PROPOSED DRAFT STANDARD FOR GINSENG PRODUCTS. COMMENTS AT STEP 3 (Republic of Korea, Australia, United States)

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1 October 2006 E Agenda Item 3(b) JOINT FAO/WHO FOOD STANDARDS PROGRAMME FAO/WHO COORDINATING COMMITTEE FOR ASIA Fifteenth Session, Seoul, Republic of Korea, November 2006 REPUBLIC OF KOREA PROPOSED DRAFT STANDARD FOR GINSENG PRODUCTS COMMENTS AT STEP 3 (Republic of Korea, Australia, United States) Background 1. The 14th Session of the FAO/WHO Regional Coordinating Committee for Asia which was held in Jeju- Do, the Republic of Korea in September 2004 agreed to forward the Proposed Draft Standard for Ginseng Products to the 28th Codex Alimentarius Commission for adoption at Step 5. However, the 28th Session of the Commission held in July 2005 returned it to Step 3 as some member countries raised concerns over the fact that some of the current provisions in the Proposed Draft Standard referred to the ginseng products beyond foods, and requested redrafting. In addition, it was also stated that the existing draft standard was not generic and that the types of ginseng covered by the standard should not be limited to a single variety of Panax ginseng C.A. Meyer (see ALINORM 05/28/41 para. 73). 2. The Coordinating Committee for Asia (CCASIA) will discuss the proposed draft standard at its 15 th Session which will be held on November 2006 in The Republic of Korea. In this connection, the Codex Secretariat sent a circular letter (CL 2006/3-ASIA, January 2006) to the member governments of the Coordinating Committee for Asia and observers, and requested to provide their comments on the existing Proposed Draft Standard for Ginseng Products, as was agreed by the 14th Session of the CCASIA, by 10th May Amendment of the Existing Proposed Draft Standard 3. The Republic of Korea has amended the existing proposed draft standard in such a manner as is shown in APPENDIX 1 of this present document. This amended standard has been prepared after reflecting the opinions and comments presented at the 28 th session of CAC and those raised during pre-coordinating meetings held early in this year between Korean experts and their counterparts from the countries interested in the standard. In particular, the amended standard has clarified the species of ginseng covered by the standard; modified the product type, product name and labeling sections so that the standard may be broadly applicable to the ginseng species; and improved the product definition and quality factor sections in order to highlight the fact that this standard addresses foods only.

2 2 4. As part of the endeavors to coordinate the standardization work before the coming session of CCASIA, Korea asked the member countries to offer their comments on the proposed draft standard; visited Malaysia, Thailand, and China last February and elucidated them the major points of the standard; and has improved the standard after satisfactorily conferring with specialists and experts from each member country. Moreover, Korea plans to pay a visit to more countries than mentioned in the above, which are much interested in the standardization of ginseng product, and discuss the amended standard with them in advance of the coming CCASIA session. Such an effort will greatly facilitate the efficient consideration of the subject concerned in the future Codex meetings. 5. The major amendments are listed below, and Appendix 2 shows the comparison between the existing proposed draft standard and the amended proposed draft standard. a) The standardization is applicable to three major ginseng species which are commercially cultivated around the world (Section 2.1). b) The classification of the products has been simplified after Section and were deleted and incorporated into Section and 2.2.2, respectively. c) The product names have been changed to more generic ones so that they may cover all ginseng species (Section and 2.2.2) d) The characteristics of Other Types of Ginseng Products are described in detail in order to emphasize that the ginseng product as a food is distributed in various types (Section 2.2.3). e) The quality factor section has been simplified in accordance with the above-mentioned item b) (section and 3.3.2), and the criteria of quality factor for Other Types of Ginseng Products have been newly established (Section 3.3.3). f) The labeling section has been also changed in accordance with the above-said points (Section 7.1, 7.2 and 7.4) Recommendation 6. The committee is invited to use the proposed draft standard on Gingseng products prepared by the Republic of Korea as basis text for the consideration in the 15 th Session of CCASIA. APPEDIX 1: Amended Proposed Draft Standard for Ginseng Product APPEDIX 2: Comparison of the Existing Proposed Draft Standard with the Amended Proposed Draft Standard 2

3 3 APPENDIX 1 AMENDED PROPOSED DRAFT STANDARD FOR GINSENG PRODUCT <Prepared by The Republic of Korea for consideration in the 15 th session of CCASIA> 1. SCOPE This standard applies to the ginseng product as defined in Section 2 below and offered for direct consumption, including for catering purposes or for repacking if required. It does not apply to the product when indicated as being intended for further processing. This standard applies to the ginseng product used as a food or food ingredient and does not apply to the product used for medicinal purposes. 2. DESCRIPTION 2.1 Product Definition The compulsory ingredient of ginseng product is fresh ginseng roots suitable to eating, derived from Panax ginseng C.A. Meyer, P. quinquefolius L. and P. notoginseng Burk, cultivated for commercial purposes and used for foods. 2.2 Types of Ginseng Product Dried Ginseng Dried Raw Ginseng Dried Raw Ginseng is manufactured when fresh ginseng roots are sun dried or hot air dried or dried using other recognized methods. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced Dried Steamed Ginseng Dried Steamed Ginseng is manufactured when fresh ginseng roots are prepared using the steaming method or other recognized methods, and dried. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced Ginseng Extract Raw Ginseng Extract Raw Ginseng Extract is manufactured when soluble components of fresh ginseng roots or Dried Raw Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. This product has a dark brown color and a high viscosity when much of the water is removed from it. The product may be also presented as a powdered type through spray- or freezedrying Steamed Ginseng Extract Steamed Ginseng Extract is manufactured when soluble components of Dried Steamed Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. This product has a dark brown color and a high viscosity when much of the water is removed from it. The product may be also presented as a powdered type through spray- or freeze-drying Other Types of Ginseng Product Other Types of Ginseng Product are permissible if they are in the following conditions: 3

4 4 (a) The products are manufactured compulsorily with fresh ginseng roots defined in Section 2.1, Dried Ginseng in Section 2.2.1, or Ginseng Extract in Section and optionally along with various foodstuffs including food additives and/or with processing aids. They may be presented in such product types as beverages, decoctions, candies, capsules, tablets, pills, tea-type products (powdered or granulated), etc. (b) The products shall meet all the relevant requirements of this standard. (c) Characteristics of the products shall be adequately described in the product labelling so as to avoid confusing or misleading consumers. 3. ESSENTIAL COMPOSITION AND QUALITY FACTORS 3.1 Compulsory Ingredients Fresh ginseng roots as defined in Section Optional Ingredients (a) Dried Ginseng (Section 2.2.1): no optional ingredient (b) Ginseng Extract (Section 2.2.2): no optional ingredient (c) Other Types of Ginseng Product (Section 2.2.3): all kinds of foodstuffs 3.3 Quality Factors Ginseng product shall have a normal flavor, color, taste and a ginsenoside pattern unique to ginseng Dried Ginseng (a) Moisture: no more than 14.0% (Powdered type: no more than 9.0%) (b) Ash: no more than 6.0% (c) Water-saturated 1-butanol extracts: no less than 20 mg/g (d) Ginsenosides Rb1 and Rg1: to be identified In addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified Ginseng Extract (a) Moisture: no more than 8.0% (applicable only to a powdered type) (b) Solids: no less than 60.0% (c) Water-insoluble solids: no more than 3.0% (d) Water-saturated 1-butanol extracts: no less than 70 mg/g (e) Ginsenosides Rb1 and Rg1: to be identified In addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified Other Types of Ginseng Product (a) Ginsenosides Rb1 and Rg1: to be identified In addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified. 3.4 Definition of Defects The following defects shall be applied to the dried ginseng. (a) Insect-damaged ginseng: Gnseng that is visibly damaged by insects or contains dead insects (b) Moldy ginseng: Gnseng that is visibly affected by mold 3.5 Classification of "Defectives" A container that fails to meet one or more of the applicable quality requirements, set out in Sections 3.3 and 3.4, shall be considered a "defective". 3.6 Lot Acceptance 4

5 5 A lot can be considered as meeting the applicable quality requirements referred to in Section 3.3, when the number of "defectives", defined in Section 3.5, does not exceed the acceptance number (c) of the appropriate sampling plan in the General Guidelines on Sampling (CAC/GL ). 4. CONTAMINANTS 4.1 Heavy Metals This product covered by the provisions of this standard shall comply with those maximum levels for contaminants established by the Codex Alimentarius Commission for the product Pesticide Residues This product covered by the provisions of this Standard shall comply with those maximum residue limits for pesticides established by the Codex Alimentarius Commission for the product. 4.3 Foreign matters This product should not contain any foreign matter which can be removed by washing and other methods in the course of treating materials or any unsanitary foreign matter contaminated in the course of manufacturing the product. 5. HYGIENE 5.1 It is recommended that the product covered by the provisions of this standard be prepared and handled in accordance with the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP , Rev ), and other relevant Codex texts, such as Codes of Hygienic Practice and Codes of Practice. 5.2 The product should comply with any microbiological criteria established in accordance with the Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL ). 6. WEIGHTS AND MEASURES 6.1 Minimum Fill The net weight of the product shall not be less than 97% of the labeled weight. 6.2 Classification of "Defectives" A container that fails to meet the requirement for minimum fill in Section 6.1 shall be considered a "defective". 6.3 Lot Acceptance A lot can be considered as meeting the requirement in Section 6.1, when the number of "defectives", defined in Section 6.2, does not exceed the acceptance number (c) of the appropriate sampling plan in the General Guidelines on Sampling (CAC/GL ). 7. LABELLING The product shall be labeled in accordance with the General Standard for the Labelling of Prepackaged Foods (Codex STAN , Rev ). 7.1 Name of the Product The name of the products defined in subsections , , and shall be Dried Raw Ginseng, Dried Steamed Ginseng, Raw Ginseng Extract, and Steamed Ginseng Extract, respectively. In this case, the products manufactured with P. ginseng C.A. Meyer can be named White Ginseng, Red Ginseng, White Ginseng Extract, and Red Ginseng Extract. The name of Other Types of Ginseng Product defined in Section shall include the appropriate additional words or phrases, which show the products are manufactured with ginseng, and the products shall be clearly distinguished from those defined in Sections and so as to avoid misleading and confusing consumers. 5

6 6 7.2 Name of the Ginseng Species and Country of Origin All ginseng products shall be labeled in the scientific or generic name of the ginseng used as a material of the products, and the country of origin of ginseng material shall be labeled for the products defined in Sections and The generic names of the ginseng species defined in Section 2.1 are listed below. (a) P. ginseng C.A. Meyer: Oriental, Asian, Chinese or Korean ginseng (b) P. quinquefolius L.: American ginseng (c) P. notoginseng Burk: Tienchi or Sanchi ginseng 7.3 Labelling of Non-Retail Containers Information about non-retail containers shall be given on the container or in accompanying documents, except that the name of the product, lot identification and the name and address of the manufacturer, packer or distributor, as well as storage instructions, shall appear on the container. However, lot identification, and the name and address of the manufacturer, packer or distributor may be replaced by an identification mark, provided that such a mark is clearly shown in the accompanying documents. 7.4 Other Labelling Requirements The products should have a clear marking to indicate that they are not intended for medicinal purposes, including other labelling(s) stipulated by any country where ginseng products are distributed. 8. METHODS OF ANALYSIS AND SAMPLING 8.1 Sampling Sampling shall be made in accordance with the General Guidelines on Sampling (CAC/GL ). 8.2 Determination of Moisture According to AOAC Determination of Solid To be conducted according to AOAC and calculated by subtracting the content of water from 100%. 8.4 Determination of Ash According to AOAC Determination of Water-insoluble Solids According to the method described in Annex A 8.6 Determination of Water-saturated 1-butanol extracts According to the method described in Annex B 8.7 Identification of Ginsenosides Rb1, Rf and Rg1 According to the method described in Annex C 6

7 7 Determination of Water-insoluble Solid Content Annex A Place ca 1g sample in 25 ml centrifugal tube with constant weight. Add 15 ml of distilled water and dissolve the sample. Centrifuge for 15 min at 3000 rpm and discard supernatant. Repeat twice this centrifugation. Dry centrifugal tube and residue to constant weight at 105. Report results in percent. water-insoluble solid content (%) = (W1-W0)/ S 100 S: weight of sample (g) W1: weight of centrifugal tube and residue after drying (g) W0: weight of centrifugal tube (g) The method mentioned in Annex A is stipulated in the Korean Food Standards Law and modifies the AOAC Official Method

8 8 Determination of water-saturated 1-butanol extracts Annex B 1. Preparation of water-saturated 1-butanol Mix 1-butanol with water in separatory funnel in the ratio of 70:30 and shake it vigorously. Let stand until the upper and lower phases are separated. Discard lower layer(water layer). 2. Analysis method 2.1 Dried Ginseng Weigh ca 5 g test portion, ground to pass 80mesh or finer sieve, into 250 ml erlenmeyer flask and reflux with 50 ml water saturated 1-butanol on a water bath at 80 C for 1 hour. Decant 1-butanol into another 250 ml erlenmeyer flask. Repeat twice the above extraction. Combine the solvent and filter into a 250 ml separatory funnel. Add 50 ml of distilled water. Shake and stand until the upper and lower layer are separated completely into two layers. Collect 1-butanol layer (upper layer) in an evaporation flask, vacuum-evaporate to dryness. Add 50 ml of diethyl ether, re-flux it on a water bath approximately at 46 C for 30 minutes, and decant the diethyl ether. Dry flask and contents to constant weight at 105 C. Report increase in weight flask as "1-butanol extracts in ginseng". Express the result as mg per gram on dried ginseng. water-saturated 1-butanol extracts(mg/g) = (A-B)/ S S: weight of sample (g) A: weight of flask after concentrating and drying extracts (mg) B: weight of flask (mg) 2.2 Ginseng Extract (including a powered type) Place 1~2 g sample in 250 ml erlenmeyer flask, dissolve in 60ml water and transfer into separating funnel. Add 60ml of diethyl ether. Shake and stand until the upper and lower layer are separated. Collect lower layer and extract with 60 ml water saturated 1-butanol for three times. Combine the solvent into a 250 ml separatory funnel. Add 50 ml of distilled water. Shake and stand until the upper and lower layer are separated completely into two layers. Collect 1-butanol layer (upper layer) in an evaporation flask with constant weight, vacuum-evaporate to dryness. Dry flask and contents to constant weight at 105 C. Report increase in weight flask as "1-butanol extracts in ginseng extract". Express the result as mg per gram on ginseng extract Other types of ginseng product Weigh enough sample to give final assay amount of crude saponin into erlenmeyer flack and add 50 ml methanol. Shake 1 hour on a shaker, decant and filter into evaporation flask. Repeat the extraction and filtration for the residue. Rinse the filter paper with 50 ml methanol. Vacuun evaporate the extract and dissolve the residue with 50 ml distilled water. Transfer the contents into separatory funnel and Add 50 ml water saturated 1- butanol. Shake and stand until the upper and lower layer are separated completely into two layers. Collect 1-butanol layer (upper layer). Re-extract the water layer twice with water saturated 1-butanol. Combine the butanol and wash with 50 ml of water. Transfer 1-butanol into evaporating flask with constant weignt. Vacuum-evaporate to dryness. Add 50 ml of diethyl ether, re-flux on water bath approximately at 46 C for 30 minutes, decant the diethyl ether. Dry flask and contents to constant weight at 105 C. Report increase in weight flask as "1-butanol extracts in ginseng extract". Express the result as mg per gram on ginseng extract. References 1. Planta medica, vol 25, pp , Chem. Pharm Bull., vol 14, pp , Korean J. Ginseng Sci., 10(2), pp ,

9 9 Identification of ginsenosides Rb1, Rf and Rg1 Annex C Ginsenosides in ginseng products can be identified either by Thin Layer Chromatography(TLC) or High Performance Liquid Chromatography(HPLC). 1. Preparation of sample solution Dilute the dried 1-butanol extract of Annex B with ten-fold volume of methanol, dissolve completely, and filter through 0.45 µm membrane filter. 2. Preparation of standard solution Dissolve standard ginsenosides, such as ginsenoside-rb1, -Rf, and -Rg1, in methanol to make a 1% solution and filter through 0.45 µm membrane filter. 3. Identification 3.1 Thin Layer Chromatography Spot 2-5 µl of the standard and sample solutions, as indicated in the above, on TLC plate (silica gel), previously dried at 110 C for 15 minutes in dry oven. Develop with an upper solution of 1- butanol:ethylacetate:water (5:1:4, v/v/v) or a lower solution of chloroform:methanol:water (65:35:10, v/v/v). Spray 10% sulfuric acid or 30% sulfuric acid-ethanol solution over TLC plate and oven dry it at 110 C for 5-10 minutes to reveal its color. Identify the ginsenosides of Ginseng products by comparing the Rf values and colors with those of standard ginsenosides. 3.2 High Performance Liquid Chromatography Prepare standard and sample solutions, as indicated in the above. Analyze ginsenoside with HPLC depending upon the operating condition. Identify ginsenosides of sample by comparing retention times of peaks with those of the standard. <Operating condition> Column: NH2 column, µ-bondapak C18 column, carbohydrate analyzing column or equivalent Detector: UV(203nm) or ELSD Eluent: UV : acetonitrile:water (30:70, v/v) ELSD : acetonitrile:water:isopropanol (94.9:5.0:0.1, v/v/v) Flow rate: 1.0 ml/min ~ 2.0 ml/min References 1. Journal of Chromatography, Volume 921, Issue 2, 6 July 2001, Pages Journal of Chromatography, Volume 868, Issue 2, 4 February 2000, Pages Journal of Chromatography, Volume 356, 1986, Pages Volume 499, 19 January 1990, Pages Planta Medica, Volume 212, Issue 1, 24 July 1981, Pages J. Pharm. Soc. Korea, 23(3,4), 1979, pp

10 10 APPENDIX 2 Comparison of the Existing Proposed Draft Standard with the Amended Proposed Draft Standard (Name of the Standard) GINSENG PRODUCTS 1. SCOPE Existing Proposed Draft Standard This standard applies to the ginseng products as defined in Section 2 below and offered for direct consumption, including for catering purposes or for repacking if required. It does not apply to the products when indicated as being intended for further processing. This standard applies to the ginseng products used as foods or food ingredients and does not apply to those products used for medicinal purposes. (Name of the Standard) GINSENG PRODUCT 1 1. SCOPE Amended Proposed Draft Standard This standard applies to the ginseng product 2 as defined in Section 2 below and offered for direct consumption, including for catering purposes or for repacking if required. It does not apply to the product 2 when indicated as being intended for further processing. This standard applies to the ginseng product 2 used as a food 2 or food ingredient 2 and does not apply to the product 2 used for medicinal purposes. 2. DESCRIPTION 2. DESCRIPTION 1 The standard name is changed to a singular collective noun. 2 This amendment is made in accordance with the use of a singular noun for the standard name.. 3 In compliance with the definition of terms in Codex Procedural Manual (Format for Codex Commodity Standards), basic ingredient is changed to compulsory ingredient. 10

11 2.1 Product Definition The Basic Ingredient of ginseng products is fresh ginseng root suitable to eating, derived from Panax ginseng C.A. Meyer, [P. quinquefolius L. and P. notoginseng Burk], cultivated for commercial purposes Dried Ginseng Dried Ginseng means the product (a) manufactured by sorting out and washing fresh ginseng roots, and then sun drying or hot air drying or drying them using other recognized methods. (b) manufactured by powdering or slicing the dried ginseng in the above section Dried Ginseng products are classified into four in the following way depending on the types of the products: Main Root Ginseng processed only from the main root or from the main root with primary lateral roots maintained. Lateral Root Ginseng processed from lateral roots and/or fine roots Powdered Ginseng processed by powdering the Main Root Ginseng or the Main Root Ginseng & the Lateral Root Ginseng Sliced Ginseng processed by slicing the Main Root Ginseng for a regular thickness in its width, length or diagonal Ginseng Extract Product Ginseng Extract Product means the product manufactured by extracting soluble components of the dried ginseng in Section (a) using water and/or ethanol. The product is classified as the follows: 2.1 Product Definition The compulsory 3 ingredient of ginseng product 2 is fresh ginseng roots suitable to eating, derived from Panax ginseng C.A. Meyer, P. quinquefolius L. and P. notoginseng Burk 4, cultivated for commercial purposes and used for foods. (delete) 5 (delete) Six kinds of ginseng species are internationally recognized (see Annex). However, other species than P. ginseng C.A. Meyer, P. quinquefolius L. and P. notoginseng Burk, which are included in this draft standard, are mostly wild species growing in nature. They are excluded from this standardization of ginseng product because the quantity of their production and consumption is so small that they do not satisfy the purposes of Codex standardization and because there are few documents stating their quality requirements. 5 Section is deleted and incorporated into Section since much of its content is overlapped with that of Section Main Root Ginseng, Lateral Root Ginseng, Powdered Ginseng, and Sliced Ginseng are deleted and descriptively stated because these terms are primarily applicable to the products manufactured with P. ginseng C.A. Meyer. 6 Section is deleted and incorporated into Section since much of its content is overlapped with that of Section

12 12 Ginseng Extract means the product manufactured by extracting soluble components of the dried ginseng using water and/or ethanol, and then filtering and concentrating them. Powdered Ginseng Extract means the product manufactured by powdering Ginseng Extract. Ginseng Compound means the product manufactured by mixing Ginseng Extract as a basic ingredient with bulking agents and adding (or not adding) the extracts of edible plants. The product may be powdered or granulated after mixing. 2.2 Types of Ginseng Dried Ginseng White Ginseng White Ginseng is manufactured when fresh ginseng roots are sun dried or hot air dried or dried using other recognized methods. The product has a milky white or light yellow color and may be classified in one of such product types as Main Root White Ginseng, Lateral Root White Ginseng, Powdered White Ginseng, and Sliced White Ginseng. 2.2 Types of Ginseng Product Dried Ginseng Dried Raw Ginseng Dried Raw Ginseng 8 is manufactured when fresh ginseng roots are sun dried or hot air dried or dried using other recognized methods. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced. 9 7 In this title, Ginseng is changed to Ginseng Product to harmonize it with the standard name. 8 White Ginseng is changed to a general term (Dried Raw Ginseng) because the name is primarily applicable to the product manufactured with P. ginseng C.A. Meyer. 9 The sentences related the color of the product has been deleted because they are applicable to some varieties of ginseng. Also, Main Root Ginseng, Lateral Root Ginseng, Powdered Ginseng, and Sliced Ginseng are deleted and descriptively stated because these terms are primarily applicable to the products manufactured with P. ginseng C.A. Meyer. 12

13 Red Ginseng Red Ginseng is manufactured when fresh ginseng roots are heated using the steaming method or other recognized methods, and dried. The product has a dark reddish brown color and may be classified in one of such product types as Main Root Red Ginseng, Lateral Root Red Ginseng, Powdered Red Ginseng, and Sliced Red Ginseng Ginseng Extract Product White Ginseng Extract Product White Ginseng Extract Product is manufactured when soluble components of white ginseng are extracted. The product may be classified in one of such product types as White Ginseng Extract, Powdered White Ginseng Extract, and White Ginseng Compound Red Ginseng Extract Product Red Ginseng Extract Product is manufactured when soluble components of red Dried Steamed Ginseng Dried Steamed Ginseng 10 is manufactured when fresh ginseng roots are prepared 11 using the steaming method or other recognized methods, and dried. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced Ginseng Extract Raw Ginseng Extract Raw Ginseng Extract 14 is manufactured when soluble components of fresh ginseng roots or Dried Raw Ginseng 15 are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. 16 This product has a dark brown color and a high viscosity when much of the water is removed from it. 17 The product may be also presented as a powdered type through spray- or freeze-drying Steamed Ginseng Extract Steamed Ginseng Extract 19 is manufactured when soluble components of Dried 10 Red Ginseng is changed to a general term (Dried Steamed Ginseng) because the name is primarily applicable to the product manufactured with P. ginseng C.A. Meyer. 11 From the standpoint of processing, it is more reasonable to use here the word prepare than heat because steaming already has the meaning of heating.. 12 See footnote Here, Product is deleted from the title so as to rhyme it with Section Dried Ginseng. 14 White Ginseng Extract is changed to Raw Ginseng Extract (See footnote 8). 15 Raw Ginseng Extract can use as its material either fresh ginseng roots or Dried Raw Ginseng. 16 Section is incorporated into this section. 17 Here, the external characteristics and physical properties of Raw Ginseng Extract are additionally described.. 18 Powdered Ginseng Extract is descriptively stated and Ginseng Compound is deleted from this section and converted into tea-type products in Section Other Types of Ginseng Product. 19 Red Ginseng Extract is changed to Steamed Ginseng Extract (See footnote 10). 20 Section is incorporated into this section. 13

14 14 ginseng are extracted. The product may be classified in one of such product types as Red Ginseng Extract, Powdered Red Ginseng Extract, and Red Ginseng Compound. 2.3 Other Types of Ginseng Product Other Types of Ginseng Product are permissible if they are in the following conditions: (a) The types are to be distinctively differentiated from the ginseng product types presented in the above Section 2.2. (b) The types shall meet all the quality-related requirements of this standard. (c) Characteristics of the types shall be adequately described in the product labeling so as to avoid confusing or misleading consumers. 3. ESSENTIAL COMPOSITION AND QUALITY FACTORS 3.1 Basic Ingredients Ginseng products as defined in Section Optional Ingredients[applicable only to ginseng compound] Sugars(including those as defined in the Codex Standard for Sugars, Codex-STAN Steamed Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. 20 This product has a dark brown color and a high viscosity when much of the water is removed from it. 21 The product may be also presented as a powdered type through spray- or freeze-drying Other Types of Ginseng Product Other Types of Ginseng Product are permissible if they are in the following conditions: (a) The products are manufactured compulsorily with fresh ginseng roots defined in Section 2.1, Dried Ginseng in Section 2.2.1, or Ginseng Extract in Section and optionally along with various foodstuffs including food additives and/or with processing aids. They may be presented in such product types as beverages, decoctions, candies, capsules, tablets, pills, tea-type products (powdered or granulated), etc. 23 (b) The products shall meet all the relevant requirements of this standard. 24 (c) Characteristics of the products shall be adequately described in the product labelling so as to avoid confusing or misleading consumers. 3. ESSENTIAL COMPOSITION AND QUALITY FACTORS 3.1 Compulsory Ingredients Fresh ginseng roots as defined in Section Optional Ingredients (a) Dried Ginseng (Section 2.2.1): no optional ingredient Here, the external characteristics and physical properties of Steamed Ginseng Extract are additionally described. 22 See footnote The characteristics of Other Types of Ginseng Product are stated in detail and the types of the product are listed (beverages, decoctions, candies, capsules, tablets, pills, tea-type products, etc.). 24 General criteria are stated for the quality requirements of Other Types of Ginseng Product.. 25 The compulsory ingredient of all ginseng products is fresh ginseng roots defined in Section Here, the optional ingredients, which are different with types of the product, are separately stated for each type. 14

15 ) Vitamins Dextrin Extracts of edible plants 3.3 Quality Factors Ginseng shall have a normal flavor, color, taste and a ginsenoside pattern unique to ginseng Dried Ginsengs (a) Moisture Main root ginseng: no more than 14.0% Lateral root ginseng: no more than 14.0% Powdered ginseng: no more than 9.0% Sliced ginseng: no more than 14.0% (b) Ash: no more than 6.0% (c) Water-saturated 1-butanol extracts: no less than 20 mg/g (d) Ginsenosides [Rb1, Rf,] Rg1: to be identified (b) Ginseng Extract (Section 2.2.2): no optional ingredient 27 (c) Other Types of Ginseng Product (Section 2.2.3): all kinds of foodstuffs Quality Factors Ginseng product shall have a normal flavor, color, taste and a ginsenoside pattern unique to ginseng Dried Ginseng (a) Moisture: no more than 14.0%(Powdered type: no more than 9.0%) 29 (delete) (delete) (b) Ash : no more than 6.0% (c) Water-saturated 1-butanol extracts: no less than 20 mg/g (d) Ginsenosides Rb1 and Rg1: to be identified In addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified Here, the optional ingredients, which are different with types of the product, are separately stated for each type. 28 Here, the optional ingredients, which are different with types of the product, are separately stated for each type. 29 The subdivision of Dried Ginseng is deleted and the quality factors of the subdivided products are incorporated accordingly. 30 In the domestic or foreign markets of ginseng, what is not genuine ginseng is traded as a ginseng product (for example, Eleutherococcus senticosus Maximowicz, which is misnamed Siberian ginseng) and deceptions are often practiced about the species of ginseng roots. In particular, as for the powdered ginseng roots, the species of ginseng cannot be distinguished with naked eyes. Consequently, the label should indicate the quality factors of the components unique to a specific ginseng species, so that the kinds of the species used can be discerned. Ginsenosides Rb1 and Rg1 are representative components that are commonly attested in each species of ginseng and Ginsenoside Rf is detected only in P. ginseng C.A.Meyer. 15

16 Ginseng Extract Products (a) Moisture Powdered ginseng extract: no more than 8.0% Ginseng compound (Granulated and Powdered type only): no more than 10.0%(b) (b) Solids Ginseng extract: no less than 60.0% Ginseng compound (Fluid type only): no less than 60.0% (c) Water-insoluble solids Ginseng extract: no more than 3.0% (d) Water-saturated 1-butanol extracts Ginseng extract: no less than 70 mg/g Powdered ginseng extract: no less than 100 mg/g Ginseng compound: no less than 7.0 mg/g (e) Ginsenosides [Rb1, Rf,] Rg1: to be identified Ginseng Extract (a) Moisture: no more than 8.0% (applicable only to a powdered type) 31 (delete) 32 (b) Solids: no less than 60.0% 33 (delete) 34 (c) Water-insoluble solids: no more than 3.0% 35 (d) Water-saturated 1-butanol extracts: no less than 70 mg/g 36 (delete) 37 (e) Ginsenosides Rb1 and Rg1: to be identified In addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified The subdivision of Ginseng Extract is deleted (see footnote 18) and, accordingly, the quality factors of the subdivided products are incorporated or deleted. 32 See footnote See footnote See footnote See footnote See footnote See footnote See footnote 30 16

17 Other Types of Ginseng Product (a) Ginsenosides Rb1 and Rg1: to be identified In addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified Definition of Defects The following defects shall be applied to the main root ginseng and the lateral root ginseng, among dried ginseng. (a) Insect-damaged ginseng: Ginseng that is visibly damaged by insects or contains dead insects. (b) Moldy ginseng: Ginseng that is visibly affected by mold 3.5 Classification of "Defectives" A container that fails to meet one or more of the applicable quality requirements, as set out in Sections 3.3 and 3.4 shall be considered a "defective." 3.6 Lot Acceptance A lot can be considered as meeting the applicable quality requirements referred to in Section 3.3, when the number of "defectives," as defined in Section 3.5, does not exceed the acceptance number (c) of the appropriate sampling plan in the Codex Alimentarius General Guidelines on Sampling. 3.4 Definition of Defects The following defects shall be applied to the dried ginseng. 40 (a) Insect-damaged ginseng: Ginseng that is visibly damaged by insects or contains dead insects. (b) Moldy ginseng: Ginseng that is visibly affected by mold. 3.5 Classification of "Defectives" A container that fails to meet one or more of the applicable quality requirements, set out in Sections 3.3 and 3.4, shall be considered a "defective". 3.6 Lot Acceptance A lot can be considered as meeting the applicable quality requirements referred to in Section 3.3, when the number of "defectives", defined in Section 3.5, does not exceed the acceptance number (c) of the appropriate sampling plan in the General Guidelines on Sampling (CAC/GL ). 4. CONTAMINANTS 4.1 Heavy Metals The products covered by the provisions of this Standard shall comply with those maximum levels for contaminants established by the Codex Alimentarius 4. CONTAMINANTS 4.1 Heavy Metals This product 2 covered by the provisions of this standard shall comply with those maximum levels for contaminants established by the Codex Alimentarius 39 Other Types of Ginseng Product include a large variety of products, which contain a very diverse quantity of ginseng. For this reason, it is more reasonable to consider that the quality factor commonly applicable to Other Types of Ginseng Product should verify if the product contains any quantity of representative ginsenosides Rb1, Rg1 (and Rf) than to establish their quality factors on the basis of the amount of crude saponin or ginsenosides contained in each of the products. 40 This rephrasing is due to the deletion of main root ginseng and lateral root ginseng from this section (See footnote 5). 17

18 18 Commission for these products. Commission for the product Pesticide Residues The products covered by the provisions of this Standard shall comply with those maximum residue limits for pesticides established by the Codex Alimentarius Commission for these products. 4.3 Foreign matters The products should not contain any foreign matter which can be removed by washing and other methods in the course of treating materials or any unsanitary foreign matter contaminated in the course of manufacturing the products. 4.2 Pesticide Residues This product 2 covered by the provisions of this standard shall comply with those maximum residue limits for pesticides established by the Codex Alimentarius Commission for the product Foreign matters This product 2 should not contain any foreign matter which can be removed by washing and other methods in the course of treating materials or any unsanitary foreign matter contaminated in the course of manufacturing the product HYGIENE 5.1 It is recommended that the product covered under the provisions of this standard be prepared and handled in accordance with the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP , Rev ), and other relevant Codex texts, such as Codes of Hygienic Practice and Codes of Practice. 5.2 The products should comply with any microbiological criteria established in accordance with the Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL ) 6. WEIGHTS AND MEASURES 6.1 Minimum Fill The net weight of the product, as percentage of the indicated weight, shall not be less than 97%. 6.2 Classification of "Defectives" A container that fails to meet the requirement for minimum fill of Section shall be considered a "defective". 5. HYGIENE 5.1 It is recommended that the product covered by the provisions of this standard be prepared and handled in accordance with the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP , Rev ), and other relevant Codex texts, such as Codes of Hygienic Practice and Codes of Practice. 5.2 The product 2 should comply with any microbiological criteria established in accordance with the Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL ). 6. WEIGHTS AND MEASURES 6.1 Minimum Fill The net weight of the product shall not be less than 97% of the labeled weight Classification of "Defectives" A container that fails to meet the requirement for minimum fill in Section 6.1 shall be considered a "defective". 41 The sentence is more clearly stated. 18

19 Lot Acceptance A lot should be considered as meeting the requirements of Section 6.1.1, when the number of "defectives", as defined in Section 6.1.2, does not exceed the acceptance number (c) of the appropriate sampling plan in the Codex Alimentarius General Guidelines on Sampling. 7. LABELLING The product shall be labeled in accordance with the Codex General Standard for the Labeling of Prepackaged Foods (Codex STAN , Rev ). 7.1 Name of the Product The name of the product types shall be White Ginseng, Red Ginseng, White Ginseng Extract Product, or Red Ginseng Extract Product as defined in Section 2.2. In addition, minimum classification types of each of the said product types, as appropriate, can be used as a name of the product. 7.2 Country of Origin and Scientific Name of Species The country of origin of both ginseng products and their materials shall be 6.3 Lot Acceptance A lot can be considered as meeting the requirement in Section 6.1, when the number of "defectives", defined in Section 6.2, does not exceed the acceptance number (c) of the appropriate sampling plan in the General Guidelines on Sampling (CAC/GL ). 7. LABELLING The product shall be labeled in accordance with the General Standard for the Labelling of Prepackaged Foods (Codex STAN , Rev ). 7.1 Name of the Product The name of the products defined in subsections , , and shall be Dried Raw Ginseng, Dried Steamed Ginseng, Raw Ginseng Extract, and Steamed Ginseng Extract, respectively. In this case, the products manufactured with P. ginseng C.A. Meyer can be named White Ginseng, Red Ginseng, White Ginseng Extract, and Red Ginseng Extract. 42 The name of Other Types of Ginseng Product defined in Section shall include the appropriate additional words or phrases, which show the products are manufactured with ginseng, and the products shall be clearly distinguished from those defined in Sections and so as to avoid misleading and confusing consumers Name of the Ginseng Species and Country of Origin All ginseng products shall be labeled in the scientific or generic name of the 42 The labeling of the product is changed in accordance with a change in the name of each of product types (see footnotes 8, 10, 14 and 19). But White Ginseng and Red Ginseng may be used to indicate the product manufactured with P. ginseng C.A.Meyer because these terms have been established as a general practice over a long period of time. 43 The detailed labeling of Other Types of Ginseng Product is additionally stated in this section. 44 Each ginseng species has different kinds and contents of ginsenosides, which are representative active components of ginseng. Therefore, a scientific or common name of the ginseng used shall be labeled so that consumers may not be misled and confused. 19

20 20 specified, and the same shall apply to the scientific name for ginseng species covered by this standard. 7.3 Labelling of Non-Retail Containers Information for non-retail containers shall be given on the container or in accompanying documents, except that the name of the product, lot identification and the name and address of the manufacturer, packer or distributor, as well as storage instructions, shall appear on the container. However, lot identification, and the name and address of the manufacturer, packer or distributor may be replaced by an identification mark, provided that such a mark is clearly identifiable with the accompanying documents. 7.4 Other Labelling Requirements The products should have clear marking to the effect that 1) they are not intended for medicinal purposes, and [2) they are used for specified population groups.] If the product is to be made in accordance to Section 2.3, the label shall specify such appropriate and additional words or phrases as will avoid misleading or confusing consumers. 8. METHODS OF ANALYSIS AND SAMPLING 8.1 Sampling ginseng used as a material of the products 44, and the country of origin of ginseng material shall be labeled for the products defined in Sections and The generic names of the ginseng species defined in Section 2.1 are listed below. (a) Panax ginseng C.A. Meyer: Oriental, Asian, Chinese or Korean ginseng (b) P. quinquefolius L.: American ginseng (c) P. notoginseng Burk: Tienchi or Sanchi ginseng 7.3 Labelling of Non-Retail Containers Information about non-retail containers shall be given on the container or in accompanying documents, except that the name of the product, lot identification and the name and address of the manufacturer, packer or distributor, as well as storage instructions, shall appear on the container. However, lot identification, and the name and address of the manufacturer, packer or distributor may be replaced by an identification mark, provided that such a mark is clearly shown in the accompanying documents. 7.4 Other Labelling Requirements The products should have a clear marking to indicate that they are not intended for medicinal purposes, including other labelling(s) stipulated by any country where ginseng products are distributed METHODS OF ANALYSIS AND SAMPLING 8.1 Sampling 45 The country of origin shall be labeled for Codex standards of fruits and vegetables. Dried Ginseng and Ginseng Extract defined respectively in Sections and are manufactured with 100% ginseng, so the concrete information on the ingredients of these products is really important to the consumers. In consequence, the country of origin of the ginseng roots used shall be labeled. 46 The meaning of specified population groups of 2) of this current draft standard is so ambiguous that it may quite possibly confuse consumers or lead consumers to misunderstand the use of the product. Subsequently, the phrase in 2) of the current draft should be amended as the underlined phrase. Meanwhile, the last sentence of this section should be also deleted since it is the same as the last paragraph of Section 7.1 of the amended draft. 20

21 21 Sampling shall be made in accordance with the FAO/WHO Codex Alimentarius General Guidelines on Sampling. In addition, the following applies to the sampling: (a) Samples shall be selected and stored in a safe place to prevent deterioration. (b) Precautions shall be taken to protect samples, sampled materials, sampling instruments, and sample containers from extraneous contamination. (c) Samples shall be placed in clean dry glass containers with airtight stoppers or closures. They shall carry details of sampling, date of sampling, name of the vendor, and other particulars of the consignment. 8.2 Determination of Moisture Content According to AOAC Determination of Solid Content To be conducted according to AOAC , and calculated based on the content of solids. 8.4 Determination of Ash Content According to AOAC Determination of Water-insoluble Solids Content According to the method described in Annex A 8.6 Determination of Water-saturated 1-butanol Extracts Content According to the method described in Annex B Sampling shall be made in accordance with the General Guidelines on Sampling (CAC/GL ) Determination of Moisture According to AOAC Determination of Solid To be conducted according to AOAC and calculated by subtracting the content of water from 100% Determination of Ash According to AOAC Determination of Water-insoluble Solids According to the method described in Annex A 8.6 Determination of Water-saturated 1-butanol extracts According to the method described in Annex B 47 The sentence added to the current draft ( In addition and the following) is deleted from this amended draft because it mentions laboratory samples, which are already stated in Section Preparation of Samples of the General Guidelines on Sampling (CAC/GL ). 48 Locator number ( ) is changed to Method number (924.45). 49 Locator number( ) is changed to Method number(924.45) and the relationship between solid content and moisture content is clarified. 50 Locator number( ) is changed to Method number(923.03). 21

22 Identification of Ginsenosides [Rb1, Rf,] Rg1 According to the method described in Annex C 8.7 Identification of Ginsenosides Rb1, Rf and Rg1 According to the method described in Annex C 22

23 23 ANNEX Ginseng Species Scientific name Common names Native to Panax ginseng C. A. Meyer Asian ginseng Oriental ginseng Chinese ginseng Korea and North-Eastern China Korean ginseng Panax quinquefolius L. American ginseng North American ginseng USA and Canada Canadian ginseng Panax notoginseng Burkill(F. H. Chen) Sanchi ginseng Tienchi ginseng South West China Panax Pseudoginseng Wallich Himalayan ginseng China Panax trifolius L. Dwarf ginseng USA and Canada Panax japonicus C. A. Meyer Bamboo ginseng Chikusetsu ginseng Japanese ginseng Japan P. ginseng, P. quinquefolius and P. notoginseng are the most commonly used herbs belonging to the same genus of Araliaceae. 23