3. Market Access Requirements
Because there are extensive market access resources readily available from governmental and/or international governmental organizations such as the International Trade Centre (ITC) of the United Nations Conference on Trade and Development (UNCTAD) and the Centre for Promotion of Imports from Development Counties (CBI) of the Netherlands, among others, only a brief overview of market access requirements will be provided in this market study, along with web links for accessing further details.
The CBI has prepared very useful market surveys covering specific EU markets, specific product(group)s or documents on market access requirements which can be downloaded from the CBI website. Go to ‘Search CBI database’ on http://www.cbi.nl/marketinfo and select the market sector concerned and an EU country.[1]
The Market Access Map is available through the ITC website. Market Access Map is an interactive application on tariffs and market access barriers. It contains the market access conditions applied at the bilateral level by over 170 importing countries to the products exported by more than 200 countries and territories. Developed by the ITC in collaboration with Centre d’Etudes Prospectives et d’Informations Internationales (CEPII), UNCTAD, and World Trade Organization (WTO), Market Access Map aims to enhance market transparency, support international trade promotion, and to facilitate the analysis of related trade policy issues. Market Access Map’s strength lies in its wide geographical coverage; its taking into account of almost all multilateral, regional and bilateral trade agreements; the integration of ad valorem equivalents (AVE) of specific tariffs; as well as certificates and rules of origin. Market Access Map is available online at: http://www.macmap.org.[2]
Other publications and resources with useful information on market access include the following:
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
EU Market Brief Essential Oils 21 2005 English Centre for the Promotion of Imports from Developing Countries http://www.cbi.nl |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
CBI Export Coaching Programme: Natural Ingredients for Pharmaceuticals and Cosmetics 5 2005 English Centre for the Promotion of Imports from Developing Countries http://www.cbi.nl/?pag=27&pid=13 |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
Indonesia Supply and Demand Survey on Pharmaceuticals and Natural Products 167 2005 English International Trade Centre UNCTAD/WTO (ITC), South-South Trade Promotion Programme http://www.intracen.org/TDC/SSTP/SUPPLYDEMANDSURVEYS/36521.pdf |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
Malaysia Supply and Demand Survey on Pharmaceuticals and Natural Products 71 2005 English International Trade Centre UNCTAD/WTO (ITC), South-South Trade Promotion Programme http://www.intracen.org/TDC/SSTP/SUPPLYDEMANDSURVEYS/36522.pdf |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
Marketing Manual and Web Directory for Organic Spices, Culinary Herbs and Essential Oils 52 2006 English International Trade Centre (ITC) http://www.intracen.org/Organics/documents/marketing-manual.pdf |
| Title No of pages Year of Publication Available in Publisher Available at |
:
: |
Market Requirements for Organic Fruits and Vegetables from the Tropics. Organic Market, Certification and Production Information for Producers and International Trading Companies 330 2003 English United Nations Conference on Trade and Development http://www.sippo.ch/files/publications/unctad_fruitsveg2003.pdf |
| Title No of pages Year of Publication Available in Publisher Available at |
:
: : |
Natural Ingredients for Pharmaceuticals and for the Food Industry: Overview and market access information for producers and international trading companies 216 2005 English Swiss Import Promotion Organization (SIPPO) and Centre for the Promotion of Imports from Developing Countries (CBI) http://www.sippo.ch/files/publications/agri_ingredients05.pdf |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
P.R. China Supply and Demand Survey on Pharmaceuticals and Natural Products |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
Singapore Supply and Demand Survey on Pharmaceuticals and Natural Products 99 2005 English International Trade Centre UNCTAD/WTO (ITC), South-South Trade Promotion Programme http://www.intracen.org/TDC/SSTP/SUPPLYDEMANDSURVEYS/36526.pdf |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
The Market for Cloves in the European Union 34 2006 English International Trade Centre UNCTAD/WTO (ITC) http://www.intracen.org |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
The Market for Nutmeg in the European Union 30 2003 English International Trade Centre UNCTAD/WTO (ITC) http://www.intracen.org |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
The Market for Turmeric in the European Union 38 2004 English International Trade Centre UNCTAD/WTO (ITC) http://www.intracen.org |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
The Natural Ingredients for Cosmetics Market in the EU 85 2006 English Centre for the Promotion of Imports from Developing Countries http://www.cbi.nl |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
The Natural Ingredients for Pharmaceuticals Market in the EU 84 2006 English Centre for the Promotion of Imports from Developing Countries http://www.cbi.nl |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
The United States Market for Natural Ingredients used in Dietary Supplements and Cosmetics 141 2003 English International Trade Centre UNCTAD/WTO (ITC) and Biotrade Facilitation Programme (BTFP) http://www.p-maps.org |
| Title No of pages Year of Publication Available in Publisher Available at |
: : : : : : |
World Markets in the Spice Trade 2000-2004 119 2006 English International Trade Centre UNCTAD/WTO (ITC) http://www.intracen.org |
3.1 EU market access requirements
According to information provided by the CBI, manufacturers in developing countries preparing to access EU markets should be aware of the market access requirements of their European trading partners and of the EU governments. Requirements are governed by legislation and through labels, codes and management systems. These requirements are based on environmental, consumer health and safety and social concerns. Suppliers need to comply with EU legislation and must be aware of additional non-legislative requirements that your trading partners in the EU might request.
Even though in the strict sense it is not the exporter who must directly comply with the EU regulations but rather the EU-based manufacturers, importers, and wholesalers etc, your EU trading partner may transfer the burden of applicable requirements onto their suppliers to facilitate compliance. Therefore, it is relevant for exporters to understand the legislative requirements applicable to suppliers based in the EU.[3] Exporters can become more valuable to their EU trade partners by taking the necessary steps prior to shipment that will facilitate regulatory compliance. This sort of cooperation and support can strengthen the trade relationship, build trust and lead to long-term commitments and loyalty from the buyers.
3.1.1 Legislative requirements (EU)
Information on legislation for natural ingredients for cosmetics, foods and pharmaceuticals can be accessed in the CBI database at http://www.cbi.nl/marketinfo. Using the “Search by Category” function, you can select sectors relevant to the ingredients in this market study including “natural ingredients for cosmetics,” “natural ingredients for pharmaceuticals,” and “food ingredients.”
When selecting “natural ingredients for cosmetics” in the CBI database, the search results will provide links to many available documents on EU market access requirements (legislative, non-legislative, tariffs and quota) as well as market surveys (product surveys and sector surveys). For example, CBI offers the following, among many other documents on legislative requirements relevant for natural cosmetic ingredients:
- EU legislation: Product safety: Directive 2001/95/EC lays down general safety principles for products.
- EU legislation: Cosmetic products and ingredients: The downloadable document provides access to information on EU legislation for cosmetic products (Directive 76/768/EEC) and its amendments.
- EU legislation: Cosmetic product testing: The official testing of cosmetic products is regulated through EU legislation.
- EU legislation: Wood packaging materials: The EU has set new phytosanitary measures for all wooden packaging material that is used with the import of goods into the EU from third countries.
- Case EU legislation: Applying EU legislation to essential oils: Essential oils can be used for various purposes in various final products, including in food, cosmetics and pharmaceuticals.
- OHS: Cosmetics and pharmaceuticals: Occupational health and safety (OHS) aspects, relevant to the production of (natural ingredients) for cosmetics and pharmaceuticals can be very diverse.
- EU market brief Essential oils: This document covers the EU market and the markets in Belgium, France, Germany, Italy, The Netherlands, Spain and the United Kingdom for essential oils.
When selecting “natural ingredients for pharmaceuticals” in the CBI database, the search results will provide links to the following, among many other documents on legislative requirements relevant for natural pharmaceutical ingredients:
-
EU market access requirements: Introduction: Market access requirements are imposed on products (and their processes) exported to the EU by EU governments and the private sector.
-
EU legislation: Wood packaging materials: The EU has set new phytosanitary measures for all wooden packaging material that is used with the import of goods into the EU from third countries.
-
EU legislation: GMP for pharmaceutical / medicinal products: Health aspects and quality of pharmaceutical products are given a lot of importance in the European Union (EU).
-
International ILO standards on working conditions: Social requirements have become increasingly important in international trade.
-
International management system: ISO 26000 on Social Responsibility (proposal): In response to the growing interest from businesses in Social Responsibility, the International Standardization Institute has taken up the challenge to …
-
Medicinal plants: Good agricultural and collection practices: Plant materials collected from wild populations or cultivation are used in the medicinal industry.
-
Case labelling programme: FSC certification for non-timber forest products: Non-timber forest products (NTFPs) can include a broad range of products ranging from food (ingredients) tot natural ingredients for cosmetics or pharmaceuticals.
-
International management system: SA8000 on social accountability: Social Accountability 8000 (SA8000) is a universal management system for companies seeking to guarantee the basic rights of their workers. The system provides …
-
Tariffs and quota for natural ingredients for pharmaceuticals in the EU: This document is a chapter from the CBI market survey ‘The natural ingredients for pharmaceuticals market in the EU, 2006’.
-
EU market access requirement: Supply chain management: Supply chain management is the oversight of products (including production processes), information, and finances as they move in a process from supplier …
-
International management system: ISO 14001 on environment: The International Organization for Standardization, ISO, is the world’s largest developer of standards.
-
International management system: OHSAS 18000 on occupational health and safety: OHSAS stands for Occupational Health and Safety Assessment Specification.
-
International management system: Process control: Process control is a system that maps all operations, including their influences on other operations, in a production process.
3.1.2 Non-legislative requirements (EU)
Social, environmental and quality related market requirements are of growing importance in international trade and are often requested by European buyers through labels, codes of conduct and management systems. [4]
3.1.2.1 Environmental market access requirements (EU)
European buyers are increasingly demanding evidence of sustainability (ecological, economical, and social sustainability) throughout the supply chain. In addition to (pioneer) natural marketplace companies whose founders and decision-makers have always believed in and have supported the sustainable agriculture and sustainable wild collection movements, respectively, increasing numbers of companies are now publishing annual corporate sustainability reports as well as corporate social responsibility reports. Such companies are looking for supply partners who can help them to achieve their mission and to improve their sustainability ratings.
Organic certification is of course non-mandated and therefore it is a voluntary activity for the producer. However when exporting natural ingredients that are labeled as certified organic to trade partners in the EU, compliance with legislative requirements under the organic regulations then become relevant for market access. For natural ingredients produced under controlled cultivation, certification according to the EC organic regulations should be taken into consideration for adding value to the crops and addressing the trend of increasing demand for certified organic ingredients and natural products. The relevant organic regulations are Council Regulation (EEC) No 2092/91 of 24 June 1991 on Organic Production of Agricultural Products, available at: http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1991/R/01991R2092-20070101-en.pdf, and Council Regulation (EC) No 1804/1999 of 19 July 1999 Supplementing Regulation (EEC) No 2092/91 on Organic Production of Agricultural Products, available at: http://europa.eu.int/eur-lex/pri/en/oj/dat/1999/l_222/l_22219990824en00010028.pdf
For wild collected natural ingredients, in order to address the growing trend for sustainably produced ingredients, a determination of the maximum optimal sustainable yield from wild collection of Malaysian botanical raw materials should be taken into consideration in order to ensure long-term sustainable trade to the global market. This should also be independently verified and certified for credibility in the marketplace. It has been reported that the local Malaysian herbal industry obtains about 50% of its required botanical raw materials from collection in the forests,[5] and the mission of the Forestry Department is to sustainably manage and develop the forest resources and optimize their contributions to national socio-economic development.[6] It is recommended that wild collection of Malaysian raw materials, that are destined for the European market (whether in the form of crude raw materials or in valued-added extracted or processed forms), should, at a minimum, be collected under the supervision of organic certification of wild crops. Above and beyond organic certification, the highest standard would be to independently verify that the raw materials were collected in conformance with the International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP).[7]
A certification scheme to consider for wild collected natural ingredients, known as “FairWild,” is available through the Swiss Import Promotion Organization (SIPPO) and certification is managed through the Institute for Marketecology (IMO).[8] FairWild Certified Malaysian natural ingredients may be a potentially strong opportunity for increasing market share while also earning a price premium over non-certified wild collected raw materials. FairWild is certifiable and provides the buyers with transparency and the assurance that products are produced in a socially and ecologically sound way. Traceability and better product safety add additional marketing arguments for the final consumer. FairWild is developed as an additional module to the ecologically focused management criteria defined in the aforementioned ISSC-MAP. This standard defines guidelines and provides tools to the collectors and producers for the planning and implementation of a sustainable resource management system – a guarantee for constant and reliable supply of raw materials for industry and traders. Organic certification of the wild collection practices is also accepted as minimum demonstration of ecologically sound production practices.
3.2.2.2 Social and Religious market access requirements (EU)
A good source of information on social market access requirements of European buyers is published in the CBI’s Market Information Database. CBI accurately reports that social issues are increasingly important market access requirements of European importers. Social issues include general labor conditions, such as minimum wage and maximum working hours as well as health and safety of the employees. European trading partners are increasingly requiring a minimum of social requirements from their suppliers in developing countries. This is accomplished through social or ethical trading requirements, suppliers’ declarations, social responsibility and social accountability schemes. Social responsibility has become a new selection criterion of European consumers. As a result of this growing trend, European importers are now including social issues, such as ethics, integrity and social accountability, in their assessment of suppliers worldwide. Big brands cannot afford the risk of negative publicity if their products were to be associated with exploitive labor conditions in developing countries.[9]
Fair Trade
A report entitled “Fair Trade in Europe 2005: Facts and Figures on Fair Trade in 25 European Countries” provides the results of a survey that collected data from national and international Fair Trade organizations in 25 European countries. As of early 2005 the annual aggregate net retail value of Fair Trade products sold in Europe exceeded 660 million Euro, well over twice the figure from five years earlier of about 260 million Euros. The increase of 154% over 5 years represents a sustained average annual increase of about 20% annually. In the UK, Fairtrade labeled teas now command a 5% market share. And in Switzerland (not part of the EU-25), 47% of all bananas are now sold with the Fairtrade label.[10] In March 2007, the German fairtrade organization, Trans Fair e.V., presented results of their 2006 annual report which revealed that in Germany alone, 18,000 tons of raw materials were imported under fair trade terms and conditions from producer groups in Latin America, Asia and Africa. This was double the amount that had been imported in the previous year. Retail sales turnover in Germany of Fairtrade labeled products climbed by about 50% to 110 million Euros. The certified organic portion of fair trade sales increased by about 10% to 70% of fair trade products being also organic.[11]
For certain cultivated Malaysian natural ingredients, Fair Trade Certification can be available which would provide distinct market differentiation, price premiums, and satisfy the growing demand for Fair Trade Certified™ ingredients and products in the Western markets. For example, Malaysia is a leading producer and exporter of cocoa butter, which is used in cosmetics and pharmaceutical products. Certified organic cocoa beans, cocoa butter and cocoa liqueur are all fair trade certifiable under the Fairtrade Labelling Organization (FLO) Fairtrade Standards for Cocoa.[12] Other fairtrade standards of potential relevance to Malaysian natural ingredient exporters include the FLO Fairtrade Standards for Herbs and Spices[13] and the FLO Fairtrade Standards for Tea,[14] as well as the FLO Fairtrade Standards for Dried Fruit, FLO Standards for Fresh Fruit, and FLO Standards for Fruit Juices.
FairWild
A certification scheme to consider for social certification of wild collected natural ingredients is “FairWild” is available through the Swiss Import Promotion Organization (SIPPO) and certification is managed through the Institute for Marketecology (IMO).[15] FairWild Certified Malaysian natural ingredients may be a potentially strong opportunity for increasing market share while also earning a price premium over non-certified wild collected raw materials. FairWild certification provides the buyers with transparency and the assurance that products are produced in a socially and ecologically sound way. Traceability and better product safety add additional marketing arguments for the final consumer. Social Accountability and Fair Trade have become important indicators to select business partners in a global market place. There are a number of approaches and label schemes available; however, they are not applicable for most wild collection products in a global market. FairWild allows collectors, workers and companies in the wild collection trade to jointly work on truly sustainable production and to receive a fair price for their goods. A small premium price is paid for certified products, which allows for social community projects in the collection areas.
ISSC-MAP
The aforementioned ISSC-MAP includes the principle of “Applying Responsible Business Practices.” To demonstrate compliance with the ISSC-MAP, in addition to the conservation, environmental, legal and ethical requirements, the wild collection of MAP resources must be undertaken to support quality, financial, and labor requirements of the market without sacrificing sustainability of the resource. This ISSC-MAP Principle includes criteria such as financial viability, training and capacity building, and worker safety and compensation, among other criteria.[16]
Religious certifications: Halal and Kosher
Religious certification of ingredients used in cosmetics, dietary supplements, foods, and pharmaceuticals is becoming increasingly important in the European natural marketplace. Companies are increasingly positioning their products towards the sensibilities of particular consumer groups, for example based on religious beliefs, such as Halal for Muslim consumers or Kosher for Jewish consumers, as well as ethical such as vegetarian or vegan, or related health concerns such as allergen-free.
Worldwide there are about 1.4 billion Muslims, of whom about 30 million live in Europe, mostly in France, the Netherlands, and the UK. And there are about 14 million Jews worldwide, of whom about 1.5 million live in Europe, mostly in France, the UK, Russia, and Germany. 5% to 10% of the French population is Muslim and 1% is Jewish. The Muslim population in the Netherlands is estimated at 5.5%, Germany 3.7%, and 2.7% in the UK.
While many suppliers of natural ingredients in Europe already offer kosher certification, many are beginning to add Halal certification for the same ingredients. In Europe, the Halal market is an area of particular growth, as second- and third-generation Muslims who have grown up in Western countries wish to eat the same kinds of foods as their non-Muslim peers, but without compromising their Halal diet. Natural ingredient suppliers serving the European market with Halal certification include, among others Carotech BHD (Malaysia), Fortitech (Denmark), Keratec (New Zealand), Marinova (Australia), Naturex (France),[17] Aloecorp (USA), and Ocean Nutrition (Canada).[18] Naturex believes that Halal certification represents a real market opportunity for its natural ingredients and has obtained Halal approval from the Islamic Food and Nutrition Council of America (IFNCA) across its four plants, in France, Morocco, New Jersey, and California.[19] France is home to the largest Muslim community (4.7 million people) in Europe, and represents its largest Halal market, with sales ranging from $2 to $4 billion in calendar 2005 (mostly foods). France’s Halal market is an expanding niche, with demand growing along with new products being offered. Halal consumption has been increasing anywhere from 7% to 15% per year since 1998. Halal products appeal particularly to the younger generation whose parents or grandparents immigrated to France. Consumers under 30 years old account for approximately 80% of France’s Halal consumers. Consumers of Arab and Berber origin buy Halal products most frequently and spend the most per month on them.[20]
3.1.2.3 Quality market access requirements (EU)
Certain quality market access requirements are legislative and other quality requirements or based on agreements made between the buyer and seller which are non-legislative. The quality requirements are dependent on the end-use of the natural ingredient. If the natural ingredient is to be used in foods or supplements the quality requirements for market access will be measurably different from the quality requirements for market access if the ingredient is going to be used in a pharmaceutical product, for example as an active pharmaceutical ingredient in a Traditional Herbal Medicinal Product (THMP), in a medical device, or in a well-established use medicinal product.
According to the World Health Organization (WHO) Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants: “Agreements between producers and buyers of medicinal plants/herbal drugs with regard to quality such as content of active principle, macroscopical and olfactory properties, limit 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.” Available on-line at: http://whqlibdoc.who.int/publications/2003/9241546271.pdf.[21] Chapter 3 of a corresponding document published by the European Medicines Agency (EMEA) entitled “Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin,” uses identical wording as the WHO Guidelines. Available on-line at: http://www.emea.europa.eu/pdfs/human/hmpc/24681605en.pdf.[22]
If a natural ingredient is exported to the EU with an end-use as an active ingredient in a THMP, it is essential to understand the EMEA’s “Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations, and Herbal Medicinal Products / Traditional Herbal Medicinal Products,” which is available on-line at: http://www.emea.europa.eu/pdfs/human/qwp/282000en.pdf.[23]
A complete list of EMEA quality guidance documents relevant to natural ingredients is shown below and also available for downloads at the EMEA web page: http://www.emea.europa.eu/htms/human/hmpc/hmpcguide.htm
Committee on Herbal Medicinal Products (HMPC) Guidance Documents
[important color=grey title=QUALITY]EMEA/HMPC/125562/06 Reflection Paper on the use of Fumigants (Adopted October 2006)
EMEA/HMPC/CHMP/CVMP/58222/06 Concept Paper on Quality of Combination Herbal Medicinal Products/Traditional Herbal Medicinal Products (Released for consultation June 2006)
EMEA/HMPC/CHMP/CVMP/287539/05 Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC (Released for consultation June 2006)
EMEA/HMPC/246816/05 Guideline on Good Agricultural and Collection Practice for starting materials of Herbal Origin (Adopted January 2006)
See also…EMEA/HMPC/11138/06 Overview of comments on the GACP Guideline
CPMP/QWP/2819/00 Rev. 1 Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products
See also…EMEA/CHMP/CVMP/QWP/40683/06 Overview of comments on the Draft Guideline Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products..
CPMP/QWP/2820/00 Rev. 1 Guideline on specifications: Test procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products
See also…EMEA/CHMP/CVMP/QWP/40728/06 Overview of comments on the Draft Guideline on Test procedures and Acceptance………[/important]
If the natural ingredient is not going to be used in a pharmaceutical product, other quality standards may be relevant. For example some the following European quality standards may be applicable for natural ingredients that are for use in food or supplement products:
- European Herbal Infusions Association (EHIA) Compendium of EHIA Guidelines: Foodstuff Specifications for Herbal Infusion Products.[24] Available : http://www.ehia-online.org/documents/foodstuff_specifications_for_herbal_infusion_products.pdf;
- EHIA Guidelines for Good Agricultural and Hygiene Practices for Raw Materials used for Herbal Infusions (GAHP).[25] Available at : http://www.ehia-online.org/documents/FINAL%20GAHP-EN2006.pdf;
- European Spice Association (ESA) Quality Minima Document.[26] Available at: http://www.esa-spices.org/content/pdfs/ESAQualityMinimaDocument191104.pdf;
- ESA Advise on Illegal Dyes.[27] Available at : http://www.esa-spices.org/content/pdfs/ESA%20Advice_rev2_June2006.pdf;
- International Organization for Standardization (ISO) Specifications for Spices and Condiments, Essential Oils, Black and Green Teas and Herbal Teas. Available (for purchase) at: http://www.iso.org/iso/en/ISOOnline.frontpage.
If the natural ingredient exported to the EU is for use in a pharmaceutical product it will need to have written specifications for test and release in conformance with an official pharmacopoeial quality control monograph. The European Pharmacopoeia (PhEur) contains quality standards monograph for natural ingredients. Additionally, there are natural ingredients quality standards monographs still official in the various national pharmacopoeias of EU Member States. After each monograph is harmonized between the pharmacopoeial commissions of the various EU Member States, the monograph is retired from the national pharmacopoeias as the new harmonized monograph is entered into the PhEur. Therefore, not all relevant monographs for natural ingredients are found (yet) in the PhEur and in some cases the required quality standards for an imported natural ingredient will be based on a monograph published in one of the national pharmacopoeias, for example the British Pharmacopoeia (BP), French Pharmacopoeia (PhFr), or German Pharmacopoeia (DAB), among many others.
3.1.3 Packaging, marking and labeling (EU)
Guidance on packaging of botanical raw materials is provided in Chapter 13 of the EMEA document “Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin,” uses identical wording as the WHO Guidelines. Available on-line at: http://www.emea.europa.eu/pdfs/human/hmpc/24681605en.pdf.[28]
[important color=grey title=13. PACKAGING]
13.1 In order to protect the product and to reduce the risk of pest attacks, early packaging is advisable.
13.2 Following processing monitored by in-process controls, the product should be packaged in clean and dry, preferably new sacks, bags or cases. The label must be clear, permanently fixed and made from non-toxic material. Information must conform to regional and/or national labelling regulations.
13.3 Reusable packaging material should be well cleaned and properly dried prior to use. No contamination should occur through reusing of bags.
13.4 Packaging materials must be stored in a clean and dry place that is free of pests and inaccessible to livestock and domestic animals. It must be guaranteed that no contamination of the product occurs by the use of packaging materials, particularly in the case of fibre bags.[/important]
Guidance on the labeling of botanical raw materials is provided in Chapter 4.2 of the World Health Organization (WHO) document “WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants,” available at: http://whqlibdoc.who.int/publications/2003/9241546271.pdf.[29]
[important color=grey title=4.2 Bulk packaging and labelling]
Processed medicinal plant materials should be packaged as quickly as possible to prevent deterioration of the product and to protect against unnecessary exposure to potential pest attacks and other sources of contamination.
Continuous in-process quality control measures should be implemented to eliminate substandard materials, contaminants and foreign matter prior to and during the final stages of packaging. Processed medicinal plant materials should be packaged in clean, dry boxes, sacks, bags or other containers in accordance with standard operating procedures and national and/or regional regulations of the producer and the end-user countries. Materials used for packaging should be non-polluting, clean, dry and in undamaged condition and should conform to the quality requirements for the medicinal plant materials concerned. Fragile medicinal plant materials should be packaged in rigid containers. Whenever possible, the packaging used should be agreed upon between supplier and buyer.
Reusable packaging material such as jute sacks and mesh bags should be well cleaned (disinfected) and thoroughly dried prior to reuse, so as to avoid contamination by previous contents. All packaging materials should be stored in a clean and dry place that is free from pests and inaccessible to livestock, domestic animals and other sources of contamination.
A label affixed to the packaging should clearly indicate the scientific name of the medicinal plant, the plant part, the place of origin (cultivation or collection site), the cultivation or collection date and the names of the grower/collector and the processor, and quantitative information. The label should also contain information indicating quality approval and comply with other national and/or regional labelling requirements.
The label should bear a number that clearly identifies the production batch. Additional information about the production and quality parameters of the medicinal plant materials may be added in a separate certificate, which is clearly linked to the package carrying the same batch number.
Records should be kept of batch packaging, and should include the product name, place of origin, batch number, weight, assignment number and date. The records should be retained for a period of three years or as required by national and/or regional authorities.[/important]
3.1.4 Tariffs and quota (EU)
Table 3.1 shows the applied tariffs for selected product codes for exporter Malaysia to importer European Union. The Market Access Map is available through the International Trade Centre (ITC) website and was developed by the ITC in collaboration with Centre d’Etudes Prospectives et d’Informations Internationales (CEPII), UNCTAD, and World Trade Organization (WTO). The ITC offers a 2-day free trial of the Market Access Map at: http://www.macmap.org.[30]
NOTE: An “ad valorem tariff” is a tariff which is imposed in percentage terms over the value of the good. For example, a 5% tariff, which means that the import tariff is 5% of the appraised value of the good in question. An “ad valorem equivalent” is when a tariff is fixed in specific or mixed terms, usually an “ad valorem equivalent” of the non ad valorem portion of the duty is calculated for reference purposes. There are several formulas for estimating the AVEs. One common approach is based on MFN trade dividing duties collected by Customs value.
Table 3.1 Importer European Union applies the following tariffs to imports of these selected natural ingredients originating from exporter Malaysia
|
Selected HS Codes |
Product description |
Applied tariffs |
Ad valorem equivalent of specific applied tariffs |
Total ad valorem equivalent tariff (estimated) |
|---|---|---|---|---|
|
070320 |
Garlic, fresh or dried |
77.05% |
|
77.05% |
|
071290 |
Dried garlic and other dried vegetables |
2.89% |
1.14% |
4.03% |
|
08029012 |
Betel nut |
0.00% |
|
0.00% |
|
0804.5030 |
Mangosteen fruit |
2.65% |
|
2.65% |
|
0902 |
Green tea leaf or black tea leaf |
0.00% |
|
0.00% |
|
090411 090412 |
Piper genus fruits, except cubeb pepper |
0.00% |
|
0.00% |
|
090420 |
Capsicum or Pimenta genus fruits |
1.53% |
|
1.53% |
|
0906 |
Cinnamon |
0.00% |
|
0.00% |
|
0907 |
Cloves |
2.80% |
|
2.80% |
|
090810 |
Nutmeg |
0.00% |
|
0.00% |
|
090820 |
Mace |
0.00% |
|
0.00% |
|
090830 |
Cardamoms |
0.00% |
|
0.00% |
|
090910 |
Star anise fruit |
0.00% |
|
0.00% |
|
090920 |
Coriander fruit |
0.00% |
|
0.00% |
|
090930 |
Cumin fruit |
0.00% |
|
0.00% |
|
090940 |
Caraway fruit |
0.00% |
|
0.00% |
|
090950 |
Fennel fruit |
0.00% |
|
0.00% |
|
091010 |
Ginger rhizome |
0.00% |
|
0.00% |
|
091030 |
Turmeric rhizome |
0.00% |
|
0.00% |
|
091050 |
Curry powder |
0.00% |
|
0.00% |
|
091091 |
Spice mixtures |
2.15% |
|
2.15% |
|
091099 |
Spices NESOI |
2.15% |
|
2.15% |
|
1210 |
Hop strobile |
5.80% |
|
5.80% |
|
121110 |
Licorice root |
0.00% |
|
0.00% |
|
1221120 |
Ginseng roots |
0.00% |
|
0.00% |
|
121190 |
Medicinal plants NESOI |
0.00% |
|
0.00% |
|
121220 |
Seaweeds and other algae |
0.00% |
|
0.00% |
|
130190 |
Natural gums, resins, gum-resins and balsam, except gum arabic |
0.00% |
|
0.00% |
|
130219 |
Vegetable saps and extracts NESOI |
0.00% |
|
0.00% |
|
130231 |
Agar-agar |
0.00% |
|
0.00% |
|
130239 |
Mucilages & thickeners NESOI |
0.00% |
|
0.00% |
|
140490 |
Vegetable products NESOI |
0.00% |
|
0.00% |
|
151311 |
Coconut oil, crude |
1.65% |
|
1.65% |
|
151319 |
Coconut oil, refined |
5.75% |
|
5.75% |
|
180400 |
Cocoa butter, fat and oil |
4.20% |
|
4.20% |
|
210120 |
Tea or maté extracts, essences & concentrations & preparations thereof |
3.25% |
|
3.25% |
|
293921 |
Quinine and its salts, in bulk |
0.00% |
|
0.00% |
|
293929 |
Cinchona alkaloids and their derivatives, in bulk; salts thereof |
0.00% |
|
0.00% |
|
3301 |
Essential oils |
0.00% |
|
0.00% |
|
330190 |
Extracted oleoresins, concentrates of essential oils |
0.00% |
|
0.00% |
|
330290 |
Mixture of odiferous substances NESOI |
0.00% |
|
0.00% |
|
400130 |
Gutta-percha |
0.00% |
|
0.00% |
SOURCE: International Trade Centre (ITC) UNCTAD/WTO. Market Access Map.
- ProFound Advisers in Development in collaboration with Jones A and Dürbeck K. CBI Market Survey: The natural ingredients for cosmetics market in the EU. Rotterdam, Netherlands: Centre for the Promotion of Imports from Development Countries (CBI). September 2006.
- International Trade Centre (ITC) / United Nations Conference on Trade and Development (UNCTAD). Market Access Map. Available at: http://www.intracen.org/mas/mac.htm.
- ProFound Advisers in Development, in collaboration with Jones A and Dürbeck K. CBI Market Survey: The natural ingredients for cosmetics market in the EU. Rotterdam, Netherlands: Centre for the Promotion of Imports from Developing Countries (CBI). September 2006.
- ProFound Advisers in Development, in collaboration with Jones A and Dürbeck K. CBI Market Survey: The natural ingredients for cosmetics market in the EU. Rotterdam, Netherlands: Centre for the Promotion of Imports from Developing Countries (CBI). September 2006.
- Mohd Azmi Muhammed Idris, Norini Haron. Supply and demand of Eurycoma longifolia (Tongkat Ali) plants with few others. Journal of Tropical Medicinal Plants. June 2001;2(1):145-154.
- Forestry Department Peninsular Malaysia. Vision, Mission, Objective. FDPM Official Website. Available at: http://www.forestry.gov.my/eMission.html
- International Standard for the Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP). Available at: http://www.floraweb.de/proxy/floraweb/map-pro.
- Swiss Import Promotion Organization (SIPPO). FairWild Standard and Certification. Available at: http://www.fairwild.org.
- Centre for the Promotion of Imports from Development Countries (CBI). Market Access Requirements in CBI’s Market Information Database. Rotterdam, Netherlands: CBI. Available at: http://www.cbi.nl.
- Krier JM. Fair Trade in Europe 2005: Facts and Figures on Fair Trade in 25 European Countries. Published by Fairtrade Labelling Organizations (FLO), International Fair Trade Association (IFAT), Network of European World Shops (NEWS!), and European Fair Trade Association (EFTA). June 2005. Available at: http://www.fairtrade.net/uploads/media/FairTradeinEurope2005.pdf.
- Trans Fair e.V. Fairtrade verdoppelt Absatz: Der Faire Handel ist so erfolgreich wie noch nie, dies berichtet die Siegelorganisation TransFair bei der Vorstellung des Jahresberichtes 2006. Trans Fair e.V. Pressemitteilung. 30 March 2007. Available at: http://www.transfair.org/presse/detailseite-presse/article/45/fairtrade-ve.html.
- Fairtrade Labelling Organizations International (FLO). Fairtrade Standards for Cocoa for Small Farmers’ Organizations. Bonn, Germany: FLO. 2005. Available at: http://www.fairtrade.net/fileadmin/user_upload/content/Cocoa_SF_Dec_05_EN.pdf.
- Fairtrade Labelling Organizations International (FLO). Fairtrade Standards for Herbs and Spices for Small Farmers’ Organizations. Bonn, Germany: FLO. 2007. Available at: http://www.fairtrade.net/fileadmin/user_upload/content/Herbs_and_Spices_SF_May_07_EN.pdf.
- Fairtrade Labelling Organizations International (FLO). Fairtrade Standards for Tea for Small Farmers’ Organizations. Bonn, Germany: FLO. 2007. Available at: http://www.fairtrade.net/fileadmin/user_upload/content/Tea_SF_March_06_EN.pdf.
- Swiss Import Promotion Organization (SIPPO). FairWild Standard and Certification. Available at: http://www.fairwild.org.
- Medicinal Plant Specialist Group. International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP). Version 1.0. Bonn, Gland, Frankfurt, and Cambridge (BfN-Skripten 195): Bundesamt für Naturschutz (BfN), MPSG/SSC/IUCN, WWF Germany, and TRAFFIC. January 2007. Available at: http://www.floraweb.de/proxy/floraweb/MAP-pro/Standard_Version1_0.pdf.
- Anon. Keratec gains worldwide halal approval. Nutraingredients.com. 2 May 2007.
- Anon. Naturex receives halal seal of approval. NutraIngredients.com Europe. 8 September 2006.
- Anon. Naturex receives halal seal of approval. NutraIngredients.com Europe. 8 September 2006.
- Journo LJ, Peacock N. France’s market for halal foods. United States Department of Agriculture (USDA) Foreign Agriculture Service (FAS) Worldwide. 30 June 2007.
- World Health Organization. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Geneva, Switzerland: WHO. 2003. Available at: http://whqlibdoc.who.int/publications/2003/9241546271.pdf.
- European Medicines Agency (EMEA) Committee on Herbal Medicinal Products (HMPC). Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin. London, UK: EMEA HMPC. February 2006. Available at: http://www.emea.europa.eu/pdfs/human/hmpc/24681605en.pdf.
- European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP). Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations, and Herbal Medicinal Products / Traditional Herbal Medicinal Products. London, UK: EMEA CHMP CVMP. March 2006. Available at: http://www.emea.europa.eu/pdfs/human/qwp/282000en.pdf.
- European Herbal Infusions Association (EHIA). EHIA Compendium of EHIA Guidelines: Foodstuff Specifications for Herbal Infusion Products. Hamburg, Germany: EHIA. 2000. Available at: http://www.ehia-online.org/documents/foodstuff_specifications_for_herbal_infusion_products.pdf.
- European Herbal Infusions Association (EHIA) EHIA Guidelines for Good Agricultural and Hygiene Practices for Raw Materials used for Herbal Infusions (GAHP). Hamburg, Germany: EHIA. 2006. Available at: http://www.ehia-online.org/documents/FINAL%20GAHP-EN2006.pdf.
- European Spice Association (ESA). ESA Quality Minima Document. Bonn, Germany: ESA. 2004. Available at: http://www.esa-spices.org/content/pdfs/ESAQualityMinimaDocument191104.pdf.
- European Spice Association (ESA). ESA Advise on Illegal Dyes. Bonn, Germany: ESA. 2006. Available at http://www.esa-spices.org/content/pdfs/ESA%20Advice_rev2_June2006.pdf.
- European Medicines Agency (EMEA) Committee on Herbal Medicinal Products (HMPC). Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin. London, UK: EMEA HMPC. February 2006. Available at: http://www.emea.europa.eu/pdfs/human/hmpc/24681605en.pdf.
- World Health Organization. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Geneva, Switzerland: WHO. 2003. Available at: http://whqlibdoc.who.int/publications/2003/9241546271.pdf.
- International Trade Centre (ITC) / United Nations Conference on Trade and Development (UNCTAD). Market Access Map. Available at: http://www.intracen.org/mas/mac.htm.
