Stoffliste Pflanzen Pflanzenteile En-20

BVL-Report · 8.
List of Substances of the Competent Federal

Government and Federal State Authorities
Category “Plants and plant parts”
List of Substances of the Competent Federal Government
and Federal State Authorities
List of Substances
of the Competent Federal
Government and
Federal State Authorities
BVL-Reporte
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ISBN 978-3-319-10731-8
ISBN 978-3-319-10732-5 (eBook)
DOI 10.1007/978-3-319-10732-5
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Contents
1 Explanatory notes on the List of Substances

of the Competent Federal Government and Federal State Authorities –
Category “Plants and plant parts” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Legal framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Instruction on how to use the List of Substances . . . . . . . . . . . . . . . . . 2
2 Decision tree: Explanatory notes on the classification of substances

in the List of Substances of the Competent Federal Government
and Federal State Authorities – Category “Plants and plant parts” . . . . . . . . 5
2.1 Classification in the lists A, B and C . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Decision tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3 List of Substances of the Competent Federal Government

and Federal State Authorities – Category “Plants and plant parts” . . . . . . . . 9
Legal basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
v
Explanatory notes on the List of Substances
of the Competent Federal Government 1
and Federal State Authorities –
1.1 Introduction visions of the Regulation (EC) No. 1334/2008 on flavour-

ings and certain food ingredients with flavouring proper-
The Lists of Substances of the Competent Federal Gov- ties for use in and on foods2 .
ernment and Federal State Authorities (lists of substances) Foods or food ingredients which have not been used
are created to facilitate the classification and assessment for human consumption to a significant degree in the EU
of substances regarding their use as food or food ingredi- before 15 May 1997 are governed by the provisions of the
ent. They are designed to serve as a reference guide for Regulation (EC) No. 258/97 on novel foods and novel food
authorities and food distributors. The final assessment ingredients (Novel Food Regulation)3 , if they fall into one
of products containing these substances or preparations of the following categories:
thereof must always be made on a case-by-case basis, giv- Foods and food ingredients with a new or intentionally
ing due regard to all criteria relevant to that assessment. modified primary molecular structure,
Lists of Substances of the Competent Federal Govern- Foods and food ingredients consisting of or isolated
ment and Federal State Authorities are to be created for from micro-organisms, fungi or algae,
various categories. To provide a uniform system for the Foods and food ingredients consisting of or isolated
lists of substances, the entries in the categories are re- from plants and food ingredients isolated from ani-
ferred to as “substances”, although they may not always mals, except for foods and food ingredients obtained
be chemically defined individual substances. A more de- by traditional propagating or breeding practices and
tailed definition may be provided in addition to the cate- having a history of safe food use
gories. Foods and food ingredients to which has been applied
The lists of substances do not claim to be complete and a production process not currently used, where that
do not exempt the food business operator from the re- process gives rise to significant changes in the com-
sponsibility to ensure that the relevant product is safe and position or structure of the foods or food ingredients
legally marketed as a food in Germany. They are subject which affect their nutritional value, metabolism or
to updating in order to take account of new scientific find- level of undesirable substances.
ings as well as developments in the food industry. Flavourings for use in foods do not fall within the scope
of the Novel Food Regulation. However, if relevant sub-
stances are used for purposes other than flavouring, they
1.2 Legal framework may need to be classified as novel within the meaning of
the Novel Food Regulation.
Article 2 of the Regulation (EC) No. 178/2002 (General Article 2 (d) of the General Food Law Regulation stipu-
Food Law Regulation)1 specifies “food” as any substance lates that food does not include medicinal products. The
or product, whether processed, partially processed or un- definition of a medicinal product is laid down in Section 2
processed, intended to be, or reasonably expected to be
ingested by humans. 2
Regulation (EC) No. 1334/2008 of the European Parliament and of the
Substances used as source materials for flavourings or Council of 16 December 2008 on flavourings and certain food ingredi-
foods with flavouring properties are governed by the pro- ents with flavouring properties for use in and on foods and amending
Council Regulation (EEC) No. 1601/91, Regulations (EC) No. 2232/96 and
1
Regulation (EC) No. 178/2002 of the European Parliament and of the (EC) No. 110/2008 and Directive 2000/13/EC
3
Council of 28 January 2002 laying down the general principles and Regulation (EC) No. 258/97 of the European Parliament and of the
requirements of food law, establishing the European Food Safety Au- Council of 27 January 1997 concerning novel foods and novel food in-
thority and laying down procedures in matters of food safety gredients
List of Substances of the Competent Federal Government and Federal State Authorities, DOI 10.1007/978-3-319-10732-5_1, 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 Medicinal F: Known exclusively for use as a food ingredient
Products (Medicinal Products Act – The Drug Law, AMG)4 , with flavouring properties or as a source material
with which the European definition of medicinal prod- for flavourings
ucts was enacted into national law in accordance with S: Known for use as a spice
Article 1 of the Directive 2001/83/EC (Medicinal Products C: Known for use as a colouring agent
Directive)5 . T: Known for use as a tea
Article 2 (g) of the General Food Law Regulation stip- Such limitations are generally not documented by
ulates that food also does not include narcotic and psy- placing a substance on List B. In exceptional cases, a sub-
chotropic substances. According to the General Food Law stance is also placed on List B if it is associated with effects
Regulation, this is laid down in the United Nations Single that necessitate a restriction of its use.
Convention on Narcotic Drugs of 19616 as well as in the Classification is made under the assumption that the
United Nations Convention on Psychotropic Substances relevant substance is used as documented in the list. Any
of 19717 . Additionally, the Narcotic Drugs Act (BtMG) ap- other use, e.g. in higher doses, can lead to effects that may
plies in German law8 . require a different classification.
3. Substances that should be treated before consump-
tion (e.g. heated) are designated by the letter “b” in the
1.3 Instruction on how to use the “Food (F)” column.
List of Substances 4. When classifying a substance as a novel food/novel
food ingredient (NF) within the meaning of the Novel
“Substances” within the meaning of this category are Food Regulation or as not novel in food supplements
plants and plant parts. The substances are viewed and (Not NFS), the Novel Food Catalogue of the Euro-
categorised as such. Preparations of substances, such as pean Commission9 was taken into account. However,
extracts or isolates, may differ from the actual substances it should be noted that this catalogue does not have
regarding their composition, especially in terms of their any entries for a large number of substances from the
nutritional and toxicological properties. In each individ- List of Substances in the category “plants and plant
ual case, it therefore needs to be determined whether the parts”. Any other available information regarding use
classification of a substance can be applied to a prepara- for human consumption to a significant degree before
tion thereof. The classification is made on the basis of 15 May 1997 was also taken into account.
a decision tree developed for this category (see Chap. 2). 5. If any restrictions of use as a food or food ingredi-
To understand the List of Substances in the category of ent are recommended for a substance (List B) due to
“plants and plant parts”, the following should additionally evidence of a pharmacological effect (No. 4 in the ex-
be noted: planatory notes on the decision tree), such a restriction
1. The sub lists have the following meanings: always refers to the substance described in that evi-
List A: Substances not recommended for use in dence (e.g. dried plant or dried plant part). Evidence
foods of a pharmacological effect that leads to a classifica-
List B: Substances for which restricted use in foods tion as a medicinal product in accordance with Sec-
is recommended tion 2 Clause 1 No. 2a AMG included court-approved
List C: Substances which cannot yet be completely sources such as monographs, marketing authorisa-
assessed due to lack of sufficient data tions or classifications of competent authorities. Other
2. If substances are usually used in foods only to a very evidence (e.g. results of clinical studies) may addition-
limited extent, for example as spices or as ingredients ally be relevant to the classification of a substance as
in the production of spirits, they are designated by the a medicinal product.
following abbreviations in the “Food (F)” column: 6. Substances for which a pharmacological effect or ef-
ficacy as a medicinal product is plausible based on
use and experience over many years (“traditional ev-
4
Law governing the Trade of Medicinal Products (Medicinal Products idence”) in accordance with Sections 39a ff. of the
Act – AMG) Medicinal Products Act will not be placed on List B
5
Directive 2001/83/EC of the European Parliament and of the Council
of 6 November 2001 on the Community code relating to medicinal prod- based on that traditional evidence alone. For a sub-
ucts for human use stance to be placed on List B, pharmacological effects,
6
Single Convention on Narcotic Drugs of 30 March 1961
7
Law approving the Convention on Psychotropic Substances of
21 February 1971
8 9
Law governing the Trade of Narcotic Drugs (Narcotic Drugs Act – http://ec.europa.eu/food/food/biotechnology/novelfood/novel_
BtMG) food_catalogue_en.htm
2
1.3 Instruction on how to use the List of Substances
as specified above in item 5, or risks must be reported Substances which, according to monographs, are in-
due to which restricted use in foods is recommended. tended for external use only are not designated as
7. The classification of substances into this list is made medicinal products in the List of Substances.
only on the basis of their effect after oral ingestion.
3
Decision tree: Explanatory notes on the classification
of substances in the List of Substances 2
of the Competent Federal Government
and Federal State Authorities –
The decision tree serves as the basis for the classification over many years in accordance with Sections 39a ff. of
of substances in the category of “plants and plant parts” as the Medicinal Products Act (AMG). At present, process-
“food (F)”, “medicinal product (MP)” and/or “novel food/ ing monographs for plants/plant parts that can be con-
novel food ingredient (NF)” as well as possible combina- tained in traditional medicinal products are being cre-
tions thereof (ambivalent substances). It also provides ated or revised by the European Medicines Agency (EMA).
instructions for the classification of the substances in the Where these monographs have been adopted and pub-
Lists A, B and C. lished, they are taken into account accordingly. Some of
Classification as a medicinal product – except for am- the plants/plant parts used therein have also long since
bivalent substances (see No. 3 below) – is made based on been used in food. A restriction (List B) was not recom-
the definition of medicinal products by function set out mended in individual cases where it would have been
in Section 2 Clause 1 No. 2a of the Medicinal Products Act done exclusively on the basis of traditional evidence of
(AMG). These are characterised by their pharmacological, pharmacological effect. Despite such evidence of phar-
metabolic or immunological effect. For the sake of clarity, macological effect, classification as ambivalent substance
the term “pharmacological effect” is used in the decision (F/MP) without any restrictions is therefore made in this
tree for this definition. Classification as a medicinal prod- case only.
uct by presentation as defined in Section 2 Clause 2 No. 1
AMG is not taken into account. No. 4: Food C medicinal product C List B
Based on the answers to the questions in the decision (Decision tree III/IV – via question 5)
tree, plants and plant parts are classified as follows: Common foods that are also used as medicinal products.
Pharmacological effects are reported above a certain dose.
No. 1: Food If no significant pharmacological effects are identified, the
(Decision tree I – via question 3) substance can be classified as food. When reaching the
Common foods without any known use as medicinal pharmacologically effective dose, it is defined as a medic-
products. Based on their previous use, any restrictions of inal product by function. This is expressed by placing the
use are not required. substance on List B.
No. 2: Food C List B No. 5: Novel food

(Decision tree III – via question 3) (Decision tree VIII – via question 9)
Common foods without any known use as medicinal The substance is not known to be used as either food or
products. a medicinal product. The substance is also not known to
Dose restrictions and restrictions of use are required be associated with any risks that would restrict its use in
due to risks posed by the constituents of the plant or plant food. The further assessment takes place in accordance
part. Such restrictions are expressed by placing the sub- with the Novel Food Regulation.
stance on List B.
No. 6: Novel food C medicinal product
No. 3: Food C traditional medicinal product (Decision tree IV/V – via question 8)
(Decision tree II – via question 5) The substance has so far been known as a medicinal prod-
For traditional herbal medicinal products, a pharmaco- uct only. However, it is not associated with any risks that
logical effect is plausible based on use and experience would 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 with 2.1 Classification in the lists A, B and C
the Novel Food Regulation.
Medicinal products and novel foods are distinguished List A
on the basis of the pharmacologically effective dose (by Substances that are not recommended for use as food or
analogy with No. 4). The substance cannot be placed on food ingredient due to known risks (No. 10) are placed on
List B as it is no common food. List A. These substances may be or may have been used as
medicinal products (No. 9).
No. 7: Novel food (Not NFS) C List C
(Decision tree VIII – via question 9) List B
A number of substances are classified as not novel ex- Substances that are only used in food and for which a dose
clusively when used in food supplements. When used in restriction is required due to certain constituents (No. 2)
foods other than food supplements, these substances are are placed on List B.
usually placed on List C, since no sufficient information is Furthermore, substances that are known as both foods
available for their conclusive assessment. and medicinal products with a pharmacological effect
demonstrated on the basis of clinical data are placed on
No. 8: Novel food (Not NFS) C List B C medicinal this list. This is also done by strict application of the de-
product cision tree in respect of basic foods in usual amounts of
(Decision tree IV/V – via question 8) intake (No. 4).
The substance is known as a medicinal product. It is addi- Finally, substances that are used as food exclusively in
tionally used in food supplements and is classified as not food supplements (but are otherwise novel foods) and are
novel in this case only. The necessary restriction of use in known as medicinal products with a demonstrable phar-
FS due to the pharmacological effect is expressed by plac- macological effect are placed on list B (No. 8).
ing the substance on List B. Substances that are known as both foods and medicinal
products with exclusively traditional evidence of phar-
No. 9: Medicinal product C List A macological effect (No. 3) are not placed on List B.
(Decision tree VI – via question 7)
The substance has so far been known as a medicinal prod- List C
uct only. Due to the associated risks, its use in food is not Substances that have so far been used exclusively in food
recommended, irrespective of the dose. supplements but are otherwise novel foods are placed on
list C (No. 7).
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.
6
2.2
Decision tree
2.2 Decision tree
Figure 1 Decision tree

* Assessment of potential use as food/food ingredient according to the Novel Food Regulation (If the substance is classified as not novel in food supplements [Not NFS], it may need
to be placed on List B.)
** Assessment of potential use as food/food ingredient according to the Novel Food Regulation (If the substance is classified as not novel in food supplements [Not NFS], it may need
to be placed on List C.)
*** See No. 3 of the explanatory notes
Abbreviations: F D food, MP D medicinal product, trad. MP D traditional medicinal product, NF D novel food/novel food ingredient, FS D food supplement
7
Government and Federal State Authorities – 3
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 Plant part F NF MP trad. MP List A List B List C

(Latin)
Abies spp. Shoot (tip) T
Achillea millefolium L. Herb, flower S, T
Aconitum napellus L. all plant parts
Acorus calamus L., syn. Acorus Rhizome F

aromaticus GARZ., Oronthium
cochinchinensis LOUR.
Actinidia deliciosa (CHEV.) Fruit

A.R. FERG.
Adonis vernalis L., syn. Adonanthe Herb
vernalis SPACH
Aegopodium podagraria L., syn. Leaf

Aegopodium angelicaefolium
ST. LAGER, Aegopodium latifolium
TURCZ.
Aesculus hippocastanum L., syn. Leaf, flower Not NFS
Aesculus castanea GILIB., Aesculus
procera SALISB., Hippocastanum
vulgare GAERTNER
Aesculus hippocastanum L., syn. Bark Not NFS
vulgare GAERTNER
10
Remarks Risks Critical plant Pharmacologically effective

substances dose
Positive monograph, indications: loss of Contraindications: hypersensitivity Proazulenes, Commission E: 4 g drug/day,

appetite, digestive problems such as mild gas- to yarrow or other Asteraceae species azulenes, equivalent preparations
trointestinal cramps, standard marketing (Commission E monograph) monoterpenes ESCOP: 2–4 g drug/3–4 times
authorisation: 1249.99.99, ESCOP mono- (e.g. camphor, a day, equivalent preparations,
graph: loss of appetite, dyspeptic disorders eucalyptol [D1,8- administration to children aged
such as mild spasmodic complaints in the ab- cineol]) between 3 and 12 only under
dominal region, WHO monograph: loss of medical supervision
appetite, common cold, dyspeptic ailments WHO: 4.5 g drug/day or 3 g
such as mild spastic discomfort of the gas- flower tea/day
trointestinal tract, as a choleretic and for the
treatment of fevers, HMPC monograph: tradi-
tional use
Negative monograph: due to risks, use in Aconitine is a strong nerve and muscle Alkaloids
MP only in homeopathic doses, monks- poison, numbness, paraesthesia, paral- (e.g. aconitine)
hood (Aconitum napellus), extremely toxic Ia ysis (Wink/Wyk), cardiac arrhythmia,
(Wink/Wyk), extremely toxic +++ (Roth/ sensitivity to cold, nausea, cramps,
Daunderer) paralysis of tongue, facial and extrem-
ity muscles, circulatory failure (Roth/
Daunderer)
Risks reported (in dependence on the vari- Risks reported for tetraploid variants Beta-asarone
ant used), use of tetraploid subspecies as e.g. A. calamus var. angustatus BESS.
source material for flavourings and foods with because of their high beta-asarone
flavouring properties prohibited by Reg. (EC) content. Beta-asarone demonstrated
No. 1334/2008, maximum amount of beta- a mutagenic and carcinogenic ef-
asarone in alcoholic beverages: 1 mg/kg, li- fect in animal experiments (Hager,
censed anthroposophic medicinal product acc. Frohne/Pfänder); diploid subspecies
to Section 21 AMG, toxic + (Roth/Daunderer), e.g. A. calamus L. var. americanus
mildly toxic II to toxic III (Wink/Wyk) (RAF.) WULFF. are free from beta-
asarone
Positive monograph, indications: slightly Nausea, vomiting, cardiac arrhythmia, cardioactive gly- Commission E: 0.6–3 g standard-
reduced cardiac output, especially when contraindications and interactions cosides (some ised Adonis powder (DAB 9)/day,
accompanied by nervous symptoms, very reported (Commission E monograph), prescription-only) equivalent preparations
toxic Ib (Wink/Wyk), highly toxic ++ (Roth/ cardiac arrest, symptoms of cardiac
Daunderer) glycoside poisoning, diuresis, digestive
tract irritation (Wink/Wyk)
Neutral monograph
Neutral monograph, HMPC monograph:

traditional use
11

(Latin)
Aesculus hippocastanum L., syn. Seed Not NFS
vulgare GAERTNER
Agrimonia eupatoria L., syn. Herb T

Agrimonia adherens GILIB., Agri-
monia officinalis LAM., Agrimonia
parviflora SPRENG., Amonia ag-
rimonoides STEUD., Aremonia
agrimonoides D.C.
Agrimonia procera WALLR., Herb T

syn. Agrimonia odorata auct.
non MILLER, Agrimonia odorata
WALLR.
Agropyron repens (L.) P. BEAUV., Root T
syn. Elymus repens (L.) GOULD,
Elytrigia repens DESV. ex NEVSKI,
Triticum repens L.
Alchemilla alpina L. em. BUSER Herb

Alchemilla vulgaris auct., Al- Herb T
chemilla vulgaris L.
Alkanna tuberculata (FORSSK.) Root
MEIKLE, syn. Alkanna tinctoria
(L.) TAUSCH, Alkanna tuberculata
GREUTER, Lithospermum tincto-
rium L.
Allium cepa L., syn. Allium escu- Bulb

lentum SALISB., Cepa esculenta
S.F. GRAY, Cepa vulgaris RENAULT,
Kepa esculenta RAFIN., Porrum
cepa RCHB.
12

substances dose
Positive monograph, indications: symp- Nausea, gastrointestinal complaints, Saponins Commission E: 100 mg aescin/
tomatic treatment of diseases of crural veins hot flushes, oedemas, vomiting, day, equivalent to 250–312.5 mg
(chronic venous insufficiency), e.g. pain and diarrhoea, hypertension, loss of con- extract in delayed release form
feeling of heaviness in legs, night leg cramps, sciousness, circulatory collapse (Wink/ 2 times a day
itching and swollen legs, WHO monograph: Wyk, Roth/Daunderer) ESCOP: equivalent to 50–150 mg
treatment of symptoms of chronic venous triterpene glycosides (calculated
insufficiency, including pain, feeling of heavi- as aescin), no administration to
ness in the legs, nocturnal calf-muscle spasms, children
itching and oedema, ESCOP monograph: WHO: 250–312.5 mg stan-
chronic venous insufficiency, varicosis, HMPC dardised comminuted extract,
monograph: treatment of chronic venous in- equivalent to 100 mg aescin
sufficiency, which is characterised by swollen
legs, varicose veins, a feeling of heaviness,
pain, tiredness, itching, tension and cramps
in the calves, traditional use, slightly toxic +
(Roth/Daunderer), mildly toxic III (Wink/
Wyk)
Positive monograph, indications: mild, non- Commission E: 3–6 g drug/day,
specific, acute forms of diarrhoea, inflam- equivalent preparations
mations of oral and pharyngeal mucosa, ESCOP: 3–12 g drug, 3 times
ESCOP monograph: Agrimony has widely a day, children!
documented uses as a remedy to treat mild
diarrhoea, HMPC monograph: in progress,
standard marketing authorisation: 2379.99.99

specific, acute forms of diarrhoea, inflam- equivalent preparations
mations of the oral and pharyngeal mucosa,
HMPC monograph: in progress
Positive monograph, indications: increase Contraindications: irrigation therapy Commission E: 6–9 g drug/day,
of urinary output for catarrhs of the lower of oedemas associated with cardiac equivalent preparations
urinary tract, adjuvant treatment of catar- or renal insufficiency (Commission E ESCOP: 5–10 g drug/day, no
rhs of the upper respiratory tract, standard monograph) administration to children under
marketing authorisation: 1169.99.99, con- the age of 12
traindications reported, ESCOP monograph:
irritable bladder and other urinary tract disor-
ders, HMPC monograph: traditional use
Neutral monograph
specific forms of diarrhoea equivalent preparations
Substance of concern (AMK – Drug Commis- Pyrrolizidine alkaloids contained in Pyrrolizidine
sion of German Pharmacists), BfArM [Federal the drug are mutagenic, carcinogenic, alkaloids
Institute for Drugs and Medical Devices] ingestion of high doses causes di-
graduated plan of 5 June 1992 concerning gestive problems and CNS disorders
medicinal products containing pyrrolizidine (Wink/Wyk)
alkaloids, toxic II (Wink/Wyk), toxic + (Roth/
Daunderer)
Positive monograph, indications: loss of ap- Ingestion of higher doses, especially in Allicin, allyl sul- Commission E: 50 g fresh onions
petite, prevention of age-dependent vascular children, causes digestive tract irrita- phide or 20 g dried drug, equivalent
changes, WHO monograph: the principal use tion accompanied by vomiting, nausea, preparations
of Bulbus Allii Cepae today is to prevent age- colic and diarrhoea (Wink/Wyk) WHO: 20 g drug/day, equivalent
dependent changes in the blood vessels, and preparations
loss of appetite, non-toxic but irritating to
skin (Roth/Daunderer), mildly toxic III (Wink/
Wyk), HMPC assessment report
13

(Latin)
Allium porrum L., syn. Allium Leaf
ampeloprasum ß. porrum GAY,
Allium laetum SALISB.
Allium sativum L., syn. Porrum Bulb
sativum RCHB.
Allium ursinum L., syn. Allium Herb S

latifolium GILIB., Allium nemorale
SALISB.
Aloe barbadensis MILL., Aloe chi- Leaf gel

nensis BAK.
Aloe barbadensis MILL., Aloe chi- Leaf juice

nensis BAK.
14

substances dose
Positive monograph, indications: adjuvant Higher doses may have a toxic effect Alliin, allicin, allyl Commission E: 4 g fresh garlic/
treatment of increased blood lipid concen- (especially in children), digestive tract sulphide day, equivalent preparations
trations, prevention of age-related vascular irritation accompanied by vomiting, ESCOP: 0.5–1 g drug/day
changes, WHO monograph: as an adjuvant excessive sweating, nausea, colic and WHO: 0.4–1.2 g powder or 2–5 g
to dietetic management in the treatment diarrhoea (Wink/Wyk) fresh garlic/day
of hyperlipidaemia, and in the prevention
of atherosclerotic (age-dependent) vascu-
lar changes. The drug may be useful in the
treatment of mild hypertension, ESCOP
monograph: prophylaxis of atherosclero-
sis, treatment of elevated blood lipid levels
insufficiently influenced by diet, also used
for respiratory tract infections and catarrhal
conditions, although clinical data to support
this indication is not available, HMPC mono-
graph: in progress, BfArM graduated plan of
11 Mar 2008 concerning medicinal products
containing plant substances or preparations
of 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)
non-toxic or hardly toxic (+) (Roth/ Ingestion of higher doses, especially in Allicin, allyl sul-
Daunderer), mildly toxic III (Wink/Wyk) children, causes digestive tract irrita- phide
tion accompanied by vomiting, nausea,
colic and diarrhoea (Wink/Wyk)
Mucilage from the parenchymatous tissue of WHO: 10–70 % of fresh gel for
the leaf interior, free from anthranoids, addi- external use
tion of isolated aloin prohibited by Reg. (EC)
No. 1334/2008, WHO monograph: (traditional
use, external)
Positive monograph, indications: con- gastrointestinal cramps observed in Anthranoids Commission E, ESCOP:
stipation, WHO monograph: short-term individual cases, long-term use/abuse (e.g. aloin/Aloe equivalent to 10–30 mg hy-
treatment of occasional constipation, ESCOP causes electrolyte loss, in particular emodin) droxyanthracene derivatives
monograph: for short term use in cases of potassium, albuminuria and haema- (calculated as barbaloin)/day, no
occasional constipation, HMPC monograph: turia. Loss of potassium may cause administration to children under
short-term use in cases of occasional consti- cardiac dysfunction and muscular the age of 10
pation, BfArM graduated plan of 21 June 1996 asthenia (Commission E processing WHO: 0.1 g drug/day, single
concerning medicinal products for human monograph), menstrual and uterine dose: 40–110 mg
use containing anthranoid-containing plant haemorrhage. Long-term use observed HMPC: equivalent to 10–30 mg
genera, toxic II (Wink/Wyk), toxic + (Roth/ to cause functional disorders of the hydroxyanthracene derivatives
Daunderer) genital system accompanied by fol- (calculated as barbaloin)/day, no
licular atresia and hypertrophy of administration to children under
interstitial tissue. Abortion may oc- the age on 12
cur, strong laxative effect, intestinal
bleeding, tenesmus, haemorrhoids, in-
creased diuresis, renal irritation (Roth/
Daunderer)
15

(Latin)
Aloe ferox MILL., syn. Aloe horrida Leaf juice
HAW., Pachidendron ferox HAW.
Alpinia galanga (L.) WILLD., syn. Rhizome S, T

Maranta galanga L.
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- Fruit Not NFS
cus visnaga L., Apium visnaga
CRANTZ
Ananas comosus (L.) MERR. Fruit

Anemone spp. all plant parts
Anemopaegma mirandum MART. Bark Not NFS
Anethum graveolens L. Fruit S
Anethum graveolens L. Herb S

Angelica archangelica L., Stem T, S
syn. Angelica archangelica ALL.
16

substances dose
Positive monograph, indications: con- gastrointestinal cramps observed in Anthranoids Commission E: 20–30 mg hy-
stipation, WHO monograph: short-term individual cases, strong laxative ef- droxyanthracene derivatives/
treatment of occasional constipation, ES- fect, intestinal bleeding, tenesmus, day, calculated as anhydrous
COP monograph: for short term use in cases haemorrhoids, increased diuresis, elec- aloin
of occasional constipation, HMPC mono- trolyte loss (in particular potassium), ESCOP: preparations equivalent
graph: short-term use in cases of occasional which may cause cardiac dysfunction to 10–30 mg hydroxyanthracene
constipation, BfArM graduated plan of 21 June and muscular asthenia, albumin- derivatives (calculated as bar-
1996 concerning medicinal products for hu- uria, haematuria (Commission E baloin)/day, no administration to
man use containing anthranoid-containing monograph), menstrual and uterine children under the age of 10
plant genera, toxic II (Wink/Wyk), toxic (Roth/ haemorrhage. Long-term use observed HMPC: equivalent to 10–30 mg
Daunderer) to cause functional disorders of the hydroxyanthracene derivatives
genital system accompanied by fol- (calculated as barbaloin)/day, no
licular atresia and hypertrophy of administration to children under
interstitial tissue, abortion may occur the age of 12
(Roth/Daunderer)
Positive monograph, indications: digestive Commission E: 2–4 g drug/day,

problems, loss of appetite equivalent preparations
Positive monograph, indications: inflam- Commission E: 5 g drug/day,
mations of the oral and pharyngeal mucosa, equivalent preparations
dry cough, mild inflammations of the gastric
mucosa, standard marketing authorisation:
1469.99.99
Positive monograph, indications: inflamma- Commission E: 6 g drug/day,
tions of the oral and pharyngeal mucosa, dry equivalent preparations
cough, ESCOP monograph: dry cough, irrita- ESCOP, WHO: 0.5–3 g drug, up to
tion of the oral pharyngeal or gastric mucosa, 15 g drug/day
WHO monograph, HMPC monograph: tradi-
tional use, standard marketing authorisation:
8899.99.99
Negative monograph: due to risks, WHO slightly phototoxic, overdose and long- Fura- WHO: 50–150 mg drug/day,
monograph: as anantispasmodic, muscle term use cause vertigo, nausea, con- nochromones administration to children only
relaxant and vasodilator, non-toxic or hardly stipation, lack of appetite, headache (e.g. visnagin, under medical supervision
toxic (+) (Roth/Daunderer) (Hänsel/Sticher, Roth/Daunderer) khellin)
toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Nausea and CNS disorders, digestive Protoanemonin
and kidney problems, blistering and
ulceration, skin rash (Wink/Wyk)
individually or mixed with other barks desig-
nated as catuaba
Positive monograph, indications: digestive Commission E, WHO: 3 g drug/
problems, WHO monograph: treatment of day, equivalent preparations
dyspepsia, gastritis and flatulence, and stom-
ach ache
Neutral monograph
Negative monograph: due to risks, slightly phototoxic Coumarins, furo-
toxic (+) (Roth/Daunderer) coumarins
17

(Latin)
Angelica archangelica L., Root F
syn. Angelica archangelica ALL.
Angelica silvestris L., syn. Angelica all plant parts Not NFS
brachyradia FREYN
Angelica sinensis (OLIV.) DIELS all plant parts Not NFS
Antennaria dioica (L.) GAERTN., Flower C

syn. Cyttarium dioicum (L.) PE-
TERM., Gnaphalium dioicum L.
Anthriscus cerefolium (L.) HOFFM. Herb S
var. cerefolium [var. sativus (LAM.)
ENDL.]
Apium graveolens L., syn. Apium Leaf S
celleri GÄRTNER, Celeri graveolens
BRITTON, Selinum graveolens
E.H.L. KRAUSE, Seseli graveolens
SCOP., Sison ruta BURM.
Apium graveolens L., syn. Apium Fruit S, T
Apium graveolens L., syn. Apium Root, stem
Aquilegia vulgaris L., syn. Aquilegia all plant parts
cornuta GILIB.
Arctium lappa L., syn. Articum ma- Root T

jus BERNH., Lappa major GAERTN.
Arctostaphylos uva-ursi (L.) Leaf Not NFS

SPRENGEL, syn. Arbutus uva-
ursi L., Arctostaphylos media
GREENE
18

substances dose
Positive monograph, indications: lack of phototoxic Coumarins, furo- Commission E: daily dose: 4.5 g
appetite, digestive problems such as mild coumarins drug or 1.5–3 g fluid extract (1:1)
gastrointestinal cramps, feeling of fullness, or 1.5 g tincture (1:5), equivalent
bloating, standard marketing authorisation: preparations
1419.99.99, ESCOP monograph: dyspeptic ESCOP: 3–6 g drug/day, no ad-
complaints such as mild gastrointestinal ministration to children
spasms, sluggish digestion, flatulence and
feeling of fullness, loss of appetite, anorexia,
bronchitis, slightly toxic (+) (Roth/Daunderer)
WHO monograph (root): traditional use, phototoxic Coumarins, furo- WHO: 4.5–9 g drug/day, no ad-
HMPC assessment report coumarins ministration to children
Neutral monograph
Estragole
(Dmethyl chavi-
col)
Negative monograph: due to risks phototoxic, Commission E: celery may Furocoumarins
induce allergic reactions and even
anaphylactic shock (celery-carrot-
mugwort syndrome)

mugwort syndrome)

mugwort syndrome)
toxic II (Wink/Wyk), toxic + (Roth/Daunderer), Vertigo, pupillary changes, dizziness, Isoquino-

whole plant, especially the seeds loss of consciousness, dyspnoea (Wink/ line alkaloids
Wyk), diarrhoea (Roth/Daunderer) (e.g. mag-
noflorine),
cyanogenic glyco-
sides
HMPC monograph: traditional use
Positive monograph, indications: inflam- Nausea and vomiting may occur Hydroquinones Commission E, WHO: 3 g in
matory diseases of the lower urinary tract, in people with a weak stomach (e.g. arbutin) 150 ml water, up to 4 times a day,
WHO monograph, HMPC monograph: tradi- (Commission E monograph), uterus no administration to children
tional use, standard marketing authorisation: contractions, long-term use may under the age of 12
8299.99.99, ESCOP monograph: uncompli- cause symptoms of poisoning such ESCOP: equivalent to 400–
cated infections of the lower urinary tract such as haemolytic anaemia, cachexia, 800 mg arbutin/day, no
as cystitis, when antibiotic treatment is not fatty liver disease and hair dis- administration to children
considered essential, mildly toxic III (Wink/ colouration resulting from the
Wyk), slightly toxic (+) (Roth/Daunderer) release of hydroquinones and/or
methylhydroquinones in the body,
contraindications and interactions
reported (Roth/Daunderer)
19

(Latin)
Arctostaphylos uva-ursi (L.) Fruit
SPRENGEL, syn. Arbutus uva-
ursi L., Arctostaphylos media
GREENE
Areca catechu L. Fruit
Argyreia nervosa (BURM.f.) BOJ., Seed

syn. Argyreia speciosa (L.f.) SWEET,
Convolvulus nervosus BURM.f.
Aristolochia spp. all plant parts
Armoracia lapathifolia GILIB., syn. Root

Armoracia rusticana G.M. SCH., Ar-
moracia sativa BERNH., Cardamine
armoracia O. KTZE.
Arnica montana L., syn. Doron- Flower
icum arnica DESF.
Aronia melanocarpa (MICHX.) Fruit

ELLIOT
Artemisia abrotanum L., syn. Herb S, T
Artemisia abrotanifolium SALISB.,
Artemisia angustifolia S.F. GRAY
Artemisia absinthium L., syn. Herb T
Absinthium majus GEOFFR.,
Absinthium officinale LAM., Ab-
sinthium vulgare LAM.
20

substances dose
toxic II (Wink/Wyk), toxic + (Roth/Daunderer), neurotoxic, arecoline activates mAChR, Alkaloids

psychotropic. Consumption in the form of therefore psychotropic, stimulates (e.g. arecoline,
“betel quids” consisting of areca seeds, betel salivation, bradycardia, respiratory and arecaidine)
leaves (Piper betle), dissolved lime as well as cardiac arrest. People who regularly
flavour-enhancing additives. When chewed, chew betel quids often suffer from oral
the alkaloid arecaidine (hydrolysis of arecol- tumours (Wink/Wyk). Higher doses
ine) is released, which has a central stimulating (8–10 g seeds) may be fatal (Hager)
effect. CNS-stimulant, narcotic
toxic Ib to very toxic II (Wink/Wyk) psychotropic, highly psychedelic, effect Ergot alkaloids
similar to that of LSD, seeing colours (e.g. lysergic acid,
(Wink/Wyk) ergine D lysergic
acid amide, LSA)
BfArM graduated plan of 3 June 1981 concern- Vomiting, gastroenteritis, drop in Aristolochic acids
ing medicinal products containing aristolochic blood pressure, cramps, tachycar-
acid, including phytotherapeutic and home- dia, serious damage to urinary tract
opathic medicinal products, and BfArM and kidneys may occur, aristolochic
graduated plan of 22 June 2010 concerning acids have a mutagenic and carcino-
medicinal products produced using plants genic effect, ingestion of higher doses
of the Asarum genus of the Aristolochiaceae may cause death in coma by apnoea
family, substance of concern (AMK), toxic II (BfArM, Roth/Daunderer)
(Wink/Wyk), toxic + (Roth/Daunderer)
Positive monograph, indications: catarrhs of gastrointestinal complaints, con- Commission E: 20 g fresh root/
the respiratory tract, adjuvant treatment of traindications reported (Commission E day, equivalent preparations
lower urinary tract infections monograph)
Positive monograph for external use only, Skin irritation, severe gastroenteritis Sesquiterpene Commission E, ESCOP, WHO:
standard marketing authorisation: 5799.99.99 accompanied by diarrhoea and gastric lactones (e.g. hele- 2 g drug/day for external use
(tincture), 8199.99.99 (flower), WHO mono- pain, headache, vertigo, bradycardia, nalin)
graph, ESCOP monograph: for external use anxiety and agitation, strong heartbeat,
only, toxic II (Wink/Wyk), slightly toxic (+) but abortifacient effect (Wink/Wyk), due
often sensitising (Roth/Daunderer), HMPC to its toxic side effects observed, arnica
monograph: in progress (external use) should not be used internally (Roth/
Daunderer) (AMKdA)
Positive monograph, indications: loss of ap- Vomiting, severe diarrhoea, dizziness, Thujone Commission E: 2–3 g drug/day
petite, digestive problems, dyskinesia of the headache and cramps (Wink/Wyk) as water extract
biliary tract, ESCOP monograph: Anorexia, for ESCOP: 1–1.5 g drug in 150 ml
example after illness, dyspeptic complaints, water up to 3 times a day
HMPC monograph: traditional use, stan-
dard marketing authorisation: 1339.99.99,
mildly toxic II to toxic III (Wink/Wyk), slightly
toxic (+) to toxic + (Roth/Daunderer)
21

(Latin)
Artemisia cina O.C. BERG et Flower, seed
C.F. SCHMIDT, syn. Artemisia
cina BERG, Artemisia mogoltavica
POLJAK.
Artemisia dracunculus L., syn. Leaf T, S

Artemisia inodora WILLD.,
Artemisia redowskyi LEBED.,
Oligosporus condimentarius CASS.
Artemisia vulgaris L., syn. Herb S, T

Artemisia lactiflora WALL. ex DC.,
Artemisia samamisica BESS.
Arum spp. all plant parts
Asarum europaeum L., syn. all plant parts

Asarum officinale MOENCH.
Aspalathus linearis (BURM.F.) Herb T

DAHLG., syn. Aspalathus contami-
nata (THUNB.) DRUCE, Aspalathus
cognata PRESL., Borbonia pinifolia
MARL., Lebeckia linearis (BURM.F.)
DC., Psoralea linearis BURM.F.
Asparagus officinalis L., syn. Rhizome
Asparagus altilis ASCHERS., As-
paragus hortensis MILL.
Aspidosperma quebracho-blanco Bark, wood
SCHLECHT., syn. Aspidosperma
chakensis SPEG., Macaglia quebra-
cho O. KTZE.
Astragalus membranaceus (FISCH) Root Not NFS
BGE., syn. Phaca membranacea
FISCH. INDC.
22

substances dose
very toxic Ib (Wink/Wyk), highly toxic ++ Loss of consciousness, epileptic fits, Sesquiterpene
(Roth/Daunderer) visual disturbances, excessive gall pro- lactones (e.g. san-
duction, icterus, diarrhoea, nausea, tonin, artemisin)
vomiting, cold spells, hypersalivation,
excessive lacrimation, dyspnoea, facial
muscle cramps, haematuria resulting
from kidney damage, crural paralysis,
delirium, coma, death by respiratory
arrest (Wink/Wyk)
concerning estragole content, s. BfR Estragole and methyl eugenol demon- Estragole
statement: http://www.bfr.bund.de/cm/ strated a genotoxic effect in in-vitro (Dmethyl chav-
208/minimierung_von_estragol_und_ and in-vivo animal experiments (SCF, icol), methyl
methyleugenol_gehalten_in_lebensmitteln. BfR) eugenol
pdf
Negative monograph: due to risks abortifacient effect reported, allergic Thujone, cam-
reactions may be induced after pre- phor, eucalyptol
vious sensitisation (Commission E (D1,8-cineol)
monograph), belongs to the most po-
tent plant allergens (Schilcher)
extremely toxic Ia (Wink/Wyk), extremely Irritating to skin, burning in the Aroin, saponins,
toxic +++ (Roth/Daunderer) mouth and throat, cardiac arrhyth- cyanogenic glyco-
mia, cramps, internal haemorrhage, sides
CNS disorders, digestive problems
(Wink/Wyk), hypersalivation, gingival,
gastrointestinal and uterine bleeding
(Roth/Daunderer)
toxic II (Wink/Wyk), toxic + (Roth/Daunderer), Ingestion of high doses causes di- Asarone, aris-
substance of concern (AMK), due to detection gestive problems and CNS disorders, tolochic acids
of aristolochic acids, BfArM graduated plan burning in the mouth and throat,
procedure resulted in recall of medicinal prod- nausea, vomiting, gastric pain, gas-
ucts containing Asarum species: http://www. troenteritis accompanied by diarrhoea
bfarm.de/cae/servlet/contentblob/1207042/ and uterine haemorrhage, in extreme
publicationFile/ cases death by central apnoea (Wink/
Wyk, Roth/Daunderer)
Positive monograph, indications: irrigation Commission E: 45–60 g drug,

therapy of inflammatory diseases of the lower equivalent preparations
urinary tract and prevention of kidney gravel
highly toxic ++ (Roth/Daunderer), toxic Ib to affects vessels (vasoconstrictive), affects Indole alkaloids
very toxic II (Wink/Wyk) respiratory activity, local anaesthetic (e.g. aspidosper-
action, emetic in high doses (Roth/ mine, yohimbine)
Daunderer, Wink/Wyk)
WHO monograph: traditional use WHO: 9–30 g/day
23

(Latin)
Atropa belladonna L. all plant parts
Avena sativa L., syn. Avena cinerea Herb

ROEM. et SCHULT.
Avena sativa L., syn. Avena cinerea Fruit
ROEM. et SCHULT.
Backhousia citriodora F. MUELL. Leaf S
Banisteriopsis caapi (SPRUCE ex Bark, wood
GRISEB.) MORTON, syn. Banisteri-
opsis inebrians MORTON
Barosma betulina (THUNB.) Leaf F

BARTL. et WENDL., syn. Agath-
osma betulina (BERG.) PILLANS
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. Tuber

Conditiva ALEF.
Betula pendula ROTH and Betula Leaf T
pubescens EHRH.
24

substances dose
Positive monograph: cramps and colic-like psychotropic, all plant parts extremely Tropane alkaloids Commission E: Belladonnae
pain in the gastrointestinal and biliary tract, toxic, dry mouth, accommodation (e.g. atropine, pulvis normatus: average single
extremely toxic Ia (Wink/Wyk), extremely difficulties, reddened and dry skin, L-hyoscyamine, dose 0.05–0.1 g, max. single dose:
toxic +++ (Roth/Daunderer), isolated tropane hyperthermia, tachycardia, hallucina- scopolamine) 0.2 g equivalent to 0.6 mg total
alkaloids contained in the drug prescription- tions, cramps, micturition difficulties, alkaloids, max. daily dose: 0.6 g
only, deadly nightshade pharmacy-only delirium, fever, cardiac arrest, apnoea, equivalent to 1.8 mg total alka-
death, contraindications and interac- loids; Belladonnae radix: average
tions with medicinal products reported single dose: 0.05 g, max. daily
(Frohne, Commission E monograph) dose: 0.3 g equivalent to 1.5 mg
total alkaloids
traditional use
traditional use
highly toxic ++ (Roth/Daunderer), toxic II Beta-carboline alkaloids contained in Beta-carboline

(Wink/Wyk), used to produce ayahuasca, yagé the drug are strong monoamine oxi- alkaloids (e.g. har-
or caapi dase (MAO) inhibitors, hallucinations, mala, harmaline)
mydriasis, hypersalivation, vomiting,
sweating, nausea, tremor, abdominal
pain, rectal tenesmus (Wink/Wyk)
Neutral monograph gastric irritation (Schilcher) Diosphenol and
pulegone
Neutral monograph: toxic II (Wink/Wyk), Isoquino-

slightly toxic (+) (Roth/Daunderer). Ripe line alkaloids
berries are edible (Roth/Daunderer), alkaloid (e.g. berberine)
content decreases with increasing maturity
(Hager)
Negative monograph: due to risks, toxic II Dizziness, nasal bleeding, vomiting, Isoquino- WHO: 0.5–1 g drug, 3 times a day,
(Wink/Wyk), slightly toxic (+) (Roth/ diarrhoea, renal irritation, nephri- line alkaloids no administration to children
Daunderer), WHO monograph: used orally tis, ingestion of higher doses causes (e.g. berberine) under the age of 12
for the treatment of digestive complaints, such poisoning by respiratory arrest and
as dyspepsia, diarrhoea, gastritis, feelings of haemorrhagic nephritis (Wink/Wyk)
distention and flatulence
Negative monograph: due to risks, toxic II Dizziness, nasal bleeding, vomiting, Isoquino-
(Wink/Wyk), slightly toxic (+) (Roth/ diarrhoea, renal irritation, nephri- line alkaloids
Daunderer) tis, ingestion of higher doses causes (e.g. berberine)
poisoning by respiratory arrest and
haemorrhagic nephritis (Wink/Wyk)
Positive monograph, indications: irrigation Contraindications: irrigation therapy Commission E: 6–10 g drug/day,
therapy of bacterial, inflammatory and other of oedemas associated with cardiac equivalent preparations, aver-
diseases of the lower urinary tract and kid- or renal insufficiency (Commission E age daily dose: 2.0–3.0 g drug,
ney gravel, adjuvant treatment of rheumatic monograph) several times a day, equivalent
symptoms, standard marketing authori- preparations
sation: 8399.99.99, ESCOP monograph: ESCOP: 2–3 g drug, 2–3 times
irrigation of the urinary tract, especially in a day, equivalent preparations
cases of inflammation and renal gravel and
as an adjuvant in the treatment of bacterial
infections, HMPC monograph: traditional
use
25

(Latin)
Bixa orellana L., syn. Bixa POIR., Seed S
Bixa platycarpa RUIZ et PAV.
Borago officinalis L. Herb S
Borago officinalis L. Seed
Boswellia serrata ROXB. ex Resin Not NFS

COLEBR., syn. Boswellia glabra
ROXB., Boswellia thurifera ROXB.
ex FLEM., Libanus thuriferus
COLEBR.
Brassica nigra (L.) KOCH, syn. Bras- Seed S
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.
Brassica oleracea L. Inflorescence, stem
Brassica oleracea L. var. suttoni- Leaf
ana LEV., syn. Crucifera brassica
E.H.L. KRAUSE
Brassica oleracea var. sabellica L. Leaf
Brugmansia spp. all plant parts
Bryonia spp. Root
26

substances dose
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 [Regulation
on the Authorisation of Food Additives], as
from 1 June 2012 use acc. to Reg. (EU) No.
1129/2011, specification acc. to Reg. (EU) No.
231/2012
Negative monograph: due to risks, toxic II contains varying amounts of toxic Pyrrolizidine
(Wink/Wyk), non-toxic to hardly toxic (+) pyrrolizidine alkaloids (PA), which alkaloids
(Roth/Daunderer), borage is a substance of are known to have an organotoxic,
concern as it contains pyrrolizidine (AMK), in particular hepatotoxic effect. PA
due to this pyrrolizidine content, it should demonstrated a carcinogenic effect
only be used sparingly (Teuscher), BfArM with a genotoxic mechanism of action
graduated plan of 5 June 1992 concerning in animal experiments (Hager). All
medicinal products containing pyrrolizidine plant parts contain varying amounts of
pyrrolizidine alkaloids.
toxic II (Wink/Wyk), licensed anthroposophic contains varying amounts of toxic Pyrrolizidine
medicinal product, indications: haemorrhoids, pyrrolizidine alkaloids (PA), which alkaloids
varicose syndrome, borage is a substance of are known to have an organotoxic,
concern as it contains pyrrolizidine (AMK), in particular hepatotoxic effect. PA
BfArM graduated plan of 5 June 1992 con- demonstrated a carcinogenic effect
cerning medicinal products containing with a genotoxic mechanism of action
pyrrolizidine, the cold-pressed oil of borage in animal experiments (Hager). All
seeds is usually used as food plant parts contain varying amounts of
pyrrolizidine alkaloids. Cold-pressed
borage oil contains no or only traces
of pyrrolizidine alkaloids. (Frohne/
Pfänder)
WHO monograph: orally for the management ESCOP: 250–3,600 mg/day
of arthritis, bronchial asthma, Crohn’s disease WHO: 1–3 g drug/day
and ulcerative colitis, ESCOP monograph:
relief of painful osteoarthritis, symptomatic
treatment of inflammatory bowel disease
Harmful in high doses (+) (Roth/Daunderer), Ingestion of high doses causes gas- Glucosinolates
toxic II–III (in high doses) (Wink/Wyk) trointestinal complaints, nausea,
vomiting, diarrhoea, severe poisoning
causes central paralysis, bradycardia
and bradypnoea, even coma and death
(Roth/Daunderer, Wink/Wyk)
formerly belonged to the genus of Datura, psychotropic, CNS-inhibitor and seda- Alkaloids (tropane
extremely toxic +++ (Roth/Daunderer), ex- tive in low concentrations, ingestion alkaloids, e.g. L-
tremely toxic Ia (Wink/Wyk) of high doses causes hallucinations, hyoscyamine,
euphoria, disorientation, insomnia L-scopolamine,
and even death by respiratory arrest atropine)
(Wink/Wyk)
Negative monograph: due to risks, use as Vertigo, vomiting, intense colic, severe Cucurbitacins
drastic laxative and emetic obsolete, very watery, sometimes also bloody diar-
toxic Ib (Wink/Wyk), highly toxic ++ ( Roth/ rhoea, gastroenteritis, kidney damage,
Daunderer) abortion, cramps, death by respiratory
arrest (Wink/Wyk, Roth/Daunderer)
27

(Latin)
Buxus sempervirens L. all plant parts
Calendula officinalis L., syn. Calen- Flower T

dula officinalis var. anemonaeflora
HORT., Calendula officinalis var.
hortensis FIORI, Calendula san-
tamaria FONT-QUER, Caltha
officinalis MOENCH
Calluna vulgaris (L.) HULL, syn. Herb T
Calluna sagittaefolia GRAY, Erica
vulgaris L.
Camellia sinensis (L.) O. KUNTZE, Leaf, leaf bud T
syn. Camellia assamica (J.W. MAS-
TERS) W. WIGHT, Camellia
chinensis (SIMS) KUNTZE, Thea
bohea L., Thea viridis RAF.
Cannabis sativa L. Seed
Capparis spinosa L. Bud S
Capsella bursa-pastoris (L.) Herb T

MEDIK., syn. Bursa pastoris WIGG.,
Capsella polymorpha CAV., Iberis
bursa-pastoris CRANTZ
Capsicum annuum L. convar. Fruit
grossum
Capsicum frutescens L. Fruit S
Carica papaya L., syn. Carica Leaf Not NFS

hermaphrodita , Papaya carica
GAERTN., Papaya vulgaris DC.
Carica papaya L., syn. Carica Fruit
hermaphrodita , Papaya carica
GAERTN., Papaya vulgaris DC.
Carthamus tinctorius L. Flower C
28

substances dose
very toxic Ib (Wink/Wyk), highly toxic ++ Contact dermatitis, ingestion causes steroidal alkaloids
(Roth/Daunderer) first excitement then paralysis and
drop in blood pressure, nausea, vom-
iting, diarrhoea, vertigo, cramps
circulatory collapse, death by respi-
ratory arrest (Wink/Wyk)
Positive monograph: for external use, WHO ESCOP: external use only
monograph, HMPC monograph: traditional WHO: external use only
use, ESCOP monograph: for external use only, Commission E: 1–2 g/150 ml for
standard marketing authorisation: 1209.99.99 external, local use
Neutral monograph
HMPC monograph: in progress (unfermented

leaves)
Cannabis sativa as well as the cannabionid 9- euphorigenic and hallucinogenic ef- Cannabinoids
tetrahydrocannabinol (THC) are subject to the fect, aphrodisiac, overdose causes (e.g. THC)
provisions of the BtMG [Narcotic Drugs Act]. cardiac complaints and CNS disorders,
According to Annex I to Section I Clause 1 state of intoxication, illusion, mydria-
BtMG, the seeds of C. sativa are exempted sis, impaired reactions, loss of sense of
from this, unless they are intended for illegal time, incorrect estimation of distance
cultivation. Processing in food production and speed, impaired concentration and
as well as distribution of products produced attention, disorientation, impaired co-
using Cannabis seeds is thus permitted under ordination, accelerated pulse, sudden
the Narcotic Drugs Act. Mildly toxic III (Wink/ blackout may occur after 1–3 months
Wyk), toxic + (Roth/Daunderer) (Roth/Daunderer)
irritating, skin irritation may oc- Leek oils, glucosi-
cur on contact with the plant (Roth/ nolates
Daunderer)
Positive monograph, indications: mild men- Commission E: 10–15 g drug/
orrhagia, nasal bleeding, HMPC monograph: day, equivalent preparations
traditional use, standard marketing authori-
sation: 1539.99.99
Positive monograph: for external use, ES- chronic poisoning resulting from Capsaicin
COP monograph: for external use, mildly abuse (e.g. overdose as spice) is ac-
toxic III (Wink/Wyk), slightly toxic + (Roth/ companied by lack of appetite, chronic
Daunderer), HMPC monograph: in progress gastritis, kidney and liver damage
(Roth/Daunderer)
Neutral monograph
WHO monograph: treatment of amenor- WHO: 3–9 g drug/day

rhoea, dysmenorrhoea and wounds or sores
with pain and swelling, and prevention of
atherosclerosis, used as colouring and colour-
ing food (safflower)
29

(Latin)
Carum carvi L., syn. Apium carvi Fruit T, S
(L.) CRANTZ, Seseli carvi LAM.,
Ligusticum carvi ROTH.
Cassia fistula L., syn. Bactyrilobium Fruit F

fistula WILLD., Cassia bonplan-
diana DC., Cassia excelsa H.B.K.,
Cassia fistuloides COLL., Catharto-
carpus excelsus G. DON
Cassia senna L. syn. Cassia acuti- Leaf, fruit
folia DEL., Senna acutifolia LINK
and Cassia angustifolia VAHL. syn.
Cassia lanceolata WIGHT et ARN.,
Senna alexandrina MILL., Senna
angustifolia BATKA
Catha edulis FORSK., syn. Catha all plant parts

edulis (VAHL.) FORSK. ex ENDL,
Celastrus edulis VAHL.
Catharanthus roseus (L.) G. DON, all plant parts

syn.Vinca rosea L., Lochnera rosea
(L.) RCHB., Ammocallis SMALL
Caulophyllum thalictroides (L.) all plant parts

MICHX., syn. Leontice thalic-
troides L.
Centaurea cyanus L., syn. Cyanus Flower T

arvensis MOENCH, Cyanus sege-
tum LAM.
30

substances dose
Positive monograph, indications: diges- Commission E: 1.5–6 g drug/day,
tive problems such as mild gastrointestinal equivalent preparations
cramps, bloating and feeling of fullness, stan- ESCOP: 1.5–6 g drug/day
dard marketing authorisation: 1109.99.99,
ESCOP monograph: spasmodic gastro-in-
testinal complaints, flatulence, bloating.
Flatulent colic of infants, HMPC monograph:
in progress
used to produce spirits
Positive monograph, indications: short- Electrolyte loss (in particular potas- Anthranoids Commission E: 20–30 mg hy-
term treatment of constipation, standard sium) may be accompanied by droxyanthracene derivatives/
marketing authorisation: 7399.99.99 (senna muscular asthenia and cardiac dys- day, calculated as sennoside B
leaves), 1259.99.99 (senna fruits, Alexandrian), function, albuminuria, haematuria, ESCOP: preparations equivalent
1269.99.99 (senna fruits, Tinnevelly), WHO pseudomelanosis coli, aggravation of to 15–30 mg hydroxyanthracene
monograph (leaves and fruits): short-term colonic inertia (development of laxa- derivatives (calculated as sen-
use in occasional constipation, ESCOP mono- tive addiction) resulting from paralysis noside B), no administration to
graph (leaves and fruits): for short-term use of intestinal muscles due to loss of children under the age of 10
in cases of occasional constipation, HMPC potassium, contraindications and in- WHO: 1–2 g drug/day equivalent
monograph (leaves and fruits): short-term teractions reported (Commission E to 10–30 mg sennosides, no ad-
treatment of occasional constipation; BfArM monograph), damage to intestinal ministration to children under
graduated plan of 21 June 1996 concerning nerves due to stimulation of uterine the age of 10
medicinal products for human use containing muscles, risk of abortion in pregnant HMPC: equivalent to 15–30 mg
anthranoid-containing plant genera, slightly women (Hager) hydroxyanthracene derivatives/
toxic (+) (Roth/Daunderer), mildly toxic III day (calculated as sennoside B),
(Wink/Wyk) no administration to children
under the age of 12
Some plant substances are prescription- psychotropic, effect similar to am- Alkaloids
only and/or are subject to the provisions phetamines, excitement, constipation, (e.g. cathi-
of the Narcotic Drugs Act (BtMG), mildly circulatory distress (Wink/Wyk, Roth/ none, cathine
toxic II to toxic III (Wink/Wyk), toxic + (Roth/ Daunderer) [DD-norpseudo-
Daunderer) ephedrine])
highly toxic ++ (Roth/Daunderer), toxic Ib to mitotic inhibition, neurological dis- Indole alkaloids
very toxic II (Wink/Wyk), BfArM graduated orders, nausea, vomiting, paraesthesia (Vinca alkaloids)
plan of 20 July 1987 concerning medicinal of hands and feet, visual disturbances
products containing Madagascar rosy periwin- and hearing, fever, inhibition of leu-
kle cocytopoiesis, loss of hair, impairment
of intestinal mucosa, constipation,
diarrhoea, neuromuscular vegeta-
tive disorders, affects CNS and mental
state, apoplexy (Wink/Wyk, Roth/
Daunderer)
toxic Ib to very toxic II (Wink/Wyk), toxic + causes diarrhoea, vomiting and gas- Quinolizidine al-
(Roth/Daunderer) troenteritis in low doses, ingestion kaloids, saponins
of high doses causes burning in the
mouth, hypersalivation, sweating, my-
driasis, uterus contractions, nausea,
paralysis, also hallucinations, delirium,
respiratory arrest (Wink/Wyk), risk of
abortion during pregnancy reported,
oestrogenic and antispasmodic effects
reported (Roth/Daunderer)
Neutral monograph
31

(Latin)
Centaurium erythraea RAFN, syn. Herb T
Centaurium minus GARSAULT,
Centaurium minus MOENCH P.P.,
Centaurium umbellatum GILIB-
ERT, Erythraea centaurium
BORKH.
Cephaelis asiatica (L.) URBAN, Herb
syn. Centella asiatica (L.) NANNF.,
Centella triflora (R. et P.) NANNF.,
Hydrocotyle asiatica L.
Cephaelis ipecacuanha (BROT.) Root

A. RICH., syn. Uragoga ipecacuanha
(WILLD.) BAILL., Psychotria
ipecacuanha (BROT.) MUELL. ARG.
(auch STOKES)
Ceratonia siliqua L., syn. Ceratonia Fruit

coriacea SALISB., Ceratonia inermis
STOKES
Chamaemelum nobile (L.) ALL., Flower T
syn. Anthemis nobilis L.
Chelidonium majus L., syn. Che- Herb
lidonium grandiflorum DC.,
Chelidonium japonicum THUNB.,
Chelidonium luteum GILIB., Cheli-
donium umbelliferum STOCK.
Chenopodium ambrosioides all plant parts

L. var. Anthelminticum A. GRAY,
syn. Chenopodium ambrosioides
L. ssp. eu-ambrosioides AELLEN
var. anthelminticum AELLEN
Chondrodendron tomentosum all plant parts

RUIZ et PAV., syn. Botryopsis platy-
phylla BENTH.
Cicer arietinum L. Seed
32

substances dose
Positive monograph, indications: lack of ap- Commission E: average daily
petite, digestive problems standard marketing dose: 6 g drug, equivalent prepa-
authorisation: 1319.99.99, ESCOP mono- rations
graph: dyspeptic complaints, lack of appetite, ESCOP: 1–4 g drug/150 ml water,
HMPC monograph: traditional use up to 3 times a day
WHO monograph, indications: extracts have Irritation of skin and mucous mem- Triterpene WHO: 0.33–0.68 g drug, 3 times
been administered orally to treat stressin- branes, ingestion of higher doses may saponins, hydro- a day, equivalent preparations
duced stomach and duodenal ulcers, toxic II cause digestive problems (Wink/Wyk) cotyline (alkaloid) ESCOP: 0.6 g drug, up to 4 times
(Wink/Wyk), toxic + (Roth/Daunderer), ESCOP a day
monograph, indications: chron. venous in-
sufficiency, varicosis, wound healing, HMPC
assessment report
WHO monograph, indications: a syrup made Pneumonia, nausea, vomiting, bloody Alkaloids WHO: 21–42 mg total alkaloid
from the roots is used as an emetic, to empty diarrhoea, pain, exhaustion, brady- (e.g. cephaeline, content (special doses for chil-
the stomach in cases of poison ingestion, ex- cardia, myoplegia, anuria (Roth/ emetine) dren)
tremely toxic +++ (Roth/Daunderer), emetines Daunderer)
prescription-only, Cephaelis ipecacuana and
Cephaelis acuminata pharmacy-only, used in
medicinal products as an ingredient of expec-
torants and emetics
Carob bean gum additive E 410
Negative monograph: due to risks, HMPC Allergic reactions may occur (Commis-
monograph: traditional use sion E monograph)
Positive monograph, indications: cramps in Inflammations and burning in the Isoquino- Commission E: 2–5 g drug/day
the biliary and gastrointestinal tract, WHO mouth, vomiting, paralysis, vesical line alkaloids WHO: 2–5 g drug/day
monograph: used for the symptomatic treat- tenesmus, dizziness, arrhythmia, gas- (e.g. chelidonine, ESCOP: 1.2–3.6 g/day
ment of mild to moderate spasms of the upper trointestinal complaints accompanied sanguinarine,
gastrointestinal tract, minor gallbladder dis- by bloody diarrhoea, bradycardia, drop berberine)
orders, and dyspeptic complaints such as in blood pressure, finally death by cir-
bloating and flatulence, ESCOP monograph: culatory collapse, hepatotoxic (Wink/
symptomatic treatment of mild to moderate Wyk, Roth/Daunderer)
spasms of the upper gastrointestinal tract,
minor gall bladder disorders, dyspeptic com-
plaints such as bloating and flatulence; BfArM
graduated plan of 9 Apr 2008 concerning
medicinal 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), HMPC
assessment report
toxic + (plant), highly toxic ++ (oil) (Roth/ Ingestion of higher doses causes Terpenes
Daunderer), very toxic, Ib (Wink/Wyk), in- CNS disorders, loss of consciousness, (monoterpenes
formation: oil prescription-only (Chenopodii paralysis, drop in blood pressure, in- e.g. ascaridole)
anthelminithici oleum) creased tendency to haemorrhage,
cerebral haemorrhage, damage to
the cochlear nerve, impaired hearing,
digestive tract inflammations accom-
panied by cramps, abortifacient (Roth/
Daunderer)
extremely toxic Ia (Wink/Wyk), pareira and strong muscle relaxant, hypotensive, Alkaloids
preparations thereof prescription-only circulatory collapse, bronchospasm, (e.g. tubocurarine)
death by cardiac arrest or respiratory
arrest (Wink/Wyk)
33

(Latin)
Cichorium intybus L. var. foliosum Leaf bud
HEGI
Cichorium intybus L. var. inty- Herb, root T
bus D ssp. intybus var. sylvestre
VISIANI D C. sylvestre G. BANK
Cichorium intybus L. var. sativum Root
LAM. et DC. D ssp. sativum (DC.)
JANCHEN var. radicosum ALEF.
Cicuta virosa L., syn. Cicuta an- all plant parts
gustifolia KIT., Cicuta aquatica
DUMORT., Selinum virosum (L.)
E.H. KRAUSE
Cimicifuga racemosa (L.) NUTT., Rhizome

syn. Actaea racemosa L., Botrophis
actaeoides RAFIN.
Cinchona pubescens VAHL, Bark F

Cinchona succirubra PAVON ex
KLOTSCH
Cinnamomum cassia NEES ex BL., Flower S

syn. Cinnamomum aromaticum
NEES, Laurus cassia NEES
Cinnamomum cassia NEES ex BL., Bark S

syn. Cinnamomum aromaticum
NEES, Laurus cassia NEES
Cinnamomum ceylanicum Bark S

BL., syn. Cinnamomum verum
J.S. PRESL, Laurus cassia BURM.
34

substances dose
Positive monograph, indications: lack of ap- Commission E: 3 g drug/day,

petite, digestive problems, HMPC monograph: equivalent preparations
traditional use
Pharmacy-only (only homeopathic drugs Burning in mouth and throat, nau- Polyacetylenes
on the market), very toxic Ib (Wink/Wyk), sea, vomiting, gastric pain, mydriasis, (e.g. cicutoxin,
extremely toxic +++ (Roth/Daunderer) headache, tremor, bradycardia, epilep- cicutol)
tic fits, delirium, coma, paralysis, death
by respiratory arrest (Wink/Wyk,
Roth/Daunderer)
Positive monograph, indications: pre- hepatotoxic, s. HMPC statement: Triterpene Commission E, WHO: 40–60 %
menstrual and dysmenorrhoeal as well as http://www.bfarm.de/SharedDocs/1_ glycosides, alcoholic extract, equivalent to
climacteric neurovegetative symptoms, WHO Downloads/DE/Pharmakovigilanz/ isoquinoline alka- 40 mg drug
monograph: treatment of climacteric symp- stufenplverf/cimicifuga_hmpc_ loids (e.g. cytisine)
toms such as hot flushes, profuse sweating, assessment.pdf?__blob=publicationFile,
sleeping disorders and nervous irritability, s. BfArM notification: http://
ESCOP monograph: climacteric symptoms www.bfarm.de/SharedDocs/1_
such as hot flushes, profuse sweating, sleep Downloads/DE/Pharmakovigilanz/
disorders and nervous irritability, BfArM stufenplverf/cimicifuga_bescheid.
graduated plan of 9 June 2009 concerning pdf?__blob=publicationFile
medicinal products containing Cimicifuga,
HMPC monograph: herbal medicinal product
for the relief of menopausal complaints such
as hot flushes and profuse sweating
Positive monograph, indications: lack of ap- Overdose may cause fever, icterus, Alkaloids (e.g. qui- Commission E: 1–3 g drug/day
petite, digestive problems such as feeling of haematuria, vomiting, diarrhoea, shiv- nine, quinidine)
fullness and bloating, standard marketing ering, dyspnoea, internal haemorrhage
authorisation: 1459.99.99, toxic II (Wink/ and respiratory arrest (Wink/Wyk,
Wyk), toxic + (Roth/Daunderer), source ma- Roth/Daunderer)
terial for quinine, dose restriction for quinine
acc. to the Flavouring Regulation, BfR state-
ment on quinine: http://www.bfr.bund.de/
cm/208/chininhaltige_getraenke_koennen_
gesundheitliich_problematisch_sein.pdf
Negative monograph: due to risks, use as taste frequently induces allergic reactions Cinnamic alde-
improver is considered to be safe (Commis- of skin and mucous membranes, con- hyde
sion E monograph) traindications reported (Commission E
monograph)
Positive monograph, indications: lack of Cinnamic alde- Commission E, WHO: 2–4 g
appetite, digestive problems such as mild gas- hyde, coumarin drug/day, equivalent prepara-
trointestinal cramps, feeling of fullness or tions
bloating, s. BfR statement: http://www.bfr.
bund.de/cm/343/neue-erkenntnisse-zu-
cumarin-in-zimt.pdf
Positive monograph, indications: lack of Cinnamic alde- Commission E, WHO: 2–4 g
appetite, digestive problems such as mild hyde, coumarin drug/day, equivalent prepara-
gastrointestinal cramps, feeling of fullness tions
or bloating, ESCOP monograph: dyspeptic
complaints such as gastrointestinal spasms,
bloating and flatulence, loss of appetite,
diarrhoea, WHO monograph, HMPC mono-
graph: traditional use, standard marketing
authorisation: 1709.99.99, s. BfR statement:
http://www.bfr.bund.de/cm/343/neue-
erkenntnisse-zu-cumarin-in-zimt.pdf
35

(Latin)
Cistus x incanus L. all plant parts Not NFS
Citrullus colocynthis (L.) SCHRAD., all plant parts

syn. Cucumis colocynthis L., Colo-
cynthis officinalis SCHRAD.
Citrus aurantifolia (CHRISTM.) Peel T

SWINGLE and Citrus latifolia
TANAKA
Citrus aurantifolia (CHRISTM.) Fruit
SWINGLE, syn. Citrus aurantiifolia
(CHRISTM. et PANZ.) SWINGLE,
Limonia acidissima HOUTT. (non
L.), Limonia aurantifolia CHRISTM.
Citrus aurantium L. ssp. auran- Leaf T

tium, syn. Citrus aurantium L. ssp.
amara (L.) ENGL, Citrus commu-
nis LEMAOUT. & DECAISN., Citrus
florida SALISB.
Citrus aurantium L. ssp. auran- Flower C
florida SALISB.
Citrus aurantium L. ssp. auran- Fruit
florida SALISB.
Citrus aurantium L. ssp. auran- Peel

florida SALISB.
Citrus latifolia TANAKA Fruit

Citrus limon (L.) BURM.f., syn. Fruit
Citrus limonum RISSO, Limon
vulgaris MILL.
Citrus limon (L.) BURM.f., syn. Peel S, T
Citrus limonum RISSO, Limon
vulgaris MILL.
Citrus paradisi MACF., syn. Citrus Fruit
decumana var. patoniaca RICCOB.,
Citrus decumana var. racemosa
ROEM.
36

substances dose
Notification of the Federal Institute for
Drugs and Medical Devices acc. to Section 21
Clause 4 AMG [Medicinal Products Act] of
4 Mar 2008 and decision of the North-Rhine
Westphalia Higher Administrative Court of
15 Mar 2010 (file ref: 13 A 2612/09) on the clas-
sification of products containing preparations
of Cistus incanus as medicinal products
Negative monograph: due to risks, highly cytotoxic, irritating to gastrointestinal Cucurbitacins
toxic ++ (Roth/Daunderer), very toxic Ib mucosa up to bloody diarrhoea, kid-
(Wink/Wyk) ney damage, haemorrhagic cystitis,
cramps, abortifacient effect (Wink/
concerning synephrine s. BfR Synephrine

statement: http://www.bfr.bund.
de/cm/343/gesundheitliche-
bewertung-von-synephrin-und-
koffeinhaltigen-sportlerprodukten-
und-schlankheitsmitteln.pdf
Positive monograph, indications: lack of phototoxic, concerning synephrine Furocoumarins Commission E: 4–6 g drug/day,
appetite, digestive problems, standard mar- s. BfR statement: http://www.bfr. equivalent preparations
keting authorisation: 1629.99.99, hardly toxic bund.de/cm/343/gesundheitliche-
(Roth/Daunderer) bewertung-von-synephrin-und-
koffeinhaltigen-sportlerprodukten-
und-schlankheitsmitteln.pdf
37

(Latin)
Citrus paradisi MACF., syn. Citrus Peel F
decumana var. patoniaca RICCOB.,
Citrus decumana var. racemosa
ROEM.
Citrus reticulata BLANCO, syn. Fruit
Citrus deliciosa TEN., Citrus nobilis
ANDR. (non LOUR.), Citrus no-
bilis var. genuina TANAKA, Citrus
nobilis var. major KERR.
Citrus reticulata BLANCO, syn. Peel T
Citrus deliciosa TEN., Citrus nobilis
ANDR. (non LOUR.), Citrus no-
bilis var. genuina TANAKA, Citrus
nobilis var. major KERR.
Citrus sinensis (L.) OSBECK, syn. Leaf T
Aurantium sinensis MILL., Citrus
aurantium LOUR. (non L.)
Citrus sinensis (L.) OSBECK, syn. Flower C
Citrus sinensis (L.) OSBECK, syn. Fruit
Citrus sinensis (L.) OSBECK, syn. Peel T, S
Cnicus benedictus L., syn. Calci- Herb T
trapa benedicta LAM., Carbenia
benedicta BENTH. et HOOK.
Cocos nucifera L., syn. Calappa nu- Seed

cifera KUNTZE, Cocos mamillaris
BLANCO
Coffea arabica L., syn. Coffea lauri- Seed
folia SALISB., Jasminum arabicum
laurifolia DEJUSS.
Cola nitida (VENT.) SCHOTT et Seed
ENDL., syn. Cola acuminata ENDL.
Colchicum autumnale L., syn. all plant parts

Colchicum commune NECK.,
Colchicum crociflorum ANDERS
Colutea arborescens L., syn. Co- all plant parts

lutea vesicaria SEGUIER
38

substances dose
Positive monograph, indications: lack of Commission E: 10–15 g drug/

appetite day, equivalent preparations
Positive monograph, indications: lack of Cnicin contained in the drug causes Sesquiterpene Commission E: 4–6 g drug/day,
appetite, digestive problems, hardly toxic but heat and burning in the throat and the lactones equivalent preparations
sensitising (Roth/Daunderer) oesophagus, nausea, colic and diar- (e.g. cnicin)
rhoea in low doses (Roth/Daunderer),
allergic reactions may occur (Commis-
sion E monograph)
Positive monograph, indications: mental Ingestion of higher doses causes Purine alkaloids Commission E: 2–6 g drug/day
and physical fatigue, HMPC monograph: headache, vertigo, sleep disturbances, (e.g. caffeine,
traditional use, mildly toxic III (Wink/Wyk), agitation and tachycardia (Wink/Wyk) theobromine)
slightly toxic (Roth/Daunderer)
Positive monograph, indications: acute at- Nausea, vomiting, watery and bloody Colchicum Commission E: 0.5–1.5 mg
tacks of gout, familial Mediterranean fever, diarrhoea, intense abdominal pain, alkaloids colchicine/day, max. dose D
cytotoxic, extremely toxic Ia (Wink/van Wyk), haematuria, drop in blood pressure, (e.g. colchicine) 8 mg colchicine
extremely toxic +++ (Roth/Daunderer) convulsions, paralysis, overdose causes
death by respiratory and circulatory
arrest (Wink/Wyk), contraindications
and interactions reported (Commis-
sion E monograph)
toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Diarrhoea, sometimes vomiting L-canavanine,
(Wink/Wyk) lectins
39

(Latin)
Conium spp. all plant parts
Consolida regalis S.F. GRAY, syn. Flower C

Delphinium consolida L.
Convallaria majalis L., syn. Conva- Herb

llaria fragrans SALISB., Convallaria
latifolia MILL., Polygonatum majale
ALL.
Convolvulus scammonia L., syn. all plant parts

Convolvulus syriacus MORIS,
Convolvulus pseudoscammonia
C. KOCH
Coriandrum sativum L., syn. Herb S, T
Coriandrum maius GOUAN, Co-
riandrum diversifolium GILIB.
Coriandrum sativum L., syn. Fruit S
Coriandrum maius GOUAN, Co-
riandrum diversifolium GILIB.
Corylus avellana L., syn. Corylus Leaf T
silverstris SALISB.
Corylus avellana L., syn. Corylus Seed
silverstris SALISB.
Crataegus laevigata (POIRET) D.C., Leaf, flower T
syn. Crataegus oxyacantha L.P.P. et
AUCT.
Crataegus laevigata (POIRET) D.C., Fruit

syn. Crataegus oxyacantha L.P.P. et
AUCT.
40

substances dose
extremely toxic +++ (Roth/Daunderer), ex- all plant parts extremely toxic, paral- Piperidine alka-
tremely toxic Ia (Wink/Wyk), used only in ysis of motor nerve ends involving loids (e.g. coniine)
homeopathic drugs the following symptoms: burning in
mouth and throat, paralysis of tongue,
vomiting, hypersalivation, diarrhoea,
tachycardia, dyspnoea, disorientation,
ascending paralysis, cold spills and
numbness, death by apnoea usually
while the patient is fully conscious
(Wink/Wyk, Roth/Daunderer)
Neutral monograph (for use as colouring in Nausea, excitement, cardiac ar- Alkaloids (e.g. del-
amounts of up to 1 %): poisonous plant, toxic + rhythmia, cramps, gastroenteritis, phinine)
(Roth/Daunderer), extremely toxic Ia (Wink/ respiratory arrest (Roth/Daunderer,
Wyk), the (toxic) alkaloids are found in the Wink/Wyk), relevant diterpene alka-
underground parts, the tops and the seeds loids are found especially in seeds and
(Rimpler). Reliable information about the al- roots (Hager)
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 %, is
considered to be safe (BGA monograph)
Positive monograph, indications: mild exer- Nausea, vomiting, diarrhoea, arrhyth- cardioactive Commission E: 0.6 g/day stan-
cise insufficiency, senile heart disease, chronic mia, hypertension, coma, cardiac glycosides dardised lily-of-the-valley
pulmonary heart disease, lily-of-the-val- arrest, interactions with medici- (e.g. convalla- powder, equivalent preparations
ley plant itself pharmacy-only, extremely nal products (Wink/Wyk, Roth/ toxin)
toxic +++ (Roth/Daunderer), very toxic Ib Daunderer, Schilcher)
(Wink/Wyk)
drastic laxative Glycoretins
Positive monograph, indications: digestive Commission E: 3 g drug/day,

problems, lack of appetite, standard market- equivalent preparations
ing authorisation: 1079.99.99
Positive monograph for combination only Commission E: 160–900 mg

(Crataegi folium cum flore), indications: de- native, water-alcohol extract
creasing cardiac output equivalent to stage II (ethanol 45 % or methanol
acc. to NYHA, active ingredients: flavonoids 70 %; DER 4–7:1 with defined
(e.g. hyperoside, rutin and OPC), effect demon- flavonoid or procyanidin
strated for standardised extracts from leaves content) equivalent to 30–
with flowers, ESCOP monograph and WHO 168.7 mg oligomer procyanidins
monograph for combinations (Crataegi calculated as epicatechin or 3.5–
folium cum flore): declining cardiac perfor- 19.8 mg flavonoids calculated as
mance corresponding to Functional Capacity hyperoside in 2 or 3 single doses
Class II as defined by the NYHA, nervous heart ESCOP, WHO: 1–1.5 g drug, 3–
complaints, support of cardiac and circulatory 4 times a day
functions, HMPC monograph: in progress
Neutral monograph, ESCOP monograph: ESCOP: 0.3–1 g drug, 3 times
cardiac complaints, support of cardiac and a day
circulatory functions, standard marketing au-
thorisation: 1349.99.99, HMPC monograph:
in progress
41

(Latin)
Crocus sativus L., syn. Crocus au- Stigma, style S
tumnalis SM., Crocus officinalis
MARTYN.
Croton spp. all plant parts
Cucumis melo L., syn. Cucumis Fruit

acidus JACQ., Cucumis deliciosus
SALISB., Melo agrestis PANG., var.
reticulata and var. cantalupa and
var. inodorus
Cucurbita pepo L., syn. Cucurbita Seed
courgero SER., Pepo melopepo
MOENCH
Cuminum cyminum L., syn. Fruit S

Cuminia cyminum J.F. GMELIN
Curcuma longa L., syn.Curcuma Rhizome S
domestica VAL.
42

substances dose
Negative monograph: due to risks, WHO As much as 5 g of stigma may cause se- Pinenes, eucalyp- WHO: 3–9 g drug/day, doses
monograph: tonic, sedative, emmenagogue, vere symptoms. Ingestion of as much tol (D1,8-cineol), below 5 g/day recommended due
prevention of arteriosclerosis, also used as as 10 g per day causes abortion and safranal to toxicity
food, psychotropic, toxic II (Wink/Wyk), uterine haemorrhage, whereas a dose
toxic + (Roth/Daunderer) of 20 g is lethal. In low doses typically
used 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, followed
by vomiting, delirium, visual distur-
bances, lethargy, tachycardia, cardiac
palpitation, central paralysis and death.
Skin and mucous membranes take on
a yellowish colour (Wink/Wyk)
extremely toxic +++ (Roth/Daunderer), ex- very toxic seeds, drastic laxative ef- Phorbol ester,
tremely toxic Ia (Wink/Wyk), use of seed oil as fect due to their croton oil content. As tiglic acid
a medicinal product, e.g. as a drastic laxative, many as 4 seeds or approx. 20 drops of
obsolete, Croton cascarilla, Croton eleuteria oil are fatal to humans, burning and
and Croton tiglium pharmacy-only, substance tickle in the mouth, vomiting, oppres-
of concern (AMK) sion and agitation, watery, sometimes
bloody diarrhoea, dizziness, vertigo,
circulatory collapse, arrhythmia,
nephritis, delirium, cocarcinogenic
effect (Wink/Wyk, Roth/Daunderer)
Positive monograph, indications: irritable Commission E, WHO: 10 g drug/

bladder, micturition difficulties resulting day, equivalent preparations
from stage I–II prostatic adenoma, active ESCOP: 10–20 g drug/day
ingredients: amongst others cucurbitin, phy-
tosterol, WHO monograph: for symptomatic
treatment of difficulties with micturition as-
sociated with stage I–II prostatic adenoma and
irritable bladder, ESCOP monograph: symp-
tomatic treatment of micturition disorders
(such as dysuria, pollakisuria, nocturia, urine
retention and hesitancy) in benign prostatic
hyperplasia at stages I and II as defined by
Alken or stage II and III as defined by Vahlen-
sieck, irritable bladder, HMPC monograph:
traditional use
Positive monograph, indications: digestive Commission E, ESCOP, WHO:

problems, WHO monograph: the principal 1.5–3 g drug/day, equivalent
use of Rhizoma Curcumae Longae is for the preparations
treatment of acid, flatulent, or atonic dys-
pepsia, ESCOP monograph: symptomatic
treatment of mild digestive disturbances and
minor biliary dysfunction, HMPC mono-
graph: traditional use, standard marketing
authorisation: 2339.99.99
43

(Latin)
Curcuma xanthorrhiza ROXB., syn. Root S
Curcuma zanthorrhiza ROXB.
Curcuma zedoaria (BERG) ROSC., Rhizome S

syn. Amomum latifolium LAM.,
Amomum zedoaria WILLD., Amo-
mum zerumbeth KOEN. non L.,
Curcuma speciosa HORT. ex LINK.,
Curcuma zerumbeth (KOEN.)
ROXB.
Cyclamen spp. Root tuber
Cyclopia genistoides (THUNB.) Herb T

R. BR.
Cydonia oblonga MILLER, syn. Fruit
Cydonia communis POIRET ex
DUHAMEL, Cydonia vulgaris DE-
LARBRE, Pyrus cydonia L., Sorbus
cydonia CRANTZ
Cymbopogon citratus (DC.) STAPF, Herb S, T
syn. Andropogon citratus DC.,
Andropogon ceriferus HACK.,
Andropogon citriodorum DESF.,
Andropogon roxburghii NEES ex
STEUD.
Cynara scolymus L., syn. Cynara Foliage leaf Not NFS
cardunculus L. ssp. Scolymus (L.)
HAY
Cynara scolymus L., syn. Cynara Receptacle, scale (buds)

cardunculus L. ssp. Scolymus (L.) leaf
HAY
Cynodon dactylon (L.) PERS., Rhizome Not NFS
syn. Capriola dactylon (L.) KTZE.,
Panicum dactylon L., Digitaria
stolonifera SCHRAD., Dactylon of-
ficinale VILL., Tibichia umbellata
KOELER
Cynoglossum officinale L., syn. Herb
Cynoglossum clandestinum DESF.
44

substances dose
Positive monograph, indications: digestive Long-term use causes gastric com- Curcuminoids, Commission E, ESCOP: 2 g drug/
problems, ESCOP monograph: symptomatic plaints, contraindications reported xanthorrhizol day, equivalent preparations
treatment of mild digestive disturbances and (Commission E monograph)
minor biliary dysfunction, HMPC mono-
graph: in progress
Neutral monograph
toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Nausea, vomiting, gastric pain, di- Saponins (e.g. cy-
arrhoea, sweats, circulatory distress, clamine)
cramps, symptoms of paralysis,
haemolysis Local irritations also re-
ported (Roth/Daunderer)
Neutral monograph
Positive monograph, indications: digestive Commission E: 6 g drug/day,

problems, WHO monograph: treatment of equivalent preparations
digestive complaints (e.g. dyspepsia, feeling ESCOP: 5–10 g dried drug/day
of fullness, flatulence, nausea, stomach ache (no administration to children)
and vomiting). Adjunct treatment of mild WHO: 1–10 g drug/day,
to moderate hypercholesterolaemia, ESCOP equivalent preparations, not
monograph: digestive complaints (e.g. stom- recommended to children under
ach ache, nausea, vomiting, feeling of fullness, the age of 12
flatulence) and hepatobiliary disturbance,
adjuvant to a low fat diet in the treatment of
mild to moderate hyperlipidaemia, HMPC
monograph: traditional use
Negative monograph: due to risks, substance contains pyrrolizidine alkaloids with Pyrrolizidine
of concern (AMK), BfArM graduated plan of hepatotoxic, carcinogenic, partly also alkaloids
5 June 1992 concerning medicinal products mutagenic and teratogenic properties
containing pyrrolizidine alkaloids (Frohne/Pfänder)
45

(Latin)
Cytisus scoparius (L.) LINK, all plant parts
syn. Genista angulata POIRET,
Sarothamnus scoparius (L.)
WIMMER ex. KOCH, Spartium
scoparium L.
Daphne spp. all plant parts
Datura spp. all plant parts
Daucus carota L. ssp. sativus Root

(HOFFM.) ARCANG.
Delphinium elatum L., syn. Del- all plant parts
phinium intermedium AIT.
Delphinium staphisagria L., syn. all plant parts

Delphinium officinale WENDER.,
Staphydis agria
Dendranthema grandiflora Flower

TZVELEV, syn. Chrysanthemum
morifolium RAMAT., Dendran-
thema grandiflora (RAMAT.)
KITAM., Dendranthema morifo-
lia (RAMAT.) TZVELEV
Dendrocalamus asper (SCHULTES Sprout b
f.) HEYNE and Dendrocalamus
latiflorus MUNRO, syn, Bambusa
latiflora (MUNRO) KURZ
Digitalis spp. all plant parts
46

substances dose
Negative monograph: due to risks associ- circulatory collapse, arrhythmia, Alkaloids Commission E: 1–1.5 g drug/day,
ated with Scotch broom flowers, Positive tachycardia, sweating, vomiting, diar- (e.g. sparteine) water-ethanol extract
monograph: for Scotch broom, indications: rhoea, dizziness, vertigo, convulsions,
functional cardiovascular disorders, standard headache, ascending paralysis, death
marketing authorisation: 1439.99.99, toxic II by apnoea, hypertonia in pregnancy,
(Wink/Wyk), toxic + (all plant parts), (Roth/ contraindications reported (Wink/
Daunderer) Wyk)
poisonous plant, extremely toxic +++ (Roth/ Burning, swelling, blistering and red- Phorbol ester
Daunderer), extremely toxic Ia (Wink/Wyk) ness in the mouth, hypersalivation, (e.g. mezerein),
swallowing difficulties, nausea, bloody cumaroyl glyco-
vomiting and bloody diarrhoea, distur- side (e.g. daphnin)
bance of consciousness, fever, cramps,
paralysis, kidney damage, tachycardia,
circulatory collapse and death. After
skin contact, there is a risk of swelling
and blistering preceded by itching and
redness (Wink/Wyk, Roth/Daunderer)
Negative monograph: due to risks associated psychotropic, calmative and seda- Tropane alkaloids
with the leaves and seeds of Datura stramo- tive in low doses, ingestion of higher (e.g. atropine,
nium, isolated alkaloids prescription-only, doses causes intense hallucinations, L-hyoscyamine,
Datura species pharmacy-only, extremely excitement, facial blush, dry mouth, scopolamine)
toxic +++ (Roth/Daunderer), extremely toxic Ia euphoria, mydriasis, disorientation,
(Wink/Wyk) insomnia, respiratory arrest and death
(Wink/Wyk)
sometimes irritating, phototoxic Furocoumarins
poisonous plant, extremely toxic +++ (Roth/ Nausea, excitement, cardiac arrhyth- Terpene alkaloids
Daunderer), extremely toxic Ia (Wink/Wyk) mia, cramps, gastrointestinal tract (e.g. delphinine)
inflammations, muscular asthenia, car-
diac arrest, central paralysis, dyspnoea,
death by myoplegia and cardioplegia
(Wink/Wyk)
Negative monograph: due to risks, extremely Nausea, excitement, cardiac arrhyth- Terpene alkaloids
toxic +++ (Roth/Daunderer), extremely mia, cramps, gastroenteritis, respirato- (e.g. delphinine,
toxic Ia (Wink/Wyk), Delphinium staphisagria ry arrest (Roth/Daunderer, Wink/Wyk), staphisine)
(stavesacre) pharmacy-only relevant diterpene alkaloids are found
especially in seeds and roots (Hager)
toxic II (Wink/Wyk), cook before consumption When injured, the sprouts release hy- cyanogenic glyco-
drocyanic acid (HCN). HCN inhibits sides
cellular respiration in mitochondria.
Symptoms of HCN poisoning. HCN
must be eliminated before consump-
tion (by cooking) (Wink/Wyk)
extremely toxic Ia (Wink/Wyk), extremely typical cardiac glycoside poison- cardioactive
toxic +++ (Roth/Daunderer) ing, very narrow therapeutic range, glycosides
bradycardia, cardiac arrest, cardiac (e.g. digoxin, digi-
arrhythmia, nausea accompanied toxin)
by constant retching, diarrhoea,
gastroenteritis, visual disturbances,
agitation, headache, convulsions, CNS
disorders, disorientation, delirium,
hallucinations, drop in blood pressure,
disturbance of consciousness, sudden
death (Wink/Wyk, Roth/Daunderer)
47

(Latin)
Dipteryx odorata (AUBL.) WILLD., Seed F
syn. Coumarouna odorata AUBL.,
Baryosma tongo GAERTN.
Dracocephalum moldavica L. Herb S
Drosera spp. Herb T
Dryopteris filix-mas (L.) SCHOTT, all plant parts

syn. Aspidium filix-mas (L.) SW.,
Lastrea filix-mas (L.) PRESL., Poly-
podium filix-mas L.
Ecballium elaterium (L.) A. RICH., all plant parts

syn. Ecballium officinale NEES,
Momordica elaterium L.
Echinacea angustifolia DC., Herb T

syn. Brauneria angustifolia (DC.)
A. HELLER, Echinacea pallida var.
angustifolia (DC.) CRONQ.
Echinacea angustifolia DC., Root T
syn. Brauneria angustifolia (DC.)
A. HELLER, Echinacea pallida var.
angustifolia (DC.) CRONQ.
Echinacea pallida (NUTT.) NUTT., Herb Not NFS

syn. Brauneria pallida BRITTON,
Echinacea angustifolia HOOKER,
Echinacea pallida (NUTT.) NUTT.
f. albida STEYERM., Rudbeckia
pallida NUTT.
Echinacea pallida (NUTT.) NUTT., Root Not NFS
syn. Brauneria pallida BRITTON,
Echinacea angustifolia HOOKER,
Echinacea pallida (NUTT.) NUTT.
f. albida STEYERM., Rudbeckia
pallida NUTT.
48

substances dose
contains coumarin, s. BgVV state- Coumarin
ment: http://www.bfr.bund.de/cm/
343/gehalte_an_cumarin_safrol_
methyleugenol_und_estragol_in_
lebensmitteln.pdf
Positive monograph, indications: paroxysmal Overdose causes inflammations in the Commission E: 3 g drug/day,
and dry cough mouth and throat, vomiting, ulcers in equivalent preparations
the digestive tract, bloody diarrhoea
(Roth/Daunderer)
Negative monograph: due to risks, toxic II Nausea, vomiting, abdominal pain, di- Acylphlorogluci-
(Wink/Wyk), toxic + (Roth/Daunderer) arrhoea, cramps, cardiac insufficiency, nols, flavaspidic
fainting fits, dyspnoea, respiratory acid
arrest, fatal poisoning (Wink/Wyk,
Roth/Daunderer), Commission E: due
to the risks (many cases of poisoning,
also with fatal outcome), internal use
cannot be justified
highly toxic ++ (Roth/Daunderer), very toxic Ib Hypersalivation, vomiting, headache, Cucurbitacins
(Wink/Wyk) severe, bloody diarrhoea, kidney dam-
age, ingestion of higher doses causes
convulsions, death by respiratory ar-
rest (Wink/Wyk)
Negative monograph: due to risks associated allergic reactions ESCOP: 3 times 1 ml extract,
with parenteral use equivalent preparations
Negative monograph: due to risks associated allergic reactions

with parenteral use, WHO monograph: Sup-
portive therapy for colds and infections of
the respiratory and urinary tract. Beneficial
effects in the treatment of these infections
are generally thought to be brought about
by stimulation of the immune response,
ESCOP monograph: adjuvant therapy and
prophylaxis of recurrent infections of the up-
per respiratory tract (common cold), HMPC
Negative monograph: due to risks associated allergic reactions
with parenteral use
Positive monograph, indications: adjuvant allergic reactions Commission E: tincture equiva-

treatment of influenza, WHO monograph: lent to 900 mg drug/day
supportive therapy for colds and infections of ESCOP: 900 mg drug/day, equiv-
the respiratory and urinary tract. Beneficial alent preparations
effects in the treatment of these infections WHO: 0.5 tsp. (approx. 1 g) in
are generally thought to be brought about 150 ml water, 3 times a day
by stimulation of the immune response,
ESCOP monograph: adjuvant therapy and
prophylaxis of recurrent infections of the up-
per respiratory tract (common cold), HMPC
49

(Latin)
Echinacea purpurea (L.) MOENCH, Herb Not NFS
syn. Brauneria purpurea (L.)
BRITTON, Echinacea intermedia
LINDLEY, Echinacea purpurea (L.)
MOENCH f. ligettii STEYERM.,
Rudbeckia hispida HOFFMGG.,
Rudbeckia purpurea L.
Echinacea purpurea (L.) MOENCH, Root Not NFS

syn. Brauneria purpurea (L.)
BRITTON, Echinacea intermedia
LINDLEY, Echinacea purpurea (L.)
MOENCH f. ligettii STEYERM.,
Rudbeckia hispida HOFFMGG.,
Rudbeckia purpurea L.
Echinopsis peruviana (BRIT- all plant parts
TON et ROSE) H.FRIEDRICH et
G.D.ROWLEY, syn. Trichocereus
peruviana
Elettaria cardamomum (L.) MA- Fruit S, T

TON, syn. Alpinia cardamomum
ROXB.
Eleutherococcus senticosus Root Not NFS

(RUPR. et MAXIM.) MAXIM., syn.
Acanthopanax senticosus (RUPR. et
MAXIM.) HARMS, Hedera senticosa
RUPR. et MAXIM.
50

substances dose
Positive monograph, indications: adjuvant Immediate allergic reactions may oc- Commission E, ESCOP, WHO:
treatment of recurrent infections of the respi- cur in individual cases (Commission E 6–9 ml pressed juice, equivalent
ratory tract and the lower urinary tract, WHO monograph) preparations
monograph: supportive therapy for colds HMPC: 6–9 ml pressed juice, no
and infections of the respiratory and urinary administration to children under
tract, beneficial effects in the treatment of the age of 12
these infections are generally thought to be
brought about by stimulation of the immune
response, ESCOP monograph: adjuvant ther-
apy and prophylaxis of recurrent infections
of the upper respiratory tract (common cold)
and also of the urogenital tract, HMPC mono-
graph: short-term prevention and treatment
of coughs and colds
Negative monograph: due to risks associated allergic reactions ESCOP: 3 times 300 mg, equiva-
Adjuvant therapy and prophylaxis of recurrent lent preparations
infections of the upper respiratory tract (com-
mon cold), HMPC monograph: traditional
use
very toxic Ib (Wink/Wyk), mescaline con- psychotropic, ingestion of higher doses Mescaline
tained in the drug is a non-marketable causes gastrointestinal complaints,
narcotic acc. to Annex 1 of the Narcotic Drugs drop in blood pressure, bradycardia,
Act (BtMG) apnoea, vasodilation, paralysis (Wink/
Wyk)
Positive monograph, indications: digestive Contraindications: in case of gall- Commission E, WHO: 1.5 g
problems, WHO monograph (seeds): treat- stones, use only after consultation with drug/day, equivalent prepara-
ment of dyspepsia a physician (Commission E mono- tions
graph)
Positive monograph, indications: tonic for Contraindications: hypertension Commission E, ESCOP, WHO:
strengthening and invigoration in case of (Commission E monograph) 2–3 g drug/day, equivalent
fatigue and faintness, decreasing physical preparations
performance and powers of concentration
as well as in convalescence, WHO mono-
graph: prophylactic and restorative tonic for
enhancement of mental and physical capac-
ities in cases of weakness, exhaustion and
tiredness, and during convalescence, ESCOP
monograph: decreased mental and physi-
cal capacities such as weakness, exhaustion,
tiredness and loss of concentration, as well as
during convalescence, HMPC monograph:
traditional use
51

(Latin)
Ephedra spp. all plant parts
Epilobium angustifolium L., syn. Herb T

Chamaenerion angustifolium
SCOP., Epilobium gesneri VILLAIN,
Epilobium persicifolium VILL.
Epilobium parviflorum SCHRE- Herb T
BER, syn. Epilobium molle LAM.,
Epilobium pubescens ROTH, Epi-
lobium rivulare HEGETSCHW.,
Epilobium villosum CURT.
Epimedium grandiflorum MORR., Herb
syn. Epimedium macranthum
MORR. et DECNE
Epimedium sagittatum (SIEB. et Herb
ZUCC.) MAXIM.
Equisetum arvense L., syn. Equise- Herb T
tum boreala (L.) BÖRNER, Allosites
arvense BRONGN.
Erysimum cheiri (L.) CRANTZ, syn. all plant parts

Cheiranthus cheiri L., Cheiranthus
corinthius BOISS.
Erythroxylum catuaba A.J. SILVA Bark
ex RAYM.-HAMET
Erythroxylum coca LAM., syn. Leaf
Erythroxylon coca LAM.
52

substances dose
Positive monograph, indications: respira- sympathomimetic properties similar Alkaloids Commission E: 300 mg total
tory diseases accompanied by mild bronchial to amphetamines (Wink/Wyk), insom- (Ephedra alkaloids/day, calculated as
spasm in adults and schoolchildren, WHO nia, agitation, irritability, headache, alkaloids, ephedrine (special doses for
monograph: treatment of nasal conges- vomiting, micturition difficulties, e.g. ephedrine, children)
tion due to hay fever, allergic rhinitis, acute tachycardia, ingestion of higher norpseu- WHO: 1–6 g drug/day, no ad-
coryza, common cold, and sinusitis. The drug doses causes drastic increase in blood doephedrine, ministration to children under
is further used as a bronchodilator in the treat- pressure, cardiac arrhythmia, develop- cathine) the age of 6
ment of bronchial asthma (4, 8, 10, 21–23)., ment of addiction (Roth/Daunderer),
toxic II (Wink/Wyk), toxic + (Roth/Daunderer), deaths in the USA due to consump-
some of the alkaloids contained in the drug tion of food supplements containing
are subject to the provisions of the BtMG Ephedra: http://www.bfr.bund.de/
(e.g. cathine), Ephedra species and prepara- de/presseinformation/2002/09/
tions prescription-only, alkaloids contained bgvv_und_bfarm_warnen__schwere_
in the drug (e.g. ephedrine) prescription-only, gesundheitsschaeden_durch_ephedra_
Ephedra species pharmacy-only. Ephedra is a kraut-1007.html
“scheduled substance” of category 1 acc. to Ar-
ticle 2a of Regulations (EC) No. 273/2004 and
No. 111/2005 and is thus subject to the provi-
sions of the Precursors Control Act (GÜG).
Positive monograph, indications: posttrau- Contraindications: oedemas associated Commission E, WHO: 6 g drug/
matic and static oedema, irrigation therapy with cardiac or renal insufficiency day, equivalent preparations
of bacterial or inflammatory diseases of the (Commission E monograph)
lower urinary tract and kidney gravel, WHO
monograph: used internally for kidney and
bladder diseases, oedema and as an adjuvant in
slimming diets. It is applied as irrigation ther-
apy for infectious and inflammatory diseases
of the genitourinary tract, and kidney stones,
HMPC monograph: traditional use, standard
marketing authorisation: 1239.99.99
toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Symptoms of cardiac glycoside poi- Cardenolides
soning accompanied by pronounced (e.g. cheirotoxin),
digestive problems (Wink/Wyk) glucosinolates
nated as catuaba
very toxic Ib (Wink/Wyk), highly toxic ++ psychotropic, strong CNS-stimulant, Alkaloids (e.g. co-
(Roth/Daunderer), psychotropic, subject to the tachycardia, overdose causes death caine)
provisions of the Narcotic Drugs Act (BtMG) by respiratory arrest, episodes of
schizophrenia, strong psychological
addiction (Wink/Wyk)
53

(Latin)
Eucalyptus globulus LABILL., syn. Leaf T
Eucalyptus cordata MIQ., Eucalyp-
tus diversifolia MIQ., Eucalyptus
gigantea DEHNH.
Eucommia ulmoides OLIV. Bark Not NFS

Euphorbia spp. all plant parts
Euphrasia officinalis L. Herb T
Fagopyrum esculentum MOENCH, Fruit

syn. Fagopyrum cereale (SALISB.)
RAFIN.
Fagopyrum esculentum MOENCH, Herb T

syn. Fagopyrum cereale (SALISB.)
RAFIN.
Feijoa sellowiana BERG, syn. Acca Fruit

sellowiana (BERG) BURRET, Or-
thostemon sellowianus BERG
Ficus carica L., syn. Caprificus in- Fruit
sectifera GASP., Ficus communis
LAM., Ficus latifolia SALISB.
Filipendula ulmaria (L.) MAXIM, Flower, herb T
syn. Spiraea ulmaria L., Ulmaria
palustris MOENCH, Ulmaria pen-
tapetala GILIB.
54

substances dose
Positive monograph, indications: coughs Higher doses of the essential oil cause Eucalyptol (D1,8- ESCOP: 100–200 mg, 2–5 times
and colds of the respiratory tract, standard CNS disorders and gastrointestinal cineol) a day
marketing authorisation: 9299.99.99, WHO complaints (Wink/Wyk), ingestion WHO: 4–6 g drug/day, no ad-
monograph (leaves, oil): traditional use, ES- of higher doses causes drop in blood ministration to children
COP monograph (oil): adjuvant treatment of pressure and bradypnoea, dyspepsia,
chronic obstructive respiratory complaints vomiting, diarrhoea, circulatory dis-
including bronchitis and bronchial asthma, tress, cardiac insufficiency, circulatory
symptomatic relief of colds and catarrh of collapse (Roth/Daunderer), ingestion
the upper respiratory tract, mildly toxic II to of Eucalyptus preparations may cause
toxic III (Wink/Wyk), slightly toxic + (Roth/ nausea, vomiting and diarrhoea in
Daunderer), HMPC monograph: traditional rare cases, contraindications reported
use (Commission E monograph)
highly toxic ++ (Roth/Daunderer), very toxic Ib Irritation of skin and mucous mem- Phorbol ester,
(Wink/Wyk) branes, allergic reactions, gastric pain, triterpenes
nausea and retching, laxative, bloody
diarrhoea, arrhythmia, hepatic and re-
nal dysfunction, coma, cocarcinogenic
(Wink/Wyk)
Neutral monograph, HMPC assessment re-
port
peel fruits before consumption The red hull surrounding the grains Naphthodi-
contains naphthodianthrones anthrones
(e.g. fagopyrin). Fagopyrin may induce (e.g. fagopyrin)
photodermatitis (fagopyrism) (Ternes)
mildly toxic III (Wink/Wyk), slightly toxic (+) contains naphthodianthrones Naphthodi-
(Roth/Daunderer), licensed medicinal product (e.g. fagopyrin), which may induce anthrones
photodermatitis. Fagopyrin not (e.g. fagopyrin)
detected in aqueous preparations
(Frohne), ingestion of high doses
causes digestive problems (Wink/Wyk).
Neutral monograph
Positive monograph, indications: adjuvant Contraindications: known hyper- Commission E: 2.5–3.5 g flower
treatment of coughs and colds, standard mar- sensitivity to salicylates (due to the or 4–5 g herb/day, equivalent
keting authorisation: 1609.99.99, ESCOP salicylates contained in the drug) preparations
monograph: supportive therapy for the com- (Commission E monograph) ESCOP: 2–6 g drug/day
mon cold, HMPC monograph: traditional
use
55

(Latin)
Foeniculum vulgare MILLER Fruit T, S
ssp. vulgare var. dulce (MILLER)
THEULLUNG, syn. Anethum
foeniculum dulce SCHKUHR
Foeniculum vulgare MILLER ssp. Fruit T, S

vulgare var. vulgare (MILLER)
THELLUNG, syn. Anethum
foeniculum vulgare SCHKUHR
Fragaria ananassa DUCHESNE ex Leaf T

ROZIER
Fragaria ananassa DUCHESNE ex Fruit

ROZIER
Fragaria vesca L., syn. Fragaria Leaf T
botryformis E. KÖNIG, Fragaria
hortensis DUCH.
Fragaria vesca L., syn. Fragaria Fruit
botryformis E. KÖNIG, Fragaria
hortensis DUCH.
Fraxinus ornus L., syn. Fraxinus Resin Not NFS
mannifera STEUD., Fraxinus ro-
tundifolia MILL., Ornus europaea
PERS.
Fumaria officinalis L., syn. Fumaria Herb Not NFS

media LOIS., Fumaria sturmii OPIZ,
Fumaria vulgaris BUB.
Galeopsis segetum NECK., syn. Herb T

Galeopsis ochroleuca LAM.
56

substances dose
Positive monograph, indications: diges- Side effects: allergic reactions of the Trans- Commission E: 5–7 g drug/day,
tive problems such as mild gastrointestinal skin and the respiratory tract observed anethole, equivalent preparations
cramps, feeling of fullness, bloating, catar- in individual cases (Commission E estragole WHO, ESCOP: 5–7 g drug/day
rhs of the upper respiratory tract, standard monograph) (Dmethyl chavi-
marketing authorisation: 5199.99.99, WHO col)
monograph: symptomatic treatment of
dyspepsia, bloating and flatulence, as an ex-
pectorant for mild inflammation of the upper
respiratory tract, treatment of pain in scrotal
hernia, and dysmenorrhoea, ESCOP mono-
graph: dyspeptic complaints such as mild,
spasmotic gastrointestinal ailments, bloating
and flatulence, catarrh of the upper respira-
tory tract, included in Annex 1 of Reg. 2001/83
(s. Commission Decision 2008/911/EC), HMPC
Positive monograph, indications: diges- Side effects: allergic reactions of skin Trans- Commission E: 5–7 g drug/day,
tive problems such as mild gastrointestinal and respiratory tract observed in anethole, equivalent preparations
cramps, feeling of fullness, bloating, catar- individual cases (Commission E mono- estragole WHO, ESCOP: 5–7 g drug/day
rhs of the upper respiratory tract, standard graph) (Dmethyl chavi-
marketing authorisation: 5199.99.99, WHO col)
monograph: symptomatic treatment of
dyspepsia, bloating and flatulence, as an ex-
pectorant for mild inflammation of the upper
respiratory tract, treatment of pain in scrotal
hernia, and dysmenorrhoea, ESCOP mono-
graph: dyspeptic complaints such as mild,
spasmotic gastrointestinal ailments, bloating
and flatulence, catarrh of the upper respira-
tory tract, included in Annex 1 of Reg. 2001/83
(s. Commission Decision 2008/911/EC), HMPC
Neutral monograph Hypersensitivity reactions may oc-
cur in patients with a predisposition
(Schilcher)
Positive monograph, indications: constipa- Sensitive patients may experience nau- Commission E: 20–30 g drug/
tion, conditions in which easy defaecation sea and bloating, contraindications: day, equivalent preparations
with a soft stool is desirable, e.g. anal fissures, intestinal occlusion (Commission E
haemorrhoids and after rectal-anal surgical monograph)
procedures
Positive monograph, indications: cramps slightly psychotropic, calmative, nar- Commission E: 6 g drug/day,
in the gall bladder, the biliary tract and the cotic, ingestion of high doses causes equivalent preparations
gastrointestinal tract, standard marketing au- burning in the mouth and throat, nau- ESCOP: 4–6 g drug/day, equiva-
thorisation: 1479.99.99, ESCOP monograph: sea, vomiting, diarrhoea, drop in blood lent preparations
digestive complaints (e.g. stomach ache, nau- pressure (Wink/Wyk)
sea, vomiting, feeling of fullness, flatulence)
due to hepatobiliary disturbance, HMPC
monograph: traditional use, toxic II (Wink/
Wyk), toxic + (Roth/Daunderer)
Positive monograph, indications: mild catar- Commission E: 6 g drug, equiva-
rhs of the respiratory tract lent preparations
57

(Latin)
Galium odoratum (L.) SCOP., syn. Herb T
Asperula odorata L., Asperula odora
SALISB., Chlorostemma odoratum
FOURR.
Galium verum L., syn. Galium Herb T

luteum LAM.
Garcinia cambogia DESROUSS., Fruit S
syn. Cambogia gutta L.
Gelsemium sempervirens (L.) Rhizome
JAUME ST.-HIL., Syn. Gelsemium
nitidum MICHX., Anonymos sem-
pervirens L.
Genista tinctoria L., syn. Cystisus Flower

tinctorius VIS., Genista depressa
BIEB.
Gentiana lutea L., syn. Asterias Root T

lutea BORKH., Swertia lutea VEST.
Geum urbanum L., syn. Caryophyl- Herb Not NFS

lata officinalis MOENCH,
Caryophyllata urbana SCOP.,
Caryophyllata vulgaris LAM., Geum
caryophyllata GILIB.
Geum urbanum L., syn. Caryophyl- Root T
lata officinalis MOENCH,
Caryophyllata urbana SCOP.,
Caryophyllata vulgaris LAM., Geum
caryophyllata GILIB.
58

substances dose
Neutral monograph: BfArM graduated plan of Consumption of sweet woodruff Coumarin
23 May 1997 concerning coumarin-contain- preparations may cause headache
ing phytopharmaceuticals and homeopathic (Roth/Daunderer)
drugs up to potency D2 containing sweet
clover (Meliloti herba) or sweet woodruff
(Gallii odorati herba) (for internal use), slightly
toxic (+) (Roth/Daunderer), maximum amount
of coumarin when adding coumarin-con-
taining foods/food ingredients to foods as
flavouring specified in Reg. (EC) No. 1334/
2008
Negative monograph: extremely toxic Ia excessive sweating, central paralysis, Indole alkaloids,
(Wink/Wyk), extremely toxic +++ (Roth/ faintness, convulsions, drop in blood steroids, iridoid
Daunderer) pressure and cardiac activity, visual glycosides
disturbances, convulsions similar to
those induced by strychnine, death by
respiratory arrest (Wink/Wyk, Roth/
Daunderer)
highly toxic ++ (Roth/Daunderer), very toxic Ib slightly psychotropic, hallucino- Quinolizidine
(Wink/Wyk) genic, diuretic, uterus contractions, alkaloids (e.g. cyti-
abdominal pain, tachycardia, cardiac sine, anagyrine)
arrhythmia, vomiting, diarrhoea, ver-
tigo (Wink/Wyk)
Positive monograph, indications: lack of ap- Headache may occasionally occur Commission E: 2–4 g drug/day
petite, digestive problems such as feeling of in patients with a particular predis- ESCOP: 0.1–2 g drug/day, special
fullness and bloating, standard marketing position, contraindications reported dosage instructions for children
authorisation: 9199.99.99, WHO monograph: (Commission E monograph) WHO: 0.1–2 g drug, up to 3 times
treatment of digestive complaints, such as a day, no administration to chil-
loss of appetite, feeling of distension and dren
flatulence. As an appetite stimulant during
convalescence, ESCOP monograph: Anorexia
e.g after illness, dyspeptic complaints, HMPC
59

(Latin)
Ginkgo biloba L., syn. Pterophyllus Leaf T
salisburiensis NELSON, Salisburia
adiantifolia SMITH
Glechoma hederacea L., syn. Leaf T

Calamintha hederacea SCOP.
Gloriosa superba L., syn. Methon- all plant parts
ica superba LAM. and Gloriosa
rothschildiana O’BRIEN. and Glo-
riosa simplex L., syn. Gloriosa
virescens LINDL., Gloriosa plan-
tii LOUD.
60

substances dose
Negative monograph: due to risks associated Contact allergies may be induced by Diterpene lac- Commission E, ESCOP, WHO:
with ginkgo leaves as well as various alcoholic the ginkgolic acids contained in the tones, ginkgolic 120–240 mg extract/day
extracts due to inadequate evidence of phar- drug (Commission E monograph) acids
macological effect and risks that cannot be
ruled out, Positive monograph for standard-
ised acetone/water dry extract, indications:
psycho-organic performance disorders, de-
mentia, impaired memory, concentration
difficulties, depression, vertigo, tinnitus,
headache, HMPC monograph: in progress,
WHO monograph: extracts have been used
for symptomatic treatment of mild to moder-
ate cerebrovascular insufficiency (demential
syndromes in primary degenerative demen-
tia, vascular dementia, and mixed forms of
both) with the following symptoms: mem-
ory deficit, disturbance in concentration,
depressive emotional condition, dizziness,
tinnitus, and headache. Such extracts are also
used to improve pain-free walking distance
in people with peripheral arterial occlusive
disease such as intermittent claudication,
Raynaud disease, acrocyanosis, and post-
phlebitis syndrome, and to treat inner ear
disorders such as tinnitus and vertigo of vas-
cular and involutive origine. Extracts and
doses other than those described in Dosage
forms and Posology are used for similar but
milder indications, ESCOP monograph:
preparations based on standardized extracts:
Symptomatic treatment of: mild to moder-
ate demetia symptoms including primary
degenerative demtia, vascular dementia and
mixed forms; cerebral insufficiency, neurosen-
sory disturbances such as: dizziness/vertigo
and tinnitus, enhancement of cognitive
performance, symptomatic treatment of pe-
ripheral arterial occlusive disease (intermittent
claudication), BfArM graduated plan of 27
May 1997 concerning medicinal products
containing 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
slightly toxic (+) (Roth/Daunderer) toxic to animals, cases of poisoning in
humans not known (Hager)
extremely toxic Ia (Wink/Wyk), highly toxic ++ Spindle poison, abortifacient effect, Colchicine
(Roth/Daunderer) nausea, pain in the throat and oesoph-
agus, cramps, arrhythmia, internal
haemorrhage, peripheral neuropathy,
abdominal pain, cold extremities, grey
skin, tachycardia, respiratory arrest re-
ported (Wink/Wyk, Roth/Daunderer)
61

(Latin)
Glycyrrhiza glabra L., syn. Gly- Root T, S
cyrrhiza echinata LEPECH.,
Glycyrrhiza glandulifera WALDST.
et KIT., Glycyrrhiza hirsuta L.,
Liquiritia officinalis MOENCH
Gratiola officinalis L. all plant parts
Grindelia robusta NUTT. and Herb Not NFS

Grindelia squarrosa PURSH
(DUN.), syn. Donia squarrosa
PURSH, Grindelia squarrosa DUN.
Guaiacum officinale L. and Gua- Wood F

iacum sanctum L., syn. Guaiacum
verticale ORTEGA
Gymnema silvestre (WILLD.) R. Leaf

BR., syn. Gymnema parviflorum
ROXB., Asclepias geminata ROXB.
Gypsophila paniculata L., syn. Root Not NFS

Arrostia paniculata (L.) RAF., Gyp-
sophila parviflora MOENCH,
Saponaria paniculata (L.) NEU-
MAYER
Hamamelis virginiana L., syn. Leaf T
Hamamelis androgyna WALT.
62

substances dose
Positive monograph, indications: catar- Long-term use and higher doses Glycyrrhizic acid Commission E: liquorice from
rhs of the upper respiratory tract, gastric may cause mineral corticoid effects 5 g/day, Succus Liquiritiae from
ulcers, standard marketing authorisation: manifesting in sodium and water 0.5 g/day
1309.99.99, WHO monograph, HMPC mono- retention, loss of potassium accom- ESCOP: 1.5–15 g drug/day
graph: traditional use, ESCOP monograph: panied by hypertension, oedemas and WHO: 5–15 g drug/day, equiva-
adjuvant therapy of gastric and duodenal hypokalaemia, in rare cases also myo- lent preparations
ulcers and gastritis, coughs and bronchial globinurina, contraindications and
catarrh, as an expectorant, special precautions interactions reported (Commission E
as specified in the LMKV [Food Labelling Reg- monograph)
ulation], as from 13 Dec 2014 as specified in
Reg. (EC) No. 1169/2011
very toxic Ib (Wink/Wyk), highly toxic ++ strong laxative effect, ingestion of high Cucurbitacins
(Roth/Daunderer) doses may cause digestive problems
accompanied by nausea, vomiting,
hypersalivation, bloody diarrhoea,
nephritis, dyspnoea and cardiac dys-
function, death by respiratory arrest,
abortifacient effect (Wink/Wyk)
Positive monograph, indications: catarrhs Side effects: irritation of gastric Commission E, ESCOP: 4–6 g
of the upper respiratory tract, ESCOP mono- mucosa observed in rare cases (Com- drug/day, equivalent prepara-
graph: productive cough, catarrhs of the upper mission E monograph) tions
respiratory tract, HMPC monograph: tradi-
tional use
Positive monograph, indications: adjuvant Ingestion of higher doses causes gas- Commission E: 4.5 g drug, equiv-
treatment of rheumatic conditions, mildly troenteritis accompanied by nausea alent preparations
toxic II to toxic III (Wink/Wyk), toxic + (Roth/ and diarrhoea, cardiac palpitation,
Daunderer) vertigo (Wink/Wyk)
toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Lack of appetite, faintness, fever, diar- Gymnemic acid
rhoea, death by apnoea, irritation of
cardiovascular system, polyuria, irrita-
tion of uterus, hypoglycaemia (Roth/
Daunderer) (Wink/Wyk)
Positive monograph, indications: catarrhs of Irritation of gastric mucosa observed Commission E: 30–150 mg drug/
the upper respiratory tract in rare cases (Commission E mono- day, equivalent preparations
graph)
Positive monograph, indications: superficial Tanning agents Commission E: 0.1–1 g drug,

skin lesions, local inflammations of skin and (tannins) several times a day, equivalent
mucosa, haemorrhoids, varicose veins, stan- preparations
dard marketing authorisation: 9699.99.99 ESCOP: 2–3 g drug 2–3 times
(witch hazel leaves), 9799.99.99 (witch hazel a day, equivalent preparations
bark), WHO monograph: external use only, WHO: 0.1–1 g drug/day, equiva-
ESCOP monograph: symptomatic treatment lent preparations
of complaints related to varicose veins such as
painful and heavy legs and of haemorrhoids,
63

(Latin)
Hamamelis virginiana L., syn. Bark Not NFS
Hamamelis androgyna WALT.
Harpagophytum procumbens Root T

(BURCH.) DC., syn. Harpagophy-
tum burcherllii DECNE
Harungana madagascariensis Leaf, bark Not NFS

LAM. ex POIR., syn. Haronga
madagascariensis (LAM. ex POIR.)
CHOISY
64

substances dose
Positive monograph, indications: superficial Tanning agents Commission E: 0.1–1 g drug,
skin lesions, local inflammations of skin and (tannins) several times a day, equivalent
mucosa, haemorrhoids, varicose veins, stan- preparations
dard marketing authorisation: 9699.99.99 ESCOP: 2–3 g drug 2–3 times
(witch hazel leaves), 9799.99.99 (witch hazel a day, equivalent preparations
bark), WHO monograph: external use only, WHO: 0.1–1 g drug/day, equiva-
ESCOP monograph: inflammation of mu- lent preparations
cous membranes of the oral cavity, short-term
symptomatic treatment of diarrhoea, HMPC
Positive monograph, indications: lack of ap- Contraindications: gastric and duo- Commission E: 1.5 g/day, prepa-
petite, digestive problems, adjuvant treatment denal ulcers, in case of gallstones, use rations of equivalent bitter
of degenerative diseases of the locomotor only after consultation with a physi- value (lack of appetite), other-
system, WHO monograph: treatment of cian (Commission E monograph) wise 4.5 g drug/day, equivalent
pain associated with rheumatic conditions, preparations, standardised ex-
treatment of loss of appetite and dyspeptic tracts equivalent to 30–100 mg
complaints, supportive treatment of degen- harpagoside
erative rheumatism, painful arthrosis and ESCOP: 2–5 g drug/day, equiva-
tendonitis, ESCOP monograph: symptomatic lent preparations
treatment of painful osteoarthritis, relief of WHO: 1–3 g drug/day, equivalent
low back pain, loss of appetite and dyspepsia, preparations
Positive monograph, indications: digestive Photosensitisation especially in light- Naphtho- Commission E: 25–50 mg drug/
problems, mild exocrine pancreatic insuffi- skinned patients due to the hypericin dianthrone day, equivalent preparations
ciency and pseudohypericin contained in derivatives
the drug, contraindications reported (leaves: hypericin,
(Schilcher) pseudohypericin),
anthraquinones
(bark: mada-
gascin)
65

(Latin)
Hedera helix L., syn. Hedera Leaf
caucasigena POJARK, Hedera
chrysocarpa WALSH
Helianthus annuus L., syn. Petal T

Helianthus cultus VENTSL., He-
lianthus erythrocarpus BARTL.,
Helianthus indicus L., Helianthus
pumilus PERS.
Helianthus annuus L., syn. Seed
Helianthus cultus VENTSL., He-
lianthus erythrocarpus BARTL.,
Helianthus indicus L., Helianthus
pumilus PERS.
Helianthus tuberosus L., syn. He- Stem tuber
lianthus mollissimus E.E. WATSON
Helichrysum arenarium (L.) Flower T

MOENCH, syn. Gnaphalium are-
narium L.
66

substances dose
Positive monograph, indications: catarrhs Local irritations of mucous mem- Saponins Commission E: average daily
of the upper respiratory tract, symptomatic branes, digestive tract irritation, dose: 0.3 g drug, equivalent
treatment of chronic bronchitis, ESCOP dizziness, tachycardia, headache, nau- preparations
monograph: coughs, particularly when associ- sea, vomiting, skin rash, CNS disorders, ESCOP: ethanolic preparations:
ated with hypersecretion of viscous mucus, as hyperthermia and cardiac palpitation 250–420 mg drug/day, deviating
adjuvant treatment of inflammatory bronchial observed in individual cases, especially doses for children, ethanol-free
diseases, toxic II (Wink/Wyk), toxic + (Roth/ in higher doses, overdose may cause preparations: 300–945 mg drug/
Daunderer), toxic + (Roth/Daunderer), HMPC death by respiratory arrest (Wink/Wyk, day, deviating doses for children
monograph: expectorant for productive Roth/Daunderer) HMPC: adults and adolescents:
cough a) single dose: 15–65 mg,
1–3 times a day up to a daily dose
of 45–105 mg (note: max. daily
dose for ethanolic ready-to-use
products: 67 mg equivalent to
420 mg drug)
b) single dose: 14–18 mg, 3 times
a day
c) single dose: 33 mg, 2 times
a day
d) single dose: 100 mg, 3 times
a day
children aged between 6 and 12:
a) single dose: 11–33 mg,
2–3 times a day up to a max.
daily dose of 33–70 mg (note:
max. daily dose for ethanolic
ready-to-use products: 34 mg
equivalent to 210 mg drug)
b) single dose: 9–18 mg,
2–3 times a day up to a max.
daily dose of 15–40 mg
c) single dose 25 mg, 2 times
a day
d) single dose: 75 mg 3 times
a day
children aged between 2 and 5:
a) single dose: 8–18 mg 2–3 times
a day up to a max. daily dose
of 24–36 mg (note: max. daily
dose for ethanolic ready-to-use
products: 24 mg equivalent to
150 mg drug)
No administration to children
under the age of 2
Positive monograph, indications: digestive Contraindications: occlusion of biliary Commission E: 3 g drug/day,

problems, WHO monograph: treatment of tract, in case of gallstones, use only equivalent preparations
dyspeptic disorders, standard marketing au- after consultation with a physician
thorisation: 1649.99.99 (Commission E monograph)
67

(Latin)
Heliotropium arborescens L., syn. all plant parts
Heliotropium corymbosum RUIZ
et PAV, Heliotropium odoratum
MOENCH, Heliotropium peru-
vianum L.
Helleborus spp. all plant parts
Herniaria glabra L. Herb T

Herniaria hirsuta L. Herb T
Hibiscus sabdariffa L., syn. Sab- Flower T
dariffa rubra KOSTEL., Sida
sabdariffa L.
Hibiscus sabdariffa L., syn. Sab- Seed Not NFS
dariffa rubra KOSTEL., Sida
sabdariffa L.
Hippophae rhamnoides L. ssp. Fruit
rhamnoides, Hippophae rham-
noides L. ssp. fluviatilis, syn.
Hippophae angustifolia “LODD.”
ex DIPPEL, Hippophae fasciculata
WALL ex STEUDEL, Hippophae
littoralis SALISB.
Hoodia gordonii (MASS.) SWEET all plant parts
Hordeum vulgare L., syn. Hordeum Fruit
sativum JESS.
Humulus lupulus L., syn. Humulus Flower
cordifolius MIQ.
Hydrastis canadensis L., syn. Rhizome

Warneria canadensis LILL., Warne-
ria diphylla RAF.
Hyoscyamus spp. all plant parts
68

substances dose
toxic II (Wink/Wyk), toxic + (Roth/Daunderer), Pyrrolizidine alkaloids contained in Pyrrolizidine
substance of concern (AMK), BfArM graduated the drug may cause liver damage alkaloids
plan of 5 June 1992 concerning medicinal (Wink/Wyk, Frohne), tachycardia,
products containing pyrrolizidine alkaloids mydriasis, central apnoea and cardiac
arrest (Wink/Wyk).
Helleborus viridis, Helleborus niger and tickle in mouth and throat, nausea, Alkaloids
various species pharmacy-only, extremely hypersalivation, mydriasis, raging (e.g. celliamine,
toxic +++ (Roth/Daunderer), extremely toxic Ia thirst, abdominal pain and colic, gas- sprintillamine),
(Wink/Wyk) trointestinal complaints, diarrhoea, cardioactive
exhaustion, symptoms of cardiac glycosides
glycoside poisoning, coma, death by (e.g. bufa-
cardiac or respiratory arrest (Wink/ dienolides),
Wyk) steroidal saponins
(e.g. helleborine)
Neutral monograph
Neutral monograph
Neutral monograph
WHO monograph: treatment of cirrhosis of WHO monograph: 40–50 g fresh

the liver , used to relieve cough with profuse fruit in 1 litre water, 2–3 cups
expectoration, to promote digestion in people a day
with prolonged gastrointestinal transit with
abdominal pain, and for treatment of amenor-
rhoea
Positive monograph, indications: emotional fresh hop cones: dermatitis on skin Commission E, ESCOP, WHO:
symptoms such as agitation and states of anx- contact, conjunctivitis, in severe cases single dose: 0.5 g drug, equivalent
iety, sleep disturbances, standard marketing vomiting, fever, dyspnoea, bradycardia preparations, no administration
authorisation: 1029.99.99, WHO monograph: and sweats (Roth/Daunderer) to children under the age of 12
as a sedative for the treatment of nervous
tension and insomnia. Treatment of dyspep-
sia and lack of appetite, ESCOP monograph:
tenseness, restlessness and sleep disorders,
WHO monograph: treatment of digestive Ingestion of higher doses causes vom- Isoquino- WHO: 0.5–1 g drug, 3 times a day
complaints, such as dyspepsia, gastritis, feeling iting, gastrointestinal complaints, line alkaloids
of distension and flatulence, toxic Ib to very uterus contractions, vasoconstrictive, (e.g. hydrastine,
toxic II (Wink/Wyk), highly toxic ++ (Roth/ CNS-depressor, spasmogenic, may berberine)
Daunderer) cause myoplegia, hallucinations, delir-
ium and cyanosis (Wink/Wyk)
Positive monograph for Hyoscyamus niger, psychotropic, calmative and sedative Tropane al- Commission E: 0.5 g standard-
indications: gastrointestinal cramps, ex- in low doses, ingestion of higher doses kaloids (e.g. ised powder (single dose), 3.0 g
tremely toxic Ia (Wink/Wyk), extremely causes hallucinations, euphoria, dis- L-hyoscyamine, standardised powder (maximum
toxic +++ (Roth/Daunderer) orientation, insomnia, fits of rage, loss L-scopolamine, daily dose)
of consciousness and death by respi- atropine)
ratory arrest, facial blush, dry mouth,
mydriasis, accelerated pulse (Wink/
Wyk)
69

(Latin)
Hypericum perforatum L., syn. Herb, flower F
Hypericum officinarum CRANTZ,
Hypericum officinale GATER ex
STEUD., Hypericum vulgare LAM.
Hyssopus officinalis L., syn. Hys- all plant parts S, T

sopus arisatus GODR., Hyssopus
canascens (DC.) NYM.
Iberis amara L., syn. Biauricula all plant parts

amara BUBANI, Crucifera iberis
KRAUSE, Thlaspi amarum CRANTZ
Ilex aquifolium L. Fruit, leaf
Ilex paraguariensis ST. HIL., syn. Leaf T

Ilex bonplandiana MÜNTER, Ilex
domestica REISS.
Illicium verum HOOK. FIL., syn. Il- Fruit T, S
licium anisatum GAERTN. NON. L.,
Illicium stellatum L.
Inula helenium L., syn. Aster he- Root S, T
lenium (L.) SCOP., Corvisartia
helenium (L.) MÉRAT, Helenium
grandiflorum GILIB.
Ipomoea purga (WENDER.) all plant parts

HAYNE, syn. Exogonium purga
(WENDER.) BENTH.
70

substances dose
Positive monograph, indications: psychoveg- Photosensitiser, enzyme inductor Naphthodi- Commission E: 2–4 g drug/day
etative disorders, depression, anxiety and/or (suppression of effect of concomitant anthrones ESCOP, WHO: 2–4 g drug/day,
nervous agitation. Oily Hypericum prepa- medication), toxic increase of sero- (e.g. hypericin, administration to children only
rations for digestive problems, standard tonin concentration in CNS (Wink/ pseudohyper- under medical supervision
marketing authorisation: 1059.99.99, WHO Wyk) icin), xanthone
monograph: symptomatic treatment of mild derivatives
and moderate depressive episodes (classified
as F32.0 and F32.1, respectively, in the Inter-
national statistical classification of diseases
and related health problems, Tenth revision
(ICD-10), ESCOP monograph: episodes of
mild depressive disorders or mild to moder-
ate depressive episodes in accordance with
ICD-10 categories F32.0, F32.1, F33.0 and F33.1,
HMPC monograph: herbal medicinal prod-
uct for the treatment of mild to moderate
depressive episodes (according to ICD-10).
short term treatment of symptoms in mild
depressive disorders, BfArM graduated plan
of 10 Oct 2005 concerning medicinal products
for internal use containing St. John’s wort (Hy-
pericum): http://www.bfarm.de/SharedDocs/
1_Downloads/DE/Pharmakovigilanz/
stufenplverf/Johanniskraut-Bescheid-051010.
pdf?_
Neutral monograph: use of hyssop as taste Consumption of oil reported to cause Pinocamphone,
improver in tea blends in amounts of up to clonic and/or tonic-clonic cramps esopinocam-
5 % is considered to be safe (Commission E (Commission E monograph) phone
monograph)
Ingredient of licensed medicinal products, Ingestion of higher doses causes vom- Cucurbitacins
toxic + (Roth/Daunderer), mildly toxic II to iting, gastroenteritis, bloody diarrhoea,
toxic III (Wink/Wyk) abdominal pain, respiratory depres-
sion, arrhythmia (Wink/Wyk)
highly toxic ++ (Roth/Daunderer), toxic Ib to gastrointestinal complaints, gas- Triterpenes,
very toxic II (Wink/Wyk) tritis, vomiting, diarrhoea, cardiac nitrile (menes-
arrhythmia, paralysis, kidney dam- daurin)
age, drowsiness, possibly death (Wink/
Wyk)
Positive monograph, indications: mental Commission E: 3 g drug/day,
and physical fatigue, HMPC monograph: equivalent preparations
traditional use
Positive monograph, indications: catarrhs Commission E: 3 g drug or 0.3 g
of the respiratory tract, digestive problems, essential oil/day, equivalent
standard marketing authorisation: 2419.99.99 preparations
Negative monograph: due to risks, practically Sesquiterpene lactones contained in Sesquiterpene
non-toxic but allergenic (Roth/Daunderer) elecampane are irritating to mucous lactones (alan-
membranes, sensitising and induce tolactones,
allergic contact dermatitis (Com- isoalantolactones)
mission E monograph), ingestion of
higher doses causes vomiting, diar-
rhoea, cramps, symptoms of paralysis
(Roth/Daunderer)
toxic II (Wink/Wyk), toxic (Roth/Daunderer), drastic laxative, gastric pain, vomiting, Convolvulin,
resin and root tuber as MP prescription-only, diarrhoea, tenesmus, nausea (Wink/ jalapin, glycoretin
whole plant pharmacy-only Wyk, Roth/Daunderer)
71

(Latin)
Ipomoea violacea L., syn. Ipomoea Seed
tricolor CAV.
Iris germanica L. and Iris pallida Rhizome F

LAM. and Iris florentina L.
Iris versicolor L., syn. Iris virginica Root
JACQ., PURSH (non L.)
Jasminum grandiflorum L. Flower T
Jasminum officinale L., Flower T
Juglans regia L., syn. Nux juglans Flower C
DUHAM.
Juglans regia L., syn. Nux juglans Seed

DUHAM.
Juglans regia L., syn. Nux juglans Peel F
DUHAM.
Juniperus communis L. Fruit S, T
Juniperus communis L. Wood T
Juniperus sabina L., syn. Sabina all plant parts

officinalis GARCKE
Krameria triandra RUIZ et PAVON, Root T

syn. Krameria lappacea (DOMBEY)
BURDET et SIMPSON, Krameria
canascens WILLD. ex SCHULTES
Laburnum anagyroides MEDICUS, all plant parts
syn. Cytisus laburnum L., Genista
laburnum KRAUSE
72

substances dose
highly toxic ++ (Roth/Daunderer), very toxic Ib psychotropic, hallucinogenic effect, Indole alkaloids
(Wink/Wyk), narcotic nausea, vomiting and faintness, in- (e.g. ergometrine,
gestion of high doses causes death by ergine, chan-
apnoea (Roth/Daunderer, Wink/Wyk) oclavin, lysergic
acid and lysergic
acid derivatives
Neutral monograph: used to produce spirits
Positive monograph: for external use, stan- The high tannin content may cause Juglone
dard marketing authorisation: 2429.99.99, irritation of gastric mucosa. Since
HMPC monograph: traditional use (external a mutagenic effect is demonstrated
use) for juglone, internal use of the drug is
contraindicated in pregnancy (Hager)
Negative monograph: due to risks, as flavour- Local daily use of preparations con- Juglone
ing in spirits production taining juglone is associated with
a high incidence of tongue cancer
and leucoplakia (Commission E mono-
graph)
Positive monograph, indications: digestive Long-term use or overdose (more than Mono- and Commission E: 2–10 g/day
problems, standard marketing authorisation: 150 mg of essential juniper oil per day, sesquiterpenes equivalent to 20–100 mg es-
1369.99.99, ESCOP monograph: traditional note by Schilcher) may cause kidney (e.g. alpha-pinene) sential oil
use, non-toxic to slightly toxic (+) (Roth/ damage (Schilcher), contraindications ESCOP: 2–3 g drug in 150 ml
Daunderer), mildly toxic II to toxic III (Wink/ reported (Commission E monograph) water, 3–4 times a day
Wyk), HMPC monograph: traditional use
Terpene, tanning
agents, lignans
extremely toxic +++ (Roth/Daunderer), ex- Ingestion causes nausea, vomiting, ab- Monoterpenes
tremely toxic Ia (Wink/Wyk), substance of dominal pain, excitement, arrhythmia, (e.g. thujone,
concern (AMK) tachycardia, convulsions, respiratory sabinene)
arrest, serious kidney and liver dam-
age, profuse internal haemorrhage,
haematuria, uterus contractions, abor-
tion, death as a result of central apnoea
in coma (Wink/Wyk). Essential oil has
a strong irritating effect on the skin,
which may even cause necrosis and
damage to deeper skin layers.
Positive monograph: for external use, stan- allergic reactions of mucous mem- ESCOP, Commission E: external
dard marketing authorisation: 1179.99.99 branes observed in very rare cases use only
(root), 7199.99.99 for external or local use only, (Commission E monograph)
ESCOP monograph: for external or local use
very toxic Ib (Wink/Wyk), extremely toxic +++ slightly psychotropic and hallucino- Quinolizidine
(Roth/Daunderer) genic, diuretic, uterus contractions, alkaloids (e.g. cyti-
abdominal pain, tachycardia, drop in sine)
blood pressure, cardiac arrhythmia,
vomiting, diarrhoea, vertigo, cramps,
headache, delirium, nicotinergic effect
(Wink/Wyk)
73

(Latin)
Lactuca virosa L., syn. Lactuca all plant parts
altissima M.B., Lactuca lactucarii
LAMOTTE, Lactuca sylvestris LAM.
Lamium album L., syn. Lamium Flower T

capitatum SM., Lamium vulgatum
var. album BENTH
Lamium album L., syn. Lamium Herb T
capitatum SM., Lamium vulgatum
var. album BENTH
Laurus nobilis L. Leaf S
Lavandula angustifolia MILL., Leaf T

syn. Lavandula officinalis CHAIX
ex VILL., Lavandula angustifolia
MUCH, Lavandula spica L.
Ledum palustre L., syn. Rhododen- Herb

dron tomentosum HARMAJA
Leonurus cardiaca L., syn. Cardiaca Herb T

trilobata LAM., Cardiaca vulgaris
MOENCH
Lepidium peruvianum CHACON, Root

syn. Lepidium meyenii WALP.
Lespedeza capitata MICHX. all plant parts Not NFS

Levisticum officinale KOCH, syn. Fruit S
Angelica levisticum ALL., Hip-
poselinum levisticum BRITTON
et ROSE, Levisticum levisticum
KARSTEN
74

substances dose
very toxic Ib (Wink/Wyk), highly toxic ++ persistent irritation of skin and mu- Sesquiterpene
(Roth/Daunderer) cous membranes, calmative properties lactones
similar to opium, visual disturbances,
headache, sweats, vertigo, drowsiness,
tachypnoea and tachycardia (Wink/
Positive monograph, indications: catarrhs of Commission E: 3 g drug/day,
the upper respiratory tract, mild infections of equivalent preparations
the oral and pharyngeal mucosa
Neutral monograph
irritating to skin, allergenic (Roth/ Eucalyptol

Daunderer) (D1,8-cineol),
sesquiterpene
lactones
Positive monograph, indications: emo- Overdose may induce hepatic and Monoterpenes, Commission E, ESCOP, WHO:
tional symptoms such as agitation, sleep renal dysfunction (Wink/Wyk) coumarins 1–2 tsp. Drug, 0.8–1.6 g/cup
disturbances, functional epigastric disor- (150 ml), 3 times a day
ders (nervous irritable stomach, ROEMHELD
syndrome, meteorism, nervous intestinal dis-
orders), standard marketing authorisation:
1119.99.99, WHO monograph: symptomatic
treatment of restlessness, insomnia, and as
a carminative and antispasmodic for gastroin-
testinal disorders of nervous origin, ESCOP
monograph: symptoms of mood disturbance
such as restlessness, agitation of insomnia,
functional abdominal complaints, mildly
toxic III (Wink/Wyk), HMPC monograph:
traditional use
Negative monograph: due to risks, toxic gastrointestinal irritation accompanied Sesquiterpenes
(Roth/Daunderer), toxic II (Wink/Wyk) by vomiting and diarrhoea, irritation (e.g. ledol, palus-
and damage of kidneys and lower uri- trol), arbutin
nary tract, sweats, pain in muscles and
joints, CNS excitement accompanied
by states of intoxication, cramps and
subsequent paralysis (Commission E
monograph)
Positive monograph, indications: nervous slightly anaesthetic, calmative (Wink/ Iridoids, diter- Commission E: 4.5 g drug, equiv-
cardiac disorders, adjuvant treatment of Wyk) penes, triterpenes alent preparations
hyperthyroidism, WHO monograph: used WHO: 2–4.5 g drug, equivalent
against cerebral ischaemia, it is also used for preparations
treatment of heart palpitations occurring with
anxiety attacks or other nervous disorders,
HMPC monograph: traditional use, mildly
toxic III (Wink/Wyk)
Statement of the Federal Institute for Risk Glucosinolates,
Assessment (BfR): http://www.bfr.bund.de/ imidazole alka-
cm/343/risikobewertung_macahaltiger_ loids
nahrungsergaenzungsmittel.pdf
phototoxic Furocoumarins
75

(Latin)
Levisticum officinale KOCH, syn. Herb S
KARSTEN
Levisticum officinale KOCH, syn. Root S, T
KARSTEN
Linaria vulgaris MILL., syn. Antir- Herb Not NFS

rhinum linaria L.
Linum usitatissimum L. Seed
Lippia triphylla (L’HÉR.) KUNTZE, Herb S, T

syn. Aloysia citrodora PALAU,
Aloysia citriodora ORTEGA ex
PERS., Aloysia sleumeri MOLD-
ENKE, Aloysia triphylla (L’HÉR.)
KUNTZE, Verbena citriodora CAV.,
Verbena triphylla L’HÉR., Zapania
citrodora LAM.
Lobelia spp. all plant parts
Lophophora williamsii (LEM. all plant parts

ex SALM-DYCK) COULT., syn.
Anhalonium williamsii (LEM. ex
SALM-DYCK) LEM., Anhalonium
lewinii HENN., Ariocarpus william-
sii VOSS., Echinocactus lewinii
(HENN.) SCHUM.
Lupinus spp. Seed
76

substances dose
phototoxic Furocoumarins
Positive monograph, indications: irrigation phototoxic Furocoumarins Commission E: 4–8 g drug/day,

therapy of inflammatory diseases of the lower equivalent preparations
urinary tract, irrigation therapy to prevent
of kidney gravel, HMPC monograph: tradi-
1569.99.99
Positive monograph, indications: habitual Cases of poisoning in humans caused cyanogenic glyco- Commission E: 1 tbsp./150 ml
constipation, colon affected by laxatives, by cyanogenic glycosides in flax sides, lignans liquid, 2–3 times a day
irritable colon, diverticulitis, as gruel prepa- not known to date (Hager, Frohne/ ESCOP: 5–10 g drug/day
ration for gastritis and enteritis, standard Pfänder) HMPC: 10–15 g, 2–3 times a day,
marketing authorisation: 1099.99.99, ESCOP no administration to children
monograph: constipation, irritable bowel under the age of 12
syndrome, diverticular disease, symptomatic
short-term treatment of gastritis and enteri-
tis, HMPC monograph: treatment of habitual
constipation or in conditions in which easy
defaecation with soft stool is desirable, tradi-
tional use, toxic II (Wink/Wyk)
Lobelia inflata prescription-only, Lobelia nicotinergic effect, vomiting, di- Piperidine alka-
species in general pharmacy-only, Lobelia arrhoea accompanied by colic and loids (e.g. lobeline)
inflata: highly toxic ++ (Roth/Daunderer), very cramps, stimulates respiration in low
toxic Ib (Wink/Wyk) doses, causes apnoea in higher doses,
bradycardia, drop in blood pressure,
convulsions, death by respiratory ar-
rest (Wink/Wyk, Roth/Daunderer)
narcotic, highly toxic ++ (Roth/Daunderer), psychotropic, hallucinogenic, visual Alkaloids
very toxic Ib (Wink/Wyk), mescaline con- disturbances and distorted thinking (e.g. mescaline)
tained in the drug is a non-marketable patterns, intense, even schizophrenic
narcotic acc. to Annex 1 of the Narcotic Drugs symptoms, loss of perception, insom-
Act (BtMG) nia, drop in blood pressure, mydriasis,
pain, respiratory depression, vasodi-
lation, faintness, liver damage and
vomiting, ascending paralysis in high
doses (Wink/Wyk, Roth/Daunderer)
low-alkaloid/alkaloid-free types are used in Lupine poisoning (caused by alkaloids) Quinolizidine
foods (sweet lupine or leached, ripe seeds of may cause hypersalivation, vomiting, alkaloids
bitter lupines) (van Wyk), other types moder- swallowing difficulties, arrhythmia,
ately to highly toxic (Roth/Daunderer), toxic convulsions and death by respiratory
(Wink/Wyk), subject to labelling requirement arrest (Wink/Wyk)
acc. to Food Labelling Regulation, statement of
the 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
77

(Latin)
Lycium barbarum L., syn. Lycium Fruit
halimifolium MILLER, Lycium
flaccidum (VEILLARD) K. KOCH
Lycopodium clavatum L., syn. Herb

Lepidotis clavata (L.) PAL. BEAUV.
Lycopus europaeus L., syn. Lyco- Herb

pus aquaticus MOENCH, Lycopus
palustris LAM., Lycopus vulgaris
PERS. and Lycopus virginicus
L., syn. Lycopus macrophyl-
lus BENTH., Lycopus uniflorus
MICHX., Lycopus virginicus
MICHX.
Macadamia ternifolia F. v. MUELL. Seed
Malpighia punicifolia L., syn. Fruit

Malpighia glabra L.
Malus domestica BORKH. Fruit
Malus sylvestris (L) MILL. Fruit
Malva sylvestris L., syn. Malva Leaf, flower T
ambigua GUSS., Malva erecta
C. PRESL., Malva mauritiana L.
Mandragora officinarum L. Root
Mangifera indica L. Fruit

Marrubium vulgare L., Marrubium Herb
album GILIB.
Marsdenia condurango REICHB. Bark T

F., syn. Gonolobus condurango
(REICHB. F.) TRIANA
78

substances dose
mildly toxic III (Wink/Wyk), highly toxic ++
(Roth/Daunderer), the presence of toxic
amounts of tropane alkaloids, which is
the basis of the above assessment, is not
confirmed in a recent BfR statement on
L. 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 poisoning Quinolizidine
similar to those induced by curare, alkaloids (e.g. ly-
excessive sweating, nausea, vertigo, copodine,
psychotropic, causes impaired sensory clavatin)
perception, impaired speech, cramps,
vomiting, diarrhoea (Wink/Wyk)
Positive monograph, indications: mild forms Long-term use and high doses may Coumarins Commission E: 1–2 g drug/
of hyperthyroidism accompanied by vegeta- cause enlargement of the thyroid day (tea), water-ethanol extract
tive-nervous disorders, mastalgia gland, sudden discontinuation of equivalent to 20 mg drug
treatment intensifies the symptoms,
interactions and contraindications
reported (Commission E monograph)
Positive monograph, indications: irritation Commission E: 5 g drug/day,

of oral and pharyngeal mucosa accompanied equivalent preparations
by dry cough, standard marketing autho- ESCOP: 1.5–2 g drug/day
risation: 1579.99.99 (mallow leaves), ESCOP
monograph for flowers: dry cough, irritation
of the oral, pharyngeal or gastric mucosa
psychotropic, root and preparations thereof calmative and sedative in low doses, Tropane
prescription-only, mandrake pharmacy-only, ingestion of higher doses causes hal- alkaloids (e.g. L-
very toxic Ib (Wink/Wyk), highly toxic ++ lucinations, euphoria, disorientation, hyoscyamine,
insomnia, vertigo, tremor, impaired D,L-scopolamine,
speech, excitement, nausea, vomiting, atropine)
mydriasis and death by central paraly-
sis (Wink/Wyk)
Positive monograph, indications: lack of ap- Ingestion of high doses causes cardiac Diterpenes Commission E: 4.5 g drug/day,
petite, digestive problems such as feeling of arrhythmia (Roth/Daunderer) (e.g. marrubiin) 2–6 tbsp. pressed juice, equiva-
fullness and bloating, catarrhs of the respira- lent preparations
tory tract, slightly toxic (+) (Roth/Daunderer),
Positive monograph, indications: lack of Ingestion of high doses may cause di- steroidal Commission E: 2–4 g drug/day,
appetite, mildly toxic II to toxic III (Wink/ gestive problems and CNS disorders glycosides equivalent preparations
Wyk), slightly toxic (+) (Roth/Daunderer) (Wink/Wyk), hypersalivation, vomit- (e.g. conduran-
ing, stiffness of extremities, convulsive gins)
fits accompanied by twitching of fa-
cial muscles, central apnoea (Roth/
Daunderer)
79

(Latin)
Matricaria recutita L., syn. Flower T
Chamomilla recutita (L.)
RAUSCHERT, Matricaria
chamomilla L. PROPARTE
Matricaria recutita L., syn. Seed Not NFS

Chamomilla recutita (L.)
RAUSCHERT, Matricaria
chamomilla L. PROPARTE
Medicago sativa L. Sprout
Melaleuca alternifolia (MAIDEN Leaf
and BETCH) CHEEL., syn.
Melaleuca linariifolia var. alternifo-
lia MAIDEN et BETCHE.
Melilotus officinalis (L.) PALLAS, Herb T

syn. Melilotus arvensis WALLR.,
Melilotus melilotus-officinalis AS-
CHERS. et GRAEBN., Melilotus
officinalis DESR. and Melilotus
altissima THUILL., syn. Melilo-
tus gigantea WENDER., Melilotus
macrorrhiza PERS.
Melissa officinalis L., Melissa Leaf S, T

altissima SM. INSIBTH. et SM.,
Thymus melissa E.H.L. KRAUSE
Mentha aquatica L., syn. Mentha Herb S, T

hirsuta HUDS.
80

substances dose
Positive monograph, indications: gastroin- Commission E: 1 tbsp. (approx.
testinal cramps and inflammatory diseases of 3 g), 3–4 times a day
the gastrointestinal tract, standard marketing ESCOP: 3 g drug, 3–4 times a day,
authorisation: 7999.99.99, WHO monograph: special dosage instructions for
symptomatic treatment of digestive ailments children
such as dyspepsia, epigastric bloating, im- WHO: 2–8 g, 3 times a day, spe-
paired digestion, and flatulence, infusions cial dosage instructions for
of camomile flowers have been used in the children, no administration to
treatment of restlessness and in mild cases children under the age of 3
of insomnia due to nervous disorders, ES-
COP monograph: symptomatic treatment
of gastrointestinal complaints such as minor
spasms, epigastric distension, flatulence and
belching, HMPC monograph: in progress
Positive monograph: for external use, the Terpenes ESCOP, WHO, Commission E:
essential oil is used mostly, which may in- (e.g. eucalyptol for external use
duce contact allergies when used externally [D1,8-cineol])
(s. BfR statement: http://www.bfr.bund.de/
cm/206/verwendung_von_unverduenntem_
teebaumoel_als_kosmetisches_mittel.pdf),
WHO monograph and ESCOP monograph
(oil): for external use
Positive monograph, indications: chronic Nausea, vomiting, headache (Roth/ Coumarin Commission E, ESCOP: equiv-
venous insufficiency (especially pain and feel- Daunderer), contains coumarin, s. alent to 3–30 mg coumarin per
ing of heaviness in legs, night leg cramps, BgVV statement: http://www.bfr. day, equivalent preparations
itching, swelling), adjuvant treatment of bund.de/cm/208/gehalte_an_cumarin_
thrombophlebitis, postthrombotic syndrome, safrol_methyleugenol_und_estragol_
haemorrhoids, lymphatic blockage, ESCOP in_lebensmitteln.pdf+O245
monograph: symptomatic treatment of prob-
lems related to varicose veins, such as painful
and heavy legs, nocturnal cramps in the legs,
itching and swelling, HMPC monograph: tra-
ditional use, BfArM graduated plan of 23 May
1997 concerning coumarin-containing phy-
topharmaceuticals and homeopathic drugs
up to potency D2 containing sweet clover
(Meliloti herba) or sweet woodruff (Gallii
odorati herba) (for internal use)
Positive monograph, indications: nervous Commission E, WHO: 1.5–4.5 g
sleep disturbances, functional gastrointestinal drug, several times a day
disorders, standard marketing authorisation: ESCOP: 2–3 g drug, 2–3 times
1149.99.99, WHO monograph, HMPC mono- a day, equivalent preparations
graph: traditional use, WHO monograph:
external use, ESCOP monograph: tenseness,
restlessness and irritability, symptomatic
treatment of digestive disorders such as mi-
nor spasms
Menthofuran,
eucalyptol (D1,8-
cineol)
81

(Latin)
Mentha pulegium L., syn. Mentha Herb S
gibraltarica WILLD., Mentha hir-
tiflora OPIZ ex TOPIZ, Pulegium
erectum MILL.
Mentha spicata L. emend. L. var. Leaf T, S

crispa BENTH.
Mentha suaveolens EHRH. Herb T, S

Mentha x piperita L., syn. Mentha Leaf T, S
piperita (L.) HUDS.
Menyanthes trifoliata L., syn. Leaf T

Menyanthes palustris TOURN,
Trifolium castoris THAL
Momordica charantia L. Fruit
Monarda didyma L., syn. Monarda Flower T

purpurea LAM., Monarda coccinea
MICHX.
Morus alba L., syn. Morus Leaf Not NFS
bombycis KOIDZ., Morus constanti-
nopolitana POIR., Morus indica L.
Morus alba L., syn. Morus Fruit
bombycis KOIDZ., Morus constanti-
nopolitana POIR., Morus indica L.
Morus nigra L. Leaf Not NFS
Morus nigra L. Fruit
Mucuna pruriens (L.) DC., syn. all plant parts
Dolichos pruriens L.
Murraya koenigii (L.) SPRENG. Leaf S

Musa acuminata X Musa bal- Fruit
bisiana, syn. Musa paradisiaca L.
Myrciaria dubia (KUNTH) Mc- Fruit Not NFS
VAUGH, syn. Psidium dubium
KUNTH
Myristica fragrans HOUTT., syn. Dried aril S
Myristica americana ROTTB.,
Myristica aromatica SWARTZ,
Myristica officinalis L.
82

substances dose
slightly toxic to toxic (Roth/Daunderer), Ingestion of higher doses causes Monoterpenes
toxic II (Wink/Wyk) contains pulegone (dose retching, vomiting, increase in blood (e.g. pulegone)
restriction acc. to Reg. (EC) No. 1334/2008) pressure, central anaesthesia-like
paralysis, death by central apnoea,
cases of poisoning after abuse as abor-
ticide known (Roth/Daunderer)
L-carvone,
limonene,
eucalyptol (D1,8-
cineol)
Positive monograph, indications: cramps in Menthol, men- Commission E: 3–6 g drug/day,

the gastrointestinal tract, the gall bladder and thone, eucalyptol equivalent preparations
the biliary tract, standard marketing authori- (D1,8-cineol) ESCOP: 1.5–3 g drug in 150 ml
sation: 1499.99.99, WHO monograph (leaves, water 3 times a day
oil), HMPC monograph: traditional use, ES- WHO: 1–3 g drug 3 times a day
COP monograph: symptomatic treatment of
digestive disorders, such as flatulence, irritable
bowel syndrome, symptomatic treatment of
coughs and colds
Positive monograph, indications: lack of unpleasant headache, ingestion of high Commission E: 1.5–3 g drug/day,
appetite, digestive problems, hardly toxic (+) doses causes vomiting and diarrhoea equivalent preparations
(Roth/Daunderer) (Roth/Daunderer)
Seeds and pericarp of ripe fruits very toxic Ib Seeds and pericarp of ripe fruits cause Cucurbitacins WHO: 2–15 g drug/day
(Wink/Wyk), therefore only young fruits severe vomiting and diarrhoea, inhibi-
should be used in food, WHO monograph: tion of ribosomal biosynthesis (Wink/
emetic, laxative and tonic Wyk)
Carvacrol, thymol
toxic + (Roth/Daunderer), toxic II (Wink/Wyk) hallucinogenic, psychotropic (Wink/ Indole alkaloids,

Wyk) levodopa, sero-
tonin
toxic when abused + (Roth/Daunderer) Ingestion of high doses causes Myristicin, safrole
headache, dizziness, changes in con-
sciousness up to hallucinations,
ventricular tachycardia, vertigo, my-
driasis, vomiting, abortifacient effect.
Safrole contained in the essential oil
has a mutagenic effect and demon-
strated a carcinogenic effect in animal
experiments (Wink/Wyk)
83

(Latin)
Myristica fragrans HOUTT., syn. Seed S
Myristica americana ROTTB.,
Myristica aromatica SWARTZ,
Myristica officinalis L.
Nasturtium officinale R. BR., Syn. Herb

Baeumerta nasturtium GAERTN.,
MEY., SCHERB.
Nelumbo nucifera GAERTN., syn. Flower C

Nelumbium nelumbo (L.) DRUCE
Nepeta cataria L., syn. Nepeta mi- Herb S, T
nor MILL., Nepeta vulgaris LAM.,
Cataria vulgaris MOENCH
Nerium oleander L., syn. Nerium Leaf
laurifolium LAM.
Ocimum basilicum L. syn. Herb S

Basilicum Indicum et citratum
RUMPH., Ocimum album L., Oci-
mum menthaefolium HOCHST. ex
BENTH.
Ocimum tenuiflorum L, Oci- Herb S

mum sanctum L., syn. Ocimum
album BLANCO, Ocimum virgatum
BLANCO
Olea europaea L., syn. Olea of- Leaf T
ficinarum CRANTZ, Olea pallida
SALISB.
Ononis spinosa L., syn. Ononis Root T
arvensis L., Ononis campestris
KOCH et ZIZ.
84

substances dose
Negative monograph: due to risks, toxic when Ingestion of high doses causes Myristicin, safrole
abused + (Roth/Daunderer), toxic II (Wink/ headache, dizziness, changes in con-
Wyk) sciousness up to hallucinations,
ventricular tachycardia, vertigo, my-
driasis, vomiting, abortifacient effect.
Safrole contained in the essential oil
has a mutagenic effect and demon-
strated a carcinogenic effect in animal
experiments (Wink/Wyk). Ingestion
of approx. 5 g of nutmeg seeds causes
a series of mental disorders, which may
manifest themselves in slight changes
in consciousness up to intense hallu-
cinations. Ingestion of 9 teaspoons of
nutmeg powder per day observed to
produce an effect similar to that of at-
ropine. The drug has an abortifacient
effect in high doses (Commission E
monograph)
Positive monograph, indications: catarrhs Contraindications: gastrointestinal Glucosinolates Commission E: daily dose: 4–6 g
of the respiratory tract, slightly toxic only in complaints observed in rare cases drug or 20–30 g fresh herb or
larger amounts (+) (Roth/Daunderer) Contraindications: gastrointestinal 60–150 g freshly pressed juice,
ulcers, inflammatory kidney diseases equivalent preparations
(Commission E monograph)
Negative monograph: due to risks, oleander Numbness of tongue and throat, nau- cardioactive gly-
glycosides prescription-only, oleander phar- sea, vomiting, cramps, disorientation, cosides
macy-only, highly toxic ++ (Roth/Daunderer), visual disturbances, diarrhoea, cardiac
extremely toxic Ia (Wink/Wyk) arrhythmia, apnoea, shock, brady-
cardia, death may occur 2–5 hours
after ingestion (Wink/Wyk, Roth/
Daunderer)
Negative monograph: due to risks contains estragole. After metabolic Estragole
activation, isolated estragole has a mu- (Dmethyl chavi-
tagenic effect. Animal experiments col)
provide indications of carcinogenic
effect. Risks during pregnancy and lac-
tation, for infants and young children
as well as during long-term use cannot
be ruled out (Schilcher)
WHO monograph: traditional use WHO: 6–12 g drug/day

traditional use
Positive monograph, indications: irriga- Contraindications reported (Commis- Commission E: 6–12 g drug/day,
tion therapy of inflammatory diseases of the sion E monograph) equivalent preparations
lower urinary tract, prevention of kidney ESCOP: 2–3 g drug, 2 times a day
gravel, standard marketing authorisation:
9899.99.99, ESCOP monograph: irrigation of
the urinary tract, especially in cases of inflam-
mation and renal gravel, and as an adjuvant in
treatment of bacterial infections of the urinary
tract, HMPC monograph: in progress
85

(Latin)
Origanum majorana L., syn. Ama- Herb S
racus majorana (L.) SCHINZ et
THELLUNG, Majorana hortensis
MOENCH
Origanum majorana L., syn. Ama- Fruit Not NFS

racus majorana (L.) SCHINZ et
THELLUNG, Majorana hortensis
MOENCH
Origanum vulgare L., syn. Orig- Herb S
anum anglicum HILL., Origanum
creticum L., Origanum latifolium
MILL., Origanum venosum WILLD.
ex BENTH.
Orthosiphon aristatus (BLUME) Leaf T
MIQUEL, syn. Orthosiphon
stamineus BENTH., Orthosiphon
spicatus (THUNB.) BAK., Ocimum
grandiflorum BOLD
Oryza sativa L. Fruit, seed

Osmanthus fragrans (THUN.) Flower
LOUR.
Paeonia officinalis (L.) emend. Flower C
WILLD., syn. Paeonia feminea
MILL., Paeonia foemina GARS.
Panax ginseng C.A. MEY., syn. Ar- Root T
alia ginseng (C.A. MEY.) BAILL.,
Panax quinquefolius L. var. coreen-
sis LIEB.
Panax notoginseng CHEN. Root Not NFS

Panax pseudoginseng WALL. Root Not NFS
Panax quinquefolius L., syn. Root Not NFS
Aralia canadensis TOURN., Au-
reliana canadensis LAFIT., Ginseng
quinquefolium WOOD., Panax
americanum RAF.
Panicum miliaceum L., syn. Pan- Seed
icum PERS.
86

substances dose
Negative monograph: due to risks Hydroquinone contained in the drug Hydroquinones
demonstrates a carcinogenic effect in and hydro-
animal experiments (Commission E quinone
monograph) derivatives
(e.g. arbutin)
Neutral monograph, WHO monograph: tra-

ditional use
Positive monograph, indications: irrigation Contraindications: oedemas associated Commission E: 6 to 12 g drug,

therapy of bacterial and inflammatory dis- with cardiac and renal insufficiency equivalent preparations
eases of the lower urinary tract and kidney (Commission E monograph) ESCOP: 2–3 g in 150 ml water,
gravel, ESCOP monograph: irrigation of the 2–3 times a day, equivalent
urinary tract, especially in cases of inflam- preparations
mation and renal gravel, and as an adjuvant
in the treatment of bacterial infections of
the urinary tract, HMPC monograph: tradi-
1159.99.99
Neutral monograph: slightly toxic (+) (Roth/ Flowers and seeds may induce gas-
Daunderer) troenteritis accompanied by vomiting,
colic and diarrhoea (Roth/Daunderer)
Positive monograph, indications: tonic for Long-term use in higher doses causes Ginsenosides Commission E: 1–2 g drug/day,
strengthening and invigoration in case of diarrhoea, insomnia, euphoria, hyper- equivalent preparations
fatigue and faintness, decreasing physical tension and oedemas. “ginseng abuse” WHO: 0.5–2 g/day, equivalent
performance and powers of concentration as syndrome (Roth/Daunderer, Frohne) preparations, no administration
well as in convalescence, WHO monograph: to children
used as a prophylactic and restorative agent
for enhancement of mental and physical ca-
pacities, in cases of weakness, exhaustion,
tiredness, and loss of concentration, and
during convalescence, ESCOP monograph:
decreased mental and physical capacities such
as weakness, exhaustion, tiredness and loss
of concentration, as well as during convales-
cence, HMPC monograph: in progress, hardly
or only slightly toxic (+) (Roth, Daunderer)
WHO monograph: traditional use WHO: 3–9 g drug/day
87

(Latin)
Papaver rhoeas L. Petal Not NFS
Papaver somniferum L., syn. Dried latex
Papaver amplexicaule STOKES,
Papaver nigrum CRANTZ, Papaver
officinale GMD., Papaver opiiferum
FORSK.
Papaver somniferum L., syn. Seed

Papaver amplexicaule STOKES,
Papaver nigrum CRANTZ, Papaver
officinale GMD., Papaver opiiferum
FORSK.
Passiflora edulis (AUBL.) SCHUM. Fruit
Passiflora incarnata L., syn. Herb T
Granadilla incarnata MEDIK.
Passiflora incarnata L., syn. Flower C

Granadilla incarnata MEDIK.
Pastinaca sativa L., syn. Pastinaca Root

opaca BERNH., Pastinaca pratensis
H. MART., Pastinaca sativa var.
edulis DC., Pastinaca sativa var.
longa ALEF., Selinum pastinacae
CRANTZ
Paullinia cupana KUNTH ex Seed
H.B.K., syn. Paullinia cupana H.B.K.,
Paullinia sorbilis (L.) MART.
88

substances dose
Neutral monograph
the clotted milky sap (Ddried latex) of plants reduced mental performance, sopor, Opium alkaloids
belonging to the Papaver somniferum species irregular respiration, anaesthetic mus- (e.g. morphine,
referred to as opium is subject to the provi- cular relaxation, nausea, vomiting, codeine, papaver-
sions of the Narcotic Drugs Act (BtMG) highly bradycardia, dizziness, vertigo, tonic- ine)
toxic ++ ( Roth/Daunderer), very toxic Ib clonic cramps, central paralysis, pul-
(Wink/Wyk) monary oedema, cerebral oedema,
anaphylaxis, acute bilateral loss of
hearing, colonic inertia, death by ap-
noea (Hager, Roth/Daunderer)
s. BfR statement on opium poppy: http://
www.bfr.bund.de/cd/6279, http://www.bfr.
bund.de/cd/7409
Positive monograph, indications: nervous HCN release due to cyanogenic gly- cyanogenic gly- Commission E: 4–8 g drug/day,
agitation, standard marketing authorisation: cosides (Passiflora incarnata contains cosides, harmala equivalent preparations
1619.99.99, WHO monograph: mild seda- at most traces of these compounds alkaloids ESCOP, WHO: 0.5–2 g drug, 3–
tive for nervous restlessness, insomnia and (Hager)), release of harmala alkaloids is 4 times a day
anxiety. Treatment of gastrointestinal disor- likely to cause hallucinogenic effects
ders of nervous origin, ESCOP monograph: (Wink/Wyk)
tenseness, restlessness and irritability with
difficulty in falling asleep, HMPC monograph:
traditional use; information provided in the
literature stating that passion flower contains
harmala alkaloids not confirmed in more re-
cent studies. Only traces of harmala alkaloids
(below 1 ppm) detected in individual samples.
Whether these amounts are sufficient for CNS
activity needs to be investigated in in-vivo
studies. (Hänsel/Sticher, Hager)
Information provided in the literature stating Release of harmala alkaloids is likely Harmala alkaloids
that passion flower contains harmala alkaloids to cause hallucinogenic effects (Wink/
not confirmed in more recent studies. Only Wyk)
traces of harmala alkaloids (below 1 ppm)
detected in individual samples. Whether these
amounts are sufficient for CNS activity needs
to be investigated in in-vivo studies. (Hänsel/
Sticher, Hager)
Myristicin, furo-
coumarin
mildly toxic III (Wink/Wyk), toxic only when CNS stimulant, ingestion of higher Caffeine, saponins ESCOP: 1–3 g drug/day, equiva-
abused + (Roth/Daunderer), ESCOP mono- doses causes poisoning accompanied lent preparations
graph: tonic in cases of fatigue, exhaustion or by headache, vertigo, cardiac palpi-
convalescence, HMPC monograph: traditional tation, sleep disturbances, agitation,
use vomiting, diarrhoea, severe diuresis
(Wink/Wyk)
89

(Latin)
Pausinystalia yohimbe all plant parts
(K. SCHUM.) PIERRE ex BEILLE,
syn. Corynanthe yohimbe
K. SCHUM.
Peganum harmala L. all plant parts
Petasites spp., e.g. Petasites hy- all plant parts

bridus (L.) GAERTN., MEY. et
SCHERB.
Petroselinum crispum (MILL.) Seed T

NYM. ex A.W. HILL., syn. Apium
hortense E.H.L. KRAUSE, Apium
petroselinum L., Apium vulgare
LAM., Carum petroselinum BENTH.
et HOOK.
Petroselinum crispum (MILL.) Herb S

et HOOK.
Petroselinum crispum (MILL.) Root
et HOOK.
90

substances dose
Negative monograph: due to risks associ- Vertigo, hypersalivation, faintness, Alkaloids
ated with Yohimbe bark, Yohimbe pharmacy- cold spills, sweats, nervous excitement, (e.g. yohimbine)
only, yohimbic acid and its esters pre- cardiac palpitation, insomnia, gastric
scription-only, very toxic Ib (Wink/Wyk), complaints, headache, gastrointestinal
highly toxic ++ (Roth/Daunderer) s. BfR complaints, increase in blood pressure
statement: http://www.bfr.bund.de/cm/ and tachycardia, tremor, irritability
350/risikobewertung-von-pflanzen-und- (Hager)
WHO monograph: treatment of different psychotropic, hallucinogenic, hyper- Indole alkaloids WHO monograph: a teaspoon
forms of myasthenia, myopathy and atony of salivation, vomiting, muscular tremor (e.g. harmine, of the preparation of a teaspoon
the bowels, highly toxic ++ (Roth/Daunderer), (Hager, Wink/Wyk, Roth/Daunderer) harmaline), of drug in one cup of water, 3–
very toxic Ib (Wink/Wyk) quinazoline al- 4 times a day
kaloids
Positive monograph: for Petasites hybridus All plant parts of butterbur contain Pyrrolizidine Commission E: 4.5–7 g drug/day
rhizoma (butterbur rootstock), indications: varying amounts of hepatotoxic alkaloids
adjuvant treatment of acute cramps in the pyrrolizidine alkaloids, which
lower urinary tract, Negative monograph: demonstrated a mutagenic and car-
due to risks associated with Petasites hybridus cinogenic effect in animal experiments
folium (butterbur leaves), classification of (Schilcher)
Petasitidis folium as substance of concern
(AMK), BfArM graduated plan of 5 June 1992
concerning medicinal products contain-
ing pyrrolizidine alkaloids, toxic + (Roth/
Daunderer), mildly toxic II to toxic III (Wink/
Wyk)
Negative monograph: due to risks, Roth/ In high doses, the essential oil in pars- Furocoumarins,
Daunderer: hardly toxic (+), mildly toxic III ley seeds and the phenyl propanoid phenyl
(Wink/Wyk) derivative apiol contained in it induce propanoids
vascular congestions and enhance the (e.g. myristicin,
contractility of the smooth muscles apiol)
of the bladder, the intestines and es-
pecially the uterus. Parsley seeds and
parsley oil therefore formerly used as
aborticide; irritation, damage to renal
epithelial tissues and cardiac arrhyth-
mia reported, higher doses of apiol
in parsley may cause fatty liver dis-
ease, emaciation, bloody stool, profuse
haemorrhage of mucous membranes
and haemorrhagic-inflammatory in-
filtrations in the gastrointestinal tract,
haemolysis, methaemoglobinuria and
anuria (Commission E monograph).
Toxic effects are not expected in usual
doses (Roth/Daunderer), phototoxic
Positive monograph, indications: irrigation like seeds, but lower essential oil con- Furocoumarins, Commission E: 6 g drug/day,
therapy of diseases of the lower urinary tract tent, phototoxic phenyl equivalent preparations
and kidney gravel, Roth/Daunderer: hardly propanoids
toxic (+), mildly toxic III (Wink/Wyk) (e.g. myristicin,
apiol)
Positive monograph, indications: irrigation like seeds, but lower essential oil con- Furocoumarins, Commission E: 6 g drug/day,
therapy of diseases of the lower urinary tract tent, phototoxic phenyl equivalent preparations
and kidney gravel, Roth/Daunderer: hardly propanoids
toxic (+), mildly toxic III (Wink/Wyk) (e.g. myristicin,
apiol)
91

(Latin)
Peumus boldus MOL., syn. Peumus Leaf
fragrans PERS., Boldea fragrans
JUSS., Boldea fragrans C. GAY
Pfaffia paniculata (MART.) Root Not NFS

KUNTZE
Phaseolus vulgaris L., syn. Phaseo- Pod b
lus nanus L.
Phaseolus vulgaris L., syn. Phaseo- Seed b

lus nanus L.
Phoenix dactylifera L. Fruit

Phyllanthus emblica L., Emblica Fruit Not NFS
officinalis GAERTN., Phyllanthus
mairei LÉV.
Physostigma venenosum BAL- Seed
FOUR
Phytolacca americana L., syn. Phy- Fruit

tolacca decandra L., Phytolacca
vulgaris CRANTZ.
Picea abies (L.) KARSTEN, syn. Shoot (tip) T

Abies excelsa LAM. et DC., Abies
picea MILLER, Pinus abies L.
92

substances dose
Positive monograph, indications: mild neurotoxic effect observed, ingestion Alkaloids Commission E: average daily
gastrointestinal cramps, digestive prob- of higher doses causes paralysis, hal- (e.g. boldine), dose: 3.0 g drug, equivalent
lems, standard marketing authorisation: lucinations and CNS disorders (Wink/ monoterpenes preparations
2329.99.99, ESCOP monograph: minor hepa- Wyk), contraindications: occlusion (e.g. ascaridole) ESCOP: 2–5 g drug/day
tobiliary dysfunction, symptomatic treatment of biliary tract, severe liver diseases,
of mild digestive disturbances, HMPC mono- pregnancy (because of ascaridole con-
graph: traditional use, toxic II (Wink/Wyk), tent). In case of gallstones, use only
toxic + (Roth/Daunderer) after consultation with a physician.
(Commission E monograph)
Positive monograph, indications: slightly Seeds and pods contain lectin Lectin (“phasin”) Commission E: 5–15 g drug/day,
diuretic, standard marketing authorisation: (“phasin”). Since phasin is a protein, equivalent preparations
8499.99.99; in unprocessed form mildly toxic II it is destroyed by cooking, but not by
to toxic III (Wink/Wyk), highly toxic ++ (Roth/ drying. Symptoms usually occur after
Daunderer), heat thoroughly before consump- 2 to 3 hours. The severity of the disease
tion, HMPC monograph: traditional use varies from case to case. Symptoms
include nausea, abdominal pain and
vomiting, gastroenteritis and cramps.
May be accompanied by bloody di-
arrhoea. Besides fever, shivering and
sweats, convulsive fits and shock may
occur. (Bonn Poison Control Centre)
in unprocessed form mildly toxic II to toxic III, Seeds and pods contain lectin Lectin (“phasin”)
highly toxic ++ (Roth/Daunderer), heat thor- (“phasin”). Since phasin is a protein,
oughly before consumption it is destroyed by cooking, but not by
drying. Symptoms usually occur after
2 to 3 hours. The severity of the disease
varies from case to case. Symptoms
include nausea, abdominal pain and
vomiting, gastroenteritis and cramps.
May be accompanied by bloody di-
arrhoea. Besides fever, shivering and
sweats, convulsive fits and shock may
occur. (Bonn Poison Control Centre)
poisonous plant, extremely toxic (Roth/ Paraesthesia, inflammation of mucous Alkaloids

Daunderer), extremely toxic (Wink/Wyk), membranes, tremor, tachycardia, per- (e.g. physostig-
physostigmine prescription-only, Physostigma sistent vertigo, death by cardioplegia mine)
species pharmacy-only and respiratory arrest (Wink/Wyk)
toxic + (Roth/Daunderer), toxic II (Wink/Wyk) Nausea, vomiting, diarrhoea, abdom- Lectins, triterpene
inal pain, colic, headache, circulatory saponins
distress, abortion may occur, fatal poi-
soning possible (Wink/Wyk, Roth/
Daunderer)
Positive monograph, indications: catarrhs of Commission E: 5–6 g drug/day
the respiratory tract
93

(Latin)
Pilocarpus jaborandi HOLMES, Leaf
syn. Pilocarpus cearensis RIZZINI,
Pilocarpus officinalis POEHL
Pimenta officinalis LINDL., syn. Fruit S

Pimenta officinalis BERG, Pimenta
vulgaris LINDL., Eugenia pimenta
DC., Myrtus pimenta L., Pimenta
dioica (L.) MERR.
Pimpinella anisum L., syn. Anisum Fruit T, S
vulgare GAERTN.
Pimpinella major (L.) HUDS., syn. Herb S

Apium pimpinella CARUEL
Pimpinella major (L.) HUDS., syn. Root T,S
Apium pimpinella CARUEL
Pimpinella saxifraga L., syn. Herb S
Pimpinella alpestris SPRENG.
Pimpinella saxifraga L., syn. Root T,S
Pimpinella alpestris SPRENG.
Pinus mugo TURRA, syn. Pinus Shoot (tip) T
echinata HORT., Pinus montana
MILLER
Pinus sylvestris L., syn. Pinus nigra Shoot (tip) T
MILL.
Piper cubeba L.f., syn. Cubeba Fruit S
officinalis RAF.
94

substances dose
Pilocarpine prescription-only, Pilocarpus parasympathomimetic effect, Imidazole
species pharmacy-only, extremely toxic (Roth/ hypersalivation, sweating, visual dis- alkaloids (e.g. pi-
Daunderer), very toxic (Wink/Wyk), substance turbances, vomiting, diarrhoea, uterus locarpine)
of concern (AMK) contractions, abortion, bradycar-
dia, cardiac palpitation, convulsions,
tremor, dyspnoea, arrhythmia, vesical
tenesmus, headache, vertigo, death
by cardiac arrest, leucocytosis (Wink/
Positive monograph, indications: diges- allergic reactions of skin, respiratory Trans-anethole, Commission E, ESCOP, WHO:
tive problems, catarrhs of the respiratory tract and gastrointestinal tract occur furocoumarins, 3 g drug/day, equivalent prepara-
tract, standard marketing authorisation: occasionally (Commission E mono- estragole tions
8099.99.99, WHO monograph (fruit and graph) (Dmethyl chavi-
oil): treatment of dyspepsia and mild in- col)
flammation of the respiratory tract, ESCOP
monograph: dyspeptic complaints such as
mild spasmodic gastrointestinal complaints,
bloating, flatulence, catarrh of the upper res-
piratory tract, HMPC monograph: traditional
use
Neutral monograph phototoxic (Hager) Furocoumarins
Positive monograph, indications: catarrhs of phototoxic (Hager) Furocoumarins Commission E: 6–12 g drug/day,
the upper respiratory tract equivalent preparations
Neutral monograph phototoxic (Hager) Furocoumarins
Positive monograph, indications: catarrhs of phototoxic (Hager) Furocoumarins Commission E: 6–12 g drug/day,
Positive monograph, indications: catarrhs of Commission E: 2–3 g drug/day,

toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Ingestion of higher doses causes Cubebin, cubebic
painful urinary tract inflammations, acid
pain in kidneys and bladder, albumin-
uria, tachycardia, nausea, vomiting,
diarrhoea, CNS disorders, spasmodic
urinary retention, accelerated pulse,
cardialgia, diarrhoea and skin rash
95

(Latin)
Piper methysticum G. FORST., syn. Rhizome
Macropiper latifolium MIQ.
Piper nigrum L., syn. Muldera Fruit S

multinervis MIQ., Piper aro-
maticum LAM., Piper trioicum
ROXB.
Piscidia erythrina L., syn. Comp- Root cortex

tosema pinnatum BENTH., Piscidia
piscipula (L.) SARG.
Pistacia vera L., syn. Pistacia nar- Seed

bonensis L., Pistacia nigricans
CRANTZ, Pistacia officinarum
AITON
Pisum sativum L. Seed
Plantago lanceolata L., Arnoglos- Herb T
sum lanceolatum (L.) GRAY,
Plantago flexuosa GAUD ex RAPIN,
Plantago lanceofolia SALISB.
Plantago major L., syn. Plantago Herb Not NFS

asiata L., Plantago latifolia SALISB.
96

substances dose
withdrawal of marketing authorisation severe hepatotoxic reactions (Wink/ Kavapyrones ESCOP: equivalent to 60–120 mg
due to risks following the graduated Wyk, Roth/Daunderer, BfArM notifica- (e.g. kavain) kavalactones/day, (no data avail-
plan procedure (BfArM notification tion on graduated plan) able for children)
of 21 Dec 2007: http://www.bfarm. WHO: 60–210 mg kavapyrones/
de/DE/Pharmakovigilanz/risikoinfo/ day
stufenplanverf/Liste/stp-kavakava.html;
jsessionid=7AF6D40DED621345B74BFDC9AD594B34.
1_cid332), Positive monograph, indications:
states of nervous anxiety, stress and agitation,
WHO monograph: short-term symptomatic
treatment of mild states of anxiety or insom-
nia, due to nervousness, stress or tension,
ESCOP monograph: anxiety, tension and
restlessness arising from various causes of
non-psychotic origin, substance of concern
(AMK): kava-kava and kavain, toxic + (Roth/
Daunderer), mildly toxic (Wink/Wyk)
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/ Vomiting, hypersalivation, sweats, Isoflavones
Wyk) dizziness and tremor, first enhanced (jamaicin, mune-
then depressed respiration, central tone, ichthynone,
paralysis, cardioplegia, used as fish and rotenone)
arrow poison (Wink/Wyk)
Positive monograph, indications: catarrhs of ESCOP, Commission E: 3–6 g

the respiratory tract, inflammatory changes drug/day, equivalent prepara-
of the oral and pharyngeal mucosa, standard tions
marketing authorisation: 1289.99.99, ESCOP WHO monograph: 2–4 g drug,
monograph: catarrhs of the respiratory tract, 3 times a day
temporary, mild inflammations of the oral
and pharyngeal mucosa, HMPC monograph:
traditional use
WHO monograph, indications: catarrh of
the respiratory tract, cough, bronchitis, in-
flammatory alterations of the oral mucosa,
phlegm congestion, nephritis, cystitis, urinary
retention, dysentery, epistaxis (nosebleed) and
excessive diaphoresis (49, 50). It is also used for
the treatment of diarrhoea and constipation
97

(Latin)
Plantago ovata FORSSKAL, syn. Seed husk
Plantago isphagula ROXB. ex
FLEMMING, Plantago brunnea
MORRIS
98

substances dose
higher swelling number than psyllium seeds, Side effects: hypersensitivity reactions Commission E, ESCOP: 4–20 g
risk of intestinal occlusion after overdose, may occur in individual cases, con- drug/day, equivalent prepara-
Positive monograph, indications: habit- traindications: pathologic stenosis of tions (children!)
ual constipation, conditions in which easy gastrointestinal tract, imminent or HMPC: 7–20 g drug/day, equiv-
defaecation is desirable, e.g. anal fissures, existing intestinal occlusion (ileus), alent preparations, special doses
haemorrhoids, after rectal-anal surgical difficult-to-control diabetes mel- for children
procedures and during pregnancy, adjuvant litus (Commission E monograph),
treatment of diarrhoea of various origins as oesophageal occlusion or obstruction
well as irritable bowel, WHO monograph: up to intestinal occlusion may occur
a bulk-forming laxative used therapeuti- on improper use (HMPC monograph)
cally for restoring and maintaining bowel
regularity, treatment of chronic constipa-
tion, temporary constipation due to illness
or pregnancy, irritable bowel syndrome and
constipation related to duodenal ulcer or di-
verticulitis, also indicated for stool softening
in the case of haemorrhoids, or after anorectal
surgery, short-term use for the symptomatic
treatment of diarrhoea of various etiologies,
ESCOP monograph: treatment of occasional
constipation, conditions in which easy defi-
cation with soft stools desireable, e.g. in cases
of anal fissures or haemorrhoids, after rectal
or anal surgery, and during pregnancy; condi-
tions which need an increased daily intake of
fibre, e.g. irritable bowel syndrome, adjuvant
symptomatic therapy in cases of diarrhoea
from various causes, as an adjunct to a low
fat diet in the treatment of mild to moderate
hypercholesterolaemia, HMPC monograph:
habitual constipation; in conditions in which
easy defaecation with soft stool is desirable,
e.g. in cases of painful defaecation after rectal
or anal surgery, anal fissures and haemor-
rhoids; in patients to whom an increased daily
fibre intake may be advisable e.g. as an adju-
vant in constipation predominant irritable
bowel syndrome, as adjuvant to diet in hyper-
cholesterolemia
99

(Latin)
Plantago ovata FORSSKAL, Seed
syn.Plantago isphagula ROXB. ex
FLEMMING, Plantago brunnea
MORRIS
Plantago psyllium L., syn. Plantago Seed

afra L., Plantago (L.) MIRB.
Podophyllum peltatum L. Root, resin
100

substances dose
Positive monograph, indications: habit- allergic reactions observed in rare Commission E: 12–40 g drug/
ual constipation, conditions in which easy cases, especially with comminuted day, equivalent preparations
defaecation is desirable, e.g. anal fissures, drug and liquid preparations (Com- ESCOP: 7–30 g/day, equivalent
haemorrhoids, after rectal-anal surgical mission E monograph), oesophageal preparations, special doses for
procedures and during pregnancy, adjuvant occlusion or obstruction up to intesti- children and for the indication of
treatment of diarrhoea of various origins as nal occlusion may occur on improper hypercholesterolaemia
well as irritable bowel, standard marketing use (HMPC monograph) WHO: 7.5 g drug in 240 ml water,
authorisation: 1549.99.99, WHO monograph: 1–3 times a day, special doses for
as a bulk-forming laxative used to restore children
and maintain regularity, Semen Plantagi- HMPC: 8–40 g drug/day, equiv-
nis is indicated in the treatment of chronic alent preparations, special doses
constipation, temporary constipation due to for children
illness or pregnancy, irritable bowel syndrome,
constipation related to duodenal ulcer or di-
verticulitis. It is also used to soften the stools
of those with haemorrhoids, or after anorectal
surgery, traditional use, ESCOP monograph:
treatment of occasional constipation, con-
ditions in which easy defication with soft
stools desireable, e.g. in cases of anal fissures
or haemorrhoids, after rectal or anal surgery,
and during pregnancy; conditions which need
an increased daily intake of fibre, e.g. irritable
bowel syndrome, adjuvant symptomatic ther-
apy in cases of diarrhoea from various causes,
HMPC monograph: treatment of habitual
constipation. In conditions in which easy de-
faecation with soft stool is desirable, e.g. in
cases of painful defaecation after rectal or anal
surgery, anal fissures and haemorrhoids.
Positive monograph, indications: habit- Contraindications: oesophageal and Commission E, ESCOP: 10–30 g
ual constipation, irritable colon, standard gastrointestinal stenosis, side effects: drug/day, equivalent prepara-
marketing authorisation: 1509.99.99, WHO allergic reactions observed in rare tions (special doses for children)
monograph: as a bulk-forming laxative used cases, especially with comminuted WHO: 7.5 g drug in 240 ml water,
to restore and maintain regularity, Semen drug (Commission E monograph), 1–3 times a day, special doses for
Plantaginis is indicated in the treatment of oesophageal occlusion or obstruction children
chronic constipation, temporary constipation up to intestinal occlusion may occur HMPC: 25–40 g drug/day, equiv-
due to illness or pregnancy, irritable bowel on improper use (HMPC monograph) alent preparations, special doses
syndrome, constipation related to duodenal for children
ulcer or diverticulitis, it is also used to soften
the stools of those with haemorrhoids, or af-
ter anorectal surgery, ESCOP monograph:
treatment of occasional constipation, con-
ditions in which easy defication with soft
stools desireable, e.g. in cases of anal fissures
or haemorrhoids, after rectal or anal surgery,
and during pregnancy, adjuvant symptomatic
therapy in cases of diarrhoea from various
causes, HMPC monograph: treatment of ha-
bitual constipation, in conditions in which
easy defecation with soft stool is desirable,
e.g. in cases of painful defecation after rectal or
anal surgery, anal fissures and haemorrhoids.
Positive monograph for external use, also Plant cytostatic, strong mitotic poison, Podophyllin,
toxic when used externally, root and prepa- haemorrhagic gastroenteritis, bloody- lignans
rations thereof as well as various substances watery diarrhoea, impaired coordina- (e.g. podophyl-
of P. peltatum prescription-only, use as ver- tion, cramps, tachycardiac arrhythmia, lotoxin, peltatin)
mifuge, laxative and diuretic reported (Roth/ paraesthesia, nephritis, coma, death by
Daunderer), very toxic Ib (Wink/Wyk), toxic + apnoea (Roth/Daunderer)
to highly toxic ++ (Roth/Daunderer)
101

(Latin)
Pogostemon patchouly PELLET., Leaf Not NFS
syn. Pogostemon cablin (BLANCO)
BENTH., Pogostemon intermedium
BENTH.
Polygala senega L. Root T
Polygonatum multiflorum (L.) all plant parts

ALL., syn Convallaria multiflora L.
Polygonum aviculare L., syn. Poly- Herb T

gonum heterophyllum LINDM.
Potentilla anserina L., syn. Ar- Herb T

gentina anserina RYDBERG,
Argentina vulgaris LAM., Dacty-
lophyllum anserina SPENNER
Potentilla erecta (L.) RÄUSCHEL, Rhizome F

syn. Potentilla tormentilla
NECKER, Potentilla tormentilla
SCHRANK, Potentilla tormentilla
STOKES, Tormentilla erecta L., Tor-
mentilla officinalis CURT.
Primula elatior (L.) HILL, Primula Flower C

veris L.
Primula veris L., syn. Primula coro- Root T

naria SALISB. Primula montana
REUT., Primula odorata GILIB. and
Primula elatior (L.) HILL
Prunus amydalus var. sativa (L.) Flower Not NFS

FOCKE, syn. Amygdalus communis
L. var. dulcis DC.
Prunus amydalus var. sativa (L.) Seed
FOCKE, syn. Amygdalus communis
L. var. dulcis DC.
Prunus amygdalus BATSCH var. Seed F
amara (DC.) FOCKE
Prunus armeniaca L., syn. Armeni- Fruit

aca vulgaris LAM.
102

substances dose
Positive monograph, indications: catar- contains saponins, long-term use Commission E, ESCOP, WHO:
rhs of the upper respiratory tract, ESCOP causes gastrointestinal irritation (Com- 1.5–3 g drug/day, equivalent
monograph: productive cough, catarrh of the mission E monograph) preparations, administration
respiratory tract, chronic bronchitis, WHO to children only under medical
monograph: traditional use supervision
toxic + (Roth/Daunderer), mildly toxic II to Nausea, diarrhoea, vomiting, used as steroidal saponins
toxic III (Wink/Wyk) emetic in traditional Russian medicine
(Roth/Daunderer)
Positive monograph, indications: mild catar- Commission E, WHO mono-
rhs of the respiratory tract, inflammatory graph: 4–6 g drug/day,
changes of the oral and pharyngeal mucosa, equivalent preparations
WHO monograph: supportive treatment of
gingivitis, used for the relief of cough and cold
symptoms
Positive monograph, indications: mild dys- Symptoms of irritable stomach may Commission E: 4–6 g drug/day,
menorrhoea, adjuvant treatment of mild, non- be aggravated (Commission E mono- equivalent preparations
specific, acute forms of diarrhoea, mild inflam- graph)
Positive monograph, indications: non- Sensitive patients may experience Commission E: 4–6 g drug/day,
specific, acute forms of diarrhoea, mild inflam- gastric complaints (Commission E equivalent preparations
mations of the oral and pharyngeal mucosa, monograph)
HMPC monograph: traditional use, s. BfR
statement: http://www.bfr.bund.de/cm/
Positive monograph, indications: catarrhs of gastric complaints and nausea ob- Commission E: 2–4 g drug/day,
the respiratory tract, WHO monograph: tradi- served in rare cases, contraindications equivalent preparations
tional use, standard marketing authorisation: reported (Commission E monograph)
1659.99.99, HMPC monograph: traditional use
Positive monograph, indications: catarrhs of Side effects: gastric complaints and Saponins Commission E, ESCOP: 0.5–1 g
the respiratory tract, standard marketing au- nausea observed in rare cases, con- (5–10 g) drug/day, equivalent
thorisation: 2389.99.99, ESCOP monograph: traindications reported (Commission E preparations
productive cough, catarrh of the respiratory monograph)
tract, chronic bronchitis, HMPC monograph:
traditional use, mildly toxic III (Wink/Wyk)
Guidelines for oils seeds as well as mixtures

and sweets produced thereof laid down in the
German Food Code
Guidelines for oils seeds as well as mixtures Hydrocyanic acid (HCN) may be re- cyanogenic
and sweets produced thereof laid down in leased on ingestion, HCN is a strong glycosides
the German Food Code: Almonds may con- respiratory inhibitor, ingestion of (e.g. amygdalin)
tain up to 5 wt% bitter almonds, very toxic Ib higher doses causes burning in the
(Wink/Wyk), toxic + to highly toxic ++ (Roth/ throat, sweating, abdominal pain,
Daunderer) vomiting, facial blush, hypersalivation,
convulsions, respiratory and cardiac
arrest (Wink/Wyk)
103

(Latin)
Prunus armeniaca L., syn. Armeni- Seed
aca vulgaris LAM.
Prunus avium L. Fruit

Prunus avium L. Stalk Not NFS
Prunus cerasus L., Cerasus vul- Fruit
garis MILL., Cerasus caproniana
DC., Prunus caproniana GAUD.,
Druparia cerasus CLAIRV.
Prunus cerasus L., Cerasus vul- Stalk Not NFS
garis MILL., Cerasus caproniana
DC., Prunus caproniana GAUD.,
Druparia cerasus CLAIRV.
Prunus domestica L., syn. Prunus Fruit
communis HUDS. Non ARCANG.,
Prunus sativa ROUY et CAMUS
Prunus persica (L.) SIEB. et ZUCC., Fruit
syn. Persica vulgaris MILL., Amyg-
dalus persica L.
Prunus spinosa L., syn. Druparia Flower T
spinosa CLAIRV.
Prunus spinosa L., syn. Druparia Fruit
spinosa CLAIRV.
Psidium guajava L. Fruit
Psidium guajava L. Leaf Not NFS
Psychotria viridis RUIZ et PAV. all plant parts
Pteridium aquilinum (L.) KUHN, all plant parts

syn. Pteris aquilina L., Asplenium
aquilinum (L.) BERNH.
Pterocarpus santalinus L.f., Wood S, T

syn. Lingoum santalinum (L.f.)
KUNTZE.
Ptychopetalum olacoides BENTH. Wood Not NFS
Pueraria lobata (WILLD.) OHWI, Root

syn. Pueraria thunbergiana (SIEB.
et ZUCC.) BENTH., Pueraria hirsuta
(THUNB.) SCHNEID. non KURZ,
Dolichos japonicus HORT.
104

substances dose
WHO monograph: symptomatic treatment Bitter apricot kernels have a high cyanogenic glyco- WHO: 3–9 g drug/day, no ad-
of asthma, cough with profuse expecto- cyanogenic glycoside content, sides ministration to children
ration and fever. The seed oil is used for e.g. amygdalin, which breaks down
treatment of constipation; Guidelines for to hydrogen cyanide during digestion,
oils seeds as well as mixtures and sweets symptoms of acute poisoning include
produced thereof: http://www.bmelv.de/ e.g. cramps, vomiting, dyspnoea, cul-
SharedDocs/Downloads/Ernaehrung/ minating in death by apnoea (BfR, FSA)
Lebensmittelbuch/LeitsaetzeOelsamen.pdf?__
blob=publicationFile
Neutral monograph
Positive monograph: for external use (mouth- Commission E: 2–4 g drug/day,

wash) equivalent preparations
WHO monograph: acute diarrhoea, gingivitis, WHO: 500 mg drug, 3–4 times
rotaviral enteritis a day, no administration to chil-
dren under the age of 12
mildly toxic III (Wink/Wyk), used to- psychotropic, hallucinogenic (Wink/ Tryptamine alka-
gether with Banisteriopsis caapi to produce Wyk) loids (e.g. N,N-
ayahuasca, a narcotic, DMT is subject to the dimethyl-
provisions of the BtMG tryptamine=DMT)
all plant parts very toxic Ib (Wink/Wyk), Increased incidence of gastric and Ptaquiloside,
toxic + (Roth/Daunderer) oesophageal carcinoma reported thiaminase,
(Frohne/Pfänder), ptaquiloside con- cyanogenic glyco-
tained in the drug is highly mutagenic sides
and causes stomach and bladder can-
cer, thiaminase contained in the drug
destroys vitamin B1 (Wink/Wyk)
Neutral monograph
Neutral monograph
Isoflavones
105

(Latin)
Pulsatilla pratensis (L.) MILL., syn. all plant parts
Anemone intermedia SCHULT.,
Anemona pratensis L., Pulsatilla
breynii RUPR.
Pulsatilla vulgaris MILL., syn. all plant parts

Anemona pulsatilla L.
Punica granatum L., syn. Grana- Fruit

tum punicum ST. LAG., Punica
florida SALISB.
Punica granatum L., syn. Grana- Peel Not NFS
florida SALISB.
Punica granatum L., syn. Grana- Bark
florida SALISB.
Pyrus communis L. Fruit

Quassia amara L., syn. Quassia alat- Wood F
ifolia STOKES, Quassia cocea VAHL,
Quassia gujanensis D. DIETR.
Quercus robur L., syn. Quercus Bark T

femina MILL., Quercus fruc-
tipendula SCHRANK, Quercus
germanica LASCH
Quillaja saponaria MOLINA, syn. Bark Not NFS

Quillaja molinae DC.
Raphanus sativus L., syn. Raphanus Root

officinalis CRANTZ, Raphanus
raphanistrum var. sativus BECK
Rauvolfia serpentina (L.) BENTH. Root

ex KURZ, syn. Ophioxylon ob-
versum MIQ., Rauvolfia observa
(MIQ.) BAILL., Rauvolfia trifoliata
(GAERTN.) BAILL.
106

substances dose
Negative monograph: due to risks, Pulsatillae central paralysis, gastrointestinal com- Protoanemonin,
herba and preparations thereof prescription- plaints (nausea, vomiting, diarrhoea), saponins
only, pasque flower pharmacy-only, toxic + irritation of mucous membranes, ir-
(Roth/Daunderer) toxic Ib to very toxic II ritation of kidneys and lower urinary
(Wink/Wyk) tract (Wink/Wyk, Roth/Daunderer),
protoanemonin contained in the drug
has an abortifacient and teratogenic
effect (Schilcher)
Negative monograph: due to risks, Pulsatillae central paralysis, gastrointestinal com- Protoanemonin,
herba and preparations thereof prescription- plaints (nausea, vomiting, diarrhoea), saponins
only, pasque flower pharmacy-only, toxic + irritation of mucous membranes, ir-
(Roth/Daunderer) toxic Ib to very toxic II ritation of kidneys and lower urinary
(Wink/Wyk) tract (Wink/Wyk, Roth/Daunderer),
protoanemonin contained in the drug
has an abortifacient and teratogenic
effect (Schilcher)
WHO monograph for bark and pericarp: WHO: pericarp 2.5–4.6 g/day, no
chronic diarrhoea, dysentery, gingivitis and administration to children under
intestinal parasites the age of 12
WHO monograph for bark and pericarp: diar- Ingestion of higher doses (more than WHO: cortex (3–9 g drug/day),
rhoea, intestinal parasites 80 g) may cause nausea, diarrhoea, no administration to children
haemorrhage, vertigo, fever, tremor, under the age of 12
circulatory collapse, visual distur-
bances (WHO monograph)
mildly toxic II to toxic III (Wink/Wyk), slightly Ingestion of high doses causes di- Quassin
toxic + (Roth/Daunderer), use as flavouring gestive problems and CNS disorders
governed by Reg. (EC) No. 1334/2008 (Wink/Wyk), gastric irritation, vom-
iting, contraindicated in pregnancy
(Roth/Daunderer)
Positive monograph, indications: external Interactions: absorption of alkaloids Commission E: 3 g drug/day,
use: inflammatory skin diseases, internal use: and other alkaline medicinal products equivalent preparations
non-specific, acute forms of diarrhoea, lo- may be reduced or inhibited (Commis-
cal treatment of mild inflammations in the sion E monograph)
mouth and throat as well as in the genital
and anal region, HMPC monograph: tradi-
9099.99.99, mildly toxic (Wink/Wyk), non-
toxic or hardly toxic (+) (Roth/Daunderer)
may be slightly toxic (Roth/Daunderer) Overdose causes gastrointestinal com- Triterpene
plaints accompanied by gastric pain saponins
and diarrhoea, irritating to mucous
membranes (Roth/Daunderer)
Positive monograph, indications: digestive Commission E: 50–100 ml
problems, especially as a result of dyskine- pressed juice/day
sia of the biliary tract, catarrhs of the upper
respiratory tract
Positive monograph, indications: mild, es- Depression, fatigue, temporary im- Indole alkaloids Commission E: 600 mg drug,
sential hypertension, WHO monograph: potence, contraindications and (e.g. reserpine, equivalent to 6 mg total alka-
treatment of mild essential hypertension, interactions with medicinal products ajmalin, yohim- loids/day
Rauwolfia alkaloids prescription-only, R. reported (Commission E monograph), bine) WHO: 200 mg powder/day, aver-
serpentina, R. tetraphylla and R. vomito- arrhythmia, bradycardia up to car- age dose D 50–300 mg/day
ria pharmacy-only, highly toxic ++ (Roth/ diac arrest, acidosis, shock (Roth/
Daunderer), very toxic Ib (Wink/Wyk) Daunderer)
107

(Latin)
Rhamnus catharticus L., syn. Fruit
Cervispina cathartica (L.) MOENCH,
R. wicklia TEN., Rhamnus wikkor
LUCÉ, Rhamnus willdenowiana
HORT. ex K. KOCH
Rhamnus frangula L., syn. Fran- Bark

gula alnus MILL., Frangula frangula
(L.) KARST., Frangula vulgaris
BORGH.
Rhamnus purshiana DC. syn. Fran- Bark

gula purshiana (DC.) COOP.
108

substances dose
Positive monograph, indications: short-term strong laxative, gastrointestinal com- Anthranoids Commission E: 20–30 mg hy-
treatment of constipation, standard mar- plaints observed in individual cases, droxyanthracene derivatives/
keting authorisation: 1089.99.99, buckthorn long-term use/abuse causes electrolyte day, no administration to chil-
berries and preparations thereof pharmacy- loss (in particular potassium), may be dren under the age of 12
only, BfArM graduated plan of 21 June 1996 accompanied by muscular asthenia
concerning medicinal products for human use and cardiac dysfunction, albuminuria,
containing anthranoid-containing plant gen- haematuria, pseudomelanosis coli,
era, toxic (Roth/Daunderer), toxic II (Wink/ aggravation of colonic inertia (devel-
Wyk) opment of laxative addiction) resulting
from paralysis of intestinal muscles
due to loss of potassium, nausea, vom-
iting, diarrhoea, renal irritation (Roth/
Daunderer), contraindications and
interactions reported (Commission E
monograph)
Positive monograph for Rhamnus frangula, gastrointestinal complaints observed Anthranoids Commission E, ESCOP: 20–
indications: conditions in which easy defae- in individual cases, long-term use/ 30 mg hydroxyanthracene
cation with a soft stool is desirable, e.g. anal abuse causes electrolyte loss (in partic- derivatives/day, calculated as
fissures, haemorrhoids, after rectal-anal ular potassium), may be accompanied glucofrangulin A
surgical procedures, constipation, standard by muscular asthenia and cardiac dys- WHO: 0.5–2.5 g drug/day, the
marketing authorisation: 9399.99.99, WHO function, albuminuria, haematuria, individually correct dose is
monograph: short-term treatment of occa- pseudomelanosis coli, aggravation of the smallest dose required to
cional constipation, as a single dose, for total colonic inertia (development of laxa- maintain a soft stool. No admin-
intestinal evacuation before X-rays and other tive addiction) resulting from paralysis istration to children under the
diagnostic examinations when electrolyte of intestinal muscles due to loss of age of 10
solutions alone are insufficient for adequate potassium, contraindications and in- HMPC: equivalent to 10–30 mg
evacuation or the use of electrolyte solutions teractions reported, nausea, vomiting, hydroxyanthracene derivatives/
is not possible, ESCOP monograph: short- bloody diarrhoea, abdominal pain, day (calculated as glucofrangulin)
term treatment of occasional constipation, nephritis, circulatory collapse, as- no administration to children
HMPC monograph: short-term use in cases sumed to be mutagenic (Commission E under the age of 12
of occasional constipation, toxic II (Wink/ monograph)
Wyk), BfArM graduated plan of 21 June 1996
concerning medicinal products for human
use containing anthranoid-containing plant
genera, toxic + (Roth/Daunderer)
Positive monograph, indications: consti- strong laxative, nausea, vomiting, Anthranoids, Commission E: 20–30 mg hy-
pation, colonic inertia, standard marketing bloody diarrhoea, abdominal pain, saponins droxyanthracene derivatives/day
authorisation: 8699.99.99, WHO monograph: nephritis, circulatory collapse, as- calculated as cascaroside A
short-term treatment of occasional consti- sumed to be mutagenic (Wink/Wyk), ESCOP: 1.5–2 g drug/day, prepa-
pation, ESCOP monograph: short-term use gastrointestinal complaints observed rations equivalent to 20–30 mg
in cases of occasional constipation, HMPC in individual cases, long-term abuse hydroxyanthracene derivates
monograph: short-term use in cases of oc- causes electrolyte loss, in particular (calculated as cascaroside A), no
casional constipation, toxic II (Wink/Wyk), potassium, albuminuria and haema- administration to children under
toxic + (Roth/Daunderer), BfArM graduated turia, pigment implantation into the the age of 10
plan of 21 June 1996 concerning medicinal intestinal mucosa (pseudomelanosis WHO: 0.3–1 g drug/day
products for human use containing anthra- coli), aggravation of colonic inertia HMPC: equivalent to 10–30 mg
noid-containing plant genera (development of laxative addiction) hydroxyanthracene derivatives/
resulting from paralysis of intesti- day (calculated as cascaroside A),
nal muscles due to loss of potassium, no administration to children
contraindications and interactions under the age of 12
reported (Commission E processing
monograph)
109

(Latin)
Rheum officinale BAILLON Root F
Rheum palmatum L., syn. Rhabar- Root F

barum palmatum (L.) MOENCH,
Rheum laciniatum PRAIN
Rheum rhabarbarum L., syn. Stem

Rheum franzenbachii MÜNT.,
Rheum muricatum BLANCO,
Rheum undulatum L.
Rhodiola rosea L. Herb Not NFS
Rhodiola rosea L. Root Not NFS
Rhododendron spp., (medicinal all plant parts

plant: Rhododendron ferrugineum
L, syn. Chamaerhododendron fer-
rugineum BUBANI)
Rhus aromatica AIT., syn. Rhus Bark

canadensis MARSH. non MILL.
110

substances dose
Positive monograph, indications: consti- contains anthranoids, disturbance Oxalic acid, an- Commission E: 20–30 mg hy-
pation, standard marketing authorisation: of electrolyte balance (in particular thranoids droxyanthracene derivatives/
1189.99.99, WHO monograph: short-term potassium), albuminuria, haema- day, calculated as rhein, 30–
treatment of occasional constipation, ESCOP turia, reflectory activation of uterus 120 mg hydroxyanthracene
monograph: short-term use in cases of oc- during pregnancy, transfer of agly- derivatives equivalent to 1.2 to
casional constipation, HMPC monograph: cones into breast milk, gastrointestinal 4.8 g drug
short-term use in cases of occasional consti- cramps observed in individual cases, ESCOP: equivalent to 15–50 mg
pation, BfArM graduated plan of 21 June 1996 contraindications and interactions hydroxyanthracene derivatives/
concerning medicinal products for human reported (Schilcher) day (calculated as rhein), no
use containing anthranoid-containing plant administration to children under
genera the age of 10
WHO: 0.5–1.5 g drug/day,
equivalent to 10–30 mg hydrox-
yanthracene derivatives
HMPC: equivalent to 20–30 mg
hydroxyanthracene derivatives/
day (calculated as rhein), no
administration to children under
the age of 12
Positive monograph, indications: consti- Disturbance of electrolyte balance (in Oxalic acid, an- Commission E: 20–30 mg hy-
pation standard marketing authorisation: particular potassium), albuminuria, thranoids droxyanthracene derivatives/
1189.99.99, WHO monograph (rhizoma): haematuria, reflectory activation of day, calculated as rhein, 30–
short-term treatment of occasional consti- uterus during pregnancy, transfer of 120 mg hydroxyanthracene
pation, ESCOP monograph: short-term use aglycones into breast milk, gastroin- derivatives, equivalent to 1.2
in cases of occasional constipation, HMPC testinal cramps observed in individual to 4.8 g drug
monograph: short-term use in cases of occa- cases, contraindications and interac- ESCOP: equivalent to 15–50 mg
sional constipation, BfArM graduated plan of tions reported (Schilcher) hydroxyanthracene derivatives/
21 June 1996 concerning medicinal products day (calculated as rhein), no
for human use containing anthranoid-con- administration to children under
taining plant genera, mildly toxic III (Wink/ the age of 10
Wyk) WHO: 0.5–1.5 g drug/day,
equivalent to 10–30 mg hydrox-
yanthracene derivatives
HMPC: equivalent to 20–30 mg
hydroxyanthracene derivatives/
day (calculated as rhein), no
administration to children under
the age of 12
slightly toxic (+) (Roth/Daunderer), mildly Cases of poisoning in children ob- Oxalic acid, an-
toxic III (Wink/Wyk) served after consumption of large thranoids
amounts of raw and unripe rhubarb
stalks (Roth/Daunderer)
s. BfR statement: http://www.bfr.bund.de/

cm/350/risikobewertung-von-pflanzen-
und-pflanzlichen-zubereitungen.pdf, HMPC
monograph: (Rhodiolae roseae rhizoma et
radix): traditional use
Negative monograph: due to risks associated Burning in mouth and throat, hy- Triterpenes
with Rhododendron ferrugineum, toxic Ib persalivation, vomiting, cramps, (e.g. ursolic acid),
to very toxic II (Wink/Wyk), toxic + to highly diarrhoea, also affects CNS: headache, hydroquinones
toxic ++ (Roth/Daunderer) faintness, convulsions, death by respi- (e.g. arbutin), an-
ratory arrest (Wink/Wyk) dromedotoxin
(grayanotoxin I)
111

(Latin)
Rhus aromatica AIT., syn. Rhus Root cortex Not NFS
canadensis MARSH. non MILL.
Rhus coriaria L., Toxicodendron Fruit S
coriaria KUNTZE.
Rhus toxicodendron L., syn. Toxi- all plant parts
codendron quercifolium (MICHX.)
GREENE, Toxicodendron toxico-
dendron (L.) BRITT
Ribes nigrum L., syn. Ribes olidum Leaf T

MOENCH
Ribes nigrum L., syn. Ribes olidum Fruit

MOENCH
Ribes rubrum L., syn. Ribes do- Fruit
mesticum JANCZ., Ribes sativum
(RCHB.) SYME
Ricinus communis L., syn. Cro- Seed
ton spinosus L., Ricinus africanus
MILL., Ricinus. inermis JACQ., Rici-
nus. vulgaris MILL.
Robinia pseudoacacia L., syn. Pseu- Flower T, S b

doacacia odorata MOENCH
Rosa canina L., syn. Rosa armata Fruit

STEV. ex BESSER, Rosa caucasica
PALL.
Rosa gallica L., syn. Rosa grandi- Petal T
flora SALISB., Rosa provincialis
AIT., Rosa provincialis HERRM.,
Rosa pumila JACQ., Rosa rubra
LAM.
Rosa x centifolia, syn. Rosa centifo- Petal T
lia x vulgaris SERINGE ex DC., Rosa
gallica x centifolia REGEL
112

substances dose
extremely toxic Ia (Wink/Wyk) strong irritation of mucous mem- Pyrocatechol

branes in mouth, throat and derivatives
gastrointestinal tract, nausea, vom- (urushiols, tox-
iting, gastroenteritis accompanied by icondendrine)
bloody diarrhoea and colic, vertigo,
dizziness, excitement and serious kid-
ney damage (Wink/Wyk)
ESCOP monograph: adjuvant in the treatment ESCOP: 20–50 g leaves/litre,
of rheumatic conditions, HMPC monograph: 250–500 ml/day, equivalent
traditional use preparations
extremely toxic +++ ( Roth/Daunderer), Nausea, bloody diarrhoea, vomiting Lectins (e.g. ricin), WHO: 1–10 ml, no administra-
extremely toxic Ia (Wink/Wyk), WHO mono- accompanied by haemorrhage, acute alkaloids tion to children under the age of
graph (oil): short-term treatment (3–5 days) gastroenteritis, nephritis, liver damage, (e.g. ricinin) 12
for acute constipation when other dietary convulsions, tachycardia, circulatory
methods or bulk-forming laxatives have not arrest, death by cardiac or circulatory
provided adequate relief. As a cathartic for use failure or uraemia, consumption of
in bowel evacuation prior to surgery 6 seeds fatal to children, 10–20 seeds
fatal to adults (Wink/Wyk)
highly toxic ++ (Roth/Daunderer), very toxic Ib all plant parts toxic, in particular seeds Lectins (e.g. robin,
(Wink/Wyk), and fruits, contains the lectins phasin phasin)
and robin, haemagglutinating prop-
erties, cytotoxic, nausea, vomiting,
diarrhoea, drowsiness, mydriasis, con-
vulsive fits, abdominal pain (Wink/
Wyk), toxicity of robin is eliminated by
heating (Roth/Daunderer)
Neutral monograph, ESCOP monograph: ESCOP: 2–5 g drug, several times
adjuvant treatment of pain and joint stiffness a day
associated with osteoarthritis
Positive monograph: for external use Commission E: 1–2 g drug/day,
equivalent preparations
Positive monograph: for external use, HMPC

monograph: in progress (external use)
113

(Latin)
Rosmarinus officinalis L., syn. Leaf S, T
Rosmarinus angustifolius MILL.,
Rosmarinus flexuosus JORD. et
FOURR., Rosmarinus laxiflorus
DENOÉ, Salvia rosmarinus SCHLEI-
DEN
Rubia tinctorum L., syn. Rubia Root

tinctoria SALISB.
Rubus fructicosus L. Leaf T
Rubus fructicosus L. Fruit

Rubus fructicosus L. Root
Rubus idaeus L., syn. Rubus Leaf T
framboesianus LAMK., Rubus
rosaefolius SM.
Rubus idaeus L., syn. Rubus Fruit
framboesianus LAMK., Rubus
rosaefolius SM.
Rubus suavissimus S. LEE, syn. Leaf T
Rubus chingii var. Suavissimus S.
LEE
Rumex acetosa L., syn. Lapathum Herb
acetosa SCOP., Lapathum pratense
LAM.
Ruscus aculeatus L. Rhizome Not NFS
114

substances dose
Positive monograph, indications: digestive Ingestion of high doses causes coma, Eucalyptol (D1,8- Commission E: 4–6 g drug/day
problems, standard marketing authorisation: tonic-clonic cramps, impaired patel- cineol), camphor, ESCOP: 2–4 g drug/day
1219.99.99, WHO monograph: carminative lar reflex, reduced pupillary reflex, alpha-pinene WHO: 4–6 g drug/day or as in-
and spasmolytic to treat dyspepsia, traditional vomiting, gastroenteritis, uterine fusion 2–4 g in 150 ml water,
use, ESCOP monograph: improvement of haemorrhage, leucocytosis, renal ir- 3 times a day
hepatic and biliary function and in dyspeptic ritation, albuminuria, in severe cases
complaints, HMPC monograph: traditional death by pulmonary oedema (Roth/
use, slightly toxic (+) (Roth/Daunderer) Daunderer), specific case reports on
this are not available (Hager); prepara-
tions, predominantly in combination
with a complex composition, formerly
used for abortion; however, case re-
ports indicating a causal connection
between ingestion of rosemary and
abortion are not known. Experimental
studies allowing for assessing the risk
are not available either (Hager)
Negative monograph: due to risks, BfArM Ingestion of high doses causes di- Hydroxyan-
graduated plan of 15 Mar 1993 concerning gestive problems, nausea, vomiting, thraquinones
medicinal products containing Rubia tinc- bloody diarrhoea, abdominal pain, (e.g. lucidin)
torum, substance of concern (AMK) mildly nephritis, assumed to be mutagenic
toxic II to toxic III (Wink/Wyk) (Wink/Wyk)
Positive monograph, indications: non- Commission E: 4.5 g drug/day,
specific, acute forms of diarrhoea, mild inflam- equivalent preparations
Neutral monograph
Neutral monograph, HMPC monograph: in
progress
slightly toxic (Roth/Daunderer) Due to the oxalic acid content, care Oxalic acid
should be taken when consuming fresh
sorrel (Frohne)
Positive monograph, indications: adjuvant Gastric complaints and nausea may Commission E, ESCOP: extract
treatment of chronic venous insufficiency (es- occur in rare cases (Commission E equivalent to 7–11 mg rusco-
pecially pain and feeling of heaviness in legs, monograph) genin/day
night leg cramps, itching, swelling), adjuvant
treatment of symptoms associated with haem-
orrhoids such as itching and burning, HMPC
monograph: traditional use, ESCOP mono-
graph: supportive therapy for symptoms of
chronic venous insuffiency, such as painful,
tired and heavy legs, tingling and swelling,
supportive therapy for symptoms of haemor-
rhoids, such as itching and burning, slightly
toxic (+) to toxic + (Roth/Daunderer), mildly
toxic III (Wink/Wyk)
115

(Latin)
Ruta graveolens L., syn. Ruta grave- Leaf, herb
olens L. var. vulgaris WILLK., Ruta
hortensis MILL.
Salix alba L. Bark T
Salvia divinorum EPLING et all plant parts

JÁTIVA
Salvia officinalis L., syn. Salvia Leaf S, T

chromatica et papillosa HOFFMG.,
Salvia maior et minor GMELI,
Salvia tomentosa MILL.
Salvia sclarea L., syn. Aethiopis Leaf S

sclarea (L.) FOURR., Salvia vulgaris
MILL.
Salvia sclarea L., syn. Aethiopis Flower Not NFS

sclarea (L.) FOURR., Salvia vulgaris
MILL.
Salvia triloba L. FIL., syn. Salvia Leaf S, T

fruticosa MILL., Salvia lobryana
AZNAV.
Sambucus ebulus L., syn. Ebulum Fruit
humile GARCKE
Sambucus nigra L., syn. Sambucus Leaf Not NFS

arborescens GILIB., Sambucus
medullina GILIB.
Sambucus nigra L., syn. Sambucus Flower

medullina GILIB.
116

substances dose
Negative monograph: due to risks, toxic + Contact dermatitis, swelling of tongue, Furocoumarins,
(Roth/Daunderer), toxic Ib to very toxic II hypersalivation, severe gastroenteritis, quinoline alka-
(Wink/Wyk) diuresis, mydriasis, visual disturbances, loids
haematuria, even death, uterus con-
tractions, therefore formerly used as
aborticide (Wink/Wyk)
Positive monograph, indications: febrile dis- gastrointestinal complaints, allergic Salicylates Commission E: 60–120 mg total
eases, rheumatic conditions, headache, WHO or pseudoallergic reactions to the sali- salicin/day
monograph: symptomatic treatment of fever cylates contained in the drug (Wichtl, ESCOP, WHO: equivalent to
and pain, and symptomatic treatment of mild Schilcher), Reye’s syndrome 120–240 mg salicin
rheumatic conditions, treatment of the com- HMPC: 1572 mg extract/day on
mon cold, traditional use, ESCOP monograph: indication of well-established
relief of low back pain, symptomatic relief of use, 260–500 mg comminuted
mild osteoarthritc and rheumatic complaints, drug, 3 times a day on indication
HMPC monograph: short-term treatment of of traditional use
low back pain, traditional use
toxic II, psychotropic (Wink/Wyk), non- Psychotropic, hallucinogenic (Wink/ Diterpenes (e.g.
marketable narcotic acc. to Annex 1 of the Wyk), sweats, headache, disorientation, salvinorin A)
Narcotic Drugs Act (BtMG) psychosis, anxiety and panic attacks
reported (www.erowid.org)
Positive monograph, indications: digestive Long-term use of alcoholic extracts Thujone, eucalyp- Commission E: 4–6 g drug/day,
problems, excessive sweat secretion, ESCOP and pure essential oil may cause tol (D1,8-cineol), equivalent preparations
monograph: inflammations and infections of epileptiform cramps (Commission E camphor ESCOP: 1–1.5 g drug in 150 ml
the mouth and throat such as stomatitis, gin- monograph) water, also several times a day
givitis and pharyngitis, hyperhidrosis, HMPC WHO: 4 g/day
monograph: traditional use, WHO mono-
graph: treatment of influenza, bronchitis,
sinusitis, meningitis and neuritis, standard
marketing authorisation: 1229.99.99, slightly
or hardly toxic (Roth/Daunderer)
Eucalyptol
(D1,8-cineol),
camphor, es-
tragole (Dmethyl
chavicol)
Eucalyptol
(D1,8-cineol),
camphor, es-
tragole (Dmethyl
chavicol)
Thujone, eucalyp-
tol (D1,8-cineol),
camphor
mildly toxic III (Wink/Wyk), toxic + (Roth/ Nausea, vomiting, diarrhoea, tickle Iridoid glycosides
Daunderer) in the throat, vertigo, headache, vi- (e.g. ebuloside),
sual disturbances, cardiac complaints, lectins
bloody diarrhoea, cases of fatal poison-
ing also known (Wink/Wyk)
mildly toxic III (Wink/Wyk), hardly toxic (+) Ingestion of higher doses causes vom- cyanogenic
iting and diarrhoea (Wink/Wyk) glycosides
(e.g. sambunigrin),
lectins
Positive monograph, indications: coughs Commission E: 10–15 g drug/
and colds, standard marketing authorisation: day, equivalent preparations
1019.99.99, WHO monograph: traditional use, WHO: 3–5 g drug, 3 times a day
117

(Latin)
Sambucus nigra L., syn. Sambucus Fruit b
medullina GILIB.
Sanicula europaea L., syn. Astrantia Herb Not NFS

diapensia SCOP., Caucalis capi-
tata SALISB., Sanicula officinalis
GOUAN, Sanicula trilobata GILIB.,
Sanicula vulgaris (KOCH) LANDOZ.
Santalum album L., syn. San- Wood Not NFS

dalum album RUMPH., Santalum
myrtifolium (L.) ROXB., Sirium
myrtifolium L.
Saponaria officinalis L., syn. Bootia Root
nervosa GILIB., Lychnis officinalis
(L.) SCOP., Saponaria hybrida MILL.,
Saponaria nervosa GILIB., Silene of-
ficinarum RUPR., Silene saponaria
FRIES.
Sassafras spp. all plant parts
Satureja biflora (Buch.-Ham. ex D. Herb

Don) Briq.
Satureja hortensis L., syn. Herb S
Clinopodium hortense O. KUNTZE,
Satureja brachiata STOKES, Satureja
officinarum CRANTZ,
Schinus molle L., syn. Schi- Fruit S
nus molle var. areira (L.) DC.,
Schinus areira L. and Schinus tere-
binthifolius RADDI, syn. Schinus
antiarthriticus MART. ex MARCH,
Schinus mellisii ENGL., Schinus
mucronulata MART.
Schisandra chinensis (TURCZ.) Fruit

BAILL., syn. Idesia polycarpa
MORR. et DEVOS, Kadsura chi-
nensis TURCZ., Maximowiczia
amurensis RUPR.
118

substances dose
Use ripe fruits, heat sufficiently (cook) before Unripe fruits, seeds and green plant cyanogenic
consumption, HMPC monograph: in progress parts contain sambunigrin and lectin glycosides
which can be deactivated by thermal (e.g. sambunigrin),
exposure (Ternes), ingestion of higher lectins
doses of unripe, unheated fruits causes
vomiting and diarrhoea (Wink/Wyk)
Positive monograph, indications: catarrhs of Commission E: 4–6 g drug/day,
the respiratory tract equivalent preparations
Positive monograph, indications: adjuvant Ingestion of high doses may cause Santalol Commission E: 1.0–1.5 g es-
treatment of lower urinary tract infections, nephritis, digestive problems, heart- sential oil/day, 10–20 g drug,
toxic + (Roth/Daunderer), toxic II (Wink/Wyk) burn, dyspepsia and haematuria, equivalent preparations
irritating to skin (Wink/Wyk)
use in foods only known as an ingredient of Irritation of gastric mucosa observed Triterpene
“halva” recipes Positive monograph, indica- in rare cases (Commission E mono- saponins
tions: catarrhs of the upper respiratory tract graph)
poisonous plant, toxic + (Roth/Daunderer), The toxicity is basically attributed to Safrole

toxic II (Wink/Wyk), BfArM graduated plans safrole contained in the drug, which is
of 19 Jan 1995 and 13 Aug 1997 concerning a genotoxic carcinogen (Hager), inges-
medicinal products containing Sassafras, tion of higher doses causes nephritis,
sassafras oil is a “scheduled substance” of cat- loss of consciousness, faintness and
egory 1 acc. to Article 2 a of Regulations (EC) liver damage, irritating to skin (Wink/
No. 273/2004 and No. 111/2005 and is thus Wyk)
subject to the provisions of the Precursors
Control Act (GÜG).
Carvacrol
Both species are commercially available. Schinus terebinthifolius: headache,

(s. Guidelines for spices and other season- swollen eyelids, digestive problems
ing ingredients), Schinus terebinthifolius: (Wink/Wyk)
highly toxic (Roth/Daunderer), toxic II (Wink/
Wyk). After consumption of small amounts of
S. terebinthifolius as spice, the reported un-
desirable effects were, however, not detected
with fruits imported from the Réunion Island
WHO monograph: treatment of chronic WHO: 1.5–6 g drug/day
cough and asthma, diabetes, urinary tract dis-
orders, as a general tonic for treating fatigue
associated with illness
119

(Latin)
Schoenocaulon officinale Seed
(SCHLECHTEND. et CHAM.)
A. GRAY, syn. Sabadilla officinarum
BRANDT, Veratrum officinale
SCHLECHTEND. et CHAM.,
Asagraea officinalis LINDL.
Scopolia spp. all plant parts
Scutellaria baicalensis GEORGI, Leaf Not NFS

syn. Scutellaria macrantha FISCH.
Scutellaria baicalensis GEORGI, Root Not NFS

syn. Scutellaria macrantha FISCH.
Senecio spp. all plant parts
Serenoa repens (BARTR.) SMALL, Fruit Not NFS

Sabal serrulata (MICH.) NUTALL ex
SCHULT., Sabal serrulata ROEM.
et SCHULT., Brahea serrulata
(MICHX.) H. WENDL., Chamaerops
serrulata MICHX., Serenoa serrulata
HOOK.
Sideritis scardica GRISEB. Herb T
120

substances dose
poisonous plant, Veratrum alkaloids prescrip- The alkaloids contained in the drug steroidal alkaloids
tion-only, highly toxic ++ (Roth/Daunderer), act as nerve and muscle poison, burn- (e.g. veratridine,
extremely toxic Ia (Wink/Wyk) ing in the mouth and throat, nausea, cevadine, saba-
diarrhoea, fits of rage, bradycardia, dine)
dyspnoea, convulsions, even death,
highly irritating to skin (Wink/Wyk),
affects CNS, mental excitement,
cramps, uncontrolled rage, paraly-
sis of the myelencephalic centres, in
low doses vertigo, darkened vision,
marasmus, hypothermia, bradycardia,
dyspnoea and gastrointestinal irrita-
tion, damage to striated muscles (Roth/
Daunderer)
Positive monograph (rhizome of Scopolia psychotropic, facial blush, dry mucosa, Tropane alkaloids Commission E: 0.25–3.0 mg
carniolica JACQ.), indications: cramps in the tachycardia, mydriasis, hallucinations, (e.g. atropine, total alkaloids/day, calculated as
gastrointestinal, biliary and lower urinary tract euphoria, disorientation, micturi- L-hyoscyamine, hyoscyamine
in adults and schoolchildren, isolated alka- tion difficulties, insomnia, death by scopolamine)
loids and rhizome prescription-only, highly respiratory arrest (Wink/Wyk, Roth/
toxic Ib (Wink/Wyk) extremely toxic +++ Daunderer)
(Roth/Daunderer)
assumed to be hepatotoxic (Parker S.
Herbal medicines, adverse reactions.
The Regulatory Affairs Journal, 1994,
5:29)
WHO monograph: treatment of fever, nau- assumed to be hepatotoxic (Parker S. WHO: 3–9 g drug/day, no ad-
sea and vomiting, acute dysentery, jaundice, Herbal medicines, adverse reactions. ministration to children under
coughs, carbuncles and sores, and threatened The Regulatory Affairs Journal, 1994, the age of 12
abortion 5:29)
Negative monograph: due to risks associated hepatotoxic, withdrawal of marketing Pyrrolizidine
with wood ragwort (Senecio fucsii), substance authorisations in 1992 for drugs con- alkaloids
of concern (AMK), toxic + (Roth/Daunderer) taining pyrrolizidine alkaloids due to
toxic II (Wink, Wyk) risks, s. Federal Gazette of 17 June 1992
Positive monograph, indications: micturi- Side effects: gastric complaints ob- Commission E, WHO: 1–2 g drug
tion difficulties resulting from benign stage served in rare cases (Commission E or 320 mg extract/day, equivalent
I–II prostatic hyperplasia, WHO monograph: monograph) preparations
treatment of lower urinary tract symptoms
(nocturia, polyuria, urinary retention) sec-
ondary to BPH stages I and II, as defined by
Alken, in cases where diagnosis of prostate
cancer is negative, ESCOP monograph: symp-
(dysuria, pollakisuria, nocturia, urinary re-
tention) in mild to moderate benign prostatic
hyperplasia (BPH), i.e. stages I and II as defined
by Alken, stages II and II as defined by Vahlen-
sieck, or a comparable severity of symptoms as
evaluated by the International Prostate Symp-
tom Score and associated diagnostic tests,
121

(Latin)
Silybum marianum (L.) GAERTN., Fruit T
syn. Carduus marianus L.,
Carthamus maculatus LAM., Cri-
sium, maculatum SCOP., Mariana
mariana (L.) HILL., Silybum macu-
latum MOENCH
Sinapis alba L., syn. Bonnania Seed S

officinalis PRESL., Brassica alba
RABENH., Crucifera lampsana
E.H.L. KRAUSE, Eruca alba NOUL.,
Sinapis hispida TEN.
Smilax officinalis KUNTH in Root

H.B.K.
Solanum dulcamara L., syn. Dulca- Stem

mara flexuosa MOENCH, Solanum
laxum ROYLE, Solanum lyratum
THUNB.
Solanum nigrum L. emend. MILL., all plant parts

syn. Solanum alpinum ZOLL. et
MOR., Solanum americanum MILL.,
Solanum vulgare PARKINS.
Solidago virgaurea L., syn. Am- Herb T

phiraphis leiocarpa DC., Dectis
decurrens RAF. var. leiocarpa
BENTH., Solidago cantonensis
LOUR.
Sorbus aucuparia L., syn. Aucu- Fruit b

paria silvestris MED.
Spartium junceum L., syn. all plant parts

Sarothamnus junceus LINK, Spar-
tianthus junceus (L.) LINK
Spinacia oleracea L. Leaf

Stachys officinalis (L.) TREVISAN, Herb Not NFS
syn. Betonia officinalis L.
122

substances dose
Positive monograph, indications: digestive Commission E, WHO: 12–15 g
problems, toxic liver damage, adjuvant treat- drug/day, equivalent prepara-
ment of chronic inflammatory liver diseases tions
and liver cirrhosis, standard marketing au- ESCOP: equivalent to 154–
thorisation: 1589.99.99, WHO monograph: 324 mg silymarin/day
supportive treatment of acute or chronic hep-
atitis and cirrhosis induced by alcohol, drugs
or toxins, HMPC monograph: in progress,
ESCOP monograph: toxic liver damage, sup-
portive treatment in patients with chronic
inflammatory liver conditions and hepatic
cirrhosis
Positive monograph: for external use, Ingestion of high doses causes gas- Glucosinolates
harmful in high doses (+) (Roth/Daunderer), trointestinal complaints, nausea,
toxic II–III (in high doses) (Wink/Wyk) vomiting, diarrhoea, severe poisoning
causes central paralysis, bradycardia
and bradypnoea, even coma and death
(Roth/Daunderer, Wink/Wyk)
Negative monograph: due to risks, slightly gastric irritation, temporary liver steroidal saponins
toxic (+) (Roth/Daunderer) damage (Commission E monograph),
diarrhoea accompanied by vomiting,
central paralysis (Roth/Daunderer)
Positive monograph: for external use, HMPC Nausea, vomiting, mydriasis, paraly- steroidal alkaloid Commission E: 1–3 g drug/day,
monograph: (traditional use, external use), sis of tongue and loss of speech, fever, glycosides equivalent preparations
BfArM only accepted external use in the post- visual snow, painful diarrhoea, al-
authorisation procedure, highly toxic ++ ternating pulse, dyspnoea, cramps,
(Roth/Daunderer), toxic Ib to very toxic II apnoea (Roth/Daunderer)
(Wink/Wyk)
highly toxic ++ ( Roth/Daunderer), toxic Ib to all plant parts toxic, including un- steroidal alkaloid
very toxic II (Wink/Wyk) ripe berries, nausea, severe vomiting, glycosides
mydriasis, paralysis of tongue, loss of
speech, fever, visual snow, painful di-
arrhoea, alternating pulse, dyspnoea,
cramps, leg cramps, finally apnoea
(Roth/Daunderer)
Positive monograph, indications: irrigation abdominal complaints, contact al- Sesquiterpene Commission E: 6–12 g drug/day,
therapy of inflammatory diseases of the lower lergies (Hager), contraindications: lactones equivalent preparations
urinary tract, prevention of urinary stones oedemas associated with cardiac or ESCOP: 2–3 g drug, 2–3 times
and kidney gravel, ESCOP monograph: irri- renal insufficiency (Commission E a day, equivalent preparations,
gation of the urinary tract, especially in cases monograph) special dosage instructions for
of inflammation and renal gravel, and as an children
adjuvant in the treatment of bacterial infec-
tions of the urinary tract, HMPC monograph:
traditional use
Neutral monograph: mildly toxic III (Wink/ Fresh mountain ash berries contain Parasorbic acid,
Wyk), slightly toxic (+), only ripe (mealy) fruits parasorbic acid, which may cause local prunasin, amyg-
should be consumed. Heat/dry before con- irritations, nausea, vomiting, diarrhoea dalin
sumption. and kidney damage. Parasorbic acid
is largely destroyed or eliminated by
drying or cooking the berries (Frohne/
Pfänder).
highly toxic ++ (Roth/Daunderer), very toxic Ib Cases of poisoning accompanied by Quinolizidine
(Wink/Wyk) vomiting, kidney damage and apnoea alkaloids (e.g. cyti-
reported (Roth/Daunderer), slightly sine)
psychotropic and hallucinogenic
(Wink/Wyk)
Neutral monograph
123

(Latin)
Stevia rebaudiana (BERTONI) Herb
HEMSL., syn. Eupatorium rebaudi-
anum BERTONI
Strophantus spp. all plant parts
Strychnos ignatii BERG., syn. Seed

Ignatia amara L. FIL., Ignatia philip-
pinensis BLUME
Strychnos nux vomica L., syn. Seed

Strychnos lucida WALL., Strychnos
colubrina WIGHT
Swertia chirata BUCH.-HAMILT., Herb, root Not NFS

syn. Agathodes chirata (DON.)
GRISEB.
Symphytum officinale L. Herb, root
Syzygium aromaticum (L.) MERR. Flower bud S

et L.M. PERRY, syn. Caryophyllus
aromaticus L., Eugenia aromatica
BAILL.
Syzygium cumini (L.) SKEELS, syn. Leaf, fruit Not NFS
Eugenia cumini (L.) DRUCE, Myrtus
cumini L.
Syzygium cumini (L.) SKEELS, syn. Bark Not NFS
cumini L.
Syzygium cumini (L.) SKEELS, syn. Seed Not NFS
cumini L.
Tabebuia impetigenosa (MAR- Bark T

TIUS ex DC.) STANDLEY, syn.
Bignonia heptaphylla sensu
auct., Gelseminum avellanedae
(LORENTZ ex GRISEB.) KUNTZE
Tabernanthe iboga BAILL. Root
Tamarindus indica L., syn. Siliqua Fruit

arabica BAUH., Tamarindus offici-
nalis HOOK.
Tamus communis L. all plant parts
124

substances dose
Steviol glycosides licensed as additive (E 960)
extremely toxic +++ (Roth/Daunderer), ex- positive inotropic effect, bradycardia Cardenolides
tremely toxic Ia (Wink/Wyk), seeds and up to cardiac arrest, bloody diar- (strophanthin,
strophanthins prescription-only, Strophan- rhoea, nausea, vomiting, oppression, strophanthidin,
tus species pharmacy-only headache and neck pain, loss of con- ouabain)
sciousness, convulsions (Wink/Wyk,
Roth/Daunderer)
extremely toxic +++ (Roth/Daunderer), ex- Cramps, epileptic fits, states of anxiety, Indole alkaloids
tremely toxic Ia (Wink/Wyk) strychnine hypersalivation, death by respiratory (e.g. strychnine,
prescription-only, Ignatius bean pharmacy- arrest (Wink/Wyk) brucine)
only
Negative monograph: due to risks, extremely Cramps, epileptic fits, states of Alkaloids
toxic Ia (Wink/Wyk), extremely toxic +++ anxiety, hypersalivation, death by (e.g. strychnine,
(Roth/Daunderer) respiratory arrest (Wink/Wyk), faint- brucine, colubrin)
ness, exhaustion, mental disorders,
icterus, permanent blindness (Roth/
Daunderer)
Positive monograph: for external use only, Pyrrolizidine alkaloids contained in Pyrrolizidine Commission E, ESCOP: external
toxic II–III (Wink/Wyk), slightly toxic (+) the drug are hepatotoxic, mutagenic alkaloids use only, equivalent preparations
(Roth/Daunderer), ESCOP monograph: for and carcinogenic. High doses inhibit with 35 % root extract
external use, BfArM graduated plan of 5 June peripheral nerves and may induce
1992 concerning medicinal products contain- digestive problems. (Wink/Wyk)
ing pyrrolizidine alkaloids
Positive monograph for external use, WHO
monograph: for external use, HMPC assess-
ment report
Positive monograph, indications: non-spe- Commission E: 3–6 g drug/day,

cific forms of diarrhoea equivalent preparations
Negative monograph: due to risks In view of safe therapeutic alternatives,

use for the treatment of diabetes melli-
tus cannot be justified. (Commission E
monograph)
mildly toxic (Wink/Wyk) Naphthoquinones are irritating to skin Naphthoquinones
and mucous membranes, ingestion of (e.g. lapachol)
high doses causes cytotoxic effects and
digestive problems (Wink/Wyk)
highly toxic ++ (Roth/Daunderer), very toxic Ib anaesthetic, psychotropic, hallucino- Indole alkaloids
(Wink/Wyk) genic, motor disturbances, paralysis, (e.g. ibogaine)
death by cardiac failure (Wink/Wyk,
Roth/Daunderer)
toxic + (Roth/Daunderer), mildly toxic III Burning in the mouth, vomiting, diar- steroidal
(Wink/Wyk) rhoea, gastroenteritis, overdose may be saponins, oxalate
fatal (Wink/Wyk) raphides
125

(Latin)
Tanacetum vulgare L., syn. Flower, herb
Chrysanthemum vulgare (L.)
BERNH., non Leucanthemum vul-
gare L.
Taraxacum officinale WEB. ex Herb, root

WIGG., syn. Taraxacum officinale
(WITH.) WIGGERS, Leontodon
officinale WITH., Leontodon tarax-
acum L.
Taraxacum officinale WEB. ex Flower T

WIGG., syn. Taraxacum officinale
(WITH.) WIGGERS, Leontodon
officinale WITH., Leontodon tarax-
acum L.
Teucrium chamaedrys L., syn. all plant parts F
Chamaedrys officinalis MOENCH,
Teucrium officinale LAM.
Theobroma cacao L., syn. Cacao Seed

guianensis AUBL., Cacao minus
GAERTN.
Theobroma cacao L., syn. Cacao Seed husk T
guianensis AUBL., Cacao minus
GAERTN.
Thevetia peruviana (PERS.) all plant parts
K. SCHUM., syn. Thevetia neriifolia
JUSS. ex STEUD., Cerbera thevetia
126

substances dose
Negative monograph: due to risks, toxic + neurotoxic properties, tonic-clonic Monoterpenes
(Roth/Daunderer), toxic II (Wink/Wyk), sub- cramps, strong tachypnoea, irregular (e.g. eucalyptol
stance of concern (AMK), tansy pharmacy- cardiac activity, liver and kidney dam- [D1,8-cineol],
only age, vomiting, severe gastroenteritis, thujone, cam-
mydriasis, abortifacient effect, loss of phor)
consciousness, death (Roth/Daunderer,
Wink/Wyk)
Taraxici herba: positive monograph, indi- Latex: vomiting, abdominal pain, di- Sesquiter- Taraxaci herba:
cations: lack of appetite, digestive problems arrhoea, superacid gastric complaints, pene lactones Commission E: 4–10 g drug,
such as feeling of fullness and bloating, contraindications reported (Roth/ (e.g. taraxinic acid 3 times a day
Taraxici radix cum herba: positive mono- Daunderer, Commission E mono- glycosides) ESCOP: 4–10 g, 3 times a day
graph, indications: disturbance of biliary flow, graph) WHO: 3–4 g comminuted drug,
stimulation of diuresis, lack of appetite, diges- 3 times a day, 0.75–1 g extract
tive problems such as feeling of fullness and Taraxaci radix cum herba:
bloating, standard marketing authorisation: Commission E: 1 tbsp. cut drug
1139.99.99 (Taraxici radix cum herba), WHO in 1 cup of water as tea or 3–4 g
monograph (Taraxaci radix cum herba): to cut or comminuted drug in 1 cup
stimulate diuresis, increase bile flow and stim- of water
ulate appetite, and for treatment of dyspepsia, ESCOP: 3–5 g, 3 times a day
ESCOP monograph (Taraxaci radix): restora- WHO: 3–4 g comminuted drug,
tion of hepatic and biliary function, dyspepsia, 3 times a day, 0.75–1 g extract
loss of appetite, (Taraxaci folium): as an ad-
junct to treatments where enhanced urinary
output is desireable, for example, rheumatism
and the prevention of renal gravel, HMPC
monograph (Taraxici radix cum herba and
Taraxaci folium): traditional use
Flavourings and food ingredients with flavour- Hepatotoxic effect reported (Hager)
ing properties produced using wall germander
may only be used to produce alcoholic bev-
erages (Reg. (EC) No. 1334/2008), maximum
amount of teucrin A in bitter spirits (5 mg/kg)
specified in Reg. (EC) No. 1334/2008, BfArM
graduated plan of 10 Aug 1992 concerning
medicinal products containing Teucrium
chamaedris (wall germander)
Neutral monograph
Neutral monograph
highly toxic ++ ( Roth/Daunderer), very Approx. 4 seeds may be fatal to chil- cardioactive gly-
toxic Ib (Wink/Wyk) dren, 8–10 seeds fatal to adults, cosides
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

(Latin)
Thuja spp. all plant parts
Thymus serpyllum L.s.I. Herb S
Thymus vulgaris L., syn. Thymus Herb S, T

aestivus REUTER ex WILLK. et
LANGE, Thymus durius DOD.
Thymus x citriodorus (PERS.) Herb S

SCHREB., syn. Thymus comptus
HORT., Thymus jankae HORT.,
Thymus lanuginosus MILL. var.
citriodorum PERS., Thymus serpyl-
lum L. var. vulgaris BENTH.
Tilia cordata MILL., syn. Tilia Leaf T
europaea L. ulmifolia L., Tilia
ulmiflora SCOP. and Tilia platy-
phyllos SCOP., syn. Tilia europaea
L. p.p., Tilia grandiflora EHRH. ex
W.D.J. KOCH
Tilia cordata MILL., syn. Tilia Flower T
europaea L. ulmifolia L., Tilia
ulmiflora SCOP. and Tilia platy-
phyllos SCOP., syn. Tilia europaea
L. p.p., Tilia grandiflora EHRH. ex
W.D.J. KOCH
Tilia tomentosa MOENCH., syn. Leaf T
Tilia argentea DESF.
Tilia tomentosa MOENCH., syn. Flower T
Tilia argentea DESF.
Tribulus terrestris L. Fruit Not NFS
Trichilia catigua A. JUSS. Bark Not NFS
Trichocereus pachanoi BRITT. et all plant parts

ROSE, syn. Echinopsis pachanoi,
Cereus peruvianus
Trifolium pratense L., syn. Tri- Flower T

folium purpureum GILIB. non
LOISEL
128

substances dose
Tree of life pharmacy-only, extremely Mydriasis, fever, visual disturbances, Monoterpenes
toxic +++ (Roth/Daunderer), very toxic Ib headache, gastroenteritis accompa- (e.g. thujone)
(Wink/Wyk) nied by severe vomiting and diarrhoea,
tachycardia, very intense cramps, de-
generative kidney, cardiac and liver
damage, death by respiratory and cir-
culatory arrest (Wink/Wyk)
Positive monograph, indications: catarrhs of Carvacrol Commission E: 4–6 g drug/day,
Positive monograph, indications: symp- Monoterpenes Commission E, ESCOP, WHO:
tomatic treatment of bronchitis and whooping (e.g. camphor, car- 1–2 g drug/day, equivalent
cough, catarrhs of the upper respiratory vacrol, eucalyptol preparations
tract, standard marketing authorisation: [D1,8-cineol])
1329.99.99, WHO monograph: traditional use,
HMPC monograph: traditional use, ESCOP
monograph: catarrh of the upper respiratory
tract, bronchial catarrh and supportive treat-
ment of pertussis, stomatitis and halitosis
Neutral monograph
Positive monograph, indications: coughs and Commission E, WHO: 2–4 g

colds, dry cough, WHO monograph: use for drug/day, equivalent prepara-
colds and cold-related coughs, dry cough, ditions
aphoretic, antispasmodic, HMPC monograph:
sation: 1129.99.99
Neutral monograph, HMPC assessment re-

port
WHO monograph: treatment of cough, contains cytotoxic saponins and Furostanol and WHO: 3–6 g drug/day, no ad-
headache and mastitis, traditional use, toxic II alkaloids. Harmala alkaloids may inter- spirostanol ministration to children under
(Wink/Wyk), s. BfR statement: http://www. calate DNA and are particularly active saponins, the age of 12
bfr.bund.de/cm/350/risikobewertung-von- after exposure to sunlight, photosen- beta-carboline
pflanzen-und-pflanzlichen-zubereitungen.pdf sitivity accompanied by pronounced alkaloids (e.g. har-
swelling of lips and ears (Wink/Wyk) mala)
nated as catuaba
very toxic Ib (Wink/Wyk), mescaline con- psychotropic, hallucinogenic, in- Alkaloids
tained in the drug is subject to the provisions gestion of higher doses causes (e.g. mescaline)
of Annex I of the Narcotic Drugs Act (BtMG) gastrointestinal complaints, drop in
blood pressure, bradycardia, respira-
tory depression, vasodilation, paralysis
(Wink/Wyk)
WHO monograph: traditional use WHO: 240–480 mg extract/day
129

(Latin)
Trifolium pratense L., syn. Tri- Leaf Not NFS
folium purpureum GILIB. non
LOISEL
Trigonella caerulea (L.) SER. var. Herb S

caerulea, syn. Trigonella melilotus-
caerulea (L.) A. et GR.
Trigonella foenum-graecum L., Seed S
syn. Buceras foenum-graecum (L.)
ALL.
Triticum aestivum L., syn. Triticum Fruit

cereale SCHRANK, Triticum
sativum LAM.
Triticum aestivum ssp. spelta L. Fruit
Tropaeolum majus L., syn. Tropae- Herb
olum elatum SALISB.
Turnera diffusa WILLD. et Leaf
SCHULTES (Turnera microphylla
DESV.) and Turnera aphrodisiaca
(LESTER f.) WARD, [Turnera diffusa
WILLD. var. aphrodisiaca (WARD)
URBAN]
Tussilago farfara L. Leaf
Tussilago farfara L. Flower, root
Uncaria tomentosa (WILLD.) DC., Bark Not NFS

syn. Nauclea cinchoneae DC.
Uncaria tomentosa (WILLD.) DC., Root Not NFS

syn. Nauclea cinchoneae DC.
130

substances dose
slight nausea and urticaria observed
in very rare cases, concerning risks of
isoflavones isolated from red clover s.
BfR statement: http://www.bfr.bund.
de/cm/343/isolierte_isoflavone_sind_
nicht_ohne_risiko.pdf
Positive monograph, indications: lack of ap- Commission E, WHO: 6 g drug/

petite, WHO monograph: as an adjunct for day
the management of hypercholesterolaemia,
and hyperglycaemia in cases of diabetes mel-
litus. Prevention and treatment of mountain
sickness, loss of appetite, Treatment of pain,
and weakness and oedema of the legs, tra-
ditional use, ESCOP monograph: adjuvant
therapy in diabetes mellitus, anorexia, as an
adjunct to a low fat diet in the treatment of
mild to moderate hypercholesterolaemia,
HMPC monograph: traditional use, standard
marketing authorisation: 2319.99.99
slightly toxic (+) (Roth/Daunderer)
Neutral monograph: mildly toxic III (Wink/ Eucalyptol (D1,8-

Wyk) cineol), arbutin
Positive monograph, indications: acute contains pyrrolizidine alkaloids with Pyrrolizidine

catarrhs of the respiratory tract accompa- hepatotoxic, carcinogenic, partly also alkaloids
nied by cough and hoarseness, acute, mild mutagenic and teratogenic properties
inflammations of the oral and pharyngeal (Frohne/Pfänder)
mucosa, BfArM graduated plan of 5 June 1992
concerning medicinal products containing
pyrrolizidine alkaloids
Negative monograph: due to risks contains pyrrolizidine alkaloids with Pyrrolizidine
hepatotoxic, carcinogenic, partly also alkaloids
mutagenic and teratogenic properties
(Frohne/Pfänder)
WHO monograph, indications: symptomatic WHO: 20–350 mg extract/day, no
treatment of arthritis, rheumatism and gastric administration to children under
ulcers, traditional use, HMPC monograph: in the age of 12
progress
Side effects: constipation, increase in pentacyclic alka-
uric acid, cardiovascular complaints loids
(Frohne, Schilcher)
131

(Latin)
Urginea maritima (L) BAKER, syn. Bulb
Scilla maritima L., Drimia maritima
(L.) STEARN., Ornithogalum mar-
itimum (L.) LAM., Stellaris scilla
MOENCH.
Urtica dioica L., syn. Urtica major Root Not NFS (whole
KANITZ, Urtica urens maxima plant)
BLACKW.
Urtica dioica L., syn. Urtica major Fruit T, S

KANITZ, Urtica urens maxima
BLACKW.
Urtica dioica L., syn. Urtica major Herb, leaf
KANITZ, Urtica urens maxima
BLACKW.
Urtica urens L. syn.Urtica minor Herb, leaf

FUCHS, Urtica minor MOENCH,
Urtica urens minima DOD.
Urtica urens L. syn.Urtica minor Root Not NFS

FUCHS, Urtica minor MOENCH,
Urtica urens minima DOD.
Vaccinium macrocarpon AITON Fruit
132

substances dose
Positive monograph, indications: mild forms Nausea, vomiting, gastric complaints, cardioactive gly- Commission E: 0.1–0.5 g/day,
of cardiac insufficiency, also when accompa- diarrhoea, irregular pulse, arrhythmia, cosides standardised sea onion powder,
nied by renal insufficiency, Scilla glycosides hypertension, coma, cardiac arrest, equivalent preparations
prescription-only, sea onion itself pharmacy- contraindications and interactions
only, highly toxic ++ (Roth/Daunderer), very reported, narrow therapeutic range of
toxic Ib (Wink/Wyk) cardioactive glycosides (Wink/Wyk,
Roth/Daunderer)
Positive monograph, indications: micturition occasionally causes mild gastroin- ESCOP, WHO: 4–6 g drug/day,
difficulties resulting from prostatic adenoma testinal complaints (Commission E equivalent preparations, no ad-
(stage I–II), WHO monograph: symptomatic monograph) ministration to children under
treatment of lower urinary tract disorders the age of 12
(nocturia, polyuria, urinary retention) result-
ing from BPH stages I and II, as defined by
Alken, in cases where diagnosis of prostate
(dysuria, pollakisuria, nocturia, urine reten-
tion) in benign prostatic hyperplasia (BPH) at
stages I and II as defined by Alken or stages
II and III as defined by Vahlensiek, HMPC
Positive monograph, indications: adjuvant painful itching accompanied by urtica- Commission E, ESCOP: 8–12 g
treatment of rheumatic conditions, irrigation tion of skin areas that come in contact drug/day, equivalent prepara-
therapy of inflammatory diseases of the lower with stinging hairs (Wink/Wyk) tions
urinary tract, prevention and treatment of
kidney gravel, standard marketing authorisa-
tion: 8599.99.99, ESCOP monograph: adjuvant
in the symptomatic treatment of arthritis,
arthrosis and/or rheumatic conditions, HMPC
Positive monograph, indications: adjuvant painful itching accompanied by urtica- Commission E, ESCOP: 8–12 g
treatment of rheumatic conditions, irrigation tion of skin areas that come in contact drug/day, equivalent prepara-
therapy of inflammatory diseases of the lower with stinging hairs (Wink/Wyk) tions
urinary tract, prevention and treatment of
kidney gravel, standard marketing authorisa-
tion: 8599.99.99, ESCOP monograph: adjuvant
in the symptomatic treatment of arthritis,
arthrosis and/or rheumatic conditions, HMPC
Positive monograph, indications: micturition occasionally causes mild gastroin- Commission E: 4–6 g drug/day,
difficulties resulting from prostatic adenoma testinal complaints (Commission E equivalent preparations
(stage I–II), WHO monograph: symptomatic monograph) ESCOP: 4–6 g drug/day, equiva-
treatment of lower urinary tract disorders lent preparations
(nocturia, polyuria, urinary retention) result- WHO: 4–6 g drug/day, no ad-
ing from BPH stages I and II, as defined by ministration to children under
Alken, in cases where diagnosis of prostate the age of 12
(dysuria, pollakisuria, nocturia, urine reten-
tion) in benign prostatic hyperplasia (BPH) at
stages I and II as defined by Alken or stages
II and III as defined by Vahlensiek, HMPC
WHO monograph: traditional use, ESCOP ESCOP: 300–750 ml juice, 200–
monograph: prevention of urinary tract infec- 500 mg dry extract, 2 times a day,
tions equivalent preparations, no ad-
ministration to children
WHO: 400–450 mg drug
133

(Latin)
Vaccinium myrtillus L., syn. Leaf T
Myrtillus niger GILIB., Myrtillus
sylvatica BUBANI
Vaccinium myrtillus L., syn. Fruit
Myrtillus niger GILIB., Myrtillus
sylvatica BUBANI
Vaccinium vitis-idaea L., syn. Leaf T

Myrtillus exigua BUBANI, Vac-
cinium rubrum DULAC, Vitis idaea
punctata MOENCH, Vitis-idaea
punctifolia S.F. GRAY
Vaccinium vitis-idaea L., syn. Fruit
Myrtillus exigua BUBANI, Vac-
cinium rubrum DULAC, Vitis idaea
punctata MOENCH, Vitis-idaea
punctifolia S.F. GRAY
Valeriana edulis NUTT. ex TORR. Root
et GRAY ssp. Procera (H.B.K.)
F.G. MEYER, syn. Valeriana mexi-
cana DC
Valeriana officinalis L. Root F
Vanilla planifolia ANDR., syn. Fruit S

Vanilla fragrans (SALISB.) AMES.,
Myrobroma fragrans SALISB.,
Vanilla aromatica S.W.
Veratrum album L., syn. Helleborus Rhizome
albus GÜLDENST., Melanthium
album THUNB.
134

substances dose
Negative monograph: due to risks, slightly Long-term use in very high doses
toxic (+), HMPC monograph: in progress (more than 20 g/day) causes chronic
poisoning (Schilcher)
Positive monograph, indications: non-spe- Commission E: 30 g drug/day,
cific, acute diarrhoea, local treatment of mild equivalent preparations
inflammations of the oral and pharyngeal WHO: 20–60 g drug/day
mucosa, standard marketing authorisation:
1009.99.99, WHO monograph: use for the
symptomatic treatment of dysmenorrhoea
associated with premenstrual syndrome, cir-
culatory disorders in patients with capillary
leakage or peripheral vascular insufficiency
and ophthalmic disorders, treatment of acute
diarrhoea and local irritation or inflammation
of the mucous membranes of the mouth and
throat, ESCOP monograph: (Extracts): symp-
tomatic treatement of problems related to
varicose veins, such as painful and heavy legs,
(dried fruit): supportive treatment of acute,
non-specific diarrhoea, HMPC monograph: in
progress
mildly toxic III (Wink/Wyk) contains 5–8 % valepotriates, vale- Valepotriates

potriates are suspected to have an
alkyleting, cytotoxic and mutagenic
effect (Hager)
Positive monograph, indications: agita- sedative properties, ingestion of higher Valepotriates Commission E, WHO: 2–3 g
tion, nervous sleep disturbances, standard doses causes headache, agitation, drug, several times a day,
marketing authorisation: 6199.99.99 (root), sleep disturbances, arrhythmia, cen- equivalent preparations, no ad-
6099.99.99 (tincture), WHO monograph: mild tral paralysis, cardiac arrest, contains ministration to children under
sedative and sleep-promoting agent, used in 0.1–2 % valepotriates (Wichtl) the age of 12
the treatment of states of nervous excitation ESCOP: 1–3 g drug/day, no ad-
and anxiety-induced sleep disturbances, ES- ministration to children under
COP monograph: relief of temporary mild the age of 12
nervous tension and/or difficulty in falling HMPC: 2–3 g drug, up to 4 times
asleep, HMPC monograph: relief of mild ner- a day, equivalent preparations,
vous tension and sleep disorders, traditional no administration to children
use, hardly toxic (+) (Roth/Daunderer), mildly under the age of 12
toxic III (Wink/Wyk), used to produce spirits
poisonous plant, extremely toxic Ia (Wink/ Hypersalivation, sneezing, burning steroidal alkaloids
Wyk), highly toxic ++ (Roth/Daunderer) bitter taste in the mouth, vomiting, (protoveratrine
bloody diarrhoea, bradycardia, drop A and protovera-
in blood pressure, vertigo, headache, trine B)
tremor, hallucinations, pain, itching,
anaesthesia, myoplegia, death by car-
diac or respiratory arrest (Wink/Wyk)
135

(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. Opulus all plant parts

glandulosus MÖNCH, Opulus vul-
garis BORKH., Viburnum lobatum
LAM.
Vinca minor L., syn. Pervinca Herb

minor (L.) SCOPOLI, Vinca ellip-
ticifolia STOKES
Viola odorata L. Flower C

Viola odorata L. Herb, rhizome Not NFS
Viola tricolor L., syn. Viola tricolor Herb C
L. ssp. tricolor, Viola tricolor L. ssp.
vulgaris (KOCH) OBORNY.
Viscum album L., syn. Viscum Fruit

stellatum D. DON.
Viscum album L., syn. Viscum Herb

stellatum D. DON.
136

substances dose
Positive monograph, indications: catarrhs Commission E: 3–4 g drug/day,
of the respiratory tract, HMPC monograph: equivalent preparations
sation: 2449.99.99
Neutral monograph
toxic + (Roth/Daunderer), mildly toxic III Nausea, clouded consciousness, Viburnin, oxalates
(Wink/Wyk) vomiting, diarrhoea, digestive tract
inflammations, cardiac arrhythmia,
cramps, dyspnoea, kidney damage
toxic + (Roth/Daunderer), mildly toxic III Nausea, clouded consciousness, Viburnin, oxalates
(Wink/Wyk) vomiting, diarrhoea, digestive tract
inflammations, cardiac arrhythmia,
cramps, dyspnoea, kidney damage
Negative monograph: due to risks, toxic + strong drop in blood pressure, may be Indole alkaloids
(Roth/Daunderer), toxic II (Wink/Wyk), sub- accompanied by cardiac complaints, (e.g. vincamine)
stance of concern (AMK), BfArM graduated circulatory distress and dyspnoea,
plan of 20 July 1987 concerning medicinal gastrointestinal complaints observed
products containing lesser periwinkle in individual cases, temporary redness
of skin (Roth/Daunderer), changes
in blood picture such as leucopenia,
lymphopenia, drop in ˛1-, ˛2- and -
globulin levels demonstrated in animal
experiments (Schilcher)
Neutral monograph
Neutral monograph
Positive monograph: for external use only, ESCOP: 1.5–4 g, 3 times a day
ESCOP monograph (internal and external
use): skin disorders such as exzema, sebor-
rhoea, impetigo and acne, as well as cradle cap
and nappy rash of infants, HMPC monograph:
traditional use
Negative monograph: due to risks, slightly Retching, raging thirst, tenesmus, Viscotoxins,
toxic to toxic + (Roth/Daunderer), toxic II bloody stool, convulsions, gastric com- lectins
(Wink/Wyk) plaints, nausea, vomiting, diarrhoea
(Wink/Wyk)
Positive monograph: homeopathic or anthro- Shivering, hyperthermia, headache, Viscotoxins,
posophic medicinal product for parenteral use anginal complaints, orthostatic cir- lectins
only, HMPC assessment report: slightly toxic culatory distress, allergic reactions
to toxic (Roth/Daunderer), toxic (Wink/Wyk) (Commission E, Roth/Daunderer)
137

(Latin)
Vitex agnus-castus L., syn. Agnus- Fruit Not NFS
castus vulgaris CARR., Vitex verti-
cillata LAM.
Vitis vinifera L. Leaf
Vitis vinifera L. Fruit

Voacanga africana STAPF. and all plant parts
Voacanga thuarsii Roem-Schu
Wisteria spp., e.g. Wisteria sinensis all plant parts

(SIMS) SWEET
Withania somnifera (L.) DUN., syn. Root

Physalis somnifera L.
138

substances dose
Positive monograph, indications: menstrual Ingestion of high doses causes dizzi- Commission E, WHO: 30–40 mg
cycle irregularities, premenstrual symptoms, ness, vertigo, soporific effect (Roth/ drug/day as water-alcohol ex-
mastalgia, WHO monograph: symptomatic Daunderer), occasionally itching and tract, no administration to
treatment of gynaecological disorders in- urticaria, contraindicated during preg- children under the age of 12
cluding corpus luteum insufficiency and nancy and lactation (Commission E ESCOP: equivalent to 30–40 mg
hyperprolactinaemia, premenstrual syndrome, monograph) (240 mg) drug/day
menstrual irregularities, cyclic mastalgia HMPC: 180 mg drug/day,
and also to treat hormonally-induced acne, equivalent preparations, no ad-
treatment of endometrial hyperplasia and ministration to children and
secondary amenorrhoea, endocrine-depen- adolescents under the age of 18
dent dermatoses (dermatitis symmetrica
dysmenorrhoica (Matzenauer-Polland syn-
drome)) acne vulgaris, eczema, acne rosacea),
hypermenorrhoea, infertility due to hyper-
prolactinaemia and luteal phase defect. Used
to treat fibroid cysts and infertility, to stop
miscarriages due to progesterone insuffi-
ciency, to help expel the placenta after birth
and also as a digestive aid, sedative, anti-in-
fective and for the treatment of hot flushes,
ESCOP monograph: premenstrual syndrome
(PMS) including symptoms such as mastody-
nia or mastalgia, menstrual cycle disorders
such as polymenorrhoea, oligomenorrhoea or
amenorrhoea, HMPC monograph: treatment
of premenstrual syndrome, traditional use,
slightly toxic (Roth/Daunderer)
ESCOP monograph: (aqueous dry extract): ESCOP: 10 g drug in 250 ml water
treatment of symptoms of chronic venous per day
insufficiency (CVI) at stages I–II as defined by
Widmer, (other preparations): symptomatic
treatment of problems related to varicosis
such as painful and heavy legs, HMPC mono-
graph: traditional use
contains psychotropic alkaloids, alkaloids Indole alkaloids are cell and nerve Indole alkaloids
contained in the drug toxic Ib to very toxic II poison, psychotropic effect, supraven- (e.g. voacangine,
(Wink/Wyk) tricular tachycardia, Adam-Stokes voacamine)
syndrome, ventricular fibrillation, drop
in blood pressure, cerebral cramps,
coma, cardiac arrest (Wink/Wyk)
toxic II (Wink/Wyk), toxic + (Roth/Daunderer) gastric complaints accompanied by Wistarin, lectins
vomiting, diarrhoea, circulatory dis-
tress, facial pallor and drowsiness,
headache, vertigo and circulatory col-
lapse (Wink/Wyk) (Roth/Daunderer)
mildly toxic III (Wink/Wyk), WHO mono- Nausea, vomiting, diarrhoea (WHO steroidal lactones WHO: 3–6 g drug/day or 250 mg,
graph: as an antistress agent to improve monograph) (withanolides), 2 times a day (depending on the
reaction time, tonic to increase energy, alkaloids indication)
improve overall health and prevent dis-
ease in athletes and the elderly, HMPC
monograph: final public statement, s. BfR
statement: http://www.bfr.bund.de/cm/
139

(Latin)
Xysmalobium undulatum (L.) R. Root
BR., syn. Asclepias undulata L., Xys-
malobium amplifolium WEIM.,
Xysmalobium dispar N. E. BR., Xys-
malobium lapathifolium DECNE.
Yucca filamentosa L., syn. Yucca all plant parts Not NFS
angustifolia hort. non PURSH,
Yucca smalliana FERN.
Zea mays L. Style T
Zea mays L. Seed

Zingiber officinale ROSC., syn. Rhizome
Amomum zingiber L.
140

substances dose
Positive monograph, indications: non- Since besides tannins the uzara root Glycosides with Commission E: preparations
specific, acute forms of diarrhoea, licensed contains cardioactive glycosides, cardenolide struc- equivalent to 1 g drug or 75 mg
medicinal product, medicinal plant, very the specified dosage must be strictly ture total glycosides, daily dose equiv-
toxic Ib (Wink/Wyk), highly toxic ++ (Roth/ observed. For this reason, only stan- alent to 4–90 mg total glycosides,
Daunderer) dardised ready-to-use medicinal calculated as uzarin
products should be administered
(Schilcher). The effect of high doses
on the heart is similar to that of digi-
talis (Commission E monograph)
WHO monograph: supportive treatment of Carvacrol WHO: 4–8 g/day

chronic nephritis, treatment of cholangitis,
hepatitis and cholecystitis, and of acute and
chronic cystitis and urethritis. Also used in the
treatment of heart disease (as a diuretic), hy-
pertension, rheumatism and diabetes mellitus
Positive monograph, indications: diges- irritating to mucous membranes Commission E: 2–4 g drug/day,
tive problems, prevention of symptoms of (Roth/Daunderer), contraindications: equivalent preparations
travel sickness, WHO monograph: prophy- vomiting in pregnancy (Commission E ESCOP, WHO: 0.5–2 g drug/day,
laxis of nausea and vomiting associated with monograph) no administration to children
motion sickness, postoperative nausea, perni- under the age of 6
cious vomiting in pregnancy, and seasickness, HMPC: 1–2 g drug, 1 hour before
ESCOP monograph: prophylaxis of the nau- start of journey, no administra-
sea and vomiting of motion sickness, and as tion to children and adolescents
a postoperative antiemetic for minor day- under the age of 18
case surgical procedures, HMPC monograph:
prevention of nausea and vomiting in motion
sickness, traditional use
141
Legal basis
Regulation (EC) No. 178/2002 of the European Parliament 13 December 2011 (BAnz I p. 2720) (Ordinance on Food
and of the Council of 28 January 2002 laying down the Supplements [NemV])
general principles and requirements of food law, estab-
lishing the European Food Safety Authority and laying Food and Feed Code in the version published on 3 June
down procedures in matters of foods safety 2013 (BAnz I p. 1426), amended by Article 4 Section 20
of the Law of 7 August 2013 (BAnz I p. 3154) (Foodstuffs,
Regulation (EC) No. 258/97 of the European Parliament Consumer Goods and Feed Code [Food and Feed Code –
and of the Council of 27 January 1997 concerning novel LFGB])
foods and novel food ingredients
Directive 2001/83/EC of the European Parliament and of
Regulation (EC) No. 1925/2006 of the European Parlia- the Council of 6 November 2001 on the Community code
ment and of the Council of 20 December 2006 on the relating to medicinal products for human use
addition of vitamins and minerals and certain other sub-
stances to food Medicinal Products Act in the version published on 12 De-
cember 2005 (BAnz I p. 3394), amended by Article 4 Sec-
Regulation (EU) No. 609/2013 of the European Parlia-
tion 11 of the Law of 7 August 2013 (BAnz I p. 3154) (Act
ment and of the Council of 12 June 2013 on food in-
on the Trade in Medicinal Products [Medicinal Products
tended for infants and young children, food for special
Act – AMG])
medical purposes, and total diet replacement for weight
control and repealing Council Directive 92/52/EEC, Com- Ordinance on the Prescription of Medicinal Products of
mission Directives 96/8/EC, 1999/21/EC, 2006/125/EC 21 December 2005 (BAnz I p. 3632), last amended by Ar-
and 2006/141/EC, Directive 2009/39/EC of the European ticle 1 of the Regulation of 19 February 2013 (BAnz I
Parliament and of the Council and Commission Regula- p. 312) (Ordinance on the Prescription of Medicinal Prod-
tions (EC) No. 41/2009 and (EC) No. 953/2009 ucts [AMVV])
Commission Regulation (EC) No. 953/2009 of 13 October
Ordinance on Pharmacy-Only and OTC Drugs of
2009 on substances that may be added for specific nutri-
24 November 1988 (BAnz I p. 2150), last amended by
tional purposes in foods for particular nutritional uses
Article 1 of the Regulation of 21 February 2011 (BAnz I
Regulation (EC) No. 1334/2008 of the European Parlia- p. 314) (Ordinance on Pharmacy-Only and OTC Drugs
ment and of the Council of 16 December 2008 on flavour- [AMVerkRV])
ings and certain food ingredients with flavouring proper-
ties for use in and on foods and amending Council Reg- Ordinance on Standard Marketing Authorisations of
ulation (EEC) No. 1601/91, Regulations (EC) No. 2232/96 3 December 1982 (BAnz I p. 1601), last amended by Ar-
and (EC) No. 110/2008 and Directive 2000/13/EC ticle 1 of the Regulation of 19 October 2006 (BAnz I
p. 2287) (Ordinance on Standard Marketing Authorisa-
Directive 2002/46/EC of the European Parliament and of tions [StandZV])
the Council of 10 June 2002 on the approximation of the
laws of the Member States relating to food supplements Single Convention of 1961 on Narcotic Drugs of 30 March
1961 (BAnz 1973 II p. 1354) (SuchtstÜbk)
Ordinance on Food Supplements of 24 May 2004 (BAnz1 I
p. 1011), last amended by Article 8 of the Regulation of Law of 30 August 1976 approving the Convention on Psy-
chotropic Substances of 21 February 1971 (BAnz 1976 II
1
BAnz D Bundesanzeiger (Federal Law Gazette) p. 1477) (PsychotrStÜbkG)
List of Substances of the Competent Federal Government and Federal State Authorities, DOI 10.1007/978-3-319-10732-5, 143
Legal basis
Narcotic Drugs Act in the version published on 1 March tween the Community and third countries in drug pre-
1994 (BAnz I p. 358), amended by Article 4 Section 7 of the cursors
Law of 7 August 2013 (BAnz I p. 3154) (Act on the Trade in
Narcotic Drugs [Narcotic Drugs Act – BtMG]) Precursors Control Act of 11 March 2008 (BAnz I p. 306),
amended by Article 4 Section 9 of the Law of 7 August
Regulation (EC) No. 273/2004 of the European Parliament 2013 (BAnz I p. 3154) (Act on the Monitoring of the Trade
and of the Council of 11 February 2004 on drug precursors in Precursors that can be misused for the Illicit Manufac-
ture of Narcotic Drugs [Precursors Control Act – GÜG])
Council Regulation (EC) No. 111/2005 of 22 December
2004 laying down rules for the monitoring of trade be-
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Roth, L., Daunderer, M. & Kormann, K. (2006). Giftpflanzen-Pflanzengifte. [WKF Inventory List of Plants and Plant Parts Used for Food], http://
Vorkommen – Wirkung – Therapie – Allergische und phototoxische wkf.de/Recht.1957.0.html?&L=0.
Reaktionen (4th ed.). Hamburg: Nikol. Wüstenfeld, M. & Haeseler, G. (1964). Trinkbrandweine und Liköre
Schenk, E. G. & Naundorf, J. (1966). Manualia Nicolai. Lexikon der tro- (4th ed.). Berlin: Paul Parey.
pischen, subtropischen und mediterranen Nahrungs- und Genussmittel
Herford: Nicolaische Verlagsbuchhandlung.
147
References
Monographs of the Federal Health Office/ Caricae papayae folium (Melonenbaumbläetter): BAnz Nr. 193a, 15 Okt
Federal Institute for Drugs and Medical Devices 1987.
Caricis rhizoma (Sandriedgraswurzelstock): BAnz Nr. 101, 1 June 1990.
(BGA/BfArM) Carvi fructus (Kümmel): BAnz Nr. 22a, 1 Feb 1990.
Caryophylli flos (Gewürznelken): BAnz Nr. 223, 30 Nov 1985.
Absinthii herba (Wermutkraut): BAnz Nr.7 228, 5 Dec 1984. Centaurea cyanus (Kornblume): BAnz Nr. 43, 2 Mar 1989.
Achillea millefolium (Schafgarbe): BAnz Nr. 22a, 1 Feb 1990. Centaurii herba (Tausendgueldenkraut): BAnz Nr. 122, 6 July 1988 and
Aconitum napellus (Blauer Eisenhut): BAnz Nr. 193a, 15 Okt 1987. BAnz Nr. 50, 13 Mar 1990 (corrected).
Adonis herba (Adoniskraut): BAnz. Nr. 85, 5 May 1988 and BAnz Nr. 22a, Chamomillae romanae flos (Römische Kamillenblüten): BAnz Nr. 221,
01.02.1990 (corrected). 25 Nov 1993.
Agni casti fructus (Keuschlammfrüchte oder Mönchspfefferfrüchte): Chelidonii herba (Schöllkraut): BAnz Nr. 90, 15 May 1985.
BAnz Nr. 226, 2 Dec 1992. Chrysanthemum vulgare (Rainfarn): Banz Nr. 122, 6 July 1988.
Agrimoniae herba (Odermennigkraut): BAnz Nr. 50, 13 Mar 1986 and Cichorium intybus (Wegwarte): BAnz Nr. 76, 23 Apr 1987 and BAnz
BAnz Nr. 50, 13 Mar 1990 (corrected). Nr. 164, 1 Sept 1990 (corrected).
Alchemilla alpinae herba (Apfelfrauenmantelkraut): BAnz. Nr. 162, Cimicifugae racemosae rhizoma (Cimicifugawurzelstock): BAnz Nr. 43,
29 Aug 1992. 2 Mar 1989.
Alchemilla herba (Frauenmantelkraut): BAnz. Nr. 173, 18 Sept 1986. Cinchonae cortex (Chinarinde): BAnz Nr. 22a, 1 Feb 1990.
Allii cepae bulbus (Zwiebel): BAnz Nr. 50, 13 Mar 1986. Cinnamomi cassiae cortex (Chinesischer Zimt): BAnz Nr. 22a, 1 Feb 1990.
Allii sativi bulbus (Knoblauchzwiebel): BAnz Nr. 122, 6 July 1988. Cinnamomi ceylanici cortex (Zimtrinde): BAnz Nr. 22a, 1 Feb 1990.
Aloe: BAnz. Nr. 133, 21 July 1993. Cinnamomi flos (Zimtblüten): BAnz Nr. 49, 11 Mar 1992.
Althaeae folium (Eibischblätter): BAnz Nr. 43, 2 Mar 1989. Citri sinensis pericarpium (Orangenschalen): BAnz Nr. 22a, 1 Feb 1990.
Althaeae radix (Eibischwurzel): BAnz Nr. 43, 2 Mar 1989. Cnici benedicta herba (Benediktenkraut): BAnz Nr. 193, 15 Okt 1987.
Ammeos visnagae fructus (Ammi-visnaga-Früchte): BAnz Nr. 71, 15 Apr Colae semen (Kolasamen): BAnz Nr.127, 12.07.1991.
1994. Colchicum autumnale (Herbstzeitlose): BAnz Nr. 173, 18 Sept 1986.
Anethi fructus (Dillfrüchte): BAnz Nr. 193a, 15 Okt 1987 and BAnz Nr. 50, Colocynthidis fructus (Koloquinthen): BAnz Nr. 164, 1 Sept 1990.
13 Mar 1990 (corrected). Condurango cortex (Condurangorinde): BAnz Nr. 193a, 15 Okt 1987 and
Anethi herba (Dillkraut): BAnz Nr. 193a, 15 Okt 1987. BAnz Nr. 50, 13 Mar 1990.
Angelicae fructus/- herba (Angelikafrüchte/-kraut): BAnz Nr. 101, 1 June Convallariae herba (Maiglöckchenkraut): BAnz Nr. 76, 23 Apr 1987 and
1990. BAnz Nr. 22a, 1 Feb 1990.
Angelicae radix (Angelikawurzel): BAnz Nr. 101, 1 June 1990. Coriandri fructus (Koriander): BAnz Nr. 173, 18 Sept 1986.
Anisi fructus (Anis): BAnz Nr. 122, 6 July 1988. Crataegi flos (Weissdornblüten): BAnz Nr. 133, 19 July 1994.
Anisi stellati fructus (Sternanis): BAnz Nr. 122, 6 July 1988. Crataegi folium (Weissdornblätter): BAnz Nr. 133, 19 July 1994.
Antennariae dioicae flos (Katzenpfötchenblüten): BAnz Nr. 162, 29 Aug Crataegi folium cum flore (Weissdornblätter mit Blüten): BAnz Nr. 133,
1992. 19 July 1994.
Apium graveolens (Sellerie): BAnz Nr. 127, 12 July 1991. Crataegi fructus (Weissdornfrüchte): BAnz Nr. 133, 19 July 1994.
Armoraciae rusticanae radix (Meerrettich): BAnz Nr. 85, 5 May 1988. Croci stigma (Safran): BAnz Nr. 76, 23 Apr 1987.
Arnicae flos (Arnikablüten): BAnz Nr. 228, 5 Dec 1984. Cucurbitae peponis semen (Kürbissamen): BAnz Nr. 223, 30 Nov 1985
Artemisia vulgaris (Beifuß): BAnz Nr. 122, 6 July 1988. and BAnz Nr. 11, 17 Jan 1991 (corrected).
Asparagi rhizoma (Spargelwurzelstock): BAnz Nr. 127, 12 July 1991. Curcumae longae rhizoma (Curcumawurzelstock): BAnz Nr. 223, 30 Nov
Atropa belladonna (Tollkirsche): BAnz Nr. 223, 30 Nov 1985. 1985 and BAnz Nr.164, 1 Sept 1990 (corrected).
Aurantii flos (Pomeranzenblüten): BAnz Nr. 128, 14 July 1993. Curcumae xanthorrhizae rhizoma (Javanische Gelbwurz): BAnz Nr. 122,
Aurantii pericarpium (Pomeranzenschale): BAnz Nr. 193a, 15 Okt 1987 6 July 1988 and BAnz Nr. 164, 1 Sept 1990 (corrected).
and BAnz Nr. 50, 13 Mar 1990 (corrected). Cymbopogon species (Cymbopogon-Arten): BAnz Nr. 22a, 1 Feb 1990.
Avenae fructus (Haferfrüchte): BAnz Nr. 85, 5 May 1988. Cynarae folium (Artischockenblätter): BAnz Nr. 122, 6 July 1988 and
Avenae herba (Haferkraut ): BAnz Nr. 193a, 15 Okt 1987. BAnz Nr. 164, 1 Sept 1990 (corrected).
Barosmae folium (Buccoblätter): BAnz Nr. 22a, 1 Feb 1990. Cynoglossi herba (Hundszungenkraut): BAnz Nr. 43, 2 Mar 1989.
Basilici herba (Basilienkraut): BAnz Nr. 54, 18 Mar 1992. Cytisi scoparii flos (Besenginsterblüten): BAnz Nr. 11, 17 Jan 1991.
Berberis vulgaris (Berberitze): BAnz Nr. 43, 2 Mar 1989. Cytisi scoparii herba (Besenginsterkraut): BAnz Nr. 11, 17 Jan 1991.
Betulae folium (Birkenblätter): BAnz Nr. 50, 13 Mar 1986. Delphinii flos (Ritterspornblüten): BAnz Nr. 80, 27 Apr 1989.
Boldo folium (Boldoblätter): BAnz Nr. 76, 23 Apr 1987 and BAnz Nr. 164 Droserae herba (Sonnentaukraut): BAnz Nr. 228, 5 Dec 1984.
vom 1 Sept 1990 (corrected). Dryopteris filix-mas (Wurmfarn): BAnz Nr. 180, 24 Sept 1993.
Borago (Boretsch): BAnz Nr. 127, 12 July 1991. Dulcamarae stipites (Bittersüssstengel): BAnz Nr. 101, 1 June 1990.
Bryoniae radix (Zaunrübenwurzel): BAnz Nr. 122, 6 July 1988. Echinacea angust./-pallida ((schmalblättr.) Sonnenhut): BAnz Nr. 162,
Bursae pastoris herba (Hirtentäschelkraut): BAnz Nr. 173, 18 Sept 1986 29 Aug 1992.
and BAnz Nr. 50, 13 Mar 1990 (corrected). Echinacea-pallidae-radix (Echinacea-pallida-Wurzel): BAnz Nr. 162,
Cacao semen (Kakaosamen): BAnz Nr. 40, 27 Feb 1991. 29 Aug 1992.
Cacao testes (Kakaoschalen): BAnz Nr. 40, 27 Feb 1991. Echinaceae purpureae herba (Purpursonnenhutkraut): BAnz Nr. 43,
Calendulae flos (Ringelblumenblüten): BAnz Nr. 50, 13 Mar 1986. 2 Mar 1989.
Calluna vulgaris (Heidekraut): BAnz. Nr. 101, 1 June 1990. Echinaceae-purpurae-radix (Purpursonnenhutwurzel): BAnz Nr. 162,
Capsicum (Paprika): BAnz Nr. 22a, 1 Feb 1990. 29 Aug 1992.
Cardamomi fructus (Kardamom): BAnz Nr. 223, 30 Nov 1985 and BAnz Eleutherococci radix (Eleutherococcus-senticosus-Wurzel): BAnz Nr. 11,
Nr. 50, 13 Mar 1990 and BAnz Nr.164, 1 Sept 1990 (corrected). 17 Jan 1991.
Cardui mariae fructus (Mariendistelfrüchte): BAnz Nr. 50, 13 Mar 1986. Ephedrae herba (Ephedrakraut): BAnz Nr. 11, 17 Jan 1991.
Caricae fructus (Feigen): BAnz Nr. 101, 1 June 1990. 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).
7
BAnz D Bundesanzeiger (Federal Law Gazette); Nr. D Number (No.)
148
References
Euphrasia officinalis (Augentrost): BAnz Nr. 162, 29 Aug 1992. Lycopi herba (Wolfstrappkraut): BAnz Nr. 22a, 1 Feb 1990.
Farfarae flos/-herba/-radix (Huflattichblüten/-kraut/-wurzel): BAnz Malvae flos (Malvenblüten): BAnz Nr. 43, 2 Mar 1989.
Nr. 138, 27 July 1990. Malvae folium (Malvenblätter): BAnz Nr. 43, 2 Mar 1989.
Farfarae folium (Huflattichblätter): BAnz Nr. 138, 27 July 1990. Manna: BAnz Nr. 22a, 1 Feb 1990.
Filipendula ulmaria (Maedesüß): BAnz Nr. 43, 2 Mar 1989. Marrubii herba (Andornkraut): BAnz Nr. 22a 1 Feb 1990.
Foeniculi fructus (Fenchel): BAnz Nr. 74, 19 Apr 1991. Mate folium (Mateblätter): BAnz Nr. 85, 5 May 1988.
Foenugraeci semen (Bockshornsamen): BAnz Nr. 22a, 1 Feb 1990. Matricariae flos (Kamillenblüten): BAnz Nr. 228, 5 Dec 1984 and BAnz
Fragariae folium (Erdbeerblätter): BAnz Nr. 22a, 1 Feb 1990. Nr. 50, 13 Mar 1990 (corrected).
Frangulae cortex (Faulbaumrinde): BAnz Nr. 133, 21 July 1993. Meliloti herba (Steinkleekraut): BAnz Nr. 50, 13 Mar 1986 and BAnz
Fumariae herba (Erdrauchkraut): BAnz Nr. 173, 18 Sept 1986. Nr. 50, 13 Mar 1990 (corrected).
Galangae rhizoma (Galgantwurzelstock): BAnz Nr. 173, 18 Sept 1986 and Melissae folium (Melissenblätter): BAnz Nr. 228, 5 Dec 1984 and BAnz
BAnz Nr. 50, 13 Mar 1990 (corrected). Nr. 50, 13 Mar 1990 (corrected).
Galegae officinalis herba (Geißrautenkraut): BAnz Nr. 180, 24 Sept 1993. Menthae piperitae folium (Pfefferminzblätter): BAnz Nr. 223, 30 Nov
Galeopsidis herba (Hohlzahnkraut): BAnz Nr. 76, 23 Apr 1987. 1985 and BAnz Nr. 50, 13 Mar 1990 and BAnz Nr.164, 1 Sept 1990 (cor-
Galii odorati herba (Waldmeisterkraut): BAnz Nr. 193a, 15 Okt 1987. rected).
Gelsemii rhizoma (Gelsemiumwurzelstock): BAnz Nr. 178, 21 Sept 1991. Menyanthis folium (Bitterkleeblätter): BAnz Nr. 22a, 1 Feb 1990.
Gentianae radix (Enzianwurzel): BAnz Nr. 223, 30 Nov 1985 and BAnz Myristica fragans (Muskatnussbaum): BAnz Nr. 173, 18 Sept 1986.
Nr. 50, 13 Mar 1990 (corrected). Myrtilli folium (Heidelbeerblätter): BAnz Nr. 76, 23 Apr 1987.
Ginkgo folium (Ginkgo-biloba-Blätter): BAnz Nr. 133, 19 July 1994. Myrtilli fructus (Heidelbeeren): BAnz Nr. 76, 23 Apr 1987 and BAnz
Ginseng radix (Ginsengwurzel): BAnz Nr. 11, 17 Jan 1991. Nr. 50, 13 Mar 1990 (corrected).
Graminis flos (Heublumen): BAnz Nr. 85, 5 May 1988. Nasturtii herba (Brunnenkressekraut): Banz Nr. 22a, 1 Feb 1990.
Graminis rhizoma (Queckenwurzelstock): BAnz Nr. 22a, 1 Feb 1990. Oleae folium (Olivenblätter): BAnz Nr. 11, 17 Jan 1991.
Grindeliae herba (Grindeliakraut): BAnz Nr. 11, 17 Jan 1991. Oleandri folium (Oleanderblätter): BAnz Nr. 122, 6 July 1988 and BAnz
Guajaci lignum (Guajakholz): BAnz Nr. 76, 23 Apr 1987. Nr. 22a, 1 Feb 1990 and BAnz Nr. 43, 2 Mar 1989 (corrected).
Gypsophilae radix (Weisse Seifenwurzel): BAnz Nr. 101, 1 June 1990. Ononidis radix (Hauhechelwurzel): BAnz Nr. 76, 23 Apr 1987 and BAnz
Hamamelidis folium et cortex (Hamamelisblätter und -rinde): BAnz Nr. 50, 13 Mar 1990 (corrected).
Nr. 154, 21 Aug 1985 and BAnz Nr. 50, 13 Mar 1990 (corrected). Origanum majorana (Majoran): BAnz Nr. 226, 2 Dec 1992.
Harpagophyti radix (Suedafrikanische Teufelskrallenwurzel): BAnz Orthosiphonis folium (Orthosiphonblätter): BAnz Nr. 50, 13 Mar 1986
Nr. 43, 2 Mar 1989 and BAnz Nr.164, 1 Sept 1990 (corrected). and BAnz Nr. 50, 13 Mar 1990 (corrected).
Harunganae madagascariensis cortex et folium (Harongarinde und Paeonia (Pfingstrose): BAnz Nr. 85, 5 May 1988.
-blätter): BAnz Nr. 50, 13 Mar 1986. Passiflorae herba (Passionsblumenkraut): BAnz Nr. 223, 30 Nov 1985 and
Hederae helicis folium (Efeublätter): BAnz Nr. 122, 6 July 1988. BAnz Nr. 50, 13 Mar 1990 (corrected).
Helenii radix (Alantwurzel): BAnz Nr. 85, 5 May 1988. Petasites hybridus/-folium (Pestwurz/-blätter): BAnz Nr. 138, 27 July
Helichrysi flos (Ruhrkrautblüten): BAnz Nr. 122, 6 July 1988 and BAnz 1990.
Nr. 164, 1 Sept 1990 (corrected). Petasitidis rhizoma (Pestwurzwurzelstock): BAnz Nr. 138, 27 July 1990.
Hepatici nobilis herba (Leberbluemchenkraut): BAnz Nr. 128, 14 July Petroselini fructus (Petersilienfrüchte): BAnz. Nr. 43, 2 Mar 1989.
1993. Petroselini herba/-radix (Petersilienkraut/-wurzel): BAnz. Nr. 43, 2 Mar
Herniariae herba (Bruchkraut): BAnz Nr. 173, 18 Sept 1986. 1989.
Hibisci flos (Hibiscusblüten): BAnz Nr. 22a, 1 Feb 1990. Phaseoli fructus sine semine (Samenfreie Gartenbohnenhülsen): BAnz
Hippocastani cortex/-flos (Rosskastanienrinde/-Blüten): BAnz Nr. 221, Nr. 50, 13 Mar 1986 and BAnz Nr. 50, 13 Mar 1990 (corrected).
25 Nov 1993. Piceae turiones recentes (Frische Fichtenspitzen): BAnz Nr. 193a, 15 Okt
Hippocastani folium (Rosskastanienblätter): BAnz Nr. 128, 14.07.1993. 1987.
Hippocastani semen (Rosskastaniensamen/Trockenextrakt aus R.- Pimpinellae herba (Bibernellkraut): BAnz Nr. 101, 1 June 1990.
samen [DAB10]): BAnz Nr. 71, 15.04.1994. Pimpinellae radix (Bibernellwurzel): BAnz Nr. 101, 1 June 1990.
Hyoscyami folium (Hyoscyamusblätter): BAnz Nr. 85, 5 May 1988. Pini turiones (Kiefernsprossen): BAnz Nr. 173, 18 Sept 1986 and BAnz
Hyperici herba (Johanniskraut): BAnz Nr. 228, 5 Dec 1984 and BAnz Nr. 50, 13 Mar 1990.
Nr. 43, 2 Mar 1989 (corrected). Piperis methystici rhizoma (Kava-Kava-Wurzelstock): BAnz Nr. 101,
Hyssopus officinalis (Ysop): BAnz Nr. 162, 29 Aug 1992. 1 June 1990.
Iridis rhizoma (Schwertlilienwurzelstock): BAnz Nr. 221, 25 Nov 1993. Plantaginis lanceolatae herba (Spitzwegerichkraut): BAnz. Nr. 223,
Juglandis folium (Walnussblätter): BAnz Nr. 101, 1 June 1990. 30 Nov 1985.
Juglandis fructus cortex (Walnussfruchtschalen): BAnz Nr. 101, 1 June Plantaginis ovatae semen (Indische Flohsamen): BAnz Nr. 22a, 1 Feb
1990. 1990 and BAnz Nr. 74, 19 Apr 1991 (corrected).
Juniperi fructus (Wacholderbeeren): BAnz Nr. 228, 5 Dec 1984. Plantaginis ovatae testa (Indische Flohsamenschalen): BAnz Nr. 22a,
Lamii albi flos (Weisse Taubnesselblüten): BAnz Nr. 76, 23 Apr 1987. 1 Feb 1990 and BAnz Nr. 74, 19 Apr 1991 (corrected).
Lamii albi herba (Weisses Taubnesselkraut): BAnz Nr. 128, 14 July 1993. Podophylli peltati rhizoma/-resina (Podophyllumwurzelstock/-Harz):
Lavandulae flos (Lavendelblüten): BAnz Nr. 228, 5 Dec 1984 and BAnz BAnz Nr. 50, 13 Mar 1986.
Nr. 50, 13 Mar 1990 (corrected). Polygalae radix (Senegawurzel): BAnz Nr. 50, 13 Mar 1986 and BAnz
Ledi palustris herba (Sumpfporstkraut): BAnz Nr. 177a, 24 Sept 1986. Nr. 50, 13 Mar 1990 (corrected).
Leonuri cardiacae herba (Herzgespannkraut): BAnz Nr. 50, 13 Mar 1986. Polygoni avicularis herba (Vogelknoeterichkraut): BAnz Nr. 76, 23 Apr
Levistici radix (Liebstoeckelwurzel): BAnz Nr. 101, 1 June 1990. 1987 and BAnz Nr. 50, 13 Mar 1990 (corrected).
Lini semen (Leinsamen): BAnz Nr. 228, 5 Dec 1984. Potentillae anserinae herba (Gänsefingerkraut): BAnz. Nr. 223, 30 Nov
Liquiritiae radix (Suessholzwurzel): BAnz Nr. 90, 15 May 1985 and BAnz 1985 and BAnz Nr. 50, 13 Mar 1990 (corrected).
Nr. 74, 19 Apr 1991 and BAnz Nr. 50, 13 Mar 1990 and BAnz Nr.178, Primulae flos (Schlüsselblumenblüten): BAnz Nr. 122, 6 July 1988 and
21 Sept 1991 (corrected). BAnz Nr. 50, 13 Mar 1990 (corrected).
Lupuli strobulus (Hopfenzapfen): BAnz Nr. 228, 5 Dec 1984 and BAnz Primulae radix (Primelwurzel): BAnz Nr. 122, 6 July 1988 and BAnz
Nr. 50, 13 Mar 1990 (corrected). Nr. 50, 13 Mar 1990 (corrected).
149
References
Pruni spinosae flos (Schlehdornblüten): BAnz Nr. 101, 1 June 1990. Taraxaci radix cum herba (Löwenzahnwurzel mit -kraut): BAnz Nr. 228,
Pruni spinosae fructus (Schlehdornfrüchte): BAnz Nr. 101, 1 June 1990. 5 Dec 1984 and BAnz Nr.164, 1 Sept 1990 (corrected).
Psyllii semen (Flohsamen): BAnz Nr. 223, 30 Nov 1985 and BAnz Nr. 50, Thymi herba (Thymiankraut): BAnz Nr. 228, 5 Dec 1984 and BAnz
13 Mar 1990 (corrected). Nr. 226, 2 Dec 1992 and BAnz Nr. 50, 13 Mar 1990 (corrected).
Ptychopetali lignum (Potenzholz): BAnz Nr. 193a, 15 Okt 1987. Tiliae flos (Lindenbüten): BAnz Nr. 164, 1 Sept 1990.
Pulmonariae herba (Lungenkraut): BAnz Nr. 193a, 15 Okt 1987. Tiliae folium (Lindenbätter): BAnz Nr. 164, 1 Sept 1990.
Pulsatillae herba (Küchenschellenkraut): BAnz Nr. 223, 30 Nov 1985. Tiliae tomentosae flos (Silberlindenbüten): BAnz Nr. 164, 1 Sept 1990.
Quercus cortex (Eichenrinde): BAnz Nr. 22a, 1 Feb 1990. Tormentillae rhizoma (Tormentillwurzelstock): BAnz Nr. 85, 5 May 1988
Raphani sativi radix (Rettich): BAnz Nr. 177a, 24 Sept 1986. and BAnz Nr. 50, 13 Mar 1990 (corrected).
Ratanhiae radix (Ratanhiawurzel): BAnz Nr. 43, 2 Mar 1989. Turnera diffusa (Damiana): BAnz Nr. 43, 2 Mar 1989.
Rauwolfiae radix (Rauwolfiawurzel): BAnz Nr. 173, 18 Sept 1986. Urticae herba/-folium (Brennesselkraut/-blätter): BAnz Nr. 76, 23 Apr
Rhamni cathartici fructus (Kreuzdornbeeren):BAnz Nr. 221, 25 Nov 1993. 1987.
Rhamni purshianae cortex (Amer.Faulbaumrinde): BAnz Nr. 133, 21 July Urticae radix (Brennesselwurzel): BAnz Nr. 173, 18 Sept 1986 and BAnz
1993. Nr. 11, 17 Jan 1991 and BAnz Nr.43, 2 Mar 1989 and BAnz Nr.50, 13 Mar
Rhei radix (Rhabarberwurzel): BAnz Nr. 133, 21 July 1993. 1990 (Correcteden).
Rhododendri ferruginei folium (Rostrote Alpenrosenblätter): BAnz Uvae ursi folium (Bärentraubenblätter): BAnz Nr. 109, 15 June 1994.
Nr. 164, 1 Sept 1990. Uzarae radix (Uzarawurzel): BAnz Nr. 164, 1 Sept 1990.
Rhoeados flos (Klatschmohnblüten): BAnz Nr. 85, 5 May 1988. Valerianae radix (Baldrianwurzel): BAnz Nr. 90, 15 May 1985 and BAnz
Rosae flos (Rosenblüten): BAnz Nr. 164, 1 Sept 1990. Nr. 50, 13 Mar 1990 (corrected).
Rosae pseudofructus cum fructibus (Hagebutten): BAnz Nr. 164, 1 Sept Verbasci flos (Wollblumen): BAnz Nr. 22a, 1 Feb 1990.
1990. Veronicae herba (Ehrenpreiskraut): BAnz Nr. 43, 2 Mar 1989.
Rosmarini folium (Rosmarinblätter): BAnz Nr.223, 30 Nov 1985 and Vincae minoris herba (Immergrünkraut): BAnz Nr. 173, 18 Sept 1986.
BAnz Nr.221, 28 Nov 1986 and BAnz Nr. 50, 13 Mar 1990. Viola odorata (Märzveilchen): BAnz Nr. 111, 17 June 1994.
Rubiae tinctorum radix (Krappwurzel): BAnz Nr. 162, 29 Aug 1992. Violae odoratae flos (Maerzveilchenblüten): BAnz Nr. 111, 17 June 1994.
Rubi fruticosi folium (Brombeerblätter): BAnz Nr. 22a, 1 Feb 1990. Violae tricoloris herba (Stiefmütterchenkraut): BAnz Nr. 50, 13 Mar 1986.
Rubi fruticosi radix (Brombeerwurzel): BAnz Nr. 22a, 1 Feb 1990. Visci albi fructus (Mistelbeeren): BAnz Nr. 128, 14 July 1993.
Rubi idaei folium (Himbeerblätter): BAnz Nr. 193a, 15 Okt 1987. Visci albi herba (Mistelkraut): BAnz Nr. 228, 5 Dec 1984.
Rusci aculeati rhizoma (Mäusedornwurzelstock): BAnz Nr. 127, 12 July Yohimbehe cortex (Yohimbeherinde): BAnz Nr. 193a, 15 Okt 1987 and
1991. BAnz Nr. 22a, 1 Feb 1990 (corrected).
Ruta graveolens (Raute): BAnz Nr. 43, 2 Mar 1989. Zedoariae rhizoma (Zitwerwurzelstock): BAnz Nr. 122, 6 July 1988.
Sabal fructus (Sägepalmenfrüchte): BAnz Nr. 43, 2 Mar 1989 and BAnz Zingiberis rhizoma (Ingwerwurzelstock): BAnz Nr. 85, 5 May 1988 and
Nr. 22a, 1 Feb 1990 and BAnz Nr. 11, 17.01.1991 (corrected). BAnz Nr.164, 1 Sept 1990 and BAnz Nr. 50, 13 Mar 1990 (corrected).
Salicis cortex (Weidenrinde): BAnz. Nr. 228, 5 Dec 1984.
Salviae folium (Salbeiblätter): BAnz Nr. 90, 15 May 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 ESCOP Monographs
Nr. 50, 13 Mar 1990 (corrected).
Santali albi lignum (Weisses Sandelholz): BAnz Nr. 43, 2 Mar 1989. ESCOP (2003). ESCOP Monographs, The Scientific Foundation for
Santali lignum rubrum (Rotes Sandelholz): BAnz Nr. 193a, 15 Okt 1987. Herbal Medicinal Products (2nd ed.). Stuttgart: Georg Thieme.
Saponariae rubrae radix (Rote Seifenwurzel): BAnz Nr. 80, 27 Apr 1989. ESCOP (2009). ESCOP Monographs (2nd ed.). Supplement 2009, Georg
Sarsaparillae radix (Sarsaparillewurzel): BAnz Nr. 164, 1 Sept 1990. Thieme Verlag KG Stuttgart.
Scillae bulbus (Meerzwiebel): BAnz Nr. 154, 21 Aug 1985 and BAnz Nr. 43,
2 Mar 1989 (corrected).
Scopoliae rhizoma (Glockenbilsenkrautwurzelstock): BAnz Nr. 177a,
24 Sept 1986.
Senecionis herba (Fuchskreuzkraut): BAnz Nr. 138, 27 July 1990. WHO Monographs
Sennae folium (Sennesblätter): BAnz Nr. 133, 21 July 1993.
Sennae fructus (Sennesfrüchte): BAnz. Nr. 133, 21 July 1993. WHO; WHO monographs on selected medicinal plants: Volume 1 (1999).
Serpylli herba (Quendelkraut): BAnz Nr. 193a, 15 Okt 1987 and BAnz WHO; WHO monographs on selected medicinal plants: Volume 2 (2002).
Nr. 50, 13 Mar 1990 (corrected). WHO; WHO monographs on selected medicinal plants: Volume 3 (2007).
Sinapis albae semen (Weisse Senfsamen): BAnz Nr. 22a, 1 Feb 1990. WHO; WHO monographs on selected medicinal plants: Volume 4 (2009).
Solidago (Goldrute): BAnz Nr. 193a, 15 Okt 1987 and BAnz Nr. 50, 13 Mar WHO; WHO monographs on medicinal plants commonly used in the
1990 (corrected). Newly Independent States (NIS) (2010).
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. HMPC Monographs
Symphyti radix (Beinwellwurzel): BAnz Nr. 138, 27 July 1990.
Syzygii cumini cortex (Syzygiumrinde): BAnz Nr. 76, 23 Apr 1987. European Medicines Agency (EMA), http://www.ema.europa.eu/
Syzygii cumini semen (Syzygiumsamen): BAnz Nr. 76, 23 Apr 1987. ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp&
Taraxaci herba (Löwenzahnkraut): BAnz Nr. 162, 29 Aug 1992. mid=WC0b01ac058001fa1d.
150
References
Community list pursuant to Article 16f of Directive Italy: Ministerio Della Salute Decreto 9 luglio 2012 Disciplina
2001/83/EC of the European Parliament and of the dell’impiego negli integratori alimentari di sostanze e preparati
vegetali (G.U. 21-7-2012 serie generale n. 169).
Council of 6 November 2001 on the Community code Italy: Ministerio Della Salute Estratti Vegetali Non Amessi Negli Integra-
relating to medicinal products for human use tori Alimentari.
Netherlands: Nieuwe Voedsel en Waren Autoriteit, Ministerie van Land-
European Medicines Agency (EMA), http://ec.europa.eu/health/ bouw, Natuur en Woedselkwaliteit (2010). Warenwetbesluit Kruiden-
human-use/herbal-medicines/index_en.htm. 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-
Lists of other member states mended for use without dose restrictions.
Austria: Federal Ministry of Health: Plants and plant parts not recom-
Belgium: Arreté Royal du 29 Aout 1997 relatif à la fabrication et au com- mended for use.
merce de denrées alimentaires composées ou contenant des plantes Sweden: Livesmedelsverket: Förteckning över växter och växtdelar som
ou préparations de plantes. är olämpliga i livsmedel (VOLM), latest update May 2010.
Belgium: Federale Overheidsdienst Volksgezondheid, Veiligheid van Slovakia: Výnos Ministerstva pôdohospodárstva Slovenskej republiky
de Voedselketen en Leefmilieu: Indicative list of plants/plant parts/ a Ministerstva zdravotníctva Slovenskej republiky zo 6. apríla 2005
substances and their novel food status (non-exhaustive list), http:// č. 2089/2005-100, ktorým sa vydáva hlava Potravinového kódexu
www.health.fgov.be/eportal/foodsafety/foodstuffs/novelfoods/ Slovenskej republiky upravujúca pochutiny.
index.htm#.UmAJPKxqfU4. United Kingdom: Medicines and Healthcare Products Regulatory
Denmark: Drogelisten Vurdering af planter, svampe og dele heraf an- Agency (MHRA): Prohibited or restricted herbal ingredients,
vendt i kosttilskud og urtete. http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedici
Ireland: Herbal Substances which may be acceptable for inclusion in nesregulation/Prohibitedorrestrictedherbalingredients/index.htm.
food supplements, IMB Draft Guideline – Version 5.1 20/04/2011. United Kingdom: Medicines and Healthcare Products Regulatory
Ireland: Herbal Substances not permitted in foods or food supplements, Agency (MHRA): List of herbal ingredients and their reported
IMB Draft Guideline – Version 5.1, 20/4/2011. uses, http://www.mhra.gov.uk/home/groups/is-pol/documents/
websiteresources/con009277.pdf.
151
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
benefit 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 classification and
evaluation of plants and plant parts regarding their use as food or food ingredients. In addition
to classification 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.
ISBN 978-3-319-10731-8
9 783319 107318

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BVL-Report · 8.

List of Substances of the Competent Federal

© 2014 Federal Office of Consumer Protection and Food Safety

Editor: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)

Editorial board: Herr F. Riedel (BVL), Herr F. Gründing (LUA Sachsen),

ViSdP: Frau N. Banspach (BVL, Press office)

Printed on acid-free paper

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

1 Explanatory notes on the List of Substances

2 Decision tree: Explanatory notes on the classification of substances

3 List of Substances of the Competent Federal Government

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

1.1 Introduction visions of the Regulation (EC) No. 1334/2008 on flavour-

No. 2: Food C List B No. 5: Novel food

2.2 Decision tree

Figure 1 Decision tree

Status: December 2013

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

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

Aconitum napellus L. all plant parts

Acorus calamus L., syn. Acorus Rhizome F

Actinidia deliciosa (CHEV.) Fruit

Aegopodium podagraria L., syn. Leaf

Remarks Risks Critical plant Pharmacologically effective

Positive monograph, indications: loss of Contraindications: hypersensitivity Proazulenes, Commission E: 4 g drug/day,

Neutral monograph, HMPC monograph:

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

Agrimonia eupatoria L., syn. Herb T

Agrimonia procera WALLR., Herb T

Alchemilla alpina L. em. BUSER Herb

Allium cepa L., syn. Allium escu- Bulb

Remarks Risks Critical plant Pharmacologically effective

Positive monograph, indications: mild, non- Commission E: 3–6 g drug/day,

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

Allium ursinum L., syn. Allium Herb S

Aloe barbadensis MILL., Aloe chi- Leaf gel

Aloe barbadensis MILL., Aloe chi- Leaf juice

Remarks Risks Critical plant Pharmacologically effective

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

Alpinia galanga (L.) WILLD., syn. Rhizome S, T

Althaea officinalis L., Leaf T

Althaea officinalis L., Root T

Althaea rosea L. Flower T

Ananas comosus (L.) MERR. Fruit

Anemopaegma mirandum MART. Bark Not NFS

Anethum graveolens L. Fruit S

Anethum graveolens L. Herb S

Remarks Risks Critical plant Pharmacologically effective

Positive monograph, indications: digestive Commission E: 2–4 g drug/day,

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

Antennaria dioica (L.) GAERTN., Flower C

Arctium lappa L., syn. Articum ma- Root T

Arctostaphylos uva-ursi (L.) Leaf Not NFS

Remarks Risks Critical plant Pharmacologically effective

Negative monograph: due to risks phototoxic, Commission E: celery may Furocoumarins

Negative monograph: due to risks phototoxic, Commission E: celery may Furocoumarins

toxic II (Wink/Wyk), toxic + (Roth/Daunderer), Vertigo, pupillary changes, dizziness, Isoquino-

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

Argyreia nervosa (BURM.f.) BOJ., Seed

Aristolochia spp. all plant parts

Armoracia lapathifolia GILIB., syn. Root

Aronia melanocarpa (MICHX.) Fruit

Remarks Risks Critical plant Pharmacologically effective