Sustainably harvested and quality controlled medicinal and aromatic plants

100 Pages·2013·3.17 MB·English

by  Carole El Hachem

INTERNATIONAL MARKET STUDY FOR
SELECTED MEDICINAL AND AROMATIC
PLANTS IN LEBANON (Alcea sps, Micromeria
sps . Origanum sps, Satureia sps, Thymus sps,
Viola sps, Thymbra spicata, Salvia fruticosa,
Cyclotrichium origanifolium)

GEF-UNDP-LARI, 2010. International market study for selected medicinal
and aromatic plants in Lebanon (Alcea sps, Micromeria sps, Origanum
sps, Satureia sps, Thymus sps, Viola sps, Thymbra spicata, Salvia
fruticosa, Cyclotrichium origanifolium). Mainstreaming Biodiversity
Management into Medicinal and Aromatic Plants (MAPs) Production
Processes in Lebanon Project. Funded by the Global Environment Facility,
implemented by the United Nations Development Program (UNDP) and
Lebanese Agricultural Research Institute (LARI), Beirut.
trade (domestic and international), and
BACKGROUND
perceived decline in wild-collected
populations. Four of these target species
This technical document was produced with
(Origanum syriacum, Origanum ehrenbergii,
the framework of the project
Althaea damascena, and Cyclotrichium
“Mainstreaming Biodiversity Management
origanifolium) are regional or national
into Medicinal and Aromatic Plants (MAPs)
endemic species that were selected based
Production Processes in Lebanon”, funded
on expert opinion that direct harvest
by the Global Environment Facility, and
pressure (intentional collection of the
executed by the Lebanese Agriculture
species for existing markets) is a factor
Research Institute and the UNDP, in
contributing to decline in resource
coordination and cooperation with the
availability in Lebanon. Two of these target
Lebanese Ministry of Agriculture. The
species (Viola libanotica and Clinopodium
project objective was to integrate
libanoticum) are endemic to Lebanon and
conservation objectives into gathering,
were selected based on expert opinion that
processing and marketing of globally
these species could be endangered by
significant medicinal and aromatic plants
indirect (unintentional) collection of wild
(MAPs).
populations because of their resemblance
to the commercially important congeneric
The project worked on both a macro level species V. odorata and M. myrtifolia (syn.
(national scale) and a micro level (pilot sites juliana). The seventh target species (Salvia
scale). On the national front the project fruticosa) is a regional endemic species
actively sought to develop and strengthen selected based on the large existing
the enabling environment for sustainable commercial wild-collection and observed
use of MAPs. The project identified negative impacts of wild harvest of this
regulatory gaps and constraints that had species on other more vulnerable species.
implications for sustainable utilization and
value chain of MAP resources.
Accordingly, several strategic interventions
were implemented on the institutional
framework. On the pilot site level, the
project worked in four sites (Mejdel-Akkar,
Assia-Batroun, Hsarat-Jbiel and Mrusti-
Chouf). These four pilot sites were
considered as experimental sites for
developing sustainable harvesting
standards, for developing and implementing
value-added processing and product
improvement, for MAP based product
marketing and sales and for certification
and branding. The pilot sites informed the
regulative framework (through scientific
findings with respect to sustainable harvest
standards), informed MAP business
development at the national level and they
showcased how to increase the profitability
of commercial MAP products.
The project focused on seven target MAP
species: Salvia fruticosa, Origanum
syriacum, Origanum ehrenbergii, Althaea
damascena, Cyclotrichium origanifolium,
Viola libanotica and Clinopodium
libanoticum. The species were selected
based on their endemism (regional or
national), estimated volume of commercial

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EXECUTIVE SUMMARY sweet violet (Viola odorata), and wild pansy
flowering aerial parts (Viola tricolor).
This study investigated the Lebanese
Since the ability and capacity for
export trade data, the legal status and
sustainable scaling-up of additional annual
market access requirements of selected
production for purposes of boosting
target markets, and the quality standards
domestic consumption of value-added
and trade specifications for ten selected
products and/or export promotion is not yet
Lebanese botanical species. Additionally,
determined for many of the Lebanese
the catalogues of the most important
species, this report recommends starting
importers, processors and distributors of
out with a focus on the one or two species
natural ingredients in Europe and North
that already have an established regulatory
America were surveyed as well as some
framework for market access in the largest
companies situated in Northern Africa and
number of countries, and for which the
Western Asia. The report provides lists of
quantities being collected in Lebanon are
botanical ingredients presently offered in
high enough to justify the development of
the catalogues of these companies from
new value-added products and markets
same genera as those prioritized from
above and beyond the local and regional
Lebanon (in the forms of whole, cut & sifted,
markets that are presently responsible for
tea-bag-cut, or powdered botanical raw
the current annual demand.
materials as well as value-added forms of
absolutes, concretes, essential oils, extracts
and oleoresins). These lists provide good The national consultant, in the report
examples of what processed forms of these “Monographs of the 7 targeted species”
ingredients are actively in trade. They can made the recommendation of developing a
also serve as a short list of potentially Lebanese geographical quality brand for the
interested companies to approach once a selected species. Although three-lobed
portfolio of Lebanese specialty products is sage leaf is produced in several other
defined and ready for market. countries (Albania, Greece, Italy, Russian
Federation, Turkey, and Republics of the
former Yugoslavia), it could be possible to
This study found that most of the prioritized
develop a unique Lebanon brand for
Lebanese species do not appear on any
differentiation of geographical origin and
positive lists in most or all of the selected
quality grade designation. This report
target markets. This was not a surprise
provides information on the various grades
since the habitat and range of many of the
and standards for three-lobed sage leaf by
species is quite limited, in some cases to
comparison to the Lebanese Standard.
Lebanon or to neighboring countries such
as Syria and/or Turkey. In some cases,
closely related species appear on some After experiencing success with the
positive lists. Since most of the prioritized launching and promoting of a range of
species would be classified as new or novel products made from this species, gradually
ingredients in many international markets, other Lebanese species could be added to
various types of submissions would need to the catalogue of specialty products from the
be made to the regulatory agencies in each region. Additional products would be based
country providing requisite human safety, on a determination that a sustainable scale-
efficacy and quality data. Information is up for new product development is feasible
provided in this report on the avenues for and practicable in each case.
filing new ingredient submissions in the EU
and USA. The types of value-added products that
could be made from Lebanese three-lobed
Three of the Lebanese species however do sage could include the following:
appear on many positive lists and have
fairly well established international trade Processed Botanical Raw Materials
status. Those are three-lobed sage leaf
(Salvia fruticosa Miller; syn.: Salvia triloba),  Food grade dried leaf, whole, cut &
sifted, ground, tea-bag-cut or

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powdered; conventional or with Even with an eventual strategy to develop a
certifications (e.g. certified organic Lebanese geographical designation and
wild and/or FairWild certified). brand for a whole range of botanical
 Pharmacopoeial grade dried leaf products, it would be useful to start out by
(e.g. Salviae trilobae folium PhEur); identifying those companies in selected
whole or cut; conventional or with destination markets who are already trading
certifications (e.g. certified organic in various Salvia and Viola species
wild and/or FairWild certified). ingredients. These companies are listed in
this report. By approaching these
Extracts and Oils companies first with natural ingredients that
they are already familiar with (and already
appear in their catalogues), the ability to
 “Salvia Triloba Leaf Extract”
bring new items later will be somewhat
marketed for use in cosmetic
easier after a good trade relationship is
products for antimicrobial, astringent
established over time.
and oral care functions.
 “Sage Triloba CO2 Extract”
Nonetheless, until the regulatory framework
marketed for use in cosmetics and
for each of the new or novel ingredients is
in perfumery, i.e. mouth water, tooth
addressed in each target market, it would
paste, shampoos, soaps etc., as
be difficult to interest buyers or to invest in
well as potential uses in food and
market development. Some of the
pharmaceutical products.
prioritized species may not have sufficient
 Sage essential oil.
quantities available to consider an
 Sage distilled water.
international approach. For some of the
species, special regional products might be
Finished Products in Retail Packs
developed specifically for the local and
regional markets that Lebanon already
 A Lebanese brand of the Unani
exports to including Jordan, Syria, Turkey,
Medicine herbal tea formulation
United Arab Emirates, and Saudi Arabia.
“Zahraa” that is presently available
in Syria. This formulation contains
Finally, with regard to the prioritized species
some of the prioritized Lebanese
that presently do not appear on any positive
species including three-lobed sage
lists in the target markets, it is
leaf.
recommended that dossiers be prepared
 A Lebanese brand of a three-lobed
and submitted to selected regulatory
sage leaf single herb tea infusion
agencies in order to affirm that the botanical
product packed in filter teabags in
ingredient is safe for use in cosmetic,
cartons.
dietary supplement, and/or food products
 A Lebanese brand of Spice
and meets the legislative market access
Seasoning Mix that contains three-
requirements. This would be a prerequisite
lobed sage leaf.
to new product development and export
 A Lebanese brand of three-lobed
promotion towards prospective buyers in
sage leaf as a single-herb spice.
the target markets.

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LIST OF ABBREVIATIONS
AAN Australian Approved Name
AGMARK Agricultural Product Grading and Marking Standards
AHPA American Herbal Products Association
APC Anthroposophical Pharmaceutical Codex
API Ayurvedic Pharmacopoeia of India
ARTG Australian Register of Therapeutic Goods
ASU Ayurveda, Siddha and Unani
AYUSH Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy
BIS Bureau of Indian Standards
BP British Pharmacopoeia
CAS# Chemical Abstract Service Number
CFR Code of Federal Regulations
CFSAN Center for Food Safety and Applied Nutrition
CosIng European Commission Cosmetic Ingredients and Substances Database
EAFUS Everything Added to Food in the United States
EDQM European Directorate for the Quality of Medicines
EFSA European Food Safety Authority
EHIA European Herbal Infusions Association
EINECS European Inventory of Existing Commercial chemical Substances
EMEA European Medicines Agency
FCC Food Chemicals Codex
F&DA Food and Drugs Act
FDA Food and Drug Administration
FRLHT Foundation for Revitalisation of Local Health Traditions
GRAS Generally Recognized As Safe
GRASE Generally Recognized As Safe and Effective
HAS List of Homoeopathic and Anthroposophic Substances
HMPC Committee on Herbal Medicinal Products
HOC Herbs of Commerce
HS Code Harmonized System Tariff Code
JP Japanese Pharmacopoeia

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KPA Complementary and Phytomedicine Products
LNHPD Licensed Natural Health Products Database
MAP Medicinal and Aromatic Plants
NDA New Drug Application
NDI New Dietary Ingredient
NHP Natural Health Product
NHPD Natural Health Products Directorate
NHPID Natural Health Products Ingredient Database
NMPB National Medicinal Plants Board
OTC Over-the-counter Medicine
PhEur European Pharmacopoeia
PhHelv Swiss Pharmacopoeia
PPRC Pharmacopoeia of the People‟s Republic of China
SPI Siddha Pharmacopoeia of India
syn. Synonym
TGA Therapeutic Goods Administration
THM Traditional Herbal Medicine
THMP Traditional Herbal Medicinal Product
UPI Unani Pharmacopoeia of India
USD United States Dollar
USP-DS United States Pharmacopeia – Dietary Supplement
USP-NF United States Pharmacopeia – National Formulary
var. Variety
WCO World Customs Organization
WEU-HMP Well Established Use Herbal Medicinal Product

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ALCEA SPP. INCLUDING Roots: Raishakhatmi; Bekhekhatmi.
Seeds: Tukhmekhatmi
ALCEA DAMASCENA MOUT. &
 Polish name: Malwa różowa
ALCEA SETOSA (BOISS.) ALEF.
 Spanish name: Malvón
(FAM. MALVACEAE)
 Turkish name: Gülhatmi
Definitions Alcea setosa (Boiss.) Alef.
Alcea acaulis (Cav.) Alef.; syn.: Althaea  Czech name: Proskurník setý
acaulis Cav. [bas]  English name: Bristly hollyhock
 Italian name: Malvone setoso
 English name: Stemless
hollyhock Assessment of current
Lebanese export trade data
Alcea apterocarpa (Fenzl) Boiss.
current main importers
 English name: Wingless
According to the national consultant‟s report
fruited hollyhock
“Monographs of the 7 targeted species,”
 Turkish name: Hatmi
Lebanon imports Alcea damascena
primarily from Syria while there are no
Alcea damascena (Mouterde) Mouterde;
traceable Lebanese exports of any Alcea
syn.: Althaea damascena Mouterde
species. Furthermore the estimated annual
market demand for A. damascena was
 English name: Damascus
assessed by UNDP at only about 3 tons.
hollyhock
Estimated demand for all Alcea spp.
 French name: Alcée de combined may reach 60 tons. There are no
damas data readily available to determine whether
 German names: Chinesische any of this estimated quantity is exported or
Stockrose; Stockmalve; Stockrose if the total is consumed domestically.
 Lebanon vernacular name: Therefore it is difficult to make any
Khetmiyeh Dimachq determination concerning who the main
importers might be, if any. Some
Alcea rosea L; syn.: Althaea rosea (L.) Cav. assumptions can be made based on the
regulatory status of Lebanese Alcea spp. in
 Pharmacopoeial name: Flores other countries. If a regulatory framework
Malvae arboreae exists in any countries for the import and
use of the prioritized Alcea species, the
 Czech names: Topolovka
possibility could then exist for Lebanese
ružová; Slézová ruže
exports to the identified countries. After
 English names: Hollyhock;
reviewing the regulatory lists of the selected
Garden hollyhock; Rose mallow
countries, however, it appears that only one
 French names: Passe rose;
species of Alcea (Alcea rosea; syn.: Althaea
Alcée
rosea) is expressly listed or approved for
 German names: Stockrose;
certain uses, and only in some countries.
Stockrosenblüten
 Hungarian name: Kerti
Even with the listing of the flowers of Alcea
mályvarózsa
(Althaea) rosea (or extracts thereof) on
 India vernacular names:
some national positive lists (indicating an
Gulkhera;
allowance for use in certain types of
Doddabindigaegidda; Gul-khaira;
products), almost no evidence was found to
Katmi; Seemaithuthi
demonstrate that any Alcea species
 Pakistan vernacular names:
ingredients are commercially traded or
Flowers: Gul-e-khaira; Gul-e-
actively used as components of cosmetic,
khatmi. Leaves: Bergekhatmi.

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food or medicinal finished products in the Food use: No Alcea species are listed in
selected export destination countries. Standard 1.4.4 “Prohibited and Restricted
Plants and Fungi” of the Australia New
Importation and use of Alcea species, other Zealand Food Standards Code.1
than Alcea rosea, in these countries could
also require the submission of a notification Medicinal use: One species, Althaea rosea
or petition to the regulatory authority for the (syn. Alcea rosea) is listed as a substance
approval or authorization of a new that may be used as an active ingredient in
substance in commerce. It appears that „Listed‟ medicines for supply in Australia
there is little or no published information (in and for export.2 No other species of Alcea
English or other European languages) are listed by the Therapeutic Goods
concerning the safety, efficacy and/or Administration (TGA). The Australian
quality of Alcea acaulis, Alcea apterocarpa, Approved Names (AANs) are Hollyhock and
Alcea damascena and/or Alcea setosa. The Rose Mallow. At a non-therapeutic dosage
availability of such data, providing sufficient level, Althaea rosea could also be used as
strength of evidence, would be necessary an excipient component for listed or
for any new notifications or petitions to add prescription medications.3
these species to national positive lists in
certain of the selected countries.  Quality: For active ingredients of
medicines in Australia, the
Assuming that commercial scale-up, above quality standards of the British
and beyond the current local annual Pharmacopoeia (BP) are the
demand of 3 tons of Alcea damascena, minimum standard that must be
could be managed sustainably, it would applied in its entirety. The
seem that a reasonable strategy would be European Pharmacopoeia
to identity and target potentially interested (PhEur) and United States
importing companies in the neighboring Pharmacopeia (USP),
countries where the population may already respectively, have also been
be familiar and accepting of the use of adopted as additional default
Alcea species in local ethno- or folk- standards under the Therapeutic
medicine practice and/or in the context of Goods Act.4
the codified Unani system of medicine. In  Listed products: No listed
this context, there might be a market that products that contain Alcea spp.
could be developed for Lebanese Alcea as an active ingredient are
species ingredients or value-added extracts present in the Australian
or mixtures in the nearby regional markets
of Egypt, Iraq, Jordan, Syria and Turkey. In
the context of folk- or traditional medicine, 1 Food Standards Australia New Zealand (FSANZ).
there may be fewer market access barriers Standard 1.4.4 Prohibited and Restricted Plants
in these countries by comparison to the and Fungi. In: Australia New Zealand Food
legislative market access requirements for Standards Code. Canberra: Commonwealth of
new products in the European Community Australia. 2010. Available at:
http://www.foodstandards.gov.au/_srcfiles/Standa
Member States or in the North American
rd_1_4_4_Prohib_plants_v113.pdf
countries of Canada, Mexico and United
2 Therapeutic Goods Administration. Substances that may
States.
be used as active ingredients in „Listed‟ medicines in
Australia. Woden (Australia): Australian Government
Department of Health and Ageing Therapeutic Goods
Regulatory framework, market
Administration. 12 December 2007. Available at:
access requirements and http://www.tga.gov.au/cm/listsubs.pdf
3 Therapeutic Goods Administration. Ingredient Summary:
requirements for use in Althaea rosea. Woden, Australia: Australian
Government Department of Health and Ageing
selected destination countries
Therapeutic Goods Administration.
4 Parliament of the Commonwealth of Australia, The Senate.
Therapeutic Goods Amendment 5 (Medical Devices and
Australia Other Measures) Act 2008. Government of Australia.
2009. Available at:
http://parlinfo.aph.gov.au/parlInfo/download/legislation/bi
Cosmetic use: No information found. lls/s707_aspassed/toc_pdf/0823020.pdf;fileType=applic
ation%2Fpdf#search=%22Pharmacopoeia%22

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Register of Therapeutic Goods products are found in the Licensed Natural
(ARTG) presently. Health Products Database (LNHPD).
This suggests that only ingredients made European Community
from one Alcea species, Alcea rosea, would
be permitted for use in therapeutic products Cosmetic use: Only one species of Alcea
in Australia. The use of other species of (Althaea rosea; syn. Alcea rosea) is listed in
Alcea could require a petition to amend and the European Commission Cosmetic
expand the list of substances used in listed Ingredients and Substances (CosIng)
medicines. database.8 Two different forms are listed,
flower extract and powdered flower:
Canada
 Althaea Rosea Flower Extract is
Cosmetic use: No Alcea spp. ingredients defined as the extract of the
are listed in the Health Canada “Cosmetic flowers of the hollyhock, Althaea
Ingredient Hotlist” 5 which is a list of rosea, Malvaceae. Chemical
substances that are restricted and Abstract Service Number (CAS#)
prohibited for use in cosmetic products in 90045-76-4, European Inventory
Canada. Nor do any Alcea spp. ingredients of Existing Commercial chemical
appear on the list of “Substances in Substances (EINECS) Number:
Cosmetics and Personal Care Products 289-940-2; Function: Skin
Regulated under the Food and Drugs Act Conditioning.
(F&DA) that were in commerce between  Althaea Rosea Flower Powder is
January 1, 1987, and September 13, 2001.” the dried, crushed flowers of the
6 This suggests that while there is no hollyhock, Althaea rosea,
express prohibition against use in cosmetic Malvaceae. Chemical Abstract
products, it is possible that an Alcea spp. Service Number (CAS#) 90045-
ingredient could be classified as new or 76-4, European Inventory of
novel. Existing Commercial chemical
Substances (EINECS) Number:
Food use: No Alcea spp. ingredients are 289-940-2; Functions:
listed in the Canada Food and Drugs Moisturizing and Skin
Regulations (2010) 7 which suggests that Conditioning.
there is no current use of plants of this
species in Canada for purposes of adding Food use: No Alcea species are listed in
aromas, colors, flavors, seasonings or the European Food Safety Authority (EFSA)
spices to food products. Compendium of botanicals that have been
reported to contain toxic, addictive,
Medicinal use: There are no monographs psychotropic or other substances of
for any Alcea species in the Natural Health concern.9 The European Herbal Infusions
Products Directorate (NHPD) Compendium Association (EHIA) includes only one
of Monographs. No Alcea-containing species, hollyhock flowers, a.k.a.
Stockrosenblüten (Althaea rosea) in its

5 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, “Inventory List of Herbals Considered as
Ontario: Health Canada. September 2009. Available at: Food.”10 Inclusion in the EHIA list means
http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs-

sesc/pdf/person/cosmet/info-ind-prof/_hot-list-
critique/hotlist-liste-eng.pdf 8 European Commission. Cosmetic Ingredients and
6 Health Canada. Substances in cosmetics and personal Substances (CosIng) Database. Available at:
care products regulated under the Food and Drugs Act http://ec.europa.eu/enterprise/cosmetics/cosing
(F&DA) that were in commerce between January 1, 9 European Food Safety Authority (EFSA). EFSA
2987, and September 13, 2001. Ottawa, Ontario: Health Compendium of botanicals that have been reported to
Canada. Available at: http://www.hc-sc.gc.ca/ewh- contain toxic, addictive, psychotropic or other
semt/contaminants/person/impact/list/person-no-cas- substances of concern. EFSA Journal 2009; 7(9):281.
eng.php Available at:
7 Canada Minister of Justice. Food and Drug Regulations. http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf
C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. 10 European Herbal Infusions Association (EHIA). EHIA
Current to 24 March 2010. Available at: Inventory List of Herbals Considered as Food. Hamburg,
http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 Germany. January 2010. Available at: http://www.ehia-
70.pdf online.org/publications.html

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