ANNEX I ASEAN GP For The Negative List Ver 3.0 (14nov14)
ANNEX I ASEAN GP For The Negative List Ver 3.0 (14nov14)
ANNEX I ASEAN GP For The Negative List Ver 3.0 (14nov14)
ANNEX I
ASEAN GUIDING PRINCIPLES FOR
INCLUSION INTO OR EXCLUSION
FROM THE NEGATIVE LIST OF
SUBSTANCES FOR TRADITIONAL
MEDICINES AND HEALTH
SUPPLEMENTS
Version 3.0
DOCUMENT INFORMATION
This version is adopted at the 18th ASEAN TRADITIONAL MEDICINES AND HEALTH
SUPPLEMENTS SCIENTIFIC COMMITTEE MEETING (ATSC) 11-13 March 2013, Nay Pyi Taw,
Myanmar and endorsed at the 19th ACCSQ TRADITIONAL MEDICINES AND HEALTH
SUPPLEMENTS PRODUCT WORKING GROUP (TMHSPWG) MEETING 28-29 June 2013, Bagan,
Myanmar.
Version
No.
1
2
Endorsement date
14th TMHSPWG Meeting
24-25 Nov 2010
16th TMHSPWG Meeting
17-18 Nov 2011
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CONTENTS
Purpose ..................................................................................................................................................... 3
Guiding principles .................................................................................................................................. 3
Appendices ............................................................................................................................................. 5
Appendix 1
Appendix 2
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PURPOSE
The ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of
Substances for Traditional Medicines and Health Supplements list the active substances
that are prohibited from being used in or being part of the composition of Traditional
Medicine and/or Health Supplement products. The list is prepared from the following
guidelines established to govern the acceptance of active substances to the list based on
scientific rationale.
GUIDING PRINCIPLES
1. A substance must carry a scientifically demonstrated/proven safety concern that its
inclusion into a Traditional Medicine and Health Supplement product will be harmful to
human health 1.
2. A substance that qualifies for inclusion into the list should carry the following details but
not limited to:
2.1. Identity of the substance
2.1.1.Taxonomy classification e.g. scientific name by genus and species
2.1.2.Common name/ traditional name
2.1.3.CAS No
2.2. Source of the substance (e.g. natural/synthetic/certain part or whole plant
/animal)
2.3. Rationale for inclusion (e.g. toxic 2 effect of the substance e.g. acute, sub-acute,
chronic, specific toxicity)
Harmful to human health is defined as any experience affecting the majority of a
population resulting in any of the following outcomes: death, a life-threatening adverse
experience, inpatient hospitalisation or prolongation of existing hospitalisation, a persistent
or significant disability/incapacity, or a congenital anomaly/birth defect. Important
medical events that may not result in death, be life-threatening, or require hospitalisation
may be considered harmful when, based on appropriate medical judgment, they may
jeopardise the individual and may require medical or surgical intervention to prevent one
of the outcomes previously listed - adapted from: IOM (Institute of Medicine). Dietary
supplements: A framework for evaluating safety. Washington, DC: The National
Academies Press; 2005
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APPENDICES
Appendix 1
This list is adopted at the 19th ACCSQ Traditional Medicines and Health Supplements Scientific Committee Meeting on 24-27 June 2013, Bagan,
Myanmar and endorsed at the 19th ACCSQ Traditional Medicines and Health Supplements Product Working Group Meeting on 28-29 June
2013, Bagan, Myanmar.
Adonis vernalis L.
Atropa belladonna L.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Pheasants eye
Whole plant
Adonitoxin
Banned
Whole plant
Aristolochic acid
Banned
Quebracho
Bark
Aspidospermine
Banned
Deadly
Nightshade
Whole plant
Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Latex
Banned
Marijuana
Whole plant
Cannabinoids
Banned
Vinca rosea,
Periwinkle
Madagascar,
Old Maid
Whole plant
Vinca alkaloids
Banned
Curare
Stems
Tubocurarine chloride
Banned
Bitter apple
Seed, fructus
Curcubitacin
Banned
Ergo
Sclerotium
Ergot alkaloids
(including Ergotamine and
Ergometrine)
Banned
Cannabis sativa L.
Cannabis indica Lam.
Chondrodendron tomentosum
Ruiz &Pav.
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Colchicum autumnale L.
Conium maculatum L.
Delphinium staphisagria L.
Digitalis spp.
(all species) containing glycoside
Excoecaria agallocha L.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Meadow saffron
Seed
Cochicine
Banned
Hemlock
Whole plant
Coniine
Banned
Stavesacre
Seeds
Delphinine,
Staphisine
Banned
Leaf
Cardiac glycoside
Banned
Bulb
Cardiac
glycoside
Banned
Blinding tree
Latex
Excoecaria phorbol
Banned
Palaung
Thay
Gelsemine &
Gelseminine (Gelsemium Indole
alkaloid)
Banned
Sea squill,
Red squill,
Sea onion,
Squill
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Vanish tree
Latex
Banned
Hyoscyamus muticus L.
Henbane,
Henblain,
Jusquaime
Whole plant
Hyoscyamine, Atropine,
Hyoscine
Banned
Savin,
Savine
Hyoscyamus niger L.
Juniperus sabina L.
Sabinyl acetate,
Sabinene, Podophyllo-toxin and others
Banned
Chaparral
Whole plant
Indian
tobacco
Whole plant
Lobeline
Banned
Spanish flies
Cantharidin
Banned
Banned
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Banned in TM
(oral)
Kratom
Whole plant
Banned
Nicotiana tabacum L.
Tobac
leaf
Nicotine
Banned
Papaver spp.
(all species) containing morphine &
derivatives and codeine
Opium
poppy
Whole plant
Banned
Jaborandi
Bark
Pilocarpine
Banned
Kava Kava
Whole plant
Banned
Roots, leaves
Podophyllin resin
Banned
Pilocarpus microphyllus
Stapf ex Wardleworth
Pilocarpus jaborandi Holmes
Pilocarpus pennatifolius
Lem.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Whole plant
Psilocybine, Psilocin
Banned
Schoenocaulon officinale
(Schltdl. & Cham.) A.Gray
Sabadilla
Seed
Veratrine
Banned
Bulb
Cardiac glycoside
Banned
whole plant
pyrrolizidine alkaloids
Banned
Bittersweet, Nightshade
Solanaceous alkaloids
Senecio aureus L.
Senecio jacobaea L.
Senecio bicolor Sch.Bip.
Senecio nemorensis L.
Senecio vulgaris L.
Senecio longilobus Benth.
Senecio scandens Buch.-Ham. ex
D.Don
Solanum dulcamara L.
Solanum americanum Mill.
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Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Whole plant
Kombe
Whole plant
Strophanthus
Alkaloids
Whole Plant
Ban Status in
TM
Spigelia marilandica L.
Banned
Banned
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Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in
TM
Periwinkle, Myrtle
Whole plant
Banned
Vinca minor L.
[Information on the reasons and supporting references is available as a compendium of the negative list.]
Appendix 2
This list is adopted at the 19th ACCSQ Traditional Medicines and Health Supplements Scientific Committee Meeting on 24-27 June 2013, Bagan,
Myanmar and endorsed at the 19th ACCSQ Traditional Medicines and Health Supplements Product Working Group Meeting on 28-29 June
2013, Bagan, Myanmar.
Abrus precatorius L.
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Common name(s)
Harmful Animal/
Plant Part(s)
Indian Licorice,
Precatory bean, Jequerity, Mutual
love Bean (China), Kudri Mani
(Tamil), Guru Ginja (Telegu)
Seed
Ban Status in HS
Banned
Aconitum spp.
(all species) containing aconite
alkaloids
Adonis vernalis L.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Monkshood, Aconite
Whole plant
Aconite alkaloids
Banned
Pheasant's eye
Whole plant
Adonitoxin
Banned
Latex, Sap
Growth hormone,
prolactin, adrenocortico-tropic
hormone,
Thyroid-stimulating hormone,
Follicle-stimulating
hormone, luteinizing
hormone,
oxytocin,
antidiuretic
hormone, thyroid hormone,
calcitonin,
parathyroid
hormone, mineralocorti-coids,
glucocorti-coids, sex hormones,
insulin, glucagon,
thymosin, estrogens,
progesterone, testosterone
Cardiac glycoside (antiarin),
Cardenolides &
Alkaloids (with cardiac arresting
potential)
Banned
Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Whole plant
Aristolochic acid
Banned
Artemisia spp.
(all species) containing artemisinin
Wormwood
Leaf
Artemisinin
Banned
Aspidosperma quebracho-blanco
Schltdl.
Quebracho
Bark
Aspido-spermine
Banned
Deadly Nightshade
Whole plant
Scopolamine; Hyoscyamine;
Atropine
Banned
Nimba,
Neem
Seeds
Azadirachtin and
derivatives
Banned
Berberine
Banned
Atropa belladonna L.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Banned
Toad,
Samsu,
kodok kerok
Venom, dried
secretion, whole body
Cinobufagin, resibufagenin,
bufagins, catecholamines:
asbufothionine
Banned
Latex
Banned
Marijuana
Whole plant
Cannabinoids
Banned
Vinca rosea,
Periwinkle Madagascar,
Old Maid
Whole plant
Vinca alkaloids
Banned
Dog bane,
Pink eyed cerbera
Seed
Digitoxinglyco-side,
Cerberine, Cerberoside, thevetin
Banned
Cannabis sativa L.
Cannabis indica Lam.
Cerbera manghas L.
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Chelidonium majus L.
Cinchona spp.
Colchicum autumnale L.
Conium maculatum L.
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Harmful Animal/
Plant Part(s)
Ban Status in HS
Indian Suicide
Tree,
Sea Mango
Seed
Cerberin, cerebroside,
odollin, odolotoxin,
thevetin and
cerapain.
Banned
Celandine,
Great Celandine,
Nipplewort
Berberine, chelidonine,
sanguinarine, coptisine,
chelerythrine
Banned
Curare
Stems
Tubocurarine chloride
Banned
Quine bark
Bark
Banned
Bitter apple
Seed, fructus
Curcubitacin
Banned
Ergo
Sclerotium
Ergot alkaloids
(including ergotamine
and ergometrine)
Banned
Meadow
saffron
Seed
Cochicine
Banned
Hemlock
Whole plant
Coniine
Banned
Common name(s)
Croton tiglium L.
Datura spp.
(all species)
containing hyoscyamine,
atropine, scopolamine and
apoatropine
Delphinium staphisagria L.
Digitalis spp.
(all species)
containing glycoside
Drimia maritima (L.) Stearn
Syn. Urginea maritima (L.) Baker
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Croton
Banned
Jimson weed,
Devils apple, Green Dragon,
Zombies Cucumber,
Moon Weed,
Trumpet Lily,
Stinkweed
Leaf, seed,
flowering or fruiting parts with
branches
Hyoscyamine, atropine,
scopolamine, apoatropine
Banned
Stavesacre
Seeds
Delphinine, Staphisine
Banned
Leaf
Cardiac glycoside
Banned
Sea squill,
red squill,
sea onion, squill
Bulb
Cardiac glycoside
Banned
Whole plant
Banned in oral
preparation
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Rhizome
Filicin,
aspidinol
Banned
Triangular spurge
Latex
Alpha euphorbol,
Beta amyrin cycloartenol Euphol
Banned
Blinding tree
Latex
Excoecaria phorbol
Banned
Fritillary bulb
Dried bulb
Banned
Gamboge
Gum resin
Cambogic acid,
-guttiferin,
-1-guttiferin
Banned
Palaung Thay
Gelsemine &
Gelseminine (Gelsemium indole
Banned
Euphorbia antiquorum L.
Euphorbia trigona Mill.
Excoecaria agallocha L.
Fritillaria spp.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
alkaloid)
Latex
Banned
Whole plant
Banned
Coral Bush,
Coral Plant,
Physic nut,
Guatemala
rhubarb
Fruits/Seeds
Phytotoxin (Toxalbumin
- Curcin)
Banned
Juniperus sabina L.
Savin,
Savine
Sabinyl acetate,
sabinene, podophyllo-toxin and
others
Banned
Lantana camara L.
Tembelekan
(tahi ayam)
Whole plant
Banned
Whole plant
Banned
Hyoscyamus muticus L.
Hyoscyamus niger L.
Jatropha multifida L.
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Chaparral
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
is the major
compound
Indian
tobacco
Whole plant
Lobeline
Banned
Spanish flies
Cantharidin
Banned
Houpo,
Houpohua,
Lamp post,
Officinal magnolia
Whole plant
Banned
Banned
Kratom
Whole plant
Banned
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Harmful Animal/
Plant Part(s)
Seed
Dopamine, Nicotine,
Physostigmine
Dried body
Cantharidin
Whole plant
Neriin
Tobac
Leaf
Nicotine
Opium poppy
Whole plant
Morphine and
derivatives,
codeine
Banned
Yohimbe
Bark
Yohimbine
Banned
Calabar bean
Seed, bean
Physostigmine
Jaborandi
Bark
Pilocarpine
Common name(s)
Cowhage, Cowage
Nerium oleander L.
Syn. Nerium indicum Mill.
Nicotiana tabacum L.
Papaver spp.
(all species) containing morphine &
derivatives and codeine
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Ban Status in HS
Banned
Banned
Banned
Banned
Banned
Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Kava Kava
Whole plant
Banned
White leadwort
Roots
Plumbagin
Rose-coloured leadwort
Plumbagin
American mayapple,
Mandrake
Roots, leaves
Podophyllin resin
Banned
Whole plant
Psilocybine, Psilocin
Banned
Pomegranate alkaloids
Wardleworth
Pilocarpus jaborandi Holmes
Pilocarpus pinnatifolius
Lem.
Plumbago zeylanica L.
Plumbago indica L.
Pomegranate
Punica granatum L.
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Banned
Banned
Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Reserpine, Rescinnamine,
ajmalane
Banned
Sanguinarine, chelerethrin,
sanguirulin, berberine, protopine
Banned
Sabadilla
Seed
Veratrine
Banned
Bulb
Cardiac glycoside
Banned
Whole plant
Pyrrolizidine alkaloids
Banned
Sanguinaria canadensis L.
Senecio aureus L.
Senecio jacobaea L.
Senecio bicolor Sch.Bip.
Senecio nemorensis L.
Senecio vulgaris L.
Senecio longilobus Benth.
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Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Bittersweet,
Nightshade
Solanaceous alkaloids
Banned
Alkaloids matrine,
cytisine
Banned
Spigeline (a strychinine-like
alkaloid)
Banned
Solanum dulcamara L.
Solanum americanum Mill.
Syn. Solanum nigrum L.
Sophora tomentosa L.
Spigelia marilandica L.
Strophanthus spp.
(all species)
containing strophanthus alkaloids
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Seed
Whole plant
Fang ji
Fen fang ji
Han fang ji
Stephania-root
Kombe
Whole plant
Whole plant
Aristolochic acid
Strophanthus
alkaloids
Banned
Banned
Common name(s)
Harmful Animal/
Plant Part(s)
Ban Status in HS
Seed
Strychnine
Banned
Whole plant
Pyrrolizidine alkaloids
Banned
Whole Plant
Banned
Strychnos nux-vomica L.
Strychnos ignatii P.J. Bergius
Nux-vomica
Symphytum officinale L.
Symphytum asperum Lepech.
Symphytum uplandicum Nyman
Comfrey
Symphytum peregrinum
Ledeb.
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Common name(s)
Harmful Animal/
Plant Part(s)
Periwinkle, Myrtle
Whole plant
Ban Status in HS
Vinca minor L.
[Information on the reasons and supporting references is available as a compendium of the negative list.]
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Banned