Plants and Plant Parts

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

Category “Plants and plant parts” BVL-Reporte

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Springer is part of Springer Science+Business Media (www.springer.com) 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, BandC ...... 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 – Category “Plants and plant parts”

1.1 Introduction visions of the Regulation (EC) No. 1334/2008 on flavourings 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 substances 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 consumption (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 Law governing the Trade of Narcotic Drugs (Narcotic Drugs Act – 9 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 – Category “Plants and plant parts”

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 AMGisnottakenintoaccount. 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-

List of Substances of the Competent Federal Government and Federal State Authorities, DOI 10.1007/978-3-319-10732-5_2, 5 © Federal Office of Consumer Protection and Food Safety (BVL) 2014 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 associated with risks. Its use in food is therefore not recommended, irrespective of the dose.

6 2.2 Decision tree

2.2 Decision tree ments [Not NFS], it may need ements [Not NFS], it may need food supplement D novel food/novel food ingredient, FS D traditional medicinal product, NF D medicinal product, trad. MP D food, MP D Decision tree * Assessment of potential use asto food/food be ingredient according placed to on the List Novel B.) Food** Regulation Assessment (If of the potential substance use as is food/food classifiedto ingredient as be according not placed tonovel on the Novel List food Food in C.) Regulation supple *** (If See the No. substance 3 is of classified as theAbbreviations: not explanatory F novel notes food in suppl Figure 1

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

Status: December 2013

List of Substances of the Competent Federal Government and Federal State Authorities, DOI 10.1007/978-3-319-10732-5_3, 9 © Federal Office of Consumer Protection and Food Safety (BVL) 2014 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 Aesculus castanea GILIB., Aesculus procera SALISB., Hippocastanum vulgare GAERTNER

10 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

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

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Aesculus hippocastanum L.,syn. Seed Not NFS Aesculus castanea GILIB., Aesculus procera SALISB., Hippocastanum vulgare GAERTNER

Agrimonia eupatoria L.,syn. Herb T Agrimonia adherens GILIB., Agri- monia officinalis LAM., Agrimonia parviflora SPRENG., Amonia agrimonoides 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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/ 2timesaday 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

Positive monograph, indications: mild, non- Commission E: 3–6 g drug/day, 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 disorders, HMPC monograph: traditional use Neutral monograph Positive monograph, indications: mild, non- Commission E: 5–10 g drug/day, 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.,Aloechi- Leaf gel nensis BAK.

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

14 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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) vascular changes. The drug may be useful in the treatment of mild hypertension, ESCOP monograph: prophylaxis of atherosclerosis, 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 monograph: 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 humans 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, increased diuresis, renal irritation (Roth/ Daunderer)

15 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 cusvisnagaL.,Apiumvisnaga 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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: traditional 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- natedascatuaba Positive monograph, indications: digestive Commission E, WHO: 3gdrug/ problems, WHO monograph: treatment of day, equivalent preparations dyspepsia, gastritis and flatulence, and stomach ache Neutral monograph Negative monograph: due to risks, slightly phototoxic Coumarins, furo- toxic (+) (Roth/Daunderer) coumarins

17 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 celleri GÄRTNER, Celeri graveolens BRITTON, Selinum graveolens E.H.L. KRAUSE, Seseli graveolens SCOP., Sison ruta BURM. Apium graveolens L.,syn.Apium Root, stem celleri GÄRTNER, Celeri graveolens BRITTON, Selinum graveolens E.H.L. KRAUSE, Seseli graveolens SCOP., Sison ruta BURM. 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 chavicol) Negative monograph: due to risks phototoxic, Commission E: celery may Furocoumarins induce allergic reactions and even anaphylactic shock (celery-carrot- mugwort syndrome)

Negative monograph: due to risks phototoxic, Commission E: celery may Furocoumarins induce allergic reactions and even anaphylactic shock (celery-carrot- 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 glycosides HMPC monograph: traditional use

Positive monograph, indications: inflam- Nausea and vomiting may occur Hydroquinones Commission E, WHO: 3gin 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, standard marketing authorisation: 1339.99.99, mildly toxic II to toxic III (Wink/Wyk), slightly toxic (+) to toxic + (Roth/Daunderer)

21 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 quebracho O. KTZE. Astragalus membranaceus (FISCH) Root Not NFS BGE., syn. Phaca membranacea FISCH. INDC.

22 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 Neutral monograph, HMPC monograph: traditional use Neutral monograph, HMPC monograph: traditional use

highly toxic ++ (Roth/Daunderer), toxic II Beta-carboline alkaloids contained in Beta-carboline (Wink/Wyk), used to produce ayahuasca, yagé thedrugarestrongmonoamineoxi- 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Bixa orellana L.,syn.BixaPOIR., 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, vomiting, diarrhoea, vertigo, cramps circulatory collapse, death by respiratory 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 authorisation: 1539.99.99 HMPC monograph: in progress

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 colouring food (safflower)

29 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 bonplandiana 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 thalictroides L.

Centaurea cyanus L., syn. Cyanus Flower T arvensis MOENCH, Cyanus segetum LAM.

30 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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-intestinal 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, mydriasis, 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 aday monograph, indications: chron. venous insufficiency, varicosis, wound healing, HMPC assessment report WHO monograph, indications: asyrupmade Pneumonia, nausea, vomiting, bloody Alkaloids WHO: 21–42 mg total alkaloid fromtherootsisusedasanemetic,toempty 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 complaints such as bloating and flatulence; BfArM graduated plan of 9 Apr 2008 concerning medicinal products for internal use containing 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 accompanied 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Cicutaan- 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 statement 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 monograph: 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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- nisLEMAOUT.&DECAISN.,Citrus florida SALISB. Citrus aurantium L. ssp. auran- Flower C tium, syn. Citrus aurantium L. ssp. amara (L.) ENGL, Citrus commu- nisLEMAOUT.&DECAISN.,Citrus florida SALISB. Citrus aurantium L. ssp. auran- Fruit tium, syn. Citrus aurantium L. ssp. amara (L.) ENGL, Citrus commu- nisLEMAOUT.&DECAISN.,Citrus florida SALISB.

Citrus aurantium L. ssp. auran- Peel tium, syn. Citrus aurantium L. ssp. amara (L.) ENGL, Citrus commu- nisLEMAOUT.&DECAISN.,Citrus 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 classification 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/ Wyk, Roth/Daunderer)

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

Stock plant Plant part F NF MP trad. MP List A List B List C (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 nobilis var. genuina TANAKA, Citrus nobilis var. major KERR. Citrus reticulata BLANCO,syn. Peel T Citrus deliciosa TEN., Citrus nobilis ANDR. (non LOUR.), Citrus nobilis 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 Aurantium sinensis MILL., Citrus aurantium LOUR. (non L.) Citrus sinensis (L.) OSBECK,syn. Fruit Aurantium sinensis MILL., Citrus aurantium LOUR. (non L.) Citrus sinensis (L.) OSBECK,syn. Peel T, S Aurantium sinensis MILL., Citrus aurantium LOUR. (non L.) 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 colouring 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 ClassIIasdefinedbytheNYHA,nervousheart ESCOP, WHO: 1–1.5 g drug, 3– complaints, support of cardiac and circulatory 4timesaday functions, HMPC monograph: in progress Neutral monograph, ESCOP monograph: ESCOP: 0.3–1 g drug, 3 times cardiac complaints, support of cardiac and aday circulatory functions, standard marketing authorisation: 1349.99.99, HMPC monograph: in progress

41 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Crocus sativus L.,syn.Crocusau- 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 uterine haemorrhage, bloody diarrhoea, haematuria and bleeding eyelids, effects on CNS such as excitement accompanied by fits of laughter, followed by vomiting, delirium, visual disturbances, 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 associated with stage I–II prostatic adenoma and irritable bladder, ESCOP monograph: symptomatic 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 dyspepsia, ESCOP monograph: symptomatic treatment of mild digestive disturbances and minor biliary dysfunction, HMPC monograph: traditional use, standard marketing authorisation: 2339.99.99

43 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Curcuma xanthorrhiza ROXB.,syn. Root S Curcuma zanthorrhiza ROXB.

Curcumazedoaria(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 officinale VILL., Tibichia umbellata KOELER Cynoglossum officinale ,syn.L. Herb Cynoglossum clandestinum DESF.

44 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective substances dose Positive monograph, indications: digestive Long-term use causes gastric com- Curcuminoids, Commission E, ESCOP: 2gdrug/ problems, ESCOP monograph: symptomatic plaints, contraindications reported xanthorrhizol day, equivalent preparations treatment of mild digestive disturbances and (Commission E monograph) minor biliary dysfunction, HMPC monograph: 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 reported (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, cardiac 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 consumption (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 damage, ingestion of higher doses causes convulsions, death by respiratory arrest (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 upper respiratory tract (common cold), HMPC monograph: traditional use 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: 0.5tsp.(approx.1g)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 upper respiratory tract (common cold), HMPC monograph: traditional use

49 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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: 6–9mlpressedjuice,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 therapy and prophylaxis of recurrent infections of the upper respiratory tract (common cold) and also of the urogenital tract, HMPC monograph: 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 (common 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 monograph: prophylactic and restorative tonic for enhancement of mental and physical capacities in cases of weakness, exhaustion and tiredness, and during convalescence, ESCOP monograph: decreased mental and physical capacities such as weakness, exhaustion, tiredness and loss of concentration, as well as during convalescence, HMPC monograph: traditional use

51 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 provisions of the Precursors Control Act (GÜG).

Positive monograph, indications: posttrau- Contraindications: oedemas associated Commission E, WHO: 6gdrug/ 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 therapy 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 individually or mixed with other barks desig- natedascatuaba 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Caprificusin- 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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) aday 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 renal dysfunction, coma, cocarcinogenic (Wink/Wyk) Neutral monograph, HMPC assessment report 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 expectorant for mild inflammation of the upper respiratory tract, treatment of pain in scrotal hernia, and dysmenorrhoea, ESCOP monograph: dyspeptic complaints such as mild, spasmotic gastrointestinal ailments, bloating and flatulence, catarrh of the upper respiratory tract, included in Annex 1 of Reg. 2001/83 (s. Commission Decision 2008/911/EC), HMPC monograph: traditional use 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 expectorant for mild inflammation of the upper respiratory tract, treatment of pain in scrotal hernia, and dysmenorrhoea, ESCOP monograph: dyspeptic complaints such as mild, spasmotic gastrointestinal ailments, bloating and flatulence, catarrh of the upper respiratory tract, included in Annex 1 of Reg. 2001/83 (s. Commission Decision 2008/911/EC), HMPC monograph: traditional use Neutral monograph Hypersensitivity reactions may occur in patients with a predisposition (Schilcher)

HMPC monograph: in progress

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

Stock plant Plant part F NF MP trad. MP List A List B List C (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 sempervirens 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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-containing 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, vertigo (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 monograph: traditional use

59 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 standardised acetone/water dry extract, indications: psycho-organic performance disorders, dementia, impaired memory, concentration difficulties, depression, vertigo, tinnitus, headache, HMPC monograph: in progress, WHO monograph: extracts have been used for symptomatic treatment of mild to moderate cerebrovascular insufficiency (demential syndromes in primary degenerative dementia, vascular dementia, and mixed forms of both) with the following symptoms: memory 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 vascular 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 moderate 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 peripheral arterial occlusive disease (intermittent claudication), BfArM graduated plan of 27 May 1997 concerning medicinal products containing Ginkgo biloba leaves, BfR statement: 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 oesophagus, cramps, arrhythmia, internal haemorrhage, peripheral neuropathy, abdominal pain, cold extremities, grey skin, tachycardia, respiratory arrest reported (Wink/Wyk, Roth/Daunderer)

61 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 dysfunction, 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: traditional 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, irritation 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, HMPC monograph: traditional use

63 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 monograph: traditional use 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 HMPC monograph: traditional use 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Hedera helix L., syn. Hedera Leaf caucasigena POJARK, Hedera chrysocarpa WALSH

Helianthus annuus L.,syn. Petal T HelianthuscultusVENTSL.,He- lianthus erythrocarpus BARTL., Helianthus indicus L., Helianthus pumilus PERS. Helianthus annuus L.,syn. Seed HelianthuscultusVENTSL.,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 arenarium L.

66 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 aday c) single dose: 33 mg, 2 times aday d) single dose: 100 mg, 3 times aday 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 aday d) single dose: 75 mg 3 times aday 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Heliotropium arborescens L.,syn. all plant parts Heliotropium corymbosum RUIZ et PAV, Heliotropium odoratum MOENCH, Heliotropium peruvianum 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 rhamnoides 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective substances dose toxic II (Wink/Wyk), toxic + (Roth/Daunderer), Pyrrolizidine alkaloids contained in Pyrrolizidine substance of concern (AMK), BfArM graduated thedrugmaycauseliverdamage 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 aday with prolonged gastrointestinal transit with abdominal pain, and for treatment of amenorrhoea

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 dyspepsia and lack of appetite, ESCOP monograph: tenseness, restlessness and sleep disorders, HMPC monograph: traditional use 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, delirium 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Asterhe- Root S, T lenium (L.) SCOP., Corvisartia helenium (L.) MÉRAT, Helenium grandiflorum GILIB.

Ipomoea purga (WENDER.) all plant parts HAYNE,syn.Exogoniumpurga (WENDER.) BENTH.

70 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 moderate depressive episodes in accordance with ICD-10 categories F32.0, F32.1, F33.0 and F33.1, HMPC monograph: herbal medicinal product 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 depression, 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: 3gdrugor0.3g 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, diarrhoea, 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Irisvirginica Root JACQ., PURSH (non L.) Jasminum grandiflorum L. Flower T Jasminum officinale L., Flower T Juglans regia L.,syn.Nuxjuglans Flower C DUHAM.

Juglans regia L.,syn.Nuxjuglans Seed DUHAM. Juglans regia L.,syn.Nuxjuglans 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 canascensWILLD.exSCHULTES Laburnum anagyroides MEDICUS, all plant parts syn. Cytisus laburnum L., Genista laburnum KRAUSE

72 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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: duetorisks,asflavour- 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 monograph) 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 damage, profuse internal haemorrhage, haematuria, uterus contractions, abortion, 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: forexternalorlocaluse 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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/ Wyk, Roth/Daunderer) Positive monograph, indications: catarrhs of Commission E: 3 g drug/day, the upper respiratory tract, mild infections of equivalent preparations theoralandpharyngealmucosa 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 disorders), standard marketing authorisation: 1119.99.99, WHO monograph: symptomatic treatment of restlessness, insomnia, and as a carminative and antispasmodic for gastrointestinal 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Levisticum officinale KOCH,syn. Herb S Angelica levisticum ALL., Hip- poselinum levisticum BRITTON et ROSE, Levisticum levisticum KARSTEN Levisticum officinale KOCH,syn. Root S, T Angelica levisticum ALL., Hip- poselinum levisticum BRITTON et ROSE, Levisticum levisticum 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 williamsii VOSS., Echinocactus lewinii (HENN.) SCHUM.

Lupinus spp. Seed

76 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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: traditional use, standard marketing authorisation: 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 enteritis, HMPC monograph: treatment of habitual constipation or in conditions in which easy defaecation with soft stool is desirable, traditional 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 arrest (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, vasodilation, 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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- lusBENTH.,Lycopusuniflorus 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 paralysis (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), HMPC monograph: traditional use 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 facial muscles, central apnoea (Roth/ Daunderer)

79 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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. alternifolia 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective substances dose Positive monograph, indications: gastroin- Commission E: 1 tbsp. (approx. testinal cramps and inflammatory diseases of 3g),3–4timesaday 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 problems related to varicose veins, such as painful and heavy legs, nocturnal cramps in the legs, itching and swelling, HMPC monograph: traditional use, BfArM graduated plan of 23 May 1997 concerning coumarin-containing phytopharmaceuticals 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 aborticide 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 consciousness up to hallucinations, ventricular tachycardia, vertigo, mydriasis, vomiting, abortifacient effect. Safrole contained in the essential oil has a mutagenic effect and demonstrated a carcinogenic effect in animal experiments (Wink/Wyk)

83 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.,OcimumalbumL.,Oci- mummenthaefoliumHOCHST.ex BENTH.

Ocimum tenuiflorum L, Oci- Herb S mum sanctum L., syn. Ocimum album BLANCO, Ocimum virgatum BLANCO Olea europaea L.,syn.Oleaof- Leaf T ficinarum CRANTZ, Olea pallida SALISB. Ononis spinosa L., syn. Ononis Root T arvensis L., Ononis campestris KOCH et ZIZ.

84 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, mydriasis, vomiting, abortifacient effect. Safrole contained in the essential oil has a mutagenic effect and demonstrated 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 hallucinations. Ingestion of 9 teaspoons of nutmeg powder per day observed to produce an effect similar to that of atropine. 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, bradycardia, 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 lactation, 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

Neutral monograph, HMPC monograph: 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 inflammation and renal gravel, and as an adjuvant in treatment of bacterial infections of the urinary tract, HMPC monograph: in progress

85 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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: traditional use

Positive monograph, indications: irrigation Contraindications: oedemas associated Commission E: 6to12gdrug, 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: traditional use, standard marketing authorisation: 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 capacities, 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 convalescence, HMPC monograph: in progress, hardly or only slightly toxic (+) (Roth, Daunderer)

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

87 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 apnoea (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 4timesaday 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 recent 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 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.) Root NYM. ex A.W. HILL.,syn.Apium hortense E.H.L. KRAUSE, Apium petroselinum L., Apium vulgare LAM., Carum petroselinum BENTH. et HOOK.

90 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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) pflanzlichen-zubereitungen.pdf 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- 4timesaday 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 containing 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 especially the uterus. Parsley seeds and parsley oil therefore formerly used as aborticide; irritation, damage to renal epithelial tissues and cardiac arrhythmia reported, higher doses of apiol in parsley may cause fatty liver disease, 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 diarrhoea. 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 diarrhoea. 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 poisoning possible (Wink/Wyk, Roth/ Daunderer) Positive monograph, indications: catarrhs of Commission E: 5–6 g drug/day the respiratory tract

93 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Pinusnigra Shoot (tip) T MILL. PipercubebaL.f.,syn.Cubeba Fruit S officinalis RAF.

94 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, bradycardia, cardiac palpitation, convulsions, tremor, dyspnoea, arrhythmia, vesical tenesmus, headache, vertigo, death by cardiac arrest, leucocytosis (Wink/ Wyk, Roth/Daunderer)

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 respiratory 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, the upper respiratory tract equivalent preparations

Positive monograph, indications: catarrhs of Commission E: 2–3 g drug/day, the upper respiratory tract equivalent preparations toxic II (Wink/Wyk), toxic + (Roth/Daunderer) Ingestion of higher doses causes Cubebin, cubebic painful urinary tract inflammations, acid pain in kidneys and bladder, albuminuria, tachycardia, nausea, vomiting, diarrhoea, CNS disorders, spasmodic urinary retention, accelerated pulse, cardialgia, diarrhoea and skin rash (Wink/Wyk, Roth/Daunderer)

95 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Piper methysticum G. FORST.,syn. Rhizome Macropiper latifolium MIQ.

Piper nigrum L.,syn.Muldera Fruit S multinervis MIQ., Piper aromaticum 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 insomnia, 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 pepper: 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, 3timesaday temporary, mild inflammations of the oral and pharyngeal mucosa, HMPC monograph: traditional use WHO monograph, indications: catarrh of the respiratory tract, cough, bronchitis, inflammatory 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Plantago ovata FORSSKAL,syn. Seed husk Plantago isphagula ROXB. ex FLEMMING, Plantago brunnea MORRIS

98 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 constipation, temporary constipation due to illness or pregnancy, irritable bowel syndrome and constipation related to duodenal ulcer or diverticulitis, 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 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 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 haemorrhoids; in patients to whom an increased daily fibre intake may be advisable e.g. as an adjuvant in constipation predominant irritable bowel syndrome, as adjuvant to diet in hyper- cholesterolemia

99 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 diverticulitis. It is also used to soften the stools of those with haemorrhoids, or after anorectal surgery, traditional use, ESCOP monograph: treatment of occasional constipation, conditions 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 therapy in cases of diarrhoea from various causes, HMPC monograph: treatment of 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 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 after anorectal surgery, ESCOP monograph: treatment of occasional constipation, conditions 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 habitual 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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,usedas 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) mations of the oral and pharyngeal mucosa, standard marketing authorisation: 9599.99.99

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/ 350/risikobewertung-von-pflanzen-und- pflanzlichen-zubereitungen.pdf 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Prunus armeniaca L., syn. Armeni- Seed aca vulgaris LAM.

Prunus avium L. Fruit Prunus avium L. Stalk Not NFS Prunus cerasus L.,Cerasusvul- Fruit garis MILL., Cerasus caproniana DC., Prunus caproniana GAUD., Druparia cerasus CLAIRV. Prunus cerasus L.,Cerasusvul- 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 children 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 cancer, thiaminase contained in the drug destroys vitamin B1 (Wink/Wyk) Neutral monograph

Neutral monograph

Isoflavones

105 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 tum punicum ST. LAG., Punica florida SALISB. Punica granatum L., syn. Grana- Bark tum punicum ST. LAG., Punica 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 disturbances (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, vomiting, 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: traditional use, standard marketing authorisation: 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, vomiting, 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 ferrugineum BUBANI)

Rhus aromatica AIT.,syn.Rhus Bark canadensis MARSH. non MILL.

110 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 hydroxyanthracene 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 hydroxyanthracene 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 toxicodendron (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.Rosagrandi- Petal T flora SALISB., Rosa provincialis AIT., Rosa provincialis HERRM., Rosa pumila JACQ., Rosa rubra LAM. Rosa x centifolia,syn.Rosacentifo- Petal T lia x vulgaris SERINGE ex DC., Rosa gallica x centifolia REGEL

112 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 kidney 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 properties, cytotoxic, nausea, vomiting, diarrhoea, drowsiness, mydriasis, convulsive 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 aday 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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- 3timesaday 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); preparations, predominantly in combination with a complex composition, formerly used for abortion; however, case reports 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 mations of the oral and pharyngeal mucosa, standard marketing authorisation: 1449.99.99

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 haemorrhoids such as itching and burning, HMPC monograph: traditional use, ESCOP monograph: supportive therapy for symptoms of chronic venous insuffiency, such as painful, tired and heavy legs, tingling and swelling, supportive therapy for symptoms of haemorrhoids, such as itching and burning, slightly toxic (+) to toxic + (Roth/Daunderer), mildly toxic III (Wink/Wyk)

115 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Ruta graveolens L.,syn.Rutagrave- 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 arborescens GILIB., Sambucus medullina GILIB.

116 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 contractions, 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 monograph: 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, estragole (Dmethyl chavicol) Eucalyptol (D1,8-cineol), camphor, estragole (Dmethyl chavicol) Thujone, eucalyptol (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 poisoning 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 HMPC monograph: traditional use

117 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Sambucus nigra L., syn. Sambucus Fruit b arborescens GILIB., Sambucus medullina GILIB.

Sanicula europaea L.,syn.Astrantia Herb Not NFS diapensia SCOP., Caucalis capitata 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 officinarum 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 terebinthifolius 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 chinensis TURCZ., Maximowiczia amurensis RUPR.

118 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 undesirable 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 disorders, as a general tonic for treating fatigue associated with illness

119 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, paralysis of the myelencephalic centres, in low doses vertigo, darkened vision, marasmus, hypothermia, bradycardia, dyspnoea and gastrointestinal irritation, 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) secondary to BPH stages I and II, as defined by Alken, in cases where diagnosis of prostate cancer is negative, ESCOP monograph: symptomatic treatment of micturition disorders (dysuria, pollakisuria, nocturia, urinary retention) 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, HMPC monograph: in progress

121 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Silybum marianum (L.) GAERTN., Fruit T syn. Carduus marianus L., Carthamus maculatus LAM., Cri- sium, maculatum SCOP., Mariana mariana (L.) HILL., Silybum maculatum 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 hepatitis and cirrhosis induced by alcohol, drugs or toxins, HMPC monograph: in progress, ESCOP monograph: toxic liver damage, supportive 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 diarrhoea, 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 infections 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 Eugenia cumini (L.) DRUCE, Myrtus cumini L. Syzygium cumini (L.) SKEELS,syn. Seed Not NFS Eugenia cumini (L.) DRUCE, Myrtus 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 officinalis HOOK. Tamus communis L. all plant parts

124 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 assessment 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 mellitus 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (Latin) Tanacetum vulgare L.,syn. Flower, herb Chrysanthemum vulgare (L.) BERNH., non Leucanthemum vulgare L.

Taraxacum officinale WEB. ex Herb, root WIGG., syn. Taraxacum officinale (WITH.) WIGGERS, Leontodon officinale WITH., Leontodon taraxacum L.

Taraxacum officinale WEB. ex Flower T WIGG., syn. Taraxacum officinale (WITH.) WIGGERS, Leontodon officinale WITH., Leontodon taraxacum 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 3timesaday 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 adjunct 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 beverages (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, bradycardia, AV block, ventricular fibrillation, death (Wink/Wyk)

127 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Thymuscomptus HORT., Thymus jankae HORT., Thymus lanuginosus MILL. var. citriodorum PERS., Thymus serpyllum 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, degenerative kidney, cardiac and liver damage, death by respiratory and circulatory arrest (Wink/Wyk) Positive monograph, indications: catarrhs of Carvacrol Commission E: 4–6 g drug/day, the upper respiratory tract equivalent preparations 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 treatment 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: traditional use, standard marketing authorisation: 1129.99.99

Neutral monograph, HMPC assessment report 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) individually or mixed with other barks desig- natedascatuaba 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, respiratory depression, vasodilation, paralysis (Wink/Wyk) WHO monograph: traditional use WHO: 240–480 mg extract/day

129 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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: 6gdrug/ petite, WHO monograph: as an adjunct for day the management of hypercholesterolaemia, and hyperglycaemia in cases of diabetes mellitus. Prevention and treatment of mountain sickness, loss of appetite, Treatment of pain, and weakness and oedema of the legs, traditional 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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) resulting from BPH stages I and II, as defined by Alken, in cases where diagnosis of prostate cancer is negative, ESCOP monograph: symptomatic treatment of micturition disorders (dysuria, pollakisuria, nocturia, urine retention) in benign prostatic hyperplasia (BPH) at stages I and II as defined by Alken or stages II and III as defined by Vahlensiek, HMPC monograph: traditional use

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 authorisation: 8599.99.99, ESCOP monograph: adjuvant in the symptomatic treatment of arthritis, arthrosis and/or rheumatic conditions, HMPC monograph: traditional use 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 authorisation: 8599.99.99, ESCOP monograph: adjuvant in the symptomatic treatment of arthritis, arthrosis and/or rheumatic conditions, HMPC monograph: traditional use 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 cancer is negative, ESCOP monograph: symptomatic treatment of micturition disorders (dysuria, pollakisuria, nocturia, urine retention) in benign prostatic hyperplasia (BPH) at stages I and II as defined by Alken or stages II and III as defined by Vahlensiek, HMPC monograph: traditional use 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 administration to children WHO: 400–450 mg drug

133 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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.Valerianamexi- 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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, circulatory 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): symptomatic 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 cardiac or respiratory arrest (Wink/Wyk)

135 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 vulgaris 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective substances dose Positive monograph, indications: catarrhs Commission E: 3–4 g drug/day, of the respiratory tract, HMPC monograph: equivalent preparations traditional use, standard marketing authorisation: 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 (Wink/Wyk, Roth/Daunderer) toxic + (Roth/Daunderer), mildly toxic III Nausea, clouded consciousness, Viburnin, oxalates (Wink/Wyk) vomiting, diarrhoea, digestive tract inflammations, cardiac arrhythmia, cramps, dyspnoea, kidney damage (Wink/Wyk, Roth/Daunderer) 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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 syndrome)) acne vulgaris, eczema, acne rosacea), hypermenorrhoea, infertility due to hyperprolactinaemia and luteal phase defect. Used to treat fibroid cysts and infertility, to stop miscarriages due to progesterone insufficiency, 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 monograph: 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 distress, facial pallor and drowsiness, headache, vertigo and circulatory collapse (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 disease in athletes and the elderly, HMPC monograph: final public statement, s. BfR statement: http://www.bfr.bund.de/cm/ 350/risikobewertung-von-pflanzen-und- pflanzlichen-zubereitungen.pdf

139 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Stock plant Plant part F NF MP trad. MP List A List B List C (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 3 List of Substances of the Competent Federal Government and Federal State Authorities – Category “Plants and plant parts”

Remarks Risks Critical plant Pharmacologically effective 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 digitalis (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), hypertension, 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, establishing 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 substances 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 properties 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 © Federal Office of Consumer Protection and Food Safety (BVL) 2014 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), amendedbyArticle4Section9oftheLawof7August 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-

144 References

Arzneimittelkommission der deutschen Ärzteschaft2 (2013). Be- and including D2/liver damage, notification of 9 June 2009), http:// denkliche Rezepturarzneimittel (Unsafe compounded drugs), www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/ http://www.akdae.de/Arzneimittelsicherheit/Weitere/Bedenkliche- stufenplverf/cimicifuga_bescheid.pdf?__blob=publicationFile. Rezepturarzneimittel.pdf. Bundesinstitut für Arzneimittel und Medizinprodukte (1987). Abwehr Arzneimittelkommission der Deutschen Apotheker3, Warnung von von Arzneimittelrisiken, Stufe II, Immergrünkrauthaltige Arzneimit- Arnikatee innerlich (Warning about ingestion of arnica tea), Pharm. tel, Bescheid vom 20.07.1987 (Prevention of drug-associated risks, Ztg., 1981, 726, 2082. stage II, medicinal products containing Vinca minor, notification of Bäumler, S. (2006). Heilpflanzenpraxis Heute. Portraits – Rezepturen – An- 20 July 1987). wendung (1st ed.). Amsterdam: Urban & Fischer Verlag Elsevier. Bundesinstitut für Arzneimittel und Medizinprodukte (2005). Ab- Blaschek, W., Ebel, S., Hackenthal, E., Holzgrabe, U., Keller, K., Reichling, wehr von Gefahren durch Arzneimittel, Stufe II hier: Johanniskraut J. & Schulz, V. (2007). Hagers Enzyklopädie der Arzneistoffe und Drogen (Hypericum)-haltige Humanarzneimittel zur innerlichen Anwen- (6th ed.). Stuttgart: Wissenschaftliche Verlagsgesellschaft. dung, Bescheid vom 10.10.2005 (Prevention of drug-associated Bundesinstitut für Arzneimittel und Medizinprodukte4 (2000). risks, stage II, here: Medicinal products for internal use in hu- BfArM warnt vor Aristolochia in Zubereitungen aus chinesischen mans containing St. John’s wort (Hypericum), notification of Heilkräutern (BfArM warns about Aristolochia in preparations of 10 Oct 2005), http://www.bfarm.de/SharedDocs/1_Downloads/DE/ Chinese herbal remedies), http://www.bfarm.de/DE/BfArM/Presse/ Pharmakovigilanz/stufenplverf/Johanniskraut-Bescheid-051010. mitteil_alt/pm01-2000.html. pdf?__blob=publicationFile. Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Bescheid Bundesinstitut für Arzneimittel und Medizinprodukte (2007). Ab- des BfArM gem. §21 Abs. 4 AMG vom 04.03.2008 zur Einstufung eines wehr von Gefahren durch Arzneimittel, Stufe II, hier: Kava-Kava Cistus-incanus-haltigen Produktes als Arzneimittel (BfArM notifica- (Piper methysticum)-haltige und Kavain-haltige Arzneimittel tion in accordance with Section 21 Clause 4 AMG of 4 Mar 2008 on einschließlich homöopathischer Zubereitungen mit einer End- the classification of a product containing Cistus incanus as a medici- konzentration bis einschließlich D4, Bescheid vom 21.12.2007 nal product). (Prevention of drug-associated risks, stage II, here: Medicinal prod- Bundesinstitut für Arzneimittel und Medizinprodukte (2008). 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Nr.: 111, S. 4805 vom 17.6.1992 wehr von Risiken durch Arzneimittel, Stufe II, Hier: Arzneimittel, (Prevention of drug-associated risks, stage II, pyrrolizidine alkaloids, die unter Verwendung von Pflanzen der Familie der Aristolochi- notice of the authorisation and registration of medicinal products, aceae mit den Gattungen Asarum, Aristolochia, Saruma und notification of 5 June 1992, Federal Gazette No. 111, p. 4805 of 17June Thottea hergestellt werden, Bescheid vom 22.07.2010 (Preven- 1992). tion of drug-associated risks, stage II, here: Medicinal products Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Ab- manufactured using plants of the Aristolochiaceae family with wehr von Gefahren durch Arzneimittel, Stufe II, hier: Schöllkraut- the genera Asarum, Aristolochia, Saruma and Thottea, notifica- haltige Arzneimittel zur innerlichen Anwendung, Bescheid vom tion of 22 July 2010), http://www.bfarm.de/DE/Pharmakovigilanz/ 08.04.2008 (Prevention of drug-associated risks, stage II, here: Medic- risikoinfo/stufenplanverf/Liste/stp-aristolochiaceae.html; inal products for internal use containing Chelidonium, notifica- jsessionid=38873A056B112E06417AC2A6120ACBEE.1_cid322. tion of 8 April 2008), http://www.bfarm.de/DE/Pharmakovigilanz/ Bundesinstitut für Arzneimittel und Medizinprodukte (2009). Abwehr risikoinfo/stufenplanverf/Liste/stp-schoellkraut.html. von Gefahren durch Arzneimittel, Stufe II hier: Cimicifuga-haltige Bundesinstitut für Arzneimittel und Medizinprodukte (2008). Hu- Arzneimittel einschließlich homöopathischer Zubereitungen mit manarzneimittel zur innerlichen Anwendung ausgenommen nach einer Endkonzentration bis einschließlich D2/Leberschädigungen, HAB 1 hergestellte homöopathische Arzneimittel, welche Drogen, Bescheid vom 09.06.2009 (Prevention of drug-associated risks, Drogenzubereitungen oder isolierte Inhaltsstoffe der Anthranoid- stage II, here: Medicinal products containing Cimicifuga, includ- (Hydroxyanthracenderivat-)haltigen Pflanzengattungen Andira, ing homeopathic preparations with a final concentration of up to Cassia, Rhamnus, Rheum oder Aloe enthalten (Medicinal products for internal use in humans, excluding homeopathic medicinal 2 Drug Commission of the German Medical Association products manufactured according to HAB 1 which contain drugs, 3 Drug Commission of German Pharmacists drug preparations or isolated ingredients of the anthranoid- (hy- 4 Federal Institute for Drugs and Medical Devices droxyanthracene derivative) containing plant genera Andira, Cassia,

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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, Ministerievan 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 List of Substances of the Competent Federal Government and Federal State Authorities

Plants and plant preparations are an important part of a balanced diet. Apart from using them as fruit, vegetables or cereals we can also enjoy them as ingredients in the form of herbs or spices or enjoy them in teas. More and more exotic plants are also available whose use as food in Germany was not known up to now. Supermarkets and drugstores also sell an increasing number of products which supposedly benefi t health and contain preparations which were previously used in Germany above all in pharmaceutical products. The present category “Plants and plant parts” of the List of Substances of the Competent Federal Government and Federal State Authorities was provided to facilitate the classifi cation and evaluation of plants and plant parts regarding their use as food or food ingredients. In addition to classifi cation under formal legal aspects the list also provides information on the possible BVL-Report · 8.8 risks involved with certain uses. The list of substances is intended as a guideline for authorities and those placing products on the market. List of Substances of the Competent Federal Government and Federal State Authorities Category “Plants and plant parts”

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