• EFSA Journal 2009; 7(9):281


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    • Abstract: EFSA Journal 2009; 7(9):281EFSA SCIENTIFIC COOPERATION (ESCO) REPORTEFSA Compendium of botanicals that have been reported to contain toxic,addictive, psychotropic or other substances of concern1European Food Safety Authority2

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EFSA Journal 2009; 7(9):281
EFSA SCIENTIFIC COOPERATION (ESCO) REPORT
EFSA Compendium of botanicals that have been reported to contain toxic,
addictive, psychotropic or other substances of concern1
European Food Safety Authority2
European Food Safety Authority (EFSA), Parma, Italy
ESCO WORKING GROUP MEMBERS
The ESCO working group was composed of:
Experts nominated by the EFSA Scientific Committee: Robert Anton, Angelo Carere, Luc Delmulle
(Chair Subgroup Compendium), Corrado L. Galli, Ivonne Rietjens (Chair Subgroup Real Cases),
Vittorio Silano (Chair Overarching Group) and Gerrit Speijers.
Experts nominated by the members of the EFSA Advisory Forum: Ilze Abolina, Judith Amberg-
Müller, Ulla Beckman-Sundh, Birgit Dusemund, Marie-Hélène Loulergue, Andrea Lugasi, Martijn
Martena, Maria Nogueira, Kirsten Pilegaard, Mauro Serafini, Jaroslav Toth, Arnold Vlietinck and
Magdalini Zika.
1 On request of EFSA, Question No EFSA-Q-2008-388b, issued on 30 April 2009.
2 Correspondence: [email protected]
For citation purposes: European Food Safety Authority; Compendium of botanicals that have been reported to contain toxic,
addictive, psychotropic or other substances of concern on request of EFSA. EFSA Journal 2009; 7(9):281. [100 pp.].
doi:10.2903/j.efsa.2009.281. Available online: www.efsa.europa.eu
© European Food Safety Authority, 2009 1
Compendium of Botanicals
PREAMBLE
This Compendium is the result of an EFSA Scientific Cooperation (ESCO) work undertaken by a
group of experts identified both by EFSA and Advisory Forum Representatives of the European
Member States.
During this one-year activity, these experts built up on previous versions of the Compendium,
considering information available from a number of existing lists of plants (see Compendium –
Sources of Information sheet), and from the scientific literature to fill information in the
Compendium. The search for information from the literature ended on 10 March 2009.
Legal disclaimer
This compendium lists in alphabetical order botanicals without any judgment on whether they are
suitable or not suitable for food applications in Europe. The compendium is part of a preparatory
work undertaken by EFSA to harmonise the methodology for assessing the safety of botanicals and
botanical preparations used in food. Without prejudice to the existing legal framework, the
compendium has no legal status and may not be used as support or evidence in any disagreement or
dispute pertaining to the legal classification of products or substances.
Purpose of the Compendium
The Compendium is intended to facilitate the implementation of the EFSA guidance for the safety
assessment of botanicals and botanical preparations intended for use as food supplements. The
Compendium aims at flagging plants or part of plants or compounds of possible concern for human
heath naturally present in the listed botanicals and that therefore require specific attention while
assessing the safety of the product(s) containing such botanical(s). For some botanicals in the
compendium adverse (toxic) effect(s) are known even though the constituent(s) of concern are not
elucidated in the literature. In some cases the whole genus was flagged because of the likely presence
of substances of concern characteristic for the toxicity of that genus.
The presence of a substance of concern in a given botanical does not mean that this substance will
also be present in the botanical preparation. This depends largely on the plant part used, as well as the
preparation method.
The Compendium contains also an “insufficient information” list regrouping botanicals that appear in
one of the sources of information, but for which the working group could not find enough information
on possible substances of concern, or for which the information present could not be verified.
The Compendium is a living list which should be periodically updated by EFSA. As a consequence,
the absence of a given species in this Compendium cannot be interpreted as this species devoid of
compounds hazardous for human health. In the same way, not mentioning a specific part of plant,
does not imply absence of substance(s) of concern in this part.
For further information on this Compendium, please contact:
[email protected]
EFSA Journal 2009; 7(9):281 2
EFSA Technical Report (2009) 281
COMPENDIUM OF BOTANICALS THAT HAVE BEEN REPORTED TO CONTAIN
TOXIC,ADDICTIVE, PSYCHOTROPIC, OR OTHER SUBSTANCES OF CONCERN
Sources of information
Code Reference
1A Plants containing toxic substances (CPMP / EMEA,1992)
Plants considered in 2005 by the Italian Ministry of Health as not suitable for use in food supplement
1B manufacturing
(www.ministerosalute.it/alimenti/dietetica/dietetica.jsp)
Spanish Regulation (Ministerio de Sanidad y Consumo Orden SCO/ 190/2004) concerning plants for
1C
which public sale is forbidden or limited because of toxicity
1D Swedish list (September 2006) concerning plants which are considered as not suitable in foods
Dutch Regulation implementing the Law 19 January 2001 on Goods and identifying pyrrolizidine
1E alkaloids containing plants (for which a maximum limit of 1 µg/kg or per litre is imposed) (E1) and plants
not to be used in herboristic products (E2)
1F Belgian Regulation (29/8/1997 and following acts) identifying plants non admitted in foods
Danish list concerning toxicological evaluation of plants in food supplements; The list contains plants
1G considered as unacceptable, plants with a restriction on daily use (max. level), and plants that are
evaluated at a daily dose (“Drogelisten” (2000) and later update (September 2006)
Plants assessed as flavourings by the Council of Europe in 2000 and 2004 belonging to Category 3 or 4
1H (restrictions recommended for use) (H1 and H2 respectively) or as Category 5 (restrictions recommended
and further data required) (H3) or Category 6 (considered not appropriate for human consumption) (H4)
List of Botanicals not admitted or restricted in food in Austria; (Codex Unterkommission
1I
Nahrungsergänzungsmittel)
The departmental order of the Danish Ministry of Health no. 698 (31. August 1993) List of euphoriants.
1J
(Latest updated 11. April 2007)
French Pharmacopoeia (10th edition): List A of medicinal plants with a traditional use and List B of
1K medicinal plants with a traditional use but whose possible undesirable effects exceed expected beneficial
therapeutical effect.
Active principles (constituents of toxicological concern) contained in natural sources of flavourings.
1L
Council of Europe, 2004
1M Plants assessed as medicinal products by WHO in 1999 (Vol. I), 2002 (Vol. 2) and 2005 (Vol. 3)
Plants assessed as medicinal products by the EMEA/HMPC since its inception, and previously by the
1N
Working Party on Herbal Medicinal Products between 1998 and 2004
1O Plants assessed as medicinal products by ESCOP (2003)
Plants identified in the Belgian Regulation (Arrêté Royal 29/8/1997 – annex list 3 and following acts) as
1P
requiring a notification before marketing
Final Public Statement on the use of herbal medicinal products containing estragole, Committee on Herbal
1Q
Medicinal Products, London 23 November 2005
1R Monographs being prepared by the EMEA/HMPC
List of botanicals in which active principles, presently used in therapy, have been identified (Morelli and
1S
Vincieri, 1989)
Final Public Statement on the use of herbal medicinal products containing methyleugenol, Committee on
1T
Herbal Medicinal Products (HMPC), London 23 November 2005
Final Public Statement on the risk associated with the use of herbal products containing aristolochia
1U
species, Committee on Herbal Medicinal Products (HMPC), London 23 November 2005
Final Public Statement on the use of herbal medicinal products containing pulegone and menthofuran,
1V
Committee on Herbal Medicinal Products (HMPC), London 23 November 2005
Final Public Statement on the use of herbal medicinal products containing asarone, Committee on Herbal
1W
Medicinal Products (HMPC), London 23 November 2005
The EuroFIR-NETTOX Plant List by Pilegaard K, Eriksen FD, Soerensen M, and Gry J. Electronic
1X version November 2006 (Revised version of the NETTOX list of Food Plants - Major European Food
Plants and Edible Mushrooms by 1997)
© European Food Safety Authority, 2009
EFSA Technical Report (2009) 281
COMPENDIUM OF BOTANICALS THAT HAVE BEEN REPORTED TO CONTAIN TOXIC,ADDICTIVE, PSYCHOTROPIC, OR OTHER SUBSTANCES OF CONCERN
This compendium lists in alphabetical order botanicals without any judgment on whether these are suitable or not suitable for food applications in Europe. This compendium is part of a preliminary work undertaken by EFSA to
harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food. Without prejudice to the existing legal framework, such compendium has no legal status and may not
be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is a living document and is therefore open for additional contributions and
comments.
Parts of plants of
Botanical name Chemical of concern / toxic effect Remarks Specific References
possible concern
Frohne D., Pfänder H.J. et Anton R. « Plantes à
1B: seeds
Abrus precatorius L. glycoproteins: abrin (lectins) Potent haemagluttinins and extremely toxic risques », Ed. Tec et Doc-Lavoisier (2009),
1C: entire plant
ISBN :978-2-7430-0907-1
Chalchat J.C., Petrovic S.D., Maksimovic Z.A.,
Gorunovic M.S. (2005). Aromatic Plants of
essential oil with beta thujone : 16.8% in essential oil beta-thujone(16,8%); pinocarvone Yugoslavia. III. Chemical Composition of
Achillea abrotanoides
Herb 1T: known to contain methyleugenol in unspecified (15,6%); 1,8-cineole (11,3%), but the content of Essential Oils of Achillea abrotanoides Vis., A.
Vis.
quantities methyleugenol has not been determined clypeolata Sibth. & Sm., A. depressa Janka and
A. stricta Schleicher et Koch. Journal of
Essential Oil Research
The hydrodistilled oil and the solvent extract contain
Achillea fragrantissima santolina alcohol, artemisia alcohol, artemisia
Herb 1Q: known to contain estragole in unspecified quantities ketone, cis-thujone and trans-thujone as major
Sch.Bip.
constituents
1H: Fresh plant oil: α-thujone 0.28%; β-thujone 1.60%;
camphor 2.93%; eucalyptol 2.24%. Dried plant oil: α-
thujone 0.40%; β-thujone 3.21%; camphor 4.43%; Contains thujones and camphor in various amounts
1H herb, flowers Natural Sources of Flavourings, Rep No.1, CoE
Achillea millefolium L. eucalyptol 4.54%. Flower oil: α-thujone 1.02%; β-thujone depending on the part of the plant from which the
1G: herb, flower (2000)
0.59%; camphor (check)%; eucalyptol 3.70-9.6%. Leaf oil: essential oil is made of;
α-Thujone 0.50%; β-thujone 0.25%; camphor 16.80%;
eucalyptol 6.09% (CoE 2000)
Genus in which some species are known to contain
Acokanthera spp. Entire plant
cardiotonic glucosides, e.g. ouabain...
Acokanthera ouabaio
1B: wood, seeds cardiotonic glycosides: g-strophanthine: ouabain... used as intraveinous arrow poisoning
Cathelineau ex Lewin
Acokanthera schimperi
1B: fruit, wood cardiotonic glycosides: g-strophanthine: ouabain... used as intraveinous arrow poisoning
Benth. & Hook.f.
Frohne D., Pfänder H.J. et Anton R. « Plantes à
Genus in which some species may contain toxic diterpenoid
Aconitum spp. 1A, 1C, 1D, 1G: entire plant risques », Ed. Tec et Doc-Lavoisier (2009),
alkaloids: e.g. aconitine,…
ISBN :978-2-7430-0907-1
1B: flowers, herbaceous plant,
Aconitum anthora L.
roots
Aconitum chasmanthum
1B: roots
Stapf.
Aconitum ferox Wall. 1B: roots
Aconitum heterophyllum
1B: roots
Wall.
© European Food Safety Authority, 2009 page 1 of 98
EFSA Technical Report (2009) 281
COMPENDIUM OF BOTANICALS THAT HAVE BEEN REPORTED TO CONTAIN TOXIC,ADDICTIVE, PSYCHOTROPIC, OR OTHER SUBSTANCES OF CONCERN
This compendium lists in alphabetical order botanicals without any judgment on whether these are suitable or not suitable for food applications in Europe. This compendium is part of a preliminary work undertaken by EFSA to
harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food. Without prejudice to the existing legal framework, such compendium has no legal status and may not
be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is a living document and is therefore open for additional contributions and
comments.
Parts of plants of
Botanical name Chemical of concern / toxic effect Remarks Specific References
possible concern
1B: leaves, herbaceous plant,
Aconitum napellus L.
roots, tubers
Aconitum variegatum L. 1B: roots
1W: known to contain asarone in unspecified quantities;
1W: leaves, rhizome;
(diploide variety contains no cis-isoasarone; tetraploide up
1T: rhizome DUKE1992A; Encyclopaedia of Herbs,Nico
Acorus calamus L. to 80% in essential oil)
1B: oil, rhizome Vermulen,1998,Rebo International,p.23.
1Q: known to contain estragole in unspecified quantities
1C: roots
1T: methyleugenol content 1.0% , 1.025 ppm (rhizome)
Acorus calamus L. var. 1W: known to contain asarone: 50-65% (leaves), 9-19%
1W: leaves, rhizome
calamus (rhizome), 0.3% (dried rhizome); triploid herb
Acorus calamus L. 1W: known to contain asarone: 85-95% (rhizome), 4.4-
1W: leaves, rhizome
var.angustatus Bess 8.3% (dried rhizome); tetraploid herb
rhizoma: 0.5-0.9% essential oil with alpha humulene, cis-
Natural sources of flavourings (Rep No 3),
Acorus gramineus Sol. Leaves, rhizome and trans- isoasarone, methyleugenol, cis-methyleugenol
Council of Europe, (2008)
and safrole; calciumoxalate raphides
Hegnauer R 1995, Ranunculaceae, 10
1B: fruit, herbaceous plant, seeds and fruits. Formerly protoanemonin was said Vergleichende Phytochemie und
Actaea spicata L. rhizome benzylisoquinoline alkaloids: magnoflorine, corytuberine to be found in fresh herb, but this couldn't be Chemataxonomie Berlin;
1C: entire plant confirmed Natural sources of flavourings (Rep No 3),
Council of Europe, (2008)
Adenium obesum root, stem, latex, seeds cardenolide glycosides: e.g. echujine
Adhatoda vasica Nees.
(See Justicia adhatoda
L.)
Frohne D., Pfänder H.J. et Anton R. « Plantes à
risques », Ed. Tec et Doc-Lavoisier (2009),
Genus in which some species may contain cardenolide ISBN :978-2-7430-0907-1
Adonis spp. entire plant
glycosides: e.g. adonitoxin,… Bruneton J. « Plantes toxiques », 3ème édition,
Ed. Tec et Doc-Lavoisier (2005), ISBN : 2- 7430-
086-7
Adonis aestivalis L. 1B: herbaceous plant Cardenolide glycosides; adonitoxin, convallatoxin,
Adonis amurensis Regel
1G: entire plant Cardenolide glycosides; adonitoxin, convallatoxin,
& Radde
Adonis annua L. 1B: herbaceous plant Cardenolide glycosides; adonitoxin, convallatoxin,
Adonis autumnalis L. 1C: entire plant Cardenolide glycosides; adonitoxin, convallatoxin,
1B: herbaceous plant, top
Adonis vernalis L. 1C: entire plant Cardenolide glycosides; adonitoxin, convallatoxin,
1G: entire plant
© European Food Safety Authority, 2009 page 2 of 98
EFSA Technical Report (2009) 281
COMPENDIUM OF BOTANICALS THAT HAVE BEEN REPORTED TO CONTAIN TOXIC,ADDICTIVE, PSYCHOTROPIC, OR OTHER SUBSTANCES OF CONCERN
This compendium lists in alphabetical order botanicals without any judgment on whether these are suitable or not suitable for food applications in Europe. This compendium is part of a preliminary work undertaken by EFSA to
harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food. Without prejudice to the existing legal framework, such compendium has no legal status and may not
be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is a living document and is therefore open for additional contributions and
comments.
Parts of plants of
Botanical name Chemical of concern / toxic effect Remarks Specific References
possible concern
poisonous potential is questionable as no toxicity is
found in mice and guinea pigs. Probably toxic
1B: leaves, fruit, herbaceous information comes from confusion with Conium Poisonous plants, Dietrich Frohne, Hans Jürgen
Aethusa cynapium L. Polyacetylenes: aethusine (= cynapine), aethusianol
plant poisoning or plants infected with the rust fungus Pfänder and Inge Alford, Blackwell, July 2005
Puccinia aethusae with consequent production of
larger amounts of the toxins
Aframomum
angustifolium (Sonn.) Bruneton J. (1996). Plantes toxiques - Vegetaux
1,8-cineole: lethal doses as low as 0.05 ml have been
K.Schum. Seeds essential oil: 1,8-cineole 4% dangereux pour l'homme et les animaux.
reported in humans. (Bruneton, 1996)
(Amomum angustifolium Tec&Doc ISBN 2-7430-169-0
Sonn.)
Ingestion of 0,35 g seeds to 10 healthy males (age
Igwe SA, Emeruwa IC, Modie JA (1999) Ocular
30-35 and b.w. 60-80 kg resulted in blurred vision by
toxicity of Aframomum melegueta (alligator
inccreasing the near point of convergence by 17%,
pepper) on healthy Igbos of Nigeria. J
resulting in double vision, and reduced the amplitude
Ethnopharmacol 65: 203-206.
of accomodation (Igwe et al. 1999). Groups of 5
Aframomum melegueta Kamtchouing, P., Mbongue, G.Y.F., Dimo, T.,
male rats received for 8 days daily orally by gavage
K.Schum. 1H: seeds Watcho, P. Jatsa, H.B., Sokeng, S.D. 2002.
Alkaloids: piperine 115 mg/kg b.w. of an aqueous extract of the fruits or
(Amomum melegueta 1G: seed Effect of Aframomum melegueta and Piper
distilled water (control). The extract:100 g dried fruit
Rosc.) guineense on sexual behaviour of male rats.
macereated in 200 ml distilled water for 12 h with a
Behav. Pharmacol. 13, 243-247.
final extract concentration of 26 mg/ml. Dosing with
Lachman et al. 1992. A guide to the medicinal
A. melegueta modified the sexual behaviour of male
plants of coastal Guyana. Common Wealth
rats by increasing sexual arousal (Kamtchouing et al.
Science Council (London). p.350
2002).
A. rugosa : 83%-96% methyleugenol and 5 International symposium on medicinal and
chemotypes T1: estragole, T2: methyleugenol, T3: aromatic plants - XXIII IHC (1992) - ISBN
Genus in which some species are known to contain in their
Agastache spp. Plant methyleugenol and limonene, T4: menthone, T5: 9789066050952; Characterisation of essential
essential oil estragole and/or methyleugenol.
menthone and pulegone; A. foeniculum: 43%-74% oil of Agastache species, D.J. Charles et al. J
methylchavicol Agr Food Chem, 1991, 31: 1946-1949
Agastache foeniculum
essential oil: 43.7%
(Pursh) Kuntze
1Q: estragole content: 555-12.160ppm (plant);
(Lophantus anisatus (Nutt.) 1Q: plant
1T: known to contain methyleugenol in unspecified
Benth., Agastache
quantities (?)
anethiodora Britton)
Agastache nepetoides 1T: known to contain methyleugenol in unspecified
Plant
(L.) Kuntze quantities (?)
1Q: estragole content: 90% (essential oil)
Agastache rugosa Kuntze Plant 1T: known to contain methyleugenol in unspecified
quantities (?)
Agathophyllum
aromaticum Willd.
(See Ravensara
aromatica Sonn.)
Medicinal Herbal Products Monograph, Prof. Dr.
essential oil from leaves: 2% (summer) -5% (winter) with Hatem El-Gabaly; Natural sources of flavourings
Agathosma cerefolium
leaves 50% phenolether from which methylchavicol and anethol ; (Rep No 3), Council of Europe, (2008)
Bartl. & Wendl.
1Q: known to contain estragole in unspecified quantities Minister of Health and Population, Egypt, in
colaboration with WHO
Government of Canada - Canadian Biodiversity
Agrostemma githago L. 1B: seeds Triterpenic Saponins: githagin (7%); agrostemmic acid Githagin is toxic. Toxin destroyed at 50°C.
Information Facility. Www.cbif.gc.ca
1B: bark from the roots, flowers, Occurrence of indol alkaloids in Ailanthus
Ailanthus altissima indolalkaloids : with canthine 6-one and beta-carboline
leaves, fruit


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