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1、Funded by the European UnionEXPORT GUIDEMedicinal and aromatic plant ingredients and productsStreet address:ITC 54-56,rue de Montbrillant 1202 Geneva,SwitzerlandPostal address:ITC Palais des Nations 1211 Geneva 10,Switzerland Telephone:+41 22 730 0111E-mail:itcregintracen.orgInternet:www.intracen.or
2、g/publicationsThe International Trade Centre(ITC)is the joint agency of the World Trade Organization and the United Nations.International Trade Centre EXPORT GUIDE Medicinal and aromatic plant ingredients and products Export Guide to Medicinal and Aromatic Plant Ingredients and Products ii About the
3、 guide Medicinal and aromatic plants are key ingredients to food,cosmetic and medicinal consumer products.The medicinal plants market alone was valued at over$3 billion in 2015 and is expanding as the use of natural ingredients grows.This guide provides all that an exporter needs to describe a produ
4、ct,understand regulatory requirements,navigate sustainability standards,improve branding and find information on buyers and trade promotion.Publisher:International Trade Centre Title:Export Guide to Medicinal and Aromatic Plant Ingredients and Products Publication date and place:Geneva,February 2023
5、 Page count:120 ITC Document Number:GIVC-23-114.E Citation International Trade Centre(2023).Export Guide to Medicinal and Aromatic Plant Ingredients and Products.ITC,Geneva.(or)Brendler,T.and Brinckmann,J.A.(2023).Export Guide to Medicinal and Aromatic Plant Ingredients and Products.International Tr
6、ade Centre,Geneva,Switzerland.For more information,contact:greentocompeteintracen.org ITC encourages the reprinting and translation of its publications to achieve wider dissemination.Short extracts of this paper may be freely reproduced,with due acknowledgement of the source.Permission should be req
7、uested for more extensive reproduction or translation.A copy of the reprinted or translated material should be sent to ITC.Digital images on the cover:Shutterstock International Trade Centre(ITC)ITC is the joint agency of the World Trade Organization and the United Nations.Export Guide to Medicinal
8、and Aromatic Plant Ingredients and Products iii Foreword The worlds biodiversity is under threat from climate change,invasive species and habitat loss from land use change.This threat is compounded by human demand for plants and trees that we use in our everyday lives.Around 26,000 plant species are
9、 documented to have medicinal or aromatic uses.Most of these plants are collected from wild populations.They range from liquorice root and rhodiola root for medicinal products and health supplements,to argan kernel oil for cosmetics,acai berries and baobab for health drinks.Trade in these plants has
10、 increased threefold since 1999.The top importers are the United States,Germany,Japan and China.The rush to supply these growing markets is placing intense pressure on the plant resources,resulting in their overexploitation and damage to wild populations.Market deals in bulk trade are usually betwee
11、n producers and ingredient processors and distributors,and do not report on sustainability,benefit sharing and labour standards in the same manner expected of finished product brand holders.Regulations and standards have emerged to address these issues.These regulations and standards are now importa
12、nt market requirements for exporters in niche markets.The medicinal and aromatic plants sector comprises many small enterprises.This guide helps them access information on markets,marketing and branding strategies,and certification.Others in the value chain can also benefit from the guide.They inclu
13、de public authorities in the forestry,agriculture and health sectors,the academic and research sector,and training and certification bodies.ITC is committed to supporting trade to enable the green transition.I hope that our partners in developing countries,specifically small businesses,will find tha
14、t this guide improves their capacity to trade,conserve and manage their local wild plant resources sustainably.Pamela Coke-Hamilton Executive Director International Trade Centre Export Guide:Medicinal and aromatic plant ingredients and products iv Acknowledgements The Export Guide:Medicinal and arom
15、atic plant ingredients and products was prepared by Thomas Brendler and Josef Brinckmann under the direction of Alexander Kasterine,Senior Adviser and Hiba Batool,Division of Sustainable and Inclusive Value Chains at the International Trade Centre(ITC).We also thank our ITC colleagues Alexandra Golo
16、vko,Ha Vu,Marie-Claude Frauenrath,Vanessa Erogbogbo,Mirhadi Seyedi,and Majid Bahrami(all ITC)for their valuable inputs and support to research and consultation process.The guide benefited from the input and permission to include selected case studies of market access,including for a novel herbal foo
17、d from Zimbabwe in the EU,an herbal food supplement from South Africa in the US,and a traditional Chinese medicine herbal medicinal product in the EU.We thank Natalie Domeisen,who managed the editorial and production process with the support of Anne Griffin(both ITC).Thanks also to Janet Hill who ed
18、ited the paper,Franco Iacovino(ITC)for layout and Serge Adeagbo(ITC)for printing support.This guide was prepared with generous funding from the European Union.Export Guide to Medicinal and Aromatic Plant Ingredients and Products v Contents Foreword iii Acknowledgements iv Contents v Acronyms ix Exec
19、utive summary xi Chapter 1 Product description 1 Medicinal and aromatic plant ingredients 1 Finished herbal products 2 Herbal cosmetic products 2 Herbal food products 4 Herbal food supplement products 6 Herbal medicinal products 7 Chapter 2 European Union classification and tariffs 8 Combined nomenc
20、lature 8 Integrated Tariff of the European Union(TARIC)10 Chapter 3 Regulatory requirements 13 Regulatory categories for herbal substances and finished products 13 Cosmetic ingredients/products 13 Food additives,enzymes,flavourings and other substances added to food 14 Food ingredients(including nov
21、el and traditional foods)and products 15 Foods for specific uses 17 Food supplement ingredients and products 18 Medicinal ingredients and products 19 Quality assurance 26 Good agricultural and collection practices 27 Good manufacturing practices 28 Quality specifications 31 Herbal ingredients used i
22、n food or food supplement products 35 Herbal ingredients with EU quality scheme certification 39 Herbal ingredients used in medicinal products 40 Limits established for adulterants and contaminants 41 Heavy metals 41 Microbial pathogens 42 Mycotoxins 43 Export Guide:Medicinal and aromatic plant ingr
23、edients and products vi Nicotine 44 Pesticide residues 45 Polycyclic aromatic hydrocarbons 46 Pyrrolizidine alkaloids 48 Tropane alkaloids 51 Radioactive contamination 52 Residues of fumigants and ionizing radiation 53 Labelling 55 Herbal ingredients 55 Herbal finished products 56 Chapter 4 Sustaina
24、ble production and trade 59 International conventions 59 Convention on Biological Diversity of the United Nations 59 Convention on International Trade in Endangered Species of the United Nations 60 European Union regulations 62 EC(proposed)directive on corporate sustainability due diligence 62 EC re
25、gulation concerning traceability and labelling of genetically modified organisms 62 EU regulation on organic production and labelling of organic products 63 Voluntary sustainability standards 64 Ethical BioTrade standard 65 Fair for Life standard 66 Fairtrade standard for herbs,herbal teas and spice
26、s 67 FairWild standard 68 International Demeter Biodynamic standard 69 Chapter 5 Export marketing 71 Main markets for MAP ingredients 71 Main MAP ingredients imported into the European Union 72 Distribution channels 72 Marketing and branding strategies for SMEs 73 Meeting prospective buyers 74 Price
27、 developments and factors influencing price 75 Main importer buyers 76 Market access to the UK after Brexit 76 Export Guide to Medicinal and Aromatic Plant Ingredients and Products vii Appendices 79 Appendix I Publicly available GACP guidelines 79 Appendix II Selected herbs with EU herbal monographs
28、 and specified quality 83 Appendix III Maximum residue levels for pesticides in herbal drugs 89 Appendix IV MAP crops produced at commercial scale in the EU 91 Appendix V MAP ingredients imported into the EU 97 Appendix VI Relevant trade shows in Europe 100 Appendix VII Selected importers/buyers(Eur
29、ope,China,India,US)101 References 107 Figures,Tables,Boxes Figure 1 Calendula officinalis 3 Figure 2 Cocos nucifera 3 Figure 3 Euphorbia antisyphilitica 4 Figure 4 Foeniculum vulgare 5 Figure 5 Illicium verum 6 Figure 6 Saccharum officinarum 7 Figure 7 Bambara groundnut(Vigna subterranea)17 Figure 8
30、 FSMP checklist 18 Figure 9 EU regulatory categories for herbal medicinal products 20 Figure 10 CTD structure 21 Figure 11 Mesembryanthemum tortuosum 26 Figure 12 Glycyrrhiza glabra 33 Figure 13 Matricaria recutica 40 Figure 14 Possible distribution channels for liquorice root exported to Europe 72
31、Table 1 Terms used for MAP ingredients and definitions 1 Table 2 HS,CN and TARIC codes using saffron as an example 8 Table 3 Tariff codes of selected MAPs used by EU,China,India and the US 9 Table 4 TARIC measures for liquorice root extract CN 1302 1200,selected countries 10 Table 5 US GMPs:Cosmetic
32、s,foods,food supplements and drugs 29 Table 6 Comparison of liquorice pharmacopoeial quality standards 34 Table 7 Publicly available quality specifications for selected herbal food ingredients 36 Table 8 Comparison of spearmint leaf food quality standards 38 Table 9 Selected herbs with EU quality sc
33、heme certification 39 Table 10 European heavy metals limits:Herbal drugs,foods and supplements 42 Table 11 Summary of PhEur microbial limits 43 Table 12 European mycotoxin limits:Herbal drugs,foods and supplements 44 Table 13 European maximum residue levels for nicotine(mg/kg)for selected MAPs 45 Ta
34、ble 14 European polycyclic aromatic hydrocarbon limits:Herbal foods and supplements 47 Table 15 Publicly available resources on PAH contamination of herbal materials 47 Table 16 European pyrrolizidine alkaloid limits:Herbal foods and supplements 49 Table 17 Publicly available resources:Mitigation of
35、 PA contamination and requirements 50 Table 18 European tropane alkaloid limits:Herbal tea infusions 51 Table 19 Publicly available resources:Mitigation of TA contamination and requirements 52 Table 20 Pharmacopoeial maximum level of radionuclide activity:Herbal drugs 53 Table 21 EPA tolerances for
36、residues of EtO and 2-chloroethanol in herbal food 54 Table 22 Comparison of EU and US maximum ionizing radiation doses:Herbal foods 55 Table 23 Labelling requirements:Cosmetic,food,food supplement,medicinal product 56 Table 24 Publicly available resources on the Nagoya Protocol 60 Table 25 Example
37、from South Korea:CITES-listed MAP species in trade 61 Export Guide:Medicinal and aromatic plant ingredients and products viii Table 26 Selected UEBT-certified MAP ingredients and producer operations 65 Table 27 Selected Fair for Life certified MAP ingredients and producer operations 66 Table 28 Sele
38、cted FLO Fairtrade certified MAP ingredients and producer operations 67 Table 29 Selected FairWild certified MAP ingredients and producer operations 68 Table 30 Selected Demeter certified MAP ingredients and producer operations 69 Table 31 Main markets for selected MAP headings in 2021 71 Table 32 O
39、ne companys leveraging of quality and sustainability certifications 74 Table 33 Fairtrade price structure for rooibos(Aspalathus linearis)herb from South Africa 75 Table 34 Selected GACPs:International,national,trade,species-specific 79 Table 35 Selected herbs with EU herbal monographs and specified
40、 quality 83 Table 36 PhEur pesticide maximum residue levels established for herbal drugs 89 Table 37 Selected MAP crops produced at commercial scale in the EU 91 Table 38 MAP ingredients imported into the EU in 2021 and top suppliers 97 Table 39 Trade shows for producers and exporters of MAP ingredi
41、ents and products 100 Table 40 Selected buyers of sustainably produced herbal materials in Europe 101 Table 41 Selected buyers of sustainably produced herbal materials in China 103 Table 42 Selected buyers of sustainably produced herbal materials in India 104 Table 43 Selected buyers of sustainably
42、produced herbal materials in the US 105 Box 1 Example of an herbal and mineral cosmetic product 2 Box 2 Example of an herbal food product 4 Box 3 Case study:Market access for an herbal novel food in the EU 16 Box 4 Case study:Market access for an herbal medicinal product 22 Box 5 Case study:Market a
43、ccess for an herbal food supplement in the US 25 Box 6 Tip:Quality certificates 27 Box 7 Tip:Buyer/seller quality agreements 31 Box 8 Tip:Selling the same ingredient in different export markets 32 Box 9 Tip:Quality specifications 32 Box 10 Tip:Temporary official controls that impact entry into the E
44、U 41 Box 11 Tip:EtO residues in herbal drugs vs food additives in the EU 54 Box 12 Tip:Value added by VSS certifications 65 Export Guide to Medicinal and Aromatic Plant Ingredients and Products ix Acronyms Unless otherwise specified,all references to dollars($)are to United States dollars,and all re
45、ferences to tonnes are to metric tons.ABS Access and benefit sharing API Active pharmaceutical ingredient CAC Codex Alimentarius Commission of the Joint FAO/WHO Food Standards Programme CBD Convention on Biological Diversity of the United Nations CHED Common health entry document CITES Convention on
46、 International Trade in Endangered Species of the United Nations CN Combined Nomenclature of the European Commission Taxation and Customs Union CSR Corporate social responsibility CTD Common technical document EC European Commission EDQM European Directorate for the Quality of Medicines and HealthCa
47、re EEA European Economic Area EFEO European Federation of Essential Oils EFFA European Flavour and Fragrance Association EFSA European Food Safety Authority EFTA European Free Trade Association EHIA European Herbal Infusions Association EINECS European Inventory of Existing Commercial Chemical Subst
48、ances ELINCS European List of Notified Chemical Substances EMA European Medicines Agency ESA European Spice Association ESG Environmental,social and governance EU European Union EUROPAM European Herb Growers Association FAO Food and Agriculture Organization of the United Nations FCC Food Chemicals C
49、odex of the United States Pharmacopeial Convention FDA Food and Drug Administration of the United States GACPs Good agricultural and collection practices GI Geographical indication GHPPs Good herbal processing practices GMO Genetically modified organism GMPs Good manufacturing practices GSP General
50、system of preferences HACCP Hazard analysis and critical control points HMPs Herbal medicinal products HMPC Committee on Herbal Medicinal Products of the European Medicines Agency HS Harmonized System nomenclature of the World Customs Organization ICH International Council for Harmonisation of Techn
51、ical Requirements for Pharmaceuticals for Human Use ICS International Classification for Standards IFEAT International Federation of Essential Oils and Aroma Trades Export Guide:Medicinal and aromatic plant ingredients and products x IFOAM International Federation of Organic Agriculture Movements IN
52、CI International Nomenclature of Cosmetic Ingredients IOFI International Organization of the Flavour Industry ISO International Organization for Standardization ITC International Trade Centre IUCN International Union for Conservation of Nature JECFA Joint FAO/WHO Expert Committee on Food Additives M
53、APs Medicinal and aromatic plants MRL Maximum residue limit of pesticide OTC Over the counter PAs Pyrrolizidine alkaloids PAHs Polycyclic aromatic hydrocarbons PhEur European Pharmacopoeia PPRC Pharmacopoeia of the Peoples Republic of China RASFF Rapid Alert System for Food and Feed REACH Registrati
54、on,Evaluation,Authorization and Restriction of Chemicals SDGs Sustainable development goals SMEs Small and medium-sized enterprises TAMC Total aerobic microbial count TARIC EU Customs Tariff TAs Tropane alkaloids TCM Traditional Chinese medicine TYMC Total combined yeasts/moulds count UEBT Union for
55、 Ethical BioTrade UNCTAD United Nations Conference on Trade and Development USP-NF United States Pharmacopoeia and National Formulary VSS Voluntary sustainability standard WCO World Customs Organization WHO World Health Organization WTO World Trade Organization Export Guide to Medicinal and Aromatic
56、 Plant Ingredients and Products xi Executive summary This export guide provides essential information needed by SME producers,processors and exporters of medicinal and aromatic plant(MAP)ingredients and the herbal products made from them,which are destined for buyers in Europe.Some comparisons are a
57、lso provided against requirements of other markets.This detailed information includes tariff and non-tariff measures and requirements as outlined in EU decisions,directives and regulations.This guide delineates requirements that are sector-specific;for example,limits that are established for the pre
58、sence of certain contaminants may be different for MAP ingredients for use in food products vs those which will be used as active ingredients in herbal medicinal products(HMPs).This guide provides small and medium-sized MAP exporters with useful shortcuts for understanding and navigating the myriad
59、market access requirements,both regulatory and voluntary.While the guide provides a concise consolidation of the relevant requirements that a successful exporter must be aware of,the guide also makes liberal use of internet addresses that the user can simply click to access and download the referenc
60、ed materials.This is not a guide that will sit on the shelf for occasional use.Persons throughout an exporting operation will find answers to questions that can potentially save their shipments from being held up or refused entry by customs authorities or rejected by the buyer.Requirements are elabo
61、rated throughout the guide using certain MAP ingredients to illustrate the main points in easily understood figures,tables and tips boxes.Depending on the size of the exporter operation,this guide may be used by managers of MAP farm or wild collection operations,post-harvest production and processin
62、g facilities,legal and regulatory compliance,sustainability standards compliance,quality assurance and quality control,and export sales and marketing.Chapter 1 provides regulatory definitions of MAP ingredients in their crude or processed forms and definitions used for finished herbal products label
63、led and marketed as cosmetics,foods,food supplements or medicines.Chapter 2 provides details on the European Union(EU)Combined Nomenclature(CN)and Integrated Tariff of the EU(TARIC)using certain MAP ingredients to illustrate.Chapter 3 summarizes the EU regulatory requirements for herbal substances u
64、sed in cosmetics,foods,food supplements or medicines,including quality assurance standards such as good agricultural and collection practices(GACPs)for MAPs and good manufacturing practices(GMPs)for processed MAP ingredients and finished products,the legal basis for the establishment of quality spec
65、ifications and testing requirements,limits that have been established for certain known contaminants of MAP ingredients,and labelling.Chapter 4 provides a summary of sustainable production and trade requirements of which exporters must be aware to succeed in the EU market and avoid bottlenecks and p
66、itfalls.This chapter covers not only international conventions of the United Nations that may impact export-import trade,but also relevant EU directives and regulations concerning corporate social responsibility(CSR),genetically modified organisms(GMOs)and rules for labelling and marketing of certif
67、ied organic MAPs and products.This chapter also summarizes selected voluntary sustainability standards that are of growing importance to buyers of MAP ingredients and products.Chapter 5 deals with export marketing,outlining the main markets for MAP ingredients,the main MAP ingredients imported into
68、the EU,distribution channels,meeting buyers at the right trade shows,and a list of selected import buyers,i.e.those companies known to be importing MAP ingredients with independent third-party evidence of sustainable production and trade,as evidenced by one or more certifications against relevant in
69、ternational VSS.Thomas Brendler,Matricaria recutica Export Guide to Medicinal and Aromatic Plant Ingredients and Products 1 Chapter 1 Product description Medicinal and aromatic plant ingredients Medicinal and aromatic plants(MAPs)is a broad category.The Medicinal Plant Specialist Group of the Intern
70、ational Union for Conservation of Nature(IUCN)provides a useful definition:“Includes plants used to produce pharmaceuticals,dietary supplement products and natural health products,beauty aids,cosmetics,and personal care products,as well as some products marketed in the culinary/food sector.”1 This s
71、ection provides definitions of terms relevant to the import,processing,trade and use of herbal ingredients and products marketed in Europe.The definitions are excerpted from European legislation(decisions,directives and regulations of the European Commission,Council,Parliament)and/or from publicatio
72、ns of EU agencies such as the European Food Safety Authority(EFSA)concerning foods and food supplements;the European Medicines Agency(EMA)and the European Directorate for the Quality of Medicines(EDQM),a directorate of the Council of Europe concerning herbal drugs and herbal medicinal products;and t
73、he Directorate General for Internal Market,Industry,Entrepreneurship and SMEs of the European Council concerning cosmetic products containing herbal ingredients.Table 1 Terms used for MAP ingredients and definitions Term Definition Botanical raw material Depending on the country,botanical raw materi
74、als may also be referred to as botanical drug,crude drug,herbal drug,herbal raw material or plant raw material.In the European Pharmacopoeia(PhEur),2 herbal drugs(Plantae medicinales)are defined as mainly whole,fragmented or broken plants or parts of plants in an unprocessed state,usually in dried f
75、orm but sometimes fresh.The word“plant”is used in the broader sense to also include algae,fungi and lichens.Certain exudates that have not been subjected to a specific treatment are also considered to be herbal drugs.3 Essential oil Essential oils(Aetherolea)are defined as an odorous product,usually
76、 of complex composition,obtained from a botanically defined plant raw material by steam distillation,dry distillation,or a suitable mechanical process without heating.Essential oils are usually separated from the aqueous phase by a physical process that does not significantly affect their compositio
77、n.4 Extract The PhEur defines herbal drug extracts(Plantarum medicinalium exracta)as:liquid(liquid extraction preparations),semi-solid(soft extracts and oleoresins)or solid(dry extracts)preparations obtained from“herbal drugs”using suitable solvents.An extract is essentially defined by the quality o
78、f the herbal drug,by its production process(extraction solvent(s),method of processing,etc.)and by its specifications.5 Fatty oil Vegetable fatty oils(Olea herbaria)are defined as:mainly solid or liquid triglycerides of fatty acids.They may contain small amounts of other lipids such as waxes,free fa
79、tty acids,partial glycerides or unsaponifiable matters.Vegetable fatty oils are obtained from the seeds,the fruit or the pit/stone/kernel of various plants by expression and/or solvent extraction,then possibly refined and hydrogenated.6 Source:European Pharmacopoeia 11th edition.European Directorate
80、 for the Quality of Medicines,at https:/www.edqm.eu/en/european-pharmacopoeia-ph.-eur.-11th-edition 1 See page 5 of the International Standard for the Sustainable Wild Collection of Medicinal and Aromatic Plants,at https:/www.bfn.de/en/publications/bfn-schriften/bfn-schriften-195-international-stand
81、ard-sustainable-wild-collection 2 Find information on the European Pharmacopoeia and how to subscribe to it at https:/www.edqm.eu/en/european-pharmacopoeia 3 Definition excerpted from the Herbal Drugs PhEur monograph,at:https:/www.edqm.eu/en/european-pharmacopoeia 4 Definition excerpted from the Ess
82、ential Oils PhEur monograph,at https:/www.edqm.eu/en/european-pharmacopoeia 5 Definition excerpted from the Herbal Drug Extracts PhEur monograph,at https:/www.edqm.eu/en/european-pharmacopoeia 6 Definition excerpted from the Vegetable Fatty Oils PhEur monograph,at https:/www.edqm.eu/en/european-phar
83、macopoeia Export Guide:Medicinal and aromatic plant ingredients and products 2 EU regulations further define herbal substances as all mainly whole,fragmented or cut plants,plant parts,algae,fungi,lichen in an unprocessed,usually dried,form,but sometimes fresh.Certain exudates that have not been subj
84、ected to a specific treatment are also considered to be herbal substances.Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system(genus,species,variety and author)and herbal preparations as obtained by subjecting herbal substances to tre
85、atments such as extraction,distillation,expression,fractionation,purification,concentration or fermentation.These include comminuted or powdered herbal substances,tinctures,extracts,essential oils,expressed juices and processed exudates.7 Finished herbal products Herbal cosmetic products The Europea
86、n Commission Directorate General for Internal Market,Industry,Entrepreneurship and SMEs maintains an online database of information on cosmetic substances and ingredients(CosIng)authorized for use in cosmetic products in Europe.8 European regulations define cosmetic product as:any substance or mixtu
87、re intended to be placed in contact with the external parts of the human body(epidermis,hair system,nails,lips and external genital organs)or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them,perfuming them,changing their appearance,protect
88、ing them,keeping them in good condition or correcting body odours.9 7 See Consolidated text of Directive 2001/83/EC,at http:/data.europa.eu/eli/dir/2001/83/2022-01-01 8 Access the European Commission CosIng(Cosmetic Substances&Ingredients)online database:https:/ec.europa.eu/growth/tools-databases/co
89、sing/index.cfm?fuseaction=search.simple 9 See Consolidated text of Regulation(EC)No 1223/2009,at https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R Box 1 Example of an herbal and mineral cosmetic product A toothpaste could be marketed as a non-medicinal herbal or natural
90、cosmetic product,containing mainly water and minerals(calcium carbonate,magnesium aluminium silicate or sodium bicarbonate)in combination with botanical ingredients such as vegetable glycerine obtained from the fatty oil of coconut(Cocos nucifera)fruit kernel,extract of calendula(Calendula officinal
91、is)flowers(or extracts of other herbs),ammoniated glycyrrhizin obtained from the aqueous extract of liquorice(Glycyrrhiza glabra)root,star anise(Illicium verum)fruit essential oil,and xanthan gum produced by fermentation of a carbohydrate with the microorganism Xanthomonas campestris,among other pos
92、sible natural cosmetic ingredients.Source:Authors of this guide Export Guide to Medicinal and Aromatic Plant Ingredients and Products 3 Figure 1 Calendula officinalis Source:Thomas Brendler Figure 2 Cocos nucifera Source:Thomas Brendler Export Guide:Medicinal and aromatic plant ingredients and produ
93、cts 4 Herbal food products European regulations define food(or foodstuff)as any substance or product,whether processed,partially processed or unprocessed,intended to be,or reasonably expected to be ingested by humans.“Food”includes drink,chewing gum and any substance,including water,intentionally in
94、corporated into the food during its manufacture,preparation or treatment.10 Food does not include feed;live animals unless they are prepared for placing on the market for human consumption;plants prior to harvesting;medicinal products;cosmetics;tobacco and tobacco products;narcotic or psychotropic s
95、ubstances;residues and contaminants;or medical devices.Figure 3 Euphorbia antisyphilitica Source:Thomas Brendler 10 See Consolidated text of Regulation(EC)No 178/2002,at https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02002 R Box 2 Example of an herbal food product A chewing
96、gum could be marketed as a non-medicinal herbal food product,containing mainly herbal ingredients such as chicle(Manilkara zapota)tree gummy exudate,candelilla(Euphorbia antisyphilitica)leaf wax,acacia(Acacia senegal)tree gummy exudate,cane(Saccharum officinarum)sugar,vegetable glycerine obtained fr
97、om the fatty oil of coconut(Cocos nucifera)fruit kernel,and non-therapeutic,food flavouring quantities of liquorice(Glycyrrhiza glabra)root extract and fennel(Foeniculum vulgare)fruit essential oil.Source:Authors of this guide Export Guide to Medicinal and Aromatic Plant Ingredients and Products 5 F
98、igure 4 Foeniculum vulgare Source:Thomas Brendler Export Guide:Medicinal and aromatic plant ingredients and products 6 Herbal food supplement products The European Food Safety Authority(EFSA)defines food supplements as concentrated sources of nutrients or other substances with a nutritional or physi
99、ological effect that are packed and marketed in a dosage form such as capsules,pills,tablets or liquids in measured doses.A wide range of nutrients and other ingredients might be present in food supplements,including,but not limited to,vitamins,minerals,amino acids,essential fatty acids,fibre and va
100、rious plants and herbal extracts.Regarding plant and herbal extracts,EFSA clarifies that the use of ingredients other than vitamins and minerals(e.g.botanicals)may be permitted for use in food supplements under other specific legislations depending on the nature of the substance(e.g.novel foods,subs
101、tances for the fortification of food,foods for specific groups).11 Figure 5 Illicium verum Source:Thomas Brendler 11 See EFSA Food Supplements information page,at https:/www.efsa.europa.eu/en/topics/topic/food-supplements Export Guide to Medicinal and Aromatic Plant Ingredients and Products 7 Herbal
102、 medicinal products EMA defines a medicinal product as a substance or combination of substances that is intended to treat,prevent or diagnose a disease,or to restore,correct or modify physiological functions by exerting a pharmacological,immunological or metabolic action.As a subset,herbal medicinal
103、 products(HMPs)are defined as any medicinal product exclusively containing as active ingredients one or more herbal substances,one or more herbal preparations,or a combination of the two.12 Figure 6 Saccharum officinarum Source:Thomas Brendler Export Guide:Medicinal and aromatic plant ingredients an
104、d products 8 Chapter 2 European Union classification and tariffs Combined nomenclature As per the European Commission Taxation and Customs Union:The Combined Nomenclature(CN)is a tool for classifying goods,set up to meet the requirements both of the Common Customs Tariff and of the EUs external trad
105、e statistics.The CN is also used in intra-EU trade statistics.It is a further development(with special EU-specific subdivisions)of the World Customs Organizations Harmonized System(HS)nomenclature.This is a systematic list of commodities applied by most trading nations(and also used for internationa
106、l trade negotiations).13 An annex to the CN Regulation is updated and published annually,including any changes that have been agreed at an international level,either at WCO,with regard to HS nomenclature,or within the framework of the World Trade Organization(WTO),with regard to conventional duty ra
107、tes.14 The first two digits are the WCO chapter in the Harmonized System(HS)and first four digits represent the WCO HS heading.The first six digits are the HS subheading for the purpose of a global uniform classification.Building on the six-digit HS code,the CN code of the European Communities adds
108、digits seven and eight.Based on the eight-digit CN code,customs duties,bans,restrictions or other measures relating to import authorizations are determined during import clearance.The ninth and 10th digits,known as TARIC(Integrated Tariff of the European Communities),encode community measures(e.g.an
109、tidumping rules,duty suspensions).An 11th digit is added for national use only,for example to encode VAT rates,national bans or restrictions.This is illustrated in Table 2 using saffron(Crocus sativus)as an example.Table 2 HS,CN and TARIC codes using saffron as an example Code Description Convention
110、al rate of duty(%)and measures Chapter HS 2 digits 09 Coffee,tea,mat and spices Heading HS 4 digits 0910 Ginger,saffron,turmeric(curcuma),thyme,bay leaf,curry and other spices:Subheading HS 6 digits 0910 20 Saffron:Subheading CN 8 digits 0910 2010 Neither crushed nor ground Free 0910 2090 Crushed or
111、 ground 8.5%Subheading TARIC 10 digits 0910 2010 00 Neither crushed nor ground Third country duty:0%;Tariff preference(selected countries):0%;Import control of organic products;Restriction on entry into free circulation(selected countries)0910 2090 00 Crushed or ground National Code Number 11 digits
112、 Country specific 11th digit Source:As of 1 January 2021:Consolidated text:Council Regulation(EEC)No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff,at https:/eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31987R2658 13 European Commission Tax
113、ation and Customs Union Combined Nomenclature information,at https:/ec.europa.eu/taxation_customs/business/calculation-customs-duties/customs-tariff/combined-nomenclature_en 14 Council Regulation(EEC)on the tariff and statistical nomenclature and on the Common Customs Tariff,at https:/eur-lex.europa
114、.eu/legal-content/en/ALL/?uri=CELEX%3A31987R2658 Export Guide to Medicinal and Aromatic Plant Ingredients and Products 9 Other countries assign additional digits for various internal reasons.For example,13 digits are used in the Import and Export Tariff of the Peoples Republic of China.The first eig
115、ht digits function as the commodity HS code,digits nine and 10 are customs supervisory additional numbers,and digits 11 to 13 are additional numbers used by China and Inspection Quarantine(CIQ).European importers must always state an 11-digit code number on the import declaration,while export declar
116、ations require only the eight-digit code.Table 3 compares the European Union CN+TARIC codes of selected MAPs with the codes used by China(CCCS+CIQ),India(ITC)and the United States(HTSUS).In some cases,specific codes are assigned for an item in its various commercially traded forms,such as whole,cut
117、or powdered,distilled essential oil,dry or liquid extract,or extracted oleoresin.In cases where a specific code is not assigned,other is used parenthetically,which indicates that the item is lumped together with other items in the same category.Table 3 Tariff codes of selected MAPs used by EU,China,
118、India and the US Description CN+TARIC CCCCS+CIQ HTSUS ITC Asafoetida(Ferula spp).oleo gum resin 1301 9000 00 (other gums and resins)1301 9030 00 101(plant product)1301 9091 90 (other gums and resins)1301 9013 1301 9030 00 102(medicinal use)Asafoetida oil 3301 2991 00(other essential oils)1301 9030 0
119、0 103 3301 2951 50 (other essential oils)3301 2990 Citrus(e.g.orange),fruit peel,dried 0814 0000 00 0814 0000 00 103(medicinal use)0814 0010 00 0814 0000 Coriander(Coriandrum sativum)fruit,neither crushed nor ground 0909 2100 00 0909 2100 00 999 0909 2100 00 0909 2190 Coriander fruit,crushed or grou
120、nd 0909 2200 00 0909 2200 00 999 0909 2200 00 0909 2200 Coriander fruit essential oil 3301 2991 00 3301 2999 99 178 3301 2922 Coriander fruit extracted oleoresin 3301 9030 00 3301 9010 90 101(other extracted oleoresins)3301 9023 Liquorice(Glycyrrhiza glabra,G.inflata,G.uralensis)root 1211 9086 00(ot
121、her medicinal plants)1211 9036 00 101(medicinal use)1211 9089 90 (other medicinal plants)1211 1000 1211 9036 00 102(food additive use)1211 9036 00 103(edible liquorice)Liquorice root extract 1302 1200 00 1302 1200 00 101(food or medicine)1302 1200 00 1302 1200 Liquorice root dry extract(powder)1302
122、1200 00 102(food additive)Liquorice root fluid extract(liquid)1302 1200 00 103(food additive)Liquorice root extract containing 10%of sucrose but no other added substances 1704 9010 00 Liquorice root and hop strobile extracted oleoresins 3301 9010 00 3301 9010 90 101(other extracted oleoresins)3301 9
123、050 00(other extracted oleoresins)3301 9029 (other extracted oleoresins)Export Guide:Medicinal and aromatic plant ingredients and products 10 Description CN+TARIC CCCCS+CIQ HTSUS ITC Saffron(Crocus sativus)stigma,neither crushed for ground 0910 2010 00 0910 2000 00 101(medicinal use)0910 2000 00 102
124、(seasoning)0910 2000 00 0910 2010 Saffron stigma,crushed or ground 0910 2090 00 0910 2090 Saffron stamen 0910 2020 Notes:CCCCS,Commodity Classification for China Customs,Statistics Peoples Republic of China;CIQ,China and Inspection Quarantine;CN,Combined Nomenclature of the European Union;HTSUS,Harm
125、onized Tariff Schedule of the United States;ITC,India Trade Classification,Department of Commerce Sources:Trade classification and tariff schedules of the European Union,India,Peoples Republic of China and the United States Integrated Tariff of the European Union(TARIC)TARIC provides a multilingual
126、consultation database integrating all measures related to EU customs tariff,commercial and agricultural legislation.15 Using liquorice root extract as an example,Table 4 shows TARIC measures for selected countries relevant to the production and trade of liquorice root and extracts made from it.Table
127、 4 TARIC measures for liquorice root extract CN 1302 1200,selected countries TARIC measures Description Countries General system of preferences(GSP)GSP-EBA special arrangement for the least-developed countries everything but arms(EBA 2005)Afghanistan GSP General arrangements(GSP 2020)India,Syria,Taj
128、ikistan GSP+incentive arrangement for sustainable development and good governance(GSP+2027)Pakistan,Uzbekistan Import control of organic products Subject to EU regulation R2306/21 See table note CD808 Afghanistan,Armenia,Azerbaijan,China(Peoples Republic of),Chinese Taipei,Georgia,India,Iran(Islamic
129、 Republic of),Japan,Kazakhstan,Korea(Republic of),Pakistan,Syria,Tajikistan,Turkey,Turkmenistan,Uzbekistan Restriction Restriction on entry into free circulation(06-01-2022 02-07-2022)See table note CD597 India,Korea(Republic of)Tariff preference 0%Afghanistan,Georgia,India,Japan,Korea(Republic of),
130、Pakistan,Syria,Tajikistan,Turkey,Uzbekistan Third country duty 3.20%.Subject to EU regulations R2658/87 and R2204/99 Afghanistan,Armenia,Azerbaijan,China(Peoples Republic of),Chinese Taipei,Georgia,India,Iran(Islamic Republic of),Japan,Kazakhstan,Korea(Republic of),Pakistan,Syria,Tajikistan,Turkey,T
131、urkmenistan,Uzbekistan 15 TARIC database,at https:/ec.europa.eu/taxation_customs/business/calculation-customs-duties/customs-tariff/eu-customs-tariff-taric_en Export Guide to Medicinal and Aromatic Plant Ingredients and Products 11 Notes:CD597:The release for free circulation of consignments of food
132、 and feed listed in Annexes I and II to regulation(EU)2019/1793 shall be subject to the presentation of a duly finalized common health entry document as provided for in Article 57(2)(b)of regulation(EU)2017/625,which confirms that the consignment is in compliance with the applicable rules referred t
133、o in Article 1(2)of that regulation.CD808:If goods bear a reference to organic production in the labelling,advertising or accompanying documents,the declarant has to present the certificate of inspection C644 as referred to in the Article 45(1)(ii)of regulation(EC)834/2007(equivalent products).If th
134、e goods are not equivalent products,code Y929 must be declared.These provisions shall apply in addition to the rules regarding the use of the common health entry document by the competent authorities at border control posts in accordance with Article 56(3),point(b)(i),of regulation(EU)2017/625 and a
135、t control points in accordance with Commission delegated regulation(EU)2019/2123 and with the rules on decisions on consignments laid down in Article 55 of regulation(EU)2017/625.Source:TARIC measures consultation database,search term liquorice Thomas Brendler,Foeniculum vulgare Export Guide to Medi
136、cinal and Aromatic Plant Ingredients and Products 13 Chapter 3 Regulatory requirements Regulatory categories for herbal substances and finished products Cosmetic ingredients/products According to regulation(EC)1223/2009,cosmetic products are defined as any substance or mixture intended to be placed
137、in contact with the external parts of the human body(epidermis,hair system,nails,lips and external genital organs)or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them,perfuming them,changing their appearance,protecting them,keeping them in
138、good condition or correcting body odours.16 The same regulation governs manufacture,safety requirements,product documentation and marketing notification procedures.Its annexes further list prohibited and restricted substances,colourants,preservatives,and other additives.It replaced directive 76/768/
139、EC and introduced some significant changes:Strengthened safety requirements for cosmetic products;Introduction of the notion of responsible person;17 Centralized notification of all cosmetic products placed on the EU market;18 Introduction of reporting of serious undesirable effects(SUE);19 New rule
140、s for the use of nanomaterials in cosmetic products.20 CosIng is the EC database with information on cosmetic ingredients contained in the appendices of regulation(EC)1223/2009,the inventory of cosmetic ingredients and opinions on cosmetic ingredients of the Scientific Committee for Consumer Safety.
141、21 Product labelling reflects the data compiled in the product information file and is governed by the principles laid out in regulation(EC)1272/2008 as amended.22 Specifically,cosmetic product labels must include:Full commercial name;Product function;Particular precautions for use;Ingredients list;
142、Expiry date;Responsible person name and address;Manufacturer name and address;Batch number;Products country of origin(if made outside the EU);Nominal quantities.16 Further details at http:/data.europa.eu/eli/reg/2009/1223/2022-07-31 17 Only cosmetic products for which a legal or natural person is de
143、signated within the EU as a responsible person can be placed on the market.The responsible person compiles the product information file and is responsible for the accurate labelling of a cosmetic product.18 The cosmetic product notification portal,at https:/single-market-economy.ec.europa.eu/sectors
144、/cosmetics/cosmetic-product-notification-portal_en 19 More information on market surveillance requirements and SUE reporting at https:/single-market-economy.ec.europa.eu/sectors/cosmetics/market-surveillance_en 20 More information on the use of nanomaterials in cosmetics at https:/single-market-econ
145、omy.ec.europa.eu/sectors/cosmetics/cosmetic-products-specific-topics/nanomaterials_en 21 The CosIng database can be found at https:/ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.simple 22 The consolidated text for regulation(EC)1272/2008,at https:/eur-lex.europa.eu/legal-con
146、tent/EN/TXT/?uri=CELEX%3A02008R Export Guide to Medicinal and Aromatic Plant Ingredients and Products 14 Colipa,the umbrella body in Europe that governs all cosmetic and product care products,provides guidelines for the evaluation of the efficacy of cosmetic products.These guidelines ai
147、m to assist the cosmetics industry to comply with the applicable European regulations for the efficacy evaluation of cosmetic products.Because methodologically sound research is essential for the efficacy evaluation,these guidelines also provide an overview of established testing methodologies.23 Re
148、gulation(EU)655/2013 provides some context for how claims related to cosmetic products need to be substantiated.24 Additional guidance is provided by a technical document compiled by the Sub-Working Group on Claims.25 Food additives,enzymes,flavourings and other substances added to food Towards the
149、end of 2008,existing legislation was consolidated into simplified regulations covering all food improvement agents,namely regulation(EC)1333/2008 on food additives,regulation(EC)1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods,regulation(EC)133
150、2/2008 on food enzymes,and directive 2009/32/EC on extraction solvents used in the production of foodstuffs and food ingredients.Food additives are defined as any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food,whether or not it has nu
151、tritive value,the intentional addition of which to food for a technological purpose in the manufacture,processing,preparation,treatment,packaging,transport or storage of such food results,or may be reasonably expected to result,in it or its by-products becoming directly or indirectly a component of
152、such foods.26 Food flavourings are defined as products not intended to be consumed as such,which are added to food in order to impart or modify odour and/or taste;made or consisting of the following categories:flavouring substances,flavouring preparations,thermal process flavourings,smoke flavouring
153、s,flavour precursors or other flavourings or mixtures thereof.27 Food enzymes are defined as products obtained from plants,animals or microorganisms or products thereof including a product obtained by a fermentation process using microorganisms.28 Regulation EC 1331/2008 introduced a common authoriz
154、ation procedure for these agents.Once authorized,these substances are included the EU lists of permitted food additives,29 flavourings30 and enzymes.The Union List of food enzymes will be adopted once EFSA has issued an opinion on each food enzyme included in the register.EFSAs expert Panel on Food
155、Additives and Flavourings conducts safety evaluations of food additives and flavourings.As part of its safety evaluations,EFSA seeks to establish an acceptable daily intake for each substance.EFSA has developed and published guidance for submission for food additive evaluations,31 data required for
156、the risk assessment of flavourings32 and submission of dossiers on food enzymes.33 To support the 23 The Colipa web portal:https:/colipa.eu/24 Full text at http:/data.europa.eu/eli/reg/2013/655/oj 25 Guidance document at https:/ec.europa.eu/docsroom/documents/24847 26 The full text of regulation(EC)
157、1333/2008 on food additives at http:/data.europa.eu/eli/reg/2008/1333/2022-07-20 27 The full text of regulation(EC)1334/2008 on flavourings at http:/data.europa.eu/eli/reg/2008/1334/2021-11-24 28 The full text of regulation(EC)1332/2008 at http:/data.europa.eu/eli/reg/2008/1332/2012-12-03 29 Access
158、the database at https:/food.ec.europa.eu/safety/food-improvement-agents/additives/database_en 30 Access the database at https:/webgate.ec.europa.eu/foods_system/main/?sector=FFL&auth=SANCAS 31 Guidance document at https:/www.efsa.europa.eu/en/efsajournal/pub/2760 32 Guidance document at https:/www.e
159、fsa.europa.eu/en/efsajournal/pub/1623 33 Guidance document at https:/www.efsa.europa.eu/en/efsajournal/pub/6851 Export Guide to Medicinal and Aromatic Plant Ingredients and Products 15 calculation by applicants of estimates of exposure to the food additive and its by-products,EFSA has developed a fo
160、od additives intake model template.34 All food additives are identified by an E number.Product labels must identify both the function of the additive in the finished food and the specific substance used,either by referring to the appropriate E number or its name.The former also applies to food enzym
161、es.Food ingredients(including novel and traditional foods)and products In Europe,regulation(EC)178/2002 lays out common principles and responsibilities pertaining to food law and food safety(including the establishment of EFSA).Therein,food is defined as any substance or product,whether processed,pa
162、rtially processed or unprocessed,intended to be,or reasonably expected to be ingested by humans.The regulation also sets demarcations,e.g.it does not cover feed,medicinal(including medical devices),cosmetic or narcotic products,live animals,plants before harvest etc.;however,it leaves oversight larg
163、ely to national legislation.35 Novel foods are a food subcategory in the context of this work;as of 2018,they are governed by Novel Foods Regulation(EU)2015/2283.Foods are considered novel if they are without a history of significant consumption within the EU prior to May 1997.To bring a novel food
164、to market,companies must apply for authorization,presenting data related to identity,composition,quality of manufacture,use and exposure,safety etc.36 The category of traditional foods from third countries(Article 14)is of relevance to this work as it provides new market opportunities for traditiona
165、l foods that can be brought to the EU market following a relatively simple notification procedure.This simplified procedure applies if the food or food ingredient:Is derived from microorganisms,fungi or algae,plants or animals,or cell/tissue cultures;Originates from primary production,i.e.rearing or
166、 growing of primary products including harvesting,milking and farmed animal production prior to slaughter,and includes hunting and fishing and the harvesting of wild products,processed or unprocessed;Has a history of safe food use,confirmed with compositional data and from experience of continued us
167、e for at least 25 years in the customary diet of a significant number of people in at least one third country.Data requirements and procedural steps for traditional foods from third countries are specified in Commission Implementing Regulation(EU)2017/2468.37 If a novel food does not meet the criter
168、ia of a traditional food from third countries,a full authorization procedure is required in which EFSA carries out a safety assessment.Data requirements and procedural steps for full procedures are specified in Commission Implementing Regulation(EU)2017/2469.38 Regulation(EC)178/2002 also stipulates
169、 the creation of a Union List of Novel Foods.This positive list contains all authorized novel foods.New novel foods are added to the Union List by means of Commission Implementing Regulations.Once a novel food is added to the Union List,the authorization(new and old)becomes generic,i.e.once authoriz
170、ed,a novel food can be used by any food business operator provided the conditions of use and specifications are met.34 More information as well as the template at https:/www.efsa.europa.eu/en/applications/food-improvement-agents/tools 35 Full text of Regulation(EC)178/2002 as amended,at http:/data.e
171、uropa.eu/eli/reg/2002/178/2022-07-01 36 Full text of Regulation(EU)2015/2283 as amended,at http:/data.europa.eu/eli/reg/2015/2283/2021-03-27 37 Full text of Commission Implementing Regulation(EU)2017/2468 as amended,at http:/data.europa.eu/eli/reg_impl/2017/2468/2021-03-27 38 Full text of Commission
172、 Implementing Regulation(EU)2017/2469 as amended,at http:/data.europa.eu/eli/reg_impl/2017/2469/2021-03-27 Export Guide to Medicinal and Aromatic Plant Ingredients and Products 16 Only newly developed scientific evidence and proprietary data can be protected for five years.This recently created cate
173、gory offers market access with reasonable effort for products that meet the criteria,even though the lack of protection may be contrary to efforts to protect traditional knowledge and access and benefit sharing(ABS).Box 3 Case study:Market access for an herbal novel food in the EU Traditional Novel
174、Food from a third country:Bambara groundnut(BIZ,Zimbabwe)Bambara groundnut(Vigna subterranea(L.)Verdc.,syn.Voandzeia subterranea(L.)Thouars)is a tropical legume with a broad and extensive history of use as a staple food in Africa and elsewhere,including South-East Asia and Brazil.Traditional use is
175、evidenced by a large body of literature,especially in Africa.Bambara groundnut is nutritionally valuable,especially due to its high protein content.Bambara groundnuts also supply next to saturating carbohydrates valuable fibres and minerals.Further,the crop is low in fat,which may be of special inte
176、rest in weight management.Bambara groundnut is particularly promising in agriculture due to its drought resistance,especially considering climate change and increasing scarcity of rain and water for irrigation.The applicant,Bio Innovation Zimbabwe(BIZ),is a specialized research organization.Its miss
177、ion is to create wealth among rural producers and provide consumers in Zimbabwe and external markets with high-quality products through the commercialization of underutilized species that are resilient to the effects of climate change.This mission entails addressing constraints to commercialization
178、along the entire value chain,targeting high-potential plant species based on sound consumer and market research.BIZ seeks to achieve multi-level impact creating wealth for households,helping communities thrive,promoting conservation of natural resources at a landscape level,and helping to grow the n
179、ational economy.Bringing Bambara groundnut to markets in Europe as a traditional novel food will allow African farmers to produce the beans on a larger scale,increasing their incomes,which in turn will strengthen the local economy.BIZ operates as an umbrella/hub organization for smallholder growers
180、of Bambara groundnut,as well as aggregators/offtakers and processors.As such,specifications and processing procedures in the application dossier while in alignment with GACPs and other certifications are generic,modelled on those for other legume crops,and designed to match EU regulations.Aspects th
181、at received specific attention in the assessment process include:Propagation,growth and harvesting conditions;Measures for production control and quality,and safety assurance:o Handling of unprocessed food and raw materials for further processing(mycotoxins,insects etc.);o Processing contaminants;An
182、alytical information on at least five independently produced batches;Full description of all the analytical methods;Potential risk of allergic reactions;Potential for nutritional disadvantage.The assessment is ongoing.Source:Bio Innovation Zimbabwe(BIZ)Export Guide to Medicinal and Aromatic Plant In
183、gredients and Products 17 Figure 7 Bambara groundnut(Vigna subterranea)Source:BIZ Foods for specific uses Foods for specific uses,governed by Regulation(EU)609/2013,39 is another category of potential significance as it splits into three subcategories:Food for specific medical purposes(FSMP):Regulat
184、ion(EU)2016/128;40 Total diet replacement for weight reduction:Directive 96/8/EU;41 Foods for infants and young children:Regulation(EU)2016/12742 and Directive 2006/125/EU.43 FSMP is defined as Food specially processed or formulated and intended for the dietary management of patients,including infan
185、ts,to be used under medical supervision;it is intended for the exclusive or partial feeding of patients with a limited,impaired or disturbed capacity to take,digest,absorb,metabolize or excrete ordinary food or certain nutrients contained therein,or metabolites,or with other medically-determined nut
186、rient requirements,whose dietary management cannot be achieved by modification of the normal diet alone.39 The full text of Regulation(EU)609/2013:http:/data.europa.eu/eli/reg/2013/609/2021-04-28 40 Full text of regulation(EU)2016/128,at http:/data.europa.eu/eli/reg_del/2016/128/2021-07-15 41 Full t
187、ext of directive 96/8/EU,at http:/data.europa.eu/eli/dir/1996/8/2007-06-20 42 Full text of regulation(EU)2016/127,at http:/data.europa.eu/eli/reg_del/2016/127/2022-04-01 43 Full text of directive 2006/125/EU,at http:/data.europa.eu/eli/dir/2006/125/oj Export Guide to Medicinal and Aromatic Plant Ing
188、redients and Products 18 Naturally occurring foodstuffs used in their natural state,without undergoing any special processing or formulation,are not considered FSMP,which is only intended for the diseased.Usage under medical supervision is a key element in classifying a product as FSMP.With the avai
189、lable EC44 and EFSA45 guidance and the fact that both the EC and EFSA might be involved in the appropriate classification of a product as FSMP,opportunities to market a product as FSMP have become more limited.It will be difficult to find arguments supporting the classification of a product as FSMP
190、if food supplements with a similar composition/dosage can be found on the EU market.In any case,a number of conditions must be met for a product to qualify for this category(see Figure 1).Figure 8 FSMP checklist Source:Prepared by the authors of this guide Food supplement ingredients and products In
191、 the EU,food(dietary)supplements are regulated by Directive 2002/46/EC as amended46 and defined as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect,alone or in combination,m
192、arketed in dose form,namely forms such as capsules,pastilles,tablets,pills and other similar forms,sachets of powder,ampoules of liquids,drop dispensing bottles,and other similar forms of liquids and powders designed to be taken in measured small unit quantities whereby nutrients may be vitamins or
193、minerals.Allowable health claims associated with aforementioned nutrients or other substances with a nutritional or physiological effect are governed by regulation(EC)1924/2006 as amended,47 articles 13.1,13.5 and 14,and pertain specifically to:Role of a nutrient or other substance in growth,develop
194、ment,and the functions of the body;Psychological and behavioural functions;Slimming,weight control,reduction of hunger,increase of satiety,reduction of energy available from the diet;Reduction of disease risk;Childrens development and health.44 EC guidance,at https:/food.ec.europa.eu/safety/labellin
195、g-and-nutrition/specific-groups/food-special-medical-purposes_en 45 Scientific and technical guidance on foods for special medical purposes,at https:/ 46 See http:/data.europa.eu/eli/dir/2002/46/oj 47 See http:/data.europa.eu/eli/reg/2006/1924/2014-12-13 Export Guide to Medicinal and Aromatic Plant
196、Ingredients and Products 19 The regulation also tasks EFSA with the assessment of the scientific substantiation and authorization of such health claims.48 However,most health claims related to botanicals have either been rejected as insufficiently substantiated or placed on hold,i.e.remain unassesse
197、d.49 Most approved claims pertain to vitamins and minerals.If the introduction of the traditional herbal registration(THR)category(see below)and,with it,the opportunity to make mild health claims based on traditional use,was intended to attract botanicals from the food supplement category,then the m
198、otion has largely failed.Marketers have shown to prefer the more economical route of manufacturing according to food standards and either promote food supplements containing botanicals without claims,relying on consumers informed choice,or formulate with vitamins and minerals to be able to use allow
199、able claims for the entire formula.While the THR directive has created a portfolio of quality herbal medicines,it has not achieved to push botanical food supplements of indiscernible quality off the market.Medicinal ingredients and products Finished HMPs require the applicant to obtain pre-marketing
200、 authorization through a product registration procedure.There are three main regulatory pathways for an HMP to gain market access in EU member states:1.HMPs with a long tradition of medicinal use(at least 30 years,including 15 in the EU)may be registered as traditional herbal medicinal products(THMP
201、s),also referred to as THRs,when an applicant submits sufficient levels of quality and safety evidence with efficacy evidence based on traditional use data.2.Another product type is the well-established use herbal medicinal product(WEU-HMP).Marketing authorization requirements for WEU-HMPs are simil
202、ar for evidence of quality,but evidence of efficacy and safety may be supported by published scientific literature.3.Stand-alone or mixed applications are another possibility whereby safety and efficacy evidence are based on the applicants own development or a combination of own studies and bibliogr
203、aphic data.It is also possible to apply for a full marketing authorization(MA),which requires new clinical trial data on a companys specific HMP.Furthermore,there are procedures for obtaining marketing authorization for anthroposophical and homoeopathic HMPs.Figure 2 summarizes the category characte
204、ristics.48 More information on how EFSA assesses health claims can be found at https:/www.efsa.europa.eu/en/topics/topic/health-claims 49 The current list of on hold assessments is available at https:/www.efsa.europa.eu/sites/default/files/2021-06/questions-on-hold-botanical-claims.xlsx.Note that,un
205、til assessed,these claims can be used to market the supplement ingredients concerned.Export Guide to Medicinal and Aromatic Plant Ingredients and Products 20 Figure 9 EU regulatory categories for herbal medicinal products Marketing authorization Registration Patient information/labelling/advertising
206、/pharmacovigilance Efficacy New,product-specific evidence(clinical trials)Bibliographic evidence Traditional use evidence (or HMPC monograph)Safety New,product-specific evidence(toxicological and safety studies)Bibliographic evidence Expert report (bibliographic)GACP/GMPs/quality assurance and contr
207、ol New(full MA)WEU-HMP THMP/THR Community herbal monographs/community list Directive 2004/24/EC Directive 2001/83/EC as amended Source:This figure prepared by the authors of this guide Commonalities shared between all three categories are requirements pertaining to standards for agriculture and coll
208、ection,manufacturing and quality control,and the format in which applications for authorizations are to be submitted to the competent authorities.The latter is referred to as CTD,a standard designed to be used across Europe,Japan,the United States and other participating countries as part of a broad
209、er attempt to harmonize aspects of the worlds drug regulations.Figure 3 presents the structure of CTD and the required information to be submitted therein.Export Guide to Medicinal and Aromatic Plant Ingredients and Products 21 Figure 10 CTD structure Notes:Module 1 holds administrative data:the app
210、lication form,expert reports,summary of product characteristics,patient information leaflet,packaging,GACP and GMP compliance,pharmacovigilance,and requirements.It is,however,not strictly part of the CTD as its format is governed by national competent authorities.Module 2 contains bibliographic or e
211、xpert evidence for traditional use or proof of efficacy,and bibliographic reviews and/or expert report of safety data and a summary of quality and production data.Module 3 is the pharmaceutical part of the dossier and presents quality data for APIs and the finished product.Modules 4 and 5 contain no
212、n-clinical and clinical study reports or traditional use evidence,respectively.50 Source:Brendler,T.,Phillips,L.D.and Spiess,S.(2009).A practical guide to licensing herbal medicinal products.London:Pharmaceutical Press.50 For more information,see https:/health.ec.europa.eu/medicinal-products/eudrale
213、x/eudralex-volume-2_en#volume-2b-presentation-and-content-of-the-dossier Export Guide to Medicinal and Aromatic Plant Ingredients and Products 22 Box 4 Case study:Market access for an herbal medicinal product First TCM THR approved by Dutch competent authorities In 2012,the Dutch Medicines Evaluatio
214、n Board(MEB)granted SU BioMedicine B.V.from the Netherlands a registration for Diao Xin Xue Kang,capsules for oral use as a traditional herbal medicinal product(THMP).These capsules contain 100 mg of an extract of dried rhizomes of Dioscorea nipponica Makino,equivalent to 5-6.67 g of dried plant mat
215、erial.The drug to extract ratio is 50.066.7:1.Diao Xin Xue Kang is used for the relief of headache and muscular pains and muscle cramps in the neck,back and legs.This use is based on traditional use only and not on demonstrated clinical efficacy.The registration of these capsules is based exclusivel
216、y on the longstanding use of D.nipponica root as a THMP in both China and Europe.The application of Diao Xin Xue Kang capsules was discussed in multiple MEB meetings.Initially,it was concluded that a full assessment of the pre-clinical safety data could not performed because the complete study repor
217、ts of the available repeated dose toxicity,genotoxicity and reproduction toxicity studies were not provided.Additional safety data were provided and the MEB decided that the pre-clinical safety data were insufficient because genotoxicity tests did not comply with existing guidelines.Furthermore,it w
218、as concluded that the submitted pharmacovigilance data did not prove that the use of Diao Xin Xue Kang is safe due to strong limitations of the provided data.Based on new data provided by the applicant,it was concluded that the submitted clinical safety data were insufficient,because extrapolation o
219、f the data provided,concerning the use in patients and the safety as acquired in China,to the European population was inadequate.The applicant was asked to substantiate the extrapolation of safety data obtained in the Chinese population to the Western population and to provide more information on th
220、e extent of use in Europe.Eventually,the MEB decided that,on the basis of the data submitted,a registration could be granted if the safety of the product is monitored with a pharmacovigilance system and the results of a genotoxicity test conducted in accordance with existing EU guidelines are submit
221、ted before the renewal of the registration.At the time of assessment and registration,no preparations of D.nipponica were registered as a medicinal product in the EU but,in China and Russia,extracts of D.nipponica had been on the market for more than 30 years.The data supplied by the applicant thus
222、substantiated 30 years of medicinal use of D.nipponica,including at least 15 years in the European Community.The herb was first recorded in 1959 and,in 1977,a monograph of D.nipponica was included in the Pharmacopoeia of the Peoples Republic of China(PPRC).Diao Xin Xue Kang capsules have been market
223、ed in China since 1970.Over the past 30 years,more than 100 million people have used the product.A product containing an extract of D.nipponica entered the Russian market in 1975.For the justification of traditional use in the EU,reference was made to European herbal handbooks,sales figures and docu
224、mented use in France,Belgium,the Netherlands,and the UK.Release specifications of the herbal substance comprised general characteristics,identification by microscope and thin-layer chromatography(TLC),foreign matter,residual solvent,microbiological quality,toxic metals,radioactivity,pesticides and m
225、arker content.Stability studies have been conducted with three production scale batches in the final container closure system.The data support the storage conditions and shelf life.A detailed description of the manufacturing process(extraction,drying,blending),including batch size,manufacturing form
226、ula,process conditions,in-process controls and flow diagram,was provided.Release specifications for the extract comprised appearance,identification by TLC fingerprint,marker content,loss on drying,residual solvent,pesticides,heavy metals,aflatoxins and microbiological purity.Identity was tested in a
227、ccordance with the monograph of the PPRC.Other parameters were tested in accordance with European Pharmacopoeia(PhEur).Stability data were presented of three production-scale batches tested under real time and accelerated conditions.The stability data provided showed no incompatibilities between the
228、 herbal preparation and the container.All specifications were met at all time points.The marker content remained stable,and no changes were observed in the phytochemical fingerprint profile.Diao Xin Xue Kang capsules are manufactured by Chengdu Diao Pharmaceutical Group Co.in Chengdu,Sichuan,Peoples
229、 Republic of China.The manufacturer was inspected by the Dutch Inspectorate,and EU GMP compliance was confirmed.Batch release of the finished medicinal product for the EU is performed by Tjoapack B.V.(Emmen,Netherlands),a company that is GMP-certified by the Dutch Inspectorate for batch releases in
230、the EU.The finished product specification includes tests for appearance,uniformity of mass,loss on drying,disintegration time,identification(chemical test and TLC),marker content and microbiological purity.Analytical data of three production scale batches were provided,demonstrating compliance with
231、the specification.Export Guide to Medicinal and Aromatic Plant Ingredients and Products 23 Stability studies were performed in accordance with the relevant International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)guidelines.Limit values were identical t
232、o these of the release specifications(within the acceptable tolerance interval for the marker of 95%-105%related to t0).Analytical procedures were identical to those used for the testing of release specifications.Expert reports written by nonclinical substantiated the safety of Diao Xin Xue Kang cap
233、sules.The expert reports included an overview of available safety data from literature.Based on experimental details provided it was not possible to ascertain if the data assessed in the review would comply with todays regulatory safety testing requirements with regards to design,conduct and analysi
234、s.However,preclinical data submitted did not indicate safety concerns.Because the longstanding use of the product is satisfactorily demonstrated,the lack of a complete standard pre-clinical safety package is considered acceptable and in compliance with the Guideline on non-clinical documentation for
235、 herbal medicinal products in applications for simplified registration.The clinical data provided(241 clinical studies including more than 16,000 patients)could only be considered as supportive because the studies were not in compliance with existing EU guidelines.As the studies were performed in Ch
236、ina,it was not clear to what extent the data can be extrapolated to the European population.However,the applicant demonstrated that extracts of D.nipponica have long history of safe use in China and in Russia.Diao Xin Xue Kang capsules to date is the only product,the composition and indication of wh
237、ich originate in a traditional medicinal paradigm outside Western herbalism,to be registered as a THR in Europe.Key learning Traditional use evidence must demonstrate significant consumption within and outside the EU for the desired indication and dosage form;Evidence for safety must comply with mod
238、ern evaluation standards;Evidence for clinical efficacy has a supportive role only;Pharmacovigilance data must be applicable to the target demographic;GACP must be demonstrated;Processing and manufacture must be GMP certified;Batch release must occur within the EU;All quality requirements pertaining
239、 to pharmaceutical manufacturing must be met.Source:CBG MEB(2012)Public Assessment Report:Diao Xin Xue Kang,capsules for oral use SU BioMedicine B.V.,The Netherlands RVG 102142,NL-PAR,at https:/db.cbg-meb.nl/pars/h102142.pdf The marketing authorization procedure evaluates efficacy,safety and pharmac
240、eutical quality of a medicinal product.The necessary documentation can be submitted to the regulatory authorities by the pharmaceutical company that intends to place the medicinal product on the market or a designated representative.51 Under the centralized authorization procedure,a pharmaceutical c
241、ompany or its representative submits a single application to EMA.After assessment by EMA,the EC issues a legally binding decision allowing the marketing authorization holder to market the medicine throughout the EU per single marketing authorization.52 Alternatively,a pharmaceutical company may appl
242、y for marketing authorization in several EU member states via the mutual recognition procedure(a marketing authorization granted in one member state to be recognized in other member states)or by decentralized procedure(a new HMP to be simultaneously authorized in several member states).Further,all m
243、ember states maintain their own national authorization procedures.A THR is generally only granted by national procedure,even though some member states allow for the mutual recognition procedure to be applied.51 For more information,see:https:/health.ec.europa.eu/medicinal-products/eudralex/eudralex-
244、volume-2_en#volume-2a-procedures-for-marketing-authorisation 52 Includes all EU member states,Norway,Iceland and Liechtenstein Export Guide to Medicinal and Aromatic Plant Ingredients and Products 24 In summary,European regulations governing market access for herbal medicinal products are strict and
245、 aligned with standards applicable to other pharmaceutical products.The traditional use category,while providing an opportunity for less well-studied APIs with strong traditional use evidence,is effectively limited to APIs with a tradition within the EU.Full marketing authorization The MA category i
246、s for new products or APIs with ingredient/product-specific evidence for safety and efficacy.Botanical ingredients or products with no history of use in the EU must be tested and documented with the same rigour as conventional medicinal products or APIs.Unfortunately,many traditional herbal ingredie
247、nts and products from paradigms other than Western herbalism that were not early introductions,e.g.by colonial powers,entrepreneurs or diaspora,and are thus not grandfathered in according to EU traditional use criteria,fall into this category.For strictly medicinal botanicals without evidence for su
248、bstantial use in the food category,this may well be the only regulatory category for EU market access.Well-established use marketing authorization The well-established use(WEU)category is effectively for me-too products that reference bibliographic evidence for efficacy and safety but come without p
249、roprietary clinical data.Provision of product-specific pre-clinical or clinical trials is not required if API(s)have been in well-established medicinal use within the EC for at least 10 years,which includes recognized efficacy and an acceptable level of safety.Traditional herbal registration The tra
250、ditional herbal registration(THR)category replaces the requirement of sufficient clinical efficacy and safety evidence with that of long-standing traditional use,specifically,for at least 30 years worldwide and 15 years within the EU.Evidence for use must be continuous,dosage forms must correspond,a
251、nd the product and health claims associated with it must be suitable for over the counter and unsupervised use.However,what constitutes sufficient evidence for traditional use is interpreted differently under national rule and is thus not fully harmonized.Community herbal monographs/community list E
252、MA has,over the last 15 years compiled close to 200 monographs and public statements for herbal medicinal products that fall into the WEU-HMP and/or THR categories.A European Union herbal monograph(formerly known as a community herbal monograph)53 reflects the scientific opinion of the HMPC on safet
253、y and efficacy data concerning the medicinal use of an herbal substance and its preparations.This opinion is based on evaluation of all available information,including non-clinical and clinical data and documented long-standing use and experience in the community.EU monographs may cover well-establi
254、shed use(marketing authorization)and traditional use(simplified registration).A final monograph can be referenced in a marketing authorization application(well-established use)or a traditional herbal registration application(traditional use part)provided that the API and associated health claims cor
255、respond with the listed preparations,dosage forms and claim language,respectively.In contrast,EU list entries are legally binding to applicants and competent authorities alike.An applicant is not required to provide safety and traditional use evidence as part of a licence application;nor may compete
256、nt authorities request additional data for the assessment if API and related health claims comply with the information contained in the EU list entry.53 EU herbal monographs are available at https:/www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Herbal/field_ema_herb_outcome/e
257、uropean-union-herbal-monograph-254;and community list entries are available at https:/www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Herbal/field_ema_herb_outcome/european-union-list-entry-256 Export Guide to Medicinal and Aromatic Plant Ingredients and Products 25 Anthroposo
258、phical and homoeopathic HMPs Homoeopathic and anthroposophical medicinal products are subject to the same application procedures as herbal medicinal products(Article 8 in Directive 2001/83/EC)regarding manufacturing procedures,technical quality of the product and all other requirements.A standard fu
259、ll MA,a simplified registration procedure(Article 14 and 15 in Directive 2001/83/EC)and a national marketing authorization based on special national rules(Article 16.2 in Directive 2001/83/EC)allow for alternative documentation of efficacy.Box 5 Case study:Market access for an herbal food supplement
260、 in the US Traditional medicine from a third country:Sceletium(Mesembryanthemum tortuosum L.)aerial parts This case study investigates and compares how a Southern African herbal medicine with great potential as an anxiolytic and mild antidepressant Mesembryanthemum tortuosum L.syn.Sceletium tortuosu
261、m(L.)N.E.Br.aerial parts fares internationally in todays regulatory environment.The plant is a succulent commonly found in the dry western parts of South Africa.It is a traditional medicinal plant used for relieving abdominal pain and hunger and to enhance mood.More recently,it has attracted attenti
262、on for its potential in the treatment of depression and anxiety,promote well-being and provide stress relief.Potential mechanisms for its observed clinical effects have been described and the main active constituents have been identified as mesembrine alkaloids and some of their individual propertie
263、s have been investigated.Many herbal ingredients from indigenous cultures and traditional paradigms of medicine have made a successful career in developed markets as foods,food supplements,cosmetics or medicines.Historically,it was the explorers,settlers and traders,who freely dispersed the ingredie
264、nts of their traditional apothecaries.This trend has slowed,primarily due to increasingly stringent regulations affecting developed markets.In the days of ethical product development,governed by the principles of the Nagoya protocol,patenting to protect such investment has become controversial.While
265、 access-benefit-sharing(ABS)agreements protect traditional knowledge at its source,it has become increasingly difficult to protect proprietary(manufacturing)knowledge in the marketplace.This dilemma is to a varying degree exacerbated by national regulations.Regulatory barriers and loopholes form a h
266、ighly heterogeneous landscape of opportunity,ranging from relatively open to almost entirely closed systems.Consequently,one and the same product may have to be force-fitted into different national regulatory categories,or the best regulatory intentions may prevent it from reaching the consumer alto
267、gether because the cost associated with market entry becomes prohibitive.For instance,Europes regulatory landscape creates a conundrum for ingredients such as sceletium.In the food(and food supplement)category,it would be considered novel;however,despite it being regulated as a food in its country o
268、f origin,competent authorities may likely not consider it suitable due to its predominant history as a traditional herbal medicine.At the same time,it has not been present in the EU marketplace for at least 15 years,nor would it be considered suitable for over-the-counter products;thus,it fails to q
269、ualify as a THMP.It has no flavour,fragrant or cosmetic uses.This leaves only one category for legal market access,through MA.Drug development,in turn,requires considerable investment and bears substantial risks to such investment.Consequently,the ingredient,while interesting,unique and potentially
270、beneficial in a therapeutic setting,has no commercial potential.Indeed,there are no legal products containing sceletium in the European marketplace to date.In the US,on the other hand,while neither the botanical drug route nor the new drug application route appear to be affordable or practical for t
271、he marketing of sceletium ingredients and products,sceletium as an ingredient that is regulated as a conventional food in its country of origin may not require notification as a new dietary ingredient to be used in dietary supplement products.Alternatively,to be used as an ingredient of a convention
272、al food or supplement product,it must be generally recognized as safe(GRAS),either through evaluation by the FDA or an independent conclusion of GRAS status.Although components of a dietary supplement product do not need to be GRAS for their intended use,GRAS substances should generally be acceptabl
273、e for use in dietary supplement products.In February 2011,independent conclusion of GRAS status was confirmed for a very specific extract of M.tortuosum and supplement products containing the extract appeared in the US market in soon after.Source:Brendler et al.(2021)Export Guide to Medicinal and Ar
274、omatic Plant Ingredients and Products 26 Figure 11 Mesembryanthemum tortuosum Source:Thomas Brendler Quality assurance For quality assurance of MAP materials,growing,harvesting and post-harvest primary processing should occur according to suitable good agricultural and collection practice(GACP)guide
275、lines.54 Secondary processing should occur according to suitable good manufacturing practice(GMP)guidelines.55 Sources:Left:WHO GACP guidelines.Centre:WHO GMP guidelines.Right:ISO 9001:2015 guidance for SMEs 54 See EMA GACPs,at https:/www.ema.europa.eu/en/good-agricultural-collection-practice-starti
276、ng-materials-herbal-origin 55 See WHO GMPs,at https:/apps.who.int/iris/bitstream/handle/10665/43672/9789241547161_eng.pdf Export Guide to Medicinal and Aromatic Plant Ingredients and Products 27 Depending on the regulatory classification of the finished herbal product,certain quality assurance stand
277、ards may be mandatory or voluntary.However,even if a standard is not required by regulation,the prospective customer may still require it of their qualified suppliers.Customers may likely require ingredient suppliers to adhere to various quality and safety standards of the International Organization
278、 for Standardization(ISO)such as:ISO 9001:2015 Quality management systems Requirements56 ISO 22000:2018 Food safety management systems Requirements Good agricultural and collection practices Sources:Left:Code of Good Agricultural Practices of Georgia,Ministry of Agriculture of Georgia.Centre left:Gu
279、ideline on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin,European Medicines Agency.Centre right:Guidelines on Good Field Collection Practices for Indian Medicinal Plants,National Medicinal Plants Board,Government of India.Right:Best Practices for Cultivation of Me
280、dicinal and Aromatic Plants,European Union and the Republic of Turkey.To preserve quality and prevent contamination in herbal materials,best practices for hygienic herb harvesting and post-harvest primary processing steps are outlined in good agricultural and collection practice(GACP)guidelines for
281、production of MAPs.For herbal materials used as active ingredients of registered HMPs,GACP implementation is a mandatory regulatory requirement.For botanical materials used as components of food or food supplement products,GACP implementation is voluntary,yet advisable.Additionally,the World Health
282、Organization(WHO)has published Good Herbal Processing Practice(GHPP)guidelines,57 which:Elaborate on post-harvest processing procedures outlined within GACP guidelines;Supplement GMP guidelines on processing procedures for production and manufacture of herbal preparations,such as extracts.56 See ISO
283、 9001 guidance for SMEs,at https:/www.iso.org/publication/PUB100406.html 57 See WHO GHPPs in Annex 1,at http:/apps.who.int/iris/bitstream/handle/10665/272452/9789241210195-eng.pdf Box 6 Tip:Quality certificates After implementation of quality assurance and quality management standards,have an indepe
284、ndent,third-party,accredited inspection and certification organization audit your operation for conformance to the standards.Your prospective customers will request copies.Make it easy for prospective customers to find and download relevant certification documents from your website.Currently valid c
285、ertificates are essential for vendor qualification purposes.Source:Authors of this report Export Guide to Medicinal and Aromatic Plant Ingredients and Products 28 Publicly available to the MAP producer and exporter are general international GACP guidelines,such as those published by WHO.58 Based on
286、the WHO guidelines,many countries have developed their own country-specific GACPs,such as those of the Indian National Medicinal Plants Board,developed in collaboration with the WHO Country Office for India.59 For export of herbal material that will be used in Europe as an active ingredient of an he
287、rbal medicinal product(HMP),evidence of crop production in conformance with the European Medicines Agency Guideline on GACPs for Starting Materials of Herbal Origin is a regulatory requirement for the applicant.The quality of herbal material must also be in conformance with European pharmacopoeial q
288、uality specifications.WHO also developed a model species-specific GACP for the anti-malarial herbal drug Artemisia annua.60 One of the objectives was to provide a model monograph to serve as the basis for countries to develop species-specific GACPs for medicinal plants of national importance.Appendi
289、x I of this guide lists selected publicly available GACP guidelines of different types international,national(country-specific),trade-sector-specific and species-specific along with links for document download.Sources:Left:Good Practices for Saffron Production in Kashmir Practical Manual,Sher-e-Kash
290、mir University of Agricultural Sciences and Technology of Kashmir,Centre left:Matricaria chamomilla L.A GACP monograph,Department of Plant Resources Nepal.Centre right:Manuel des bonnes pratiques de collecte du romarin Rosmarinus officinalis,Haut Commissariat aux Eaux et Forts et la Lutte Contre la
291、Dsertification(Maroc).Right:WHO monograph on good agricultural and collection practices(GACP)for Artemisia annua L.Good manufacturing practices Good manufacturing practices(GMPs)are part of a quality system covering the manufacture and testing of APIs(e.g.an herbal drug extract that will be used in
292、a licenced or registered medicine),cosmetic products,food products,food supplement products and medicinal products.GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product.EU legislation requires that manufacturers of cosmetic,food and medicinal
293、 products must follow certain GMP procedures.Food supplements are subject to food GMP,hygienic and safety rules.In the US,however,cosmetic GMPs are guidelines rather than rules and there are somewhat different GMP rules for food and food supplements.Table 5 lists different levels of GMP in the US al
294、ong with links for downloading the rules.The rest of this section of the guide elaborates on GMP regulations in the EU.58 See WHO GACPs,at https:/apps.who.int/iris/handle/10665/42783 59 See the National Medicinal Plants Board website to download GACP documents,at https:/nmpb.nic.in/60 See WHO GACPs
295、for Artemisia annua,at https:/apps.who.int/iris/handle/10665/43509 Export Guide to Medicinal and Aromatic Plant Ingredients and Products 29 Table 5 US GMPs:Cosmetics,foods,food supplements and drugs Type of product Code of Federal Regulations Which GMP?Cosmetic guidance only Cosmetic Good Manufactur
296、ing Practices61 Food 21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing,Packing,or Holding Human Food62 Dietary supplement 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing,Packaging,Labelling,or Holding Operations for Dietary Supplements63 Food and/or dietary su
297、pplement 21 CFR Part 117 Current Good Manufacturing Practice,Hazard Analysis,and Risk Based Preventive Controls for Human Food64 Drug 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing Processing,Packing,or Holding of Drugs65 21 CFR Part 211 Current Good Manufacturing Practice for
298、Finished Pharmaceuticals66 Source:United States Food and Drug Administration(FDA)EU GMPs for cosmetics The manufacture of cosmetic products for marketing within the EU must comply with GMP with a view to ensuring the functioning of the internal market and a high level of protection of human health.6
299、7 Compliance with GMP is presumed by the competent authority where the product is marketed if the manufacture is occurring in accordance with relevant harmonized standards,such as,specifically:ISO 22716:2007 Cosmetics Good Manufacturing Practices(GMP)Guidelines on Good Manufacturing Practices68 When
300、 a cosmetic product is placed on the EU market,the manufacturers responsible person must also prepare a product information file and retain it for period of 10 years(readily accessible in electronic or other format at the address indicated on the finished product label)past the date on which the las
301、t batch was placed on the market.Among other content requirements,the file must contain a description of the method of manufacturing and a statement on compliance with GMP,as well as data on any animal testing performed by the product manufacturer or ingredient suppliers,including any animal testing
302、 performed to meet the legislative or regulatory requirements of third countries.61 See https:/www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices 62 See https:/www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-110 63
303、 See https:/www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111 64 See https:/www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117 65 https:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.1 66 See https:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSe
304、arch.cfm?CFRPart=211 67 See Consolidated text:Regulation(EC)No 1223/2009 on cosmetic products(Text with EEA relevance),at https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R 68 ISO 22716:2007(en)Cosmetics GMP available to purchase,at https:/www.iso.org/standard/36437.html
305、Export Guide to Medicinal and Aromatic Plant Ingredients and Products 30 EU GMPs for foods EU food safety policy includes standards for ensuring food hygiene,plant health and control of contamination from external substances,such as pesticides.69 The scope includes both traditional and novel foods a
306、s well as food supplements.There are general rules regarding:Farm to fork strategy for a fair,healthy and environmentally friendly food system;Methods of sampling and analysis for the control of levels of certain elements in foodstuffs;Specific rules on organic food production,labelling and control.
307、While the European Commission(EC)regulation on food safety established the European Food Safety Authority(EFSA)and food safety procedures,GMP is not part of the regulation.70 Food GMP rules and audits of facilities for compliance are handled in Europe by national authorities.Of most relevance to GMP
308、 for manufacture of herbal food products in the EU are:EC regulation on the hygiene of foodstuffs,71 which covers the principles of hazard analysis and critical control points(HACCP)and the application of good hygiene practice;EU regulation on GMP for materials and articles intended to come into con
309、tact with food.72 EU GMPs for food supplements In the EU,food supplement products are regulated as foods.73 Therefore,food regulations are applicable.A non-profit organization,Food Supplements Europe,has published an elaborated guide on GMP for manufacturers of food supplements.74 EU GMPs for herbal
310、 medicinal active substances Pre-marketing authorization is required for placement of herbal medicinal products on to the EU market.The manufacturing authorization holder is required to comply with the principles and guidelines of GMP for medicinal products and to use only active substances that hav
311、e been manufactured in accordance with GMP for active substances and distributed in accordance with good distribution practices for active substances.Therefore,the authorization holder must verify the GMP and good distribution practice compliance by the manufacturer of the active substance by conduc
312、ting audits at the manufacturing and distribution sites.75 This means that the manufacturer and exporter of an herbal active substance that will be used as an active ingredient of an authorized HMP in the EU must manufacture the ingredient in compliance with EU GMPs and be subject to external audits
313、.EU guidelines to GMP of HMPs are publicly available to download in Annex 7 of Volume 4 of The rules governing medicinal products in the European Union.76 69 See European Union food safety policy information,at https:/eur-lex.europa.eu/summary/chapter/30.html?expand=3010,301005,301001#arrow_301001 7
314、0 See Consolidated text:Regulation(EC)No 178/2002 on general principles and requirements of food law,at https:/eur-lex.europa.eu/eli/reg/2002/178/2022-07-01 71 See Consolidated text:Regulation(EC)No 852/2004 on the hygiene of foodstuffs,at https:/eur-lex.europa.eu/eli/reg/2004/852/2021-03-24 72 See
315、Consolidated text:Commission Regulation(EC)No 2023/2006 on GMP for food contact materials and articles,at https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R 73 See EFSA Food Supplements information,at https:/www.efsa.europa.eu/en/topics/topic/food-supplements 74 See FSE g
316、uide on GMP for food supplements,at https:/foodsupplementseurope.org/publications-guidelines/75 See Article 46 of Consolidated text:Directive 2001/83/EC on the Community code relating to medicinal products for human use,at https:/eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L
317、1 76 See EC Volume 4 of The rules governing medicinal products in the European Union,at https:/ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en Export Guide to Medicinal and Aromatic Plant Ingredients and Products 31 Quality specifications When an herbal substance is intended for
318、 use as an active ingredient of an HMP,a quality specification must be established corresponding to a monograph published in the PhEur or of a monograph published in a national pharmacopoeia of an EU member state.The EMA guideline on quality of herbal medicinal products states:77 If a monograph for
319、an herbal substance exists in the PhEur or another Pharmacopoeia referred to in Annex I of Directive 2001/83/EC or in Annex II of Regulation(EU)2019/6,as amended,the herbal substance must be in accordance with this monograph.If no monograph for the herbal substance is given in a Pharmacopoeia referr
320、ed to in Annex I of Directive 2001/83/EC or in Annex II of Regulation(EU)2019/6,as amended,a comprehensive specification for the herbal substance must be developed which should be set out in the same way as the monographs on herbal drugs in the PhEur.However,if an herbal substance will be used as a
321、component of a food or food supplement product,quality specifications may be established on the basis of various publicly available standards such as:Codex Alimentarius International Food Standards;78 Combined Compendium of Food Additive Specifications,Joint FAO/WHO Expert Committee on Food Additive
322、s(JECFA);79 European Spice Association(ESA)Quality Minima Document;80 ISO Food Technology Standards,ICS(International Classification for Standards)67.140(Tea.Coffee.Cocoa),67.200(Edible oils and fats.Oilseeds),and 67.220(Spices and condiments.Food additives);81 United Nations Economic Commission for
323、 Europe(UNECE)agricultural quality standards.82 The image below shows selected publicly available guidance documents on the quality of herbs,both governmental(mandatory)and trade association(voluntary).77 See EMA guidelines on quality of herbal medicinal products,at https:/www.ema.europa.eu/en/quali
324、ty-herbal-medicinal-products-traditional-herbal-medicinal-products#current-effective-version-section 78 See Codex Alimentarius International Food Standards,at https:/www.fao.org/fao-who-codexalimentarius/codex-texts/list-standards/en/79 See JECFA Combined Compendium of Food Additive Specifications o
325、nline edition,at https:/www.fao.org/3/a0691e/a0691e00.htm 80 See ESA Quality Minima Document,at https:/www.esa-spices.org/index-esa.html/publications-esa 81 See ISO(ICS 67)Food Technology Standards,at https:/www.iso.org/ics/67/x/82 See UNECE Agricultural Quality Standards,at https:/unece.org/trade/w
326、orking-party-agricultural-quality-standards-wp7 Box 7 Tip:Buyer/seller quality agreements To support quality assurance:Agreements between producers and buyers of medicinal plants/herbal substances with regard to quality such as content of active principle,macroscopical and olfactory properties,limit
327、 values for microbial contamination,chemical residues and heavy metals etc.,must be based on recognized regional and/or national specifications and should be laid down in written form.Source:European Medicines Agency(EMA)GACPs Export Guide to Medicinal and Aromatic Plant Ingredients and Products 32
328、Sources:Left:European Medicines Agency;Centre:European Federation of Associations of Health Product Manufacturers(EHPM);Right:European Spice Association(ESA)Box 8 Tip:Selling the same ingredient in different export markets A successful producer,exporter and marketer of herbal materials will likely d
329、evelop business with customers in several different export markets,each with different quality requirements for market access.The same herbal ingredient may require very different analyses and accompanying documentation for access to the European market versus other destinations.Therefore,it is impo
330、rtant to understand any differences in official quality standards and the test methods that are used in the foreign market to determine acceptable quality.Source:Authors of this guide Box 9 Tip:Quality specifications Buyers situated in countries that do not have a national pharmacopoeia may base the
331、ir quality specification requirements on a pharmacopeial monograph of another country.For example,Canada does not have a national pharmacopoeia.In its Quality of Natural Health Products Guide,the Natural and Non-prescription Natural Health Products Directorate lists the following pharmacopoeias and
332、international standards as acceptable in their entirety:United States Pharmacopeia;British Pharmacopoeia;European Pharmacopoeia;French Pharmacopoeia;Pharmacopoeia Internationalis;Japanese Pharmacopoeia;and the Food Chemicals Codex.It is expected that if a monograph is published in one of these pharm
333、acopoeias,the pharmacopoeial monograph specifications should be considered as minimum specifications used for testing of the medicinal ingredient and finished product.Source:Section 1.5.4(Acceptable pharmacopoeias)of the NNHPD Quality of Natural Health Products Guide:https:/www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-docume