韩国保健食品检测标准(英文版).pdf

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1、 Contents General Provisions .Common Standards and Specifications .1 Ingredients used for manufacturing health functional food.2 Common Standards for manufacturing process.3 Common specifications.4 Application of standards and specifications of health functional food.5 Pass/Fail determination about

2、standards and specifications.6 Preservation and distribution standards.7 Sampling and handling .Standards and Specifications for each functional ingredient .1 Nutrients .1.1 Vitamins and Minerals .1.1.1 Vitamin A.1.1.2 Beta-carotene.1.1.3 Vitamin D.1.1.4 Vitamin E.1.1.5 Vitamin K .1.1.6 Vitamin B1 .

3、1.1.7 Vitamin B2 .1.1.8 Niacin.1.1.9 Pantothenic acid .1.1.10 Vitamin B6.1.1.11 Folic acid.1.1.12 Vitamin B12.1.1.13 Biotin .1.1.14 Vitamin C .1.1.15 Calcium.1.1.16 Magnesium .1.1.17 Iron.1.1.18 Zinc.1.1.19 Copper.1.1.20 Selenium.1.1.21 Iodine .1.1.22 Manganese.1.1.23 Molybdenum.1.1.24 Potassium.1.1

4、.25 Chrome .1.2 Dietary fiber .1.3 Protein.1.4 Essential fatty acid .2 Functional ingredients .2.1 Terpenes .2.1.1 Ginseng .2.1.2 Red ginseng .2.1.3 Plants containing chlorophyll.2.1.4 Chlorella/Spirulina .2.2 Phenols .2.2.1 Green tea extracts .2.2.2 Aloe whole leaves.2.2.3 Propolis extracts .2.2.4

5、Coenzyme Q10.2.2.5 Soybean isoflavone .2.3 Fatty acid and lipids .2.3.1 Edible oil containing omega-3 fatty acid .2.3.2 Edible oil containing gamma-linolenic acid .2.3.3 Lecithin.2.3.4 Squalene .2.3.5 Phytosterol/Phytosterolester.2.3.6 Shark liver oil containing alkoxyglycerol.2.3.7 Edible oil conta

6、ining octacosanol.2.3.8 Japanese apricot extracts.2.3.9 Conjugated linoleic acid.2.3.10 Garcinia cambogia extracts.2.3.11 Lutein.2.3.12 Haematococcus pluvialis extracts.2.3.13 Saw palmetto extracts .2.4 Sugar and Carbohydrates .2.4.1 Glucosamine .2.4.2 N-acetylglucosamine .2.4.3 Mucopolysaccharidemu

7、coprotein.2.4.4 Dietary fiber Guar gum/Guar gum hydrolysateGlucomannan(Konjacmannan)Oat Indigestible maltodextrin Soybean fiber Tree ear(Auricularia auricular)Wheat fiber Barley fiber Arabic gum(acacia gum)Corn bran Inulin/Chicory extracts Psyllium husk Polydextrose Fenugreek seed.2.4.5 Aloe gel .2.

8、4.6 Ganoderma lucidum fruit body extracts.2.4.7 Chitosan/Chitooligosaccharide.2.4.8 Fructooligosaccharide .2.5 Fermentation microorganisms .2.5.1 Probiotics.2.5.2 Red yeast rice .2.6 Amino acid and proteins .2.6.1 Soybean protein A.Annexed the Table 1 Table of random sampling numbers and usage metho

9、d B.Annexed the Table 2 Nutrient reference value C.Annexed the Table 3 Dietary Reference Intakes for Koreans D.Annexed the Table 4 Application Table for Testing Methods General Provisions 1.Purposes of the Health Functional Food Code 1)This Code establishes the standards and specifications for manuf

10、acturing,processing,production,import,distribution,storage,etc.,of health functional food for sale.2)This Code promotes the distribution of standardized health functional food and assures the consumers safety through providing the standards and specifications for functional ingredients and final pro

11、duct for health functional food.3)This Code also intends to establish a transparent and scientific regulatory system of health functional food through providing regulatory guidelines to the authorized officers.2.Scope of the Code 1)The standards and specifications regarding manufacturing,processing,

12、production,import,distribution,storage,etc.,of health functional food under the Chapter 14 of the Health Functional Food Act;2)The ingredients or the compounds of health functional food under the Chapter 15 of the Health Functional Food Act;and 3)Regulation for labeling standards of health functiona

13、l food under the Chapter 17 of the Health Functional Food Act.3.Contents of the Code 1)This Code covers general provisions,general standards and specifications,standards and specifications for each functional ingredient,and testing methods.2)The standards and specifications for each functional ingre

14、dient are classified into sections according to the types of health claims,into divisions according to the characteristics of active compound(or marker compound)of functional ingredients,and into groups according to the functional ingredients.(1)The sections are classified into nutrients,which have

15、nutrient function and functional ingredients,in order to separately categorize the products being intended to supplement nutrients.(2)The divisions are classified into terpenes,phenols,fatty acid and lipids,etc according to the characteristics of active compounds(or marker compounds)of functional in

16、gredients.(3)The groups are classified into vitamins and minerals,edible oil containing gamma-linolenic acid products,glucosamine,etc.,which are ingredients provided in the sections or the divisions.3)The standards and specifications for each functional ingredient cover standards for manufacturing,s

17、pecifications,specific requirements for the final products and testing methods.(1)The standards for manufacturing cover raw materials,preparation and/or processing,content of active compound or component(or marker compound),and cautions for preparation or processing.Especially the cautions for prepa

18、ration or processing include the standards of poisonous or deleterious substances which shall be controlled during manufacturing process.(2)The term specifications refers to the specifications of functional ingredients and/or final products manufactured/processed using functional ingredients therewi

19、th.(3)The prerequisite for the health functional food cover health claims,intake amount,and warning notice for intake,etc.(4)The testing methods cover testing methods for each specification.4)The testing methods cover general principles,general testing methods,and testing methods for individual comp

20、onents.4.Scientific evaluation for safety and claims and setting the standard and specification The scientific evaluation of safety and claims and setting the standard and specifications for functional ingredients listed in this Code are subject to Regulation on Approval of Functional Ingredients fo

21、r Health Functional Food.5.Adding functional ingredients in this Code The functional ingredients recognized under the Regulation on Approval of Functional Ingredients for Health Functional Food can be added to the Code in case where the functional ingredient falls under any of the following subparag

22、raphs.However,when,after being recognized as a functional ingredient,the business person request the protection of data,the adding of the functional ingredient can be postponed,till five years from the data of the item manufacturing report or import report,provided the validity of the request.1)In t

23、he case where,after recognized as functional ingredient,two or more years have passed from the date of the item manufacturing report or the import report or where,after recognition,three or more business persons file the item manufacturing report or the import report;or 2)In case where the person wh

24、o has obtained the recognition under the provision of Article 14(2)of the Health Functional Food Act requests the adding(Provided three or more persons obtain the recognition,two-third of them shall request the adding together).6.This Health Functional Food Code shall be principally interpreted and

25、applied by general provisions and general standards and specifications,except otherwise specified.I.Common Standards and Specifications I.1 The ingredients used for manufacturing health functional food shall be as follows:1)Functional ingredients(1)The functional ingredient is a substance providing

26、health benefits and falls under any of the following subparagraphs:(a)processed raw material originated from animal,plant or microorganism;(b)extract or purified substance of any ingredient described in subparagraph(a);(c)synthetic duplicate of purified substance of any ingredient described in subpa

27、ragraph(b);or(d)combination of any ingredients described in subparagraph(a),(b),or(c).(2)The functional ingredients shall be:(a)specified by the standards and specifications of functional ingredients of this Code;or(b)recognized under Chapter 15 of the Health Functional Food Act and Regulation on Ap

28、proval of Functional Ingredient for Health Functional Food.In this case only the business person who obtains the certificate can use it.2)Nutrients The term nutrient means vitamins and minerals,dietary fiber,protein,essential fatty acid,etc.3)Other ingredients(1)The term other ingredients means any

29、ingredient or component which can be used for manufacturing health functional food without setting specific standard and specification.(2)The other ingredients shall:(a)meet the standards and specifications of food;(b)meet the standards and specifications of food additives;or(c)be 1)Functional ingre

30、dients or 2)Nutrients.Provided that warning notice for intake shall be provided and less than daily intake value set by the Commissioner of the Food and Drug Administration shall be used.The functional ingredient under 1.1).(2).(b)can only be used by the business person who obtains the certificate.4

31、)Raw materials(1)The term raw material means source material used for manufacturing ingredients.(2)The requirements for raw materials shall be as follows:(a)It has good quality and freshness,and it is not decomposed or deteriorated;(b)The safety shall be ensured under the 5.General specifications of

32、 food of Article 2 of the Common Standards and Specifications for detrimental contaminants such as heavy metal,pathogens,mycotoxins,radioactivity,etc,or residues such as pesticides,veterinary medicines,etc and foreign materials,etc;(c)For raw material used for manufacturing,any foreign material such

33、 as soil,sand,dust,etc shall be sufficiently removed,it shall be washed with drinking water,and any non-edible parts shall be sufficiently removed;and(d)The water treatment,etc shall be in conformity with the Management of Drinking Water Act,the alcoholic products shall be in conformity with the Liq

34、uor Tax Act,salt shall meet the Salt Management Act,and livestock products shall be in conformity with the Livestock processing Act.I.2 Common standards for manufacturing process 1)The health functional food under this Code shall be manufactured or processed in order to supplement nutrients that may

35、 be deficient in daily meal or to provide functional ingredients useful for human body in a form of capsule,tablet,powder,granule,liquid,pill,paste,syrup,gel,bar,etc which is easy to intake per serving.The conventional food or the food which substitutes for meal shall be authorized by the Commission

36、er of the Food and Drug Administration under the Article 14(2)and 15(2)of the Health Functional Food Act.2)It is recommended to apply Good Manufacturing Practices as possible.3)The health functional food shall be manufactured with functional ingredients and the standards for using the functional ing

37、redients shall be as follows:(1)The functional ingredients shall be conformed the standards for manufacturing/processing and specifications under II.Standards and Specifications for Each Functional Ingredient of this Code or the Regulation on Approval of Functional Ingredient for Health Functional F

38、ood;(2)In case where an ingredient of the health functional food which is subject to the permission(or report)is purchased and used,the manufacture business permission for the ingredient in question shall be obtained or the import report shall be filed.The ingredient shall conform to the standards a

39、nd specifications of the permission(or report).The adulterate ingredients such as product whose sell-by-date has been passed shall not be used;(3)The ingredients shall be used according to the daily intake value and cautions for preparation or processing established for each functional ingredient;an

40、d(4)Two or more functional ingredients can be combined.In this case,it should be verified that the safety and health benefits are maintained.4)Vitamins and minerals shall be used according to the maximum level under the II.Standards and Specifications for each functional ingredient II.1 Nutrients II

41、.1.1 Vitamins and Minerals.5)In case where other ingredients are used,the safety and the maintenance of health benefits for functional ingredients should be primarily considered and the following requirements for use should be observed:(1)It shall meet the relevant standards and specifications of th

42、e Food Code,the Food Additive Code,or the Health Functional Food Code;and(2)It shall be manufactured to contain nutrients which may cause detrimental effects such as fat,cholesterol,sodium,saturated fat and trans fat as low as possible.6)The solvent for extracting functional ingredients shall be sub

43、ject to II.Standards and Specifications for Each Functional Ingredient of this Code or the Regulation on Approval of Functional Ingredient for Health Functional Food,and the extraction solvent shall meet the Standards and Specifications of the Food Additive.7)If a food additive that cannot be used i

44、n a certain health functional food is derived from a raw material for which the food additive can be allowed to use,the restriction on the use of food additives may not apply within the range of such deriving from the raw material.8)Article 2 General Standards and Specifications of Food in General o

45、f the Food Code shall apply to the residues such as pesticides,veterinary drug,etc of health functional food.In case where the Food Code provides specific standards for processed products(for example,concentrate,powder,etc),the individual standards in question shall apply in preference to the common

46、 standards.9)In case where radiation is used for health functional food,the source and type of radiation are 60Co gamma ray and the following standards shall be applied:(1)Absorbed dose of permitted health functional food Health functional food Absorbed dose Aloe vera powder Not more than 7kGy Ginse

47、ng,Red ginseng Not more than 7kGy Chlorella,Spirulina Not more than 7kGy (2)Irradiated health functional food shall not be reirradiated and health functional food,which is manufactured/processed from irradiated functional ingredient,shall not be reirradiated.(3)The irradiated health functional food

48、shall be sold packaged.10)The Food Code shall apply unless this Code otherwise provides.Other standards for manufacture shall be as follows:(1)Machine/utensil and other facilities,which are utilized in health functional food manufacturing and processing,shall be hygienically maintained and managed.(

49、2)The container or the package of health functional food shall be subject to the Food Code under the Food Sanitation Act.(3)The water used for manufacturing health functional food shall meet the Management of Drinking Water Act.(4)Thawing of frozen raw material shall be hygienically performed.(5)The

50、 health functional food shall be refrigerated,frozen,or appropriately pasteurized or sterilized depending on the product characteristics.(6)During manufacturing health functional food,heat treatment,cooling,or freezing process shall appropriately carried out considering the health benefits and the s