Labeling Standard of Health Functional Food

Labeling Standard of Health Functional Food Enacted by Korea Food & Drug Administration Notification No. 2004-6, Jan. 31, 2004 Amended by Korea Food & Drug Administration Notification No. 2005-65, Nov. 11, 2005 Amended by Korea Food & Drug Administration Notification No. 2007-16, Mar. 22, 2007 Article 1 (Purpose) The purpose of this Notification 1s to contribute toward the quality improvement of health functional food and provide the consumers with correct information by establishing the standards for information, methods, etc., which shall be declared on the labels of health functional food as prescribed m Article 17 of the rHealth Functional Food ActJ (hereinafter referred to as the "Act"). Article 2 (Definitions of terms) For the purpose of this Notification, the definitions of terms shall be as follows: 1. The term "product name" means the umque name indicating the true nature of each individual food. 2. The term "sell-by-date" means the period of time the last date of offer to sale to consumer from the date of manufacture under any stated storage instructions. 3. The term "date of manufacture" means the date on which no further manufacturing or processing other than packaging becomes necessary (for those products that, after packaging, undergo additional manufacturing process such as sterilization or pasteurization, etc., it refers to the point when the final process is completed). Provided, for capsule type, it means the date on which filling and molding processes are completed; for the types of tablet, fluid, etc. it means the date on which manufacturing process is finished except filling and packaging steps. 4. The term "raw material" means any material used in the manufacture of health functional food and present in the final product. Provided, any food (including a purified water) or any food additive which is used in manufacturing or processing but not remained in the final product is excluded. 5. The term "component" means any chemical substance, mixture, or single substance separated from food, etc. or composed of raw material present in the final product. 6. The term "serving size" means an amount customarily consumed per eating occasion by a person representing the main consumer group depending on the nature of food. 7. The term "nutrition information display" means the declaration of the nutrient content and the percentage of daily reference value, etc. contained in a certain amount of product. 8. The term "daily reference value" means the average daily intake of nutrients by single Korean established for the food labelling. 9. The term "recommended daily allowances" mean the recommended amounts of nutrients to intake by single Korean, which each amount of nutrients necessary per day is determined according to sex and age groups. 10. The term "function information display" means the degree of functional component or marker compound present in a certain amount of product, the health claims and others. 170 11. The term "health claim" means the labeling of functionality as prescribed in Article 3(2) of the rHealth Functional Food ActJ (hereinafter referred to as the "Act"). In this case, health claims include nutrient function claims, other function claims and reduction of disease risk claims. 12. The term "main ingredient" means any mam ingredient or major component representing the functionality of health functional food. 13. The term "principal display panel" means the side panel generally shown to consumers when purchasing a health functional food. 14. The term "information display panel" means that part of the label easy to read by consumers, which contains the information not in principle display panel of the product. Article 3 (Subject of label) The health functional foods subject to labeling according to this labeling standard shall be as follows: 1. The health functional food manufactured by health functional food manufacturing business permission under Article 5 of the Act (including any functional ingredient or component; hereinafter the same shall apply); and 2. The health functional food reported for import under Article 8 of the Act. Article 4 (Label requirements) The information declared on the label under Article 17(1) of the Act shall be as follows: 1. letters of "health functional food" or diagram that stands for "health functional food" (Provided, claims of "health functional food ingredient" for ingredient product of health functional food); 2. the product name; 3. the name and place of business establishment; 4. the shell-by-date and the storage method; 5. net contents; 6. nutrition information (including the nutrient and its content, and the percentage of daily reference values or recommended daily allowances); 7. function information (including functional component or marker compound of functional ingredient, and its content); 8. the consumption amounts, the consumption method and the warning notice for consumption; 9. the name and content of raw materials; 10. an disclaim that it is not a medicine for preventing and curing diseases; and 11. miscellaneous matters as prescribed in the detailed labeling standards of health functional food Article 5 (Labeling methods) The labeling methods of label statements under Article 4 shall be as follows: 1. General matters a. Labels shall be written in Korean, but Chinese characters or foreign languages can be written in tandem with Korean for better consumer understanding; in this case, the type size of Chinese characters or foreign languages shall not be larger than that of Korean letters. Provided, for imported health functional foods and trademarks registered under the Trademark 171 Act, the type size of foreign languages in label may be larger than that of Korean letters. b. Labels shall be printed on the each container or package of minimal sales unit sold to consumers. Provided, for collection of a whole granular item packaged product, the product name and the name of business establishment shall be declared on the individual wrap. c. Label shall be printed with a color distinguished from the background color that is conspicuous and easy to read by consumers. Provided, That if a carving seal or a stamp, etc. is used to recognize the label information, in order to prevent the alteration of part of label statements, etc. such as the sell-by-date, etc., this shall not be apply. d. Labeling shall be printed with unerasable ink, or used by a seal or a stamp, etc. Provided, if a print, a seal or a stamp, etc. can not be used for label due to the nature of packaging materials such as the tank truck (lorry), the drum, the bottle product or th plastic container, the paper or the processing paper or the plastic package for materials purpose not sold to consumers directly, etc., a Label, etc. on which label statements are printed or written, can be used. e. A container or a package that bears the label of a different manufacture business shall not be used. Provided, if the container does not have harmful effects on health functional food and is only used to supply the raw materials to another business establishment, this may not apply. 2. The location of label The label shall be placed where is most likely to be seen by the consumer. Provided, the label statements prescribed in Article 4(1), (2) and (5) shall be labeled on the principal display panel and information under Article 4(3), (6), (7) and (10) and miscellaneous matters prescribed in subparagraph (11) shall be declared en bloc on the information display panel. 3. The type size a. The type size under Article 4(1) and (5) shall be 12 points or larger. Provided, if the type size prescribed m subparagraph 2 is smaller than 22 points, the type size may be 7 points or more. b. The type size under Article 4(2) shall be at least half of the largest type size used m label and shall be at least 7 points or more. c. The type size under Article 4(3), (4), (7), (8) and (10) shall be 7 points or more and other type size shall be above 6 points. Article 6 (Detailed labeling standards and methods) Detailed labeling standards and methods of health functional food shall be as follows: 1. Letters of health functional food or diagram that stands for health functional food a. The health functional food shall contain the letters of "health functional food" or the diagram that stands for health functional food shown below on principal display panel; and 172 b. For the ingredients or components of health functional food, letters of "health functional food ingredient" shall be declared on principal display panel. 2. The product name a. The product name shall be the unique name indicating the true nature of the product and be the name recorded in business permission, or item manufacture report or import report; b. The name defined by the standard and specifications under Article 14(1) of the Act (A part of the name indicating the true nature of the product may be used) or the name recognized by the Commissioner of the Food and Drug Administration under Article 14(2) of the Act shall be used. In this case, the trade name, or the brand or virtual name may be used together; c. If the treatment condition, etc. during manufacturing may be used together due to the nature of the product, the additional terms (drying, concentration, restoration, smoking, etc.) necessary for consumers not to mislead or confuse shall be used together with the product name or declared around the product name; d. The expression corresponding to the false or exaggerated labeling and advertising under Article 18 of the Act, or any expression misleading or confusing with other health functional food shall not be used; and e. When the product name of imported health functional food is written in Korean, and the original name in foreign language may be translated into Korean and labeled. In this case, it shall comply with the provisions of a) through d). 3. The name and place of business establishment a. Title and place of health functional food manufacture business establishment shall be the name and place recorded in the business permission certificate. In this case, the place may be replaced by a location that is responsible for exchanging the returned products; b. Title and place of health functional food import business establishment shall be the name and place recorded in the business report certificate and the names of exporting country and manufacture business establishment shall be labeled in tandem. In this case, if the names of exporting country and manufacture business establishment are written in foreign language, the additional label in Korean may not be necessary; and c. When the health functional sales business wants any additional label for its business name and place of business establishment, trademark or logo, etc., the type size for shall be equal to or smaller than that used for the name and place of manufacturing business establishment, trademark or logo, etc. 4. The sell-by-date and storage instructions a. The sell-by-date shall be labeled as follows: 1) The sell-by-date shall be labeled as "until 00year00month00day" or "until yy.mm.dd", 173 or "until 0000year00month00day" or "until yyyy.mm.dd" and if it is difficult ed hoc to label the sell-by-date on the principal display panel, the position where it is labeled instead shall be declared on the principal display panel; 2) In the case of imported health functional foods, if the order of the sell-by-date used in exporting country is different from the above 1), the order of year, month and day shall be illustrated in order to consumers understand easily; and 3) If date of manufacture is labeled together, the sell-by-date shall be labeled as "within 00 days from the date of manufacture" for less than 1 month, "within 00 months from the date of manufacture" for less than 12 months or "within 00years from the date of manufacture" for 1 yea or more. In this case, the date of manufacture shall be labeled as "00year00month00day" or "until yy.mm.dd", or "0000year00month00day" or " yyyy.mm.dd." b. If different products with different sell-by-date are packaged together, only the shortest sell-by-date among the products shall be labeled. c. If there are specified conditions for use or storage of the product, they shall be labeled together with the sell-by-date. In this case, the products required to maintain freezing or refrigeration condition continuously shall be labeled as rkeep frozen.!l or rkeep refrigerated.!l and the freezing or refrigeration temperatures necessary to maintain the quality of the product shall be declared. 5. The net content a. It shall be declared with weight, volume or counts according to its property. If the content is solid or semi-solid, it shall be declared by weight; for liquid, by volume; for mixture of solid and liquid, either by weight or volume. If net content is declared with counts, the weight or volume shall be added in parenthesis together; b. In the case of tablet-type products, the number of tablets and the total weight within a container or a package for sales shall be declared. In the case of capsule-type products, the number of capsules and the net contents excluding the weight of the coating materials shall be declared. 6. The nutrition information a. The name, content per servmg size, and percentage of daily reference values (%, excluding the calories) in Annexed the Table 1, Daily Reference Values (or relevant Koreans' recommended daily allowances for each of specific groups) for calories, carbohydrate, protein, fat and sodium shall be labeled as follows: Provided, vitamins, minerals (excluding sodium) and other nutrients may be labeled arbitrary. In this case, the name, content and percentage ( % ) in Annexed the Table 1, Daily Reference Values or relevant Koreans' recommended daily allowances for each of specific groups) of the nutrient in question shall be labeled. while the name and content shall be labeled if daily reference value is not established. 1) Calories shall be expressed in kilocalorie (kcal) units. It shall be expressed to nearest 5 kcal increment and less than 5 kcal may be expressed as zero. Calories shall be the sum of values multiplied 4, 4, 9, 7, 3 and 2.4 kcal by per gram (g) of carbohydrate, protein, fat, alcohol, organic acid and sugar-alcohol, respectively. Provided, if the content of dietary fiber 174 in carbohydrate is to be declared, the content of carbohydrate not including dietary fiber can be used for calculation. 2) Carbohydrate shall be expressed in gram (g) units and expressed to nearest 1 g increment. Carbohydrates less than 1 g may be expressed as "less than 1 g" and less than 0.5 g as zero. In this case, the content of carbohydrates refers to the value of health functional food weight not including the contents of crude protein, crude fat, moisture and ash. If dietary fiber or sugars are to be declared, the name and its content shall be added in parenthesis right below carbohydrate according to the labeling methods of carbohydrate. 3) Proteins shall be expressed in gram (g) units and expressed to nearest 1 g increment. Protein less than 1 g may be expressed as "less than 1 g" and less than 0.5 g as zero. 4) Fat shall be expressed in gram (g) units. It shall be expressed to nearest 0.5 g increment up to and including 5 g, and 1 g increment above 5 g, except that amount less than 0.5 g may be expressed as zero. a) If saturated fatty acid or unsaturated fatty acid is to be declared, the name and its content shall be added in parenthesis right below fat according to the labeling methods of fat. b) If cholesterol 1s to be declared, the name and its content in mg shall be labeled right below fat, and be expressed to nearest 5 mg increment. If the content is 2 mg or more up to less than 5 mg, it may be expressed as "less than 5 mg" and less than 2 mg as zero. 5) Sodium shall be expressed in mg units, and expressed to nearest 5 mg increment for 5 mg or more up to 120 mg or less and 10 mg increment for more than 120 mg, and as zero for less than 5 mg 6) If the content of carbohydrate, protein, fat and sodium is expressed as zero, the labeling may be omitted. b. The allowable tolerance limit between the labeled and measured values of nutrient shall be as follows: 1) The measured values of calorie, sugars, fat, saturated fat, cholesterol and sodium shall be less than 120% of each of the labeled values; the measured values of vitamin, mineral, protein, carbohydrate and dietary fiber shall be 80% or more of each of the labeled values. Provided, if the specification of component according to the standards and specifications of health functional food in Article 14 of the Act is described as "the labeled value or more," the measured value shall be the labeled value or more; if it is described as "the labeled value or less," the measured value shall be the labeled value or less; and if it is described or more - or less," the measured value shall be within the range of the labeled value. 2) Even when the measured value is beyond the range prescribed in 1), it shall be recognized as the allowable tolerance limit within the labeled range per unit value according to provision a). c. The nutritional information display with the function information display in subparagraph 7 shall be declared in the information display panel according to annexed the Table 2, Outline and Methods of Nutrition and Function Information Display. 7. The function information 175 a. The label of functional component shall be declared with a representative functional component or a marker compound of functional ingredient and its content of the relevant product. In this case, the content of functional component or marker compound shall be expressed as the value containing per serving size. If it is difficult to identify the functional component or marker compound, the functional ingredient and its content may be declared. Provided, the product for processing not sold to consumers directly may declare the final content containing per unit value of functional component or marker compound. b. If the health claim is to be declared, it shall be classified as the nutrient function claim that shows the physiological activity of nutrient on growth, promotion and normal function of human body; the other function claim, excluding the nutrient function, that has specific effects on normal function of human body or biological activity so that shows health contribution or function enhancement, or health maintenance or improvement; and the reduction of disease risk claim that reduces the disease risk or health problem by consuming of food through the total meals, and declared to conform the followings: 1) The product shall be notified or recognized according to the standards and specifications or ingredients components in Article 14 or 15 of the Act. 2) It shall be recognized by generally known scientific data that sufficiently prove the declared effect of functionality and health-related condition. 3) The nutrient function claim shall be limited to the nutrients established the daily reference values in Annexed the Table 1. 4) It shall not contain the relevant functional component, ingredient or nutrient those amount may increase the risk of disease or make the unhealthy condition worse. 5) The health claim shall not be the misleading content that may foster the excessive consumption of specific food such as excess intake of daily reference value or criticise the good food habits such as the daily balanced diet. 6) The component or marker compound of functional ingredient subject to health claim shall be officially recognized or may quantitative test recognized by the Commissioner of the Food and Drug Administration. 7) It shall be received a prior deliberation according to the Labeling and Advertising Deliberation Regulation of Health Functional Food in Article 16 of the Act. 8. The consumption amount, consumption method, and warning notice for consumption a. The amount recommended for consumption per eating occasion by each of consumption group, consumption frequency and consumption method for the relevant product shall be labeled. b. If there exist any group concerning the abnormal symptom or side effect when consumed the relevant product, or any warning notice for the possible side effect and the amount, etc. due to excess intake, it shall be declared. 9. The name of raw material and content a. The name of raw material which represents the functionality of the relevant product shall be declared first and others in descending order of amount used. Provided, the name of raw material which is not remaining in the final products may not be declared. b. When any compound raw material (a product manufactured by using at least two raw 176 materials) is used, the name of compound raw material shall be declared and the names of raw materials in descending order of amount used shall be declared in parenthesis. Provided, the name of relevant raw material may not be declared if the compound raw material consists of less than 5% of the product or the names of raw material is identified clearly in the name of compound raw material. c. Notwithstanding the provision of item b, if the product contains egg (limited to poultry), milk, buckwheat, peanut, soybean, wheat, mackerel, crab, pork, peach or tomato, known to cause allergy among Koreans or the raw ingredients that are the processing product manufactured by using those foods as raw materials, the names of those raw materials shall be declared [for example: in case of using chicken egg - "chicken egg," in case of using yolk - "yolk (chicken eggs)"]. d. The purified water used for manufacture shall be declared as raw material. Provided, if the purified water used is not remaining in the final product or is declared as salt water, syrup or meat stock, the purified water used may not be declared. e. The genetically modified food, etc. manufactured with the raw materials of agricultural, livestock, fishery products, etc. grown or raised by DNA recombinant techniques, etc. that select the useful DNAs among DNAs of organism and combine them with DNAs of other organism shall be declared as "genetically modified" or "(containing) genetically modified 00" in parenthesis just beside the name of raw material or component in accordance with the Labeling Standard for Genetically Modified Foods as referred to the provision of Article 10\(1) of Food Sanitation Act, f. Notwithstanding the provision of item b, if food additive prescribed the usage limit in the Official Book of Food Additives is used or added (It limits those originated from the ingredient product that the food additive is used intentionally.), the name of food additive added and its intended use shall be declared. g. If the content of soluble component (or extract) used as raw material is declared, the solid content (percentage) of each of raw materials contained in the product shall be declared. 10. Any disclaim that it is not a medicine for preventing and curing disease shall be labeled on the lower portion of primary display panel or information display panel in parallel with bottom side so it is easy to read by consumers. 11. Miscellaneous matters as prescribed in the detailed labeling standards of health functional food a. If the component originated from animal (including food additive) is used, the name of component, originated animal and used part shall be declared. Provided, the item that does not have the potential contamination of BSE in manufacturing process such as empty capsule may be exempted. b. If it is any irradiated health functional food (including ingredient of health functional food) or manufactured with any irradiated raw material, the name of irradiation business and dose of irradiation shall be declared, and the indication for irradiated product and the irradiation logo shall be declared so it is easy to read by consumers. 177 c. The packing material shall be declared on the synthetic resm container or wrappmg sheet used for the product. In this case, it may be labeled according to the material of synthetic resin such as polyvinylchloride(PVC), polyethylene(PE), fluorinated polyethylene and polypropylene(PP), polystyrene(PS), polychlorovinylidene(PVDC), polyethyleneterephthalate(PET), phenolformaldehyde (PF), etc. or with the English abbreviation which it is used generally. d. If recommended before and after drinking, hangover cure, etc. is to be labeled, the warning statement, "excessive drinking compromises your health," etc. shall be labeled together. e. The term "natural" shall be labeled only for the health functional food that does not contain any artificial (combined) flavoring agent, synthetic color, synthetic preservative or any other artificial or post-harvest-added synthetic component, and that has not gone through additional processes other than a process of eliminating inedible part or minimal physical processes. f. The term "100%" may be labeled only when no other materials than the raw materials subject to label are added. g. The product that is added and used aspartame shall bear the indication, "phenylalanine 1s contained." h. For ginseng or red gmseng product, the following statements may be used: 1) Ginseng or other name indicating ginseng (including the product name), design and figure may be labeled or used only for the product complied with the standards and specifications for ginseng and red ginseng product. Provided, this shall not apply the case that is prescribed in other the acts and subordinate statues. 2) The compound ratio (percentage) of raw ginseng used for ginseng and red ginseng product shall be categorized into and declared as ginseng hair root and ginseng root. 3) When the ginseng design is labeled on the package of ginseng product, the label shall be referred to the standard design of ginseng product in annexed the Table (3)(1), Provided, this shall not apply when any design to symbolize ginseng is labeled. 4) If the origin of ginseng is to be declared in product description or on product package, the Standard Sentence for the Origin of Ginseng in Annexed the Table 3 (2) shall be applied mutatis mutandis 5) The product name may be labeled in Chinese characters. 6) "Special product of Korea" in Korean or Chinese characters may be labeled in the products for domestic market while "Special product of Korea" in English or the importing country's language may be labeled in the products for export. i. The letters of "GMP application business" or the diagram showing that it is a GMP application business (hereinafter referred to as "GMP certification diagram") may be shown on the product of good manufacturing practices (GMP) application business. Provided, That if 178 the GMP certification diagram is shown, it shall be shown m accordance with the GMP certification diagram, annexed the Table 4. Article 7 (Allowable tolerance of weight, etc.) To indicate the net content as prescribed in Article 4(5), allowable tolerance between the labeled content on the container or package and the measured content shall be as prescribed in annexed the Table 5. Article 8 (Special cases of application) Notwithstanding the provisions of Articles 4 and 5, it may be labeled as follows by considering the nature of health functional food: 1. In case of ingredient product of health functional food, the label statements prescribed m Article 4 (6), (8), (10), and (11) may not be applicable. 2. If it is difficult to label the bundle statement declared on information display panel except principal display panel in accordance with the provision of Article 5 (2) with prescribed size due to lack of display panel area, only the requirements in Article 4 (3), (4) and (8) (consumption amount and consumption method) may be declared on each container or package of minimal sales unit and other requirements may be written on the product description packaged with the product. In this case, "Referred to product description" shall be labeled. 3. The exporting health functional food may be labeled according to the request of importer. 4. If the statement required to label on principal display panel in accordance with the provision of Article 5 (2) is to declare on information display panel due to unavoidable reason, it shall be declared with the type size of at least 12 points. 5. When the health functional food manufacture business establishment imports raw material or component (hereinafter, "own ingredient for health functional food") to manufacture its own product, the label statements in Article 4 (6), (8), (10) and (11) may not be declared and the label requirements in Korean may be omitted if there is a label used by exporting country among the label statements of own ingredient for health functional food. 6. When the product name is declared in accordance with the provision of Article 6 (2) b, the name prescribed on the standards and specifications may not be included in the product name if the name prescribed on the standards and specifications, etc. is clearly labeled around the product name (just above, below or beside) with the type size of at least half of the biggest type size of product name. Article 9 (Application of Mutatis Mutandis) The Labeling Standards of Food, etc. under the provision of Article 10 of the Food Sanitation Act shall apply mutatis muntandis for any food additive, apparatus or container and package, and organic processed food and organic agricultural product or use of analogous terminology, etc. that the labeling standards are not prescribed by the provisions of this Notification. ADDENDA (Jan. 31, :m4) Article 1 (Enforcement date) This Notification shall enter into force on the date of its 179 announcement. Article 2 (Transitional measures) The labeling of the health functional food manufactured or imported by a person who has business report under Food Sanitation Act at the time this Notification enters into force may be complied with the Labeling Standards of Food, etc. under the provision of Article 10 of the Food Sanitation Act until August 26, 2004. Article 3 (Amendment of other notifications) (1) Among the Labeling Standards of Food, etc. under Food Sanitation Act and subordinate statues, the labeling standards of each of the products relevant to the standards and specifications of health functional food under the Articles 14 and 15 of this Act such as health supplement food, nutrition supplement food in special nutrition food, ginseng and red ginseng product (excluding ginseng and red ginseng drinks, and other ginseng and red ginseng products) shall be deleted. (2) The Labeling Standards of Genetically Modified Food, etc. shall be amended as follows:"under Article 7 of the Food Sanitation Act and Article 14 of the Health Functional Food Act" shall replace "under Article 7 of this Act" in each subparagraph of Article 3", "nutrition supplement product in health functional food" shall replace "nutrition supplement food in special nutrition food" in Article 3(17)," and "business person for import and sales business of food, etc. and business person for health functional food manufacturing business or health functional food import business under the provision of Article 2 of the Enforcement Decree of the Health Functional Food Act" shall replace "business person for import and sales business of food, etc." in Article 4. ADDENDA (Nov. 11, ao5) (1) (Enforcement date) This Notification shall enter into force on the date of its announcement. (2) (Transitional measures) The health functional food manufactured or imported by a person who has business permission or business report at the time this Notification enters into force may be labeled by the previous regulation until May 31, 2007, ADDENDA (Mar. 22, '2IXJl) (1) (Enforcement date) This Notification shall enter into force on the date of its announcement. 180 [Annexed the Table 1] Daily Reference Value Nutrients Default Nutrients Default Nutrients Default value value value Carbohydrate(g) 328 Iron(mg) 15 Pantothenic 5 acid(mg) Dietary fiber(g) 25 Vitamin D(,ug) 5 Phosphorus(mg) 700 Protein(g) 60 Vitamin E(mga-TE) 10 Iodine(,ug) 75 Fat(g) 50 Vitamin K(,ug) 55 Magnesium(mg) 220 Saturated fat(g) 15 Vitamin B1(mg) 1.0 Zinc(mg) 12 Cholesterol ( mg) 300 Vitamin Bz(mg) 1.2 Selenium(,ug) 50 Sodium(mg) 3,500 Niacin(mg NE) 13 Copper(mg) 1.5 Potassium(mg) 3,500 Vitamin B6(mg) 1.5 Manganese(mg) 2.0 Vitamin A(,ug RE) 700 Folic acid(,ug) 250 Chromium(,ug) 50 Vitamin C(mg) 55 Vvitamin B12(.ug) 1.0 Molybdenum(,ug) 25 Calcium(mg) 700 Biotin(,ug) 30 Vit A, Vit D and Vit E can be additionally indicated with IU unit in parenthesis while following the above reference table. 181 [Annexed the Table 2] Outline and Methods of Nutrition and Functional Information Display 1. Nutrition, function information display content (illustration) < illustration 1 > < illustration 2 > CD Nutrition and function infonnation CD Nutrition and function infonnation CZ) serving size CZ) serving size @per serving size content @% daily reference value @per serving size content @% daily reference value @calories 150kcal @calories 150kcal @carbohydrate 23g 7% dietary fiber 3g 12% @carbohydrate 23g 7% sugars 10g ®protein 2g 3% ®protein 2g 3% @fat 6g 11% @fat 6g 11% saturated fatty 2g acid ®sodium 55mg 2% unsaturated fatty 3g acid cholesterol 10mg 3% @)vitamin C 11 mg 20% ®sodium 55mg 2% @calcium 20mg 7% ®vitamin C 11 mg 20% @calcium 20mg 7% @functional component or Qmg marker compound @functional component or Qmg marker compound @HIE% daily reference value: ratio of nutrient reference value l!E¾ daily reference value: ratio of nutrient reference value < illustration 3 > CD Nutrition and @per content @% daily @per content @% daily serving size reference value serving size reference value function infonnation @calorie 150kcal ®protein 2g 3% CZ) serving size @carbohydrate 23g 7% @fat 6g 11% dietary fiber 3g 12% ®sodium 55mg 2% @)vitamin C 11 mg 20% @calcium 20mg 7% @functional component Qmg or marker compound , .... lS.% daily reference value: ratio of nutrient reference value < illustration 4 > Nutrition and function infonnation Total 12 servings Serving size (35g) content per serving: calories kcal, carbohydrate Og(O%), protein Og(O%), fat Og(O%), sodium Qmg(O%), vitamin C Qmg(O%), calcium Qmg(O%), functional component or marker compound Qmg is.Numbers in parenthesis are the ratio of nutrient reference value. 182 2. Labeling method a. Common requirements CD When it is labeled on product, only labeling items shall be labeled except for labeled number by item. (2) It shall be labeled with Gothic or HumanGothic type of letter. ® For calories, carbohydrate, protein, fat and sodium, it shall be labeled with thick Gothic or HumanGothic type of 7 points or bigger. @ It shall be labeled with the methods given at illustrations 1) through 3) according to product packaging form. Provided, That if labeling as illustrations 1) through 3) is impossible due to the small area of labeling, then it may be labeled as illustration 4). b. Labeling methods by each label items shall be as follows: CD Nutrition and function information: Labeling with thick Gothic or HumanGothic type of 8 points or bigger as possible; * In case of health claim, the functionality shall be labeled in dotted line. (2) Serving size: Labeling with the weight or count, etc. per serving size of the product; * Since the upper portion of labeling requirements is designated for mandatory nutrients label, it shall be labeled with thick line (about 1.0-1.5mm) to distinguish lower portion of same panel from the upper portion. ® Content per serving size: Labeling with 6 points or bigger; @ % daily reference value: Labeling with 6 points or bigger; ®-®: The content and percentage of daily reference value by each kind of nutrients shall be labeled with 6 points or bigger. In this case, ® for carbohydrate, it may be categorized into and labeled as dietary fiber and sugars, ® for fat, it may be categorized into and labeled as saturated fatty acid, unsaturated fatty acid, cholesterol, etc. * Below the upper portion of labeling requirement (@-®), voluntary nutrients label and nutrients of nutrition supplement product shall be labeled, and it shall be labeled with medium thick line (about 0.5-0.Smm) to distinguish those from mandatory label requirements. ® Vitamins: If the vitamins contained or added in product are to be emphasized, the names, its content per serving size and daily reference value of each vitamin shall be labeled. @ Minerals: If the minerals (calcium, iron, etc.) contained or added in product are to be emphasized, the names, its content per serving size and daily reference value of each mineral shall be labeled. * The content of functional component or marker compound of functional ingredient shall be labeled at the lower portion of labeling requirements and it shall be labeled with medium thick line (about 0.5-0.Smm) to distinguish those from voluntary label requirements. @ Functional components other than nutrients: The label of functional component shall be declared the representative functional component or marker compound of functional ingredient and its content of such product. In this case, content of functional ingredient or marker compound shall be labeled with content per serving size and If it is difficult to identify the functional component or marker compound, the functional ingredient and its content may be 183 declared. @) The notice that "% daily reference value" is the ratio of daily reference value shall labeled. 184 [Annexed the Table 3] 1 . The standard design of ginseng 185 2. The standard sentence for origin of ginseng 1) Korean Afl;;! ~'f'.tf.fiJ1f-E7 q::im~ N:Fai'f§oJl f1Ri>}O:j \[c,1 tm~Jtl.2 .. .£ 11'.ffl:£1~9-.:il ~yq xitl::~ §C~ ..Q...£~ q::im~ fiJrl5c/,W~~(gijJUc5GfiJ33-48)~ :t:;laI~ ~ ,~gt~JoJl Afl;~ 0 1;; 0 1 ~1g gci\Z:£1~ .:il :&t~ l!fi'i'fm~'.tf.J!r(gg*c196-22O)~ ~{rr~~ ~ '{jj~M/iJ oJl ~ tl!l~:n 113=1Jq::i Afl;~c~U 21:n°1 .L& ~:£1 ~..Q.. v1 .=r:&t~ r i5 g 511J~J, 1ii1$ M!*~*~J ~ W ;! ~:nfiW~ gc~oJl f1Ri>}i:.:J. Afl; 0 l jt m:~ :rm ~;tt fl.£-"7 11'.ffl:£1°7 *~ ffi.§:;~~ {!¥:~oJl ~~~ l:l} ~..Q..vj *]}!115{iii:%..Q...£ 7J}Al !i~i>}~ g g ~ 4- ~ ~yq reuEAfl;;! 5G* ~m ~ ftm4 ~~~ q::imt-t!!:n~ ~LLroJl E!fti>}~~ -3;1°14 'ali 0 1 ~l&:£1°7 mi'r~ oJl u:}c} Ail¥J..Q...£ ~;r:gi>}7Jl :£1~.:il ~moJl-"1~ ~~ Wifr§.(gg*c1567-1608)uJ11f-E1 .=r gc~ 0 1 ~~ -3;1 ..Q..,£ .!i! O} -~ Afl;~ AI~~~ t:7 -2.. {11 ~~ ~ 7}~ ,}J..Q...£ .!i! 'fJ y i:::i-. 2) English ORIGIN OF KOREAN GINSENG The medicinal use of Ginseng was already well known to chinese civil herb doctor several thousands years ago. The name of Ginseng can be found in various chinese historical records many of which were written as early as B.C 100. According to many chinese medicinal books ever published, Ginseng has been generally used as a medicine for human health in most of the oriental countries. Korean Ginseng originally grew in deep mountains both of Korea and China. However, this wild Korean Ginseng was so scarcely found to obtain that its supply could not meet ever increasing demand, and therefore from 16th century, it has been cultivated on the farm as a mass supply in Korea. 3) Japanese Afl;ti ~'f'.tf.fiJJ: 0 q::imO) N:Fai'at= f1R0, JJ:< tm~fflc: L-C 11'.ffl~hi Lt~o ;t,lxJ::.O) gc~i=ti q=imO) fiJrl5Gii'i'f~~(gijJHc5GfiJ 33-48'.tf.)O) :t:;laIO)~ r~gt~J i= Aff;i5iJ" fr#iln-C gci\Z~ h :&tiliX ii'i'fm~'.tf.{~(gg*c 196-220'.tf.)O) ~{rp~O)~ '{~~llweJ i=ti ~~:n 113:JJq=t Afl;~c~U 21:JJiJ".l&~~ h -C :t3 0 ;!'t:&tO) 'i5fi;31J~J 1ii1$J!4~~J ~ ~ < 0) ft:nfiWO) §c~i={tcht:l:'Afi;iJ" •m~ :rm~:ttfl c: L C 11'.ffl ~ h l[~ffi §;;~O) {!¥:~i= ~~Lt~ J.i::. c: 7'.~ J.i i= L-C *]}!115{iii:%t= i -r· !i~~ ht~::. c: ti 186 Jj'rj~C7)il1[ t) --C'TiJ", X r'sJ)J'gA~ti x*ftmitLu' ftm C ~~ L ,~ q=rm:ttg1JC7) ~LLU::: El 1±. ~ ht~ t O)iJ{ ~ < j)f(I&~ h mffi'i~ h~ i::: {jft,, AI1¥,n=~t:g-t ~ J: -5 i::: t;c Y) 11!¥m--c•ti ~UfWffi!l.(1567-1608)~ftJ: t) JtO)gc.~i= ~JJ>,fl"(t,,~0)/::'.: {t<ht:f' ff~A~O) AI~;l::g'ti :rtt:Rv>~s!:.~ ff-:>lv>~.:.c c~~~h i -t O 4) Chinese fi'e4- ISC=f~fiJ, A~tEq=rm'fi~s!:.J::, C.~j)f(tltl~,tm:!if 5j)l±z'.9Wj q=rm 'fiJ?~J 5cw~ft(Z-5cfiJ 33-48 ~) ~jqr~z ';@;tl~J q=r, :w1J! ~cg, t1:t~x!lxJ::1'f ~llc.tG 'i&~J Jtxwm*~1-1tcz-x196-220~) ~1rr~~ z '{i*~J q=r, ~~1JP'l, 1u-w 113fi, Jtq=ri13c~UA~~ llt:w 21f!, t1:t1& , ;gg,'3U~J 'iii$11l*~~J ~ lltr~ ~, m7fll2llGA~EfJ:l;:f]1j:, §J?f~e.Afi{*ffl!, A:W~::k~Jlx~ m r"sJ!mA~, ~~ftm:&~lli::zq=rmJ!!Ut~ WZ7Z~1i:4&J, ~izgj)f(~~~~' 7f~~fizE!ff, il&ti-t:W AI~;!::gz!j,!~, -g:m.i~IUfWffi!i~ft(Z-~ 1567-1608 ~) tit~ ;EJ!AI~;l::g'J{g)()lx ~imJtA~~~zs!:.it :i1r-7friJ:f'lzJIUttg 187 [Annexed the Table 4] GMP certification diagram 1. Ratio and color code of the diagram 7}. Ratio : width : length = 1 * 0.83 1-J-. Color code : Phantom color 355C 188 [Annexed the Table 5] Allowable Tolerance (Range) between Labeled and Measured Content Items Labeled cm1:.alt Allowable toknnre 3g or less 5% Ginseng and red ginseng more than 3g and 100g or less 3% products more than 100g and 1,CXX)g or less 2% more than 1,CXX)g 1% Health functional food 50g[ ml ]or less 4% more than 50g[ml] and lOOg[ml] or less 3% other than ginseng and more than lOOg[ml] and 1,CXX)g[ml] or less 2% red ginseng products more than 1,CXDg[ml] 1% 189 Appendix Recommended Daily Allowances for Korean by Ages weight height energy protein vitamin vitamin vitamin vitamin vitamin vitamin niacin Age A D E C B1 B2 (kg) cm kcal g µ,gRE mga-TE mgNE µ,g mg mg mg infant 0-4(mo) * 5.6 58 500 15(3:l) 350 5(10) 3 35(50) 0.2(0.3) 0.3(0.4) 2(3) 5-11 9.3 73 750 20 350 10 4 35 0.4 0.5 5 toddler 1-3(yr) 14 92 1200 25 350 10 5 40 0.6 0.7 8 4-6 19 111 1600 30 400 10 6 50 0.8 1.0 11 7-9 27 127 1800 40 500 10 7 60 0.9 1.1 12 boy 10-12(yr) 38 144 2200 55 600 10 8 70 1.1 1.3 15 13-15 54 162 2500 70 700 10 10 70 1.3 1.5 17 16-19 64 172 2700 75 700 10 10 70 1.4 1.6 18 20-29 67 174 2500 70 700 5 10 70 1.3 1.5 17 30-49 68 170 2500 70 700 5 10 70 1.3 1.5 17 50-64 68 168 2300 70 700 10 10 70 1.2 1.4 15 65-74 64 167 2000 65 700 10 10 70 1.0 1.2 13 more 75 60 166 1800 60 700 10 10 70 1.0 1.2 13 girl 38 144 2000 55 600 10 8 70 1.0 1.2 13 10-12(yr) 51 158 2100 65 700 10 10 70 1.1 1.3 14 13-15 54 160 2100 60 700 10 10 70 1.1 1.3 14 16-19 54 161 2000 55 700 5 10 70 1.0 1.2 13 20-29 30-49 55 158 2000 55 700 5 10 70 1.0 1.2 13 50-64 57 157 1900 55 700 10 10 70 1.0 1.2 13 65-74 54 154 1700 55 700 10 10 70 1.0 1.2 13 more 75 52 152 1600 55 700 10 10 70 1.0 1.2 13 pregnant first half +150 +15 +o +5 +o +15 +o.3 +o.3 +1.0 second half +350 +15 +100 +5 +2 +15 +o.4 +o.4 +2.0 lactation +400 +20 +350 +5 +3 +35 +o.4 +o.5 +4.0 190 Age weight height energy protein vitamin 85 folic acid calcium phosphate iron** zinc (kg) cm kcal g mg µg mg mg mg mg infant 0-4(mo) * 5.6 58 500 15(20) 0.1(0.2) 60(100) 200(300) 100(200) 2(6) 2(4) 5-11 9.3 73 750 20 0.4 70 300 300 8 4 toddler 1-3(yr) 14 92 1200 25 0.5 80 500 500 8 6 4-6 19 111 1600 30 0.6 100 600 600 9 8 7-9 27 127 1800 40 0.8 150 700 700 10 9 boy 10-12(yr) 38 144 2200 55 1.1 200 800 800 12 12 13-15 54 162 2500 70 1.4 250 900 900 16 12 16-19 64 172 2700 75 1.5 250 900 900 16 12 20-29 67 174 2500 70 1.4 250 700 700 12 12 30-49 68 170 2500 70 1.4 250 700 700 12 12 50-64 68 168 2300 70 1.4 250 700 700 12 12 65-74 64 167 2000 65 1.4 250 700 700 12 12 more 75 60 166 1800 60 1.4 250 700 700 12 12 girl 10-12(yr) 38 144 2000 55 1.1 200 800 800 16 10 13-15 51 158 2100 65 1.4 250 800 800 16 10 16-19 54 160 2100 60 1.4 250 800 800 16 10 20-29 54 161 2000 55 1.4 250 700 700 16 10 30-49 55 158 2000 55 1.4 250 700 700 16 10 50-64 57 157 1900 55 1.4 250 700 700 12 10 65-74 54 154 1700 55 1.4 250 700 700 12 10 more 75 52 152 1600 55 1.4 250 700 700 12 10 pregnant first half +150 +15 +D.5 +250 +300 +300 +4 * * +3 second half +350 +15 +D.5 +250 +300 +300 +8 * * +3 lactation +400 +20 +D.6 +100 +400 +400 +2 +6 * recommended daily intake for nourishing infant with breast-feeding (recommended daily intake for nourishing infant with bottle feeding) * * recommend amount for iron supplement [The Korean Nutrition Society : recommended nutrition intake for Korean (7th revision, 2()(X))] 191