen Praxis (5th ed.). Berlin: Springer.

Wagner, H. & Wiesenauer, M. (2003). Phytotherapie. Phytotherapie undpflanzlicheHomöopathika (2nd ed.). Stuttgart:WissenschaftlicheVer-lagsgesellschaft.

Wichtl, M. (2008). Teedrogen und Phytopharmaka. Ein Handbuch fürdie Praxis auf wissenschaftlicher Grundlage (5th ed.). Stuttgart: Wis-senschaftliche Verlagsgesellschaft.

Wichtl, M. (1989). Teedrogen. Ein Handbuch für die Praxis auf wis-senschaftlicher Grundlage (2nd ed.). Stuttgart: Wissenschaftliche Ver-lagsgesellschaft.

Wikipedia: The Free Encyclopedia, http://de.wikipedia.org.Wink, M., van Wyk, B. E. & Wink, C. (2008). Handbuch der giftigen und

psychoaktivenPflanzen (1st ed.). Stuttgart:WissenschaftlicheVerlags-gesellschaft.

Wirtschaftsvereinigung Kräuter- und Früchtetees e.V. [Herbal and FruitTeaTradeAssociation] (2013). WKF Inventarliste Lebensmitteldrogen[WKF Inventory List of Plants and Plant Parts Used for Food], http://wkf.de/Recht.1957.0.html?&L=0.

Wüstenfeld, M. & Haeseler, G. (1964). Trinkbrandweine und Liköre(4th ed.). Berlin: Paul Parey.

147



http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.html#opinions




http://www.botanicalforum.eu/uploads/EBF.TFG4.EU%20neg.list.version.2.pdf

http://www.botanicalforum.eu/uploads/EBF.TFG4.EU%20neg.list.version.2.pdf

http://de.wikipedia.org

http://wkf.de/Recht.1957.0.html?&L=0

http://wkf.de/Recht.1957.0.html?&L=0

References

Monographs of the Federal Health Office/Federal Institute for Drugs and Medical Devices(BGA/BfArM)

Absinthii herba (Wermutkraut): BAnz Nr.7 228, 5 Dec 1984.Achilleamillefolium (Schafgarbe): BAnz Nr. 22a, 1 Feb 1990.Aconitum napellus (Blauer Eisenhut): BAnz Nr. 193a, 15 Okt 1987.Adonis herba (Adoniskraut): BAnz. Nr. 85, 5 May 1988 and BAnz Nr. 22a,

01.02.1990 (corrected).Agni casti fructus (Keuschlammfrüchte oder Mönchspfefferfrüchte):

BAnz Nr. 226, 2 Dec 1992.Agrimoniae herba (Odermennigkraut): BAnz Nr. 50, 13 Mar 1986 and

BAnz Nr. 50, 13 Mar 1990 (corrected).Alchemilla alpinae herba (Apfelfrauenmantelkraut): BAnz. Nr. 162,

29 Aug 1992.Alchemilla herba (Frauenmantelkraut): BAnz. Nr. 173, 18 Sept 1986.Allii cepae bulbus (Zwiebel): BAnz Nr. 50, 13 Mar 1986.Allii sativi bulbus (Knoblauchzwiebel): BAnz Nr. 122, 6 July 1988.Aloe: BAnz. Nr. 133, 21 July 1993.Althaeae folium (Eibischblätter): BAnz Nr. 43, 2 Mar 1989.Althaeae radix (Eibischwurzel): BAnz Nr. 43, 2 Mar 1989.Ammeos visnagae fructus (Ammi-visnaga-Früchte): BAnz Nr. 71, 15 Apr

1994.Anethi fructus (Dillfrüchte): BAnzNr. 193a, 15Okt 1987 andBAnzNr. 50,

13 Mar 1990 (corrected).Anethi herba (Dillkraut): BAnz Nr. 193a, 15 Okt 1987.Angelicae fructus/-herba (Angelikafrüchte/-kraut): BAnzNr. 101, 1 June

1990.Angelicae radix (Angelikawurzel): BAnz Nr. 101, 1 June 1990.Anisi fructus (Anis): BAnz Nr. 122, 6 July 1988.Anisi stellati fructus (Sternanis): BAnz Nr. 122, 6 July 1988.Antennariae dioicae flos (Katzenpfötchenblüten): BAnz Nr. 162, 29 Aug

1992.Apium graveolens (Sellerie): BAnz Nr. 127, 12 July 1991.Armoraciae rusticanae radix (Meerrettich): BAnz Nr. 85, 5 May 1988.Arnicae flos (Arnikablüten): BAnz Nr. 228, 5 Dec 1984.Artemisia vulgaris (Beifuß): BAnz Nr. 122, 6 July 1988.Asparagi rhizoma (Spargelwurzelstock): BAnz Nr. 127, 12 July 1991.Atropa belladonna (Tollkirsche): BAnz Nr. 223, 30 Nov 1985.Aurantii flos (Pomeranzenblüten): BAnz Nr. 128, 14 July 1993.Aurantii pericarpium (Pomeranzenschale): BAnz Nr. 193a, 15 Okt 1987

and BAnz Nr. 50, 13 Mar 1990 (corrected).Avenae fructus (Haferfrüchte): BAnz Nr. 85, 5 May 1988.Avenae herba (Haferkraut ): BAnz Nr. 193a, 15 Okt 1987.Barosmae folium (Buccoblätter): BAnz Nr. 22a, 1 Feb 1990.Basilici herba (Basilienkraut): BAnz Nr. 54, 18 Mar 1992.Berberis vulgaris (Berberitze): BAnz Nr. 43, 2 Mar 1989.Betulae folium (Birkenblätter): BAnz Nr. 50, 13 Mar 1986.Boldo folium (Boldoblätter): BAnz Nr. 76, 23 Apr 1987 and BAnz Nr. 164

vom 1 Sept 1990 (corrected).Borago (Boretsch): BAnz Nr. 127, 12 July 1991.Bryoniae radix (Zaunrübenwurzel): BAnz Nr. 122, 6 July 1988.Bursae pastoris herba (Hirtentäschelkraut): BAnz Nr. 173, 18 Sept 1986

and BAnz Nr. 50, 13 Mar 1990 (corrected).Cacao semen (Kakaosamen): BAnz Nr. 40, 27 Feb 1991.Cacao testes (Kakaoschalen): BAnz Nr. 40, 27 Feb 1991.Calendulae flos (Ringelblumenblüten): BAnz Nr. 50, 13 Mar 1986.Calluna vulgaris (Heidekraut): BAnz. Nr. 101, 1 June 1990.Capsicum (Paprika): BAnz Nr. 22a, 1 Feb 1990.Cardamomi fructus (Kardamom): BAnz Nr. 223, 30 Nov 1985 and BAnz

Nr. 50, 13 Mar 1990 and BAnz Nr.164, 1 Sept 1990 (corrected).Cardui mariae fructus (Mariendistelfrüchte): BAnz Nr. 50, 13 Mar 1986.Caricae fructus (Feigen): BAnz Nr. 101, 1 June 1990.

7 BAnz D Bundesanzeiger (Federal Law Gazette); Nr. DNumber (No.)

Caricae papayae folium (Melonenbaumbläetter): BAnz Nr. 193a, 15 Okt1987.

Caricis rhizoma (Sandriedgraswurzelstock): BAnz Nr. 101, 1 June 1990.Carvi fructus (Kümmel): BAnz Nr. 22a, 1 Feb 1990.Caryophylli flos (Gewürznelken): BAnz Nr. 223, 30 Nov 1985.Centaurea cyanus (Kornblume): BAnz Nr. 43, 2 Mar 1989.Centaurii herba (Tausendgueldenkraut): BAnz Nr. 122, 6 July 1988 and

BAnz Nr. 50, 13 Mar 1990 (corrected).Chamomillae romanae flos (Römische Kamillenblüten): BAnz Nr. 221,

25 Nov 1993.Chelidonii herba (Schöllkraut): BAnz Nr. 90, 15 May 1985.Chrysanthemum vulgare (Rainfarn): Banz Nr. 122, 6 July 1988.Cichorium intybus (Wegwarte): BAnz Nr. 76, 23 Apr 1987 and BAnz

Nr. 164, 1 Sept 1990 (corrected).Cimicifugae racemosae rhizoma (Cimicifugawurzelstock): BAnz Nr. 43,

2 Mar 1989.Cinchonae cortex (Chinarinde): BAnz Nr. 22a, 1 Feb 1990.Cinnamomi cassiae cortex (Chinesischer Zimt): BAnzNr. 22a, 1 Feb 1990.Cinnamomi ceylanici cortex (Zimtrinde): BAnz Nr. 22a, 1 Feb 1990.Cinnamomi flos (Zimtblüten): BAnz Nr. 49, 11 Mar 1992.Citri sinensis pericarpium (Orangenschalen): BAnz Nr. 22a, 1 Feb 1990.Cnici benedicta herba (Benediktenkraut): BAnz Nr. 193, 15 Okt 1987.Colae semen (Kolasamen): BAnz Nr.127, 12.07.1991.Colchicum autumnale (Herbstzeitlose): BAnz Nr. 173, 18 Sept 1986.Colocynthidis fructus (Koloquinthen): BAnz Nr. 164, 1 Sept 1990.Condurango cortex (Condurangorinde): BAnz Nr. 193a, 15 Okt 1987 and

BAnz Nr. 50, 13 Mar 1990.Convallariae herba (Maiglöckchenkraut): BAnz Nr. 76, 23 Apr 1987 and

BAnz Nr. 22a, 1 Feb 1990.Coriandri fructus (Koriander): BAnz Nr. 173, 18 Sept 1986.Crataegi flos (Weissdornblüten): BAnz Nr. 133, 19 July 1994.Crataegi folium (Weissdornblätter): BAnz Nr. 133, 19 July 1994.Crataegi folium cum flore (Weissdornblättermit Blüten): BAnz Nr. 133,

19 July 1994.Crataegi fructus (Weissdornfrüchte): BAnz Nr. 133, 19 July 1994.Croci stigma (Safran): BAnz Nr. 76, 23 Apr 1987.Cucurbitae peponis semen (Kürbissamen): BAnz Nr. 223, 30 Nov 1985

and BAnz Nr. 11, 17 Jan 1991 (corrected).Curcumae longae rhizoma (Curcumawurzelstock): BAnz Nr. 223, 30Nov

1985 and BAnz Nr.164, 1 Sept 1990 (corrected).Curcumae xanthorrhizae rhizoma (Javanische Gelbwurz): BAnz Nr. 122,

6 July 1988 and BAnz Nr. 164, 1 Sept 1990 (corrected).Cymbopogon species (Cymbopogon-Arten): BAnz Nr. 22a, 1 Feb 1990.Cynarae folium (Artischockenblätter): BAnz Nr. 122, 6 July 1988 and

BAnz Nr. 164, 1 Sept 1990 (corrected).Cynoglossi herba (Hundszungenkraut): BAnz Nr. 43, 2 Mar 1989.Cytisi scoparii flos (Besenginsterblüten): BAnz Nr. 11, 17 Jan 1991.Cytisi scoparii herba (Besenginsterkraut): BAnz Nr. 11, 17 Jan 1991.Delphinii flos (Ritterspornblüten): BAnz Nr. 80, 27 Apr 1989.Droserae herba (Sonnentaukraut): BAnz Nr. 228, 5 Dec 1984.Dryopteris filix-mas (Wurmfarn): BAnz Nr. 180, 24 Sept 1993.Dulcamarae stipites (Bittersüssstengel): BAnz Nr. 101, 1 June 1990.Echinacea angust./-pallida ((schmalblättr.) Sonnenhut): BAnz Nr. 162,

29 Aug 1992.Echinacea-pallidae-radix (Echinacea-pallida-Wurzel): BAnz Nr. 162,

29 Aug 1992.Echinaceae purpureae herba (Purpursonnenhutkraut): BAnz Nr. 43,

2 Mar 1989.Echinaceae-purpurae-radix (Purpursonnenhutwurzel): BAnz Nr. 162,

29 Aug 1992.Eleutherococci radix (Eleutherococcus-senticosus-Wurzel):BAnzNr. 11,

17 Jan 1991.Ephedrae herba (Ephedrakraut): BAnz Nr. 11, 17 Jan 1991.Equiseti Herba (Schachtelhalmkraut): BAnz Nr. 173, 18 Sept 1986.Eucalypti folium (Eucalyptusblätter): BAnz Nr. 177a, 24 Sept 1986 and

BAnz Nr. 50, 13 Mar 1990 (corrected).

148

References

Euphrasia officinalis (Augentrost): BAnz Nr. 162, 29 Aug 1992.Farfarae flos/-herba/-radix (Huflattichblüten/-kraut/-wurzel): BAnz

Nr. 138, 27 July 1990.Farfarae folium (Huflattichblätter): BAnz Nr. 138, 27 July 1990.Filipendula ulmaria (Maedesüß): BAnz Nr. 43, 2 Mar 1989.Foeniculi fructus (Fenchel): BAnz Nr. 74, 19 Apr 1991.Foenugraeci semen (Bockshornsamen): BAnz Nr. 22a, 1 Feb 1990.Fragariae folium (Erdbeerblätter): BAnz Nr. 22a, 1 Feb 1990.Frangulae cortex (Faulbaumrinde): BAnz Nr. 133, 21 July 1993.Fumariae herba (Erdrauchkraut): BAnz Nr. 173, 18 Sept 1986.Galangae rhizoma (Galgantwurzelstock): BAnz Nr. 173, 18 Sept 1986 and

BAnz Nr. 50, 13 Mar 1990 (corrected).Galegae officinalis herba (Geißrautenkraut): BAnz Nr. 180, 24 Sept 1993.Galeopsidis herba (Hohlzahnkraut): BAnz Nr. 76, 23 Apr 1987.Galii odorati herba (Waldmeisterkraut): BAnz Nr. 193a, 15 Okt 1987.Gelsemii rhizoma (Gelsemiumwurzelstock): BAnz Nr. 178, 21 Sept 1991.Gentianae radix (Enzianwurzel): BAnz Nr. 223, 30 Nov 1985 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Ginkgo folium (Ginkgo-biloba-Blätter): BAnz Nr. 133, 19 July 1994.Ginseng radix (Ginsengwurzel): BAnz Nr. 11, 17 Jan 1991.Graminis flos (Heublumen): BAnz Nr. 85, 5 May 1988.Graminis rhizoma (Queckenwurzelstock): BAnz Nr. 22a, 1 Feb 1990.Grindeliae herba (Grindeliakraut): BAnz Nr. 11, 17 Jan 1991.Guajaci lignum (Guajakholz): BAnz Nr. 76, 23 Apr 1987.Gypsophilae radix (Weisse Seifenwurzel): BAnz Nr. 101, 1 June 1990.Hamamelidis folium et cortex (Hamamelisblätter und -rinde): BAnz

Nr. 154, 21 Aug 1985 and BAnz Nr. 50, 13 Mar 1990 (corrected).Harpagophyti radix (Suedafrikanische Teufelskrallenwurzel): BAnz

Nr. 43, 2 Mar 1989 and BAnz Nr.164, 1 Sept 1990 (corrected).Harunganae madagascariensis cortex et folium (Harongarinde und

-blätter): BAnz Nr. 50, 13 Mar 1986.Hederae helicis folium (Efeublätter): BAnz Nr. 122, 6 July 1988.Helenii radix (Alantwurzel): BAnz Nr. 85, 5 May 1988.Helichrysi flos (Ruhrkrautblüten): BAnz Nr. 122, 6 July 1988 and BAnz

Nr. 164, 1 Sept 1990 (corrected).Hepatici nobilis herba (Leberbluemchenkraut): BAnz Nr. 128, 14 July

1993.Herniariae herba (Bruchkraut): BAnz Nr. 173, 18 Sept 1986.Hibisci flos (Hibiscusblüten): BAnz Nr. 22a, 1 Feb 1990.Hippocastani cortex/-flos (Rosskastanienrinde/-Blüten): BAnz Nr. 221,

25 Nov 1993.Hippocastani folium (Rosskastanienblätter): BAnz Nr. 128, 14.07.1993.Hippocastani semen (Rosskastaniensamen/Trockenextrakt aus R.-

samen [DAB10]): BAnz Nr. 71, 15.04.1994.Hyoscyami folium (Hyoscyamusblätter): BAnz Nr. 85, 5 May 1988.Hyperici herba (Johanniskraut): BAnz Nr. 228, 5 Dec 1984 and BAnz

Nr. 43, 2 Mar 1989 (corrected).Hyssopus officinalis (Ysop): BAnz Nr. 162, 29 Aug 1992.Iridis rhizoma (Schwertlilienwurzelstock): BAnz Nr. 221, 25 Nov 1993.Juglandis folium (Walnussblätter): BAnz Nr. 101, 1 June 1990.Juglandis fructus cortex (Walnussfruchtschalen): BAnz Nr. 101, 1 June

1990.Juniperi fructus (Wacholderbeeren): BAnz Nr. 228, 5 Dec 1984.Lamii albi flos (Weisse Taubnesselblüten): BAnz Nr. 76, 23 Apr 1987.Lamii albi herba (Weisses Taubnesselkraut): BAnz Nr. 128, 14 July 1993.Lavandulae flos (Lavendelblüten): BAnz Nr. 228, 5 Dec 1984 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Ledi palustris herba (Sumpfporstkraut): BAnz Nr. 177a, 24 Sept 1986.Leonuri cardiacae herba (Herzgespannkraut): BAnz Nr. 50, 13 Mar 1986.Levistici radix (Liebstoeckelwurzel): BAnz Nr. 101, 1 June 1990.Lini semen (Leinsamen): BAnz Nr. 228, 5 Dec 1984.Liquiritiae radix (Suessholzwurzel): BAnz Nr. 90, 15 May 1985 and BAnz

Nr. 74, 19 Apr 1991 and BAnz Nr. 50, 13 Mar 1990 and BAnz Nr.178,21 Sept 1991 (corrected).

Lupuli strobulus (Hopfenzapfen): BAnz Nr. 228, 5 Dec 1984 and BAnzNr. 50, 13 Mar 1990 (corrected).

Lycopi herba (Wolfstrappkraut): BAnz Nr. 22a, 1 Feb 1990.Malvae flos (Malvenblüten): BAnz Nr. 43, 2 Mar 1989.Malvae folium (Malvenblätter): BAnz Nr. 43, 2 Mar 1989.Manna: BAnz Nr. 22a, 1 Feb 1990.Marrubii herba (Andornkraut): BAnz Nr. 22a 1 Feb 1990.Mate folium (Mateblätter): BAnz Nr. 85, 5 May 1988.Matricariae flos (Kamillenblüten): BAnz Nr. 228, 5 Dec 1984 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Meliloti herba (Steinkleekraut): BAnz Nr. 50, 13 Mar 1986 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Melissae folium (Melissenblätter): BAnz Nr. 228, 5 Dec 1984 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Menthae piperitae folium (Pfefferminzblätter): BAnz Nr. 223, 30 Nov

1985 and BAnz Nr. 50, 13Mar 1990 and BAnz Nr.164, 1 Sept 1990 (cor-rected).

Menyanthis folium (Bitterkleeblätter): BAnz Nr. 22a, 1 Feb 1990.Myristica fragans (Muskatnussbaum): BAnz Nr. 173, 18 Sept 1986.Myrtilli folium (Heidelbeerblätter): BAnz Nr. 76, 23 Apr 1987.Myrtilli fructus (Heidelbeeren): BAnz Nr. 76, 23 Apr 1987 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Nasturtii herba (Brunnenkressekraut): Banz Nr. 22a, 1 Feb 1990.Oleae folium (Olivenblätter): BAnz Nr. 11, 17 Jan 1991.Oleandri folium (Oleanderblätter): BAnz Nr. 122, 6 July 1988 and BAnz

Nr. 22a, 1 Feb 1990 and BAnz Nr. 43, 2 Mar 1989 (corrected).Ononidis radix (Hauhechelwurzel): BAnz Nr. 76, 23 Apr 1987 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Origanummajorana (Majoran): BAnz Nr. 226, 2 Dec 1992.Orthosiphonis folium (Orthosiphonblätter): BAnz Nr. 50, 13 Mar 1986

and BAnz Nr. 50, 13 Mar 1990 (corrected).Paeonia (Pfingstrose): BAnz Nr. 85, 5 May 1988.Passiflorae herba (Passionsblumenkraut): BAnzNr. 223, 30Nov 1985 and

BAnz Nr. 50, 13 Mar 1990 (corrected).Petasites hybridus/-folium (Pestwurz/-blätter): BAnz Nr. 138, 27 July

1990.Petasitidis rhizoma (Pestwurzwurzelstock): BAnz Nr. 138, 27 July 1990.Petroselini fructus (Petersilienfrüchte): BAnz. Nr. 43, 2 Mar 1989.Petroselini herba/-radix (Petersilienkraut/-wurzel): BAnz. Nr. 43, 2 Mar

1989.Phaseoli fructus sine semine (Samenfreie Gartenbohnenhülsen): BAnz

Nr. 50, 13 Mar 1986 and BAnz Nr. 50, 13 Mar 1990 (corrected).Piceae turiones recentes (Frische Fichtenspitzen): BAnz Nr. 193a, 15 Okt

1987.Pimpinellae herba (Bibernellkraut): BAnz Nr. 101, 1 June 1990.Pimpinellae radix (Bibernellwurzel): BAnz Nr. 101, 1 June 1990.Pini turiones (Kiefernsprossen): BAnz Nr. 173, 18 Sept 1986 and BAnz

Nr. 50, 13 Mar 1990.Piperis methystici rhizoma (Kava-Kava-Wurzelstock): BAnz Nr. 101,

1 June 1990.Plantaginis lanceolatae herba (Spitzwegerichkraut): BAnz. Nr. 223,

30 Nov 1985.Plantaginis ovatae semen (Indische Flohsamen): BAnz Nr. 22a, 1 Feb

1990 and BAnz Nr. 74, 19 Apr 1991 (corrected).Plantaginis ovatae testa (Indische Flohsamenschalen): BAnz Nr. 22a,

1 Feb 1990 and BAnz Nr. 74, 19 Apr 1991 (corrected).Podophylli peltati rhizoma/-resina (Podophyllumwurzelstock/-Harz):

BAnz Nr. 50, 13 Mar 1986.Polygalae radix (Senegawurzel): BAnz Nr. 50, 13 Mar 1986 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Polygoni avicularis herba (Vogelknoeterichkraut): BAnz Nr. 76, 23 Apr

1987 and BAnz Nr. 50, 13 Mar 1990 (corrected).Potentillae anserinae herba (Gänsefingerkraut): BAnz. Nr. 223, 30 Nov

1985 and BAnz Nr. 50, 13 Mar 1990 (corrected).Primulae flos (Schlüsselblumenblüten): BAnz Nr. 122, 6 July 1988 and

BAnz Nr. 50, 13 Mar 1990 (corrected).Primulae radix (Primelwurzel): BAnz Nr. 122, 6 July 1988 and BAnz

Nr. 50, 13 Mar 1990 (corrected).

149

References

Pruni spinosae flos (Schlehdornblüten): BAnz Nr. 101, 1 June 1990.Pruni spinosae fructus (Schlehdornfrüchte): BAnz Nr. 101, 1 June 1990.Psyllii semen (Flohsamen): BAnz Nr. 223, 30 Nov 1985 and BAnz Nr. 50,

13 Mar 1990 (corrected).Ptychopetali lignum (Potenzholz): BAnz Nr. 193a, 15 Okt 1987.Pulmonariae herba (Lungenkraut): BAnz Nr. 193a, 15 Okt 1987.Pulsatillae herba (Küchenschellenkraut): BAnz Nr. 223, 30 Nov 1985.Quercus cortex (Eichenrinde): BAnz Nr. 22a, 1 Feb 1990.Raphani sativi radix (Rettich): BAnz Nr. 177a, 24 Sept 1986.Ratanhiae radix (Ratanhiawurzel): BAnz Nr. 43, 2 Mar 1989.Rauwolfiae radix (Rauwolfiawurzel): BAnz Nr. 173, 18 Sept 1986.Rhamni cathartici fructus (Kreuzdornbeeren):BAnzNr. 221, 25Nov1993.Rhamni purshianae cortex (Amer.Faulbaumrinde): BAnz Nr. 133, 21 July

1993.Rhei radix (Rhabarberwurzel): BAnz Nr. 133, 21 July 1993.Rhododendri ferruginei folium (Rostrote Alpenrosenblätter): BAnz

Nr. 164, 1 Sept 1990.Rhoeados flos (Klatschmohnblüten): BAnz Nr. 85, 5 May 1988.Rosae flos (Rosenblüten): BAnz Nr. 164, 1 Sept 1990.Rosae pseudofructus cum fructibus (Hagebutten): BAnz Nr. 164, 1 Sept

1990.Rosmarini folium (Rosmarinblätter): BAnz Nr.223, 30 Nov 1985 and

BAnz Nr.221, 28 Nov 1986 and BAnz Nr. 50, 13 Mar 1990.Rubiae tinctorum radix (Krappwurzel): BAnz Nr. 162, 29 Aug 1992.Rubi fruticosi folium (Brombeerblätter): BAnz Nr. 22a, 1 Feb 1990.Rubi fruticosi radix (Brombeerwurzel): BAnz Nr. 22a, 1 Feb 1990.Rubi idaei folium (Himbeerblätter): BAnz Nr. 193a, 15 Okt 1987.Rusci aculeati rhizoma (Mäusedornwurzelstock): BAnz Nr. 127, 12 July

1991.Ruta graveolens (Raute): BAnz Nr. 43, 2 Mar 1989.Sabal fructus (Sägepalmenfrüchte): BAnz Nr. 43, 2 Mar 1989 and BAnz

Nr. 22a, 1 Feb 1990 and BAnz Nr. 11, 17.01.1991 (corrected).Salicis cortex (Weidenrinde): BAnz. Nr. 228, 5 Dec 1984.Salviae folium (Salbeiblätter): BAnz Nr. 90, 15May 1985 and BAnz Nr. 50,

13 Mar 1990 (corrected).Sambuci flos (Holunderblüten): BAnz Nr. 50, 13 Mar 1986.Saniculae herba (Sanikelkraut): BAnz Nr. 177a, 24 Sept 1986 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Santali albi lignum (Weisses Sandelholz): BAnz Nr. 43, 2 Mar 1989.Santali lignum rubrum (Rotes Sandelholz): BAnz Nr. 193a, 15 Okt 1987.Saponariae rubrae radix (Rote Seifenwurzel): BAnz Nr. 80, 27 Apr 1989.Sarsaparillae radix (Sarsaparillewurzel): BAnz Nr. 164, 1 Sept 1990.Scillae bulbus (Meerzwiebel):BAnzNr. 154, 21Aug 1985 andBAnzNr. 43,

2 Mar 1989 (corrected).Scopoliae rhizoma (Glockenbilsenkrautwurzelstock): BAnz Nr. 177a,

24 Sept 1986.Senecionis herba (Fuchskreuzkraut): BAnz Nr. 138, 27 July 1990.Sennae folium (Sennesblätter): BAnz Nr. 133, 21 July 1993.Sennae fructus (Sennesfrüchte): BAnz. Nr. 133, 21 July 1993.Serpylli herba (Quendelkraut): BAnz Nr. 193a, 15 Okt 1987 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Sinapis albae semen (Weisse Senfsamen): BAnz Nr. 22a, 1 Feb 1990.Solidago (Goldrute): BAnz Nr. 193a, 15 Okt 1987 and BAnz Nr. 50, 13Mar

1990 (corrected).Sorbi aucupariae fructus (Ebereschenbeeren): BAnz Nr. 122, 6 July 1988.Spinaciae folium (Spinatblätter): BAnz Nr. 85, 5 May 1988.Stramonii folium/-semen (Stramoniumblätter/-samen): BAnz Nr. 22a,

1 Feb 1990.Strychni semen (Brechnussamen): BAnz Nr. 173, 18 Sept 1986.Symphyti radix (Beinwellwurzel): BAnz Nr. 138, 27 July 1990.Syzygii cumini cortex (Syzygiumrinde): BAnz Nr. 76, 23 Apr 1987.Syzygii cumini semen (Syzygiumsamen): BAnz Nr. 76, 23 Apr 1987.Taraxaci herba (Löwenzahnkraut): BAnz Nr. 162, 29 Aug 1992.

Taraxaci radix cum herba (Löwenzahnwurzel mit -kraut): BAnz Nr. 228,5 Dec 1984 and BAnz Nr.164, 1 Sept 1990 (corrected).

Thymi herba (Thymiankraut): BAnz Nr. 228, 5 Dec 1984 and BAnzNr. 226, 2 Dec 1992 and BAnz Nr. 50, 13 Mar 1990 (corrected).

Tiliae flos (Lindenbüten): BAnz Nr. 164, 1 Sept 1990.Tiliae folium (Lindenbätter): BAnz Nr. 164, 1 Sept 1990.Tiliae tomentosae flos (Silberlindenbüten): BAnz Nr. 164, 1 Sept 1990.Tormentillae rhizoma (Tormentillwurzelstock): BAnz Nr. 85, 5May 1988

and BAnz Nr. 50, 13 Mar 1990 (corrected).Turnera diffusa (Damiana): BAnz Nr. 43, 2 Mar 1989.Urticae herba/-folium (Brennesselkraut/-blätter): BAnz Nr. 76, 23 Apr

1987.Urticae radix (Brennesselwurzel): BAnz Nr. 173, 18 Sept 1986 and BAnz

Nr. 11, 17 Jan1991andBAnzNr.43, 2Mar 1989 andBAnzNr.50, 13Mar1990 (Correcteden).

Uvae ursi folium (Bärentraubenblätter): BAnz Nr. 109, 15 June 1994.Uzarae radix (Uzarawurzel): BAnz Nr. 164, 1 Sept 1990.Valerianae radix (Baldrianwurzel): BAnz Nr. 90, 15 May 1985 and BAnz

Nr. 50, 13 Mar 1990 (corrected).Verbasci flos (Wollblumen): BAnz Nr. 22a, 1 Feb 1990.Veronicae herba (Ehrenpreiskraut): BAnz Nr. 43, 2 Mar 1989.Vincae minoris herba (Immergrünkraut): BAnz Nr. 173, 18 Sept 1986.Viola odorata (Märzveilchen): BAnz Nr. 111, 17 June 1994.Violae odoratae flos (Maerzveilchenblüten): BAnz Nr. 111, 17 June 1994.Violae tricoloris herba (Stiefmütterchenkraut):BAnzNr. 50, 13Mar 1986.Visci albi fructus (Mistelbeeren): BAnz Nr. 128, 14 July 1993.Visci albi herba (Mistelkraut): BAnz Nr. 228, 5 Dec 1984.Yohimbehe cortex (Yohimbeherinde): BAnz Nr. 193a, 15 Okt 1987 and

BAnz Nr. 22a, 1 Feb 1990 (corrected).Zedoariae rhizoma (Zitwerwurzelstock): BAnz Nr. 122, 6 July 1988.Zingiberis rhizoma (Ingwerwurzelstock): BAnz Nr. 85, 5 May 1988 and

BAnz Nr.164, 1 Sept 1990 and BAnz Nr. 50, 13 Mar 1990 (corrected).

ESCOPMonographs

ESCOP (2003). ESCOP Monographs, The Scientific Foundation forHerbal Medicinal Products (2nd ed.). Stuttgart: Georg Thieme.

ESCOP (2009). ESCOP Monographs (2nd ed.). Supplement 2009, GeorgThieme Verlag KG Stuttgart.

WHOMonographs

WHO;WHOmonographs on selectedmedicinal plants: Volume1 (1999).WHO;WHOmonographs on selectedmedicinal plants: Volume2 (2002).WHO;WHOmonographs on selectedmedicinal plants: Volume3 (2007).WHO;WHOmonographs on selectedmedicinal plants: Volume4 (2009).WHO; WHO monographs on medicinal plants commonly used in the

Newly Independent States (NIS) (2010).

HMPCMonographs

European Medicines Agency (EMA), http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp&mid=WC0b01ac058001fa1d.

150

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp&mid=WC0b01ac058001fa1d



References

Community list pursuant to Article 16f of Directive2001/83/EC of the European Parliament and of theCouncil of 6 November 2001 on the Community coderelating to medicinal products for human use

European Medicines Agency (EMA), http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm.

Lists of other member states

Belgium: Arreté Royal du 29 Aout 1997 relatif à la fabrication et au com-merce de denrées alimentaires composées ou contenant des plantesou préparations de plantes.

Belgium: Federale Overheidsdienst Volksgezondheid, Veiligheid vande Voedselketen en Leefmilieu: Indicative list of plants/plant parts/substances and their novel food status (non-exhaustive list), http://www.health.fgov.be/eportal/foodsafety/foodstuffs/novelfoods/index.htm#.UmAJPKxqfU4.

Denmark: Drogelisten Vurdering af planter, svampe og dele heraf an-vendt i kosttilskud og urtete.

Ireland: Herbal Substances which may be acceptable for inclusion infood supplements, IMB Draft Guideline – Version 5.1 20/04/2011.

Ireland: Herbal Substances not permitted in foods or food supplements,IMB Draft Guideline – Version 5.1, 20/4/2011.

Italy: Ministerio Della Salute Decreto 9 luglio 2012 Disciplinadell’impiego negli integratori alimentari di sostanze e preparativegetali (G.U. 21-7-2012 serie generale n. 169).

Italy: MinisterioDella SaluteEstratti Vegetali NonAmessi Negli Integra-tori Alimentari.

Netherlands: NieuweVoedsel enWarenAutoriteit,Ministerievan Land-bouw,Natuur enWoedselkwaliteit (2010). Warenwetbesluit Kruiden-preparaten.

Austria: Federal Ministry of Health: Austrian Food Code, IVth ed., Sec-tion B31, Tea and tea-like products.

Austria: Federal Ministry of Health: Plants and plant parts recom-mended for use without dose restrictions.

Austria: Federal Ministry of Health: Plants and plant parts not recom-mended for use.

Sweden: Livesmedelsverket: Förteckning över växter och växtdelar somär olämpliga i livsmedel (VOLM), latest update May 2010.

Slovakia: Výnos Ministerstva pôdohospodárstva Slovenskej republikya Ministerstva zdravotníctva Slovenskej republiky zo 6. apríla 2005č. 2089/2005-100, ktorým sa vydáva hlava Potravinového kódexuSlovenskej republiky upravujúca pochutiny.

United Kingdom: Medicines and Healthcare Products RegulatoryAgency (MHRA): Prohibited or restricted herbal ingredients,http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/Prohibitedorrestrictedherbalingredients/index.htm.

United Kingdom: Medicines and Healthcare Products RegulatoryAgency (MHRA): List of herbal ingredients and their reporteduses, http://www.mhra.gov.uk/home/groups/is-pol/documents/websiteresources/con009277.pdf.

151

http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

http://www.health.fgov.be/eportal/foodsafety/foodstuffs/novelfoods/index.htm#.UmAJPKxqfU4



http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/Prohibitedorrestrictedherbalingredients/index.htm

http://www.mhra.gov.uk/home/groups/is-pol/documents/websiteresources/con009277.pdf

http://www.mhra.gov.uk/home/groups/is-pol/documents/websiteresources/con009277.pdf

9 7 8 3 3 1 9 1 0 7 3 1 8

ISBN 978-3-319-10731-8

BVL-Report · 8.8

List of Substances of the Competent Federal Government and Federal State AuthoritiesCategory “Plants and plant parts”

List of Substances of the Competent Federal Government and Federal State Authorities

Plants and plant preparations are an important part of a balanced diet. Apart from using them as fruit, vegetables or cereals we can also enjoy them as ingredients in the form of herbs or spices or enjoy them in teas. More and more exotic plants are also available whose use as food in Germany was not known up to now.

Supermarkets and drugstores also sell an increasing number of products which supposedly benefi t health and contain preparations which were previously used in Germany above all in pharmaceutical products.

The present category “Plants and plant parts” of the List of Substances of the Competent Federal Government and Federal State Authorities was provided to facilitate the classifi cation and evaluation of plants and plant parts regarding their use as food or food ingredients. In addition to classifi cation under formal legal aspects the list also provides information on the possible risks involved with certain uses. The list of substances is intended as a guideline for authorities and those placing products on the market.

List of Substances of the Competent Federal Government and ...

Documents

Transcript of List of Substances of the Competent Federal Government and ...