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

1 | P a g e EXECUTIVE SUMMARY sweet violet (Viola odorata), and wild pansy flowering aerial parts (Viola tricolor). This study investigated the Lebanese export trade data, the legal status and Since the ability and capacity for market access requirements of selected sustainable scaling-up of additional annual target markets, and the quality standards production for purposes of boosting and trade specifications for ten selected domestic consumption of value-added Lebanese botanical species. Additionally, products and/or export promotion is not yet the catalogues of the most important determined for many of the Lebanese importers, processors and distributors of species, this report recommends starting natural ingredients in Europe and North out with a focus on the one or two species America were surveyed as well as some that already have an established regulatory companies situated in Northern Africa and framework for market access in the largest Western Asia. The report provides lists of number of countries, and for which the botanical ingredients presently offered in quantities being collected in Lebanon are the catalogues of these companies from high enough to justify the development of same genera as those prioritized from new value-added products and markets Lebanon (in the forms of whole, cut & sifted, above and beyond the local and regional tea-bag-cut, or powdered botanical raw markets that are presently responsible for materials as well as value-added forms of the current annual demand. 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 This study found that most of the prioritized former Yugoslavia), it could be possible to Lebanese species do not appear on any develop a unique Lebanon brand for positive lists in most or all of the selected differentiation of geographical origin and target markets. This was not a surprise quality grade designation. This report since the habitat and range of many of the provides information on the various grades species is quite limited, in some cases to and standards for three-lobed sage leaf by Lebanon or to neighboring countries such comparison to the Lebanese Standard. 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

2 | P a g e 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  “Salvia Triloba Leaf Extract” appear in their catalogues), the ability to marketed for use in cosmetic bring new items later will be somewhat products for antimicrobial, astringent easier after a good trade relationship is and oral care functions. established over time.  “Sage Triloba CO2 Extract” marketed for use in cosmetics and Nonetheless, until the regulatory framework in perfumery, i.e. mouth water, tooth for each of the new or novel ingredients is paste, shampoos, soaps etc., as addressed in each target market, it would well as potential uses in food and be difficult to interest buyers or to invest in pharmaceutical products. market development. Some of the  Sage essential oil. prioritized species may not have sufficient  Sage distilled water. quantities available to consider an 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.

3 | P a g e 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

4 | P a g e 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

5 | P a g e ALCEA SPP. INCLUDING Roots: Raishakhatmi; Bekhekhatmi. ALCEA DAMASCENA MOUT. & Seeds: Tukhmekhatmi  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 fruited hollyhock According to the national consultant‟s report “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  Czech names: Topolovka use of the prioritized Alcea species, the ružová; Slézová ruže possibility could then exist for Lebanese  English names: Hollyhock; exports to the identified countries. After Garden hollyhock; Rose mallow reviewing the regulatory lists of the selected  French names: Passe rose; countries, however, it appears that only one Alcée species of Alcea (Alcea rosea; syn.: Althaea rosea) is expressly listed or approved for  German names: Stockrose; Stockrosenblüten certain uses, and only in some countries.  Hungarian name: Kerti mályvarózsa Even with the listing of the flowers of Alcea (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.

6 | P a g e 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: Member States or in the North American http://www.foodstandards.gov.au/_srcfiles/Standa 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: http://www.tga.gov.au/cm/listsubs.pdf access requirements and 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

7 | P a g e 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

8 | P a g e that this plant is currently employed by the Additionally, there is evidence that Alcea herbal infusions trade in a European damascena is used in Syria as a member state as food plant for making tea component of one Unani medicinal herbal infusions. tea formulation. On that basis it would seem possible to gain marketing authorization in Medicinal use: There is no Alcea spp. India for an otherwise established Unani European Community Herbal (therapeutic) medicinal preparation. Monograph published by the European Medicines Agency (EMEA) nor is there a Additionally, there exists the possibility that European Pharmacopoeia (quality) Alcea rosea is already used in Indian Monograph published by the European medicinal products, but possibly Directorate for the Quality of Medicines misidentified as Althaea officinalis L. (EDQM). (marshmallow). There is some evidence that hollyhock and marshmallow are India commercially traded in Indian markets using the same local vernacular name (khatmi) Medicinal use: No Alcea species and that the two herbal drugs may be ingredients are listed in any of the considered to be interchangeable in herbal pharmacopoeias of Indian Systems of medicinal preparations. Medicine (e.g. Ayurvedic Pharmacopoeia of India, Siddha Pharmacopoeia of India Pakistan and/or Unani Pharmacopoeia of India). Additionally, no Alcea species are found in Medicinal use: Alcea (Althaea) rosea the comprehensive checklist of 1,289 appears to be traded, labeled and used botanicals, pertaining to 960 plant taxa, that interchangeably with Althaea officinalis, were identified in the recent “Demand and which shares the same local vernacular Supply of Medicinal Plants in India 2008,”11 names of gul-e-khaira and gul-e-khatmi. which was initiated by the National There is confusion and disagreement Medicinal Plants Board (NMPB), Ministry of concerning the differentiation of these two Health & Family Welfare, Department of plants for use in the Unani system of AYUSH (Ayurveda, Yoga & Naturopathy, medicine in Pakistan. Even though the Unani, Siddha and Homoeopathy), and was Unani Pharmacopoeia and related carried out by Drs. D.K. Ved and G.S. therapeutic compendia specify Goraya, of the Foundation for Revitalisation marshmallow (Althaea officinalis) as the of Local Health Traditions (FRLHT). official drug under the aforementioned vernacular names, a market survey found The absence of any species of Alcea in the all trade samples in Pakistani markets to be checklists and/or pharmacopoeias of the Alcea rosea.13 Indian Systems of Medicine would suggest that it could be difficult to gain marketing South Africa authorization for Alcea species as a component of an Ayurvedic, Siddha or Medicinal use: Althaea rosea is listed in Unani (ASU) herbal medicinal product in the “Western Herbal” Schedule On India. With that said, there is some Complementary and Alternative Medicines evidence that Alcea rosea is used in Indian for therapeutic use in South Africa.14 folk- or ethnomedicine, outside of the codified Indian Systems of Medicine.12

13 Maryum Akram. Taxonomic evaluation of market sample 11 Ved DK, Goraya GS. Demand and Supply of Medicinal of medicinal plants parts used in traditional medicines of Plants in India. Dehra Dun, India: Bishen Singh Pakistan [Thesis]. Department of Biological Sciences/ Mahendra Pal Singh. 2008. Quaid-i-Azam University, Islamabad, Pakistan. 2004. 12 Arunachalam S. Science on the periphery enriches Available at: http://eprints.hec.gov.pk/2344/1/2199.htm mainstream science, but at what cost? The case of 14 Medicines Control Council. Medicines and Related ethnobotany. In: Sciences of the South, Volume 6. Substances Act, 1965. Schedules on Complementary Paris, France. 1996. Available at: and Alternative Medicines made in terms of the http://horizon.documentation.ird.fr/exl- Medicines and Related Substances Act, 1965 (Act No. doc/pleins_textes/pleins_textes_7/carton07/010008908. 101 of 1965); Amendment. Staatskoerant. 22 August pdf 2008; No. 31334. Available at:

9 | P a g e Switzerland Medicinal use: The dried aerial parts of Alcea damascena (Mout.) Mout. are Cosmetic use: No information found. reportedly used as a component of a Unani Medicine herbal tea formulation known as Dietary supplement use: No Alcea "Zahraa," commercially available in 18 species are included on the list of Damascus. substances that may be used in dietary or food supplement products in Switzerland. United States of America

Food use: Althaea rosea (syn.: Alcea Cosmetic use: No Alcea species known to rosea) is included on the positive list of be used in cosmetic products in the USA. substances that may be used as flavor, spice or seasoning ingredients in food Dietary supplement use: Hollyhock (Alcea products or in non-medicinal herbal tea rosea L.; Syn.: Althaea rosea (L.) Cav.) is products.15 listed in the Herbs of Commerce, 2nd edition,19 which indicates that it was in U.S. Medicinal use: The dried, fully developed commerce prior to 1994 and therefore flowers with calices of Alcea rosea L. are should be permitted for use in herbal dietary used as starting materials for the supplement products and should not require manufacture of Anthroposophical Medicinal the submission of a New Dietary Ingredient Products.16 Alcea rosea is included in the (NDI) submission. Additionally, as per Swissmedic “Liste HAS” (List of federal regulation 21 CFR §101.4, the Food Homoeopathic and Anthroposophic and Drug Administration (FDA) requires that Substances), with the synonym “Malva the common or usual name of botanical arborea” for use in Anthroposophical ingredients used in dietary supplement Medicines only for oral and/or parenteral products must be consistent with the names use at a homoeopathic dilution of D12.17 standardized in the Herbs of Commerce, Anthroposophical Alcea rosea medicines copies of which may be obtained from the are classified as complementary and American Herbal Products Association.20 phytomedicine products (KPA) requiring pre-marketing authorization and product Food use: None. No species of Alcea are licensing through Swissmedic. Retail listed as “Generally Recognized as Safe” distribution is limited to Category D (GRAS) for use in food products. Its use in (available in both pharmacies and foods could require the submission of a drugstores; without prescription but only GRAS notification to the Food and Drug after consultation with pharmacy staff). Administration (FDA).

Syria Medicinal use: No species of Alcea are listed as “Generally Recognized as Safe and Effective” (GRASE) active ingredients for use in over-the-counter (OTC) or prescription drug products for human use. http://www.piasa.co.za/Filestructure/Legislation/Comple Its use in medicinal products would require mentary%20and%20Alternative%20Medicines/GG%203 1334%20-%20Page%2031%20to%20180.pdf 15 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und 18 Carmona MD, Llorach R, Obon C, Rivera D. "Zahraa", a Zubereitungen als Arzneimittel oder als Lebensmittel“. Unani multicomponent herbal tea widely consumed in Bern, Switzerland: Swissmedic. 11 December 2006. Syria: components of drug mixtures and alleged Available at: medicinal properties. J Ethnopharmacol 2005 Dec 1; http://www.swissmedic.ch/marktueberwachung/00662/in 102(3):344-350. dex.html?lan 19 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American 16 International Association of Anthroposophic Pharmacists Herbal Products Association’s Herbs of Commerce, 2nd (IAAP). Anthroposophical Pharmaceutical Codex (APC), Edition. Silver Spring, MD: American Herbal Products Second Edition. Dornach, Switzerland: IAAP. November Association. 2000. 2007. Available at: 20 United States Food and Drug Administration (FDA). Food; http://www.iaap.org.uk/downloads/codex.pdf designation of ingredients. In: Code of Federal 17 Swissmedic. Liste homöopathischer und Regulations, Title 21, Part 101, Section 101.4 (21 CFR anthroposophischer Stoffe (Liste HAS). Bern, §101.4). Washington, DC: National Archives and Switzerland: Swissmedic. August 2008. Available at: Records Administration. 2009;15-19: http://www.swissmedic.ch/rechtstexte/00201/00203/inde http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 x.html?lan 01.4.pdf

10 | P a g e a New Drug Application (NDA) process with India FDA approval. Food: There are no quality standards Information on existing quality published for any species of Alcea, neither standards, compendial in the Bureau of Indian Standards (BIS) quality standards for spices, concentrates standards or trade and oleoresins, in the 1995 Prevention of specifications of relevance to Food Adulteration (PRA) Act and Rules this species in selected standards for spices, nor in the Agricultural Product Grading and Marking (AGMARK) destination countries Standards.

Australia Medicine: There are no quality standards monographs or therapeutic compendial Medicinal: Although the Therapeutic monographs published for any species of Goods Administration (TGA) lists an Alcea in any of India‟s national Ingredient Summary page for Althaea rosea pharmacopoeias covering botanical stating that it can be used as an active substances used in the Indian Systems of ingredient or non-medicinal excipient Medicine (Ayurveda, Siddha, and Unani). ingredient of Listed Medicines and/or Prescription Medicines, there are no known Switzerland quality standards or trade specifications. Nor are there presently any Medicines that Medicine: The dried, fully developed contain this plant for sale in Australia. flowers with calices of Alcea rosea L. are listed in the Anthroposophical European Community Pharmaceutical Codex (APC), Second Edition, 2007, in Appendix 2.2.: Starting Cosmetic: Although Althaea rosea (syn. materials of botanical origin.21 However Alcea rosea) ingredients are listed in the there is no quality standards monograph for European Commission Cosmetic this species in the Swiss Pharmacopoeia Ingredients and Substances (CosIng) (PhHelv). database, no evidence was found of any official quality standards or trade United States of America specifications defining the grades or qualities that may be used in cosmetics in Food: There are no standards published for the EC. any species of Alcea neither in the Code of Federal Regulations (CFR), the Food Food: Although the European Herbal Chemicals Codex (FCC) nor in the National Infusions Association (EHIA) lists Althaea Formulary monographs of the United States rosea (syn. Alcea rosea) as a botanical Pharmacopeia (USP-NF). considered as food for use in non-medicinal herb teas, no evidence was found of any Dietary Supplement: There are no trade specifications to define the grades standards published for any species of and qualities that may be used in European Alcea in the Dietary Supplements herbal teas. monographs of the United States Pharmacopeia (USP-DS). Medicine: There are no Alcea species monographs in the European Medicine: There are no standards Pharmacopoeia published by the European published for any species of Alcea neither Directorate for the Quality of Medicines (EDQM). There are no known licensed or registered herbal medicinal products in the 21 International Association of Anthroposophic European Community that contain an Alcea Pharmacists (IAAP). Anthroposophical species ingredient. Pharmaceutical Codex (APC), 2nd Ed. Dornach, Switzerland: IAAP. November 2007.: http://www.iaap.org.uk/downloads/codex.pdf

11 | P a g e in the Code of Federal Regulations (CFR)  Cercis siliquastrum L. subsp. nor in the monographs of the United States hebecarpa (Bornm.) Yalt. and Pharmacopeia (USP). subsp. siliquastrum. (Leguminosae);  Colutea cilicica Boiss. et Bal. in Proposed innovative value- Boiss. (Leguminosae); added MAP products using this  Crataegus aronia (L.) Bosc. ex DC. (Rosaceae); ingredient  Cytisopsis pseudocytisus (Boiss.) Fertig. (Leguminosae); The national consultant‟s report  Eleagnus angustifolia L. “Monographs of the 7 targeted species” (Elaeagnaceae); proposed innovative value-added products  Equisetum telmateia Ehrh. for Alcea damascena as a tisane or herbal (Equisetaceae); tea or as a component of herbal tea  Helichrysum stoechas (L.) Moench. formulations. The consultant also proposed subsp. barrelieri (Ten.) Nyman. the development of geographic origin and (Compositae); trademarks for Lebanese quality and  Matricaria recutita L. (Compositae); country of origin designation.  Mentha longifolia L. subsp. noeana (Boiss. ex. Briq.) Briq. (Labiatae); The present estimated annual demand of  Mentha spicata L. subsp. only 3 tons for Alcea damascena is quite condensata (Briq.) Greuter and low for consideration of developing Burdet (Labiatae); innovative new products. If the expert  Micromeria myrtifolia Boiss. and resource assessment should determine that Hohen (Labiatae); significantly higher amounts of this species Paronychia argentea Lam. could be harvested annually under a  (Caryophyllaceae); controlled sustainable resource management plan, then it would make  Phlomis syriaca Boiss. (Labiatae); sense to consider the development of  Rosa damascena Mill. (Rosaceae); innovative value-added products. If  Salvia fruticosa Mill. (Labiatae); sustainable scaling up is deemed possible,  Sambucus nigra L. (Caprifoliaceae); new innovative products for the local market  Spartium junceum L. as well as for export promotion to (Leguminosae); and neighboring countries could be envisaged.  Zea mays L. (Gramineae). In that scenario, it could be interesting to develop and brand finished herbal tea Three of the medicinal plant species products that contain Alcea damascena as typically found in the Syrian-made Unani a component of identified folk- or traditional herbal tea mixtures are also mentioned or (Unani) medicinal herbal teas, but with a prioritized for the Lebanon project; Alcea Lebanese geographic origin designation. As damascena, Micromeria myrtifolia and an example to model from, the Unani herbal Salvia fruticosa. Thus it would seem tea that is presently marketed in Syria by conceivable to develop a Lebanese brand the name of “Zahraa”, which can contain of this traditional Unani herbal tea, possibly anywhere from 6 to 14 medicinal plants, among other traditional combinations, to among them Alcea damascena as a main label and market not only in Lebanon but for component. “Zahraa” herbal teas in Syria export to nearby countries or regions where may contain Alcea damascena plant parts Unani herbal teas may have a market in combination with plant parts of five or potential, for example Egypt, Iraq, Jordan, more of the following listed species: Occupied Palestinian Territory, and Syria. Marketing authorization for Unani medicinal  Aloysia triphylla (L‟Herit.) Britt. herbal teas in the European Community (Malvaceae); would be costly and extremely difficult for a  Astragalus cf. amalecitanus Boiss.; Lebanese enterprise under the current regulatory framework for traditional herbal medicinal products in the EC. Such herbal tea formulations however could have a

12 | P a g e better chance of obtaining marketing example in Bangladesh, Canada, India, authorization in certain Commonwealth Kenya, Malaysia, Pakistan, Singapore, Nations that have a less complicated South Africa, Sri Lanka, and Tanzania, regulatory pathway for the authorization of possibly among other countries where traditional Unani medicinal products, for Unani medicine is practiced.

13 | P a g e Cyclotrichium origanifolium This review found that Cyclotrichium (Labill.) Manden. & Scheng. origanifolium does not appear on any national positive lists of any of the selected (Lamiaceae) counties. Almost no evidence was found to demonstrate that any ingredients made Definitions from Cyclotrichium origanifolium are commercially traded or actively used Cyclotrichium origanifolium (Labill.) outside of its limited range of Lebanon and Manden. & Seng. (Fam.: Lamiaceae) Turkey. There is a small but growing body of scientific literature investigating the Synonyms: Calamintha origanifolia (Labill.) chemistry composition and pharmacological Boiss., Clinopodium origanifolium Labill. properties of the essential oil obtained from the aerial parts of the plant. This would suggest that, depending on the totality of Common names: evidence compiled on its safety and efficacy, an export market for the distilled  English name: Marjoram- essential oil could be developed. This would leaved calamint also be dependent on the existence of a  French name: Calamenthe; quantity and quality sufficient to satisfy Feuilles d‟origan export demand requirements that can also  German name: Bergminze be produced sustainably.  Lebanese vernacular names: Hashishet El-Basha; Hashishet El- Regulatory framework, market Jabal; Hashishet El-Bahsa; Na'ana'iyyé; Hashishat-al-daght; access requirements and Ishbet sannine; Ishbet mar Simaan; requirements for use in selected destination countries عشبة صنين، حشيشة البحصة  Turkish vernacular names: Kizotu; Köpeknanesi; Karabaşotu; Naneruhu; Australia Eşekkirildi. Cosmetic use: No information found. Assessment of current Lebanese export trade data Food use: Cyclotrichium origanifolium is current main importers not listed in Standard 1.4.4 “Prohibited and Restricted Plants and Fungi” of the Australia New Zealand Food Standards According to the national consultant‟s report Code.22 “Monographs of the 7 targeted species,” there are no data on the import or export trade of Cyclotrichium origanifolium in Medicinal use: Cyclotrichium origanifolium Lebanon. Furthermore, the size of the is not listed as a substance that may be used as an active or excipient ingredient in Lebanese market for Cyclotrichium 23 origanifolium was estimated at only about 4 „Listed‟ medicines for supply in Australia. tons with a wholesale market value of about This suggests that it could require a petition USD $40,500. Therefore it is difficult to to amend and expand the list of substances make any determination concerning who the main importers might be, if any. Some 22 assumptions can be made based on the Food Standards Australia New Zealand (FSANZ). Standard 1.4.4 Prohibited and Restricted Plants and regulatory status of Cyclotrichium Fungi. In: Australia New Zealand Food Standards Code. origanifolium in other countries. If a Canberra: Commonwealth of Australia. 2010. Available at: regulatory framework were to exist in any http://www.foodstandards.gov.au/_srcfiles/Standard_1_ countries for the import and use of 4_4_Prohib_plants_v113.pdf Cyclotrichium origanifolium, the possibility 23 Therapeutic Goods Administration. Substances that may be used as active ingredients in „Listed‟ medicines in could then exist for Lebanese exports to the Australia. Woden (Australia): Australian Government identified countries. Department of Health and Ageing Therapeutic Goods Administration. 12 December 2007. Available at: http://www.tga.gov.au/cm/listsubs.pdf

14 | P a g e used in listed medicines in order to achieve Cosmetic Ingredients and Substances marketing authorization for this species in (CosIng) database.27 medicinal products. Food use: Cyclotrichium origanifolium is Canada not listed in the European Food Safety Authority (EFSA) Compendium of Cosmetic use: Cyclotrichium origanifolium botanicals that have been reported to is not listed in the Health Canada “Cosmetic contain toxic, addictive, psychotropic or Ingredient Hotlist” 24 which is a list of other substances of concern.28 substances that are restricted and Cyclotrichium origanifolium is not listed in prohibited for use in cosmetic products in the European Herbal Infusions Association Canada. Nor does Cyclotrichium (EHIA) “Inventory List of Herbals origanifolium appear on the list of Considered as Food.”29 Absence of this “Substances in Cosmetics and Personal species in the EHIA list means that this Care Products Regulated under the Food plant is not currently employed by the and Drugs Act (F&DA) that were in herbal infusions trade in a European commerce between January 1, 1987, and member state as food plant for making tea September 13, 2001.” 25 This suggests that infusions. while there is no express prohibition against use in cosmetic products, it is possible that Medicinal use: The European Medicines Cyclotrichium origanifolium could be Agency (EMEA) has no plans to publish a classified as new or novel. European Community Herbal (therapeutic) Monograph for Cyclotrichium origanifolium Food use: Cyclotrichium origanifolium is nor is there a European Pharmacopoeia not listed in the Canada Food and Drugs (quality) Monograph published by the Regulations (2010) 26 which suggests that European Directorate for the Quality of there is no current use in Canada for Medicines (EDQM). Such monographs purposes of adding aromas, colors, flavors, would only be prioritized for development in seasonings or spices to food products. the event that marketing authorization was granted by one or more of the EC Member Medicinal use: There are no monographs States. for Cyclotrichium origanifolium in the Natural Health Products Directorate India (NHPD) Compendium of Monographs. No Cyclotrichium origanifolium products are Medicinal use: Cyclotrichium origanifolium found in the Licensed Natural Health is not listed in any of the pharmacopoeias of Products Database (LNHPD). Indian Systems of Medicine (e.g. Ayurvedic Pharmacopoeia of India, Siddha European Community Pharmacopoeia of India and/or Unani Pharmacopoeia of India). Additionally, it is Cosmetic use: Cyclotrichium origanifolium not found in the comprehensive checklist of is not listed in the European Commission 1,289 botanicals, pertaining to 960 plant taxa, that were identified in the recent

24 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, “Demand and Supply of Medicinal Plants in Ontario: Health Canada. September 2009. Available at: 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 27 European Commission. Cosmetic Ingredients and 25 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, 28 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: 26 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. 29 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

15 | P a g e India 2008,”30 which was initiated by the This inclusion of these three related species National Medicinal Plants Board (NMPB), in the Aromatherapy Schedule of Ministry of Health & Family Welfare, substances could imply that there would be Department of AYUSH, and was carried out a chance for the listing and authorization of by Drs. D.K. Ved and G.S. Goraya, of the the essential oil of aerial parts of Foundation for Revitalisation of Local Cyclotrichium origanifolium. Health Traditions (FRLHT). Switzerland The absence of Cyclotrichium origanifolium in the checklists and/or pharmacopoeias of Cosmetic use: No information found. the Indian Systems of Medicine would suggest that it could be difficult to gain Dietary supplement use: Cyclotrichium marketing authorization for it as a origanifolium is not included on the list of component of an Ayurvedic, Siddha or substances that may be used in dietary or Unani (ASU) herbal medicinal product in food supplement products in Switzerland. India. Food use: Cyclotrichium origanifolium is South Africa not included on the positive list of substances that may be used as flavor, Medicinal use: Cyclotrichium origanifolium spice or seasoning ingredients in food is not listed in any of the Schedules on products or in non-medicinal herbal tea Complementary and Alternative Medicines products.32 for therapeutic use in South Africa.31 However, some related species are listed in Medicinal use: Cyclotrichium origanifolium the Aromatherapy Schedule 2 as follows: is not included on the “Stoffliste” (List of Substances used in medicinal products).33  Approved name: Calamintha nepeta; This would suggest that marketing Common name: Wild basil. authorization as a medicinal substance in  Approved name: Calamintha Switzerland would not be possible unless officinalis (syn.: Calamintha the List of Substances were amended to clinopodium, Melissa calaminta); include this species. Common names: Calamintha, Calamint, Common calamint, Mill United States of America mountain, Mountain balm, Mountain mint, Basil thyme, Nepeta (oil), Cosmetic use: Cyclotrichium origanifolium French marjoram (oil), Wild basil is not known to be used in cosmetic (oil), Catnip (oil); products in the U.S.  Approved name:: Calamintha sylvatica; Common names: Dietary supplement use: Cyclotrichium Calamintha, Calarnint, Common origanifolium is not listed in the Herbs of calarnint, Mill mountain, Mountain Commerce, 2nd edition,34 which indicates balm, Mountain mint, Basil thyme, that it did not appear in U.S. commerce Nepeta (oil), French marjoram (oil), prior to 1994 and therefore would likely Wild basil (oil), Catnip (oil). require the pre-marketing submission of a

32 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und Zubereitungen als Arzneimittel oder als Lebensmittel“. 30 Ved DK, Goraya GS. Demand and Supply of Medicinal Bern, Switzerland: Swissmedic. 11 December 2006. Plants in India. Dehra Dun, India: Bishen Singh Available at: Mahendra Pal Singh. 2008. http://www.swissmedic.ch/marktueberwachung/00662/in 31 Medicines Control Council. Medicines and Related dex.html?lan Substances Act, 1965. Schedules on Complementary 33 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. and Alternative Medicines made in terms of the August 2008. Available at: Medicines and Related Substances Act, 1965 (Act No. http://www.swissmedic.ch/daten/00080/00256/index.htm 101 of 1965); Amendment. Staatskoerant. 22 August l?lang=de 2008; No. 31334. Available at: 34 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American http://www.piasa.co.za/Filestructure/Legislation/Comple Herbal Products Association’s Herbs of Commerce, 2nd mentary%20and%20Alternative%20Medicines/GG%203 Edition. Silver Spring, MD: American Herbal Products 1334%20-%20Page%2031%20to%20180.pdf Association. 2000.

16 | P a g e New Dietary Ingredient (NDI) notification to concentrates and oleoresins, in the 1995 the FDA. Prevention of Food Adulteration (PRA) Act and Rules standards for spices, nor in the Food use: None. Cyclotrichium Agricultural Product Grading and Marking origanifolium is not listed as “Generally (AGMARK) Standards. Recognized as Safe” (GRAS) for use in food products. Its use in foods could require Medicine: There are no quality standards the submission of a pre-marketing GRAS monographs or therapeutic compendial notification to the FDA. monographs published for Cyclotrichium origanifolium in any of India‟s national Medicinal use: Cyclotrichium origanifolium pharmacopoeias covering botanical is not listed as a “Generally Recognized as substances used in the Indian Systems of Safe and Effective” (GRASE) active Medicine (Ayurveda, Siddha, and Unani). ingredient for use in over-the-counter (OTC) or prescription drug products for human Switzerland use. Its use in medicinal products would require a New Drug Application (NDA) Cosmetic, Food, Medicine: There are no process with FDA approval. known quality standards or trade specifications for Cyclotrichium Information on existing quality origanifolium for any use. There is no standards, compendial monograph in the Swiss Pharmacopoeia (PhHelv). There are no licensed or standards or trade registered herbal medicinal products that specifications of relevance to contain this species. this species in selected destination countries United States of America Food: There are no standards published for Australia Cyclotrichium origanifolium neither in the Code of Federal Regulations (CFR), the Cosmetic, Food or Medicine: There are Food Chemicals Codex (FCC) nor in the no known quality standards or trade National Formulary monographs of the specifications for Cyclotrichium United States Pharmacopeia (USP-NF). origanifolium for any use. There are no listed herbal medicinal products that contain Dietary Supplement: There are no this plant for sale in Australia. standards published for Cyclotrichium origanifolium in the Dietary Supplements European Community monographs of the United States Pharmacopeia (USP-DS). Cosmetic, Food or Medicine: There are no known quality standards or trade Medicine: There are no standards specifications for Cyclotrichium published for Cyclotrichium origanifolium in origanifolium for any use. There is no the Code of Federal Regulations (CFR) nor monograph in the European in the monographs of the United States Pharmacopoeia. There are no known Pharmacopeia (USP). licensed or registered herbal medicinal products in the European Community that contain this species. Proposed innovative value- added MAP products using this India ingredient

Food: There are no quality standards The national consultant‟s report published for Cyclotrichium origanifolium, “Monographs of the 7 targeted species” neither in the Bureau of Indian Standards proposed innovative value-added products (BIS) quality standards for spices, for the dried aerial parts of Cyclotrichium

17 | P a g e origanifolium as a component of tisanes or If a market for the essential oil fraction were herbal teas. Also suggested was to develop to develop this could cause a significant an international market for the essential oil. strain on the available supply due to the This would require a significant scale-up large amount of fresh plant material that is due to the high quantities of fresh aerial necessary for production of oil. parts that would be necessary for a commercial oil distillation operation for If sustainable scaling up is deemed export promotion. The consultant also possible, new innovative products for the proposed the development of geographic local market as well as for export promotion origin and trademarks for Lebanese quality could be envisaged. In that scenario, it and country of origin designation. could be interesting to develop and brand finished herbal tea products as well as The current estimated annual demand of essential oils for aromatherapy with a only 4 tons for Cyclotrichium origanifolium is Lebanese geographic origin designation. If quite low for consideration of developing external market demand should arise as a innovative new products. Outside of micro- result of positive results from published or small enterprises, there would hardly be research, the importation and use of an economy of scale to justify new product Cyclotrichium origanifolium in countries development at this annual level of raw outside of the region could require the material availability. If the expert resource submission of a notification or petition to the assessment should determine that regulatory authorities for the approval or significantly higher amounts of this species authorization of a new substance in could be harvested annually under a commerce for human use. The availability controlled sustainable resource of safety, efficacy and quality data, management plan, then it could make providing a sufficient strength of evidence, sense to consider the development of would be necessary for assessment by the innovative value-added products, including relevant national authorities of each target the essential oil for food uses (e.g. flavor destination market. The levels of evidence component in liqueurs) and/or medicinal required would vary depending on the uses (e.g. for aromatherapy inhalant use or intended use (cosmetic, dietary topical application in creams or ointments). supplement, food or medicine).

18 | P a g e Micromeria sps including determination concerning who the main (Micromeria libanotica Boiss., importers of this species might be, if any. Some assumptions can be made based on Micromeria myrtifolia Boiss. et the regulatory status of Micromeria Hohen and Micromeria juliana libanotica in other countries. If a regulatory L.) framework were to exist in any countries for the import and use of Micromeria libanotica, the possibility could then exist for Lebanese Definitions exports to the identified countries.

Micromeria barbata Boiss. et Ky (Fam. This review found that Micromeria libanotica Lamiaceae) does not appear on any national positive lists of any of the selected counties. Almost  English name: Bearded no evidence was found to demonstrate that savory any ingredients made from Micromeria libanotica are commercially traded or Micromeria juliana (L.) Bentham ex Reichb. actively used outside of its limited range of (Fam.: Lamiaceae) Lebanon and Syria. There is a small amount of published literature investigating Micromeria libanotica Boiss. (Fam. the chemistry composition and Lamiaceae) pharmacological properties of the essential oil obtained from the aerial parts of the  English name: Lebanon plant. This could suggest that, depending savory on the totality of evidence compiled on its  French name: Micromerie safety and efficacy, an export market for the libanaise distilled essential oil could be developed.  German name: Lebanischer This potentiality would be dependent on the Ysop existence of a quantity and quality sufficient to satisfy prospective export demand  Lebanese vernacular names: Zoufa requirements that can also be produced lubnan; Shummaysah lubnāniyyah sustainably. زوفى لبنانية,

Micromeria myrtifolia Boiss. et Hohen (Fam. Regulatory framework, market Lamiaceae) access requirements and requirements for use in  Turkish vernacular names: selected destination countries boğumlu çay; dağ çayi; kaya; yarpuzu; sümbül çiçeği; viks çiçeği; Australia keklik otu; kaya kekiği; kekik; topuk çayi; haydar otu. Cosmetic use: No information found.

Assessment of current Food use: Micromeria libanotica is not Lebanese export trade data listed in Standard 1.4.4 “Prohibited and current main importers Restricted Plants and Fungi” of the Australia New Zealand Food Standards 35 According to the national consultant‟s report Code. “Monographs of the 7 targeted species,” imports of Micromeria species come mainly from Syria. No Lebanese exports were 35 detected. Furthermore the size of the Food Standards Australia New Zealand (FSANZ). Lebanese market for Micromeria libanotica Standard 1.4.4 Prohibited and Restricted Plants and Fungi. In: Australia New Zealand Food Standards Code. was estimated at about 5 tons with a Canberra: Commonwealth of Australia. 2010. Available wholesale market value of about USD at: $26,900. Therefore it is difficult to make any http://www.foodstandards.gov.au/_srcfiles/Standard_1_ 4_4_Prohib_plants_v113.pdf

19 | P a g e Medicinal use: Micromeria libanotica is not Health Products Directorate (NHPD) listed as a substance that may be used as Compendium of Monographs. No an active or excipient ingredient in „Listed‟ Micromeria libanotica products are found in medicines for supply in Australia.36 This the Licensed Natural Health Products suggests that it could require a petition to Database (LNHPD). amend and expand the list of substances used in listed medicines in order to achieve European Community marketing authorization for this species in medicinal products. Cosmetic use: Micromeria libanotica is not listed in the European Commission Canada Cosmetic Ingredients and Substances (CosIng) database.40 One other species of Cosmetic use: Micromeria libanotica is not Micromeria is listed in CosIng, an extract of listed in the Health Canada “Cosmetic the flowers, leaves and stems of Micromeria Ingredient Hotlist” 37 which is a list of chamissonis (Benth.) Greene which is used substances that are restricted and as a skin conditioning ingredient in prohibited for use in cosmetic products in cosmetics. Canada. Nor does Micromeria libanotica appear on the list of “Substances in Food use: Micromeria libanotica is not Cosmetics and Personal Care Products listed in the European Food Safety Regulated under the Food and Drugs Act Authority (EFSA) Compendium of (F&DA) that were in commerce between botanicals that have been reported to January 1, 1987, and September 13, 2001.” contain toxic, addictive, psychotropic or 38 This suggests that while there is no other substances of concern.41 Micromeria express prohibition against use in cosmetic libanotica is not listed in the European products, it is possible that Micromeria Herbal Infusions Association (EHIA) libanotica could be classified as new or “Inventory List of Herbals Considered as novel. Food.”42 Absence of this species in the EHIA list means that this plant is not Food use: Micromeria libanotica is not currently employed by the herbal infusions listed in the Canada Food and Drugs trade in a European member state as food Regulations (2010) 39 which suggests that plant for making tea infusions. there is no current use in Canada for purposes of adding aromas, colors, flavors, Medicinal use: The European Medicines seasonings or spices to food products. Agency (EMEA) has no plans to publish a European Community Herbal (therapeutic) Medicinal use: There are no monographs Monograph for Micromeria libanotica nor is for Micromeria libanotica in the Natural there a European Pharmacopoeia (quality) Monograph published by the European 36 Therapeutic Goods Administration. Substances that may Directorate for the Quality of Medicines be used as active ingredients in „Listed‟ medicines in (EDQM). Such monographs would only be Australia. Woden (Australia): Australian Government Department of Health and Ageing Therapeutic Goods prioritized for development in the event that Administration. 12 December 2007. Available at: marketing authorization was granted by one http://www.tga.gov.au/cm/listsubs.pdf 37 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, or more of the EC Member States. Ontario: Health Canada. September 2009. Available at: 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 40 European Commission. Cosmetic Ingredients and 38 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, 41 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: 39 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. 42 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

20 | P a g e India Dietary supplement use: Micromeria libanotica is not included on the list of Medicinal use: Micromeria libanotica is not substances that may be used in dietary or listed in any of the pharmacopoeias of food supplement products in Switzerland. Indian Systems of Medicine (e.g. Ayurvedic Pharmacopoeia of India, Siddha Food use: Micromeria libanotica is not Pharmacopoeia of India and/or Unani included on the positive list of substances Pharmacopoeia of India). Additionally, it is that may be used as flavor, spice or not found in the comprehensive checklist of seasoning ingredients in food products or in 1,289 botanicals, pertaining to 960 plant non-medicinal herbal tea products.45 taxa, that were identified in the recent “Demand and Supply of Medicinal Plants in Medicinal use: Micromeria libanotica is not India 2008,”43 which was initiated by the included on the “Stoffliste” (List of National Medicinal Plants Board (NMPB), Substances used in medicinal products).46 Ministry of Health & Family Welfare, This would suggest that marketing Department of AYUSH, and was carried out authorization as a medicinal substance in by Drs. D.K. Ved and G.S. Goraya, of the Switzerland would not be possible unless Foundation for Revitalisation of Local the List of Substances were amended to Health Traditions (FRLHT). One other include this species. species of Micromeria is included in the FRLHT survey, Micromeria biflora (Buch.- Syria Ham. ex D.Don) Benth, Indian wild thyme, which is used in Indian folk medicine but not Medicinal use: The dried aerial parts of in the codified Indian Systems of Medicine. Micromeria libanotica are reportedly used as a component of a Unani Medicine herbal The absence of Micromeria libanotica in the tea formulation known as "Zahraa" checklists and/or pharmacopoeias of the commercially available in Damascus.47 Indian Systems of Medicine would suggest that it could be difficult to gain marketing United States of America authorization for it as a component of an Ayurvedic, Siddha or Unani (ASU) herbal Cosmetic use: Micromeria libanotica is not medicinal product in India. known to be used in cosmetic products in the U.S. South Africa Dietary supplement use: Micromeria Medicinal use: Micromeria libanotica is not libanotica is not listed in the Herbs of listed in any of the Schedules on Commerce, 2nd edition,48 which indicates Complementary and Alternative Medicines 44 that it did not appear in U.S. commerce for therapeutic use in South Africa. prior to 1994 and therefore would likely require the pre-marketing submission of a Switzerland

45 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und Cosmetic use: No information found. Zubereitungen als Arzneimittel oder als Lebensmittel“. Bern, Switzerland: Swissmedic. 11 December 2006. Available at: http://www.swissmedic.ch/marktueberwachung/00662/in dex.html?lan 46 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. 43 Ved DK, Goraya GS. Demand and Supply of Medicinal August 2008. Available at: Plants in India. Dehra Dun, India: Bishen Singh http://www.swissmedic.ch/daten/00080/00256/index.htm Mahendra Pal Singh. 2008. l?lang=de 47 44 Medicines Control Council. Medicines and Related Carmona MD, Llorach R, Obon C, Rivera D. "Zahraa", a Substances Act, 1965. Schedules on Complementary Unani multicomponent herbal tea widely consumed in and Alternative Medicines made in terms of the Syria: components of drug mixtures and alleged Medicines and Related Substances Act, 1965 (Act No. medicinal properties. J Ethnopharmacol 2005 Dec 1; 101 of 1965); Amendment. Staatskoerant. 22 August 102(3):344-350. 2008; No. 31334. Available at: 48 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American http://www.piasa.co.za/Filestructure/Legislation/Comple Herbal Products Association’s Herbs of Commerce, 2nd mentary%20and%20Alternative%20Medicines/GG%203 Edition. Silver Spring, MD: American Herbal Products 1334%20-%20Page%2031%20to%20180.pdf Association. 2000.

21 | P a g e New Dietary Ingredient (NDI) notification to Food Adulteration (PRA) Act and Rules the FDA. standards for spices, nor in the Agricultural Product Grading and Marking (AGMARK) Food use: None. Micromeria libanotica is Standards. not listed as “Generally Recognized as Safe” (GRAS) for use in food products. Its Medicine: There are no quality standards use in foods could require the submission of monographs or therapeutic compendial a pre-marketing GRAS notification to the monographs published for Micromeria FDA. libanotica in any of India‟s national pharmacopoeias covering botanical Medicinal use: Micromeria libanotica is not substances used in the Indian Systems of listed as a “Generally Recognized as Safe Medicine (Ayurveda, Siddha, and Unani). and Effective” (GRASE) active ingredient for use in over-the-counter (OTC) or Switzerland prescription drug products for human use. Its use in medicinal products would require Cosmetic, Food, Medicine: There are no a New Drug Application (NDA) process with known quality standards or trade FDA approval. specifications for Micromeria libanotica for any use. There is no monograph in the Information on existing quality Swiss Pharmacopoeia (PhHelv). There are standards, compendial no licensed or registered herbal medicinal products that contain this species. standards or trade specifications of relevance to United States of America this species in selected destination countries Food: There are no standards published for Micromeria libanotica neither in the Code of Federal Regulations (CFR), the Food Australia Chemicals Codex (FCC) nor in the National Formulary monographs of the United States Cosmetic, Food or Medicine: There are Pharmacopeia (USP-NF). no known quality standards or trade specifications for Micromeria libanotica for Dietary Supplement: There are no any use. There are no listed herbal standards published for Micromeria medicinal products that contain this plant for libanotica in the Dietary Supplements sale in Australia. monographs of the United States Pharmacopeia (USP-DS). European Community Medicine: There are no standards Cosmetic, Food or Medicine: There are published for Micromeria libanotica in the no known quality standards or trade Code of Federal Regulations (CFR) nor in specifications for Micromeria libanotica for the monographs of the United States any use. There is no monograph in the Pharmacopeia (USP). European Pharmacopoeia. There are no known licensed or registered herbal medicinal products in the European Proposed innovative value- Community that contain this species. added MAP products using this ingredient India The national consultant‟s report Food: There are no quality standards “Monographs of the 7 targeted species” published for Micromeria libanotica, neither proposed innovative value-added products in the Bureau of Indian Standards (BIS) for the dried aerial parts of Micromeria quality standards for spices, concentrates libanotica as a component of tisanes or and oleoresins, in the 1995 Prevention of herbal teas. The consultant also proposed

22 | P a g e the development of geographic origin and  Colutea cilicica Boiss. et Bal. in trademarks for Lebanese quality and Boiss. (Leguminosae); country of origin designation.  Crataegus aronia (L.) Bosc. ex DC. (Rosaceae); The current estimated annual demand of 5  Cytisopsis pseudocytisus (Boiss.) tons for dried aerial parts of Micromeria Fertig. (Leguminosae); libanotica is quite low for consideration of  Eleagnus angustifolia L. developing innovative new products. (Elaeagnaceae); Outside of micro- or small enterprises, there  Equisetum telmateia Ehrh. would hardly be an economy of scale to (Equisetaceae); justify new product development at this  Helichrysum stoechas (L.) Moench. annual level of raw material availability. If subsp. barrelieri (Ten.) Nyman. the expert resource assessment should (Compositae); determine that significantly higher amounts  Matricaria recutita L. (Compositae); of this species could be harvested annually  Mentha longifolia L. subsp. noeana under a controlled sustainable resource (Boiss. ex. Briq.) Briq. (Labiatae); management plan, then it could make  Mentha spicata L. subsp. sense to consider the development of condensata (Briq.) Greuter and innovative value-added products. Burdet (Labiatae);  Paronychia argentea Lam. If sustainable scaling up is deemed (Caryophyllaceae); possible, new innovative products for the  Phlomis syriaca Boiss. (Labiatae); local market as well as for export promotion  Rosa damascena Mill. (Rosaceae); to neighboring countries could be  Salvia fruticosa Mill. (Labiatae); envisaged. In that scenario, it could be interesting to develop and brand finished  Sambucus nigra L. (Caprifoliaceae); herbal tea products that contain Micromeria  Spartium junceum L. libanotica as a component of identified folk- (Leguminosae); and or traditional (Unani) medicinal herbal teas,  Zea mays L. (Gramineae). but with a Lebanese geographic origin designation. As an example to model from, Three of the medicinal plant species the Unani herbal tea that is presently typically found in the Syrian-made Unani marketed in Syria by the name of “Zahraa”, herbal tea mixtures are also mentioned or which can contain anywhere from 6 to 14 prioritized for the Lebanon project; Alcea medicinal plants, among them a different damascena, Micromeria myrtifolia and Micromeria species (Micromeria myrtifolia Salvia fruticosa. Thus it would seem Boiss. and Hohen). Perhaps a Lebanese conceivable to develop a Lebanese brand version of the Syrian Unani herbal tea of this traditional Unani herbal tea, possibly known as “Zahraa” could be developed among other traditional combinations, to using the Lebanese species of Micromeria label and market not only in Lebanon but for in place of the Syrian species. Lebanese export to nearby countries or regions where “Zahraa” herbal tea could contain aerial Unani herbal teas may have a market parts of Micromeria libanotica in potential, for example Egypt, Iraq, Jordan, combination with plant parts of five or more Occupied Palestinian Territory, and Syria. of the following listed species: Marketing authorization for Unani medicinal  Alcea damascena (Mouterde) herbal teas in the European Community Mouterde would be costly and extremely difficult for a  Aloysia triphylla (L‟Herit.) Britt. Lebanese enterprise under the current (Malvaceae); regulatory framework for traditional herbal  Astragalus cf. amalecitanus Boiss.; medicinal products in the EC. Such herbal  Cercis siliquastrum L. subsp. tea formulations however could have a hebecarpa (Bornm.) Yalt. and better chance of obtaining marketing subsp. siliquastrum. authorization in certain Commonwealth (Leguminosae); Nations that have a less complicated regulatory pathway for the authorization of

23 | P a g e traditional Unani medicinal products, for South Africa, Sri Lanka, and Tanzania, example in Bangladesh, Canada, India, possibly among other countries where Kenya, Malaysia, Pakistan, Singapore, Unani medicine is practiced.

24 | P a g e Origanum ehrenbergii Boiss outside of its limited range of Lebanon. There is a small amount of published literature investigating the chemistry Definitions composition and pharmacological properties of the essential oil obtained from Origanum ehrenbergii Boiss (Fam. the aerial parts of the plant. This could Lamiaceae) suggest that, depending on the totality of evidence compiled on its safety and  English name: Ehrenberg‟s efficacy, an export market for the distilled marjoram essential oil could be developed and  French name: Origan possibly also for other forms such as d‟Ehrenberger oleoresin. This potentiality would be  German name: dependent on the existence of a quantity Ehrenbergerischer Majoram and quality sufficient to satisfy prospective  Lebanese vernacular names: Al export demand requirements that can also Zouwayba'a; Za'atar-al-snawbar; be produced sustainably. زعيتري، Za'atar jordi; Za'aytri Regulatory framework, market Assessment of current access requirements and Lebanese export trade data requirements for use in current main importers selected destination countries

According to the national consultant‟s report Australia “Monographs of the 7 targeted species,” there are no Lebanese exports except Cosmetic use: No information found. possibly in cases of species misidentification where Origanum Food use: Origanum ehrenbergii is not ehrenbergii might be labeled as Origanum listed in Standard 1.4.4 “Prohibited and syriacum. The size of the Lebanese market Restricted Plants and Fungi” of the for Origanum ehrenbergii was estimated at Australia New Zealand Food Standards about 173 tons with a wholesale market Code.49 value of about USD $0.72 million. Since this species is not presently known to be Medicinal use: Origanum ehrenbergii is not exported, it would be difficult to make any listed as a substance that may be used as determination concerning who the main an active or excipient ingredient in „Listed‟ importers of this species might be, if any. medicines for supply in Australia.50 This Some assumptions can be made based on suggests that it could require a petition to the regulatory status of Origanum amend and expand the list of substances ehrenbergii in other countries. If a used in listed medicines in order to achieve regulatory framework were to exist in any marketing authorization for this species in countries for the import and use of medicinal products. Two other species of Origanum ehrenbergii, the possibility could Origanum are listed for use in therapeutic then exist for Lebanese exports to the identified countries.

49 This review found that Origanum Food Standards Australia New Zealand (FSANZ). ehrenbergii does not appear on any Standard 1.4.4 Prohibited and Restricted Plants and national positive lists of any of the selected Fungi. In: Australia New Zealand Food Standards Code. Canberra: Commonwealth of Australia. 2010. Available counties, although some lists non- at: specifically allow Origanum spp. which http://www.foodstandards.gov.au/_srcfiles/Standard_1_ would indicate allowance to import and use 4_4_Prohib_plants_v113.pdf 50 Therapeutic Goods Administration. Substances that may in products. Almost no evidence was found be used as active ingredients in „Listed‟ medicines in to demonstrate that any ingredients made Australia. Woden (Australia): Australian Government from Origanum ehrenbergii are Department of Health and Ageing Therapeutic Goods Administration. 12 December 2007. Available at: commercially traded or actively used http://www.tga.gov.au/cm/listsubs.pdf

25 | P a g e products in Australia. They are Origanum ehrenbergii products are found in the majorana and Origanum vulgare. Licensed Natural Health Products Database (LNHPD). Using the search field “Ingredient Canada Name” and the criteria “Origanum” there were 36 results found in the LNHPD Cosmetic use: Origanum ehrenbergii is not showing licensed products that contain listed in the Health Canada “Cosmetic either dried leaf, extracts of dried leaf or Ingredient Hotlist” 51 which is a list of essential oils of the leaves of Origanum 54 substances that are restricted and vulgare. If sufficient evidence of safety prohibited for use in cosmetic products in and efficacy could be compiled to meet the Canada. Nor does Origanum ehrenbergii requirements, there would appear to be no appear on the list of “Substances in restriction against a company submitting a Cosmetics and Personal Care Products product license application for the Regulated under the Food and Drugs Act marketing authorization of a Natural Health (F&DA) that were in commerce between Product (NHP) containing Origanum January 1, 1987, and September 13, 2001.” ehrenbergii as a medicinal ingredient. 52 This suggests that while there is no express prohibition against use in cosmetic European Community products, it is possible that Origanum ehrenbergii could be classified as new or Cosmetic use: Origanum ehrenbergii is not novel. listed in the European Commission Cosmetic Ingredients and Substances Food use: Origanum ehrenbergii is not (CosIng) database.55 However, cosmetic specifically listed in the Canada Food and ingredients made from other species of Drugs Regulations (2010), 53 suggesting Origanum are listed in CosIng including: that there is no current use in Canada for purposes of adding aromas, colors, flavors,  extract obtained from the herbs of the seasonings or spices to food products. Spanish Marjoram, Origanum cretium; However, Division 7, Section B.07.028 [S]  essential oil obtained from the herbs of the regulations for Spices, Dressings and of the Spanish Marjoram, Origanum Seasonings, should, in principle, permit any cretium; species of Origanum to be imported,  volatile oil obtained from the flowers labeled and used under the common name of Origanum heracleoticum; “oregano.” The Canadian regulation defines  volatile oil obtained from the flowers “oregano” as the whole or ground dried of Sweet Marjoram, Origanum leaves of Origanum vulgare L. or Origanum majorana L.; spp.  extract obtained from the herbs of the Sweet Marjoram, Origanum majorana Medicinal use: There are no monographs L.; for Origanum ehrenbergii in the Natural  essential oil obtained from the herbs Health Products Directorate (NHPD) of the Sweet Marjoram, Origanum Compendium of Monographs. No Origanum majorana L.;  extract of the leaves of the Sweet 51 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, Marjoram, Origanum majorana L.; Ontario: Health Canada. September 2009. Available at: volatile oil distilled from the leaves of http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs-  sesc/pdf/person/cosmet/info-ind-prof/_hot-list- the Sweet Marjoram, Origanum critique/hotlist-liste-eng.pdf majorana L.; 52 Health Canada. Substances in cosmetics and personal care products regulated under the Food and Drugs Act  extract of the flowering end of the (F&DA) that were in commerce between January 1, Wild Marjoram, Origanum vulgare L.; 2987, and September 13, 2001. Ottawa, Ontario: Health Canada. Available at: http://www.hc-sc.gc.ca/ewh- semt/contaminants/person/impact/list/person-no-cas- 54 Health Canada Natural Health Products Directorate eng.php (NHPD). Licensed Natural Health Products Database 53 Canada Minister of Justice. Food and Drug Regulations. (LNHPD). Available at: http://webprod.hc- C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng Current to 24 March 2010. Available at: 55 European Commission. Cosmetic Ingredients and http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 Substances (CosIng) Database. Available at: 70.pdf http://ec.europa.eu/enterprise/cosmetics/cosing

26 | P a g e

 extract of the flowers, leaves and

stems of the Wild Marjoram,

Origanum vulgare L.;

 dried, shredded leaves of the Wild

Marjoram, Origanum vulgare L.;

ble concern ble

 extract of the leaves of the Wild

Parts of plants of Parts of of plants possi Chemical of concern / toxic effect Remarks Specific References Marjoram, Origanum vulgare L.; Botanicalname  volatile oil distilled from the leaves of Origanu 1Q: 1Q: leaf Active the Wild Marjoram, Origanum vulgare m plant estragol (1X) principles L.; majoran fruits, e (constituen  volatile oil obtained from the whole a L. herb content: ts of (EHIA 96-550 chemical plant of Wild Marjoram, Origanum list) 1L: ppm 1L: concern) vulgare L herb Herb contained essenti essenti in natural The CosIng listings of cosmetic ingredients al oil al oil: sources of campho flavourings made from four other species of Origanum r, 2%. , Council of suggests that, in principle, with sufficient (CoE, Europe, evidence of safety, the additional listing of 2005) 2005. ingredients made from Origanum Origanu 1P: leaf of m herba O. ehrenbergii should be possible. vulgare vulgar L. e L. Food use: Origanum ehrenbergii is not ssp. listed in the European Food Safety vulgar e (1X) Authority (EFSA) Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or SOURCES OF INFORMATION FOR ORIGANUM IN THE TABLE other substances of concern.56 However, two other species of Origanum are listed as Code Reference follows (see next page for definition of 1L Active principles (constituents of toxicological codes): concern) contained in natural sources of flavourings. Council of Europe, 2004 1P Plants identified in the Belgian Regulation (Arrêté Royal 29/8/1997 – annex list 3 and following acts) as requiring a notification before marketing 1Q Final Public Statement on the use of herbal medicinal products containing estragole, Committee on Herbal Medicinal Products, London 23 November 2005 1X The EuroFIR-NETTOX Plant List by Pilegaard K, Eriksen FD, Soerensen M, and Gry J. Electronic version November 2006 (Revised version of the NETTOX list of Food Plants - Major European Food Plants and Edible Mushrooms by 1997)

Origanum ehrenbergii is not listed in the European Herbal Infusions Association (EHIA) “Inventory List of Herbals Considered as Food.”57 Absence of this species in the EHIA list means that this plant is not currently employed by the herbal infusions trade in a European

56 member state as food plant for making tea European Food Safety Authority (EFSA). EFSA Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other 57 European Herbal Infusions Association (EHIA). EHIA substances of concern. EFSA Journal 2009; 7(9):281. Inventory List of Herbals Considered as Food. Hamburg, Available at: Germany. January 2010. Available at: http://www.ehia- http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf online.org/publications.html

27 | P a g e infusions. Two other species of Origanum The absence of Origanum ehrenbergii in are listed, Origanum majorana (herb) and the checklists and/or pharmacopoeias of Origanum vulgare (herb). the Indian Systems of Medicine suggests that it could be difficult to gain marketing Medicinal use: The European Medicines authorization for it as a component of an Agency (EMEA) has no plans to publish a Ayurvedic, Siddha or Unani (ASU) herbal European Community Herbal (therapeutic) medicinal product in India. Monograph for Origanum ehrenbergii nor is there a European Pharmacopoeia (quality) It may be possible for Origanum ehrenbergii Monograph published by the European to enter Indian commerce however as a Directorate for the Quality of Medicines food flavor, spice or seasoning ingredient (EDQM). Such monographs would only be under the common name of oregano. prioritized for development in the event that marketing authorization was granted by one South Africa or more of the EC Member States. EMEA monographs for Origanum majorana (herb Medicinal use: Origanum ehrenbergii is not and fruit) are scheduled for assessment but listed in any of the Schedules on have a low priority. There is a European Complementary and Alternative Medicines Pharmacopoeia (PhEur) quality standards for therapeutic use in South Africa.59 monograph for the dried leaves and flowers, separated from the stems, of Origanum Switzerland onites L. or Origanum vulgare L. subsp. hirtum (Link) Ietsw., or a mixture of both Cosmetic use: No information found. species. Dietary supplement use: Origanum India ehrenbergii is not included on the list of substances that may be used in dietary or Medicinal use: Origanum ehrenbergii is not food supplement products in Switzerland. listed in any of the pharmacopoeias of Indian Systems of Medicine (e.g. Ayurvedic Food use: Origanum ehrenbergii is not Pharmacopoeia of India, Siddha included on the positive list of substances Pharmacopoeia of India and/or Unani that may be used as flavor, spice or Pharmacopoeia of India). Additionally, it is seasoning ingredients in food products or in not found in the comprehensive checklist of non-medicinal herbal tea products.60 1,289 botanicals, pertaining to 960 plant However, Origanum vulgare L. ssp. vulgare taxa, that were identified in the recent is listed well as Origanum majorana L. (syn. “Demand and Supply of Medicinal Plants in Majorana hortensis Moench.). India 2008,”58 which was initiated by the National Medicinal Plants Board (NMPB), Medicinal use: Origanum ehrenbergii is not Ministry of Health & Family Welfare, included on the “Stoffliste” (List of Department of AYUSH, and was carried out Substances used in medicinal products).61 by Drs. D.K. Ved and G.S. Goraya, of the Foundation for Revitalisation of Local

Health Traditions (FRLHT). Only one 59 Medicines Control Council. Medicines and Related species of Origanum is included in the Substances Act, 1965. Schedules on Complementary FRLHT survey, Origanum majorana L., and Alternative Medicines made in terms of the Medicines and Related Substances Act, 1965 (Act No. Sweet marjoram herb, which is used in 101 of 1965); Amendment. Staatskoerant. 22 August codified Indian Systems of Medicine of 2008; No. 31334. Available at: Ayurveda, Siddha and Unani, as well as in http://www.piasa.co.za/Filestructure/Legislation/Comple mentary%20and%20Alternative%20Medicines/GG%203 the Homoeopathic System of Medicine. 1334%20-%20Page%2031%20to%20180.pdf 60 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und Zubereitungen als Arzneimittel oder als Lebensmittel“. Bern, Switzerland: Swissmedic. 11 December 2006. Available at: http://www.swissmedic.ch/marktueberwachung/00662/in 58 Ved DK, Goraya GS. Demand and Supply of Medicinal dex.html?lan Plants in India. Dehra Dun, India: Bishen Singh 61 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. Mahendra Pal Singh. 2008. August 2008. Available at:

28 | P a g e This would suggest that marketing Food use: Origanum ehrenbergii is not authorization as a medicinal substance in specifically listed as “Generally Recognized Switzerland would not be possible unless as Safe” (GRAS) for use in food products. the List of Substances were amended to However, essential oils, oleoresins (solvent- include this species. However, “Origani free), and natural extractives (including aetheroleum” (essential oil of oregano) is distillates) of the non-species-specific classified as an approved active substance “Origanum” (Origanum spp.) are classified of complementary and phytomedicine as GRAS for their intended use as food products (KPA) requiring pre-marketing ingredients.64 Additionally, natural authorization and product licensing through ingredients made from “Dittany of Crete” Swissmedic. Retail distribution is limited to (Origanum dictamnus L.) are classified as Category D (available in both pharmacies natural flavoring substances and natural and drugstores; without prescription but adjuvants that may be safely used in food only after consultation with pharmacy staff). products.65 Thus, it would appear to be For test and release of active ingredients of permitted for U.S. buyers to import licensed medicines, the pharmacopoeial Origanum ehrenbergii and to use the dried standards in force for Switzerland are both herb or essential oil as a food flavoring the European Pharmacopoeia (PhEur) and ingredient. the Swiss Pharmacopoeia (PhHelv). Additionally, both Origanum majorana and Medicinal use: Origanum ehrenbergii is not Origanum vulgare are included in the listed as a “Generally Recognized as Safe Swissmedic “Liste HAS” (List of and Effective” (GRASE) active ingredient Homoeopathic and Anthroposophic for use in over-the-counter (OTC) or Substances) for oral and/or parenteral use prescription drug products for human use. at various specified homoeopathic Its use in medicinal products would require dilutions.62 a New Drug Application (NDA) process with FDA approval. United States of America Information on existing quality Cosmetic use: Origanum ehrenbergii is not standards, compendial known to be used in cosmetic products in the U.S. standards or trade specifications of relevance to Dietary supplement use: Origanum this species in selected ehrenbergii is not listed in the Herbs of destination countries Commerce, 2nd edition,63 which indicates that it did not appear in U.S. commerce prior to 1994 and therefore would likely Australia require the pre-marketing submission of a New Dietary Ingredient (NDI) notification to Cosmetic, Food or Medicine: There are the FDA. Two other species of Origanum no known quality standards or trade are listed in the Herbs of Commerce. They specifications for Origanum ehrenbergii for are sweet marjoram (Origanum majorana any use. There are no listed herbal L.) and oregano (Origanum vulgare L. ssp. medicinal products that contain this plant for hirtum; syn.: Origanum heracleoticum auct. sale in Australia. non. L.).

64 United States Food and Drug Administration. Essential http://www.swissmedic.ch/daten/00080/00256/index.htm oils, oleoresins (solvent-free), and natural extractives l?lang=de (including distillates). In: Code of Federal Regulations, 62 Swissmedic. Liste homöopathischer und Title 21, Part 182, Section §182.20. Washington, DC: anthroposophischer Stoffe (Liste HAS). Bern, National Archives and Records Administration. 01 April Switzerland: Swissmedic. August 2008. Available at: 2009. http://www.swissmedic.ch/rechtstexte/00201/00203/inde 65 United States Food and Drug Administration. Natural x.html?lan flavoring substances and natural substances used in 63 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American conjunction with flavors. In: Code of Federal Herbal Products Association’s Herbs of Commerce, 2nd Regulations, Title 21, Part 172, Section §172.510. Edition. Silver Spring, MD: American Herbal Products Washington DC: National Archives and Records Association. 2000. Administration. 01 April 2009.

29 | P a g e Canada Switzerland

Food: Title 7, Section B.07.028 [S] of the Cosmetic, Food, Medicine: There are no Food and Drug Regulations defines known quality standards or trade “Oregano” as the whole or ground dried specifications for Origanum ehrenbergii for leaves of Origanum vulgare L. or Origanum any use. There is no monograph in the spp. Thus it would appear that Origanum Swiss Pharmacopoeia (PhHelv). There are ehrenbergii could conceivably be imported no licensed or registered herbal medicinal and traded under the common name products that contain this species. “oregano” so long as it meets the following Canadian Oregano standard. Oregano shall United States of America contain not-more-than 10 per cent total ash, two per cent ash insoluble in hydrochloric Food: There are no standards published acid, and 10 per cent moisture; and not less specifically for the species Origanum than 2.5 milliliters volatile oil per 100 grams ehrenbergii in the Code of Federal 66 of spice. Regulations (CFR), the Food Chemicals Codex (FCC) nor in the National Formulary European Community monographs of the United States Pharmacopeia (USP-NF). However, there is Cosmetic, Food or Medicine: There are an FCC monograph for “Origanum Oil, no known quality standards or trade Spanish Type,” for use as a flavoring agent. specifications for Origanum ehrenbergii for Spanish Type Origanum Oil FCC is the any use. There is no monograph in the volatile oil obtained by steam distillation European Pharmacopoeia. There are no from the flowering herb Thymus capitatus known licensed or registered herbal Hoffm. et Link and various species of medicinal products in the European Origanum (Fam. Labiatae).67 The FCC also Community that contain this species. lists the non-species-specific “Oleoresin Origanum,” which is obtained by the solvent India extraction of the dried flowering herb Origanum spp. (Fam. Labiatae) as a dark Food: There are no quality standards brown-green semisolid. Based on the fact published for Origanum ehrenbergii, neither that both the CFR and FCC allow food in the Bureau of Indian Standards (BIS) ingredients (in the forms of essential oils quality standards for spices, concentrates and oleoresins) to be made from Origanum and oleoresins, in the 1995 Prevention of spp. would suggest that it should be Food Adulteration (PRA) Act and Rules possible for a U.S. buyer to import, process standards for spices, nor in the Agricultural and use Origanum ehrenbergii as a food Product Grading and Marking (AGMARK) ingredient. Standards. Dietary Supplement: There are no Medicine: There are no quality standards standards published for Origanum monographs or therapeutic compendial ehrenbergii in the Dietary Supplements monographs published for Origanum monographs of the United States ehrenbergii in any of India‟s national Pharmacopeia (USP-DS). pharmacopoeias covering botanical substances used in the Indian Systems of Medicine: There are no standards Medicine (Ayurveda, Siddha, and Unani). published for Origanum ehrenbergii in the Code of Federal Regulations (CFR) nor in the monographs of the United States Pharmacopeia (USP).

66 Canada Minister of Justice. Food and Drug Regulations. C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. 67 Food Ingredients Expert Committee. Origanum Oil, Current to 24 March 2010. Available at: Spanish Type. In: Food Chemicals Codex, Seventh http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 Edition (FCC 7). Rockville, MD: United States 70.pdf Pharmacopeial Convention. 2010; 751-752.

30 | P a g e Proposed innovative value- The current estimated annual demand of added MAP products using this 173 tons for dried aerial parts of Origanum ehrenbergii is considerable. If the expert ingredient resource assessment should determine that significantly higher amounts of this species The national consultant‟s report could be harvested annually under a “Monographs of the 7 targeted species” controlled sustainable resource proposed innovative value-added products management plan, then it could make for the dried aerial parts of Origanum sense to consider the development of ehrenbergii as a component of tisanes or innovative value-added products for export herbal teas. Also suggested was to develop promotion with a Lebanon geographical an international market for the essential oil. brand. However, since this species does This would require a significant scale-up not expressly appear on any known positive due to the high quantities of fresh aerial lists, it may be classified as a new or novel parts that would be necessary for a ingredient that would require the commercial oil distillation operation for submission of a petition to the regulatory export promotion. The consultant also authorities to gain market access. It is also proposed carvacrol production from the possible that this species is being exported leaves and flowers as well as the potential but mislabeled as another Origanum importance of the species for honey species. If there is evidence that this production. Finally, the development of species has been exported for some time to geographic origin and trademarks for American and European buyers, it might not Lebanese quality and country of origin be exceptionally difficult to petition for an designation for all aforementioned products. expansion of the positive list definitions for Origanum species food or dietary supplement ingredients.

31 | P a g e Origanum syriacum L. Even though evidence of significant domestic use and export exist, this review found that Origanum syriacum does not Definitions expressly appear on any national positive lists of any of the selected counties. Some Origanum syriacum L. (syn.: Majorana lists, however, non-specifically allow syriaca (L.) Rafin; Origanum maru auct.; Origanum spp. which would indicate the Fam. Lamiaceae) allowance to import and use this species as generic “oregano” in food products. This is  English names: Lebanese indeed the case for Canada and the United oregano, Syrian oregano, Wild States, both of which permit any species of marjoram; Bible hyssop Origanum to be used under the common  German names: Echter name “oregano.” Since it is known that a Staudenmajoram; Syrischer Ysop significant amount is presently exported, the  Lebanese vernacular names: assumption is made here that it is being exported generically as “oregano” without زعتر، Zūbā' ; Za'atar  Turkish vernacular name: Kekik clear species differentiation on export documents, labels and markings. Since Assessment of current Canada and the United States are known to be importers, a reasonable assumption that Lebanese export trade data this species is presently in use as a food current main importers flavor and seasoning ingredient in certain North American countries. According to the national consultant‟s report “Monographs of the 7 targeted species,” In any case, the national consultant stated Lebanese exports of ground oregano that limited quantities available from wild (Za'atar) are considerable at an estimated collection are, in and of themselves, a at 636 tons per year corresponding to an limiting factor for increasing exports beyond estimated FOB value of USD $712,000 with the current level. Almost all of the supply is the main importers being Bahrain, Canada, wild harvested. Thus, developing new the United States, France, the United Arab innovative value-added products for the Emirates, and Qatar. Total annual domestic and export markets should be estimated quantity was estimated at 1,753 dependent on the outcomes of the resource tons with an estimated wholesale market assessments followed by implementation of value of USD $7,247,531. The World a rigorous management plan. If it should be Customs Organization (WCO) assigns a determined that significantly greater annual general 6-digit Harmonized System Tariff quantities can be sustainably harvested, Code (HS Code) of HS 121190 for oregano then the decision to create new demand (Origanum spp), but this code is shared by with new products should be considered. literally hundreds of other medicinal plant Additionally, as part of the resource species. Lebanese Customs has not management plan, species differentiation assigned a specific 8- or 10- digit HS Code should be mastered and correct labeling for oregano but presumably Lebanese and marking of the harvests should result in exports of Origanum species are included better data and greater transparency. within their 8-digit HS 12119090 (“other” Indeed, while some target destination medicinal plants). Lebanese Customs countries may permit the import and use of states that HS 12119090 includes, as multiple species under a single common examples, cannabis, chamomile, dried mint name, there may be other legislative and/or and sage. Based on the WCO 6-digit non-legislative market requirements for classifications, Lebanon Customs should be accurate botanical identification. including Origanum spp. and Salvia spp. under their HS12119090. The Turkish Customs Tariff 2010 utilizes a specific 10- digit HS 1211908535 for tracking exports of “Wild Marjoram (Oregano).”

32 | P a g e Regulatory framework, market 71 This suggests that while there is no access requirements and express prohibition against use in cosmetic products, it is possible that Origanum requirements for use in syriacum could be classified as new or selected destination countries novel.

Australia Food use: Origanum syriacum is not specifically listed in the Canada Food and 72 Cosmetic use: No information found. Drugs Regulations (2010), suggesting that there is no current use in Canada for Food use: Origanum syriacum is not listed purposes of adding aromas, colors, flavors, in Standard 1.4.4 “Prohibited and Restricted seasonings or spices to food products. Plants and Fungi” of the Australia New However, Division 7, Section B.07.028 [S] Zealand Food Standards Code.68 of the regulations for Spices, Dressings and Seasonings, should, in principle, permit any Medicinal use: Origanum syriacum is not species of Origanum to be imported, listed as a substance that may be used as labeled and used under the common name an active or excipient ingredient in „Listed‟ “oregano.” The Canadian regulation defines medicines for supply in Australia.69 This “oregano” as the whole or ground dried suggests that it could require a petition to leaves of Origanum vulgare L. or Origanum amend and expand the list of substances spp. Since it is know that Lebanon is used in listed medicines in order to achieve exporting this species to Canada it must be marketing authorization for this species in assumed that it is entering the Canadian medicinal products. Two other species of market as per this food regulation as the Origanum are listed for use in therapeutic non-specific Origanum spp. products in Australia. They are Origanum majorana and Origanum vulgare. Medicinal use: There are no monographs for Origanum syriacum in the Natural Health Canada Products Directorate (NHPD) Compendium of Monographs. No Origanum syriacum products are found in the Licensed Natural Cosmetic use: Origanum syriacum is not Health Products Database (LNHPD). Using listed in the Health Canada “Cosmetic the search field “Ingredient Name” and the Ingredient Hotlist” 70 which is a list of criteria “Origanum” there were 36 results substances that are restricted and found in the LNHPD showing licensed prohibited for use in cosmetic products in products that contain either dried leaf, Canada. Nor does Origanum syriacum extracts of dried leaf or essential oils of the appear on the list of “Substances in leaves of Origanum vulgare.73 If sufficient Cosmetics and Personal Care Products evidence of safety and efficacy could be Regulated under the Food and Drugs Act compiled to meet the requirements, there (F&DA) that were in commerce between would appear to be no restriction against a January 1, 1987, and September 13, 2001.” company submitting a product license application for the marketing authorization 68 Food Standards Australia New Zealand (FSANZ). Standard 1.4.4 Prohibited and Restricted Plants and Fungi. In: Australia New Zealand Food Standards Code. 71 Health Canada. Substances in cosmetics and personal Canberra: Commonwealth of Australia. 2010. Available care products regulated under the Food and Drugs Act at: (F&DA) that were in commerce between January 1, http://www.foodstandards.gov.au/_srcfiles/Standard_1_ 2987, and September 13, 2001. Ottawa, Ontario: Health 4_4_Prohib_plants_v113.pdf Canada. Available at: http://www.hc-sc.gc.ca/ewh- 69 Therapeutic Goods Administration. Substances that may semt/contaminants/person/impact/list/person-no-cas- be used as active ingredients in „Listed‟ medicines in eng.php Australia. Woden (Australia): Australian Government 72 Canada Minister of Justice. Food and Drug Regulations. Department of Health and Ageing Therapeutic Goods C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. Administration. 12 December 2007. Available at: Current to 24 March 2010. Available at: http://www.tga.gov.au/cm/listsubs.pdf http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 70 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, 70.pdf Ontario: Health Canada. September 2009. Available at: 73 Health Canada Natural Health Products Directorate http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs- (NHPD). Licensed Natural Health Products Database sesc/pdf/person/cosmet/info-ind-prof/_hot-list- (LNHPD). Available at: http://webprod.hc- critique/hotlist-liste-eng.pdf sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng

33 | P a g e of a Natural Health Product (NHP)  volatile oil obtained from the containing Origanum syriacum as a whole plant of Wild Marjoram, medicinal ingredient. Origanum vulgare L

European Community The CosIng listings of cosmetic ingredients made from four other Cosmetic use: Origanum syriacum is not species of Origanum suggests that, listed in the European Commission in principle, with sufficient evidence Cosmetic Ingredients and Substances of safety, the additional listing of (CosIng) database.74 However, cosmetic ingredients made from Origanum ingredients made from other species of syriacum should be possible. Origanum are listed in CosIng including: Food use: Origanum syriacum is  extract obtained from the herbs not listed in the European Food of the Spanish Marjoram, Safety Authority (EFSA) Origanum cretium; Compendium of botanicals that have  essential oil obtained from the been reported to contain toxic, herbs of the Spanish Marjoram, addictive, psychotropic or other 75 Origanum cretium; substances of concern. However,  volatile oil obtained from the two other species of Origanum are flowers of Origanum listed as follows (see next page for heracleoticum; definition of codes):  volatile oil obtained from the flowers of Sweet Marjoram, Botanic Parts Chemic Remar Specific al name of al of ks Referenc Origanum majorana L.; plants concer es  extract obtained from the herbs of n / of the Sweet Marjoram, possib toxic Origanum majorana L.; le effect concer  essential oil obtained from the n herbs of the Sweet Marjoram, Origanu 1Q: 1Q: leaf Active Origanum majorana L.; m plant estragol (1X) principles  extract of the leaves of the majoran fruits, e (constitue Sweet Marjoram, Origanum a L. herb content: nts of (EHIA 96-550 chemical majorana L.; list) 1L: ppm 1L: concern)  volatile oil distilled from the herb Herb contained leaves of the Sweet Marjoram, essenti essenti in natural Origanum majorana L.; al oil al oil: sources of campho flavouring  extract of the flowering end of r, 2%. s, Council the Wild Marjoram, Origanum (CoE, of Europe, vulgare L.; 2005) 2005.  extract of the flowers, leaves and Origanu 1P: leaf of m herba O. stems of the Wild Marjoram, vulgare vulgare Origanum vulgare L.; L. L. ssp.  dried, shredded leaves of the vulgare Wild Marjoram, Origanum (1X) vulgare L.;  extract of the leaves of the Wild Marjoram, Origanum vulgare L.;  volatile oil distilled from the leaves of the Wild Marjoram, Origanum vulgare L.; 75 European Food Safety Authority (EFSA). EFSA Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other 74 European Commission. Cosmetic Ingredients and substances of concern. EFSA Journal 2009; 7(9):281. Substances (CosIng) Database. Available at: Available at: http://ec.europa.eu/enterprise/cosmetics/cosing http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf

34 | P a g e SOURCES OF INFORMATION FOR India ORIGANUM IN THE TABLE Medicinal use: Origanum syriacum is not Code Reference listed in any of the pharmacopoeias of 1L Active principles (constituents of toxicological Indian Systems of Medicine (e.g. Ayurvedic concern) contained in natural sources of Pharmacopoeia of India, Siddha flavourings. Council of Europe, 2004 1P Plants identified in the Belgian Regulation Pharmacopoeia of India and/or Unani (Arrêté Royal 29/8/1997 – annex list 3 and Pharmacopoeia of India). Additionally, it is following acts) as requiring a notification not found in the comprehensive checklist of before marketing 1,289 botanicals, pertaining to 960 plant 1Q Final Public Statement on the use of herbal medicinal products containing estragole, taxa, that were identified in the recent Committee on Herbal Medicinal Products, “Demand and Supply of Medicinal Plants in 77 London 23 November 2005 India 2008,” which was initiated by the 1X The EuroFIR-NETTOX Plant List by National Medicinal Plants Board (NMPB), Pilegaard K, Eriksen FD, Soerensen M, and Ministry of Health & Family Welfare, Gry J. Electronic version November 2006 (Revised version of the NETTOX list of Food Department of AYUSH, and was carried out Plants - Major European Food Plants and by Drs. D.K. Ved and G.S. Goraya, of the Edible Mushrooms by 1997) Foundation for Revitalisation of Local Health Traditions (FRLHT). Only one Origanum syriacum is not listed in the species of Origanum is included in the European Herbal Infusions Association FRLHT survey, Origanum majorana L., (EHIA) “Inventory List of Herbals Sweet marjoram herb, which is used in Considered as Food.”76 Absence of this codified Indian Systems of Medicine of species in the EHIA list means that this Ayurveda, Siddha and Unani, as well as in plant is not currently employed by the the Homoeopathic System of Medicine. herbal infusions trade in a European member state as food plant for making tea The absence of Origanum syriacum in the infusions. Two other species of Origanum checklists and/or pharmacopoeias of the are listed, Origanum majorana (herb and Indian Systems of Medicine suggests that it fruit) and Origanum vulgare (herb). could be difficult to gain marketing authorization for it as a component of an Medicinal use: The European Medicines Ayurvedic, Siddha or Unani (ASU) herbal Agency (EMEA) has no plans to publish a medicinal product in India. It may be European Community Herbal (therapeutic) possible for Origanum syriacum to enter Monograph for Origanum syriacum nor is Indian commerce however as a food flavor, there a European Pharmacopoeia (quality) spice or seasoning ingredient under the Monograph published by the European common name of oregano. Directorate for the Quality of Medicines (EDQM). Such monographs would only be South Africa prioritized for development in the event that marketing authorization was granted by one Medicinal use: Origanum syriacum is not or more of the EC Member States. EMEA listed in any of the Schedules on monographs for Origanum majorana (herb Complementary and Alternative Medicines and fruit) are scheduled for assessment but for therapeutic use in South Africa.78 have a low priority. There is a European Pharmacopoeia (PhEur) quality standards monograph for the dried leaves and flowers, separated from the stems, of Origanum 77 Ved DK, Goraya GS. Demand and Supply of Medicinal onites L. or Origanum vulgare L. subsp. Plants in India. Dehra Dun, India: Bishen Singh Mahendra Pal Singh. 2008. hirtum (Link) Ietsw., or a mixture of both 78 Medicines Control Council. Medicines and Related species. Substances Act, 1965. Schedules on Complementary and Alternative Medicines made in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965); Amendment. Staatskoerant. 22 August 76 European Herbal Infusions Association (EHIA). EHIA 2008; No. 31334. Available at: Inventory List of Herbals Considered as Food. Hamburg, http://www.piasa.co.za/Filestructure/Legislation/Comple Germany. January 2010. Available at: http://www.ehia- mentary%20and%20Alternative%20Medicines/GG%203 online.org/publications.html 1334%20-%20Page%2031%20to%20180.pdf

35 | P a g e Switzerland at various specified homoeopathic dilutions.81 Cosmetic use: No information found. United States of America Dietary supplement use: Origanum syriacum is not included on the list of Cosmetic use: Origanum syriacum is not substances that may be used in dietary or known to be used in cosmetic products in food supplement products in Switzerland. the U.S.

Food use: Origanum syriacum is not Dietary supplement use: Origanum included on the positive list of substances syriacum is not listed in the Herbs of that may be used as flavor, spice or Commerce, 2nd edition,82 which indicates seasoning ingredients in food products or in that it did not appear in U.S. commerce non-medicinal herbal tea products.79 prior to 1994 and therefore would likely However, Origanum vulgare L. ssp. vulgare require the pre-marketing submission of a is listed well as Origanum majorana L. (syn. New Dietary Ingredient (NDI) notification to Majorana hortensis Moench.). the FDA. Two other species of Origanum are listed in the Herbs of Commerce. They Medicinal use: Origanum syriacum is not are sweet marjoram (Origanum majorana included on the “Stoffliste” (List of L.) and oregano (Origanum vulgare L. ssp. Substances used in medicinal products).80 hirtum; syn.: Origanum heracleoticum auct. This would suggest that marketing non. L.). authorization as a medicinal substance in Switzerland would not be possible unless Food use: Origanum syriacum is not the List of Substances were amended to specifically listed as “Generally Recognized include this species. However, “Origani as Safe” (GRAS) for use in food products. aetheroleum” (essential oil of oregano) is However, essential oils, oleoresins (solvent- classified as an approved active substance free), and natural extractives (including of complementary and phytomedicine distillates) of the non-species-specific products (KPA) requiring pre-marketing “Origanum” (Origanum spp.) are classified authorization and product licensing through as GRAS for their intended use as food Swissmedic. Retail distribution is limited to ingredients.83 Additionally, natural Category D (available in both pharmacies ingredients made from “Dittany of Crete” and drugstores; without prescription but (Origanum dictamnus L.) are classified as only after consultation with pharmacy staff). natural flavoring substances and natural For test and release of active ingredients of adjuvants that may be safely used in food licensed medicines, the pharmacopoeial products.84 Thus, it would appear to be standards in force for Switzerland are both permitted for U.S. buyers to import the European Pharmacopoeia (PhEur) and Origanum syriacum and to use the dried the Swiss Pharmacopoeia (PhHelv).

Additionally, both Origanum majorana and 81 Swissmedic. Liste homöopathischer und Origanum vulgare are included in the anthroposophischer Stoffe (Liste HAS). Bern, Swissmedic “Liste HAS” (List of Switzerland: Swissmedic. August 2008. Available at: http://www.swissmedic.ch/rechtstexte/00201/00203/inde Homoeopathic and Anthroposophic x.html?lan Substances) for oral and/or parenteral use 82 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American Herbal Products Association’s Herbs of Commerce, 2nd Edition. Silver Spring, MD: American Herbal Products Association. 2000. 83 United States Food and Drug Administration. Essential oils, oleoresins (solvent-free), and natural extractives 79 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und (including distillates). In: Code of Federal Regulations, Zubereitungen als Arzneimittel oder als Lebensmittel“. Title 21, Part 182, Section §182.20. Washington, DC: Bern, Switzerland: Swissmedic. 11 December 2006. National Archives and Records Administration. 01 April Available at: 2009. http://www.swissmedic.ch/marktueberwachung/00662/in 84 United States Food and Drug Administration. Natural dex.html?lan flavoring substances and natural substances used in 80 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. conjunction with flavors. In: Code of Federal August 2008. Available at: Regulations, Title 21, Part 172, Section §172.510. http://www.swissmedic.ch/daten/00080/00256/index.htm Washington DC: National Archives and Records l?lang=de Administration. 01 April 2009.

36 | P a g e herb or essential oil as a food flavoring specifications for Origanum syriacum for ingredient. any use. There is no monograph in the European Pharmacopoeia. There are no Medicinal use: Origanum syriacum is not known licensed or registered herbal listed as a “Generally Recognized as Safe medicinal products in the European and Effective” (GRASE) active ingredient Community that contain this species. for use in over-the-counter (OTC) or prescription drug products for human use. India Its use in medicinal products would require a New Drug Application (NDA) process with Food: There are no quality standards FDA approval. published for Origanum syriacum, neither in the Bureau of Indian Standards (BIS) Information on existing quality quality standards for spices, concentrates standards, compendial and oleoresins, in the 1995 Prevention of Food Adulteration (PRA) Act and Rules standards or trade standards for spices, nor in the Agricultural specifications of relevance to Product Grading and Marking (AGMARK) this species in selected Standards. destination countries Medicine: There are no quality standards monographs or therapeutic compendial Australia monographs published for Origanum syriacum in any of India‟s national Cosmetic, Food or Medicine: There are pharmacopoeias covering botanical no known quality standards or trade substances used in the Indian Systems of specifications for Origanum syriacum for Medicine (Ayurveda, Siddha, and Unani). any use. There are no listed herbal medicinal products that contain this plant for Switzerland sale in Australia. Cosmetic, Food, Medicine: There are no Canada known quality standards or trade specifications for Origanum syriacum for Food: Title 7, Section B.07.028 [S] of the any use. There is no monograph in the Food and Drug Regulations defines Swiss Pharmacopoeia (PhHelv). There are “Oregano” as the whole or ground dried no licensed or registered herbal medicinal leaves of Origanum vulgare L. or Origanum products that contain this species. spp. Thus it would appear that Origanum syriacum could conceivably be imported United States of America and traded under the common name “oregano” so long as it meets the following Food: There are no standards published Canadian Oregano standard. Oregano shall specifically for the species Origanum contain not-more-than 10 per cent total ash, syriacum in the Code of Federal two per cent ash insoluble in hydrochloric Regulations (CFR), the Food Chemicals acid, and 10 per cent moisture; and not less Codex (FCC) nor in the National Formulary than 2.5 milliliters volatile oil per 100 grams monographs of the United States of spice. 85 Pharmacopeia (USP-NF). However, there is an FCC monograph for “Origanum Oil, European Community Spanish Type,” for use as a flavoring agent. Spanish Type Origanum Oil FCC is the Cosmetic, Food or Medicine: There are volatile oil obtained by steam distillation no known quality standards or trade from the flowering herb Thymus capitatus Hoffm. et Link and various species of 85 Canada Minister of Justice. Food and Drug Regulations. Origanum (Fam. Labiatae).86 The FCC also C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. Current to 24 March 2010. Available at: http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 86 Food Ingredients Expert Committee. Origanum Oil, 70.pdf Spanish Type. In: Food Chemicals Codex, Seventh

37 | P a g e lists the non-species-specific “Oleoresin be viewed very cautiously until solid Origanum,” which is obtained by the solvent resource assessment data is available. extraction of the dried flowering herb Origanum spp. (Fam. Labiatae) as a dark Finally, the development of geographic brown-green semisolid. Based on the fact origin and trademarks for Lebanese quality that both the CFR and FCC allow food and country of origin designation for all ingredients (in the forms of essential oils aforementioned products. If sustainable and oleoresins) to be made from Origanum scaling up is deemed possible, new spp. would suggest that it could be innovative products such as those possible for a U.S. buyer to import, process suggested by the national consultant for the and use Origanum syriacum as a food regional markets as well as for export ingredient. promotion could be envisaged. It would seem necessary to first determine what Dietary Supplement: There are no additional quantities of this species could be standards published for Origanum syriacum sustainably harvested annually, above and in the Dietary Supplements monographs of beyond the current harvest levels, before the United States Pharmacopeia (USP-DS). new product development and export market promotion should ensue. A really Medicine: There are no standards interesting product concept could be a published for Origanum syriacum in the Lebanese brand of the Za'atar mix using Code of Federal Regulations (CFR) nor in Origanum syriacum, among other local the monographs of the United States herbs special to Lebanon (e.g. Satureja Pharmacopeia (USP). thymbra or Thymbra spicata), with sesame seeds and Mediterranean sea salt. If the Proposed innovative value- condiment mix carried Organic Wild and FairTrade or FairWild logo designations added MAP products using this along with a Lebanese geo-authentic ingredient branding, this could be very interesting for the natural, organic and ethical trade The national consultant‟s report markets of Europe and North America “Monographs of the 7 targeted species” proposed innovative value-added products for the dried aerial parts of Origanum syriacum as a component of tisanes or herbal teas. Also suggested was to develop an international market for the essential oil. This would require a significant scale-up due to the high quantities of fresh aerial parts that would be necessary for a commercial oil distillation operation for export promotion. The consultant also proposed carvacrol production from the leaves and flowers as well as the potential importance of the species for honey production. Scaling up for carvacrol production (obtained from the essential oil fraction) would also require a significant quantity of starting material. Scaling up essential oil and/or carvacrol production would require such a significantly increased amount of starting raw material that this innovative new product suggestion should

Edition (FCC 7). Rockville, MD: United States Pharmacopeial Convention. 2010; 751-752.

38 | P a g e Salvia fruticosa Miller processed forms prepared from the leaf), it (Lamiaceae) is difficult to know precisely the main destinations of Lebanon‟s sage exports. The World Customs Organization (WCO) Definitions lumps three-lobed sage leaf under a general 6-digit code HS 121190 that is Botanical name: Salvia shared by hundreds of other species. In any fruticosa Miller case, we do have export trade data for Lebanese exports of “other” medicinal Synonym: Salvia triloba L. fil.; S. libanotica plants classified under the 8-digit HS Codes Boiss. et gaill.) 12119000 and 12119090. In 2009, Jordan was the main importer of Lebanese “other” Pharmacopoeial name: Salviae medicinal plants exported under HS trilobae folium 12119090 at a trade volume of 223 tons, followed by Saudi Arabia at 85 tons, Kuwait Common names: 19 tons, Yemen 17 tons, and Turkey at 16 tons. This would appear to correspond to some amount of the three-lobed sage  English names: Three-lobed exports from Lebanon. However, it must sage; Three-lobe sage; Greek Sage; also be considered that Lebanese Customs Turkish Sage use of HS 12119090 should also include  French name: Sauge trilobee; exports of Origanum species. Feuille de sauge à trois lobes  German name: Dreilappiger Concerning other potential export markets, Salbei; Griechischer Salbei some assumptions can be made based on  Greek names: Phaskos; Alyphaskia the regulatory status of Salvia fruticosa in  Lebanese vernacular names: other countries. If a regulatory framework Kassiin, Maryamiyeh, were to exist in any countries for the import and use of Salvia fruticosa, the possibility عيزقان، مريمية، ,Kouwaysseh, Ayzakan could then exist for additional Lebanese قويصة، قصعين  Spanish names: Hoja de salvia exports to the identified countries. triloba; Salvia real; Sabia real  Turkish vernacular names: This review found that Salvia fruticosa Adacayi; Adacay of Izmir; appears on many national positive lists of Elma yagi the selected counties. Thus the ability of Lebanon to reach new markets beyond its Assessment of current current main customers of Jordan, Saudi Lebanese export trade data Arabia, Kuwait, Yemen and Turkey, could be possible but dependant on a range of current main importers factors including: According to the national consultant‟s report  the ability to sustainably scale-up “Monographs of the 7 targeted species,” beyond current annual demand; there are significant exports of Salvia  whether the Lebanese material fruticosa. The size of the Lebanese market would test in compliance with the for Salvia fruticosa plant parts is estimated standards in the other countries (e.g. at 100 tons valued at USD $0.2 million. But Does it meet or exceed the the majority of Lebanon‟s three-lobed sage European Pharmacopoeial quality leaf is exported. The annual total quantity standard established for three-lobed estimated to be wild collected and sold is sage leaf?); and about 1000 tons with and estimated market size of USD $4 million.  what the competitive landscape looks like. Several other countries harvest and export this species Because there is no specific Harmonized including Albania, Greece, Italy, System Tariff Code (HS Code) established Russian Federation, Turkey, and for three-lobed sage leaf (or for other

39 | P a g e Republics of the former Yugoslavia, “Cosmetic Ingredient Hotlist” 89 which is a among others. list of substances that are restricted and prohibited for use in cosmetic products in Regulatory framework, market Canada. access requirements and While Salvia fruticosa does not expressly requirements for use in appear on the list of “Substances in selected destination countries Cosmetics and Personal Care Products Regulated under the Food and Drugs Act Australia (F&DA) that were in commerce between January 1, 1987, and September 13, 2001,” Cosmetic use: No information found. many sage ingredients are listed which could conceivably include this species.90 Food use: Salvia spp. are not listed in Several other “Sage” or “Salvia” ingredients Standard 1.4.4 “Prohibited and Restricted are found on the list which suggests that a Plants and Fungi” of the Australia New correlation could be made to this species. Zealand Food Standards Code.87 For example, the list includes Tincture of Salvia, Infusion of Sage, Salvia hispanica, Root of Red Rooted Salvia (Radix Salviae Medicinal use: Salvia fruticosa is listed as Miltiorrhizae), Salvia sclarea (Clary) Sage a substance that may be used as an active Extract, Salvia lavandulaefolia, Sage flower, or excipient ingredient in „Listed‟ medicines Sage powder, Essential Oil of Medicinal for supply in Australia.88 Additionally, seven Sage, Sage Essence, and Sage Glycolic other species of Salvia are listed for use in Extract. therapeutic products in Australia. They are Salvia chinensis, Salvia hispanica, Salvia hispanorium, Salvia lavandulaefolia, Salvia Food use: Three-lobed sage leaf is listed in the Canada Food and Drug Regulations miltiorrhiza, Salvia officinalis, and Salvia 91 sclarea. Therefore, it would appear that (2010), which confirms that there is Australia could be a destination market for current use in Canada for purposes of Lebanese Salvia fruticosa, so long as it adding aromas, colors, flavors, seasonings meets the British Pharmacopoeia (BP) or spices to food products. Title 7 Section quality standard. Australia requires B.07.034. [S] of the regulations defines medicinal substances to test in compliance “Sage” as the whole or ground dried leaves with the corresponding BP monograph. of the sage plant Salvia officinalis L., Salvia There is a BP monograph for three-lobed triloba L. or Salvia lavandulaefolia Vahl. sage leaf. Note: The BP 2010 monograph is identical to the European Pharmacopoeia Medicinal use: There are not yet any (PhEur) monograph. monographs for any Salvia species ingredients in the Natural Health Products Canada Directorate (NHPD) Compendium of Monographs. However, several products containing various Salvia species Cosmetic use: Salvia species ingredients are not listed in the Health Canada 89 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, Ontario: Health Canada. September 2009. Available at: http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs- sesc/pdf/person/cosmet/info-ind-prof/_hot-list- 87 Food Standards Australia New Zealand (FSANZ). critique/hotlist-liste-eng.pdf Standard 1.4.4 Prohibited and Restricted Plants and 90 Health Canada. Substances in cosmetics and personal Fungi. In: Australia New Zealand Food Standards Code. care products regulated under the Food and Drugs Act Canberra: Commonwealth of Australia. 2010. Available (F&DA) that were in commerce between January 1, at: 2987, and September 13, 2001. Ottawa, Ontario: Health http://www.foodstandards.gov.au/_srcfiles/Standard_1_ Canada. Available at: http://www.hc-sc.gc.ca/ewh- 4_4_Prohib_plants_v113.pdf semt/contaminants/person/impact/list/person-no-cas- 88 Therapeutic Goods Administration. Substances that may eng.php be used as active ingredients in „Listed‟ medicines in 91 Canada Minister of Justice. Food and Drug Regulations. Australia. Woden (Australia): Australian Government C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. Department of Health and Ageing Therapeutic Goods Current to 24 March 2010. Available at: Administration. 12 December 2007. Available at: http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 http://www.tga.gov.au/cm/listsubs.pdf 70.pdf

40 | P a g e ingredients are found in the Licensed o Antimicrobial: Helps control Natural Health Products Database the growth of micro-organisms on the (LNHPD). Using the search field “Ingredient skin. Name” and the criteria “Salvia” there were o Astringent: Contracts the 82 results found in the LNHPD.92 If skin. sufficient evidence of safety and efficacy o Oral care: Provides cosmetic could be compiled to meet the effects to the oral cavity, e.g. cleansing, requirements, there would appear to be no deodorizing, protecting. restriction against a company submitting a product license application for the Food use: Salvia fruticosa is not listed in marketing authorization of a Natural Health the European Food Safety Authority (EFSA) Product (NHP) containing Salvia fruticosa Compendium of botanicals that have been as a medicinal ingredient, so long as the reported to contain toxic, addictive, Salvia fruticosa conformed to the quality psychotropic or other substances of standard of the European Pharmacopoeia concern.94 However other species of Salvia (PhEur). The NHPD accepts the standards are listed including entire plant of Salvia of the PhEur, as well as of the BP and USP, divinorum Epling et Jativa (due to for the test and release of medicinal psychotropic activity), herb of Salvia ingredients of NHPs in Canada. lavendulifolia Vahl (due to no history of use in the EU prior to 1997), dried herb and European Community leaves of Salvia officinalis L., and flowers and herb of Salvia sclarea L. (due to toxic Cosmetic use: Salvia triloba is listed in the activity of some components of the European Commission Cosmetic essential oil). Salvia triloba (leaf) is listed in Ingredients and Substances (CosIng) the European Herbal Infusions Association database.93 Here below is the CosIng listing (EHIA) “Inventory List of Herbals for “Salvia Triloba Leaf Extract” which list Considered as Food.”95 Presence of this the cosmetic ingredient functions of species in the EHIA list means that this antimicrobial, astringent and oral care: plant is currently employed by the herbal infusions trade in a European member state The CosIng definitions for the three listed as food plant for making tea infusions. Two functions for Salvia Triloba Leaf Extract are other species of Salvia are also listed, as follows: Salvia officinalis (leaf) and Salvia sclarea (flower and leaf).

Medicinal use: The European Medicines Agency (EMEA) currently has no plans to develop and publish a European Community Herbal (therapeutic) Monograph on Salvia fruticosa. There are EMEA monographs published for Salvia officinalis L., folium (Sage Leaf) and Salvia officinalis L., aetheroleum (Sage Oil). However there is already a European Pharmacopoeia (quality standards) Monograph for “Three- Lobed Sage Leaf” published by the European Directorate for the Quality of

94 European Food Safety Authority (EFSA). EFSA Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other 92 Health Canada Natural Health Products Directorate substances of concern. EFSA Journal 2009; 7(9):281. (NHPD). Licensed Natural Health Products Database Available at: (LNHPD). Available at: http://webprod.hc- http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng 95 European Herbal Infusions Association (EHIA). EHIA 93 European Commission. Cosmetic Ingredients and Inventory List of Herbals Considered as Food. Hamburg, Substances (CosIng) Database. Available at: Germany. January 2010. Available at: http://www.ehia- http://ec.europa.eu/enterprise/cosmetics/cosing online.org/publications.html

41 | P a g e Medicines (EDQM).96 The existence of an Ayurvedic, Siddha or Unani (ASU) herbal official quality standards monograph for use medicinal product in India. Possibly this of the dried leaf in the European species could enter Indian commerce as a Community would indicate that eventually a non-medicinal spice or seasoning corresponding therapeutic monograph component for use in food products. could become prioritized for development by the EMEA. South Africa

India Medicinal use: Salvia fruticosa is not listed in any of the Schedules on Complementary Medicinal use: Salvia fruticosa is not listed and Alternative Medicines for therapeutic in any of the pharmacopoeias of Indian use in South Africa.98 However, other Systems of Medicine (e.g. Ayurvedic species of Salvia are listed. Since the dried Pharmacopoeia of India, Siddha leaf of Salvia fruticosa has an official quality Pharmacopoeia of India and/or Unani standards monograph published in the Pharmacopoeia of India). Additionally, it is European Pharmacopoeia, it seems likely not found in the comprehensive checklist of that it should be permitted for use as a 1,289 botanicals, pertaining to 960 plant medicinal ingredient also in South Africa. taxa, that were identified in the recent “Demand and Supply of Medicinal Plants in Switzerland India 2008,”97 which was initiated by the National Medicinal Plants Board (NMPB), Cosmetic use: No information found. Ministry of Health & Family Welfare, However, since “Salvia Triloba Leaf Extract” Department of AYUSH, and was carried out is used as a cosmetic ingredient within the by Drs. D.K. Ved and G.S. Goraya, of the European Union it is conceivable that some Foundation for Revitalisation of Local cosmetic products in Switzerland might also Health Traditions (FRLHT). However, five contain this ingredient even though other species of Salvia are found in the Switzerland is not a European Union FRLHT survey, fruit of Salvia aegyptiaca L., Member State. known as “Balangoo,” which is used in the Ayurvedic and Unani systems of medicine, Dietary supplement use: Salvia triloba is fruit of Salvia haematodes L., known as included on the list of substances that may “Behman,” which is used in the Unani be used in dietary or food supplement system of medicine but also in folk products in Switzerland. However, there are medicine, fruit and leaf of Salvia content (maximum) limits for the levels of moorcroftiana Wall. ex Benth., known as estragole (I), alpha-thujone, beta-thujone, “Tuk marian” or as “Tuth,” which is used eucalyptol, camphor, and carvacrol that only in folk medicine, fruit of Salvia plebeia may occur in the dietary supplement R.Br., known as “Kachora,” which is used in product. the Ayurvedic and Siddha Systems of Medicine, and fruit of Salvia sclarea L., Food use: Salvia triloba is included on the known as “Behman safed,” used in the positive list of substances that may be used Unani System of Medicine. as flavor, spice or seasoning ingredients in food products or in non-medicinal herbal tea The absence of Salvia fruticosa in the products.99 However, there are content checklists and/or pharmacopoeias of the

Indian Systems of Medicine suggests that it 98 Medicines Control Council. Medicines and Related could be difficult to gain marketing Substances Act, 1965. Schedules on Complementary authorization for it as a component of an and Alternative Medicines made in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965); Amendment. Staatskoerant. 22 August 2008; No. 31334. Available at: 96 European Directorate for the Quality of Medicines http://www.piasa.co.za/Filestructure/Legislation/Comple (EDQM). Sage Leaf, Three-Lobed. In: European mentary%20and%20Alternative%20Medicines/GG%203 Pharmacopoeia, 6th Edition. Strasbourg, France: EDQM. 1334%20-%20Page%2031%20to%20180.pdf 2010. 99 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und 97 Ved DK, Goraya GS. Demand and Supply of Medicinal Zubereitungen als Arzneimittel oder als Lebensmittel“. Plants in India. Dehra Dun, India: Bishen Singh Bern, Switzerland: Swissmedic. 11 December 2006. Mahendra Pal Singh. 2008. Available at:

42 | P a g e (maximum) limits for the levels of estragole Food use: Greek sage (Salvia triloba) is (I), alpha-thujone, beta-thujone, eucalyptol, listed as a spice or other natural seasoning camphor, and carvacrol that may occur in and flavoring that is generally recognized as the food product. safe (GRAS) for its intended use in food products.102 Additionally, essential oils, Medicinal use: “Salviae trilobae folium” is oleoresins (solvent-free), and natural included on the “Stoffliste” (List of extractives (including distillates) of Greek Substances used in medicinal products).100 sage leaf (Salvia triloba L.) are classified as This means that marketing authorization as GRAS for their intended use as food a medicinal substance in Switzerland is ingredients.103 possible. Three-lobed sage leaf is classified as an approved active substance of Medicinal use: No ingredients made from complementary and phytomedicine any Salvia species are listed as a products (KPA) requiring pre-marketing “Generally Recognized as Safe and authorization and product licensing through Effective” (GRASE) active ingredient for use Swissmedic. Depending on the indications in over-the-counter (OTC) or prescription for use, retail distribution is limited to either drug products for human use. Its use in Category D (available in both pharmacies medicinal products would require a New and drugstores; without prescription but Drug Application (NDA) process with FDA only after consultation with pharmacy staff) approval. or Category E (available in both pharmacies and drugstores, without prescription and Information on existing quality without consultation with pharmacy staff). For test and release of active ingredients of standards, compendial licensed or registered medicines, the standards or trade pharmacopoeial standards in force for specifications of relevance to Switzerland are both the European this species in selected Pharmacopoeia (PhEur) and the Swiss Pharmacopoeia (PhHelv). destination countries

United States of America In addition to the Lebanese standards for dried sage leaf, quality standards were Cosmetic use: Salvia fruticosa is not found in the Canadian Food and Drug known to be used in cosmetic products in Regulations 2010, the British the U.S. Pharmacopoeia 2010 (BP 2010), and in the European Pharmacopoeia 6th Edition 2010 (PhEur 6.0). The BP 2010 monograph Dietary supplement use: Three-lobe sage however is identical to that of the PhEur 6.0 (Salvia fruticosa Mill.; Syn: Salvia triloba L. monograph. The table here below f.) is listed in the Herbs of Commerce, 2nd compares the Canadian, European and edition,101 which indicates that it appeared Lebanese standards that would apply to the in U.S. commerce prior to 1994 and dried leaf of Salvia fruticosa. therefore would not require pre-marketing submission of a New Dietary Ingredient (NDI) notification to the FDA. Eleven other species of Salvia are also listed in the 102 Herbs of Commerce. United States Food and Drug Administration. Spices and other natural seasonings and flavoring. In: Code of Federal Regulations, Title 21, Part 182, Section §182.10. Washington, DC: National Archives and Records Administration. 01. April 2009. Available at: http://www.swissmedic.ch/marktueberwachung/00662/in http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 dex.html?lan 82.10.pdf 100 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. 103 United States Food and Drug Administration. Essential August 2008. Available at: oils, oleoresins (solvent-free), and natural extractives http://www.swissmedic.ch/daten/00080/00256/index.htm (including distillates). In: Code of Federal Regulations, l?lang=de Title 21, Part 182, Section §182.20. Washington, DC: 101 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American National Archives and Records Administration. 01 April Herbal Products Association’s Herbs of Commerce, 2nd 2009. Available at: Edition. Silver Spring, MD: American Herbal Products http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 Association. 2000. 82.20.pdf

43 | P a g e Standard Canadian European Lebanes Australia Food and Pharmacop e Drug oeia Standard Regulatio s Medicine: Salvia fruticosa, if used as an ns active ingredient of a Listed or Registered Identificati No Macroscopic Macrosco medicinal product, must test and on tests: standard pic compliance with the quality standard of the No Microscopic Microsco British Pharmacopoeia (BP) as published in standard pic the BP 2010 monograph “Three-lobed Sage Thin-layer 104 chromatogra Leaf.” phy Character No Spicy odour Distinctiv Canada s standard when e, strong ground, and similar to aromatic Food: Salvia triloba is included within the eucalyptus smell and statutory definition of “Sage” and is oil odour therefore permitted for use as a seasoning Foreign Max 12% Max 8.0% of Max 3% or spice of food products, as per Title 7, matter stems stems of coarse excluding Max 2.0% of woody Section B.07.034. [S] of the Canadian Food 105 petioles other foreign stems; and Drug Regulations, which defines and matter Max 5% “Sage” as the whole or ground dried leaves foreign brown of the sage plant Salvia officinalis L., Salvia material leaves; of plant Max 1% triloba L. or Salvia lavandulaefolia Vahl., origin other and shall contain: foreign organic (a) not more than matter; Free of insect (i) 12 per cent stems excluding petioles parts and and foreign material of plant origin, rodent feces Water Max Max 100 Max 12% (ii) 10 per cent total ash, 10.0% ml/kg (m/m) Total ash Max Max 10.0% Max (iii) one per cent ash insoluble in 10.0% 11.0% hydrochloric acid, and Acid- Max 1.0% No standard Max 2.0% insoluble ash (iv) 10 per cent moisture; and Essential Min one Min 18 ml/kg Min 1.5% oil mL in the whole (ml/100g, (b) not less than one milliliter volatile oil per volatile oil drug dry basis) per 100 g (anhydrous 100 grams of spice. of spice drug) and min 12 ml/kg Medicine: If Salvia triloba is used as a in the cut medicinal ingredient of a license Natural drug (anhydrous Health Product (NHP) in Canada, the drug). quality of the Salvia triloba leaf must test in Heavy Not Max 1.0 ppm Not compliance with the European metals specified cadmium; specified Pharmacopoeia (quality standards) Max 5.0 ppm Monograph for “Three-Lobed Sage Leaf” lead; Max 0.1 ppm mercury Pesticide Not Meets the Not residues specified requirements specified 104 PhEur British Pharmacopoeial Committee. Three-lobed Sage General Leaf. In: British Pharmacopoeia 2010. London, UK: The Chapter Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA). 2010. 2.8.13 105 Canada Minister of Justice. Food and Drug Regulations. C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. Current to 24 March 2010. Available at: http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 70.pdf

44 | P a g e published by the European Directorate for B. Reduce to a powder (355) (2.9.12). The the Quality of Medicines (EDQM).106 powder is greyish-green and tomentose. Examine under a microscope using chloral European Community: hydrate solution R. The powder shows the following diagnostic characters: very Cosmetic, Food or Medicine: There is a numerous, whole or fragmented, covering European Pharmacopoeia (quality and glandular trichomes, scattered and standards) Monograph for “Three-Lobed attached to fragments of the epidermises; Sage Leaf” published by the European covering trichomes articulated, uniseriate, Directorate for the Quality of Medicines thick-walled and bluntly tapering, those on (EDQM).107 Here below are the quality the upper epidermis straight, those on the requirements for use in a medicinal product lower epidermis longer, tortuous and more in the European Community: densely packed; glandular trichomes, some with a unicellular or bicellular head and a DEFINITION stalk consisting of from 1-4 cells, the majority having a short, unicellular stalk and Whole or cut, dried leaves of Salvia a head composed of 8 radiating cells with a fructicosa Mill. (S. triloba L. fil). raised common cuticle; the upper epidermis with pitted and beaded cells, somewhat polygonal, with a few diacytic stomata CONTENT (2.8.3); the lower epidermis with sinuous or wavy-walled cells and numerous diacytic Minimum 18 ml/kg of essential oil in the stomata. whole drug (anhydrous drug) and minimum 12 ml/kg of essential oil in the cut drug C. Examine the chromatogram obtained in (anhydrous drug). the test for thujone. CHARACTERS Results: The chromatogram obtained with the test solution shows a blue zone due to Spicy odour when ground, similar to cineole, equal or greater in size and eucalyptus oil. intensity to the zone in the chromatogram obtained with the reference solution. IDENTIFICATION Further zones are present.

A. The lamina of the whole three-lobed TESTS sage leaf is about 8-50 mm long and about 4-20 mm wide, and oblong-ovate or Thujone. Thin-layer chromatography lanceolate. The margin is finely crenate and (2.2.27): undulate but indistinct owing to the dense hairy covering on both surfaces. The base Test solution: Shake 0.3 g of the freshly is obtuse and sometimes bears 1 or 2 more powdered drug (355) (2.9.12) with 5.0 ml of or less developed lobes. The upper surface anhydrous ethanol R for 5 min. is grey-tomentose pubescent, the lower surface is densely white-tomentose Reference solution: Dissolve 20 µl of pubescent; the venation is indistinct. The thujone R and 25 µl of cineole R in 20 ml of densely white-tomentose pubescent petiole is about 1 mm in diameter. anhydrous ethanol R. Plate: TLC silica gel plate R.

106 Mobile phase: Ethyl acetate R, toluene R European Directorate for the Quality of Medicines (EDQM). Sage Leaf, Three-Lobed. In: European (5:95 V/V). Pharmacopoeia, 6th Edition. Strasbourg, France: EDQM. 2010. 107 European Directorate for the Quality of Medicines Application: 20 µl, as bands. (EDQM). Sage Leaf, Three-Lobed. In: European Pharmacopoeia, 6th Edition. Strasbourg, France: EDQM. 2010. Development: Over a path of 15 cm.

45 | P a g e Drying: In air. Cosmetic, Food, Medicine: There are no known quality standards or trade Detection: Spray with a 200 g/l solution of specifications for Salvia fruticosa for any phosphomolybdic acid R in anhydrous use. There is no monograph in the Swiss ethanol R and heat at 100-105 °C for 10 Pharmacopoeia (PhHelv), however min. Examine in daylight. Switzerland does accept the quality standards of the European Pharmacopoeia, Results: The chromatogram obtained with for which there is a monograph for Three- the reference solution shows in the middle lobed Sage Leaf. There are no licensed or part a blue zone (cineole) and in the upper registered herbal medicinal products that part a pink-blue zone (thujone). The contain this species in Switzerland. chromatogram obtained with the test However, there are licensed products in solution shows no zone or a very faint pink- Switzerland that contain ingredients made blue zone due to thujone. from other species of Salvia.

Foreign matter (2.8.2): Maximum 8 per United States of America cent of stems and maximum 2 per cent of other foreign matter. Food: There are no standards published for Salvia fruticosa in the Code of Federal Water (2.2.13): Maximum 100 ml/kg, Regulations (CFR), the Food Chemicals determined on 20.0 g. Codex (FCC) nor in the National Formulary monographs of the United States Total ash (2.4.16): Maximum 10.0 per cent. Pharmacopeia (USP-NF). The FCC does contain monographs for three other Salvia ASSAY species ingredients:

Carry out the determination of essential oils  Clary Oil FCC: Essential oil obtained in herbal drugs (2.8.12). Use 20.0 g of drug, by steam distillation from the if necessary cut immediately before the flowering tops and leaves of the assay, a 500 ml flask, 250 ml of water R as clary sage plant, Salvia sclarea L. the distillation liquid. Add 0.50 ml of xylene  Dalmatian Type Sage Oil FCC: R in the graduated tube. Distil at a rate of 2- Essential oil obtained by steam 3 ml/min for 2 h. distillation from the partially dried leaves of the plant Salvia officinalis India L.  Spanish Type Sage Oil FCC: Essential oil obtained by distillation Food: There are no quality standards from the plants of Salvia published for Salvia fruticosa, neither in the lavandulaefolia Vahl. or Salvia Bureau of Indian Standards (BIS) quality hispanorium Lag. standards for spices, concentrates and oleoresins, in the 1995 Prevention of Food Adulteration (PRA) Act and Rules standards Dietary Supplement: There are no for spices, nor in the Agricultural Product standards published for any species of Grading and Marking (AGMARK) Salvia in the Dietary Supplements Standards. monographs of the United States Pharmacopeia (USP-DS). Medicine: There are no quality standards monographs or therapeutic compendial Medicine: There are no standards monographs published for Salvia fruticosa published for any species of Salvia in the in any of India‟s national pharmacopoeias Code of Federal Regulations (CFR) nor in covering botanical substances used in the the monographs of the United States Indian Systems of Medicine (Ayurveda, Pharmacopeia (USP). Siddha, and Unani).

Switzerland

46 | P a g e Proposed innovative value-  Essential oil for use as a component added MAP products using this of aromatherapy, bath, cosmetic or food products; ingredient  Steam distillate water;  Extract of the leaf as a component of The national consultant‟s report cosmetic products. “Monographs of the 7 targeted species” stated that there are significant exports of The current estimated annual wild collection Salvia fruticosa from Lebanon and and sales of approximately 1000 tons is suggested a number of ideas for value- significant. If the expert resource adding potential. Proposed innovative assessment should determine that value-added products for the Salvia significantly higher amounts of this species fruticosa could include: could be harvested annually under a controlled sustainable resource  Cut dried leaf as a component of management plan, then it could make tisanes or herbal tea products; sense to consider the development of  Cut or whole dried leaf as a innovative value-added products for component of Lebanese seasonings international export promotion with a or spice mixes; Lebanese quality and country of origin designation.

47 | P a g e Satureia sps including (Satureia find interested buyers and to develop new thymbra L. & Satureia cuneifolia markets. Ten.) Regulatory framework, market Definitions access requirements and requirements for use in Satureia cuneifolia Ten. (syn. Satureja selected destination countries cuneifolia Ten.) Australia  Turkish vernacular names: Dağ kekiği, kekik, sivri kekik, klc kekik, Cosmetic use: No information found. yayla kekigi, ar kekigi, seytan kekik Food use: Neither Satureia cuneifolia Satureia thymbra L. (syn. Satureja thymbra (Satureja cuneifolia) nor Satureia thymbra L.) (Satureja thymbra) are listed in Standard 1.4.4 “Prohibited and Restricted Plants and  Turkish vernacular names: Fungi” of the Australia New Zealand Food 108 Girit sateri, sahil sivrisi, kara kekik Standards Code.

Assessment of current Medicinal use: Neither Satureia cuneifolia (Satureja cuneifolia) nor Satureia thymbra Lebanese export trade data (Satureja thymbra) are listed as substances current main importers that may be used as an active or excipient ingredient in „Listed‟ medicines for supply in 109 Satureja spp. was not included national Australia. This suggests that it could consultant‟s report “Monographs of the 7 require a petition to amend and expand the targeted species.” It would be difficult to list of substances used in listed medicines make any determination concerning who in order to achieve marketing authorization the main importers of this species might be, for this species in medicinal products. Two if any. Some assumptions can be made other species of Satureia are listed for use based on the regulatory status of Satureja in therapeutic products in Australia. They cuneifolia and/or Satureja thymbra in other are summer savory (Satureia hortensis) and countries. If a regulatory framework were to winter savory (Satureia montana). exist in any countries for the import and use of either species, the possibility could then Canada exist for Lebanese exports to the identified countries. Cosmetic use: Neither Satureia cuneifolia (Satureja cuneifolia) nor Satureia thymbra This review found that neither species (Satureja thymbra) are listed in the Health appears on any national positive lists of any Canada “Cosmetic Ingredient Hotlist” 110 of the selected counties. Almost no evidence was found to demonstrate that 108 Food Standards Australia New Zealand (FSANZ). either of these species are commercially Standard 1.4.4 Prohibited and Restricted Plants and Fungi. In: Australia New Zealand Food Standards Code. traded or actively used outside of Lebanon. Canberra: Commonwealth of Australia. 2010. Available Thus, before export promotion can be at: recommended, it would be wise to consider http://www.foodstandards.gov.au/_srcfiles/Standard_1_ 4_4_Prohib_plants_v113.pdf the submission of human safety and quality 109 Therapeutic Goods Administration. Substances that may data to selected national regulatory be used as active ingredients in „Listed‟ medicines in agencies in an effort to get these species Australia. Woden (Australia): Australian Government Department of Health and Ageing Therapeutic Goods officially listed and recognized as safe for Administration. 12 December 2007. Available at: use in cosmetic, dietary supplement or food http://www.tga.gov.au/cm/listsubs.pdf 110 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, products. Without their appearance on Ontario: Health Canada. September 2009. Available at: national positive lists, it will be difficult to 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

48 | P a g e which is a list of substances that are meet the requirements, there would appear restricted and prohibited for use in cosmetic to be no restriction against a company products in Canada. Nor do these species submitting a product license application for appear on the list of “Substances in the marketing authorization of a Natural Cosmetics and Personal Care Products Health Product (NHP) containing Satureja Regulated under the Food and Drugs Act cuneifolia and/or Satureja thymbra as a (F&DA) that were in commerce between medicinal ingredient. January 1, 1987, and September 13, 2001.” 111 This suggests that while there is no European Community express prohibition against use in cosmetic products, it is possible that these species Cosmetic use: Neither Satureia cuneifolia could be classified as new or novel. (Satureja cuneifolia) nor Satureia thymbra (Satureja thymbra) are listed in the Food use: Neither Satureia cuneifolia European Commission Cosmetic (Satureja cuneifolia) nor Satureia thymbra Ingredients and Substances (CosIng) (Satureja thymbra) are specifically listed in database.114 However, cosmetic ingredients the Canada Food and Drugs Regulations made from other species of Satureia / (2010), 112 suggesting that there is no Satureja are listed in CosIng including: current use in Canada for purposes of adding aromas, colors, flavors, seasonings  extract of the Savory, Satureja or spices to food products. Two other hortensis L.; species of Satureja, however, are listed in  extract of the leaves of the Division 7, Section B.07.035 [S] of the Savory, Satureja hortensis L.; regulations for Spices, Dressings and  essential oil obtained from the Seasonings. The Canadian regulation whole plant of the Savory, defines “savory” as the whole or ground Satureja hortensis L; dried leaves of Satureja hortensis L. or  volatile oil obtained from the herb Satureja montana L. of the Summer Savory, Satureia montana L., Medicinal use: There are no monographs for either Satureia cuneifolia (Satureja The CosIng listings of cosmetic ingredients cuneifolia) or Satureia thymbra (Satureja made from four other species of Satureia / thymbra) in the Natural Health Products Satureja suggests that, in principle, with Directorate (NHPD) Compendium of sufficient evidence of safety, the additional Monographs. No products containing either listing of ingredients made from either of these species are found in the Licensed Satureia cuneifolia (Satureja cuneifolia) or Natural Health Products Database Satureia thymbra (Satureja thymbra) should (LNHPD). Using the search field “Ingredient be possible. Name” and the criteria “Satureja” there was 1 result found in the LNHPD, but this was Food use: Neither Satureia cuneifolia for an herbal tea product that contains 113 (Satureja cuneifolia) nor Satureia thymbra Satureja montana. If sufficient evidence (Satureja thymbra) are listed in the of safety and efficacy could be compiled to European Food Safety Authority (EFSA) Compendium of botanicals that have been 111 Health Canada. Substances in cosmetics and personal reported to contain toxic, addictive, care products regulated under the Food and Drugs Act (F&DA) that were in commerce between January 1, psychotropic or other substances of 2987, and September 13, 2001. Ottawa, Ontario: Health concern.115 However, one other species of Canada. Available at: http://www.hc-sc.gc.ca/ewh- semt/contaminants/person/impact/list/person-no-cas- eng.php 112 Canada Minister of Justice. Food and Drug Regulations. 114 European Commission. Cosmetic Ingredients and C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. Substances (CosIng) Database. Available at: Current to 24 March 2010. Available at: http://ec.europa.eu/enterprise/cosmetics/cosing http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 115 European Food Safety Authority (EFSA). EFSA 70.pdf Compendium of botanicals that have been reported to 113 Health Canada Natural Health Products Directorate contain toxic, addictive, psychotropic or other (NHPD). Licensed Natural Health Products Database substances of concern. EFSA Journal 2009; 7(9):281. (LNHPD). Available at: http://webprod.hc- Available at: sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf

49 | P a g e Satureja is listed as follows (see next page Medicinal use: The European Medicines for definition of codes): Agency (EMEA) has no plans to publish a European Community Herbal (therapeutic) Monograph for either Satureia cuneifolia

(Satureja cuneifolia) or Satureia thymbra

(Satureja thymbra) nor is there a European xic

Pharmacopoeia (quality) Monograph

name Parts of plants of possible concern Chemical of concern / to effect Specific Reference s Botanical published by the European Directorate for Saturej 1T: 1T: Natural a plant methyleuge sources the Quality of Medicines (EDQM). Such monta nol content: of monographs would only be prioritized for na L. 25-415 ppm flavourin 1H: development in the event that marketing Herb, gs (Rep authorization was granted by one or more leave 1H: Herb No 3), of the EC Member States. s. and leaves Council

essential of oil: Europe, India (2008) carvacrol 30-40%, Medicinal use: Neither Satureia cuneifolia eucalyptol (Satureja cuneifolia) nor Satureia thymbra 0.59%, camphor (Satureja thymbra) are listed in any of the 0.21%, pharmacopoeias of Indian Systems of thujones. Medicine (e.g. Ayurvedic Pharmacopoeia of (CoE, India, Siddha Pharmacopoeia of India 2008) and/or Unani Pharmacopoeia of India). Additionally, neither species are found in SOURCES OF INFORMATION FOR the comprehensive checklist of 1,289 SATUREJA MONTANA IN THE TABLE botanicals, pertaining to 960 plant taxa, that were identified in the recent “Demand and Code Reference Supply of Medicinal Plants in India 2008,”117 1H Plants assessed as flavourings by the Council of Europe in 2000 and 2004 which was initiated by the National belonging to Category 3 or 4 (restrictions Medicinal Plants Board (NMPB), Ministry of recommended for use) (H1 and H2 Health & Family Welfare, Department of respectively) or as Category 5 (restrictions AYUSH, and was carried out by Drs. D.K. recommended and further data required) (H3) or Category 6 (considered not Ved and G.S. Goraya, of the Foundation for appropriate for human consumption) (H4) Revitalisation of Local Health Traditions

1T Final Public Statement on the use of (FRLHT). herbal medicinal products containing methyleugenol, Committee on Herbal The absence of these species in the Medicinal Products (HMPC), London 23 November 2005 checklists and/or pharmacopoeias of the Indian Systems of Medicine suggests that it Neither Satureia cuneifolia (Satureja could be difficult to gain marketing cuneifolia) nor Satureia thymbra (Satureja authorization for it as a component of an thymbra) are listed in the European Herbal Ayurvedic, Siddha or Unani (ASU) herbal Infusions Association (EHIA) “Inventory List medicinal product in India. of Herbals Considered as Food.”116 Absence of this species in the EHIA list South Africa means that this plant is not currently employed by the herbal infusions trade in a Medicinal use: Neither Satureia cuneifolia European member state as food plant for (Satureja cuneifolia) nor Satureia thymbra making tea infusions. Two other species of (Satureja thymbra) are listed in any of the Satureja are listed, Satureja biflora (herb) Schedules on Complementary and and Satureja hortensis (herb).

116 European Herbal Infusions Association (EHIA). EHIA Inventory List of Herbals Considered as Food. Hamburg, 117 Ved DK, Goraya GS. Demand and Supply of Medicinal Germany. January 2010. Available at: http://www.ehia- Plants in India. Dehra Dun, India: Bishen Singh online.org/publications.html Mahendra Pal Singh. 2008.

50 | P a g e Alternative Medicines for therapeutic use in products (KPA) requiring pre-marketing South Africa.118 authorization and product licensing through Swissmedic. Retail distribution is limited to Switzerland Category D (available in both pharmacies and drugstores; without prescription but Cosmetic use: No information found. only after consultation with pharmacy staff). For test and release of active ingredients of Dietary supplement use: Neither Satureia licensed medicines, the pharmacopoeial cuneifolia (Satureja cuneifolia) nor Satureia standards in force for Switzerland are both thymbra (Satureja thymbra) are included on the European Pharmacopoeia (PhEur) and the list of substances that may be used in the Swiss Pharmacopoeia (PhHelv). dietary or food supplement products in Additionally, Satureja hortensis included in Switzerland.‟ the Swissmedic “Liste HAS” (List of Homoeopathic and Anthroposophic Substances) for oral use at various Food use: Neither Satureia cuneifolia 121 (Satureja cuneifolia) nor Satureia thymbra specified homoeopathic dilutions. (Satureja thymbra) are included on the positive list of substances that may be used United States of America as flavor, spice or seasoning ingredients in food products or in non-medicinal herbal tea Cosmetic use: Neither Satureia cuneifolia products.119 However, two other species of (Satureja cuneifolia) nor Satureia thymbra Satureja are listed. Satureja hortensis and (Satureja thymbra) are known to be used in Satureja montana are permitted for food cosmetic products in the U.S. use but with upper maximum limits for some of their constituents including estragole, Dietary supplement use: Neither Satureia eucalyptol, and thujone. cuneifolia (Satureja cuneifolia) nor Satureia thymbra (Satureja thymbra) are listed in the nd 122 Medicinal use: Neither Satureia cuneifolia Herbs of Commerce, 2 edition, which (Satureja cuneifolia) nor Satureia thymbra indicates that it did not appear in U.S. (Satureja thymbra) are included on the commerce prior to 1994 and therefore “Stoffliste” (List of Substances used in would likely require the pre-marketing medicinal products).120 This would suggest submission of a New Dietary Ingredient that marketing authorization as a medicinal (NDI) notification to the FDA. Three other substance in Switzerland would not be species of Satureja are listed in the Herbs possible unless the List of Substances were of Commerce. They are yerba buena amended to include this species. However, (Satureja douglasii), summer savory “Saturejae montanae aetheroleum” (Satureja hortensis) and winter savory (essential oil of winter savory) is classified (Satureja montana). as an approved active substance of complementary and phytomedicine Food use: Neither Satureia cuneifolia (Satureja cuneifolia) nor Satureia thymbra (Satureja thymbra) are specifically listed as 118 Medicines Control Council. Medicines and Related “Generally Recognized as Safe” (GRAS) for Substances Act, 1965. Schedules on Complementary and Alternative Medicines made in terms of the use in food products. However, both Medicines and Related Substances Act, 1965 (Act No. Satureja hortensis and Satureja montana as 101 of 1965); Amendment. Staatskoerant. 22 August classified as spices and other natural 2008; No. 31334. Available at: http://www.piasa.co.za/Filestructure/Legislation/Comple mentary%20and%20Alternative%20Medicines/GG%203 1334%20-%20Page%2031%20to%20180.pdf 119 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und Zubereitungen als Arzneimittel oder als Lebensmittel“. 121 Swissmedic. Liste homöopathischer und Bern, Switzerland: Swissmedic. 11 December 2006. anthroposophischer Stoffe (Liste HAS). Bern, Available at: Switzerland: Swissmedic. August 2008. Available at: http://www.swissmedic.ch/marktueberwachung/00662/in http://www.swissmedic.ch/rechtstexte/00201/00203/inde dex.html?lan x.html?lan 120 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. 122 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American August 2008. Available at: Herbal Products Association’s Herbs of Commerce, 2nd http://www.swissmedic.ch/daten/00080/00256/index.htm Edition. Silver Spring, MD: American Herbal Products l?lang=de Association. 2000.

51 | P a g e seasonings and flavorings that GRAS for (Satureja thymbra), neither in the Bureau of their intended use in food products. 123 Indian Standards (BIS) quality standards for spices, concentrates and oleoresins, in the Medicinal use: Neither Satureia cuneifolia 1995 Prevention of Food Adulteration (Satureja cuneifolia) nor Satureia thymbra (PRA) Act and Rules standards for spices, (Satureja thymbra) are listed as a nor in the Agricultural Product Grading and “Generally Recognized as Safe and Marking (AGMARK) Standards. Effective” (GRASE) active ingredient for use in over-the-counter (OTC) or prescription Medicine: There are no quality standards drug products for human use. Its use in monographs or therapeutic compendial medicinal products would require a New monographs published for either Satureia Drug Application (NDA) process with FDA cuneifolia (Satureja cuneifolia) or Satureia approval. thymbra (Satureja thymbra) in any of India‟s national pharmacopoeias covering botanical Information on existing quality substances used in the Indian Systems of standards, compendial Medicine (Ayurveda, Siddha, and Unani). standards or trade Switzerland specifications of relevance to this species in selected Cosmetic, Food, Medicine: There are no destination countries known quality standards or trade specifications for either Satureia cuneifolia (Satureja cuneifolia) or Satureia thymbra Australia (Satureja thymbra) for any use. There is no monograph in the Swiss Pharmacopoeia Cosmetic, Food or Medicine: There are (PhHelv). There are no licensed or no known quality standards or trade registered herbal medicinal products that specifications for either Satureia cuneifolia contain this species. (Satureja cuneifolia) or Satureia thymbra (Satureja thymbra) for any use. There are United States of America no listed herbal medicinal products that contain this plant for sale in Australia. Food: There are no standards published specifically for either Satureia cuneifolia European Community (Satureja cuneifolia) or Satureia thymbra (Satureja thymbra) in the Code of Federal Cosmetic, Food or Medicine: There are Regulations (CFR), the Food Chemicals no known quality standards or trade Codex (FCC) nor in the National Formulary specifications for either Satureia cuneifolia monographs of the United States (Satureja cuneifolia) or Satureia thymbra Pharmacopeia (USP-NF). However, there is (Satureja thymbra) for any use. There is no an FCC monograph for “Savory Oil monograph in the European (Summer Variety),” for use as a flavoring Pharmacopoeia. There are no known agent. Summer Variety Savory Oil FCC is s licensed or registered herbal medicinal the volatile oil obtained by steam distillation products in the European Community that from the whole dried plant Satureia contain this species. hortensis L.124

India Dietary Supplement: There are no standards published for either Satureia Food: There are no quality standards cuneifolia (Satureja cuneifolia) or Satureia published for either Satureia cuneifolia thymbra (Satureja thymbra) in the Dietary (Satureja cuneifolia) or Satureia thymbra

123 United States Food and Drug Administration. Spices and other natural seasonings and flavorings. In: Code of 124 Food Ingredients Expert Committee. Savory Oil (Summer Federal Regulations, Title 21, Part 182, Section Variety). In: Food Chemicals Codex, Seventh Edition §182.10. Washington DC: National Archives and (FCC 7). Rockville, MD: United States Pharmacopeial Records Administration. 01 April 2009. Convention. 2010;911.

52 | P a g e Supplements monographs of the United the types of food ingredients typical for States Pharmacopeia (USP-DS). summer and winter savory, albeit with a special Lebanese geo-authentic branding. If Medicine: There are no standards these species are presently being exported published for either Satureia cuneifolia under a general common name of savory, (Satureja cuneifolia) or Satureia thymbra without species differentiation, this would (Satureja thymbra) in the Code of Federal need to be clarified in order to promote a Regulations (CFR) nor in the monographs distinct point of differentiation from other of the United States Pharmacopeia (USP). savory seasoning mixes or products. But it is not known whether a quantity high Proposed innovative value- enough to justify new product development and export promotion is available through added MAP products using this sustainable harvesting practices. ingredient Concerning domestic consumption, it is Neither Satureia cuneifolia (Satureja known that these species are sometimes cuneifolia) nor Satureia thymbra (Satureja used as components of “Za‟atar” mix, either thymbra) are included in national in combination with or in place of Origanum consultant‟s report “Monographs of the 7 syriacum. Thus, an interesting product targeted species.” Without access to concept could be a Lebanese brand of the average annual harvest, production, Za'atar mix using Satureja thymbra with domestic consumption and export trade Origanum syriacum, possibly among other data, it is difficult to make any suggestions local herbs special to Lebanon (e.g. for new products for these species. Thymbra spicata), with sesame seeds and Mediterranean sea salt. If the condiment If their intended use is closely comparable mix carried Organic Wild and FairTrade or or near identical to that of other species of FairWild logo designations along with a Satureja, for example as flavor and Lebanese geo-authentic branding, this seasoning condiments like summer savory could be very interesting for the natural, and winter savory, then the organic and ethical trade markets of Europe recommendations would likely lean towards and North America.

53 | P a g e Thymbra spicata L. Food use: Thymbra spicata is not listed in Standard 1.4.4 “Prohibited and Restricted Plants and Fungi” of the Australia New Definitions Zealand Food Standards Code.125

Thymbra spicata L. (Fam. Lamiaceae) Medicinal use: Thymbra spicata is not listed as a substance that may be used as Common names: an active or excipient ingredient in „Listed‟ medicines for supply in Australia.126 This  Lebanese vernacular name: suggests that it could require a petition to amend and expand the list of substances Assessment of current Lebanese export used in listed medicines in order to achieve trade data current main importers marketing authorization for this species in medicinal products. Thymbra spicata was not included national consultant‟s report “Monographs of the 7 Canada targeted species.” It would be difficult to make any determination concerning who Cosmetic use: Thymbra spicata is not the main importers of this species might be, listed in the Health Canada “Cosmetic if any. Some assumptions can be made Ingredient Hotlist,” 127 which is a list of based on the regulatory status of Thymbra substances that are restricted and spicata in other countries. If a regulatory prohibited for use in cosmetic products in framework were to exist in any countries for Canada. Nor does Thymbra spicata appear the import and use of either species, the on the list of “Substances in Cosmetics and possibility could then exist for Lebanese Personal Care Products Regulated under exports to the identified countries. the Food and Drugs Act (F&DA) that were in commerce between January 1, 1987, and This review found that this species does not September 13, 2001.” 128 This suggests that appear on any national positive lists of any while there is no express prohibition against of the selected counties. Almost no use in cosmetic products, it is possible that evidence was found to demonstrate that Thymbra spicata could be classified as new Thymbra spicata is commercially traded or or novel. actively used outside of Lebanon. Thus, before export promotion can be Food use: Thymbra spicata is not listed in recommended, it would be wise to consider the Canada Food and Drugs Regulations the submission of human safety and quality data to selected national regulatory agencies in an effort to get this species 125 Food Standards Australia New Zealand (FSANZ). officially listed and recognized as safe for Standard 1.4.4 Prohibited and Restricted Plants and use in cosmetic, dietary supplement or food Fungi. In: Australia New Zealand Food Standards Code. products. Without its appearance on Canberra: Commonwealth of Australia. 2010. Available at: national positive lists, it will be difficult to http://www.foodstandards.gov.au/_srcfiles/Standard_1_ find interested buyers and to develop new 4_4_Prohib_plants_v113.pdf 126 Therapeutic Goods Administration. Substances that may markets. 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: http://www.tga.gov.au/cm/listsubs.pdf access requirements and 127 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, requirements for use in Ontario: Health Canada. September 2009. Available at: http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs- selected destination countries sesc/pdf/person/cosmet/info-ind-prof/_hot-list- critique/hotlist-liste-eng.pdf 128 Health Canada. Substances in cosmetics and personal Australia care products regulated under the Food and Drugs Act (F&DA) that were in commerce between January 1, 2987, and September 13, 2001. Ottawa, Ontario: Health Cosmetic use: No information found. Canada. Available at: http://www.hc-sc.gc.ca/ewh- semt/contaminants/person/impact/list/person-no-cas- eng.php

54 | P a g e (2010), 129 suggesting that there is no Monograph for Thymbra spicata nor is there current use in Canada for purposes of a European Pharmacopoeia (quality) adding aromas, colors, flavors, seasonings Monograph published by the European or spices to food products. Directorate for the Quality of Medicines (EDQM). Such monographs would only be Medicinal use: There are no monographs prioritized for development in the event that for Thymbra spicata in the Natural Health marketing authorization was granted by one Products Directorate (NHPD) Compendium or more of the EC Member States. of Monographs. Furthermore, no Thymbra spicata products are found in the Licensed India Natural Health Products Database (LNHPD).130 Medicinal use: Thymbra spicata is not listed in any of the pharmacopoeias of European Community Indian Systems of Medicine (e.g. Ayurvedic Pharmacopoeia of India, Siddha Cosmetic use: Thymbra spicata is not Pharmacopoeia of India and/or Unani listed in the European Commission Pharmacopoeia of India). Additionally, it is Cosmetic Ingredients and Substances not found in the comprehensive checklist of (CosIng) database.131 1,289 botanicals, pertaining to 960 plant taxa, that were identified in the recent Food use: Thymbra spicata is not listed in “Demand and Supply of Medicinal Plants in 134 the European Food Safety Authority (EFSA) India 2008,” which was initiated by the Compendium of botanicals that have been National Medicinal Plants Board (NMPB), reported to contain toxic, addictive, Ministry of Health & Family Welfare, psychotropic or other substances of Department of AYUSH, and was carried out concern.132 Thymbra spicata is not listed in by Drs. D.K. Ved and G.S. Goraya, of the the European Herbal Infusions Association Foundation for Revitalisation of Local (EHIA) “Inventory List of Herbals Health Traditions (FRLHT). Considered as Food.”133 Absence of this species in the EHIA list means that this The absence of Thymbra spicata in the plant is not currently employed by the checklists and/or pharmacopoeias of the herbal infusions trade in a European Indian Systems of Medicine suggests that it member state as food plant for making tea could be difficult to gain marketing infusions. authorization for it as a component of an Ayurvedic, Siddha or Unani (ASU) herbal Medicinal use: The European Medicines medicinal product in India. Agency (EMEA) has no plans to publish a European Community Herbal (therapeutic) South Africa

Medicinal use: Thymbra spicata is not 129 Canada Minister of Justice. Food and Drug Regulations. C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. listed in any of the Schedules on Current to 24 March 2010. Available at: Complementary and Alternative Medicines http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 for therapeutic use in South Africa.135 70.pdf 130 Health Canada Natural Health Products Directorate (NHPD). Licensed Natural Health Products Database Switzerland (LNHPD). Available at: http://webprod.hc- sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng 131 European Commission. Cosmetic Ingredients and Substances (CosIng) Database. Available at: 134 Ved DK, Goraya GS. Demand and Supply of Medicinal http://ec.europa.eu/enterprise/cosmetics/cosing Plants in India. Dehra Dun, India: Bishen Singh 132 European Food Safety Authority (EFSA). EFSA Mahendra Pal Singh. 2008. Compendium of botanicals that have been reported to 135 Medicines Control Council. Medicines and Related contain toxic, addictive, psychotropic or other Substances Act, 1965. Schedules on Complementary substances of concern. EFSA Journal 2009; 7(9):281. and Alternative Medicines made in terms of the Available at: Medicines and Related Substances Act, 1965 (Act No. http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf 101 of 1965); Amendment. Staatskoerant. 22 August 133 European Herbal Infusions Association (EHIA). EHIA 2008; No. 31334. Available at: Inventory List of Herbals Considered as Food. Hamburg, http://www.piasa.co.za/Filestructure/Legislation/Comple Germany. January 2010. Available at: http://www.ehia- mentary%20and%20Alternative%20Medicines/GG%203 online.org/publications.html 1334%20-%20Page%2031%20to%20180.pdf

55 | P a g e Cosmetic use: No information found. prescription drug products for human use. Its use in medicinal products would require Dietary supplement use: Thymbra spicata a New Drug Application (NDA) process with is not included on the list of substances that FDA approval. may be used in dietary or food supplement products in Switzerland. Information on existing quality standards, compendial Food use: Thymbra spicata is not included on the positive list of substances that may standards or trade be used as flavor, spice or seasoning specifications of relevance to ingredients in food products or in non- this species in selected 136 medicinal herbal tea products. destination countries Medicinal use: Thymbra spicata is not Australia included on the “Stoffliste” (List of Substances used in medicinal products).137 This would suggest that marketing Cosmetic, Food or Medicine: There are authorization as a medicinal substance in no known quality standards or trade Switzerland would not be possible unless specifications for Thymbra spicata for any the List of Substances were amended to use. There are no listed herbal medicinal include this species. products that contain this plant for sale in Australia. United States of America European Community Cosmetic use: Thymbra spicata is not known to be used in cosmetic products in Cosmetic, Food or Medicine: There are the U.S. no known quality standards or trade specifications for Thymbra spicata for any use. There is no monograph in the Dietary supplement use: Thymbra spicata nd European Pharmacopoeia. There are no is not listed in the Herbs of Commerce, 2 known licensed or registered herbal edition,138 which indicates that it did not medicinal products in the European appear in U.S. commerce prior to 1994 and Community that contain this species. therefore would likely require the pre- marketing submission of a New Dietary Ingredient (NDI) notification to the FDA. India

Food use: Thymbra spicata is not listed as Food: There are no quality standards “Generally Recognized as Safe” (GRAS) for published for Thymbra spicata, neither in use in food products. the Bureau of Indian Standards (BIS) quality standards for spices, concentrates and oleoresins, in the 1995 Prevention of Medicinal use: Thymbra spicata is not Food Adulteration (PRA) Act and Rules listed as a “Generally Recognized as Safe standards for spices, nor in the Agricultural and Effective” (GRASE) active ingredient Product Grading and Marking (AGMARK) for use in over-the-counter (OTC) or Standards.

136 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und Zubereitungen als Arzneimittel oder als Lebensmittel“. Medicine: There are no quality standards Bern, Switzerland: Swissmedic. 11 December 2006. monographs or therapeutic compendial Available at: http://www.swissmedic.ch/marktueberwachung/00662/in monographs published for Thymbra spicata dex.html?lan in any of India‟s national pharmacopoeias 137 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. covering botanical substances used in the August 2008. Available at: http://www.swissmedic.ch/daten/00080/00256/index.htm Indian Systems of Medicine (Ayurveda, l?lang=de Siddha, and Unani). 138 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American Herbal Products Association’s Herbs of Commerce, 2nd Edition. Silver Spring, MD: American Herbal Products Switzerland Association. 2000.

56 | P a g e Cosmetic, Food, Medicine: There are no the 7 targeted species.” Without access to known quality standards or trade average annual harvest, production, specifications for Thymbra spicata for any domestic consumption and export trade use. There is no monograph in the Swiss data, it is difficult to make any suggestions Pharmacopoeia (PhHelv). There are no for new products for this species. licensed or registered herbal medicinal products that contain this species. If their intended use is closely comparable or near identical to that of other “za‟atar” United States of America type seasoning components, then the recommendations would likely lean towards Food: There are no standards published similar types of food ingredients typical, specifically for the species Thymbra spicata albeit with a special Lebanese geo- in the Code of Federal Regulations (CFR), authentic branding. But it is not known the Food Chemicals Codex (FCC) nor in the whether a quantity high enough to justify National Formulary monographs of the new product development and export United States Pharmacopeia (USP-NF). promotion is available through sustainable harvesting practices. Dietary Supplement: There are no standards published for Thymbra spicata in Concerning domestic consumption, it is the Dietary Supplements monographs of known that this species is sometimes used the United States Pharmacopeia (USP-DS). as component of “Za‟atar” mix, either in combination with or in place of Origanum Medicine: There are no standards syriacum. Thus, an interesting product published for Thymbra spicata in the Code concept could be a Lebanese brand of the of Federal Regulations (CFR) nor in the Za'atar mix using Thymbra spicata with monographs of the United States Origanum syriacum, possibly among other Pharmacopeia (USP). local herbs special to Lebanon (e.g. Satureja thymbra), with sesame seeds and Mediterranean sea salt. If the condiment Proposed innovative value- mix carried Organic Wild and FairTrade or added MAP products using this FairWild logo designations along with a ingredient Lebanese geo-authentic branding, this could be very interesting for the natural, Thymbra spicata was not included in organic and ethical trade markets of Europe national consultant‟s report “Monographs of and North America.

57 | P a g e Thymus sps including (Thymus Table 1: Lebanese Exports of Thyme & Bay hirsutus Bieb. & Thymus 2002-2006 (COMTRADE) syriacus Boiss.) Perio Trad Commodi Trade Net Unit d e ty Value Weight Definitions Flow (USD) (kg) 2002 Expo Thyme; $126,43 155,71 Weight Botanical name: Thymus hirsutus rt bay 7 7 in leaves kilogram Bieb. (Lamiaceae) [HS as s reported  English name: Thyme code 091040]  Botanical name: Thymus syriacus Boiss. 2003 Expo Thyme; $59,354 42,788 Weight rt bay in (Lamiaceae) leaves kilogram [HS as s Assessment of current reported code Lebanese export trade data 091040] current main importers 2004 Expo Thyme; $54,000 49,765 Weight rt bay in leaves kilogram No species of the genus Thymus were [HS as s included in the national consultant‟s report reported “Monographs of the 7 targeted species.” code Based on the Export trade data that was 091040] provided for this report from Lebanese 2005 Expo Thyme; $86,000 69,278 Weight Customs, Lebanon applies the 8-digit rt bay in Harmonized System Tariff Code (HS Code) leaves kilogram [HS as s 09109910 for tracking its exports of thyme reported herb. However, it is not clear which species code of Thymus are exported by Lebanon under 091040] this HS Code. In 2009, Lebanon exported 2006 Expo Thyme; $71,927 37,297 Weight 37,525 kg of thyme. The main importers rt bay in were United Arab Emirates (20 tons), leaves kilogram Paraguay (4 tons), Qatar (3 tons), and [HS as s reported France (2 tons). It should be noted however code that the United Nations Commodity Trade 091040]

Statistics Database (COMTRADE) utilizes a SOURCE: UN Comtrade Database 6-digit HS Code 091040 for tracking of thyme herb exports, but COMTRADE lumps thyme together with bay leaf under the same code. The most recent COMTRADE data is listed for 2006. The COMTRADE 2006 total for Lebanese exports of thyme (and bay) under HS 091040 is 37,297 kg whilst the 2006 total from Lebanese Customs under HS 09109910 is 45,161 kg. The main destinations according to COMTRADE, in 2006, were UAE, USA, Canada and Bahrain. Table 1 shows COMTRADE data for Lebanese exports of Thyme & Bay 2002 through 2006. Table 2 shows Lebanese Customs export trade data for Thyme 2007 through 2009.

58 | P a g e Table 2: Lebanese Exports of Thyme 2007- them in the market place from ordinary 2009 (Lebanese Customs) grades of thyme. Since these species of Thymus do not appear on any known Net positive lists, there may be some market Trad Trade Perio Commodit Weig access barriers until safety and quality data e Value Unit d y ht Flow (USD) are submitted for these specific species to (kg) the various national authorities. In the Thyme: event, that certain countries have already [HS as Weight been importing these species (must Expo reported $126,55 45,11 in 2007 rt code 7 6 kilogram unidentified or mislabeled as other Thymus 09109910 s species), then it might be possible to ] request an amendment to the national Thyme: positive lists to expand the list of [HS as Weight permissible species associated with the Expo reported $114,20 49,24 in 2008 common name “Thyme.” rt code 0 6 kilogram 09109910 s ] Regulatory framework, market Thyme: access requirements and [HS as Weight Expo reported $101,49 37,48 in requirements for use in 2009 rt code 4 8 kilogram selected destination countries 09109910 s ] Australia SOURCE: Lebanese Customs Cosmetic use: No information found. Concerning other potential export markets, beyond Lebanon‟s current main trade partners, some assumptions can be made Food use: Thymus spp. are not listed in based on the regulatory status of Thymus Standard 1.4.4 “Prohibited and Restricted Plants and Fungi” of the Australia New hirsutus and/or Thymus syriacus in other 139 countries. If a regulatory framework were to Zealand Food Standards Code. exist in any countries for the import and use of these other Thymus species the Medicinal use: Neither Thymus hirsutus possibility could then exist for additional nor Thymus syriacus are listed as Lebanese exports to the identified substances that may be used as an active countries. This review found that neither or excipient ingredient in „Listed‟ medicines 140 Thymus hirsutus nor Thymus syriacus for supply in Australia. This suggests that appear on any national positive lists of the it could require a petition to amend and selected counties. Although it is possible expand the list of substances used in listed that these species are being imported under medicines in order to achieve marketing a general non-specific listing of “Thyme authorization for these species in medicinal (Thymus species). products. However, several other species of Thymus are listed with certain restrictions, The current average annual exports of which is informative. Table 3 shows the thyme by Lebanon are relatively low, thyme ingredients that are presently ranging between 37 to 69 tons in total. permitted for use as either active Thyme herb is a widely traded commodity 139 Food Standards Australia New Zealand (FSANZ). globally and there are many competitors Standard 1.4.4 Prohibited and Restricted Plants and from Mediterranean countries of Africa, Fungi. In: Australia New Zealand Food Standards Code. Europe and western Asia. Thus if a Canberra: Commonwealth of Australia. 2010. Available at: sustainable scale-up were possible for http://www.foodstandards.gov.au/_srcfiles/Standard_1_ Lebanon to pursue a larger market share 4_4_Prohib_plants_v113.pdf 140 beyond the current main customers, it Therapeutic Goods Administration. Substances that may be used as active ingredients in „Listed‟ medicines in would be advisable to associate a specific Australia. Woden (Australia): Australian Government geographical brand and quality to the Department of Health and Ageing Therapeutic Goods Administration. 12 December 2007. Available at: Lebanese species in order to differentiate http://www.tga.gov.au/cm/listsubs.pdf

59 | P a g e substances (A) at therapeutic dosage levels Regulated under the Food and Drugs Act or as excipients (E) at sub-therapeutic (F&DA) that were in commerce between dosage levels as components of Listed January 1, 1987, and September 13, 2001,” Medicines in Australia. other Thyme ingredients are listed which could conceivably include this species.142 Table 3: Thyme ingredients allowed for use Several other “Thyme” or “T” ingredients in Listed Medicines in Australia are found on the list which suggests that a correlation could be made to this species. INGREDIENT USE RESTRICTIONS For example, the list includes Red Thyme Oil, Polyquaternary Thyme Extract, Thymus Thyme herb A, E Serpyllum Oil, Wild Thyme Oil, Thymian Oil, dry and Thyme Leaves Extract. Thyme oil A, E Permitted without restriction in preparations containing 50% or less. When the concentration is Food use: Neither Thymus hirsutus nor greater than 50%, the nominal Thymus syriacus are listed in the Canada capacity of the container must be Food and Drug Regulations (2010), 143 25 mL or less, a RFI must be fitted which suggests that there is no current use on the container and the label must include the statement CHILD. in Canada for purposes of adding aromas, colors, flavors, seasonings or spices to food Thymus A, E Permitted without restriction in capitatus preparations containing 50% or products. Title 7 Section B.07.038. [S] of less of thyme oil. When the the regulations defines “Thyme” as the concentration of thyme oil is more dried leaves and flowering tops of the than 50%, the nominal capacity of thyme plant Thymus vulgaris L. or Thymus the container must be 25 mL or zygis L. less, a RFI must be fitted on the container and the label must include the statement CHILD. Medicinal use: There are no monographs Thymus A, E As per Thymus capitatus (see for these species of Thymus in the Natural mastichina above). Health Products Directorate (NHPD) Compendium of Monographs. There is one Thymus A, E As per Thymus capitatus (see NHPD monograph only for the flowering serpyllum above). tops of Thymus vulgaris L.144 Several products that contain Thymus vulgaris Thymus A, E As per Thymus capitatus (see ingredients are found in the Licensed vulgaris above). Natural Health Products Database (LNHPD). In any case, if sufficient evidence Thymus zygis A, E As per Thymus capitatus (see of safety, efficacy and quality could be above). compiled to meet the requirements, there

would appear to be no restriction against a company submitting a product license Canada application for the marketing authorization of a Natural Health Product (NHP) Cosmetic use: Thymus species ingredients are not listed in the Health Canada “Cosmetic Ingredient Hotlist” 141 which is a 142 Health Canada. Substances in cosmetics and personal care products regulated under the Food and Drugs Act list of substances that are restricted and (F&DA) that were in commerce between January 1, prohibited for use in cosmetic products in 2987, and September 13, 2001. Ottawa, Ontario: Health Canada. Canada. Available at: http://www.hc-sc.gc.ca/ewh- semt/contaminants/person/impact/list/person-no-cas- eng.php While neither Thymus hirsutus nor Thymus 143 Canada Minister of Justice. Food and Drug Regulations. C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. syriacus appear on the list of “Substances Current to 24 March 2010. Available at: in Cosmetics and Personal Care Products http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 70.pdf 144 Health Canada Natural Health Products Directorate 141 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, (NHPD). Thyme. In: NHPD Compendium of Ontario: Health Canada. September 2009. Available at: Monographs. Ottawa, Ontario: Natural Health Products http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs- Directorate. 12 February 2008. Available at: sesc/pdf/person/cosmet/info-ind-prof/_hot-list- http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb- critique/hotlist-liste-eng.pdf dgpsa/pdf/prodnatur/mono_thyme-eng.pdf

60 | P a g e containing either Thymus hirsutus or  Thymus Vulgaris Extract is the extract of Thymus syriacus as a medicinal ingredient. the whole plant of the Thyme, Thymus vulgaris L., Lamiaceae; European Community  Thymus Vulgaris Flower/Leaf Extract is an extract of the flowers and leaves of Cosmetic use: Neither Thymus hirsutus the Thyme, Thymus vulgaris L., nor Thymus syriacus are listed in the Lamiaceae; European Commission Cosmetic  Thymus Vulgaris Flower/Leaf Oil is the Ingredients and Substances (CosIng) volatile oil obtained from the flowers and database,145 which suggests that there is no leaves of the Thyme, Thymus vulgaris L., current use in cosmetic products within the Lamiaceae; European Union. However, many other  Thymus Vulgaris Flower/Leaf/Stem Thyme ingredients are listed in CosIng Extract is the extract of the leaves, Database as described here below: flowers and stems of the Thyme, Thymus vulgaris L., Lamiaceae ;  Thymus Capitatus Herb Extract is an  Thymus Vulgaris Herb Extract is an extract obtained from the herbs of the extract obtained from the herbs of the Spanish Origanum, Thymus capitatus, Thyme, Thymus vulgaris L., Lamiaceae; Lamiaceae;  "Thyme oil". Thymus Vulgaris Herb Oil is  Thymus Capitatus Herb Oil is an an essential oil obtained from the herbs essential oil obtained from the herbs of of the Thyme, Thymus vulgaris L., the Spanish Origanum, Thymus Lamiaceae. It contains 20-40% thymol capitatus, Lamiaceae; and carvacrol, cymene, pinene, linalool,  Thymus Citriodorus Flower/Leaf Extract bornyl acetate; is an extract of the flowers and leaves of  Thymus Vulgaris Leaf is a plant material the Thymus citriodorus, Lamiaceae; derived from the dried, crushed leaves of  Thymus Mastichina Flower Oil is the the Thyme, Thymus vulgaris L., volatile oil obtained from the flowers of Lamiaceae; the Thyme, Thymus mastichina L.,  Thymus Vulgaris Leaf Extract is an Lamiaceae; extract of the leaves of the Thyme,  Thymus Mastichina Herb Extract is an Thymus vulgaris L., Lamiaceae; extract obtained from the herbs of the  Thymus Vulgaris Leaf Water Extract is thyme, Thymus mastichina L., an aqueous solution of the steam Lamiaceae; distillate obtained from the leaves of the  Thymus Mastichina Herb Oil is an Thyme, Thymus vulgaris L., Lamiaceae; essential oil obtained from the herbs of  Thymus Zygis Flower Oil is the volatile the thyme, Thymus mastichina, oil obtained from the flower tips of the Lamiaceae; Thyme, Thymus zygis L., Lamiaceae;  Thymus Quinquecostatus Extract is the  Thymus Zygis Herb Extract is an extract extract of the whole plant, Thymus obtained from the herbs of the Thyme, quinquecostatus, Labiatae; Thymus zygis L., Lamiaceae;  Thymus Serpyllum Extract is an extract  Thymus Zygis Herb Oil is an essential oil of the herb of the Wild Thyme, Thymus obtained from the herbs of the Thyme, serpyllum L., Lamiaceae; Thymus zygis L., Lamiaceae, syn. Red  Thymus Serpyllum Leaf Extract is the thyme oil. extract of the leaves of the Wild Thyme, Thymus serpyllum L., Lamiaceae ; Food use: Neither Thymus hirsutus nor  Thymus Serpyllum Oil is an essential oil Thymus syriacus are listed in the European obtained from the herbs of the Wild Food Safety Authority (EFSA) Compendium Thyme, Thymus serpyllum L., of botanicals that have been reported to Lamiaceae; contain toxic, addictive, psychotropic or other substances of concern.146 However,

145 European Commission. Cosmetic Ingredients and 146 European Food Safety Authority (EFSA). EFSA Substances (CosIng) Database. Available at: Compendium of botanicals that have been reported to http://ec.europa.eu/enterprise/cosmetics/cosing contain toxic, addictive, psychotropic or other

61 | P a g e three other species of Thymus are listed as yptol (2008 20'%, ) follows in Table 4. camp hor Table 4: Thymus species listed in EPSA 3.9%. Compendium of Botanicals of Concern (CoE, 2008)

SOURCES OF INFORMATION FOR

ORIGANUM IN THE TABLE

e Code Reference

1H Plants assessed as flavourings by the

nam Parts of plants of possible concern Chemical of concern / toxic effect Remarks Specific References Botanical Council of Europe in 2000 and 2004 Thy 1H: 1H: Natur belonging to Category 3 or 4 (restrictions mus Herb Herb al recommended for use) (H1 and H2 serp . essen sourc respectively) or as Category 5 (restrictions yllum tial es of recommended and further data required) L. oil: flavou (H3) or Category 6 (considered not eme Carva rings appropriate for human consumption) (H4) nd. crol (Rep 1M Plants assessed as medicinal products by Mill. 37%, No 3), WHO in 1999 (Vol. I), 2002 (Vol. 2) and 2005 camp Coun (Vol. 3) hor, cil of 1P Plants identified in the Belgian Regulation eucal Europ (Arrêté Royal 29/8/1997 – annex list 3 and yptol. e, following acts) as requiring a notification (CoE, (2008 before marketing 2008) )

Thy 1M: 1H: 1P: Natur mus whol Herb food al Neither Thymus hirsutus nor Thymus vulga e and contai sourc syriacus are listed in the European Herbal ris L. leav leave ning es of Infusions Association (EHIA) “Inventory List es, s the flavou of Herbals Considered as Food.”147 flow essen herba rings ering tial ceous (Rep Absence of these species in the EHIA list tops oil: parts No 3), means that are not currently employed by 1N: carva must Coun the herbal infusions trade in a European herb crol have cil of member state as food plant for making tea 1O: 9- the Europ whol 60%, warnin e, infusions. Three other species of Thymus e eucal g not (2008 are listed, Thymus citriodorus (herb), leav yptol to ) Thymus serpyllum (herb) and Thymus es, 1.15 ingest vulgaris (herb). flow %, more ering camp than 4 tops hor g/day Medicinal use: The European Medicines 1H: 0.3%. of the Agency (EMEA) currently has no plans to Herb (CoE, dry develop and publish a European , 2008) herb Community Herbal (therapeutic) Monograph leav es. on Thymus hirsutus and/or Thymus

Thy 1H: 1H: Natur syriacus. However, there are EMEA mus Herb Herb al monographs published for Thymus vulgaris zygis . essen sourc L. and Thymus zygis L., Herba (Thyme L. tial oil es of 148 (yield flavou Herb) and for Thymus vulgaris L. and 0.5- rings Thymus zygis L., aetheroleum (Thyme 1.2%) (Rep : No 3), 147 carva Coun European Herbal Infusions Association (EHIA). EHIA Inventory List of Herbals Considered as Food. Hamburg, crol cil of Germany. January 2010. Available at: http://www.ehia- 25%, Europ online.org/publications.html eucal e, 148 European Medicines Agency (EMEA). Final Community Herbal Monograph on Thymus vulgaris L. and Thymus zygis L., Herba. London, UK: European Medicines substances of concern. EFSA Journal 2009; 7(9):281. Agency (EMEA). 31 October 2007. Available at: Available at: http://www.ema.europa.eu/pdfs/human/hmpc/thymi_her http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf ba/23411306enfin.pdf

62 | P a g e Oil).149 Additionally there are European and Thymus syriacus in the checklists Pharmacopoeia (quality standards) and/or pharmacopoeias of the Indian Monographs published by the European Systems of Medicine suggests that it could Directorate for the Quality of Medicines be difficult to gain marketing authorization (EDQM) for “Thyme” (whole leaves and for either as a component of an Ayurvedic, flowers separated from the previously dried Siddha or Unani (ASU) herbal medicinal stems of Thymus vulgaris L. or Thymus product in India. Possibly this species could zygis L. or a mixture of both species), enter Indian commerce as a non-medicinal “Thyme Oil” (essential oil obtained by steam spice or seasoning component for use in distillation from the fresh flowering aerial food products. parts of Thymus vulgaris L. or Thymus zygis L. or a mixture of both species), and South Africa “Wild Thyme” (whole or cut, dried aerial 150 parts of Thymus serpyllum L.s.l.). For use Medicinal use: Neither Thymus hirsutus as active substances of registered herbal nor Thymus syriacus are listed in any of the medicinal products in the European Schedules on Complementary and Community a quality standards monograph Alternative Medicines for therapeutic use in and corresponding therapeutic compendial South Africa.152 However, two other species monograph would normally be necessary of Thymus are listed. Thymus serpyllum L. for pre-marketing authorization. and Thymus vulgaris L. are listed in the Anthroposophical Medicine Schedule and India Thymus vulgaris L. is also listed in the Aromatherapy Schedule. Medicinal use: Neither Thymus hirsutus nor Thymus syriacus are listed in any of the Switzerland pharmacopoeias of Indian Systems of Medicine (e.g. Ayurvedic Pharmacopoeia of Cosmetic use: No information found. India, Siddha Pharmacopoeia of India and/or Unani Pharmacopoeia of India). Dietary supplement use: Neither Thymus Additionally, they are not found in the hirsutus nor Thymus syriacus are expressly comprehensive checklist of 1,289 included on the list of substances that may botanicals, pertaining to 960 plant taxa, that be used in dietary or food supplement were identified in the recent “Demand and 151 products in Switzerland. However, there is a Supply of Medicinal Plants in India 2008,” non-species-specific listing for “Thymian” which was initiated by the National a.k.a. “Thym vrai” (Thymus spec.) as well Medicinal Plants Board (NMPB), Ministry of as a separate listing for Thymus Health & Family Welfare, Department of satureioides Coss. et Bal. Thus it would AYUSH, and was carried out by Drs. D.K. appear that any species of Thymus could Ved and G.S. Goraya, of the Foundation for conceivably qualify for use in supplement Revitalisation of Local Health Traditions products in Switzerland so long as the (FRLHT). Only one species of Thymus is ingredient also complied with the limits for found in the FRLHT survey, Thymus content of camphor, carvacrol and serpyllum L., known as Ban Ajwain and/or eucalyptol. Satar Farsi, which is wild collected for use in the Ayurvedic and Unani Systems of Food use: Neither Thymus hirsutus nor Medicine. The absence of Thymus hirsutus Thymus syriacus are expressly included on the positive list of substances that may be 149 European Medicines Agency (EMEA). Draft Community used as flavor, spice or seasoning Herbal Monograph on Thymus vulgaris L. and Thymus zygis oefl. ex L., Aetheroleum. London, UK: European Medicines Agency (EMEA). 14 May 2009. Available at: 152 Medicines Control Council. Medicines and Related http://www.ema.europa.eu/pdfs/human/hmpc/thymi_aet Substances Act, 1965. Schedules on Complementary heroleum/13190109en.pdf and Alternative Medicines made in terms of the 150 European Directorate for the Quality of Medicines Medicines and Related Substances Act, 1965 (Act No. (EDQM). European Pharmacopoeia, 6th Edition. 101 of 1965); Amendment. Staatskoerant. 22 August Strasbourg, France: EDQM. 2010. 2008; No. 31334. Available at: 151 Ved DK, Goraya GS. Demand and Supply of Medicinal http://www.piasa.co.za/Filestructure/Legislation/Comple Plants in India. Dehra Dun, India: Bishen Singh mentary%20and%20Alternative%20Medicines/GG%203 Mahendra Pal Singh. 2008. 1334%20-%20Page%2031%20to%20180.pdf

63 | P a g e ingredients in food products or in non- One of the listed Thyme ingredients, Thymi medicinal herbal tea products.153 However, Extractum Siccum (dried thyme extract), is there is a non-species-specific listing for classified, however, as Category C, which “Thymian” a.k.a. “Thym vrai” (Thymus means that it is available without spec.) but with content (maximum) limits for prescription but only after consultation with the levels of eucalyptol, camphor, and a doctor or pharmacist. For test and release carvacrol, that may occur in the food of active ingredients of licensed or product. registered medicines, the pharmacopoeial standards in force for Switzerland are both Medicinal use: Neither Thymus hirsutus the European Pharmacopoeia (PhEur) and nor Thymus syriacus are expressly included the Swiss Pharmacopoeia (PhHelv). on the “Stoffliste” (List of Substances used in medicinal products).154 However, several United States of America „Thyme” ingredients are listed including Thymi aetheroleum (essential oil of thyme), Cosmetic use: Neither Thymus hirsutus Thymi extractum aquosum liquidum (liquid nor Thymus syriacus are known to be used aqueous extract of thyme), Thymi extractum in cosmetic products in the U.S. aquosum siccum (dried aqueous extract of thyme), Thymi extractum ethanolicum et Dietary supplement use: Neither Thymus glycerolicum (ethanolic and glycolic extract hirsutus nor Thymus syriacus are listed in of thyme), Thymi extractum ethanolicum the Herbs of Commerce, 2nd edition,155 liquidum (liquid ethanolic extract of thyme), which indicates that neither species Thymi extractum ethanolicum siccum (dried appeared in U.S. commerce prior to 1994 ethanolic extract of thyme), Thymi and therefore would require pre-marketing extractum fluidum normatum (standardized submission of a New Dietary Ingredient fluidextract of thyme), Thymi extractum (NDI) notification to the FDA. Six other liquidum (fluidextract of thyme), Thymi species of Thymus are listed in the Herbs of extractum siccum (dried extract of thyme), Commerce; lemon thyme (Thymus × Thymi herba (thyme herb), Thymi herbae citriodorus (Pers.) Schreb. ex Schweigg. & recentis succus (fresh pressed juice of Körte), wild thyme (Thymus praecox Opiz), thyme herb), Thymi pulvis (powdered thyme lemon thyme (Thymus pulegioides L.), wild herb), and Thymi recentis extractum thyme (Thymus serpyllum L.), thyme ethanolicum liquidum (liquid ethanolic (Thymus vulgaris L.), and Spanish thyme extract of fresh thyme herb). These various (Thymus zygis L.). thyme ingredients are classified as approved active substances of Food use: Neither Thymus hirsutus nor complementary and phytomedicine Thymus syriacus are listed as generally products (KPA) requiring pre-marketing recognized as safe (GRAS) for use in food authorization and product licensing through products. However, other species of Swissmedic. Depending on the indications Thymus are listed. “Spanish Origanum” for use, retail distribution is limited to either (Thymus capitatus Hoffm. et Link.) is listed Category D (available in both pharmacies as a natural flavoring substance that may and drugstores; without prescription but be used in food products in appropriate only after consultation with pharmacy staff) forms (plant parts, fluid and solid extracts, or Category E (available in both pharmacies concentrates, absolutes, oils, oleoresins, and drugstores, without prescription and and distillates).156 Thyme (Thymus vulgaris) without consultation with pharmacy staff).

155 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American Herbal Products Association’s Herbs of Commerce, 2nd 153 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und Edition. Silver Spring, MD: American Herbal Products Zubereitungen als Arzneimittel oder als Lebensmittel“. Association. 2000. Bern, Switzerland: Swissmedic. 11 December 2006. 156 United States Food and Drug Administration. Natural Available at: flavoring substances and natural substances used in http://www.swissmedic.ch/marktueberwachung/00662/in conjunction with flavors. In: Code of Federal dex.html?lan Regulations, Title 21, Part 172, Section §172.510. 154 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. Washington, DC: National Archives and Records August 2008. Available at: Administration. 01 April 2009. Available at: http://www.swissmedic.ch/daten/00080/00256/index.htm http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 l?lang=de 72.510.pdf

64 | P a g e and wild thyme (Thymus serpyllum) are monograph in the European listed as spices or other natural seasonings Pharmacopoeia. There are no known and flavorings that are GRAS for an licensed or registered herbal medicinal intended use in food products.157 products in the European Community that Additionally, essential oils, oleoresins contain these species. There are (solvent-free), and natural extractives monographs and registered medicines that (including distillates) of Thyme (Thymus contain other Thymus species. vulgaris L. and Thymus zygis L. var. gracilis Boiss.) and wild thyme (Thymus serpyllum India L.) are classified as GRAS for their intended 158 use as food ingredients. Food: There are no quality standards published for either Thymus hirsutus or Medicinal use: No ingredients made from Thymus syriacus, neither in the Bureau of any Thymus species are listed as a Indian Standards (BIS) quality standards for “Generally Recognized as Safe and spices, concentrates and oleoresins, in the Effective” (GRASE) active ingredient for use 1995 Prevention of Food Adulteration in over-the-counter (OTC) or prescription (PRA) Act and Rules standards for spices, drug products for human use. Its use in nor in the Agricultural Product Grading and medicinal products would require a New Marking (AGMARK) Standards. Drug Application (NDA) process with FDA approval. Medicine: There are no quality standards monographs or therapeutic compendial Information on existing quality monographs published for either Thymus standards, compendial hirsutus or Thymus syriacus in any of India‟s national pharmacopoeias covering standards or trade botanical substances used in the Indian specifications of relevance to Systems of Medicine (Ayurveda, Siddha, this species in selected and Unani). destination countries Switzerland Australia Cosmetic, Food, Medicine: There are no known quality standards or trade Cosmetic, Food or Medicine: There are specifications for either Thymus hirsutus or no known quality standards or trade Thymus syriacus for any use. There is no specifications for either Thymus hirsutus or monograph in the Swiss Pharmacopoeia Thymus syriacus for any use. (PhHelv). There are no licensed or registered herbal medicinal products that European Community contain either of these species. There are licensed products in Switzerland that Cosmetic, Food or Medicine: There are contain ingredients made from other no known quality standards or trade species of Thymus. specifications for either Thymus hirsutus or Thymus syriacus for any use. There is no United States of America

157 United States Food and Drug Administration. Spices and other natural seasonings and flavoring. In: Code of Food: There are no standards published for Federal Regulations, Title 21, Part 182, Section either Thymus hirsutus or Thymus syriacus §182.10. Washington, DC: National Archives and Records Administration. 01. April 2009. Available at: in the Code of Federal Regulations (CFR), http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 the Food Chemicals Codex (FCC) nor in the 82.10.pdf National Formulary monographs of the 158 United States Food and Drug Administration. Essential oils, oleoresins (solvent-free), and natural extractives United States Pharmacopeia (USP-NF). (including distillates). In: Code of Federal Regulations, The FCC does contain monographs for four Title 21, Part 182, Section §182.20. Washington, DC: other Thymus species ingredients: National Archives and Records Administration. 01 April 2009. Available at: http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 82.20.pdf

65 | P a g e  Oleoresin Thyme FCC: Obtained by The national consultant‟s report the solvent extraction of the dried “Monographs of the 7 targeted species” did flowering plant Thymus vulgaris L. or not include any Thymus species. Assuming Thymus zygis L. and its var. gracelis that these species could be added to Boissier (Fam. Labiatae). various positive lists beyond the current  Spanish Type Marjoram Oil FCC: known importers, proposed innovative Essential oil obtained by steam value-added products could include: distillation from the flowering plant Thymus mastichina L. (Fam.  Cut dried aerial parts as a Labiatae). component of tisanes or herbal tea  Spanish Type Origanum Oil FCC: products; Essential oil obtained by steam  Cut or whole dried aerial parts as a distillation from the flowering herb component of Lebanese Thymus capitatus Hoffm. et Link and seasonings or spice mixes; various species of Origanum (Fam.  Essential oil for use as a component Labiatae). of aromatherapy, bath, cosmetic or  Thyme Oil FCC: Essential oil food products; obtained by distillation from the  Oleoresin for use as a component of flowering plant Thymus vulgaris L., food products; or Thymus zygis L., and its var.  Steam distillate water for use as a gracilis Boissier (Fam. Labiatae). component of cosmetic products;  Extract of the aerial parts as a Dietary Supplement: There are no component of cosmetic or standards published for any species of medicinal products. Thymus in the Dietary Supplements monographs of the United States If the expert resource assessment should Pharmacopeia (USP-DS). determine that significantly higher amounts of this species could be harvested annually Medicine: There are no standards under a controlled sustainable resource published for any species of Thymus in the management plan, then it could make Code of Federal Regulations (CFR) nor in sense to consider the development of the monographs of the United States innovative value-added products for Pharmacopeia (USP). international export promotion with a Lebanese quality and country of origin Proposed innovative value- designation. added MAP products using this ingredient

66 | P a g e Viola sps including (Viola any ingredients made from Viola libanotica libanotica Boiss. & Viola are commercially traded or actively used outside of its limited range of Lebanon. odorata L.) Regulatory framework, market Definitions access requirements and Viola libanotica Boiss. (Fam. Violaceae) requirements for use in selected destination countries  English name: Lebanon violet  French name: Violette du liban Australia  German name: Lebanische Veilchen  Lebanese vernacular names: Cosmetic use: No information found. بنفسج لبناني Banafsaj lubnānī, Banafsaj Food use: Viola spp. are not listed in Viola odorata L. Standard 1.4.4 “Prohibited and Restricted Plants and Fungi” of the Australia New 159  English name: Sweet violet Zealand Food Standards Code.  German name: Märzveilchen Medicinal use: Viola libanotica is not listed as a substance that may be used as an Assessment of current active or excipient ingredient in „Listed‟ Lebanese export trade data medicines for supply in Australia.160 This current main importers suggests that it could require a petition to amend and expand the list of substances According to the national consultant‟s report used in listed medicines in order to achieve “Monographs of the 7 targeted species,” marketing authorization for this species in there are neither imports nor exports of medicinal products. However, three other Viola libanotica. However there is mention species of Viola are listed for use in of Lebanese imports of dried flowers of therapeutic products in Australia. They are Viola odorata from Iran. There does not sweet violet (Viola odorata), European wild appear to be much trade for Viola libanotica pansy (Viola tricolor), and Tokyo violet although there is trade of mixed species of (Viola yedoensis), two of which are reported Viola, usually Viola odorata imported from to occur in Lebanon. Therefore, it would Iran admixed with Viola libanotica. The size appear that Australia could be a destination of the Lebanese market for Viola spp. dried market for at least these two Viola species flowers is estimated at 30 tons valued at (odorata and tricolor). USD $95,000. Since this species is not presently known to be exported, it would be Canada difficult to make any determination concerning who the main importers of this Cosmetic use: Viola species ingredients species might be, if any. Some assumptions are not listed in the Health Canada 161 can be made based on the regulatory status “Cosmetic Ingredient Hotlist” which is a of Viola libanotica in other countries. If a regulatory framework were to exist in any 159 Food Standards Australia New Zealand (FSANZ). countries for the import and use of Viola Standard 1.4.4 Prohibited and Restricted Plants and Fungi. In: Australia New Zealand Food Standards Code. libanotica, the possibility could then exist for Canberra: Commonwealth of Australia. 2010. Available Lebanese exports to the identified at: countries. http://www.foodstandards.gov.au/_srcfiles/Standard_1_ 4_4_Prohib_plants_v113.pdf 160 Therapeutic Goods Administration. Substances that may This review found that Viola libanotica does be used as active ingredients in „Listed‟ medicines in Australia. Woden (Australia): Australian Government not appear on any national positive lists of Department of Health and Ageing Therapeutic Goods any of the selected counties, although some Administration. 12 December 2007. Available at: lists allow other species of Viola. Almost no http://www.tga.gov.au/cm/listsubs.pdf 161 Health Canada. Cosmetic Ingredient Hotlist. Ottawa, evidence was found to demonstrate that Ontario: Health Canada. September 2009. Available at:

67 | P a g e list of substances that are restricted and odorata aerial parts [Naturtech Labs, Inc - prohibited for use in cosmetic products in Viola Odorata; Natural Product Number: Canada. Nor do any Viola species appear 80007080], carries the approved label on the list of “Substances in Cosmetics and statement “Used in Traditional Western Personal Care Products Regulated under Herbalism as an expectorant to aid the the Food and Drugs Act (F&DA) that were treatment of coughs, colds and bronchitis.” in commerce between January 1, 1987, and Another licensed product, containing a September 13, 2001.” 162 This suggests that hydroalcoholic tincture of Viola tricolor while there is no express prohibition against aerial parts [Gaia Garden Herbals use in cosmetic products, it is possible that Heartsease Tincture; Natural Product Viola libanotica could be classified as new Number: 80015490], carries the approved or novel. label statement “Traditionally used in Western Herbalism as an alterative for the Food use: Viola spp. are not listed in the symptomatic relief of chronic skin conditions Canada Food and Drugs Regulations such as eczema.” If sufficient evidence of (2010), 163 suggesting that there is no safety and efficacy could be compiled to current use in Canada for purposes of meet the requirements, there would appear adding aromas, colors, flavors, seasonings to be no restriction against a company or spices to food products. submitting a product license application for the marketing authorization of a Natural Medicinal use: There are no monographs Health Product (NHP) containing any of the for any Viola species ingredients in the Viola species as a medicinal ingredient. Natural Health Products Directorate (NHPD) Compendium of Monographs. European Community However, several products containing Viola species ingredients are found in the Cosmetic use: Viola libanotica is not listed Licensed Natural Health Products Database in the European Commission Cosmetic (LNHPD). Using the search field “Ingredient Ingredients and Substances (CosIng) Name” and the criteria “Viola” there were 39 database.165 However, cosmetic ingredients results found in the LNHPD.164 The Viola- made from other species of Viola are listed containing medicinal products with in CosIng including: marketing authorization in Canada contain mainly extracts of Viola odorata or Viola  Hydrolyzed Viola Tricolor Extract is tricolor. Some licensed products however the hydrolysate of an extract of the contain homoeopathic dilutions of mother Pansy, Viola tricolor L., Violaceae, tinctures from either of these species. Three derived by acid, enzyme or other of the 39 licensed products contain Tokyo method of hydrolysis; violet herb (Viola yedoensis). As examples  Viola Mandshurica Flower Extract is of approved uses in Canada for some the extract obtained from the flowers species of Viola, one licensed product, of the plant Manchuria Violet, Viola containing a hydroalcoholic tincture of Viola mandshurica, Violaceae;  Viola Odorata Flower Extract is an http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs- extract of the flowers of the Sweet sesc/pdf/person/cosmet/info-ind-prof/_hot-list- critique/hotlist-liste-eng.pdf Violet, Viola odorata L., Violaceae; 162 Health Canada. Substances in cosmetics and personal  Viola Odorata Flower Water is the care products regulated under the Food and Drugs Act (F&DA) that were in commerce between January 1, steam distillate obtained from the 2987, and September 13, 2001. Ottawa, Ontario: Health flowers of the Sweet Violet, Viola Canada. Available at: http://www.hc-sc.gc.ca/ewh- odorata L., Violaceae; semt/contaminants/person/impact/list/person-no-cas- eng.php  Viola Odorata Flower/Leaf Extract is 163 Canada Minister of Justice. Food and Drug Regulations. an extract of the flowers and leaves of C.R.C., c. 870. Ottawa, Ontario: Minister of Justice. the Sweet Violet, Viola odorata L., Current to 24 March 2010. Available at: http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._8 Violaceae; 70.pdf 164 Health Canada Natural Health Products Directorate (NHPD). Licensed Natural Health Products Database 165 European Commission. Cosmetic Ingredients and (LNHPD). Available at: http://webprod.hc- Substances (CosIng) Database. Available at: sc.gc.ca/lnhpd-bdpsnh/start-debuter.do?lang=eng http://ec.europa.eu/enterprise/cosmetics/cosing

68 | P a g e  Viola Odorata Leaf Cera is the wax “Inventory List of Herbals Considered as obtained from the leaves of Sweet Food.”167 Absence of this species in the Violet, Viola odorata L., Violaceae; EHIA list means that this plant is not  Viola Odorata Leaf Extract is an currently employed by the herbal infusions extract of the leaves of the Sweet trade in a European member state as food Violet, Viola odorata L., Violaceae; plant for making tea infusions. Two other  Viola Odorata Oil is the volatile oil species of Viola are listed, Viola odorata obtained from the flowers of the (flowers) and Viola tricolor (aerial parts). sweet violet, Viola odorata, Violaceae; Medicinal use: The European Medicines  Viola Prionantha Powder is the Agency (EMEA) plans to publish a Draft powder obtained from the dried, European Community Herbal (therapeutic) ground Grass, Viola prionantha, Monograph on “Viola tricolor L., herba cum Violaceae; flore” (EMA/HMPC/131734/2009) for public 168  Viola Tricolor Extract is an extract of comment until 15 July 2010. There is the herb and flowers of the Pansy, already a corresponding European Viola tricolor L., Violaceae; Pharmacopoeia (quality standards)  Viola Tricolor Flower Juice is the Monograph for “Wild Pansy Flowering juice expressed from the flowers of Aerial Parts” (Viola arvensis Murray and/or the Pansy, Viola tricolor L., Viola tricolor L.) published by the European Violaceae. Directorate for the Quality of Medicines 169  Viola Tricolor Flower/Leaf/Stem (EDQM). Water is an aqueous solution of the steam distillate obtained from the India flowers, leaves and stems of the Pansy, Viola tricolor L., Violaceae; Medicinal use: Viola libanotica is not listed  Viola Yedoensis Extract is an extract in any of the pharmacopoeias of Indian of the plant, Viola yedoensis, Systems of Medicine (e.g. Ayurvedic Violaceae. Pharmacopoeia of India, Siddha Pharmacopoeia of India and/or Unani The CosIng listings of cosmetic ingredients Pharmacopoeia of India). Additionally, it is made from these five other species of Viola not found in the comprehensive checklist of suggests that, in principle, with sufficient 1,289 botanicals, pertaining to 960 plant evidence of safety, the additional listing of taxa, that were identified in the recent Viola libanotica “Demand and Supply of Medicinal Plants in ingredients made from 170 should be possible. But, in any case, some India 2008,” which was initiated by the of listed ingredients for use in European National Medicinal Plants Board (NMPB), cosmetic products are obtained from Ministry of Health & Family Welfare, species that also occur in Lebanon, Viola Department of AYUSH, and was carried out odorata and Viola tricolor. by Drs. D.K. Ved and G.S. Goraya, of the Foundation for Revitalisation of Local Food use: Viola libanotica is not listed in Health Traditions (FRLHT). However, four the European Food Safety Authority (EFSA) Compendium of botanicals that have been 167 European Herbal Infusions Association (EHIA). EHIA reported to contain toxic, addictive, Inventory List of Herbals Considered as Food. Hamburg, Germany. January 2010. Available at: http://www.ehia- psychotropic or other substances of online.org/publications.html concern.166 168 European Medicines Agency (EMEA) Committee on Herbal Medicinal Products (HMPC). Report of the 34th HMPC meeting, held 10-11 March 2010. London, UK: Viola libanotica is not listed in the European EMEA. 2010. Available at: Herbal Infusions Association (EHIA) http://www.ema.europa.eu/pdfs/human/hmpc/19012410 en.pdf 169 European Directorate for the Quality of Medicines 166 European Food Safety Authority (EFSA). EFSA (EDQM). Wild Pansy Flowering Aerial Parts. In: Compendium of botanicals that have been reported to European Pharmacopoeia, 6th Edition. Strasbourg, contain toxic, addictive, psychotropic or other France: EDQM. 2010. substances of concern. EFSA Journal 2009; 7(9):281. 170 Ved DK, Goraya GS. Demand and Supply of Medicinal Available at: Plants in India. Dehra Dun, India: Bishen Singh http://www.efsa.europa.eu/en/scdocs/doc/280rax1.pdf Mahendra Pal Singh. 2008.

69 | P a g e other species of Viola are found in the products in Switzerland. However, Viola FRLHT survey, flower of Viola canescens tricolor is listed. Wall., known as “Banafasha,” which is used only in folk medicine, flower, leaf and/or Food use: Viola libanotica is not included whole plant of Viola cinerea Boiss., known on the positive list of substances that may as “Banafasha phood,” which is used in the be used as flavor, spice or seasoning Ayurvedic system of medicine, flower of ingredients in food products or in non- Viola odorata L., also known as medicinal herbal tea products.172 However, “Banafasha,” which is used in Ayurvedic Viola odorata is listed. and Unani Systems of Medicine, as well as in the Homoeopathic System of Medicine. Medicinal use: Viola libanotica is not Additionally, the flower of Viola pilosa Bi., included on the “Stoffliste” (List of also known as “Banafasha,” is listed in the Substances used in medicinal products).173 survey, reportedly used in both the This would suggest that marketing Ayurvedic System of Medicine as well as in authorization as a medicinal substance in folk medicine. Switzerland would not be possible unless the List of Substances were amended to The absence of Viola libanotica in the include this species. However, several checklists and/or pharmacopoeias of the ingredients made from Viola tricolor are Indian Systems of Medicine suggests that it listed including “Violae tricoloris herba” could be difficult to gain marketing (aerial parts of Viola tricolor), “Violae authorization for it as a component of an tricoloris herbae extractum ethanolicum Ayurvedic, Siddha or Unani (ASU) herbal liquidum” (ethanolic liquid extract of dried medicinal product in India. However, aerial parts of Viola tricolor), “Violae another Viola species which occurs in tricoloris herbae pulvis” (powdered aerial Lebanon, Viola odorata has some market parts of Viola tricolor), and “Violae tricoloris demand and medical use in India. It is both herbae recentis extractum ethanolicum cultivated and wild harvested in India. liquidum” (ethanolic liquid extract of fresh aerial parts of Viola tricolor). These listed South Africa ingredients are classified as approved active substances of complementary and Medicinal use: Viola libanotica is not listed phytomedicine products (KPA) requiring in any of the Schedules on Complementary pre-marketing authorization and product and Alternative Medicines for therapeutic licensing through Swissmedic. Retail use in South Africa.171 However, Viola distribution is limited to Category D odorata is listed in both the “Aromatherapy (available in both pharmacies and Schedule” and the “Ayurveda & Unani Tibb drugstores; without prescription but only Schedule.” For use in Ayurveda or Unani after consultation with pharmacy staff). For Medicines in South Africa, the maximum test and release of active ingredients of daily dosage is set as 12 g. licensed medicines, the pharmacopoeial standards in force for Switzerland are both Switzerland the European Pharmacopoeia (PhEur) and the Swiss Pharmacopoeia (PhHelv). Cosmetic use: No information found. Additionally, both Viola odorata and Viola tricolor are included in the Swissmedic Dietary supplement use: Viola libanotica “Liste HAS” (List of Homoeopathic and is not included on the list of substances that Anthroposophic Substances) for oral and/or may be used in dietary or food supplement 172 Swissmedic. Liste: „Einstufung pflanzlicher Stoffe und 171 Medicines Control Council. Medicines and Related Zubereitungen als Arzneimittel oder als Lebensmittel“. Substances Act, 1965. Schedules on Complementary Bern, Switzerland: Swissmedic. 11 December 2006. and Alternative Medicines made in terms of the Available at: Medicines and Related Substances Act, 1965 (Act No. http://www.swissmedic.ch/marktueberwachung/00662/in 101 of 1965); Amendment. Staatskoerant. 22 August dex.html?lan 2008; No. 31334. Available at: 173 Swissmedic. Stoffliste. Bern, Switzerland: Swissmedic. http://www.piasa.co.za/Filestructure/Legislation/Comple August 2008. Available at: mentary%20and%20Alternative%20Medicines/GG%203 http://www.swissmedic.ch/daten/00080/00256/index.htm 1334%20-%20Page%2031%20to%20180.pdf l?lang=de

70 | P a g e parenteral use at various specified appear to be permitted for U.S. buyers to homoeopathic dilutions.174 import Origanum syriacum and to use the dried herb or essential oil as a food United States of America flavoring ingredient.

Cosmetic use: Viola libanotica is not Medicinal use: No ingredients made from known to be used in cosmetic products in any Viola species are listed as a “Generally the U.S. Recognized as Safe and Effective” (GRASE) active ingredient for use in over- Dietary supplement use: Viola libanotica the-counter (OTC) or prescription drug is not listed in the Herbs of Commerce, 2nd products for human use. Its use in edition,175 which indicates that it did not medicinal products would require a New appear in U.S. commerce prior to 1994 and Drug Application (NDA) process with FDA therefore would likely require the pre- approval. marketing submission of a New Dietary Ingredient (NDI) notification to the FDA. Information on existing quality Five other species of Viola are listed in the standards, compendial Herbs of Commerce. They are marsh blue violet (Viola cuculiata Aiton), sweet violet standards or trade (Viola odorata L.), violet (Viola sororia specifications of relevance to Willd.), heartsease, a.k.a. European wild this species in selected pansy (Viola tricolor L.), and Tokyo violet destination countries (Viola yedoensis Makino). Australia Food use: Viola libanotica is not listed as “Generally Recognized as Safe” (GRAS) for use in food products. However, essential Cosmetic, Food or Medicine: There are oils, oleoresins (solvent-free), and natural no known quality standards or trade extractives (including distillates) and specifications for Viola libanotica for any absolute of flowers and leaves of Viola use. There are no listed herbal medicinal odorata L. are classified as GRAS for their products that contain this plant for sale in intended use as food ingredients.176 Australia. There are listed medicines Additionally, natural ingredients made from containing other species of Viola. “Pansy” (Viola tricolor L.) and/or “Swiss violet” (Viola calcarata L.) are classified as European Community natural flavoring substances and natural adjuvants that may be safely used in Cosmetic, Food or Medicine: There are alcoholic beverages only.177 Thus, it would no known quality standards or trade specifications for Viola libanotica for any 174 Swissmedic. Liste homöopathischer und use. There is no monograph in the anthroposophischer Stoffe (Liste HAS). Bern, European Pharmacopoeia. There are no Switzerland: Swissmedic. August 2008. Available at: http://www.swissmedic.ch/rechtstexte/00201/00203/inde known licensed or registered herbal x.html?lan medicinal products in the European 175 McGuffin M, Kartesz JT, Leung A&, Tucker AO. American Community that contain this species. There Herbal Products Association’s Herbs of Commerce, 2nd Edition. Silver Spring, MD: American Herbal Products are monographs for, and registered Association. 2000. medicines that contain, other Viola species, 176 United States Food and Drug Administration. Essential oils, oleoresins (solvent-free), and natural extractives particularly European wild pansy flowering (including distillates). In: Code of Federal Regulations, aerial parts (Viola arvensis Murray and/or Title 21, Part 182, Section §182.20. Washington, DC: Viola tricolor L.). National Archives and Records Administration. 01 April 2009. Available at: http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 82.20.pdf 177 United States Food and Drug Administration. Natural flavoring substances and natural substances used in conjunction with flavors. In: Code of Federal Regulations, Title 21, Part 172, Section §172.510. Washington DC: National Archives and Records http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 Administration. 01 April 2009. Available at: 72.510.pdfn

71 | P a g e India Code of Federal Regulations (CFR) nor in the monographs of the United States Food: There are no quality standards Pharmacopeia (USP). published for Viola libanotica, neither in the Bureau of Indian Standards (BIS) quality Proposed innovative value- standards for spices, concentrates and added MAP products using this oleoresins, in the 1995 Prevention of Food Adulteration (PRA) Act and Rules standards ingredient for spices, nor in the Agricultural Product Grading and Marking (AGMARK) The national consultant‟s report Standards. “Monographs of the 7 targeted species” stated that Viola libanotica does not appear Medicine: There are no quality standards to offer significant value-adding monographs or therapeutic compendial opportunities and that other Viola species monographs published for Viola libanotica would be more marketable. Proposed in any of India‟s national pharmacopoeias innovative value-added products for the covering botanical substances used in the flowers of Viola odorata could be as a Indian Systems of Medicine (Ayurveda, component of tisanes or herbal teas. Other Siddha, and Unani). valued-added products for Viola odorata would be the essential oil as well as steam Switzerland distillate water. Finally, the development of geographic origin and trademarks for Cosmetic, Food, Medicine: There are no Lebanese quality and country of origin known quality standards or trade designation for all Viola species products. specifications for Viola libanotica for any use. There is no monograph in the Swiss The current estimated annual demand of 30 Pharmacopoeia (PhHelv). There are no tons for dried flowers or aerial parts of Viola licensed or registered herbal medicinal species is considerable. If the expert products that contain this species. There resource assessment should determine that are licensed products in Switzerland that significantly higher amounts of this species contain ingredients made from other could be harvested annually under a species of Viola. controlled sustainable resource management plan, then it could make United States of America sense to consider the development of innovative value-added products for export promotion with a Lebanon geographical Food: There are no standards published for brand. If the other Viola species already any species of Viola in the Code of Federal recognized in the target export markets Regulations (CFR), the Food Chemicals (e.g. sweet violet and wild pansy) can be Codex (FCC) nor in the National Formulary clearly differentiated, there may be better monographs of the United States chances for these, particularly with buyers Pharmacopeia (USP-NF). in the European Community. It may be necessary to demonstrate and document Dietary Supplement: There are no comparable safety and efficacy of Viola standards published for any species of libanotica to Viola odorata and/or Viola Viola in the Dietary Supplements tricolor before it would gain acceptance in monographs of the United States Europe as a component of herbal medicinal Pharmacopeia (USP-DS). products. Medicine: There are no standards published for any species of Viola in the

72 | P a g e INFORMATION ON PROCESS Further details are provided in the REQUIRED TO GAIN “Herbal Substances Australian Approved Names (AAN) List” in the MARKET ACCESS IN TGA Approved Terminology for DESTINATION COUNTRIES Medicines, which is available on-line at: WHERE THE SPECIES IS http://www.tga.gov.au/docs/pdf/aan/aan herb3.pdf.179 The list does not include NOT PRESENTLY LISTED OR substances that may be used as PERMITTED FOR USE homoeopathic preparations. The Office of Complementary Medicines is Many countries publish their own currently conducting a review of negative and positive lists of substances homoeopathic substance permitted in for use in various classes of goods listed medicines. The Australian TGA (cosmetics, dietary supplements, foods, also maintains a list of proprietary medicines). There is however no ingredients which have been used in comprehensive global listing or Listed Medicines but which are not database and therefore one must check usable in ELF3 (Electronic Listing each individual list for each targeted Facility) until further information export market. The following are a few regarding proprietary ingredient examples of negative and positive lists purpose, restricted ingredients and from selected countries of relevance to quantities of restricted ingredients have exporters of natural medicinal been supplied to the TGA; available on- ingredients and products. line at: http://www.tga.gov.au/cm/elf3pring.pdf. Australia: The Therapeutic Goods 180 Administration (TGA) maintains a list of “Substances that may be used in Listed Canada: The Health Canada Natural Medicines in Australia,” which is Health Products Directorate (NHPD) available on-line at: maintains several lists of natural http://www.tga.gov.au/cm/listsubs.pdf.178 ingredients that may occur in natural These substances are eligible for use in health products (NHPs) either as medicines that may be listed on the medicinal ingredients or as non- Australian Register of Therapeutic medicinal ingredients. These lists are Goods for supply in Australia. The list available on-line. includes the approved role of the substance (i.e. active, excipient, and/or  List of single ingredient and component), and any restrictions and product monographs for natural conditions that apply to the substance health products (NHPs). These when used in Listed Medicines. Some monographs may be used to help substances are permitted as food speed up the evaluation of the excipients only. These substances (e.g. safety and efficacy of medicinal apple, pear) refer only to edible ingredients commonly used in NHPs substances fit for human consumption sold in Canada. They can also serve as a food. Only certain preparations are as reliable sources of product permitted for most food excipients: fresh information for consumers. Available dry or powdered plant material and fresh, dried or concentrated juices. 179 Therapeutic Goods Administration. Herbal Substances Juice preparations may only be named AAN List. In: TGA Approved Terminology for Medicines. where the fresh plant part has a high Woden: Australian Government, Department of Health water content. and Ageing, Therapeutic Goods Administration. July 1999. Available at: http://www.tga.gov.au/docs/pdf/aan/aanherb3.pdf 180 Therapeutic Goods Administration. Proprietary 178 Therapeutic Goods Administration. Substances that may ingredients which have been used in Listed Medicines be used in Listed Medicines in Australia. Woden: but which are not usable in ELF3 until further Australian Government, Department of Health and information is provided. Woden: Australian Government, Ageing, Therapeutic Goods Administration. 12 Department of Health and Ageing, Therapeutic Goods December 2007. Available at: Administration. 15 July 2004. Available at: http://www.tga.gov.au/cm/listsubs.pdf http://www.tga.gov.au/cm/elf3pring.pdf

73 | P a g e at: http://www.hc-sc.gc.ca/dhp- supporting its non-medicinal use for mps/prodnatur/applications/licen- all proposed non-medicinal prod/monograph/index-eng.php ingredients when submitting an  The Natural Health Products application for a product license. Ingredients Database (NHPID)  Food ingredients and food provides information on acceptable additive ingredients are listed in medicinal and non-medicinal the Canada Food and Drug ingredients used in NHPs in Canada Regulations. at: in order to assist applicants with the http://laws.justice.gc.ca/PDF/Regula submission of their product license tion/C/C.R.C.,_c._870.pdf applications. The NHPID is available on-line at: http://www.hc- European Union: The European sc.gc.ca/dhp- Medicines Agency (EMEA) is mps/prodnatur/applications/online- developing Community Herbal enligne/nhpid-bipsn-eng.php and Monographs and a Community List of contains the following information: Herbal Substances for the registration, marketing authorization and labeling of 1. Medicinal ingredients; Traditional Herbal Medicinal Products 2. Non-medicinal ingredients; (THMPs) and Well Established Use 3. Non-Natural Health Product Herbal Medicinal Products (WEU-HMP). (NHP) ingredients (not allowed These lists and monographs are as medicinal ingredients in available on-line. natural health products or under specific restrictions);  Community Herbal Monographs. 4. Selected single-ingredient NHPD These monographs provide a monographs; harmonized approach to the 5. Ingredient details relevant to scientific assessment of herbal their type (for example, medicinal products in the EU, and Chemical Abstracts Service the Member States shall take them (CAS) numbers for chemical into account when they examine an substances, organism parts and application relating to a product for preparations for organism which a Community monograph has substances, etc.); been established. Available at: 6. Medicinal, non-medicinal, and http://www.emea.europa.eu/htms/hu non-NHP ingredient restriction man/hmpc/hmpcmonographsdraft.ht details; and m 7. Controlled vocabularies that  Community List of Herbal represent a standard for the Substances, preparations and electronic transmission of core combinations thereof for use in sets of natural health product traditional herbal medicinal information (e.g. lists for dosage products (THMPs). This list is forms, route of administrations, established by the Committee on ingredient categories, organism Herbal Medicinal Products (HMPC), parts, organism preparations, in accordance with Directive non-medicinal purposes, etc.) 2001/83/EC. The list is being developed through entries of For any non-medicinal ingredient not structured information relating to contained in the NHPID or used individual herbal substances or outside of the stated limitations, the preparations. Available at: Natural Health Products Directorate http://www.ema.europa.eu/htms/hu (NHPD) may require a safety man/hmpc/hmpcmonographs.htm assessment. If there is a particular The principle underlying the safety concern with a non-medicinal development of the positive list is to ingredient, the NHPD may request remove the need for many additional information. The applicant companies each to have to produce should provide information similar evidence of traditional use

74 | P a g e and safety where this has already http://www.cfsan.fda.gov/~dms/cos- been clearly accepted. There will be 210.html. an agreed list of herbal substances  Dietary Supplement ingredients: accompanied by the therapeutic For a natural ingredient to be indication, specified strength, route permitted for use in a dietary of administration and any relevant supplement product there must be safety information. An applicant documentary evidence that such seeking to register a product species was marketed in the United containing a substance on the list in States prior to 15 October 1994. It is the form and for the indications as also the responsibility of finished specified on the list could then refer product manufacturers and to this list rather than have to distributors to ensure that the demonstrate traditional use and particular natural ingredients that safety. The applicant would still they use as components of dietary need to demonstrate quality.181 supplement products are safe for  Inventory of Herbal Substances human consumption, do not contain for Assessment.182 This list shows contaminants, are properly identified the status (as of March 2010) of all on the label, are legally marketed, herbal substances that have been and conform to all governing prioritized for the development of a regulations. Although the FDA does Community Herbal (therapeutic) not endorse the American Herbal Monograph. Available at: Products Associations‟ (AHPA) http://www.ema.europa.eu/pdfs/hum publication “Herbs of Commerce,” an/hmpc/49407907en.pdf 2nd Edition (2000),183 for the purpose of determining whether a botanical was in U.S. commerce prior to 1994, the Herbs of United States of America: Whether a Commerce does provide a very natural botanical ingredient may be good indication that the ingredient present in a product is dependent on was likely in commerce prior to the regulatory framework for the finished 1994. If a natural ingredient was not product, i.e. cosmetic, dietary marketed in the USA prior to 1994, it supplement, drug or food product. Some is classified as New Dietary information is available on-line to help Ingredient (NDI) and is subject to determine the status and framework for the 1997 regulation “Premarket natural ingredients: Notification for a New Dietary Ingredient”: http://edocket.access.gpo.gov/cfr_2  Cosmetic ingredients: For natural 184 ingredients used in cosmetic 009/aprqtr/pdf/21cfr190.6.pdf products, the FDA provides Additional information on the NDI guidance on basic requirements for process is available on-line at: color additives and cosmetics at: http://www.fda.gov/Food/DietarySup http://www.cfsan.fda.gov/~dms/cos- plements/ucm109764.htm col.html. The list of ingredients that Information on how to submit an NDI are prohibited and restricted for use notification is available on-line at: in cosmetics is available at: http://www.fda.gov/Food/DietarySup plements/NewDietaryIngredientsNoti

183 McGuffin M, Kartesz JT, Leung AY, Tucker AO (eds.). 181 Medicines and Healthcare products Regulatory Agency American Herbal Products Association’s Herbs of (MHRA). Frequently asked questions: What is the role of Commerce, 2nd Edition. Silver Spring MD: American the positive list? London: MHRA. 2008. Herbal Products Association. 2000. 182 European Medicines Agency (EMEA) Committee on 184 Food and Drug Administration. New Dietary Ingredient Herbal Medicinal Products (HMPC). Inventory of Herbal Notification. In: Code of Federal Regulations, Title 21, Substances for Assessment. London: European Section 190.6 (21 CFR §190.6). Washington, DC: Medicines Agency HMPC. 10 January 2008. Available National Archives and Records Administration. at: 2009;601-602. Available at: http://www.emea.europa.eu/pdfs/human/hmpc/4940790 http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr1 7en.pdf 90.6.pdf

75 | P a g e ficationProcess/HowtoSubmitNotific The EAFUS list of substances ations/default.htm contains ingredients added directly  Drug ingredients: For a natural to food that FDA has either ingredient to be permitted for use in approved as food additives or listed an over-the-counter (OTC) or or affirmed as GRAS. Nevertheless, prescription drug product, the it contains only a partial list of all ingredient, if the active food ingredients that may in fact be pharmaceutical ingredient, must be lawfully added to food, because classified by the FDA as Generally under federal law some ingredients Recognized as Safe and Effective may be added to food under a (GRASE) and included in a positive GRAS determination made therapeutic monograph published in independently from the FDA. The list Title 21 of the Code of Federal contains many, but not all, of the Regulations (21 CFR) which are substances subject to independent available on-line.185 Some GRAS determinations. ingredients, however, are not yet For information about the GRAS entered in the current edition of the notification program please consult CFR and can only be found listed in the Inventory of GRAS Notifications a tentative final monograph. These at: monographs are posted on-line at http://www.cfsan.fda.gov/~rdb/opa- the “Rulemaking History for Non- gras.html prescription Products: Drug Additional information on the status Category List,” available at: of Food and Color Additives can be http://www.fda.gov/Drugs/Developm obtained from the Food Additive entApprovalProcess/DevelopmentR Status List at: esources/Over-the- http://www.cfsan.fda.gov/~dms/opa- CounterOTCDrugs/StatusofOTCRul appa.html or from the Color Additive emakings/default.htm Status List, available at: Natural ingredients that are http://www.fda.gov/ForIndustry/Color classified as GRASE active Additives/ColorAdditiveInventories/u ingredients in the CFR monographs cm106626.htm have corresponding quality standards monographs published in the United States Pharmacopeia – National Formulary (USP-NF).186  Food ingredients: For a natural ingredient to be permitted for use in a food product in the United States it must be classified by the FDA as Generally Recognized as Safe (GRAS) for use in foods. The FDA Center for Food Safety and Applied Nutrition (CFSAN) maintains a food additive database known as the “Everything Added to Food in the United States (EAFUS),” available on-line at: http://www.fda.gov/Food/FoodIngred ientsPackaging/ucm115326.htm

185 Food and Drug Administration. Title 21 Food and Drugs. In: Code of Federal Regulations. Washington, DC: National Archives and Records Administration. 2008. Available at: http://www.gpoaccess.gov/cfr/index.html 186 United States Pharmacopeia Convention. United States Pharmacopeia – National Formulary (USP 32-NF 27). Rockville, MD: United States Pharmacopeia Convention. 2009.

76 | P a g e Wholesale distributors, processors and importers of natural ingredients in selected destination countries potentially interested in these species

The catalogues of the following selected major importers, processors and distributors of botanical ingredients were surveyed. The listed companies are mostly situated in European countries (France, Germany, Italy, Spain, United Kingdom), North American countries (Canada, United States), Northern African countries (Egypt), and Western Asian countries (Turkey). Below each entry it is noted whether any ingredients of the ten genera are offered, what form, if known, and what country of origin, if known.

ADECO (Egypt) http://www.adecoherbs.com

Origanum ingredients offered:

 Sweet marjoram herb (Origanum majorana), certified organic  Sweet marjoram root (Origanum majorana), certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis).certified organic

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), certified organic

Agromisr (Egypt) http://www.agromisr.org

Origanum ingredients offered:

 Sweet marjoram herb (Origanum majorana), crushed, fine-cut or powder, certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis).crushed or powdered, certified organic

Alfred Galke GmbH (Germany) http://www.galke.com

Salvia ingredients offered:

 Dalmatian sage leaf, PhEur-grade, whole, cut or powdered  Greek (three-lobed) sage, food-grade, whole or cut, certified organic

Satureja ingredients offered:

 Savory wort, DAB-grade (Erg.B6), rubbed, cut or powdered

Thymus ingredients offered:

 Thyme herb, PhEur-grade, rubbed  Thyme herb, food-grade, rubbed, certified organic

77 | P a g e Viola ingredients offered:

 Sweet violet flowers (Viola odorata), whole  Sweet violet herb (Viola odorata), whole or cut  Sweet violet root (Viola odorata), whole or cut

Algart International (Canada) http://www.algart.ca

Origanum ingredients offered:

 Oregano herb (Origanum vulgaris)

Salvia ingredients offered:

 Sage leaf (Salvia officinalis)

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris)

AMD Verde (Egypt) http://www.amd-verde.com

Origanum ingredients offered:

 Sweet marjoram herb (Origanum majorana), crushed, certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis).certified organic

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), certified organic

Arcotrade (Egypt) http://www.arcotrade-eg.com

Alcea ingredients offered:

 Hollyhock flower (Alcea rosea), whole, dried

Origanum ingredients offered:

 Sweet marjoram herb (Origanum majorana), rubbed

BDS Natural Products (USA): http://www.bdsnatural.com

Origanum ingredients offered:

 Turkish Oregano herb

Salvia ingredients offered:

78 | P a g e  Sage leaf (Salvia officinalis), whole or ground

Satureja ingredients offered:

 Savory

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), whole or ground

BI Nutraceuticals (USA) http://www.botanicals.com

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), whole, powdered or tea-bag-cut

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), whole, powdered or tea-bag-cut

Bio International Organic Inc. (Canada) http://www.biorganic.ca

Origanum ingredients offered:

 Oregano herb (Origanum vulgare)  Sweet marjoram herb (Origanum majorana)

Salvia ingredients offered:

 Sage leaf (Salvia officinalis)

Satureja ingredients offered:

 Savory (species??)

Thymus ingredients offered:

 Lemon thyme herb (Thymus citriodorus)  Thyme herb (Thymus vulgaris or Thymus zygis)

Birlik S.A. (Turkey) http://www.birlikas.com

Origanum ingredients offered:

 Oregano herb

Salvia ingredients offered:

 Sage leaf

Blumeks Ltd (Turkey) http://www.blumeks.com

79 | P a g e Origanum ingredients offered:

 Oregano, rubbed, whole, extra quality, fancy quality, regular quality, FAQ quality

Salvia ingredients offered:

 Sage leaf, rubbed, whole, or powdered

Thymus ingredients offered:

 Thyme leaf, whole, ground or powdered

Destilaciones Bordas Chinchurreta, SA (Spain) http://www.bordas-sa.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare)  Oregano (Origanum vulgare) oleoresin

Salvia ingredients offered:

 Spanish sage leaf (Salvia lavandulaefolia), Spain  Spanish sage (Salvia lavandulaefolia), essential oil and oleoresin

Thymus ingredients offered:

 Spanish marjoram (Thymus mastichina), Spain  Spanish marjoram (Thymus mastichina) absolute, essential oil, and oleoresin  Spanish Origanum herb (Thymus capitatus), Spain  Spanish Origanum (Thymus capitatus) essential oil  Spanish thyme herb (Thymus zygis), Spain  Spanish thyme (Thymus zygis) absolute, concrete, essential oil, and oleoresin

 Thyme herb (Thymus vulgaris), Spain  Thyme herb (Thymus vulgaris), essential oil and oleoresin

Dr. F. Elshobaki (Egypt) http://www.elshobaki.com

Origanum ingredients offered:

 Sweet marjoram herb (Origanum majorana)

Salvia ingredients offered:

 Sage leaf (Salvia officinalis)

Dixa AG (Switzerland) http://www.dixa.ch

Origanum ingredients offered:

 Oregano herb (Origanum vulgare), food-grade, cut, powdered, or rubbed and cleaned

80 | P a g e Salvia ingredients offered:

 Clary sage leaf (Salvia sclarea), cut  Sage leaf (Salvia officinalis), food grade, whole, selected  Sage leaf essential oil (Salvia officinalis), PhHelv-grade  Three-lobed sage leaf (Salvia triloba), PhEur-grade, cut or powdered  Three-lobed sage leaf tincture 1:8 (w/v) (Salvia triloba)

Satureja ingredients offered:

 Savory herb (species??), food-grade, cut or powdered

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris or Thymus zygis), PhEur-grade, powdered or rubbed and cleaned  Thyme herb (Thymus vulgaris or Thymus zygis) essential oil, PhEur-grade  Thyme herb (Thymus vulgaris or Thymus zygis) fluidextract, PhHelv-grade  Thyme herb (Thymus vulgaris) tincture 1:5 (w/v)

Viola ingredients offered:

 Mountain pansy flower (Viola lutea)  Sweet violet flower (Viola odorata), whole, cut or powdered  Sweet violet root (Viola odorata), whole, cut or powdered  Wild pansy herb (Viola arvensis or Viola tricolor), PhEur-grade, cut or powde4red  Wild pansy herb (Viola arvensis or Viola tricolor) tincture 1:10 (w/v)  Wild pansy flower (Viola tricolor)

EGINTEX Co. (Egypt) http://www.egintex.com

Origanum ingredients offered:

 Sweet marjoram herb (Origanum majorana), green crushed, grey crushed or fine-cut

Egy Herbal (Egypt) http://www.egyherbal.com

Origanum ingredients offered:

 Oregano herb (Origanum vulgaris), certified organic, Egypt

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), certified organic, Egypt

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), certified organic, Egypt

EPO S.r.L. (Italy) http://www.eposrl.com/eposrl

Origanum ingredients offered:

81 | P a g e  Oregano herb (Origanum vulgaris) fluidextract

Salvia ingredients offered:

 Sage leaf (Salvia officinalis) dry aqueous extract  Sage leaf (Salvia officinalis) fluidextract  Sage leaf (Salvia officinalis) glycolic extract

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris) dry aqueous extract  Thyme herb (Thymus vulgaris) fluidextract  Thyme herb (Thymus vulgaris) glycolic extract  Wild thyme herb (Thymus serpyllum) fluidextract

Viola ingredients offered:

 Wild pansy herb (Viola tricolor) dry aqueous extract  Wild pansy herb (Viola arvensis or Viola tricolor) fluidextract

Essential Fine Oils (Spain) http://www.essentialfineoils.com

Salvia ingredients offered:

 Clary sage flowering tops (Salvia sclarea) essential oil, Spain  Sage leaf (Salvia officinalis) essential oil, Spain  Spanish sage leaf (Salvia lavandulaefolia) essential oil, Spain

Thymus ingredients offered:

 Spanish Origanum (Thymus capitatus) essential oil, Spain  Spanish thyme (Thymus zygis) essential oil, Spain  Thyme herb (Thymus vulgaris) essential oil, Spain

Flavex Naturextrakte (Germany) http://www.flavex.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare) CO2 extract

Salvia ingredients offered:

 Chia seed (Salvia hispanica) CO2 extract  Sage leaf (Salvia officinalis) extract, 35% diterpene phenols  Sage leaf (Salvia officinalis) CO2 extract, 5% Oleanolic / Ursolic acid  Three-lobed safe leaf (Salvia triloba) extract, 35% diterpene phenols  Three-lobed sage leaf (Salvia triloba) CO2 extract, 5% Oleanolic / Ursolic acid

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris) CO2 extract

82 | P a g e Frontier Natural Products Coop (USA) http://www.frontiercoop.com Origanum ingredients offered:

 Oregano leaf (Origanum vulgare subsp. hirtum), cut & sifted, flakes or powder, certified organic  Sweet marjoram leaf (Origanum majorana), cut & sifted, flakes or powder, certified organic

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole, certified organic  Sage leaf (Salvia officinalis), Grade Prime #1, whole, ground, powdered, rubbed, certified organic

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), cut & sifted, certified organic  Winter savory leaf (Satureja montana), whole, cut & sifted, powdered, certified organic

Thymus ingredients offered:

 Lemon thyme herb (Thymus × citriodorus), certified organic  Thyme herb (Thymus vulgaris), Extra Fancy Grade, certified organic, whole, flakes or powder

GfN Selco (Germany) http://www.gfn-selco.de

Viola ingredients offered:

 Wild pansy herb (Viola arvensis or Viola tricolor) extract

Giza Seeds and Herbs (Egypt) http://www.gizaseeds.com

Origanum ingredients offered:

 Sweet marjoram leaf (Origanum majorana)

Heinrich Klenk GmbH (Germany) http://www.klenk-herbline.de

Origanum ingredients offered:

 Oregano herb (Origanum vulgare subsp. hirtum), cut & sifted or rubbed

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), hand-picked, whole or cut (8 mm), certified organic

Satureja ingredients offered:

 Savory herb (species??), rubbed

Thymus ingredients offered:

83 | P a g e  Thyme herb (Thymus vulgaris), rubbed

Viola ingredients offered:

 Sweet violet flower (Viola odorata), whole  Sweet violet herb (Viola odorata), whole,  Wild pansy flower (Viola arvensis or Viola tricolor), whole  Wild pansy herb (Viola arvensis or Viola tricolor) whole

Herbes del Moli (Spain) http://www.herbesdelmoli.com

Micromeria ingredients offered:

 White-leaved savory herb (Micromeria fructicosa), certified organic

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), certified organic  Oregano leaf (Origanum vulgare) essential oil, certified organic  Sweet marjoram leaf (Origanum majorana), certified organic  Sweet marjoram leaf (Origanum majorana) essential oil, certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis) essential oil, certified organic  Spanish sage (Salvia lavandulifolia) essential oil, certified organic

Satureja ingredients offered:

 Savory herb (species??), essential oil, certified organic

Thymus ingredients offered:

 Pebrella leaf (Thymus piperella), certified organic  Thyme herb (Thymus vulgaris), certified organic  Thyme herb (Thymus vulgaris) essential oil, certified organic

Viola ingredients offered:

 Wild pansy herb (Viola arvensis or Viola tricolor), certified organic

High Quality Organics (USA) http://www.hqorganics.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), certified organic  Sweet marjoram leaf (Origanum majorana), certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis) certified organic

84 | P a g e Satureja ingredients offered:

 Savory herb (species??), essential oil, certified organic

Thymus ingredients offered:

 Lemon thyme herb (Thymus × citriodora)  Thyme herb (Thymus vulgaris), certified organic

Jenaer Pflanzenrohstoffe (Germany) http://jenaer-pflanzenrohstoffe.com

Origanum ingredients offered:

 Oregano herb (Origanum vulgare), whole

Salvia ingredients offered:

 Clary sage herb (Salvia sclarea), whole  Sage leaf (Salvia officinalis), whole  Three-lobed sage leaf (Salvia triloba), whole

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), rubbed

Viola ingredients offered:

 Wild pansy herb (Viola arvensis or Viola tricolor), whole

Jürgen Serr Herb Service (Germany) http://www.herb-service.com

Alcea ingredients offered:

 Rose-mallow / hollyhock (Alcea rosea), certified organic

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare subsp. hirtum), cut & sifted, tea-bag-cut, powder, certified organic  Sweet marjoram leaf (Origanum majorana), cut & sifted, tea-bag-cut, powder, certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), cut & sifted, tea-bag-cut, powder, certified organic

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), cut & sifted, tea-bag-cut, powder, certified organic  Winter savory leaf (Satureja montana), cut & sifted, tea-bag-cut, powder, certified organic

85 | P a g e Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), cut & sifted, tea-bag-cut, powder, certified organic  Wild thyme herb (Thymus serpyllum), cut & sifted, tea-bag-cut, powder, certified organic

Viola ingredients offered:

 Sweet violet root (Viola odorata), cut & sifted, tea-bag-cut, powder, certified organic

Kekik Tarim (Turkey) http://www.oreganoft.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), rubbed  Oregano water (Origanum vulgare)

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), whole or rubbed

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), rubbed or crushed  Thyme herb water (Thymus vulgaris)

Kräuter Mix GmbH (Germany) http://www.kraeuter-mix.de

Origanum ingredients offered:

 Oregano herb (Origanum vulgare)  Sweet marjoram leaf (Origanum majorana)

Salvia ingredients offered:

 Sage leaf (Salvia officinalis)  Three-lobed sage leaf (Salvia triloba)

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis)  Winter savory leaf (Satureja montana)

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris)

L'Herbier du Diois (France) http://www.herbier-du-diois.com

Origanum ingredients offered:

 Oregano herb (Origanum vulgare), dried or fresh, certified organic

86 | P a g e  Sweet marjoram leaf (Origanum majorana), dried or fresh, certified organic

Salvia ingredients offered:

 Clary sage leaf (Salvia sclarea) essential oil, certified organic  Sage leaf (Salvia officinalis), dried or fresh, certified organic  Sage leaf (Salvia officinalis, dried extract, certified organic  Sage leaf (Salvia officinalis) essential oil, certified organic  Spanish sage leaf (Salvia lavandulifolia), dried or fresh, certified organic  Spanish sage leaf (Salvia lavandulifolia), essential oil, certified organic

Satureja ingredients offered:

 Winter savory leaf (Satureja montana), dried or fresh, certified organic  Winter savory leaf (Satureja montana), dried extract, certified organic  Winter savory leaf (Satureja montana), essential oil, certified organic

Thymus ingredients offered:

 Lemon thyme herb (Thymus × citriodorus), dried or fresh, certified organic  Thyme herb (Thymus vulgaris), dried or fresh, certified organic  Thyme herb (Thymus vulgaris) essential oil, certified organic  Wild thyme herb (Thymus serpyllum), dried or fresh, certified organic

Viola ingredients offered:

 Wild pansy herb (Viola arvensis or Viola tricolor), dried or fresh, certified organic

Liberty Natural Products (USA) http://www.libertynatural.com

Origanum ingredients offered:

 Moroccan oregano herb (Origanum compactum) essential oil, Morocco  Oregano herb (Origanum vulgare), whole, dried herb, USA  Oregano herb (Origanum vulgare), powdered herb, Turkey  Oregano herb (Origanum vulgare) essential oil, from wild collection in Hungary and or Turkey  Oregano herb (Origanum vulgare) tincture, USA  Syrian marjoram herb (Origanum syriacum) essential oil  Turkish oregano herb (Origanum minutiflorum) essential oil, Turkey

Salvia ingredients offered:

 Blue mountain sage (Salvia stenophylla) essential oil, South Africa  Chia seed (Salvia hispanica) fixed oil  Clary sage (Salvia sclarea) absolute, France  Clary sage flower (Salvia sclarea), dried, USA  Clary sage (Salvia sclarea) distillate water, USA  Clary sage (Salvia sclarea) essential oil, Bulgaria, France, Hungary, Russia, Ukraine or USA origins  Sage leaf (Salvia officinalis), dried powder, Italy  Sage leaf (Salvia officinalis) essential oil, Hungary or Ukraine origins  Spanish sage leaf (Salvia lavandulifolia) essential oil, Spain

87 | P a g e Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis) essential oil, Hungary  Winter savory leaf (Satureja montana) essential oil, Albania

Thymus ingredients offered:

 Orange thyme herb (Thymus fragrantissimus), dried, whole, USA  Red thyme herb (Thymus vulgaris) carvacrol type essential oil, Hungary  Spanish marjoram herb (Thymus mastichina) essential oil, Spain  Spanish oregano herb (Thymus capitatus) essential oil, Albania or Hungary origins  Spanish thyme herb (Thymus zygis) essential oil, Spain  Spanish thyme herb (Thymus zygis) essential oil, FCC-grade, USA  Thyme borneol (Thymus satureioides) essential oil, Morocco  Thyme herb (Thymus vulgaris), dried, whole, USA  Thyme herb (Thymus vulgaris) tincture, USA  Thyme leaf (Thymus vulgaris), dried, cut & sifted, Peru  Wild thyme herb (Thymus serpyllum) essential oil, Albania

Viola ingredients offered:

 Sweet violet herb (Viola odorata), powdered  Sweet violet leaf (Viola odorata), cut & sifted, USA  Sweet violet leaf (Viola odorata) absolute, Egypt  Sweet violet leaf (Viola odorata) concrete, Egypt

Long Life Herbals (Egypt) http://www.longlifeherbals.com

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), ground

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), ground

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), ground

Mane Flavour & Fragrance (France) http://www.mane.com

Salvia ingredients offered:

 Clary sage (Salvia sclarea) absolute

Viola ingredients offered:

 Sweet violet herb (Viola odorata) absolute, Egypt or France origins  Sweet violet leaf (Viola odorata) concrete, France

Martin Bauer GmbH (Germany) http://www.martin-bauer.com

88 | P a g e Origanum ingredients offered:

 Oregano herb (Origanum vulgare), cut & sifted, tea-bag-cut, powdered  Sweet marjoram herb (Origanum majorana), cut & sifted, tea-bag-cut, powdered

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), cut & sifted, tea-bag-cut, powdered  Three-lobed sage leaf (Salvia triloba), cut & sifted, tea-bag-cut, powdered

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), cut & sifted, tea-bag-cut, powdered  Wild thyme herb (Thymus serpyllum), cut & sifted, tea-bag-cut, powdered

Viola ingredients offered:

 Wild pansy aerial parts (Viola tricolor), cut & sifted, tea-bag-cut, powdered

Moellhausen (Italy) http://www.moellhausen.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare) essential oil and oleoresin

Salvia ingredients offered:

 Sage leaf (Salvia officinalis) essential oil

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis) essential oil

Thymus ingredients offered:

 Spanish origanum herb (Thymus capitatus) essential oil and oleoresin  Thyme leaf (Thymus vulgaris) essential oil

Monteloeder (Spain) http://www.monteloeder.com

Origanum ingredients offered:

 Oregano herb (Origanum vulgare) extract

Salvia ingredients offered:

 Sage leaf (Salvia officinalis) extract

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris) extract

89 | P a g e Mountain Rose Herbs (USA) http://www.mountainroseherbs.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), dried, certified organic, USA  Oregano leaf (Origanum vulgare) essential oil, certified organic  Sweet marjoram herb (Origanum majorana), dried certified organic, Egypt

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole, certified organic, Mexico  Clary sage leaf (Salvia sclarea) essential oil, certified organic, USA  Sage leaf (Salvia officinalis), dried, certified organic, USA  Sage leaf (Salvia officinalis) essential oil, certified organic, USA  White sage whole leaf on stem (Salvia apiana), dried, California

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), dried, certified organic, Turkey  Winter savory leaf (Satureja montana), dried, certified organic, Argentina  Winter savory leaf (Satureja montana) essential oil, certified organic, Hungary

Thymus ingredients offered:

 Lemon thyme herb (Thymus × citriodorus), dried, certified organic, USA  Spanish marjoram herb (Thymus mastichina) essential oil, certified organic, Spain  Spanish thyme herb (Thymus zygis) essential oil, certified organic, Spain  Thyme leaf (Thymus vulgaris), dried, certified organic, Egypt

Viola ingredients offered:

 Sweet violet leaf (Viola odorata), dried, certified organic, Hungary

Müggenburg Pflanzenliche Rohstoffe (Germany) http://www.paulmueggenburg.de

Origanum ingredients offered:

 Oregano herb (Origanum vulgare), dried rubbed

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole  Chinese salvia root (Salvia miltiorrhiza), whole  Clary sage herb (Salvia sclarea), whole  Sage leaf (Salvia officinalis), whole, cut or powdered

Satureja ingredients offered:

 Summer savory herb or leaf (Satureja hortensis), dried, whole  Winter savory herb (Satureja montana), dried, whole or rubbed

90 | P a g e Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), dried, whole, rubbed or powdered

Viola ingredients offered:

 Sweet violet flower (Viola odorata), dried, whole  Wild pansy aerial parts (Viola tricolor), dried, cut & sifted or powdered

Naturex (France) http://www.naturex.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare) dry extract 4:1 (w./w)

Salvia ingredients offered:

 Chinese salvia root (Salvia miltiorrhiza) dry extract 4:1 (w/w)  Clary sage leaf (Salvia sclarea) dry extract, 2.5% rosmarinic acid  Sage leaf (Salvia officinalis) dry extract 4:1 (w/w)

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris) extract, 2% essential oil  Thyme herb (Thymus vulgaris) dry extract, 6% total phenolic acids and flavonoids

Viola ingredients offered:

 Wild pansy aerial parts (Viola tricolor) dry extract 4:1 (w/w)

Nile Herbs (Egypt) http://www.nileherbs.com

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), certified organic

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), certified organic

Organa (Egypt) http://organa-egy.com

Origanum ingredients offered:

 Sweet marjoram leaf (Origanum majorana), certified organic, Egypt

Organic Partners (UK) http://organicpartners.com

Alcea ingredients offered:

 Hollyhock flower (Alcea rosea), dried whole, certified organic

91 | P a g e Origanum ingredients offered:

 Oregano leaf (Origanum spp.), dried, whole, cut or powder, certified organic, Turkey  Oregano leaf (Origanum spp.) essential oil, certified organic  Sweet marjoram leaf (Origanum majorana), dried, cut or powder, certified organic, Egypt  Sweet marjoram leaf (Origanum majorana) essential oil, certified organic

Salvia ingredients offered:

 Clary sage (Salvia sclarea) essential oil, certified organic  Red sage tops (Salvia officinalis var purpurea), dried, cut, certified organic, UK  Sage leaf (Salvia officinalis), dried, whole, cut or powder, certified organic, Poland  Sage leaf (Salvia officinalis) essential oil, certified organic  Sage leaf (Salvia officinalis) hydrosol, certified organic, France  Three-lobed sage leaf (Salvia triloba), dried, cut, certified organic, Turkey

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), dried, cut, certified organic, France  Winter savory herb (Satureja montana), dried, cut certified organic

Thymus ingredients offered:

 Lemon thyme leaf (Thymus × citriodorus), dried, whole or cut, certified organic, France  Spanish marjoram herb (Thymus mastichina) essential oil, certified organic, Spain  Spanish thyme herb (Thymus zygis), dried, certified organic, Spain  Thyme leaf (Thymus vulgaris), dried, whole, cut or powder, certified organic, Kenya or Turkey origins  Thyme leaf (Thymus vulgaris) essential oil, certified organic, Kenya  Thyme leaf (Thymus vulgaris) hydrosol, certified organic, Kenya  Wild thyme herb (Thymus serpyllum), dried, certified organic

Viola ingredients offered:

 Sweet violet leaf (Viola odorata), dried, cut, certified organic, Bosnia & Herzegovina  Wild pansy aerial parts (Viola tricolor), dried, cut, certified organic, Poland

Ozsoy Agroland (Turkey) http://www.ozsoyagroland.com

Origanum ingredients offered:

 Oregano herb  Oregano extract

Salvia ingredients offered:

 Sage leaf

Thymus ingredients offered:

 Thyme herb or leaf

92 | P a g e Pacific Botanicals (USA) http://www.pacificbotanicals.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), dried, certified organic, USA  Sweet marjoram leaf (Origanum majorana), dried, certified organic, Egypt

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole, certified organic, Mexico  Sage leaf (Salvia officinalis), dried, whole, cut or powder, certified organic, USA

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), dried, whole, cut or powder, certified organic, Turkey

Pharaonic BioHerb (Egypt) http://www.pharoherb.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), dried, certified organic  Sweet marjoram leaf (Origanum majorana), dried, certified organic

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), dried, certified organic

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), dried, certified organic

Ph. Seyfried Gewürzmühle GmbH (Germany) http://www.seyma.de

Origanum ingredients offered:

 Oregano herb (Origanum vulgare), dried

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), dried

Satureja ingredients offered:

 Summer savory herb or leaf (Satureja hortensis), dried  Winter savory herb (Satureja montana), dried

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), dried

PharmaNutrients Botanical Corp (Canada) http://www.pharmanutrients.ca

93 | P a g e Origanum ingredients offered:

 Oregano herb (Origanum vulgare), dried

Salvia ingredients offered:

 Sage leaf (Salvia officinalis), dried

Satureja ingredients offered:

 Summer savory herb or leaf (Satureja hortensis), dried  Winter savory herb (Satureja montana), dried

Thymus ingredients offered:

 Thyme herb (Thymus vulgaris), dried

Plantex (France) http://www.plantex.fr

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare) extract 4:1 (w/w)  Sweet marjoram leaf (Origanum majorana) 4:1 (w/w), 2% essential oil

Salvia ingredients offered:

 Clary sage herb (Salvia sclarea) extract 5:1 (w/w)  Sage leaf (Salvia officinalis) extract 4:1 (w.w), 1% essential oil

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris) extract 5:1 (w/w) 1.5% essential oil

Viola ingredients offered:

 Wild pansy whole plant (Viola tricolor) dry extract 8:1 (w/w), 3% rutin

Royal for Herbs (Egypt) http://www.royalforherbs.com

Origanum ingredients offered:

 Sweet marjoram leaf (Origanum majorana), crushed, certified organic

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), certified organic

San Francisco Herb & Natural Food Co. (USA) http://www.herbspicetea.com

Origanum ingredients offered:

94 | P a g e  Oregano leaf (Origanum vulgare), cut & sifted or powder, certified organic, USA; conventional from Turkey  Sweet marjoram leaf (Origanum majorana), cut & sifted or powder, Egypt  Sweet marjoram leaf (Origanum majorana) essential oil,

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole or ground, Mexico  Chinese salvia root (Salvia miltiorrhiza), whole, China  Clary sage (Salvia sclarea) essential oil  Sage leaf (Salvia officinalis), cut & sifted or powder, certified organic, USA; conventional from Albania  Sage leaf (Salvia officinalis) essential oil  White sage flower (Salvia apiana), dried, USA

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), whole, cut & sifted or powder, Poland;, certified organic from USA

Thymus ingredients offered:

 Lemon thyme leaf (Thymus citriodorus), cut & sifted or powder, USA  Spanish origanum herb (Thymus capitatus) essential oil  Thyme herb (Thymus vulgaris), whole, cut & sifted or powder, Morocco, Spain or USA; certified organic from USA  Thyme leaf (Thymus vulgaris) essential oil

Viola ingredients offered:

 Sweet violet herb (Viola odorata), whole, cut & sifted or powdered, Pakistan  Wild pansy aerial parts (Viola tricolor), cut or powdered, Romania

Selim Uludag (Turkey) http://www.selimuludag.com.tr

Origanum ingredients offered:

 Oregano herb

Salvia ingredients offered:

 Sage leaf

Thymus ingredients offered:

 Thyme herb or leaf

Starwest Botanicals (USA) http://www.starwest-botanicals.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), cut & sifted or powder, certified organic, Turkey  Oregano leaf (Origanum vulgare) essential oil, certified organic, Spain

95 | P a g e  Sweet marjoram leaf (Origanum majorana), cut & sifted, certified organic, Egypt

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole, certified organic, Mexico  Clary sage (Salvia sclarea) essential oil, France  Sage leaf (Salvia officinalis), dried, cut & sifted or powder, certified organic, Croatia or Egypt origins  Sage leaf (Salvia officinalis) essential oil, Republics of the Former Yugoslavia

Satureja ingredients offered:

 Summer savory leaf (Satureja hortensis), cut & sifted, certified organic, Croatia

Thymus ingredients offered:

 Spanish marjoram herb (Thymus mastichina) essential oil, Spain  Thyme herb (Thymus vulgaris), cut & sifted or powder, certified organic, Egypt  Thyme leaf (Thymus vulgaris) essential oil, Spain

Viola ingredients offered:

 Sweet violet herb (Viola odorata), cut & sifted or powdered, Bulgaria

Whole Herb Company (USA) http://www.wholeherbcompany.com

Origanum ingredients offered:

 Oregano leaf (Origanum vulgare), dried  Oregano leaf (Origanum vulgare) essential oil  Sweet marjoram leaf (Origanum majorana), dried

Salvia ingredients offered:

 Chia seed (Salvia hispanica), whole  Sage leaf (Salvia officinalis), dried  Sage leaf (Salvia officinalis) essential oil

Satureja ingredients offered:

 Savory leaf (Satureja capitata), dried  Summer savory herb (Satureja hortensis), dried

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), dried  Thyme leaf (Thymus vulgaris) essential oil

Worlée Naturprodukte (Germany) http://www.worlee.de

Origanum ingredients offered:

96 | P a g e  Oregano leaf (Origanum vulgare), dried  Sweet marjoram leaf (Origanum majorana), dried

Salvia ingredients offered:

 Three-lobed sage leaf (Salvia triloba), dried

Satureja ingredients offered:

 Summer savory herb (Satureja hortensis), dried

Thymus ingredients offered:

 Thyme leaf (Thymus vulgaris), dried

97 | P a g e