Health Functional

Food Code

2021
1. The translated document herein reflects the Ministry of Food and
Drug Safety Notification (No. 2020-92, September 23, 2020).

2. The translated document into English herein is a service

provided for user's convenience and it shall not be construed
as having official authority. Ministry of Food and Drug Safety
shall bear no legal responsibility for the accuracy of such
translation, and in case of any divergence of interpretation of
the Korean and English version thereof, the Korean version
shall apply.

3. For accurate content of the Notification, please refer to MFDS

website (www.mfds.go.kr).
Chapter 1. General Provisions ····································································· 1

Chapter 2. Common Standards and Specifications ···································· 7

1. The ingredients used for manufacturing health functional food ·················· 9
2. Common standards for manufacturing process ············································ 10
3. Application of the standards and specifications of health functional food
··························································································································· 15
4. Pass/Fail determination about standards and specifications ························ 18
5. Preservation and distribution standards ························································· 19
6. Sampling and handling ··················································································· 20

Chapter 3. Standards and specifications for each functional ingredient ··· 27

1. Nutrients ············································································································ 29
1-1 Vitamin A ·································································································· 31
1-2 β-Carotene ·································································································· 32
1-3 Vitamin D ·································································································· 33
1-4 Vitamin E ·································································································· 34
1-5 Vitamin K ·································································································· 36
1-6 Vitamin B1 ································································································· 37
1-7 Vitamin B2 ································································································· 38
1-8 Niacin ········································································································· 39
1-9 Pantothenic acid ························································································ 40
1-10 Vitamin B6 ······························································································· 41
1-11 Folic acid ································································································· 42
1-12 Vitamin B12 ····························································································· 43
1-13 Biotin ········································································································ 44
1-14 Vitamin C ································································································ 45
1-15 Calcium ···································································································· 46
1-16 Magnesium ······························································································· 48
 1-17 Iron ··········································································································· 49
1-18 Zinc ·········································································································· 51
1-19 Copper ······································································································ 52
1-20 Selenium ··································································································· 53
1-21 Iodine ······································································································· 54
1-22 Manganese ······························································································· 55
1-23 Molybdenum ···························································································· 56
1-24 Potassium ································································································· 57
1-25 Chromium ································································································ 59
1-26 Dietary fiber ···························································································· 60
1-27 Proteins ····································································································· 61
1-28 Essential fatty acid ················································································· 63

2. Functional ingredients ······················································································ 64

2-1 Ginseng ······································································································ 64
2-2 Red Ginseng ······························································································ 66
2-3 Plants containing chlorophyll ··································································· 68
2-4 Chlorella ····································································································· 69
2-5 Spirulina ····································································································· 71
2-6 Green tea extracts ····················································································· 73
2-7 Aloe whole leaves ···················································································· 75
2-8 Propolis extracts ························································································ 76
2-9 Coenzyme Q10 ·························································································· 78
2-10 Soybean isoflavone ················································································· 80
2-11 Guava leaf extracts ················································································· 82
2-12 Banaba leaf extracts ··············································································· 83
2-13 Ginkgo leaf extracts ··············································································· 84
2-14 Milk thistle extracts ················································································ 86
2-15 Evening primrose seed extracts ····························································· 88
2-16 Edible oil containing EPA and DHA ·················································· 89
2-17 Edible oil containing gamma-linolenic acid ········································ 91
2-18 Lecithin ···································································································· 93
2-19 Squalene ··································································································· 95
2-20 Phytosterol / Phytosterolester ································································· 96
2-21 Shark liver oil containing alkoxyglycerol ············································ 98
2-22 Edible oil containing octacosanol ························································· 99
2-23 Japanese apricot extracts ······································································ 100
2-24 Conjugated linoleic acids ····································································· 101
2-25 Garcinia cambogia extracts ·································································· 103
2-26 Marigold flower extracts ······································································ 105
2-27 Haematococcus pluvialis extracts ························································ 107
2-28 Saw palmetto fruit extracts ································································· 109
2-29 Phosphatidylserine ················································································· 111
2-30 Glucosamine ··························································································· 113
2-31 NAG ······································································································· 115
2-32 Mucopolysaccharide·mucoprotein ························································· 116
2-33 Guar gum / Guar gum hydrolysate ···················································· 118
2-34 Glucomannan ························································································· 120
2-35 Oat dietary fiber ··················································································· 121
2-36 Indigestible maltodextrin ······································································ 122
2-37 Soybean dietary fiber ··········································································· 124
2-38 Tree ear dietary fiber ··········································································· 125
2-39 Wheat dietary fiber ··············································································· 126
2-40 Barley dietary fiber ·············································································· 127
2-41 Arabic gum ···························································································· 128
2-42 Corn bran dietary fiber ········································································ 129
2-43 Inulin / Chicory extracts ······································································ 130
2-44 Psyllium husk dietary fiber ································································· 131
2-45 Polydextrose ··························································································· 132
2-46 Fenugreek seed dietary fiber ······························································· 133
 2-47 Aloe gel ································································································· 134
2-48 Ganoderma lucidum fruit body extracts ············································· 135
2-49 Chitosan / Chitooligosaccharide ·························································· 136
2-50 Fructooligosaccharide ············································································ 138
2-51 Probiotics ······························································································· 139
2-52 Red yeast rice ······················································································· 141
2-53 Soybean protein ····················································································· 142
2-54 Theanine ································································································· 143
2-55 MSM ······································································································ 145
2-56 Poly γ-glutamic acid ············································································· 146
2-57 Hyaluronic acid ····················································································· 147
2-58 Rhodiola rosea L. extracts ··································································· 149
2-59 Bilberry extracts ···················································································· 150
2-60 Garlic ······································································································ 152
2-61 Raffinose ································································································ 153
2-62 Agar powder ·························································································· 155
2-63 Creatine ·································································································· 157
2-64 Hydrolyzed milk protein ······································································ 159
2-65 Phellinus linteus extracts ······································································ 161
2-66 Tomato extracts ····················································································· 163
2-67 Amorphophallus konjac extracts ·························································· 165
2-68 Sophora japonica L. fruit extracts ······················································ 167

[Annexed the Table 1] Table of random sampling numbers and usage method
······················································································ 168
[Annexed the Table 2] Nutrient reference value ·············································· 171
[Annexed the Table 3] Dietary Reference Intakes for Koreans ····················· 172
[Annexed the Table 4] Application Table for Testing Methods ···················· 174
[Annexed the Table 5] Negative List for Health Functional Food Ingredients
······················································································ 175
Chapter

General Provisions

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 Chapter 1. General Provisions

1. Purposes of the Health Functional Food Code

1) This Code establishes the standards and specifications for manufacturing,
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 consumer’s safety through providing the standards and
specifications for functional ingredients and final product 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,
production, import, distribution, storage, etc. of health functional food
under the Article 14 of the Health Functional Foods Act.
2) The ingredients or the compounds of health functional food under the
Article 15 of the Health Functional Foods 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 ingredient are classified
into sections according to the types of health claims and into groups
according to the functional ingredients.
(1) The sections are classified into nutrients, which intend to supplement
nutritional factors and functional ingredients.
(2) The groups are classified into vitamins and minerals, edible oil containing
gamma-linolenic acid products, glucosamine, etc. which are ingredients
provided in the sections.

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 3) The standards and specifications for each functional ingredient cover
standards for manufacturing, specifications, 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 preparation 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 therewith.
(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 components.

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 for Health Functional
Food.

5. Definition of products
1) The definitions of product types
(1) “Tablet” refers to a product which is compressed into a shape.
(2) “Capsule” refers to a product which is filled in or encapsulated with
capsule base. There are two types of capsules, hard capsules and soft
capsules.
(3) “Pill” refers to a product which is in spherical shape.
(4)　“Granule” refers to a product which is in a granular shape.

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 (5) “Liquid” refers to a product which is in liquid state with fluidity or a
form which is concentrated the liquid state one as it is.
(6) “Powder” refers to a product whose size is smaller than that of
granules.
(7) “Flake” refers to thin and flat sculpture.
(8) “Paste” refers to half-solid state of flow with strong viscosity between
solid and liquid.
(9) “Syrup” refers to half-liquid of weak viscosity between solid and liquid.
(10) “Gel” refers to a solid of fluidity or semi-solid state made by adding
gelling agent such as pectin, gelatin, agar, etc. to the liquid.
(11) “Jelly” refers to a solid of no fluidity or semi-solid state made by
adding gelling agent such as pectin, gelatin, agar, etc. to the liquid.
(12) “Bar” refers to a form of a stick.
(13) “Film” refers to a form of thin film.
2) The definitions of product types according to disintegration
The terms of Delayed release products means a product that does not
disintegration in the acid condition of the stomach when ingested, but
has the characteristics of being disintegrated in the intestines.

6. Adding functional ingredients in this Code

1) The functional ingredients recognized under the Regulation on Approval
of Functional Ingredients for Health Functional Food can be added to the
Code in case 6 years have passed from the date of recognition and more
than 50 item manufacturing reports.
2) Adding health claim of functional ingredient, change of daily intake
amount or preparation and/or processing by article 10 (2) of Regulation
on Approval of Functional Ingredients for Health Functional Food can be
added to the code in case 3 years have passed from the date of
recognition (Except, persons who obtain the recognition wants to add to
the code).

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 Chapter

Common Standards and

Specifications

- 7 -
 Chapter 2. Common Standards and Specifications

1. The ingredients used for manufacturing health functional food

1) Functional ingredients
(1) “The functional ingredient” is a substance providing health benefits and
falls under any of the following subparagraphs.
(a) Processed raw material originated from animal, plant, microorganism or water.
(b) Extract or purified substance of any ingredient described in
subparagraph (a).
(c) Synthetic duplicate of purified substance of any ingredient described in
subparagraph (b).
(d) Combination of any ingredients described in subparagraph (a), (b), or (c).
(2) The functional ingredients shall be as follow.
(a) Specified by the standards and specifications of functional ingredients
of this Code.
(b) Recognized under Article 15 of the Health Functional Foods Act and
Regulation on Approval 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 ingredient or component which
can be used for manufacturing health functional food without setting
specific standard and specification.
(2) The other ingredients shall be as follow.
(a) Meet the Food Code.
(b) Meet the Food Additives Code.
(c) Be 1) Functional ingredients or 2) Nutrients. In the case warning
notice for intake shall be provided and less than daily intake value set
by the Ministry of Food and Drug Safety shall be used. The functional

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 ingredient under 1.1).(2).(b) can only be used by the business person
who obtains the certificate.
4) 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 of detrimental contaminants such as heavy metal,
pathogens, mycotoxins, radioactivity, etc. or residues such as pesticides,
veterinary medicines, etc. and foreign materials, etc shall be ensured
under the 3. Standards and Specifications for General Foods of
Chapter 2. Common Standards and Specifications for General Foods in
the Food Code.
(c) For raw material used for manufacturing, any foreign material such 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.
(d) Ethanol used in health functional products shall be in conformity with
standards of the Liquor Tax Act, Salt, water treatment, etc. shall be
in conformity with the Food Code, and livestock and livestock
products shall be in conformity with the Livestock Products Sanitary
Control Act.

1-1. The ingredients cannot be used for manufacturing health functional food
1) Ingredients that known to have serious toxicity or side effects including
[Annexed 5].
2) Ingredients that used only for the purpose of medicine or requires
medical expertise in the method or amount of intake.

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 be deficient in daily

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 meal or to provide functional ingredients useful for human body in a
form of capsule, tablet, powder, granule, liquid, pill, flake, paste, syrup,
gel, jelly, bar, film, etc. which is easy to intake per serving. The
conventional food or the food which substitutes for meal shall be
authorized by the Ministry of Food and Drug Safety under the Regulation
on Approval of Functional Ingredient for Health Functional Food. But
fermented milk (except fermented milk powder) in the Food Code do not
need to be authorized.
2) Deleted
3) The health functional food shall be manufactured with functional
ingredients and the standards for using the functional ingredients shall be
as follows.
(1) Functional ingredients shall meet manufacturing/processing and specifications
under Chapter 3. Standards and Specifications for Each Functional
Ingredient of this Code or the Regulation on Approval of Functional
Ingredient for Health Functional Food.
(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 and 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.
(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 1. Nutrients of Chapter 3. Standards and Specifications for each
functional ingredient.
5) In case where other ingredients are used, the safety and the maintenance

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 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 the Food
Code, the Food Additive Code, or the Health Functional Food Code.
(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 subject to
Chapter 3. 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 Food
Additives Code.
7) If a food additive that cannot be used in 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) 3. Standards and Specifications for General Foods of Chapter 2. Common
Standards and Specifications for General of 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 standards.
9) In case where radiation is used for health functional food, Chapter 2.
Common Standards and Specifications for General in the Food Code shall
be applied.
(1) Absorbed dose of permitted health functional food

Health functional food Purpose Absorbed dose

Aloe vera powder Pasteurization No more than 7 kGy
Ginseng, Red ginseng Pasteurization No more than 7 kGy
Chlorella, Spirulina Pasteurization No more than 7 kGy

(2) Irradiated health functional food shall not be reirradiated and health
functional food, which is manufactured/processed from irradiated

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 functional ingredient, shall not be reirradiated.
(3) The irradiated health functional food 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.
(2) The container or the package of health functional food shall be conforming
to the Standards and Specifications for Utensils, Containers and Packages.
A material used for the purpose of maintaining quality of the product
by removing moisture, odor and oxygen inside the food package shall
be packaged in a way that prevents it from transferring to the food,
using materials conforming to the Standards and Specifications for
Utensils, Containers and Packages.
(3) The water used for manufacturing health functional food shall meet the
Drinking Water Management Act.
(4) Coated material or additives used for delayed release products capsule,
granule, tablet shall meet the criteria of the Food Additives Code, or
Regulation on pharmaceuticals approval notification and review
[Annexed 7] 1. 5), (6) Delayed release materials and 7) Delayed
released product coating materials.
(5) Thawing of frozen raw material shall be hygienically performed.
(6) The health functional food shall be refrigerated, frozen, or appropriately
pasteurized or sterilized depending on the product characteristics.
(7) During manufacturing health functional food, heat treatment, cooling, or
freezing process shall appropriately carried out considering the health
benefits and the safety of products.
(8) If it is intended to recover the food containers and packaging materials
and re-use them, they shall be cleaned to remove any impurities. They
shall be used only after it is verified that there are no impurities.
(9) The health functional food shall be promptly and hygienically wrapped
as possible to prevent contamination by microbes.

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11) The following food additives shall not used in Health functional food
which manufactured for children under the Article 14 (1) of the Health
Functional Foods Act.
(1) Colour (Except, used as coated material for tablet or capsule)
Copper Chlorophyll and salt (Sodium, Potassium), Iron Sesquioxide, Food
Green No.3, Food Green No.3 Aluminium Lake, Food Red No.2, Food Red
No.2 Aluminium Lake, Food Red No.3, Food Red No.40, Food Red No.40
Aluminium Lake, Food Red No.102, Food Blue No.1, Food Blue No.1
Aluminium Lake, Food Blue No.2, Food Blue No.2 Aluminium Lake,
Food Yellow No.4, Food Yellow No.4 Aluminium Lake, Food Yellow
No.5, Food Yellow No.5 Aluminium Lake, Titanium Dioxide, Caramel
Color (In case of ginseng and red ginseng product)
(2) Color retention agent
Sodium Nitrite, Sodium Nitrate, Potassium Nitrate
(3) Preservative
Natamycin, Nisin, Sodium Dehydroacetate, Sorbic Acid and salt (potassium,
calcium) (Except liquid products and aloe leaf products), Benzoic Acid and
salt (Sodium, potassium, calcium) (Except aloe leaf and gel products),
Hydroxybenzoate (Methyl, ethyl), Propionic Acid and salt (Sodium, calcium)
(Except for flavoring purpose)
(4) Bleaching agent
Sodium Metabisulfite, Potassium Metabisulfite, Sulfur Dioxide, Sodium
Bisulfite, Sodium Sulfite, Sodium Hydrosulfite
(5) Antioxidant
Butylated Hydroxy Toluene, Propyl Gallate, Butylated Hydroxy Anisole, Disodium
Ethylenediaminetetraacetate, Calcium Disodium Ethylenediaminetetraacetate,
tert-Butylhydroquinone
(6) Food additives containing aluminium
Sodium Aluminium Phosphate, Acidic, Sodium Silicoaluminate, Sodium
Aluminium Phosphate, Basic, Aluminium Ammonium Sulfate, Aluminium
Potassium Sulfate
12) Product which serving amount is over 30 mg of iron shall use safety

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 container which meet Article 3 of Regulation on Drug Safety Containers,
Packaging and Medication measuring instruments.

3. Application of the standards and specifications of health functional food

1) As a general rule, Chapter 2. Common Standards and Specifications and
Chapter 3. Standards and Specifications for Each Functional Ingredient or
the standards and specifications which are recognized under the
Regulation on Approval of Functional Ingredient for Health Functional
Food shall apply together with the specifications of functional ingredients
and final products which are manufactured or processed with functional
ingredients (See, Table 1).
2) The specifications of each functional compound provided in Chapter 3.
Standards and Specifications for Each Functional Ingredient shall apply
differently to the semi-processed products which are not for consumer
sale and the final products which are manufactured with the
semi-processed products. Provided, that if the semi-processed product is
made mixed with fructose, starch, glucose, lactose, dextrin, etc. and with
a functional ingredient, the content of the functional compound (or
marker compound) shall meet the standards for manufacturing of the
functional ingredient according to the conversion considering the
combination ratio.
3) In case where two or more functional ingredients are combined, all
specifications of the functional ingredients in question shall apply and in
case of overlapping specifications the stricter specification shall apply.
4) Standards and specifications by product types are as belows.
(1) The health functional food in tablet, capsule, pill, and granule shall be
passed for disintegration test. The testing method shall be conform
Chapter 4. 2-1. Disintegration test of this Code. However, the disintegration
test shall not apply to the following cases.
(a) In case where it is taken by chewing or melting.
(b) In case where it is a granule product whose residue is five percent or
less with the No.35 (500 µm) strainer.

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 (2) The total aerobic bacteria shall not be over 100 per 1 mL. The testing
method shall conform to 4. Microorganism testing method 4.5.1 Total
aerobic counts of Chapter 8. General Testing Method of the Food
Code. This specification shall not apply to the health functional food as
follows.
(a) In case where probiotics are used as the functional ingredients.
(b) In case oil type products
(c) In case of the products, on which the sterilization process has been
carried out. In this case the total aerobic bacteria shall be negative.
5) Heavy metal specifications of functional ingredients which Chapter 3.
Standards and specifications for each health functional ingredients does
not determine are lead (No more than 1.0 mg/kg), cadmium (no more
than 0.3 mg/kg).
6) For The product, to which vitamins and minerals are added more than
the minimum level under the chapter 3. Standards and Specifications for
Each Functional Ingredient, the contents of nutrient and the ratio (%) for
the nutrient reference value shall be labeled under the Standards of Label
of Health Functional Food, and the specifications for labeled vitamins
and minerals provided in Chapter 3. Standards and Specifications for
Each Functional Ingredient of this Code shall apply.
7) Notwithstanding the standards and specifications of this Code, the
standards and specifications which are required by the importers under
Article 14 (3) of the Health Functional Foods Act may apply to the
health functional food for the export purpose.
8) Health Functional Food Code shall be principally interpreted and applied
by general provisions and general standards and specifications, except
otherwise specified.

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[Table 1] Decision tree for setting the standards and specifications of health
functional food

<Specifications to be applied>
1. Apply the specification Capsule, tablet, → Disintegration
1)
by product types in the pill, granule
common specification Liquid2) → Total aerobic bacteria

2. Apply the specifications of labeled vitamins

and minerals contents.
※ In case where is added the minimum content
→ Nutrient content
level provided in Chapter 3.Standards and
Specifications for each functional ingredient
or more.

→ Appearance
3. Apply 2) Specification of “Chapter 3. Content of functional compound
Standards and Specifications for each functional (or marker compound)
ingredient
Apply the specifications approved under the Heavy metal
Regulation on Approval of Functional Solvent residue
Ingredient for Health functional food(for
Coliforms
the functional compound (or marker
compound), 80∼120% of the labeled value
shall be applied. Nevertheless, if the
Ministry of Food and Drug Safety
recognizes the range for the labeled value
Others (mycotoxins, etc.)
of a functional compound (or marker
compound) in the certificate, it shall be
subject to the certificate.)

Bacterial growth (canned or

4. Others (preservation methods, etc.) →
bottled type and retort type)

1) Except for one which is taken by chewing or melting and the case where it is a granule
product whose residue is five percent or less with the No.35 (500 µm) strainer.
2) Except when probiotics are used as functional ingredients and for oil type products.

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4. Pass/Fail determination about standards and specifications
1) Health functional food shall be judged in accordance with the standards
and specifications recognized by the Ministry of Food and Drug Safety
(hereinafter referred to as pass/fail determination), and the specifications
shall apply to the final health functional products.
2) Pass/Fail determination about hazardous substances (heavy metal, pesticide
residue, etc.) shall be in conformity with the regulation in the Food Code
and Food additive Code and of which the standards and specifications are
not specified in the relevant Code, it may be in conformity with Codex
Alimentarius Commission (hereinafter referred to as CAC) regulation.
Where there are no standards and specifications in relevant Code and
CODEX regulation, the Ministry of Food and Drug Safety can apply the
standard and specification after a comprehensive review of the relevant
data about materials such as foreign countries’ standards and
specifications, Acceptable Daily Intake (ADI), related intake of health
functional food, etc.
3) Pass/Fail determination about the standards and specifications recognized
by Ministry of Food and Drug Safety is principally performed, however,
when a new method is judged to be more precise, this method can be
used. Especially, tests of microorganism or toxins, etc. may be performed
with a commercial kit and automated analytical equipment. When various
results with different outcomes are difficult to judge, the test shall be
performed and judged in preference to the specified method.
4) In the event that the standards and specifications are not designated by
the Ministry of Food and Drug Safety or the testing method is not stated
even though standards and specifications are designated, tests can be
performed in accordance with the testing methods stated in CODEX
regulation, AOAC (Association of Official Analytical Chemists), and PAM
(Pesticide Analytical Manual). In cases where the above testing method is
not available, authorized testing methods, which are specified in other
regulations or internationally recognized, can be applied. Provided that, in
this case the testing method and its source shall be submitted. However,
vitamin contents test of water solubility vitamin with soft capsule

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 products can use testing methods that business operator submitted. In this
case, the testing method and its source shall be submitted under the
Regulation on Approval of Functional Ingredients for Health Functional
Food [Annexed the Table 1].
5) Pass/fail determination with test result through testing methods is judged
by the comparison of experimental value (acquired value from test) with
standard value (standardized and specified value, n digit), after the
experimental value shall be rounded off to the nearest whole number in
one place number more than standard value.
6) The Standards and Specifications of capsule product shall apply to the
product contents except for the capsule base. However, microorganism,
illegal compounds, disintegration test and appearance test shall be
inclusion the capsule base and water solubility vitamin with soft capsule
products, etc. can use testing method that business operator submitted.
7) The detection of food additives (preservatives, etc.) that cannot be used
and are derived from raw materials (including capsule base, coating base)
combined to health functional food shall not be subject to the
specifications.
8) “Must not be detected” means not to be detected by tests, which are
specified in this Code.
9) In the event that multiple test samples are requested in the same
condition pursuant to “6. Sampling and Handling Methods” in this
Notification, the entire samples shall be treated as nonconforming if one
or more samples do not conform to the requirement.

5. Preservation and distribution standards

1) All health functional food shall be hygienically dealt with before selling,
and the storage area and store shall be located in a clean environment.
Rat and insect-proof management shall be thoroughly performed.
2) The health functional food handling place shall be protected from rain,
snow, and chemical products, agricultural chemicals and poison, which are
harmful to humans, shall not be kept in the same place.
3) One will be cautious that foreign material is not mixed, and health

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 functional food shall be kept separated from other final health functional
products which may affect its taste.
4) Final health functional products shall be kept and distributed at a cool
place and the health functional food, of which storage cannot be
continued for 7 days at normal temperature, shall be kept and distributed
at the refrigeration or freezing facility as long as possible.
5) The frozen-products shall be frozen to minimize deterioration. Thawed
products shall not be frozen again.
6) Transport of frozen or cold-storage products shall be performed with use
of a vehicle able to maintain the specified temperature or in an
equivalent or better manner.
7) One shall be cautious that moisture absorption shall not happen to food,
which may absorb moisture.
8) One shall be cautious that container/packaging shall not be damaged or
severely impacted during transportation or packaging of final health
functional product.
9) Any product which has been decomposed, deteriorated or damaged during
the storage shall not be sold.
10) After frozen health functional food is thawed, it shall not be distributed
as room temperature or chilled health functional food, and the room
temperature or chilled health functional food shall not be distributed as
frozen health functional food. Also chilled health functional food shall
not be distributed at room temperature.
11) In case the storage and distribution standard is not provided in this
Code, The Food Code shall apply unless preservation and distribution
standards in this Code states otherwise.

6. Sampling and handling

1) Meaning of sampling and handling
Sampling shall be scientifically performed in securing its efficiency in the
selection of test target, sampling, handling and transportation/test, etc.
Authorized officers shall collect sample from the inspection target - in

- 20 -
 accordance with [Annexed the Table 1] Article 20 of Health Functional
Foods Act and perform tests on both the suitability to standard specification
and the safeguards against contaminants. They may take administrative
action according to the test results. Because its important purpose, the
authorized officers shall perform their duty with full knowledge about
sampling and handling methods.
2) Definition
(1) Sample: material collected from test target.
(2) Sample Unit: An object to be sampled, such as foods of the same type
that are produced/manufactured/processed/packaged under the same
condition.
(3) Test Target: A test object that is not packaged to be distributed and
sold as is to the final consumer.
3) General Guidance of Sampling
(1) Sampling shall be performed by a person specified in Article 20 of
Health Functional Foods Act and Article 22 of the Enforcement Rule
of the Health Functional Foods.
(2) A minimum quantity of sample shall be collected that will represent
overall test target in consideration of the test purpose and test items, etc.
(3) Sampling shall be conducted to ensure representativeness of the test
objects by using “Annexed the Table 1. Table of random sampling
numbers and usage method” However, if there are reasons for not
using such tables, a person responsible for sampling may select/sample
a test object at his/her discretion.
(4) A sample is, generally, collected from the test target with the same lot
number, manufacture date and expiration date. After understanding
several points such as product class, health functional food type,
manufacturing company, symbol, export country, export date, arrival
date, cargo vessel, transportation vehicle, cargo train, and packaging
type and appearance, etc. and considering the health functional food
characteristics and test purpose, sampling shall be performed.
(5) When a sample is collected, the test target shall not be damaged. In
case of collecting sample before packaging or after opening packaged

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 test target, foreign matter shall not be adulterated and the sample shall
be not contaminated by microorganisms.
(6) At the time of sampling, specimens shall be taken according to the
Sampling Decision Table.

<Sampling Decision Table>

Size of Test Objects (kg) Sampling Locations Test Samples
~ Less than 500 2 1
Not less than 500 ~ Less than 2,000 3 1
Not less than 2,000 ~ Less than 10,000 5 1
Not less than 10,000 ~ 8(4×2) 2
※ For test objects with a size not less than 10,000 kg, take 2 samples in total,
each of which is obtained by sampling from not less than 4 locations and
combining them to make one sample.

(7) Collected sample shall be sealed so that it shall be able to be opened

only by breakdown.
(8) Specimens that are difficult to obtain according to the Sampling
Decision Table, such as frozen samples, large packaged samples and
foods in distribution, etc. may be sampled by a sampler at his/her
discretion, ensuring their representativeness, within the amount of
collection.
4) Technique in Sampling and Handling
In the event of sampling, the physical, chemical and biological state of
health functional food samples shall be considered, such as test objectives,
the type, quantity, possibility of contamination and homogeneity of test
foods, etc.
(1) Sampling Technique
(a) In case of heterogeneous test health functional food
① It is generally necessary to collect a lot of samples when the sample
is heterogeneous. In case of collecting a small quantity of sample
because of test efficiency and economical efficiency, the sample can
be collected from a suspected target after considering its appearance
and storage condition, etc.
② A product, which is not homogeneous because of characteristics such

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 as sedimentation, floating, etc. shall be wholly treated as homogeneous
as possible and the sample shall be collected so that it has
representative characteristics.
(b) Homogeneity judgment according to test items
Sample homogeneity is dependent on test items. Because it is regarded
that health functional food components such as heavy metal, etc. are
homogeneous, even though the test health functional food is judged to be
heterogeneous, a sample can be collected.
(c) Sampling of packaged health functional food
① A sample of health functional food, which is circulated in a container
or packaging such as a can, bottle, box, etc. shall be collected in
itself, not to be opened as possible.
② For health functional food which is put into large container and
packaging, some of the health functional food, which represents the
whole test target can be collected as a sample.
(d) Sampling of refrigerated and frozen health functional food
In case of sampling of refrigerated or frozen health functional food, a
sample shall be collected as its status is maintained.
(e) Sampling to Require Microorganism test
① When a sample is collected, transported, or stored, an airtight
container/package shall be used so that its sampling state can be
maintained.
② When a portion of health functional food is collected as a sample, it
shall be aseptically performed by using sterilized utensil/container, etc.
③ The sample shall be, except in unavoidable situations, collected from
normally stored and circulated products.
④ The sample shall be collected from completely packaged products,
except in special sampling cases due to relevant information and
special collection plan.
(f) Sampling of gas-generation health functional food
① In the event that test result is affected by gas which is generated
from the sample at normal temperature, one packaged product shall
be collected in itself as sample unit, without opening the package.

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 ② However, when a portion of health functional food is collected as a
sample, the collected sample shall be immediately sealed and cooled
as soon as possible so that test result shall not be affected.
(g) Paste or Syrup type and so on
① In the event that sampling is difficult because of the high viscosity
of the sample, it can be collected in reducing its viscosity by proper
method such as heating in a range not to affect the test result.
② In the event that normal method cannot make the sample
homogeneous because it is high viscous and heterogeneous, the
sample is collected after being treated by using utensil to make it
homogeneous by a method not to affect the test result.
(h) Precautions for sampling according to acid value
Samples shall be placed into airtight containers that block light and the
space volume of the container and temperature change shall be
minimized as much as possible in order to prevent the acceleration of
fat oxidation due to light or temperature, etc.
(i) Sampling from containers
① In cases where multiple containers are one test object, they shall be
opened for sampling according to the following table. However, the
number of containers to open may be adjusted, considering the
number of sampling locations, etc. specified in this Sampling and
Handling Methods.

Number of
1-3 4-6 7-10 11-20 21-30 31-
containers
Containers 1 Not less Not less Not less Not less Not less
to open than 2 than 3 than 4 than 6 than 8

② In cases where representative samples cannot be collected from foods

loaded in containers, sampling may be done after not less than 1/3 of
the foods are unloaded from containers test such foods, etc. In this
case, for refrigerated/frozen samples, shipment may be unloaded in
places where storage temperatures may be maintained.
(2) Recording of Sampling Statement
The authorized officers shall submit the relevant sample with sampling

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 statement in sampling. However, in the event that it is allowed that the
omission of the sampling statement does not affect standard specification
test, the observer does not need to submit it.
(3) Sample Transportation Technique
(a) A collected sample shall be transported to the test room in itself so
that it is not contaminated, broken, damaged, thawed and deformed.
(b) In case of transporting sample a long distance or by public vehicle, it
shall be specially attentively packaged not to be damaged.
(c) Transportation of frozen sample
① Frozen samples shall be transported in itself.
② In case of not utilizing freezer, sample can be transported in
maintaining its frozen state by dry ice.
(d) Transportation of refrigerated sample
Cold sample shall be transported in maintaining its temperature. In
maintaining its refrigeration temperature by using ice, please be cautious
so that the sample should not be contaminated by water melted from
ice. In case of using dry ice, please be cautious so that the sample is
not frozen.
(e) Transportation of Sample for Microorganism test
① Samples with the possibility of spoilage deterioration
A sample, which requires microbiological test, shall be aseptically
collected into sterilized container and transported to the examination
agency in maintaining its cold storage temperature (no more than 5±
3℃) within 24 hours. When refrigeration temperature cannot be
maintained or the sample cannot be immediately transported because of
an unavoidable situation, it shall be re-collected or its test is requested
to the examination agency after recording its collection date and status.
② Samples without the possibility of spoilage deterioration
If there is no possibility of spoilage deterioration during transportation
it is not always necessary to transport the sample at refrigeration
temperature, even though it requires microbiological test. However,
please be cautious to contamination and damage of sample and
packaging, etc.

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 ③ Caution when using ice, etc.
In using ice, etc. please be cautious so that sample is not contaminated
by water melted from ice.
(f) Transportation of gas-generation sample
When a portion of health functional food is collected as a sample, it
shall be transported in properly cold or frozen state.
5) Sampling Utensil and Container
(1) Sampling utensil and container shall be suitable to sampling purpose
because of various class, shape, and container/packaging of the sample.
(2) They shall be suitable to Standard and Specification of Utensil,
Container and Package.
(3) Convenient utensil and containers shall be used in transportation,
cleaning, and sterilization. Parts, which are in direct contact with the
sample, or with the utensil and container to collect the sample for
microbiological test, shall be sterilized.
(4) Utensil and container, which are contacted directly with the sample,
shall not affect test result.
(5) Class of Utensil and Containers for Sampling
(a) Sampling instruments
Scales, tweezers, scissors, knives, can openers, hammers, chain saws or
saws, driers, pipettes, cutters, liquid sampling pumps or tubes, ladles,
and funnels, etc.
(2) Sampling containers/packages
Sampling bags (large, medium and small) and sampling bottles
(wide-mouth bottles), etc.
(3) Sampling instruments for microbiological testing
Sterile bags, sterile bottles, disposable sterile plastic pipettes, sterile
pipettes inspirators, disposable sterile gloves, 70% ethyl alcohol, sterilized
stainless-steel ladles and sterilized stainless-steel forceps, etc.
(4) Devices for transportation of refrigerated/frozen samples
Coolers, ice packs and real-time temperature recorders, etc.
(5) Others
Safety helmets, portable ladders, sanitary boots, tapes, coolers, cameras
and writing tools, etc.

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 Chapter

Standards and specifications

for each functional ingredient

- 27 -
 Chapter 3. Standards and specifications for each
functional ingredient

1. Nutrients
1) The health functional food having vitamins and/or minerals as functional
ingredients are intended for use in supplementing the daily diet with
vitamins and/or minerals. Therefore, these products neither substitute for a
meal nor supplement other ingredients. The health functional food having
vitamins and/or minerals as functional ingredients shall be manufactured
in forms such as capsules, tablets, powders, granules, liquids or pills, etc.
that are designed to be taken in measured small-unit quantities but not in
a conventional food form.
2) The health functional food having vitamins and/or minerals as functional
ingredients may contain all vitamins and minerals that comply with this
Code, a single vitamin and/or mineral or an appropriate combination of
vitamins and/or minerals.
3) Minimum level of each vitamins and/or minerals in those products per
daily portion of consumption shall be not less than 30% of the Nutrient
Reference Value (Annexed the Table 2). When a certain health functional
product specifies the intended age group for consumption, the minimum
level of each vitamins and/or minerals shall be not less than 30% of the
intake levels for the particular age group recommended by the Korean
Dietary Reference Intakes (Annexed the Table 3). When there are more
than two recommended intake levels for the age group, the higher level
shall be used.
4) A maximum amounts of vitamins and minerals in health functional food
per daily portion of consumption are designed to ensure safety from
excess intake of vitamin and/or mineral shall be applied to the
recommended standards for labeling value of final health functional
product.
5) If a certain health functional food contains vitamins and/or minerals at
30% or more of nutrient reference value, those vitamins and/or minerals

- 29 -
 shall be presented in nutrition fact. However, it is not compulsory to
describe all health claims of each nutrient (nutrient function claim) in the
label.
6) The sources or chemical forms of vitamins and minerals that are allowed
in the manufacture or processing of health functional food are listed in
this Code. The purity criteria or specifications for each source of
vitamins and/or minerals shall be in conformity with the Food Code or
the Food Additive Code.
7) Despite the 6) regulation, the material that specifies in this Notification
but the standards and specifications are not established in Food Code or
the Food Additive Code may be determined by the Minister of Food and
Drug Safety with such as provisions of the CODEX Alimentarius
Commission (CAC) or major foreign standards/specifications.

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1-1 Vitamin A

1) Standards for manufacturing

(1) Ingredients
(a) Retinyl Palmitate
(b) Retinyl Acetate
※ Use vitamin A in oil or dry formed that are listed in the Food
Additives Code.
(c) It shall be manufactured or processed from food ingredients to
supplement vitamin A.
(2) Vitamin A and β-carotene ingredients can be mixed to supplement
vitamin A. In this case, the standard for minimum level is in the sum
of vitamin A and β-carotene, and the maximum level should be
considered differently regarding its chemical forms.
(3) Conversion factor of β-carotene into vitamin A is by multiplying 1/2 to
the content of β-carotene. (However, 1-2. 1). (1). (c) for manufactured
or processed β-carotene ingredients that are prepared by pulverizing or
simple extraction with water or fermented ethanol, the conversion factor
is by multiplying 1/6 to the contents of β-carotene.)

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin A: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for vision adaptation in dark places
(b) Necessary for the normal structure and function of skin and mucosa
(c) Necessary for the normal growth and development of epithelial cells
(2) Daily intake amount: 210 ~ 1,000 µg RE (699.93 ~ 3,333 IU)

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin A: Chapter 4. 3-1 Vitamin A
(3) Coliform: Referred to [Annexed the Table 4]

- 31 -
1-2 β-Carotene

1) Standards for manufacturing

(1) Ingredients
(a) Processed ingredient in edible and oily form after extraction of β-carotene
from edible algae (dunaliella, chlorella, spirulina), green-leaf plants (seed,
fruit), or carrots
(b) β-Carotene
(c) It shall be manufactured or processed from food ingredients to
supplement β-carotene.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) β-Carotene: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for dark adaptation in dark places
(b) Necessary for the normal structure and function of skin and mucosa
(c) Necessary for the normal growth and development of epithelial cells
(2) Daily intake amount
(a) In the case of 1). (1). (a) and (b): 0.42 ~ 7 mg
(b) In the case of 1). (1). (c): 1.26 mg or more

MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake
(a) Consult a health care practitioner prior to intake if you a tobacco user
(b) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) β-Carotene: Chapter 4. 3-2 β-Carotene
(3) Coliform: Referred to [Annexed the Table 4]

- 32 -
1-3 Vitamin D

1) Standards for manufacturing

(1) Ingredients
(a) Vitamin D2 (Ergocalciferol)
(b) Vitamin D3 (Cholecalciferol)
(c) It shall be manufactured or processed from food ingredients to supplement
vitamin D.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin D: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the normal absorption and utilization of calcium and
phosphorus
(b) Necessary for the normal structure and maintenance of bones
(c) May help to reduce the risk of osteoporosis.
(2) Daily intake amount: 3 ~ 10 µg (120 ~ 400 IU)
(3) Warning notice for intake
(a) Consult a health care practitioner prior to intake if you are taking
medicines or having hypercalcemia of malignancy
(b) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin D: Chapter 4. 3-3 Vitamin D
(3) Coliform: Referred to [Annexed the Table 4]

- 33 -
1-4 Vitamin E

1) Standards for manufacturing

(1) Ingredients
(a) d-α-Tocopherol
※ Use d-α-Tocopherol Concentrate and mixed d-Tocopherol Concentrate that are
listed in the Food Additives Code.
(b) dl-α-Tocopherol
(c) d-α-Tocopheryl Acid Succinate
(d) d-α-Tocopheryl Acetate
(e) dl-α-Tocopheryl Acetate
(f) It shall be manufactured or processed from food ingredients to
supplement vitamin E.
(2) Conversion factor
(a) The synthetic tocopherol labeled as ‶dl-″ has half the activity, thus the
conversion factor is by multiplying 1/2, in case of item 1). (1). (b) and (e).
(b) Vitamin E in food exists in four different forms of α, β, γ, and δ
with different bioactivity. In the case of 1). (1). (f), vitamin E content is
estimated from following equation.
※ Vitamin E contents (mg α-TE) = 1.0×(α-tocopherol) + 0.5×(mg β-tocopherol)
+ 0.1×(mg γ-tocopherol) + 0.03×(mg δ-tocopherol)

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin E: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the protection of cell from free radicals
MFDS Notice 2020-63, Jul. 10, 2020, Enforcement date: Jul. 11, 2021
(1) Health claim: Necessary for the protection of cell from free radicals
by anti-oxidant activity

- 34 -
 (2) Daily intake amount: 3.3 ~ 400 mg α-TE(4.917 ~ 596 IU)

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin E: Chapter 4. 3-4 Vitamin E
(3) Coliform: Referred to [Annexed the Table 4]

- 35 -
1-5 Vitamin K

1) Standards for manufacturing

(1) Ingredients
(a) Vitamin K (Phylloquinone, Phytonadione)
(b) It shall be manufactured or processed from food ingredients the supplement
vitamin K.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin K: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the normal blood coagulation
(b) Necessary for the normal bone structure
(2) Daily intake amount: 21 ~ 1,000 μg

MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake
(a) Consult a health care practitioner who are taking medicine related to
blood coagulation
(b) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin K: Chapter 4. 3-5 Vitamin K
(3) Coliform: Referred to [Annexed the Table 4]

- 36 -
1-6 Vitamin B 1

1) Standards for manufacturing

(1) Ingredients
(a) Dibenzoyl Thiamine
(b) Dibenzoyl Thiamine Hydrochloride
(c) Thiamine Naphthalene-1,5-Disulfonate
(d) Thiamine Dilaurylsulfate
(e) Thiamine Thiocyanate
(f) Thiamine Hydrochloride
(g) Thiamine Mononitrate
(h) It shall be manufactured or processed from food ingredients to supplement
vitamin B1.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin B1: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the normal carbohydrates and energy metabolism
(2) Daily intake amount: 0.36 ~ 100 mg
MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake: Consult a health care practitioner and stop
intake if you are having adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin B1: Chapter 4. 3-6 Vitamin B1
(3) Coliform: Referred to [Annexed the Table 4]

- 37 -
1-7 Vitamin B 2

1) Standards for manufacturing

(1) Ingredients
(a) Riboflavin
(b) Riboflavin 5'-Phosphate Sodium
(c) It shall be manufactured or processed from food ingredients to supplement
vitamin B2..

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin B2: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the energy production in the body
(2) Daily intake amount: 0.42 ~ 40 mg
MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake: Consult a health care practitioner and stop
intake if you are having adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin B2: Chapter 4. 3-7 Vitamin B2
(3) Coliform: Referred to [Annexed the Table 4]

- 38 -
1-8 Niacin

1) Standards for manufacturing

(1) Ingredients
(a) Nicotinic Acid
(b) Nicotinamide
(c) It shall be manufactured or processed from food ingredients to supplement
niacin.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Niacin: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims : Necessary for the energy production in the body
(2) Daily intake amount
(a) Nicotinic Acid: 4.5 ~ 23 mg
(b) Nicotinamide: 4.5 ~ 670 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Niacin: Chapter 4. 3-8 Niacin
(3) Coliform: Referred to [Annexed the Table 4]

- 39 -
1-9 Pantothenic acid

1) Standards for manufacturing

(1) Ingredients
(a) Sodium Pantothenate
(b) Calcium Pantothenate
(c) It shall be manufactured or processed from food ingredients to supplement
pantothenic acid.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Pantothenic acid: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the normal metabolism of lipids, carbohydrates,
and proteins and energy production
(2) Daily intake amount: 1.5 ~ 200 mg
MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake: Consult a health care practitioner and stop
intake if you are having adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Pantothenic acid: Chapter 4. 3-9 Pantothenic acid
(3) Coliform: Referred to [Annexed the Table 4]

- 40 -
1-10 Vitamin B 6

1) Standards for manufacturing

(1) Ingredients
(a) Pyridoxine Hydrochloride
(b) It shall be manufactured or processed from food ingredients to supplement
vitamin B6.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin B6: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the utilization of proteins and amino acids
(b) Necessary for the maintenance of normal blood homocysteine levels
(2) Daily intake amount: 0.45 ~ 67 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin B6: Chapter 4. 3-10 Vitamin B6
(3) Coliform: Referred to [Annexed the Table 4]

- 41 -
1-11 Folic acid

1) Standards for manufacturing

(1) Ingredients
(a) Folic Acid
(b) (6S)-5-Methyltetrahydrofolic Acid, Glucosamine Salt
(c) It shall be manufactured or processed from food ingredients to supplement
folic acid.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Folic acid: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the formation of cell and blood
(b) Necessary for the normal development of fetal neural tube
(c) Necessary for the maintenance of normal blood homocysteine levels
(2) Daily intake amount: 120 ~ 400 μg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Folic acid: Chapter 4. 3-11 Folic acid
(3) Coliform: Referred to [Annexed the Table 4]

- 42 -
1-12 Vitamin B 12

1) Standards for manufacturing

(1) Ingredients
(a) Cyanocobalamin
(b) It shall be manufactured or processed from food ingredients to supplement
vitamin B12.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin B12: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the normal metabolism of folic acid
(2) Daily intake amount: 0.72 ~ 2,000 μg
MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake: Consult a health care practitioner and stop
intake if you are having adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin B12: Chapter 4. 3-12 Vitamin B12
(3) Coliform: Referred to [Annexed the Table 4]

- 43 -
1-13 Biotin

1) Standards for manufacturing

(1) Ingredients
(a) Biotin
(b) It shall be manufactured or processed from food ingredients to supplement
biotin.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Biotin: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the normal metabolism of lipids, carbohydrates,
and proteins and energy production
(2) Daily intake amount: 9 ~ 900 µg
MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake: Consult a health care practitioner and stop
intake if you are having adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Biotin: Chapter 4. 3-13 Biotin
(3) Coliform: Referred to [Annexed the Table 4]

- 44 -
1-14 Vitamin C

1) Standards for manufacturing

(1) Ingredients
(a) L-Ascorbic acid
(b) Sodium L-Ascorbate
(c) L-Ascorbyl Stearate
(d) Calcium L-Ascorbate
(d)-1 Calcium Ascorbate with added threonate
(e) L-Ascorbyl Palmitate
(f) It shall be manufactured or processed from food ingredients to supplement
vitamin C.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Vitamin C: 80 ~ 150% of labeled amount
(3) Threonate: Below 2% (Limited to Calcium Ascorbate with added threonate)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the normal structure and maintenance of the connective
tissuep
(b) Necessary for the absorption of iron
(c) Necessary for protection of cell from free radicals
MFDS Notice 2020-63, Jul. 10, 2020, Enforcement date: Jul. 11, 2021
(1) Health claim
(c) Necessary for the protection of cell from free radicals by anti-oxidant activity

(2) Daily intake amount: 30 ~ 1,000 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Vitamin C: Chapter 4. 3-14 Vitamin C
(3) Threonate: Chapter 4. 2-5-8 Threonate
(4) Coliform: Referred to [Annexed the Table 4]

- 45 -
1-15 Calcium

1) Standards for manufacturing

(1) Ingredients
(a) Calcium Citrate
(b) Calcium Gluconate
(c) Calcium Glycerophosphate
(d) Calcium Oxide
(e) Calcium Hydroxide
(f) Calcium Chloride
(g) Calcium Lactate
(h) Calcium Phosphate, Tribasic
(i) Calcium Phosphate, Dibasic
(j) Calcium Phosphate, Monobasic
(k) Calcium Carbonate
(l) Calcium Sulfate
(m) It shall be manufactured or processed from food ingredients to supplement
calcium.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Calcium: 80 ~ 150% of labeled amount
(3) Lead (mg/kg): 3.0 or less (In the case of using calcined calcium such
as cow bone powder and shell powder)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the formation of bones and teeth
(b) Necessary for the normal function of nerve and muscle
(c) Necessary for normal coagulation of blood
(d) May help to reduce the risk of osteoporosis
(2) Daily intake amount: 210 ~ 800 mg

- 46 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Calcium: Chapter 4. 3-16 Calcium
(3) Lead: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 47 -
1-16 Magnesium

1) Standards for manufacturing

(1) Ingredients
(a) Magnesium Gluconate
(b) Magnesium Oxide
(c) Magnesium Hydroxide
(d) Magnesium Chloride
(e) Magnesium Carbonate
(f) Magnesium Sulphate
(g) Magnesium Phosphate, Dibasic
(h) Magnesium Phosphate, Tribasic
(i) Magnesium L-Lactate
(j) It shall be manufactured or processed from food ingredients to supplement
magnesium.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Magnesium: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the normal energy utilization
(b) Necessary for the normal maintenance of the nerve and muscle
(2) Daily intake amount: 94.5 ~ 250 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Magnesium: Chapter 4. 3-15 Copper, Magnesium, Manganese, Molybdenum,
Selenium, Chromium
(3) Coliform: Referred to [Annexed the Table 4]

- 48 -
1-17 Iron

1) Standards for manufacturing

(1) Ingredients
(a) Ferric Citrate
(b) Ferric Ammonium Citrate
(c) Ferrous Gluconate
(d) Ferric Phosphate
(e) Ferrous Lactate
(f) Ferrous Fumarate
(g) Ferric Pyrophosphate
(h) Sodium Ferric Pyrophosphate
(i) Ferrous Sulphate
(j) Heme Iron
(k) Ferric Chloride
(l) Iron Reduced
(m) Sodium ferrous citrate
(n) It shall be manufactured or processed from food ingredients to supplement
iron.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Iron: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for oxygen transport and blood production in the body
(b) Necessary for energy production
(2) Daily intake amount: 3.6 ~ 15 mg
(3) Warning notice for intake: Excessive consumption should be avoided for
kids less than 6 years of age

- 49 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Iron: Chapter 4. 3-18 Iron
(3) Coliform: Referred to [Annexed the Table 4]

- 50 -
1-18 Zinc

1) Standards for manufacturing

(1) Ingredients
(a) Zinc Gluconate
(b) Zinc Oxide
(c) Zinc Sulphate
(d) It shall be manufactured or processed from food ingredient to supplement
zinc.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Zinc: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for normal immune function
(b) Necessary for normal cell division
(2) Daily intake amount: 2.55 ~ 12 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Zinc: Chapter 4. 3-19 Zinc
(3) Coliform: Referred to [Annexed the Table 4]

- 51 -
1-19 Copper

1) Standards for manufacturing

(1) Ingredients
(a) Cupric Gluconate
(b) Cupric Sulphate
(c) It shall be manufactured or processed from food ingredients to supplement
copper.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Copper: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the transport and utilization of iron
(b) Necessary for the protection of cell from free radicals
(2) Daily intake amount: 0.24 ~ 7.0 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Copper: Chapter 4. 3-15 Copper, Magnesium, Manganese, Molybdenum,
Selenium, Chromium
(3) Coliform: Referred to [Annexed the Table 4]

- 52 -
1-20 Selenium

1) Standards for manufacturing

(1) Ingredients
(a) Sodium Selenite
(b) Sodium Selenate
(c) It shall be manufactured or processed from food ingredients to supplement
selenium.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Selenium: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the protection of cell from free radicals
(2) Daily intake amount: 16.5 ~ 135 μg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Selenium: Chapter 4. 3-15 Copper, Magnesium, Manganese, Molybdenum,
Selenium, Chromium
(3) Coliform: Referred to [Annexed the Table 4]

- 53 -
1-21 Iodine

1) Standards for manufacturing

(1) Ingredients
(a) Potassium Iodide
(b) It shall be manufactured or processed from food ingredients to supplement
iodine.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Iodine: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the synthesis of thyroid hormone
(b) Necessary for energy production
(c) Necessary for the development of the nerve system
(2) Daily intake amount: 45 ~ 150 μg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Iodine: Chapter 4. 3-17 Iodine
(3) Coliform: Referred to [Annexed the Table 4]

- 54 -
1-22 Manganese

1) Standards for manufacturing

(1) Ingredients
(a) Manganese Gluconate
(b) Manganese Chloride
(c) Manganese Sulphate
(d) Manganese Citrate
(e) It shall be manufactured or processed from food ingredients to supplement
manganese.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Manganese: 80 ~ 150% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) Necessary for the normal bone structure
(b) Necessary for energy utilization
(c) Necessary for protection of cell from free radicals
(2) Daily intake amount: 0.9 ~ 3.5 mg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Manganese: Chapter 4. 3-15 Copper, Magnesium, Manganese, Molybdenum,
Selenium, Chromium
(3) Coliform: Referred to [Annexed the Table 4]

- 55 -
1-23 Molybdenum

1) Standards for manufacturing

(1) Ingredients
(a) Ammonium Molybdate
(b) Sodium Molybdate
(c) It shall be manufactured or processed from food ingredients to supplement
molybdenum.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Molybdenum: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for the activity of oxidoreductase
(2) Daily intake amount: 7.5 ~ 230 μg

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Molybdenum: Chapter 4. 3-15 Copper, Magnesium, Manganese, Molybdenum,
Selenium, Chromium
(3) Coliform: Referred to [Annexed the Table 4]

- 56 -
1-24 Potassium

1) Standards for manufacturing

(1) Ingredients
(a) Potassium Citrate
(b) Potassium Gluconate
(c) Potassium Glycerophosphate
(d) Potassium Chloride
(e) Potassium Lactate
(f) Potassium Bicarbonate
(g) Potassium Carbonate
(h) Potassium Phosphate, Monobasic
(i) Potassium Phosphate, Dibasic
(j) It shall be manufactured or processed from food ingredients to supplement
potassium.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Potassium: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: Necessary for balance of water and electrolyte balancing
in the body
(2) Daily intake amount: 1.05 ~ 3.7 g

MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake
(a) Consult a health care practitioner prior to intake if you have kidney
or stomach diseases
(b) Consult a health care practitioner and stop intake if you are having
adverse event

- 57 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Potassium: Chapter 4. 3-20 Potassium
(3) Coliform: Referred to [Annexed the Table 4]

- 58 -
1-25 Chromium

1) Standards for manufacturing

(1) Ingredients
(a) Chromic Chloride
(b) It shall be manufactured or processed from food ingredients to supplement
chromium.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Chromium: 80 ~ 180% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(1) Health claim: Involved in the metabolism of carbohydrates, lipids and
proteins

(2) Daily intake amount: 0.009 ~ 9 mg

MFDS Notice 2020-92, Sep. 23, 2020, Enforcement date: Sep. 24, 2021
(3) Warning notice for intake
(a) Consult a health care practitioner prior to intake if you have diabetes
(b) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Chromium: Chapter 4. 3-15 Copper, Magnesium, Manganese, Molybdenum,
Selenium, Chromium
(3) Coliform: Referred to [Annexed the Table 4]

- 59 -
1-26 Dietary fiber

1) Standards for manufacturing

(1) Raw materials and preparation and/or processing: Food ingredients
containing dietary fibers that are indigestible by the human digestive
enzymes shall be processed into edible forms
(2) Dietary fiber products are intended to supplement of dietary fiber that
may be deficient in daily meal. The ingredients of the dietary fiber
products shall be in conformity with the standards and specifications
for health functional food, food or food additives.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber: 80% or more of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Nutrient function: Supplementation of dietary fiber
(2) Daily intake amount: 5 g or more as dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

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1-27 Proteins

1) Standards for manufacturing

(1) Raw materials: Legumes, oils, eggs, fishes, shellfishes, meats, nuts,
cereals, edible insects
※ Edible insects should be on the list of the Food Code.
(2) Preparation and/or processing: The raw materials shall be in edible
form either by separating and purifying or by decomposed with
protease and autodigestive enzyme.
(3) Protein products are intended to supplement of proteins that may be
deficient in daily meals. The ingredient of the protein products shall be
in conformity with the standards and specifications for food or food additives.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Crude protein: 80 ~ 120% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Nutrient function
(a) Components of the physical tissues such as muscle and connective tissue
(b) Necessary for the normal formation of enzymes, hormones and antibodies
(c) Necessary for the transport and storage of essential nutrients or active
materials in the body
(d) Necessary for the balance maintenance of fluid and acid-base balance
(e) Necessary for the synthesis of energy, glucose, and lipid
(2) Daily intake amount: 12.0 g or more as protein
(3) Amino acid score of the final products shall be 85 or more, and
individual amino acids may be added to final products to adjust amino
acid score.
(4) Warning notice for intake: The individual who has an allergy to specific
protein must be cautious to intake

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 4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Crude protein: Chapter 4. 3-21 Crude protein
(3) Coliform: Referred to [Annexed the Table 4]

【 Composition table of standard essential amino acids for amino acid score conversion 】
(Unit: mg/g crude protein)
Methion Phenylal
Classific Iso Trypto
Histidine leucine Lysine ine＋ anine＋ Threonine Valine
ation leucine phan
Cysteine Tyrosine
Composi
19 28 66 58 25 63 34 11 35
tion

※ Amino acid score

The content of each essential amino acid in a product is analyzed in terms of mg
amino acid per g crude protein. Then, the content of each essential amino acid is
divided by the standard content of each essential amino acid shown in the above
table, followed by multiplication of 100 to the ratio to convert the ratio into
percentage.
Among the percentage values of all the essential amino acids, the lowest
percentage value is called “amino acid score”. The amino acid score of a product
shall be 85 or more.

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1-28 Essential fatty acid

1) Standards for manufacturing

(1) Raw materials and preparation and/or processing: Ingredients containing
linoleic and linolenic acid shall be processed into edible forms.
(2) Essential fatty acid products are intended to supplement essential fatty
acid that may be deficient in daily meal. The ingredients shall be in
conformity with the standards and specifications for health functional
food, food or food additives.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Linoleic acid, linolenic acid, or the sum of these: 80 ~ 120% of
labeled amount
(3) Residual solvent (mg/kg): 5.0 or less (in case of using hexane)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Nutrient function: Supplementation of essential fatty acid
(2) Daily intake amount: 4.0 g or more as linoleic acid or 0.6 g or more
as linolenic acid

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) The sum of linoleic acid and linolenic acid: Chapter 4. 3-32 Fatty acid
(3) Residual solvent: Referred to [Annexed the Table 4]
(4)　Coliform: Referred to [Annexed the Table 4]

- 63 -
2. Functional ingredients

2-1 Ginseng
1) Standards for manufacturing
(1) Raw material: Ginseng (Panax ginseng C.A. Meyer)
※ Raw ginseng (undried ginseng), white ginseng (raw ginseng dried up without
being cooked by sunbeams, hot blast or by other methods), taegeuk ginseng (raw
ginseng cooked in boiling water and then dried up)
(2) Preparation and/or processing
(a) It shall be in edible form by pulverizing.
(b) It shall be in edible form either by extraction the raw materials with
water or ethanol (including mixture of water and ethanol), concentration
or fermentation after extraction.
(3) Content of functional compound (or marker compound): It shall be
contained not less than 0.8 mg/g as the sum of ginsenoside Rg1 and Rb1.
(4) Conditions for manufacturing: Root of Ginseng as raw material shall be
in conformity with Ginseng Industry Act and 4 years or more. Dried
young ginseng (chunmisam), ginseng seedling (myosam), skin (sampi)
and ginseng marc shall not be used. Damaged ginseng can be used
after removing the damaged part.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) The sum of ginsenoside Rg1 and Rb1
(a) Semi-processed product: More than labeled amount
(b) Final product: 80% or more of labeled amount
(3) Total aerobic bacteria: No more than 3,000/1 mL (limited to concentrate)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support immune function, relieve from fatigue
(2) Daily intake amount: 3 ~ 80 mg/g as the sum of ginsenoside Rg1 and Rb1

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MFDS Notice 2020-63, Jul. 23, 2020, Enforcement date: Jul. 11, 2021
(1) Health claim: May help to support immune function, relieve from
fatigue, maintain bone health
(2)　Daily intake amount
　　(a) May help to support immune function, relieve from fatigue: 3 ~ 80
mg/g as the sum of ginsenoside Rg1 and Rb1
(b) May help to maintain bone health: 25 mg/g as the sum of ginsenoside
Rg1 and Rb1

(3) Warning notice for intake: The individual who are taking medicines
related with diabetes and/or blood coagulation should be cautious to
intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Ginsenoside Rg1 and Rb1: Chapter 4. 3-54 Ginsenoside
(3) Total aerobic bacteria: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 65 -
2-2 Red Ginseng

1) Standards for manufacturing

(1) Raw material: Ginseng (Panax ginseng C.A.Meyer)
※ Red ginseng, steamed by vapor or other methods and dried fresh ginseng.
(2) Preparation and/or processing
(a) It shall be in edible form by pulverizing the raw materials.
(b) It shall be in edible form either by extracting the raw materials with
water or ethanol (including mixture of water and ethanol) and filtering,
or concentrating or fermenting after filtration.
(3) Content of functional compounds (or marker compounds): The sum of
ginsenoside Rg1, Rb1 and Rg3 shall be contained 2.5 mg/g or more.
(4) Conditions for manufacturing: Root of Ginseng as raw material shall be
in conformity with Ginseng Industry Act and 4 years or more. Dried
young ginseng (chunmisam), ginseng seedling (myosam), skin (sampi)
and ginseng marc shall not be used. Damaged ginseng can be used
after removing the damaged part.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) The sum of ginsenoside Rg1, Rb1 and Rg3
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Total aerobic bacteria: No more than 3,000/1 mL (limited to concentrate)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claim: May help to support immune function, relieve from
fatigue, maintain healthy blood flow by inhibiting blood coagulation of
platelet, improve memory, support anti-oxidant activity, improve
menopausal women’s health

- 66 -
 (2) Daily intake amount
(a) May help to support immune function and relieve from fatigue: 3 ~
80 mg/g as the sum of ginsenoside Rg1, Rb1 and Rg3
(b) May help to maintain healthy blood flow by inhibiting blood
coagulation of platelet, improve memory, support anti-oxidant activity:
2.4 ~ 80 mg/g as the sum of ginsenoside Rg1, Rb1 and Rg3
(c) May help to improve menopausal women’s health: 25 ~ 80 mg/g as
the sum of ginsenoside Rg1, Rb1 and Rg3
(3) Warning notice for intake: The individual who are taking medicines
related with diabetes and/or blood coagulation should be cautious to in
take

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Ginsenoside Rg1, Rb1 and Rg3: Chapter 4. 3-54 Ginsenoside
(3) Total aerobic bacteria: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 67 -
2-3 Plants containing chlorophyll

1) Standards for manufacturing

(1) Raw material
(a) Barley sprout (sprout of barley, oat or wheat) or young leaf before
forming ear in whole or part
(b) Grown leaf, petiole and stem in whole or part of alfalfa
(c) Edible seaweeds containing chlorophyll in whole or part
(d) Single plant in whole or part as edible plants except barley sprout,
alfalfa and seaweeds
(2) Preparation and/or processing: The raw materials shall be in edible
form either itself, or by pressed and dried.
(3) Content of functional compounds (or marker compounds): Total
chlorophyll shall be contained 2.4 mg/g or more in barley plumule, 0.6
mg/g or more in alfalfa, and 1.2 mg/g or more in seaweeds and other
plant.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total chlorophyll
(a) Semi-processed product: More than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Total pheophorbide (mg/kg): No more than 1,000
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy skin, anti-oxidant activity
(2) Daily intake amount: 8 ~ 150 mg as total chlorophyll

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total chlorophyll: Chapter 4. 3-55 Total chlorophyll
(3) Total pheophorbide: Chapter 4. 3-56 Total pheophorbide
(4) Coliform: Referred to [Annexed the Table 4]

- 68 -
2-4 Chlorella

1) Standards for manufacturing

(1) Raw material: Chlorella genus algae
(2) Preparation and/or processing: Chlorella genus algae shall be in edible
form by artificially cultured and dried.
(3) Content of functional compounds (or marker compounds): Total
chlorophyll shall be contained 10 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total chlorophyll
(a) Semi-processed product: More than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 3.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 0.5
(4) Total pheophorbide (mg/kg): No more than 1,000
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy skin, anti-oxidant activity,
improve immune function, maintain healthy blood cholesterol level
(2) Daily intake amount
(a) May help to maintain healthy skin, anti-oxidant activity: 8 ~ 150 mg
as total chlorophyll
(b) May help to improve immune function, maintain healthy blood cholesterol
level: 125 ~ 150 mg as total chlorophyll

- 69 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total chlorophyll: Chapter 4. 3-55-1 Total chlorophyll (method 1)
(3) Lead, Cadmium, Mercury: Referred to [Annexed the Table 4]
(4) Total pheophorbide: Chapter 4. 3-56 Total pheophorbide
(5) Coliform: Referred to [Annexed the Table 4]

- 70 -
2-5 Spirulina

1) Standards for manufacturing

(1) Raw material: Spirulina genus algae
(2) Preparation and/or processing: Spirulina genus algae shall be in edible
form by artificially cultured and dried.
(3) Content of functional compounds (or marker compounds): Total chlorophyll
shall be contained 5 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total chlorophyll
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 3.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 0.5
(4) Total pheophorbide (mg/kg): No more than 1,000
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy skin, anti-oxidant activity,
maintain healthy blood cholesterol level
(2) Daily intake amount
(a) May help to skin health and anti-oxidative activity: 8 ~ 150 mg as
total chlorophyll
(b) May help to maintain healthy blood cholesterol level: 40 ~ 150
mg as total chlorophyll

- 71 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total chlorophyll: Chapter 4. 3-55-2 Total chlorophyll (method 2)
(3) Lead, Cadmium, Mercury: Referred to [Annexed the Table 4]
(4) Total pheophorbide: Chapter 4. 3-56 Total pheophorbide
(5) Coliform: Referred to [Annexed the Table 4]

- 72 -
2-6 Green tea extracts

1) Standards for manufacturing

(1) Raw material: Green tea (Camellia sinensis, Thea sinensis) leaf
(2) Preparation and/or processing: It shall be in edible form by filtering
after extracting the raw materials with water, fermented ethanol
(including mixture of water and fermented ethanol), or ethyl acetate.
(3) Content of functional compounds (or marker compounds): Catechin shall
be contained 200 mg/g or more. Catechin shall be the sum of
(-)-epigallocatechin (EGC), (-)-epigallocatechin gallate (EGCG), (-)-epicatechin
(EC) and (-)-epicatechin gallate (ECG) and all four kinds of catechin
shall be confirmed. However, in the case of the final product, all four
kinds of catechin may not be confirmed.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Catechin
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) (-)-epigallocatechin gallate, EGCG(mg): No more than 300 as daily
intake amount
(4) Caffeine (mg/kg): No more than 50,000
(5) Solvent residue (mg/kg): No more than 50.0 (in case of using ethyl acetate)
(6) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support anti-oxidant activity, reduce body
fat, maintain healthy blood cholesterol level
(2) Daily intake amount: 0.3 ~ 1 g as catechin
(3) Warning notice for intake
(a) Children, pregnant and lactating women should be avoid to intake
(b) Consult a health care practitioner prior to intake if you are taking
medicines or having liver disease

- 73 -
 (c) It may cause side-effect such as anxiousness, insomnia or etc. due to
caffeine
(d) Intake after meal
(e) Be careful for taking food containing caffeine
(f) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Catechin: Chapter 4. 3-46 Catechin
(3) Caffeine: Chapter 4. 2-5-2 Caffeine
(4) Solvent residue: Chapter 4. 2-5-5 Ethyl acetate
(5) Coliform: Referred to [Annexed the Table 4]

- 74 -
2-7 Aloe whole leaves

1) Standards for manufacturing

(1) Raw material: Aloe (Aloe vera, Aloe arborescence, Aloe saponaria) leaf
(2) Preparation and/or processing
(a) After removing non-edible parts from the raw materials, it shall be in
edible form by drying and pulverizing.
(b) After removing non-edible parts from the raw materials, it shall be in
edible form either by grinding, and/or concentrating.
(3) Content of functional compounds (or marker compounds): Anthraquinone
compounds (as anhydrous barbaloin) shall be contained more than 2.0 mg/g.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Anthraquinone compounds (as anhydrous barbaloin)
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy bowel function
(2) Daily intake amount: 20 ~ 30 mg as anhydrous barbaloin
(3) Warning notice for intake
(a) Children, pregnant and lactating women should be avoid to intake
(b) Consult a health care practitioner prior to intake if you are taking
medicines or having liver, stomach, kidney diseases
(c) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Anthraquinone compounds (as anhydrous barbaloin): Chapter 4. 3-47
Anthraquinone compounds (as anhydrous barbaloin)
(3) Coliform: Referred to [Annexed the Table 4]

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2-8 Propolis extracts

1) Standards for manufacturing

(1) Raw material: Propolis made from resin collected from plant mixed
with secretion of honeybee.
(2) Preparation and/or processing: After removing wax, it shall be in edible
form by extracting the raw materials with water, ethanol (including the
mixture of water and ethanol), or carbon dioxide (supercritical fluid extraction).
(3) Content of functional compounds (or marker compounds): Total flavonoids
shall be contained 10 mg/g or more, and ρ-coumaric and cinnamic
acids shall be confirmed.
(4) Conditions for manufacturing: Diethylene glycol shall not be used.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total Flavonoids
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) ρ-coumaric acid: It shall be confirmed
(4) Cinnamic acid: It shall be confirmed
(5) Lead (mg/kg): No more than 5.0
(6) Diethylene glycol: Not detected
(7) Tetracycline (mg/kg): Not detected
(8) Chlorotetracycline (mg/kg): Not detected
(9) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support anti-oxidant activity and antimicrobial
activity in oral cavity
※ Antimicrobial activity in oral cavity shall be limited to the types allowing
direct contact with oral cavity and intake amount shall not be applied.
(2) Daily intake amount: 16 ~ 17 mg as total flavonoids

- 76 -
 (3) Warning notice for intake: The individual who has an allergy to
propolis should be cautious to intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total flavonoids: Chapter 4. 3-49 Total flavonoid
(3) ρ-Coumaric acid and cinamic acid: Chapter 4. 3-49 ρ-Coumaric acid
and cinamic acid confirmation
(4) Lead: Referred to [Annexed the Table 4]
(5) Diethylene glycol: Chapter 4. 2-5-3 Diethylene glycol
(6) Tetracycline, Chlorotetracycline: Referred to [Annexed the Table 4]
(7) Coliform: Referred to [Annexed the Table 4]

- 77 -
2-9 Coenzyme Q10

1) Standards for manufacturing

(1) Raw material: Agrobacterium tumefaciens, Paracoccus denitrificans,
Pseudomonas aeruginosa
(2) Preparation and/or processing: It shall be in edible form by purifying
and concentrating after extracting above culture products with hexane,
acetone, isopropyl alcohol or ethyl acetate.
(3) Content of functional compounds (or marker compounds): Coenzmye
Q10 shall be contained 980 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Coenzyme Q10
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (In case of using)
(a) Hexane (mg/kg): No more than 5.0
(b) Acetone (mg/kg): No more than 30.0
(c) Isopropyl alcohol (mg/kg): No more than 50.0
(d) Ethyl acetate (mg/kg): No more than 50.0
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support anti-oxidant activity, maintain
healthy blood pressure
(2) Daily intake amount: 90 ~ 100 mg as coenzyme Q10

- 78 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Coenzyme Q10: Chapter 4. 3-52 coenzyme Q10
(3) Solvent residue: Chapter 4. 2-5-5 Ethyl acetate, referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 79 -
2-10 Soybean isoflavone

1) Standards for manufacturing

(1) Raw material: Soybean (Glycine max. L.N)
(2) Preparation and/or processing
(a) It shall be in edible form by filtering or concentrating after extracting
the raw materials with water or ethanol (including mixture of water
and ethanol).
(b) It shall be in edible form by extracting with water or ethanol
(including mixture of water and ethanol), and filtering or concentrating
after fermenting the raw materials.
(3) Content of functional compounds (or marker compounds): Aglycone
soybean isoflavone(the sum of soybean isoflavone glycoside (Daidzin,
Genistin, Glycitin) applied the conversion factor and aglycone
(Daidzein, Genistein, glycitein)) shall be contained 35 mg/g or more.
(4) Conversion factor: In case of soybean isoflavone glycoside (Daidzin,
Genistin, Glycitin), as aglycone soybean isoflavone, the conversion
factor is by multiplying 1/1.6 to the contents of soybean isoflavone
glycoside.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Soybean isoflavone (as aglycone)
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

- 80 -
3) Prerequisite for the health functional food
(1) Health claims: May help to maintain bone health
(2) Daily intake amount: 24 ~ 27 mg as aglycone soybean isoflavone
(3) Warning notice for intake
(a) Infants, children, pregnant and lactating women should be cautious to intake
(b) The individual who has an allergy to soybean should be cautious to intake
(c) The individual who are sensitive to the estrogen should be cautious to intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Soybean isoflavone: Chapter 4. 3-53 Soybean isoflavone
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 81 -
2-11 Guava leaf extracts

1) Standards for manufacturing

(1) Raw material: Guava (Psidium gujava) leaf
(2) Preparation and/or processing: It shall be in edible form by filtering
and concentrating after extracting the raw materials with hot water.
(3) Content of functional compounds (or marker compounds): Total
polyphenol shall be contained 250 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total polyphenol
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 0.5
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy postprandial glucose level
(2) Daily intake amount: 120 mg as total polyphenol

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total polyphenol: Chapter 4. 3-59 Total polyphenol
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 82 -
2-12 Banaba leaf extracts

1) Standards for manufacturing

(1) Raw material: Banaba (Lagerstroemia speciosa) leaf
(2) Preparation and/or processing: It shall be in edible form by filtering
and concentrating after extracting the raw materials with ethanol
(including mixture of water and ethanol).
(3) Content of functional compounds (or marker compounds): Corosolic
acid shall be contained 9 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Corosolic acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy postprandial glucose level
(2) Daily intake amount: 0.45 ~ 1.3 mg as corosolic acid

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Corosolic acid: Chapter 4. 3-60 Corosolic acid
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 83 -
2-13 Ginkgo leaf extracts

1) Standards for manufacturing

(1) Raw material: Ginkgo (Ginko biloba) leaf
(2) Preparation and/or processing: It shall be in edible form by filtering
and concentrating after grinding the raw materials and extracting with
ethanol (including mixture of water and ethanol).
(3) Content of functional compounds (or marker compounds): Flavonol
glycoside shall be contained 240 mg/g or more and the ratio of
quercetin and kaempferol shall be 0.8 ~ 1.2.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Flavonol glycoside
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Ginkgolic acid (mg/kg): No more than 5.0
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to improve memory, improve blood flow and
circulation
(2) Daily intake amount: 28 ~ 36 mg as flavonol glycoside
(3) Warning notice for intake
(a) Pregnant and lactating women, children, perioperative patient should be
careful for intake
(b) People who are taking medicine (related with blood coagulation)
should be careful for intake

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4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Flavonol glycoside: Chapter 4. 3-61 Flavonol glycoside
(3) Ginkgolic acid: Chapter 4. 3-62 Ginkgolic acid
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 85 -
2-14 Milk thistle (Carduus Marianus) extracts

1) Standards for manufacturing

(1) Raw material: Silybum marianum
(2) Preparation and/or processing: It shall be in edible form by extracting
the raw materials with ethano l(including mixture of water and ethanol)
or filtering, concentrating and purifying after pressing or defatting by
hexane the raw material and extracting with ethanol (including mixture
of water and ethanol). Hexane and ethyl acetate can be used in the
purification process.
(3) Content of functional compounds (or marker compounds): Silymarin
shall be contained 320 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Silymarin
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (limited to using solvent)
(a) Hexane (mg/kg): No more than 5.0
(b) Ethyl acetate (mg/kg): No more than 50.0
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help with liver health
(2) Daily intake amount: 130 mg as silymarin

- 86 -
 (3) Warning notice for intake
(a) The individual who has an allergy should stop to intake
(b) The individual who has digestive system discomfort such as diarrhea,
stomachache, abdominal inflation should be careful for intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Silymarin: Chapter 4. 3-63 Silymarin
(3) Solvent residue: Referred to [Annexed the Table 4], Chapter 4. 2-5-5
Ethyl acetate
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 87 -
2-15 Evening primrose seed extracts

1) Standards for manufacturing

(1) Raw material: Seed of evening primrose (Oenothera biennis)
(2) Preparation and/or processing: It shall be in edible form by filtering,
concentrating after pressing or defatting by hexane the raw material and
extracting with ethanol(including mixture of water and ethanol).
(3) Content of functional compounds (or marker compounds): PGG
(Penta-O-galloyl beta-D-glucose) shall be contained 20 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) PGG
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Hexane (mg/kg): No more than 5.0 (limited to using solvent)
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy postprandial glucose level
(2) Daily intake amount: 4 ~ 8.4 mg as PGG

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) PGG: Chapter 4. 3-64 PGG
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 88 -
2-16 Edible oil containing EPA and DHA

1) Standards for manufacturing

(1) Raw material: Edible fishes, seaweeds, Pagophilus groenlandicus
(2) Preparation and/or processing: The oil shall be in edible form by heating
the raw material, pressing and extracting with hexane or carbon dioxide
(supercritical fluid extraction) and then filtering or esterification after
extraction.
(3) Content of functional compounds (or marker compounds): As the sum
of EPA and DHA, it shall be contained 180 mg/g or more from edible
fishes, 120 mg/g or more from Pagophilus groenlandicus and 300 mg/g
or more from seaweeds.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) The sum of EPA and DHA
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (mg/kg): No more than 5.0 (in case of using hexane)
(4) Acid value: no more than 3.0 (semi-processed product and product with
antioxidant added to them)
(5) Peroxide value: no more than 5.0 (semi-processed product and product
with antioxidant added to them)
(6) Anisidine value: no more than 20.0 (semi-processed product and
product with antioxidant added to them)
(7) Total Oxidation value (TOTOX) (2 × peroxide value + anisidine
value): no more than 26.0 (semi-processed product and product with
antioxidant added to them)
(8) Heavy metal
(a) Lead (mg/kg): No more than 3.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 0.5

- 89 -
 (9) Coliform: Negative
3) Prerequisite for the health functional food
(1) Health claims: May help to maintain healthy triglyceride level, maintain
healthy blood flow, improve memory, maintain eye health as the
improvement of dry eyes
(2) Daily intake amount
(a) May help to maintain healthy triglyceride level, maintain healthy blood
flow: 0.5 ~ 2 g as the sum of EPA and DHA
(b) May help to improve memory: 0.9 ~ 2 g as the sum of EPA and DHA
(c) May help to maintain eye health as the improvement of dry eyes: 0.6 ~
1 g as the sum of EPA and DHA
(3) Warning notice for intake
(a) Consult a health care practitioner prior to intake if you are taking
medicines related with blood coagulation and/or anti-platelet and/or
antihypertensive agents
(b) It may cause side-effect such as skin reaction
(c) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) EPA and DHA: Chapter 4. 3-32 fatty acids
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Acid value: Referred to [Annexed the Table 4]
(5) Peroxide value: Referred to [Annexed the Table 4]
(6) Anisidine value: Chapter 4. 2-6-1 Anisidine value
(7) Lead, Cadmium, Mercury: Referred to [Annexed the Table 4]
(8) Coliform: Referred to [Annexed the Table 4]

- 90 -
2-17 Edible oil containing gamma-linolenic acid

1) Standards for manufacturing

(1) Raw material: Evening primrose (Oenothera biennis, Oenothera caespitesa,
Oenothera hookeri, Oenothera odorata) seed, Borage (Borago officinalis L.),
Black currant (Ribes grossulalis, Ribes ussuriense, Ribes nigrum) seed
(2) Preparation and/or processing: The oil shall be in edible form by
pressing the raw materials and extracting with hexane or carbon dioxide
(supercritical fluid extraction) and then filtering.
(3) Content of functional compounds (or marker compounds): Gamma
linolenic acid shall be contained 70 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Gamma linolenic acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (mg/kg): No more than 5.0 (in case of using hexane)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy blood flow, improve premenstrual syndrome condition,
improve skin condition of immune hypersensitivity reaction
(2) Daily intake amount
(a) May help to maintain healthy blood cholesterol level, maintain healthy
blood flow: 240 ~ 300 mg as gamma linolenic acid
(b) May help to improve premenstrual syndrome condition: 210 ~ 300 mg
as gamma linolenic acid
(c) May help to improve skin condition of immune hypersensitivity reaction:
160 ~ 300 mg as gamma linolenic acid

- 91 -
 (3) Warning notice for intake: Infants, children should consult a doctor prior
to intake (In case of ‘May help to improve skin condition of immune
hypersensitivity reaction’ product)

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Gamma linolenic acid: Chapter 4. 3-32 Fatty acid (Gamma linolenic
acid shall be used standard compound)
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 92 -
2-18 Lecithin

1) Standards for manufacturing

(1) Raw material: Soybean, egg yolk
(2) Preparation and/or processing
(a) Soybean lecithin: It shall be in edible form by filtering soybean oil,
hydrogenating, separating and extracting oil from lecithin saponificable
material.
(b) Egg yolk lecithin: It shall be in edible form by extracting egg yolk with
water or fermented ethanol (including mixture of water and fermented
ethanol), filtering and then removing solvent.
(3) Content of functional compounds (or marker compounds): Phospholipid
(as an acetone insoluble substance) shall be contained 360 mg/g or
more. Phosphatidylcholine in phospholipid shall be contained 100 mg/g
or more in soybean lecithin, and 600 mg/g or more in egg yolk
lecithin.
(4) Conditions for manufacturing: Cholesterol shall be contained 10,000
mg/kg or less in egg yolk lecithin.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Phospholipid (as an acetone insoluble substance)
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Phosphatidylcholine in Phospholipid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(4) Cholesterol (mg/kg): No more than 10,000 (in case of using egg yolk lecithin)
(5) Solvent residue (mg/kg): No more than 5.0 (in case of using hexane)
(6) Lead (mg/kg): No more than 2.0
(7) Coliform: Negative

- 93 -
3) Prerequisite for the health functional food
(1) Health claims: May help to maintain healthy blood cholesterol level
(2) Daily intake amount: 1.2 ~ 18 g as lecithin
(3) Warning notice for intake : The individual who has an allergy to soybean
or egg yolk should be cautious to intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Phospholipid: Chapter 4. 3-33 Phospholipid (as a acetone insoluble substance)
(3) Phosphatidylcholine in phospholipid: Chapter 4. 3-34 Phosphatidicolin
contents in phospholipid
(4) Cholesterol: Chapter 4. 3-35 Cholesterol
(5) Solvent residue: Referred to [Annexed the Table 4]
(6) Lead: Referred to [Annexed the Table 4]
(7) Coliform: Referred to [Annexed the Table 4]

- 94 -
2-19 Squalene

1) Standards for manufacturing

(1) Raw material: Shark liver
(2) Preparation and/or processing: It shall be in edible form by washing
non-saponificable material with water or fermented ethanol (including
mixture of water and fermented ethanol), after repeating distillation and
saponification of the oil extracted from the raw materials.
(3) Content of functional compounds (or marker compounds): Squalene shall
be contained 980 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Squalene
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support anti-oxidant activity
(2) Daily intake amount: 10 g as squalene
(3) The amount of vitamin A and D in final product shall not be exceed
the maximum level of Chapter 3. 1-1 vitamin A and Chapter 3. 1-3
vitamin D (The amount of vitamin A and D must be labeled).

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Squalene: Chapter 4. 3-37 Squalene
(3) Coliform: Referred to [Annexed the Table 4]

- 95 -
2-20 Phytosterol / Phytosterolester

1) Standards for manufacturing

(1) Raw material and preparation and/or processing
(a) The mixture of β-sitosterol, brassicasterol, stigmasterol and campesterol,
as distillate which are obtained during deodorization of soybean, corn or
canola oil, shall be in edible form by extracting and purifying.
(b) The substance of above (a) shall be in edible form by esterifying fatty
acids originated from edible oil.
(2) Content of functional compounds (or marker compounds): Phytosterol
shall be contained 900 mg/g or more. However, in case of using
phytosterol ester as ingredients, the sum of total phytosterol and free
phytosterol shall be contained 800 mg/g or more and contents of free
phytosterol 100 mg/g or less.
(3) Conditions for manufacturing: When analyzing phytosterol, all of β
-sitosterol, brassicasterol, stigmasterol and campesterol shall be detected.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Phytosterol (in case of using phytosterol as ingredients)
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Content of phytosterolester (in case of using phytosterolester as ingredients)
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level
(2) Daily intake amount
(a) 0.8 ~ 3 g as phytosterol (in case of using phytosterol as ingredients)
(b) 1.28 ~ 4.8 g as phytosterolester (in case of using phytosterolester as ingredients)
(3) Warning notice for intake: It may inhibit the absorption of β-carotene

- 96 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Phytosterol: Chapter 4. 3-38 Phytosterol
(3) Phytosterolester
(a) Content of total phytosterol: Chapter 4. 3-38 Phytosterol
(b) Free phytosterol: Chapter 4. 3-39 Free phytosterol
(c) Content of phytosterolester = (total phytosterol - free phytosterol) × 1.6
(4) Coliform: Referred to [Annexed the Table 4]

- 97 -
2-21 Shark liver oil containing alkoxyglycerol

1) Standards for manufacturing

(1) Raw material: Shark liver
(2) Preparation and/or processing: It shall be in edible form by washing
non-saponificable material with water, deodorizing, heating and filtering
after removal of squalene and saponificable material in the oil extracted
from the raw materials.
(3) Content of functional compounds (or marker compounds): Alkoxyglycerol
shall be contained 180 mg/g or more, and batyl alcohol shall be
confirmed.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Alkoxyglycerol
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Batyl alcohol: It shall be confirmed
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support immune function
(2) Daily intake amount: 0.6 ~ 2.7 g as alkoxyglycerol
(3) The amount of vitamin A and D in final product shall not be exceed
the maximum level of Chapter 3. 1. 1-1 vitamin A and Chapter 3. 1.
1-3 vitamin D (The amount of vitamin A and D must be labeled).

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Alkoxyglycerol: Chapter 4. 3-40 Alkoxyglycerol
(3) Batyl alcohol: Chapter 4. 3-41 Batyl alcohol confirmation
(4) Coliform: Referred to [Annexed the Table 4]

- 98 -
2-22 Edible oil containing octacosanol

1) Standards for manufacturing

(1) Raw material
(a) Rice bran
(b) Sugarcane
(2) Preparation and/or processing: It shall be in edible form by recrystallizing
with fermented ethanol or hexane after saponifying the oil containing
octacosanol extracted from the raw materials.
(3) Content of functional compounds (or marker compounds): Octacosanol
shall be contained 100 mg/g or more in case of manufacturing from
rice bran wax, and 540 mg/g or more in case of manufacturing from
sugarcane wax.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Octacosanol
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (mg/kg): No more than 5.0 (in case of using hexane)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to improve endurance capacity
(2) Daily intake amount: 7 ~ 40 mg as octacosanol

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Octacosanol: Chapter 4. 3-42 Octacosanol
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 99 -
2-23 Japanese apricot extracts

1) Standards for manufacturing

(1) Raw material: Japanese apricot (Prunus mune Sieb. et Zucc)
(2) Preparation and/or processing: It shall be in edible form by filtering
and concentrating after extracting the raw materials with hot water.
(3) Content of functional compounds (or marker compounds): Citric acid
shall be contained 300 mg/g or more.
(4) Conditions for manufacturing: Cyanide shall be removed.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Citric acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Cyanide: Not detected
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to relieve fatigue
(2) Daily intake amount: 1 ~ 1.3 g as citric acid

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Citric acid: Chapter 4. 3-36 Citric acid
(3) Cyanide: Chapter 4. 2-5-1 Cyanide
(4) Coliform: Referred to [Annexed the Table 4]

- 100 -
2-24 Conjugated linoleic acids

1) Standards for manufacturing

(1) Raw material: Safflower seed oil
(2) Preparation and/or processing
(a) After saponifying and conjugated isomerizing the raw materials, the
fatty acid shall be in edible form by extracting with fermented ethanol
or hexane, or purifying, deodorizing and filtering.
(b) Triglyceride form: After glycerifying conjugated linoleic acid in fatty
acid form with lipase, it shall be in edible form by extracting with
fermented ethanol or hexane, or purifying, deodorizing and filtering.
(3) Content of functional compounds (or marker compounds): Conjugated
linoleic acid (the sum of cis-9 and trans-11 conjugated linoleic acid,
trans-10 and cis-12 conjugated linoleic acid, and cis-9 and cis-11
conjugated linoleic acid) shall be contained 660 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Content of conjugated linoleic acid (The sum of cis-9/trans-11,
trans-10/cis-12, cis-9/cis-11, and trans-9/trans-11 conjugated linoleic acids).
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Contents of cis-9/trans-11 and trans-10/cis-12 conjugated linoleic acids (%):
No less than 90% of conjugated linoleic acid content
(4) Contents of trans-9/trans-11 conjugated linoleic acid (%): No more than
3.0 (limited to semi-processed product)
(5) Acid value: No more than 10.0 (limited to semi-processed product of
glyceride form)
(6) Lead (mg/kg): No more than 3.0
(7) Cadmium (mg/kg): No more than 1.5
(8) Arsenic (mg/kg): No more than 5.0
(9) Mercury (mg/kg): No more than 0.5

- 101 -
 (10) Solvent residue (mg/kg): No more than 5.0 (in case of using hexane)
(11) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to reduce body fat in the overweight adult
(2) Daily intake amount: 1.4 ~ 4.2 g as conjugated linoleic acid
(3) Warning notice for intake
(a) It may cause gastrointestinal disorder
(b) Infant and pregnant women should be avoid intake
(c) Diet control and exercises together are effective in reducing body fat

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Content of conjugated linoleic acid: Chapter 4. 3-32 Fatty acid
(3) Content of cis-9/trans-11 and trans-10/cis-12 conjugated linoleic acids (%):
Chapter 4. 3-32 Fatty acid
(4) Content of trans-9/trans-11 conjugated linoleic acid (%): Chapter 4.
3-32 Fatty acid
(5) Acid value: Referred to [Annexed the Table 4]
(6) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(7) Solvent residue: Referred to [Annexed the Table 4]
(8) Coliform: Referred to [Annexed the Table 4]

- 102 -
2-25 Garcinia cambogia extracts

1) Standards for manufacturing

(1) Raw material: Garcinia cambogia fruit peel
(2) Preparation and/or processing: It shall be in edible form by extracting
the raw materials with water or fermented ethanol (including mixture of
water and fermented ethanol), binding with calcium, potassium or
sodium, magnesium salt single or mixed, and neutralizing sufficiently.
(3) Content of functional compounds (or marker compounds): Total
(-)-hydroxycitric acid shall be contained 600 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total (-)-hydroxycitric acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.4
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to reduce body fat by inhibit carbohydrates
from being synthesized into fat
(2) Daily intake amount: 750 ~ 2,800 mg as total (-)-hydroxycitric acid
(3) Warning notice for intake
(a) Children, pregnant and lactating women should be avoid to intake
(b) Consult a health care practitioner prior to intake if you are taking
medicines or having liver, heart, kidney diseases, allergy and asthma
(c) Consult a health care practitioner and stop intake if you are having
adverse event

- 103 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total (-)-hydroxycitric acid: Chapter 4. 3-43 Total (-)-hydroxycitric acid
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 104 -
2-26 Marigold flower extracts

1) Standards for manufacturing

(1) Raw material: Marigold (Tagetes erecta) flower
(2) Preparation and/or processing: The oil shall be in edible form by
crystallizing and pulverizing after extracting the raw materials with
hexane or carbon dioxide (supercritical fluid extraction) and saponifying.
When crystallizing, ethyl acetate can be used.
(3) Content of functional compounds (or marker compounds): Lutein shall
be contained 700 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Lutein
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (limited to using solvent)
(a) Hexane (mg/kg): No more than 5.0
(b) Ethyl acetate (mg/kg): No more than 50.0
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May helps the eye health by maintaining the density of
macular pigments which can be decreased by aging
(2) Daily intake amount: 10 ~ 20 mg as lutein
(3) Warning notice for intake: When taken in excessive amounts, it may
turn the skin yellow temporarily

- 105 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Lutein: Chapter 4. 3-44 Lutein
(3) Solvent residue: Chapter 4. 2-5-5 Ethyl acetate, Referred to [Annexed
the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 106 -
2-27 Haematococcus pluvialis extracts

1) Standards for manufacturing

(1) Raw material: Haematococcus pluvialis
(2) Preparation and/or processing: It shall be in edible form by extracting
with carbon dioxide (supercritical fluid extraction) or acetone and
purifying, after pulverizing dried culture of the raw materials.
(3) Content of functional compounds (or marker compounds): Astaxanthin
shall be contained 60 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Astaxanthin
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Acetone (mg/kg): No more than 30.0 (in case of using acetone)
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to improve eye fatigue
(2) Daily intake amount: 4 ~ 12 mg as astaxanthin
(3) Warning notice for intake
(a) When taken in excessive amounts, it may turn the skin yellow temporarily
(b) It may inhibit the absorption of β-carotene

- 107 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Astaxanthin: Chapter 4. 3-45 Astaxanthin
(3) Acetone: Referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 108 -
2-28 Saw palmetto fruit extracts

1) Standards for manufacturing

(1) Raw material: Saw palmetto (Serenoa repens) fruit
(2) Preparation and/or processing: The oil shall be in edible form by
filtering, concentrating, and purifying after extracting the raw materials.
with fermented ethanol or carbon dioxide (supercritical fluid extraction).
(3) Content of functional compounds (or marker compounds): Lauric acid
shall be contained 220 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Lauric acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain prostate health
(2) Daily intake amount: 70 ~ 115 mg as lauric acid
(3) Warning notice for intake
(a) The product is for adult man only
(b) Consult a health care practitioner prior to intake if you are perioperative
patient or having hemorrhagic disease or taking medicines related to
blood coagulation
(c) The individual who has an allergy may cause side-effect such as
hypersensitivity reaction

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 (d) It may cause digestive system discomfort such as nausea, etc. and
diarrhea so intake after meal
(e) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Lauric acid: Chapter 4. 3-32 Fatty acid
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

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2-29 Phosphatidylserine

1) Standards for manufacturing

(1) Raw material: Soybean lecithin
(2) Preparation and/or processing: It shall be in edible form by purifying
after extracting with water, ethanol, hexane or acetone with raw
material reacted by phospholiphase with L-serine.
(3) Content of functional compounds (or marker compounds): Phosphatidylserine
shall be contained 380 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Phosphatidylserine
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Solvent residue (In case of using)
(a) Hexane (mg/kg): No more than 5.0
(b) Acetone (mg/kg): No more than 10.0
(4) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help improve cognition which can be decreased by
aging, maintain skin health from skin damage by UV radiation,
maintain skin moisturizing
(2) Daily intake amount: 300 mg as phosphatidylserine
(3) Warning notice for intake
(a) Pregnant and lactating women should be careful for intake

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 (b) It may cause side-effect such as insomnia, gastrointestinal disorder in
a state of excessive intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Phosphatidylserine : Chapter 4. 3-70 Phosphatidylserine
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

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2-30 Glucosamine

1) Standards for manufacturing

(1) Raw material: A shell of crustacea (crab, shrimp, etc.), Mollusk (squid,
cuttlefish, etc.) bone, Aspergillus niger
(2) Preparation and/or processing
(a) Glucosamine hydrochloride: Chitin ( β -1,4 bound polym er of
N-acetylglucosamine) or chitosan (deacetylated ingredients of above
obtained chitin) obtained by deproteinizing and decalciumating the raw
materials, shall be in edible form by crystallizing after hydrolyzing
with hydrochloric acid or chitosanase and neutralizing by washing with
water or fermented ethanol sufficiently.
(b) Glucosamine sulphate: Chitin (β-1,4 bound polymer of N-acetylglucosamine)
or chitosan (deacetylated ingredients of above obtained chitin) obtained
by deproteinizing and decalciumating the raw materials, shall be in
edible form by hydrolyzing with hydrochloric acid, substituting with
sulfuric acid, binding with NaCl or KCl single or mixed, crystallizing
and neutralizing by washing with water or fermented ethanol
sufficiently.
(3) Content of functional compounds (or marker compounds): Glucosamine
sulphate or hydrochloride shall be contained 980 mg/g or more.
(4) Conditions for manufacturing: When neutralizing, it shall be sufficiently
washed with water or ethanol.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Glucosamine hydrochloride or sulphate
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 5.0
(b) Cadmium (mg/kg): No more than 1.5

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 (c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 4.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy joint and cartilage
(2) Daily intake amount: 1.5 g as glucosamine hydrochloride or sulphate
(3) Warning notice for intake
(a) Pregnant and lactating women should be avoid to intake
(b) Consult a health care practitioner prior to intake if you are perioperative
patient or taking medicines related to blood coagulation or having
liver, heart disease, diabetes, high blood pressure, asthma
(c) The individual who has an allergy to crab and/or shrimp should be
cautious to intake (limited to using crab and/or shrimp as raw material)
(d) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Glucosamine: Chapter 4. 3-23 Glucosamine
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

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2-31 NAG (N-acetylglucosamine)

1) Standards for manufacturing

(1) Raw material: A shell of crustacean (crab, shrimp, etc.), Mollusk
(squid, cuttlefish, etc.) bone
(2) Preparation and/or processing: The acetyl monosaccharide shall be in
edible form obtained by swelling, hydrolyzing with chitosanase,
desalinizing, concentrating, filtering, and drying from Chitin (β-1,4
bound polymer of N-acetylglucosamine) obtained by deproteinizing and
decalciumating the raw materials.
(3) Content of functional compounds (or marker compounds): N-acetylglucosamine
shall be contained 950 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) N-acetylglucosamine
(a) Semi-processed product: No less than labeled amount
(b) Final product: 90 ~ 110% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy joint and cartilage,
maintain healthy skin moisturizing
(2) Daily intake amount
(a) May help to joint and cartilage health: 0.5 ~ 1 g as N-acetyl glucosamine
(b) May help to skin moisturizing: 1 g as N-acetyl glucosamine
(3) Warning notice for intake: The individual who has an allergy to crab
and/or shrimp should be cautious to intake (limited to using crab and/or
shrimp as raw material)

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) N-Acetyl glucosamine: Chapter 4. 3-24 N-Acetyl glucosamine
(3) Coliform: Referred to [Annexed the Table 4]

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2-32 Mucopolysaccharide·mucoprotein

1) Standards for manufacturing

(1) Raw material: Cartilage tissues of cattle, swine, sheep, horses, rabbits,
donkeys, deer, shark, poultry, squid, crab, fish, shellfish
(2) Preparation and/or processing: After extracting raw material with hot
water or hydrolyzing with enzyme, it shall be in edible form by
filtering, concentrating and drying.
(3) Content of functional compounds (or marker compounds): Mucopolysaccharide·
mucoprotein shall be contained 770 mg/g or more, and the ratio of protein and
chondroitin sulfate shall be 1.0 ~ 9.0 (1:1 ~ 9:1).

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Mucopolysaccharide·protein
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Ratio of protein and chondroitin sulfate: 1.0 to below 9.0
(4) Salmonella: Negative
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health clams: May help to maintain healthy joint and cartilage
(2) Daily intake amount: 1.2 ~ 1.5 g as mucopolysaccharide·mucoprotein

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Mucopolysaccharide·mucoprotein
(a) Chondroitin sulfate: Chapter 4. 3-28 Chondroitin sulfate
(b) Protein: About 10 g of sample are grinded and mixed rapidly before
absorbing moisture and 30 mg is weighed accurately, and then Chapter 4.
3-21 Crude protein.

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 ※ Based on gelatin protein (18% of nitrogen content) in ingredients, nitrogen
conversion coefficient of 5.56 shall be applied.
(c) Mucopolysaccharide·mucoprotein content: It shall be calculated by the
sum of chondroitin sulfate and protein obtained from (a) and (b).
(3) Ratio of protein and chondroitin sulfate: The ratio of protein and
chondroitin sulfate obtained from (1) of Testing Methods.
(4) Salmonella: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 117 -
2-33 Guar gum / Guar gum hydrolysate

1) Standards for manufacturing

(1) Raw material: Legume family guar (Cyamopsis tetragonolobus TAUB)
(2) Preparation and/or processing
(a) High molecular weight galactomannan polysaccharide shall be in edible
form obtained by pulverizing the seed albumen parts from the raw
materials or extracting with warm or hot water.
(b) Galactomannan obtained by method of (a) shall be in edible form by
hydrolysis.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 660 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Lead (mg/kg): No more than 2.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy postprandial glucose level, maintain healthy bowel
function, maintain healthy gastrointestinal bacteria population
(2) Daily intake amount
(a) May help to maintain healthy blood cholesterol level, maintain healthy
postprandial glucose level, maintain healthy bowel function: 9.9 ~ 27 g
as dietary fiber of guar gum or its hydrolysate
(b) May help to maintain healthy gastrointestinal bacteria population: 4.6 ~
27 g as dietary fiber of guar gum or its hydrolysate

- 118 -
 (3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Lead: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 119 -
2-34 Glucomannan (Konjac, Konjacmannan)

1) Standards for manufacturing

(1) Raw material: Arum family konjac (Amorphophallus konjq) rhizome
(2) Preparation and/or processing: Polysaccharides shall be in edible form
by extracting the raw materials with isopropyl alcohol and purifying.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 690 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Solvent residue (mg/kg): No more than 50.0
(4) Lead (mg/kg): No more than 2.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy bowel function
(2) Daily intake amount: 2.7 ~ 17 g as glucomannan dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Lead: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 120 -
2-35 Oat dietary fiber

1) Standards for manufacturing

(1) Raw material: Oat (Avena sativa, Avena sterilisand, Avena strigosa) bran
(2) Preparation and/or processing: It shall be in edible form by washing,
drying, pulverizing and extracting.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 200 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy postprandial glucose level
(2) Daily intake amount
(a) May help to maintain healthy blood cholesterol level: 3 g or more as
oat dietary fiber
(b) May help to maintain healthy postprandial glucose level: 0.8 g or
more as oat dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

- 121 -
2-36 Indigestible maltodextrin

1) Standards for manufacturing

(1) Raw material: Corn starch
(2) Preparation and/or processing: The roasted-dextrin shall be obtained by
heating the raw materials. The indigestible components shall be in
edible form by hydrolyzing the roasted-dextrin with α-amylase (Bacillus
subtilis or Bacillus licheniformis origin) and amyloglucosidase
(Aspergillus niger origin) and purifying and then separating from dextrin.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 850 mg/g or more (In case of liquid, 580 mg/g or more).

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Dextrose equivalent (D.E.): 8.0 ~ 18.0 (limited to Semi-processed product)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy postprandial glucose level,
maintain healthy triglyceride level, maintain healthy bowel function
(2) Daily intake amount
(a) May help to maintain healthy postprandial glucose level: 11.9 ~ 30 g
as indigestible maltodextrin dietary fiber (in case of liquid ingredients,
11.6 ~ 44 g)
(b) May help to maintain healthy triglyceride level: 12.7 ~ 30 g as
indigestible maltodextrin dietary fiber (in case of liquid ingredients,
12.7 ~ 44 g)
(c) May help to maintain healthy bowel function: 2.5 ~ 30 g as indigestible
maltodextrin dietary fiber (in case of liquid ingredients, 2.3 ~ 44 g)

- 122 -
 (3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber (method 2)
(3) Dextrose equivalent (D.E.): Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 123 -
2-37 Soybean dietary fiber

1) Standards for manufacturing

(1) Raw material: Soybean (Glycine max L.N)
(2) Preparation and/or processing: The dietary fiber shall be in edible form
by defatting and deproteinizing the raw materials, and then separating.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 600 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy postprandial glucose level, maintain healthy bowel function
(2) Daily intake amount
(a) May help to maintain healthy blood cholesterol level, maintain healthy
bowel function: 20 ~ 60 g as soybean dietary fiber
(b) May help to maintain healthy postprandial glucose level: 10 ~ 60 g as
soybean dietary fiber
(3) Warning notice for intake
(a) Should be taken with sufficient water except for liquid type product
(b) The individual who has an allergy to soybean should be cautious to intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

- 124 -
2-38 Tree ear dietary fiber

1) Standards for manufacturing

(1) Raw material: Tree ear (Auricularia auricula judae)
(2) Preparation and/or processing: It shall be in edible form by drying and
pulverizing the raw materials.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 450 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy bowel function
(2) Daily intake amount: 12 g as tree ear dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

- 125 -
2-39 Wheat dietary fiber

1) Standards for manufacturing

(1) Raw material: Wheat (Triticum turgidum durum, or T. spp )
(2) Preparation and/or processing
(a) The dietary fiber shall be in edible form by separating from by-product
during flour manufacturing process.
(b) The outer skins or stems of the raw materials shall be in edible form
by washing, drying and pulverizing.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 700 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy postprandial glucose level,
maintain healthy bowel function
(2) Daily intake amount
(a) May help to maintain healthy postprandial glucose level: 6 ~ 36 g as
wheat dietary fiber
(b) May help to maintain healthy bowel function: 36 g as wheat dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

- 126 -
2-40 Barley dietary fiber

1) Standards for manufacturing

(1) Raw material: Barley (Hordeum vulgare)
(2) Preparation and/or processing
(a) The dietary fiber shall be in edible form by defatting and
deproteinizing the raw materials.
(b) The outer skins or grains of the raw materials shall be in edible form
by drying.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 500 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy bowel function
(2) Daily intake amount: 20 ~ 25 g as barley dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

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2-41 Arabic gum (acacia gum)

1) Standards for manufacturing

(1) Raw material: Legume family acacia senegal (Acacia senegal
WILLDENOW) or other same genus plants
(2) Preparation and/or processing
(a) It shall be in edible form by drying and desalinizing the secretion of
raw materials.
(b) It shall be in edible form by mechanically pressing the secretion of
raw materials.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 800 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Lead (mg/kg): No more than 2.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy bowel function
(2) Daily intake amount: 20 g as arabic gum dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Lead: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

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2-42 Corn bran dietary fiber

1) Standards for manufacturing

(1) Raw material: Corn (Zea mays) bran
(2) Preparation and/or processing: It shall be in edible form by pulverizing
the raw materials.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 800 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy postprandial glucose level
(2) Daily intake amount: 10 g as corn bran dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

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2-43 Inulin / Chicory extracts

1) Standards for manufacturing

(1) Raw material: Chicory (Chicorium intybus) or other Compositae family
plants
(2) Preparation and/or processing: It shall be in edible form by extracting
the root of raw materials with hot water and then purifying.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 800 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy postprandial glucose level, maintain healthy bowel function
(2) Daily intake amount
(a) May help to maintain healthy blood cholesterol level, maintain healthy
postprandial glucose level: 7.2 ~ 20 g as inulin / chicory dietary fiber
(b) May help to maintain healthy bowel function: 6.4 ~ 20 g as inulin /
chicory dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

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2-44 Psyllium husk dietary fiber

1) Standards for manufacturing

(1) Raw material: Psyllium husk (Plantago ovata or Plantago spp.)
(2) Preparation and/or processing: It shall be in edible form by pulverizing
the raw materials.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 790 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
maintain healthy bowel function
(2) Daily intake amount
(a) May help to maintain healthy blood cholesterol level: 5.5 g or more
as psyllium husk dietary fiber
(b) May help to maintain healthy bowel function: 3.9 g or more as
psyllium husk dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

- 131 -
2-45 Polydextrose

1) Standards for manufacturing

(1) Raw material and preparation and/or processing: It shall be synthesized
from glucose and sorbitol, using organic acid such as citric acid. The
degree of polymerization shall be about 12 in average.
(2) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 650 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Lead (mg/kg): No more than 0.5
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy bowel function
(2) Daily intake amount: 4.5 ~ 12 g as polydextrose dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Lead: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

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2-46 Fenugreek seed dietary fiber

1) Standards for manufacturing

(1) Raw material: Fenugreek (Trigonella foenum-graecum) seed
(2) Preparation and/or processing: It shall be in edible form by pulverizing
or defatting the raw materials.
(3) Content of functional compounds (or marker compounds): Dietary fiber
shall be contained 450 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy postprandial glucose level
(2) Daily intake amount: 12 ~ 50 g as fenugreek seed dietary fiber
(3) Warning notice for intake: Should be taken with sufficient water except
for liquid type product

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Dietary fiber: Chapter 4. 3-26 Dietary fiber
(3) Coliform: Referred to [Annexed the Table 4]

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2-47 Aloe gel

1) Standards for manufacturing

(1) Raw material: Aloe vera (Aloe vera) leaf
(2) Preparation and/or processing
(a) After removing non-edible parts and outer skins, it shall be in edible
form by separating, drying and pulverizing the gel compound.
(b) After removing non-edible parts and outer skins, it shall be in edible
form by separating and i) pulverizing or pressing the gel compound,
ii) concentrating thereof, iii) drying and pulverizing the concentrate.
(3) Content of functional compounds (or marker compounds): Total
polysaccharide shall be contained 30 mg/g or more in solids.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total polysaccharide (The polysaccharides originated from other
ingredients shall be labeled separately)
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Anthraquinone compounds (as anhydrous barbaloin) (%): No more than 0.005
(It shall be converted based on the concentration ratio of ingredients
and aloe gel converted content as a standard of aloe vera gel 100%)
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy skin, maintain healthy
gastrointestinal function, support immune system
(2) Daily intake amount: 100 ~ 420 mg as total polysaccharide content

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total polysaccharide: Chapter 4. 3-27 total polysaccharide
(3) Anthraquinone compounds (as anhydrous barbaloin): Chapter 4. 3-47
Anthraquinone compounds (as anhydrous barbaloin)
(4) Coliform: Referred to [Annexed the Table 4]

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2-48 Ganoderma lucidum fruit body extracts

1) Standards for manufacturing

(1) Raw material: Ganoderma lucidum (Ganoderma lucidum or Ganoderma
tsugae) fruit body
(2) Preparation and/or processing: It shall be in edible form by filtering
and concentrating after extracting the raw materials with hot water.
(3) Content of functional compounds (or marker compounds): β-Glucan
shall be contained 10 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) β-Glucan (The β-glucan originated from other ingredients shall be
labeled separately.)
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of the labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood flow
(2) Daily intake amount: 24 ~ 42 mg as β-glucan

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) β-Glucan: Chapter 4. 3-25 β-glucan
(3) Coliform: Referred to [Annexed the Table 4]

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2-49 Chitosan / Chitooligosaccharide

1) Standards for manufacturing

(1) Raw material: A shell of crustacean (crab, shrimp, etc.), Mollusk
(squid, cuttlefish, etc.) bone
(2) Preparation and/or processing
(a) Chitosan: It shall be in edible form by diacetylating chitin (β-1,4
bound polymer of N-acetylglucosamine) obtained by deproteinizing and
decalcifying the raw materials.
(b) Chitooligosaccharide: It shall be in edible form by hydrolyzing
chitosan obtained from preparation and/or processing of (a) with
enzyme.
(3) Content of functional compounds (or marker compounds): The degree of
deacetylation (glucosamine remaining ratio in sugar chains) of chitosan
shall be contained 80% or more. Chitosan (as glucosamine) shall be
contained 800 mg/g or more and chitooligosaccharide 200 mg/g or
more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Chitosan or Chitooligosaccharide
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 3.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level,
reduce body fat

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 (2) Daily intake amount
(a) May help to maintain health blood cholesterol level: 1.2 ~ 4.5 g as
sum of chitosan and chitooligosaccharide
(b) May help to reduce body fat: 3.0 ~ 4.5 g as chitosan, 3 g as
chitooligosaccharide
(3) Warning notice for intake: The individual who has an allergy to crab
and/or shrimp should be cautious to intake (limited to using crab and/or
shrimp as raw material)

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Chitosan: Chapter 4. 3-29 Chitosan (as total glucosamine)
(3) Chitooligosaccharide: Chapter 4. 3-30 Chitooligosaccharide
(4) Lead, Cadmium, Mercury: Referred to [Annexed the Table 4]
(5)　Coliform: Referred to [Annexed the Table 4]

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2-50 Fructooligosaccharide

1) Standards for manufacturing

(1) Raw material and preparation and/or processing
(a) β-1,2 oligosaccharides bound sucrose with 1~3 fructose units shall be
manufactured·processed with transferase or microorganisms having
transferase after making liquid by melting sugar.
(b) It shall be manufactured·processed by hydrolyzing inulin with enzyme.
(2) Content of functional compounds (or marker compounds): Fructooligosaccharide
shall be contained 410 mg/g or more. The content of fructo-oligosaccharide
shall be calculated by sum of 1-kestose (GF2), nystose (GF3) and
fructofuranosylnystose (GF4).

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Fructooligosaccharide
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Lead (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy gastrointestinal bacteria
population, maintain healthy bowel function
(2) Daily intake amount: 3 ~ 8 g as fructooligosaccharide
(3) Warning notice for intake
(a) It may cause gastrointestinal gas, burp, stomachache, abdominal inflation
(b) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Fructooligosaccharide: Chapter 4. 3-31 Fructooligosaccharide
(3) Lead: Referred to [Annexed the Table 4]
(4)　Coliform: Referred to [Annexed the Table 4]

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2-51 Probiotics

1) Standards for manufacturing

(1) Raw material: The following probiotics itself or mixed

Kind(Scientific name)
L.acidophilus, L.casei, L.gasseri, L.delbrueckii ssp.
Lactobacillus bulgaricus, L.helveticus, L.fermentum, L.paracasei,
L.plantarum, L.reuteri, L.rhamnosus, L.salivarius
Lactococcus Lc. lactis
Enterococcus E.faecium, E.faecalis
Streptococcus S.thermophilus
Bifidobacterium B.bifidum, B.breve, B.longum, B.animalis ssp. lactis

(2) Preparation and/or processing

(a) It shall be in edible form by culturing and pulverizing the above
probiotics. During culturing it shall be meet manufacturing / processing
standards and specification (coliforms, salmonella spp, listeria
monocytogenes, staphylococcus aureus only) of ‘Fermented milk
(except fermented milk powder)’ in the Food Code.
(b) Enterococcus sp. strain can be used only when there is no antibiotic
resistance and toxic gene.
(3) Content of functional compounds (or marker compounds): Live bacteria
shall be contained 100,000,000 CFU/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Probiotics number: No less than labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to increase the number of beneficial bacteria
and control harmful bacteria in the gut maintain healthy bowl function

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MFDS Notice 2020-63, Jul. 10, 2020, Enforcement date: Jul. 11, 2021
(1) Health claim: May help to increase the number of beneficial bacteria
and control harmful bacteria in the gut help to maintain healthy
bowel function, maintain gut health

(2) Daily intake amount: 100,000,000 ~ 10,000,000,000 CFU

(3) Warning notice for intake
(a) Consult a health care practitioner prior to intake if you are taking
medicines or having disease
(b) The individual who has an allergy may cause side-effect such as
hypersensitivity reaction
(c) Teach children how to intake daily amount so that they do not over intake
(d) Consult a health care practitioner and stop intake if you are having
adverse event

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Probiotics number: Chapter 4. 3-57 for lactic acid bacteria, Chapter 4.
3-58 for bacillus- and coccus-form of lactic acid bacteria and
bifidobacteria
(3)　Coliform: Referred to [Annexed the Table 4]

- 140 -
2-52 Red yeast rice

1) Standards for manufacturing

(1) Raw material: Rice and red yeast (Monascus anka, Monascus purpures,
Monascus pilosus, and Monascus ruber)
(2) Preparation and/or processing: It shall be in edible form by pulverizing
after solid-state fermentation by inoculating rice (except for steamed
rice) with red yeast.
(3) Content of functional compounds (or marker compounds): Total
monacolin K shall be contained 0.5 mg/g or more, and active form of
monacolin K shall be confirmed.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and off-flavor
(2) Total monacolin K
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Active form of monacolin K: It shall be confirmed
(4) Citrinin (mg/kg): No more than 0.05
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level
(2) Daily intake amount: 4 ~ 8 mg as total monacolin K

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total monacolin K: Chapter 4. 3-51 Total monacolin K
(3) Active form of monacolin K: It shall be confirmed according to total
monacolin K testing method of above (1).
(4) Citrinin: Chapter 4. 2-5-4 Citrinin
(5)　Coliform: Referred to [Annexed the Table 4]

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2-53 Soybean protein

1) Standards for manufacturing

(1) Raw materials: Soybean (Glycine max L.N)
(2) Preparation and/or processing
(a) It shall be in edible form by separating and purifying after removing
lipid from the raw materials.
(b) It shall be in edible form by separating and purifying with pulverizing
after soaking the raw material.
(3) Content of functional compounds (or marker compounds): Crude protein
shall be contained 400 mg/g or more based on dried materials and
daidzein and genistein shall be confirmed.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Crude protein
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Daidzein: It shall be confirmed.
(4) Genistein: It shall be confirmed.
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level
(2) Daily intake amount: 15 g or more as soybean protein
(3) Warning notice for intake: The individual who has an allergy to soybean
protein should be cautious to intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Crude protein: Chapter 4. 3-21 Crude protein
(3) Daidzein, Genistein: Chapter 4. 3-50 Confirmation of daidzein and genistein
(4) Coliform: Referred to [Annexed the Table 4]

- 142 -
2-54 Theanine

1) Standards for manufacturing

(1) Raw materials: L-Glutamine, Ethyl amine
(2) Preparation and/or processing
(a) It shall be in edible form by crystallizing with ethanol after concentrating
and purifying the raw material which reacted with glutaminase.
(b) It shall meet the standards and specification of food additives when
chemical synthesis of raw materials are used.
(3) Content of functional compounds (or marker compounds): L-Theanine
shall be contained 940 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) L-Theanine
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to relaxation of tension by stress
(2) Daily intake amount: 200 ~ 250 mg as L-Theanine
(3) Warning notice for intake
(a) Combined intake with drinks which contain caffiene (coffee, green tea,
black tea, etc.) should be careful
(b) Pregnant and lactating women, children, perioperative patient should be
careful for intake

- 143 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) L-Theanine: Chapter 4. 3-66 L-Theanine
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 144 -
2-55 MSM (Methyl sulfonylmethane, Dimethylsulfone)

1) Standards for manufacturing

(1) Raw materials and preparation and/or processing: It shall be in edible
form by distillating, purifying, filtering, concentrating and crystallizing
after oxidation with DMSO (Dimethyl sulfoxide).
(2) Content of functional compounds (or marker compounds): MSM shall
be contained 980 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) MSM
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 0.1
(b) Cadmium (mg/kg): No more than 0.1
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 0.1
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy joint and cartilage
(2) Daily intake amount: 1.5 ~ 2.0 g as MSM

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) MSM: Chapter 4. 3-67 MSM
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 145 -
2-56 Poly γ-glutamic acid

1) Standards for manufacturing

(1) Raw materials: Bacillus subtilis
(2) Preparation and/or processing: It shall be in edible form by cultivating
raw material and filtering or crystallizing after neutralizing sufficiently
with potassium, calcium, sodium, magnesium salt single or mixed.
(3) Content of functional compounds (or marker compounds): Poly γ-glutamic
acid shall be contained 700 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Poly γ-glutamic acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 0.5
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support calcium absorption
(2) Daily intake amount: 60 ~ 70 mg as poly γ-glutamic acid

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Poly γ-glutamic acid: Chapter 4. 3-68 Poly γ-glutamic acid
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 146 -
2-57 Hyaluronic acid

1) Standards for manufacturing

(1) Raw materials: Cockscomb, Streptococcus zooepidemicus
(Only Sreptococcus zooepidemicus can use as raw material for ‘May help to
maintain skin health from skin damage by UV radiation’ health claim products)
(2) Preparation and/or processing: It shall be in edible form by extracting or
cultivating·extracting the raw material and purifying or process as sodium salt.
(3) Content of functional compounds (or marker compounds): Hyaluronic
acid shall be contained 900 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Hyaluronic acid
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Moisture: No more than 10% (Only Semi-processed product)
(4) Heavy metal
(a) Lead (mg/kg): No more than 2.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain skin moisturizing, maintain skin
health from skin damage by UV radiation
(2) Daily intake amount
(a) May help to maintain skin moisturizing: 120 ~ 240 mg as hyaluronic acid
(b) May help to maintain skin health from skin damage by UV radiation:
240 mg as hyaluronic acid

- 147 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Hyaluronic acid: Chapter 4. 3-69 Hyaluronic acid
(3) Moisture: Referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 148 -
2-58 Rhodiola rosea L. extracts

1) Standards for manufacturing

(1) Raw materials: Rhodiola rosea L. root
(2) Preparation and/or processing: It shall be in edible form by filtering
and concentrating after extracting the raw materials with ethanol
(including mixture of water and ethanol).
(3) Content of functional compounds (or marker compounds): Rosavin shall
be contained 20 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Rosavin
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to relieve from fatigue by stress
(2) Daily intake amount: 200 ~ 600 mg as Rhodiola rosea L. extracts

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Rosavin: Chapter 4. 3-70 Rosavin
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 149 -
2-59 Bilberry extracts

1) Standards for manufacturing

(1) Raw materials: Vaccinium myrtillus L. fruit
(2) Preparation and/or processing: It shall be in edible form by filtering,
concentrating, purifying after extracting the raw materials with ethanol
(including mixture of water and ethanol).
(3) Content of functional compounds (or marker compounds): Anthocyanosides
shall be contained 300 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Anthocyanosides
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to improve eye fatigue
(2) Daily intake amount: 240 mg as bilberry extracts (72 ~ 108 mg as
Anthocyanosides)
MFDS Notice 2019-91, Oct. 16, 2019, Enforcement date: Mar. 1, 2021
(2)　Daily intake amount: 160 ~ 240 mg as bilberry extracts (50 ~ 108 mg
as Aanthocyanosides)

- 150 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Anthocyanosides: Chapter 4. 3-71 Anthocyanosides
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 151 -
2-60 Garlic

1) Standards for manufacturing

(1) Raw materials: Allium sativum L bulb
(2) Preparation and/or processing: It shall be in edible form by freeze
drying and pulverizing after removing inedible part of raw materials.
(3) Content of functional compounds (or marker compounds): Alliin shall
be contained 10 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Alliin
(a) Semi-processed product: No less than labeled amount
(b) Final product: No less than 80% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 0.5
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 0.5
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy blood cholesterol level
(2) Daily intake amount: 0.6 ~ 1.0 g as garlic powder

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Alliin: Chapter 4. 3-72 Alliin
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 152 -
2-61 Raffinose

1) Standards for manufacturing

(1) Raw materials: Beta vulgaris var. saccharifera root
(2) Preparation and/or processing: It shall be in edible form by extracting
molasses from raw materials and filtering with diatomite, ion exchange
chromatography (Na) and evaporation, crystallizing with ethanol,
separation, dissolving, filtering with diatomite, crystallizing with ethanol,
separation, drying with reduced pressure (3 hours), pulverizing.
(3) Content of functional compounds (or marker compounds): Raffinose
shall be contained 980 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Raffinose
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.3
(c) Mercury (mg/kg): No more than 0.3
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims
(a) May help to improve beneficial bacteria and control harmful bacteria in the gut
(b) May help to maintain healthy bowel function
(2) Daily intake amount: 3 ~ 5 g as raffinose
(3) Warning notice for intake: It may cause diarrhea if you take more than
daily intake amount

- 153 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Raffinose: Referred to [Annexed the Table 4]
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 154 -
2-62 Agar powder

1) Standards for manufacturing

(1) Raw materials: Gelidium amansil
(2) Preparation and/or processing: It shall be in edible form by processing
the raw material with 1 ~ 2% sodium hydroxide solution for 1 hour,
wash with purified water (pH 9 ~ 10), acid treatment (sulfuric acid,
neutralized as pH 6.5 ~ 7.5) and wash once, steaming (90 ~ 100℃, 2
hours) and extraction, filtering with perlite or diatomite, coagulation,
dehydration, cutting, drying, pulverizing.
(3) Content of functional compounds (or marker compounds): Total dietary
fiber shall be contained 80.0% or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Total dietary fiber
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Hot water insoluble residue(%) : No more than 4.0
(4) Heavy metal
(a) Lead (mg/kg): No more than 0.3
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.2
(d) Arsenic (mg/kg): No more than 0.3
(5) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain healthy bowel function
(2) Daily intake amount: 2 ~ 5 g as agar powder (1.6 ~ 4.0 g as total
dietary fiber)
(3) Warning notice for intake
(a) Children, pregnant and lactating women should be careful for intake

- 155 -
 (b) Should be taken with sufficient water
(c) When taken in excessive amounts, it may cause minor diarrhea, vomit,
bowel frequency, abdominal inflation and headache

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Total dietary fiber: Chapter 4. 3-26 (please revise it) dietary fiber
3-26-1 dietary fiber (method 1) 4.2 Total dietary fiber (TDF)
(3) Hot water insoluble residue : Referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 156 -
2-63 Creatine

1) Standards for manufacturing

(1) Raw materials: Water solution of sodium sarcosinate and cyanamide
(2) Preparation and/or processing: It shall be in edible form by reacting the
water soultion of Sodium sarcosinate (20℃, pH 9.6 with hydrochloric
acid) and Cyanamide at 80 ~ 85℃ for 90 minutes, heating and stirring
at 80℃ for 2 hours, cooling for 4 hours and crystallizing, decompression
filtering, wash with water at 40℃, pulverizing as powder and vacuum
dehydration at 40℃, 20 mbar.
(3) Content of functional compounds (or marker compounds): Creatine
monohydrate shall be contained 990 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Creatine monohydrate
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Dicyandiamide (mg/kg) : No more than 50.0
(4) Dihydrotriazine (mg/kg): Not detected
(5) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.5
(c) Mercury (mg/kg): No more than 0.5
(d) Arsenic (mg/kg): No more than 1.0
(6) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to improve athletic ability while muscle training
(2) Daily intake amount: 3 g as creatine
(3) Warning notice for intake
(a) Consult a doctor prior to intake if you are taking medicines related to
kidney or having kidney problem

- 157 -
 (b) Children, pregnant and lactating women should be avoid intake
(c) Caffeine may reduce the function of creatine
(d) Should be taken with sufficient water incase of dehydration
(e) Do not intake too much

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Creatine monohydrate: Chapter 4. 3-73 Creatine monohydrate
(3) Dicyandiamide : Chapter 4. 2-5-6 Dicyandiamide
(4) Dihydrotriazine: Chapter 4. 2-5-7 Dihydrotriazine
(5) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(6) Coliform: Referred to [Annexed the Table 4]

- 158 -
2-64 Hydrolyzed milk protein

1) Standards for manufacturing

(1) Raw materials: Skim milk
(2) Preparation and/or processing: It shall be in edible form by centrifuge
and separating casein from the raw materials, alkalization and hydrolysis
with trypsin (40 ~ 50℃, pH 7.5 ~ 9.0), acidification and heat treatment
for 1.5 min at 90℃, spray drying (180 ～ 200℃, airsparging).
(3) Content of functional compounds (or marker compounds): α
shall be contained 18 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) α
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.1
(c) Mercury (mg/kg): No more than 0.1
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to relaxation of tension by stress
(2) Daily intake amount: 150 mg as hydrolyzed milk protein (2.7 ~ 4.1 mg
as α )
(3) Warning notice for intake
(a) Pregnant and lactating women, children should be careful for intake
(b) The individual who has an allergy to milk or milk product should be
cautious to intake

- 159 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) α : Chapter 4. 3-74 α
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 160 -
2-65 Phellinus linteus extracts

1) Standards for manufacturing

(1) Raw materials: Phellinus linteus (3 ~ 4 years old dry)
(2) Preparation and/or processing: It shall be in edible form by pulverizing
the raw material under 3mm size, extracting (110℃, 96 ~ 100 hours)
with water (10 times more amount than materials), high-press filtering,
drying (75 ~ 80℃, heat dry), pulverizing.
(3) Content of functional compounds (or marker compounds): β-glucan shall
be contained 87 mg/g or more.
(4) Conditions for manufacturing: Raw material shall be in confirmed as
Phellinus linteus by ITS-5.8S rDNA sequence analysis, shall be
inoculation with nutrient culture medium which protected from
microbial contamination and cultivated for 3~4 years, Phellinus linteus
shall be obtained in the form of dark brown fruit body which has been
identified the spore formation.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) β-glucan
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 0.4
(c) Mercury (mg/kg): No more than 0.3
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to support immune function
(2) Daily intake amount: 3.3 g as Phellinus linteus extracts (287.1 ~ 534.6
mg as β-glucan)

- 161 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) β-glucan: Chapter 4. 3-25 β-glucan
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 162 -
2-66 Tomato extracts

1) Standards for manufacturing

(1) Raw materials: Lycopersicon esculentum
(2) Preparation and/or processing: It shall be in edible form by pulverizing
the raw material and centrifuge (75 ~ 110℃, 2,600 ~ 4,000 g),
extracting with ethyl acetate, remove solvent and homogenization.
(3) Content of functional compounds (or marker compounds): all-trans-lycopene
shall be contained 40 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) all-trans-lycopene
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 1.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative
(5) Solvent residue (mg/kg): No more than 50.0 (in case of using Ethyl acetate)

3) Prerequisite for the health functional food

(1) Health claims: May help to support anti-oxidant activity
(2) Daily intake amount: 5.7 ~ 15 mg as all-trans-lycopene
(3) Warning notice for intake
(a) The individual who has an allergy may cause hypersensitivity reaction
(b) When taken in excessive amounts, it may turn the skin orange color temporarily
(c) Pregnant and lactating women, children should be careful for intake

- 163 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) all-trans-lycopene: Chapter 4. 3-75 Lycopene
(3) Solvent residue: Referred to [Annexed the Table 4]
(4) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(5) Coliform: Referred to [Annexed the Table 4]

- 164 -
2-67 Amorphophallus konjac extracts

1) Standards for manufacturing

(1) Raw materials: Amorphophallus konjac
(2) Preparation and/or processing: It shall be in edible form by
stirr-extraction by-product which leftover from manufacture of
glucomannan from the raw materials with ethanol (3000 L), decompress
concentrating and mixing with ethanol and water (ethanol 30 L, water
100 L), recovey of lipid ingredients after adding salt, vaccum
concentrating and add β-cyclodextrin (ratio of 30 (extracts): 70 (β
-cyclodextrin)), drying and pulverizing.
(3) Content of functional com pounds (or m arker compounds):
Glucosylceramide shall be contained 22.5 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) ucosylceramide
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Heavy metal
(a) Lead (mg/kg): No more than 2.0
(b) Cadmium (mg/kg): No more than 1.0
(c) Mercury (mg/kg): No more than 1.0
(d) Arsenic (mg/kg): No more than 1.0
(4) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to maintain skin moisturizing
(2) Daily intake amount: 1.2 ~ 1.8 mg as Glucosylceramide
(3) Warning notice for intake: Pregnant and lactating women should be
avoid intake

- 165 -
4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Glucosylceramide: Chapter 4. 3-76 Glucosylceramide
(3) Lead, Cadmium, Mercury, Arsenic: Referred to [Annexed the Table 4]
(4) Coliform: Referred to [Annexed the Table 4]

- 166 -
2-68 Sophora japonica L. fruit extracts

1) Standards for manufacturing

(1) Raw materials: Sophora japonica L. fruit
(2) Preparation and/or processing: It shall be in edible form by selection,
washing, extracting with 60% ethanol at 80℃ for 2 hours, cooling,
concentrating, precipitation, recover sidement and spry drying.
(3) Content of functional compounds (or marker compounds): Sophoricoside
shall be contained 100 mg/g or more.

2) Specifications
(1) Appearance: Unique color and flavor, no off-taste and no off-flavor
(2) Sophoricoside
(a) Semi-processed product: No less than labeled amount
(b) Final product: 80 ~ 120% of labeled amount
(3) Coliform: Negative

3) Prerequisite for the health functional food

(1) Health claims: May help to improve menopausal women’s health
(2) Daily intake amount: 350 mg as Sophora japonica L. fruit extracts
(3) Warning notice for intake
(a) Children, pregnant and lactating women should be careful for intake
(b) The individual who are sensitive to the estrogen should be cautious to
intake

4) Testing methods
(1) Appearance: Chapter 4. 2-7 Appearance testing method
(2) Sophoricoside: Chapter 4. 3-77 Sophoricoside
(3) Coliform: Referred to [Annexed the Table 4]

- 167 -
[Annexed the Table 1] Table of random sampling numbers and usage method

1 2 3 4 5 6 7 8 9 10
1 95767 26878 94971 75204 64775 52647 35672 97456 89815 16767 1
2 81934 99378 73901 46997 11173 80744 51957 50801 25785 40475 2
3 64959 10235 55441 87439 04966 96170 22582 13512 60227 81391 3
4 88488 81729 60733 84690 94315 10841 99296 47844 87998 01066 4
5 22306 61346 09026 66275 78204 11563 67457 69438 98753 23478 5

6 01436 13553 53487 19706 30740 83272 69602 99251 81599 79264 6
7 35962 90832 21604 29620 01151 81945 61894 91583 41133 83955 7
8 80319 01462 60338 69763 32812 84076 10555 88707 92309 34505 8
9 32141 01977 57874 25052 11567 35505 04797 21900 81703 11848 9
10 99197 78637 67636 35765 36871 22555 94013 15118 81620 76730 10

11 04030 88194 08580 86080 76119 62260 81248 51732 89078 21940 11
12 99835 54210 80413 82015 07459 93910 93694 41184 65698 31977 12
13 26400 63946 83204 36388 30497 24021 93962 25555 00357 93441 13
14 64363 11259 59066 92948 72291 31804 82029 15789 04683 34455 14
15 82878 87304 33618 19490 88779 38883 14481 77089 58544 22761 15

16 19485 82792 88195 31877 74902 13212 02514 47152 17292 62081 16
17 72762 47963 14380 96130 74633 21388 22096 24987 50056 26487 17
18 53747 17433 51614 97763 90426 47833 58245 14890 77303 35338 18
19 84760 29591 96142 02207 79847 89559 66803 15461 39639 23187 19
20 42365 42338 66105 03782 83727 14200 57263 85617 95577 88654 20

21 44336 05322 04540 75989 51385 52279 16661 91446 48811 25346 21
22 52930 61970 05808 22807 85460 22723 61318 23281 63426 69030 22
23 50436 54490 50650 59386 25572 23267 44039 08759 33702 34580 23
24 24980 54548 49428 91704 86913 92940 86923 22428 47877 20510 24
25 94186 95540 75071 10076 10263 27664 98534 81171 61507 74976 25

- 168 -
 1 2 3 4 5 6 7 8 9 10
26 12359 46569 11050 90529 49289 94545 02258 20678 18898 50931 26
27 57132 49387 74792 50937 62339 43401 82825 03692 37836 68752 27
28 71239 49511 07466 15364 86050 31093 16730 73587 79875 43576 28
29 03935 83975 28893 66615 14015 22410 90938 35961 36373 84810 29
30 72801 73777 79101 26592 45424 00899 78462 74336 60478 13852 30

31 80252 11587 10862 11627 89857 07788 46817 55863 35713 44712 31
32 69388 92356 81282 33832 56676 35132 07119 27613 01304 70032 32
33 40225 60304 13526 47601 12751 19233 02057 28447 46676 29541 33
34 59925 62338 78784 63228 82603 31755 72733 80303 91066 52537 34
35 31172 89780 95384 51947 13841 74371 81016 39798 26690 00978 35

36 45587 42590 08443 20404 15100 74747 50642 34480 68080 23169 36
37 37819 60911 94740 05536 94042 17969 36747 92151 07501 67660 37
38 51402 74213 01105 15098 61470 23047 28521 58559 59305 08761 38
39 93873 99143 82254 53647 11010 68668 25888 36209 65412 00066 39
40 97645 51836 11835 99276 86466 67647 60834 30704 06711 11128 40

41 13123 15323 24885 74046 49145 99982 48231 26711 87670 22062 41
42 72110 70217 23475 48152 83457 01585 90915 69308 89090 77158 42
43 13751 40714 99330 05232 97056 40788 70005 36274 78649 50897 43
44 83809 98109 48292 06947 15924 08787 03919 72577 12906 80694 44
45 46264 57933 37607 58926 60772 62523 66260 95270 46469 45110 45

46 97426 78630 06115 44047 42350 88455 61426 08812 04255 87718 46
47 74715 09140 90315 03927 82118 00800 14314 06984 88951 10983 47
48 92481 55828 20144 77853 18100 13196 12279 20903 01252 00731 48
49 40176 70724 99476 34567 10214 97743 15770 78474 75691 59930 49
50 90176 19360 74015 89080 36337 40242 39621 71369 72350 73430 50

- 169 -
※ Use of random sampling numbers

If 1,000 boxes of agricultural products are stacked, 10 boxes of each

horizontal, vertical, and height, as shown in the figure below, the following
is explained to select a box to collect samples using a random number table.

① Select a box randomly.

Ex: If you select the second box from the top of the far left side
randomly, it is "a" in the above figure.
② Select a point in the Table of Random Numbers.
Ex: You randomly select 75071 located in column 3, row 25 in the
random number table, then again randomly select the fourth
number 7.
③ Read three numbers upward, downward, leftward, or rightward.
Ex: If you select to read rightward, then 7, 1, 1 are being read from
the random number table.
④ A box that will be used for sampling is selected by counting boxes
in three sequential directions based in the three selected number.
Ex: If you choose to count boxes rightward, upward, and inward
sequence, count 7 rightward from position a, then 1 upward, and
finally 1 inward to select the box for sampling, thus box b in the
diagram is selected.

- 170 -
[Annexed the Table 2] Nutrient reference value

Reference Reference Reference

Nutrient Nutrient Nutrient
value value value
Carbohydrate Chromium Molybdenum
324 30 25
(g) (µg) (µg)
Sugar Calcium Vitamin B12
100 700 2.4
(g) (mg) (µg)
Dietary fiber 25 Iron 12 Biotin 30
(g) (mg) (µg)
Protein 55 Vitamin D 10 Pantothenic acid 5
(g) (µg) (mg)
Fat 54 Vitamin E 11 Phosphorus 700
(g) (mgα-TE) (mg)
Saturated fat 15 Vitamin K 70 Iodine 150
(g) (µg) (µg)
Cholesterol Vitamin B1 Magnesium
300 1.2 315
(mg) (mg) (mg)
Sodium Vitamin B2 Zinc
2,000 1.4 8.5
(mg) (mg) (mg)
Potassium 3,500 Niacin 15 Selenium 55
(mg) (mg NE) (µg)
Vitamin A Vitamin B6 Copper
700 1.5 0.8
(µg RE) (mg) (mg)
Vitamin C Folic acid Manganese
(mg) 100 (µg) 400 (mg) 3.0

- 171 -
 [Annexed the Table 3] Dietary Reference Intakes for Koreans

n-6 n-3 Dietary

Age Carbohydrate Fat unsaturated unsaturated Proteins Water fiber VitaminA VitaminD VitaminE VitaminK VitaminC Thiamin Riboflavin Niacin VitaminB6 Folic acid VitaminB12
(g) (g) (g) (g) (g) (mL) (g) (μg RE) (μg) (mg α-TE) (μg) (mg) (mg) (mg) (mg NE) (mg) (μg DFE) (㎍)
RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI
Infant 0∼ 60 25 2.0 0.3 9.5 700 350 5 3 4 35 0.2 0.3 2 0.1 65 0.3
5(Mon)
6～11 90 25 4.5 0.8 15 800 450 5 4 7 45 0.3 0.4 3 0.3 80 0.5
Child 1∼2
(age) 15 1,100 10 300 5 5 25 35 0.5 0.5 6 0.6 150 0.9
3～5 20 1,500 15 350 5 6 30 40 0.5 0.6 7 0.7 180 1.1

Male 6∼8(age) 30 1,800 20 450 5 7 45 55 0.7 0.9 9 0.9 220 1.3

9～11 40 2,100 20 600 5 9 55 70 0.9 1.2 12 1.1 300 1.7
12～14 55 2,300 25 750 10 10 70 90 1.1 1.5 15 1.5 360 2.3
15～18 65 2,600 25 850 10 11 80 105 1.3 1.7 17 1.5 400 2.7
- 172 -

19～29 65 2,600 25 800 10 12 75 100 1.2 1.5 16 1.5 400 2.4

30～49 60 2,500 25 750 10 12 75 100 1.2 1.5 16 1.5 400 2.4
50～64 60 2,200 25 750 10 12 75 100 1.2 1.5 16 1.5 400 2.4
65～74 55 2,100 25 700 15 12 75 100 1.2 1.5 16 1.5 400 2.4
75 ~ 55 2,100 25 700 15 12 75 100 1.2 1.5 16 1.5 400 2.4
Female6∼ 25 1,700 20 400 5 7 45 60 0.7 0.8 9 0.9 220 1.3
8(age) 40 1,900 20 550 5 9 55 80 0.9 1.0 12 1.1 300 1.7
9～11 50 2,000 20 650 10 10 65 100 1.1 1.2 15 1.4 360 2.3
12～14 50 2,000 20 600 10 11 65 95 1.2 1.2 14 1.4 400 2.4
15～18 55 2,100 20 650 10 12 65 100 1.1 1.2 14 1.4 400 2.4
19～29 50 2,000 20 650 10 12 65 100 1.1 1.2 14 1.4 400 2.4
30～49 50 1,900 20 600 10 12 65 100 1.1 1.2 14 1.4 400 2.4
50～64 45 1,800 20 550 15 12 65 100 1.1 1.2 14 1.4 400 2.4
65～74 45 1,800 20 550 15 12 65 100 1.1 1.2 14 1.4 400 2.4
75~
Pregnancy +15/ +200 +5 +70 +0 +0 +0 +10 +0.4 +0.4 +4 +0.8 +220 +0.2
+30
Lactation +25 +700 +5 +490 +0 +3 +0 +40 +0.4 +0.5 +3 +0.8 +150 +0.4

[A corporation The Korean Nutrition Society: Korean Dietary Reference Intakes (2015)
 Pantothenic
Age acid Biotin Calcium Phosphorus Sodium Chlorine Potassium Magnesium Iron Zinc Copper Fluorine Manganese Iodine Selenium Molybdenum Crome
(mg) (μg) (mg) (mg) (g) (g) (g) (mg) (mg) (mg) (μg) (mg) (mg) (μg) (μg) (μg) (μg)

RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI RI AI
Infant 0∼5(Mon) 1.7 5 210 100 0.12 0.18 0.4 30 0.3 2 240 0.01 0.01 130 9 0.2
6～11 1.9 7 300 300 0.37 0.56 0.7 55 6 3 310 0.5 0.8 170 11 5.0
Child 1∼2 (age) 2 9 500 450 0.9 1.3 2.0 80 6 3 280 0.6 1.5 80 23 12
3～5 2 11 600 550 1.0 1.5 2.3 100 6 4 320 0.8 2.0 90 25 12
Male 6∼8(age) 3 15 700 600 1.2 1.9 2.6 160 9 6 440 1.0 2.5 100 35 20
9～11 4 20 800 1,200 1.4 2.1 3.0 230 10 8 580 2.0 3.0 110 45 25
12～14 5 25 1,000 1,200 1.5 2.3 3.5 320 14 8 740 2.5 4.0 130 60 35
15～18 5 30 900 1,200 1.5 2.3 3.5 400 14 10 840 3.0 4.0 130 65 40
19～29 5 30 800 700 1.5 2.3 3.5 350 10 10 800 3.5 4.0 150 60 30 35
30～49 5 30 800 700 1.5 2.3 3.5 370 10 10 800 3.0 4.0 150 60 25 35
50～64 5 30 750 700 1.5 2.3 3.5 370 10 9 800 3.0 4.0 150 60 25 35
65～74 5 30 700 700 1.3 2.0 3.5 370 9 9 800 3.0 4.0 150 60 25 35
75 ~ 5 30 700 700 1.1 1.7 3.5 370 9 9 800 3.0 4.0 150 60 25 35
Female6∼8(age) 3 15 700 550 1.2 1.9 2.6 150 8 5 440 1.0 2.5 100 35 15
9～11 4 20 800 1,200 1.4 2.1 3.0 210 10 8 580 2.0 3.0 110 45 20
12～14 5 25 900 1,200 1.5 2.3 3.5 290 16 8 740 2.5 3.5 130 60 25
15～18 5 30 800 1,200 1.5 2.3 3.5 340 14 9 840 2.5 3.5 130 65 25
19～29 5 30 700 700 1.5 2.3 3.5 280 14 8 800 3.0 3.5 150 60 25 25
30～49 5 30 700 700 1.5 2.3 3.5 280 14 8 800 2.5 3.5 150 60 25 25
50～64 5 30 800 700 1.5 2.3 3.5 280 8 7 800 2.5 3.5 150 60 25 25
65～74 5 30 800 700 1.3 2.0 3.5 280 8 7 800 2.5 3.5 150 60 25 25
75~ 5 30 800 700 1.1 1.7 3.5 280 7 7 800 2.5 3.5 150 60 25 25
Pregnancy +1 +0 +0 +0 +1.5 +2.3 +0 +40 +10 +2.5 +130 +0 +0 +90 +4 +5
Lactation +2 +5 +0 +0 +1.5 +2.3 +0.4 +0 +0 +5.0 +480 +0 +0 +190 +10 +20

* Recommended Intake: As the RI is the daily nutrient intake recommended by age, it should be calculated on the basis of
average requirements.
* Adequate Intake: In the absence of recommended intake, AI should be calculated on the basis of dietary reference intakes of
healthy individuals from epidemiological study
* Recommended Intake for Pregnancy Woman: Per the second and third trimester of pregnancy

- 173 -
[Annexed the Table 4] Application Table for Testing Methods

Testing item Reference Testing methods

Moisture 8. General testing methods 2. 2.1.1 Moisture
Ash 8. General testing methods 2. 2.1.2 Ash
Crude fat 8. General testing methods 2. 2.1.5.1 Crude fat
Acid value 8. General testing methods 2. 2.1.5.3.1 Acid value
Peroxide 8. General testing methods 2. 2.1.5.3.5 Peroxide value
value
Reducing 8. General testing methods 2. 2.1.4.1.2 Reducing
sugar sugar
Tar 8. General testing methods 3. 3.4 Colouring
Lead 8. General testing methods 9. 9.1 Heavy metal
Cadmium 8. General testing methods 9. 9.1 Heavy metal
Mercury 8. General testing methods 9. 9.1 Heavy metal
Arsenic 8. General testing methods 9. 9.1 Heavy metal
Total aerobic 8. General testing methods 4. 4.5 Total aerobic
counts counts
Coliforms Food 8. General testing methods 4. 4.7 Coliforms
E. coli Code 8. General testing methods 4. 4.8 E. coli
Salmonella 8. General testing methods 4. 4.11 Salmonella
Bacterial 8. General testing methods 4. 4.6 Bacterial growth
growth
8. General testing methods 8. 8.3.115 Doxycycline,
Tetracycline Lincomycin, Ciprofloxacin, Erythromycin, Enrofloxacin,
Chlorotetracy Oxytetracycline, Chlortetracycline, Tylosin, Tetracycline,
cline
Trimethoprim
8. General testing methods 9. 9.2.2 Aflatoxin (B1,
Aflatoxin
B2, G1 and G2)
Dextrose 5. Standards and specifications by food type 4. 4-4.
equivalent Glucose 6) Testing methods of microorganism (1)
(D.E.) Dextrose equivalent (D.E.)
Raffinose 8. General testing methods 6. 6.2.1 Oligosaccharide
Hot water 8. General testing methods 6.11.1.2 Hot water
insoluble
residue insoluble residue
Solvent
residues Health
Functional 4. Specification and Standards 2. 2-5-5 Ethyl acetate
(Ethyl Food Code
acetate)
Solvent 2. Specification and Standards 4. (a) Food Additives
residues Food ‘Oleoresin Paprika’
Solvent Additives
residues Code 2. Specification and Standards 4. (a) Food Additives
(Isopropanol) ‘Glucomannan’

- 174 -
[Annexed the Table 5] Negative List for Health Functional Food Ingredients

1. Ingredients of plant origin

Name Scientific name Other names

Euphorbiae Kansui Euphorbia kansui Liou Euphorbiae kansui Radix
Radix ex Wang
Gelsemine Gelsemine sempervirens
Pharbitis Seed Pharbitis nil Choisy, Pharbitidis Semen, Pharbitis
Pharbitis purpurea Voigt Seed
Farfarae Flower Tussilago farfara Linné Farfarae flos, Farfarae herba,
Farfarae radix, Ass's foot,
Bull's foot, Colt's foot,
Coltsfoot, Coughwort,
Farfara, Foal's wort,
Fieldhove, Horse hoof,
Horse-foot, Horse-shoe,
Horsehoof
Pregnum harmala
Pregnum harmala Linné
Linné
Datura Datura stramonium Datura Leaf, Daturae Folium
Linné, Datura metel
Nees, or Closely related
plants
Euphorbiae Euphorbia pekinensis
pekinensis Radix Ruprechta
Rhubarb Rheum palmatum Linné, Rhubarb, Rhei Radix et
Rheum tanguticum Rhizoma
Maximowicz ex Balf.,
Rheum officinale Baillon
Hemlock Conium maculatum Hemlock, Conium leaf and
fruits
Garciniae Resina Garcinia hanburyi Gutti
Hooker f., or Closely
related plants
Digitalis Digitalis purpurea Linné Digitalis leaf, Digitalis
folium

- 175 -
 Name Scientific name Other names
Aristolochiae Aristolochia contorta
fructus Bunge, Aristolochia spp.

Nux Vomica Strychnos nux-vomica Nux Vomica, Strychni

Linné Semen
Verbenae Herba Verbena officinalis Linné Verbenalin, Vervain
Ephedra Herb Ephedra sinica Stapf, Ephedra Herb, Ephedrae
Ephedra intermedia Herba, Ephedrae Radix
Schrenk et C.A.Meyer,
Ephedra equisetina
Bunge
Lobelia Rhodea japonica Roth
Aspidium Dryopteris crassirhizoma Male Fern, Crassirhizomae
Nakai Rhizoma
Moutan Root Bark Paeonia suffruticosa Moutan Cortex
Andrews
Cocculi Radix Cocculus trilobus De Cocculi radix
Candole
Akebia Stem Akebia quinata Decaisne Akebia Caulis
Pinellia Tuber Pinellia ternata
Breitenbach
Sinomenium Stem Sinomenium acutum Sinomeni Caulis et Rhizoma
and Rhizom Rehder et Wilson
Saposhnikovia Saposhnikovia divaricata Saposhnikoviae Radix
Root Schiskin
Chelidonii Herba Chelidonium majus Linné
Aconiti Koreani Aconitum koreanum
Tuber Raymond
Dictamni Cortex Dictamnus dasycarpus
Turcz
Veratrum Veratrum nigrum Linné White Hellebore, Veratri
var. ussuriense Loes. fil. Rhizoma et Radix
or Closely related plants

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 Name Scientific name Other names
Belladonna Atropa belladonna Linné Belladonna Root,
Belladonnae Radix
Strychni Ignatii Strychnos ignatii Bergius Strychni Ignatii Semen
Semen
Adonis Adonis amurensis Regel
et Radde
Prepared Aconite Aconitum carmichaeli Aconite, Aconiti Tuber,
Debeaux Pulvis Aconiti Tuberis
Purificatum, Oriental Aconite
Areca Areca catechu Linné Areca Semen
Henbane leaf Hyoscyamus niger Hyoscyami Folium
Linné

Phytolaccae Radix Phytolacca esculenta Phytolaccae Radix, Poke

Houttuyn, or Closely Root
related plants
Granate Bark Punica granatum Granate Bark, Granati Cortex
Linné
Senecio Senecio aureus, Senecio Golden ragwort, Dusty
cineraria, Senecio miller, Ragwort, Groundsel
jacobaea, Senecio
nemorensis fuchsii C.
Gmelin
Scopolia Scopolia japonica Scopoliae Rhizoma
Maximowiczi, or Closely
related plants
Strophanthus Strophanthus kombe Strophanthi Semen,
Oliver, or Closely related Strophanthus Seed
plants
Wormwood Artemisia absinthium
Papaveris semen Papaver somniferum L. Papaveris semen
Jalapae Ipomoea purga Hayne Jalapa Root, Jalapae Tuber
Lily of Valley Convallaria keiskei Convallariae Herba
Herb Miquel

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 Name Scientific name Other names
Yohimbe Pausinystalia yohimbe, Yohimbe bark
Coryanthe yohimbe
Rue Ruta graveolens Rue, Herb-of-Grace,
L.sspvulgaris Villkomm Herbygrass, Ruta, Vinruta
Genkwa Flos Daphne genkwa Seibold
et Zuccarini
Clematidis Radix Clematis mandshurica Clematis mandshurica
Maximowicz Ruprecht, Clematis patens
Morren & Decaisne,
Clematis terniflora De
Candole
Rauwolfia Radix Rauwolfia serpentina Rauwolfia Lindians Snake
Bentham or Closely Root
related plants
Ailanthi radicis Ailanthus altissima
Cortex Swingle
Arisaematis Rhizoma Arisaema amurense Arisaema Rhizome
Maximowicz, Arisaema
erubescens Schott,
Arisaema heterophyllum
Blume
Madder Root Rubia akane Nakai or
Closely related plants
Aristolochiae radix Aristolochia contorta
Bunge, Aristolochia spp.
Korean Aconite Aconitum ciliare
Root Decaisne or Closely
related plants
Chaparral larrea tridentata Greasewood, Cresote bush,
Hediondilla
Kava kava Piper methysticum
Cascara sagrada Rhamnus purshiana De Cascara sagrade bark
canddle
Khat Catha edulis qat, gat, chat, miraa
Comfrey Symphytum officinale common comfrey, knitbone

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 Name Scientific name Other names
Colocynth Citrullus colocynthis L. Bitter Apple, Bitter
Schrader Cucumber, Egusi, Vine of
Sodom, Wild Gourd
Colchicum Colchicum authumnale Colchicum corm
Quina Cinchona succirubra Cinchona Bark
Pavon et Klotzschor or
Closely related plants
Tansy Tanacetum vulgare L., Tansy flower and herb
Chrysanthemum vulgare
L. Bernhardi
Ipecac Cephaelis ipecacuanha A. Ipecacuanhae Radix et
Richard, Cephaelis Rhizoma
acuminata Karsten
Tubocurarine Chondrodendron Pareira
tomentosum
Croton See Croton Tiglium Linné Croton Semen
Dysosma pleiantha Dysosma pleiantha
(Hance) Woods (Hance) Woods.
Squill Urginea scilla Steinheil Scillae Bulbus
Apricot Kernel Prunus armeniaca Linné Armeniacae Semen
var. ansu Maximowicz,
Prunus mandschurica
Koehne var. glabra
Nakai, Prunus sibrica
Linné, Prunus armeniaca
Linné

Phellodendron Phellodendron amurense Phellodendri Cortex

Bark Ruprecht, Phellodendron
chinense Schneider

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2. Ingredients of animal origin

Dried thyroid

Bile & gall bladder

Ergot

Blister beetle Cantharides, Cantharis

Venom

Human placenta

Human Blood

Musk Moschus

Toad Venom Bufonis Venenum, Toad Venom

Worm body of Scolopendra subspinipes

Scolopendrae Corpus
mutilans Linné Koch

Pituitary gland

Bee venom

Prostate

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3. Other ingredients

Name
Lobeline or its salts

Bulbocapnine or its salts

Brucine or its salts

Sabina oil

Cepharanthin

Agaritine or its salts

Arecoline or its salts

Kainic acid

Cotarnine or its salts

Tropacocaine or its salts

Radioactive substance

Compounds which chemical structure are similar to drug compounds as

prescribed by Illegal compounds in the Food code Chapter 2. Common
standards and specifications for general foods 3. Standards ans
Specifications for general foods 10) Illegal compounds

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