2011-04-04

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Malaysia-South Korea Palm Oil Trade Fair and Seminar

Eunju Kim

Laws for food safety in Korea

• Food sanitation act• Functional foods for health act• Special act on safety control of

children's dietary life• Prevention of contagious disease act• National health promotion act• Food industry promotion act• Agricultural products quality control

act• Processing of livestock products act • Livestock「 Prevention of contagious

disease act 」• Livestock industry act• Control of livestock and fish feed act• Agrochemicals control act• Pharmaceutical affairs act• Fertilizer control act

• Ginseng industry act• Grain management act• Environmental friendly agriculture

fosterage act• Marine products quality control act • Act on special measures for the

control of public health crimes• School meals act• School health act• Water supply and water works

installation act• Management of drinking water act• Salt management act• Liquor tax law • Foreign trade act • Industrial standardization act • Transboundary movement, etc. of

living modified organisms act

Framework Act on Food Safety (Act 9121 established on 2008. 06. 13. )

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Health Functional Food Code

KFDA Health Functional Food DivisionTel) 8243-719-2454~8Http://hfoodi.kfda.go.kr

Food & Drugs Act- Health Claims- NHPS

NLEA, FDAMA, DSHEA- Health Claims- Dietary Supplements

건강기능식품법-건강기능식품

FUFOSE - Health Claims- Functional Foods

(Proposed)

Nutrition Improvement Act-FOSHU, FNFC

FSANZ- Health Claims

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Food vs. Health Functional Foods

Food Functional Food HFF

• Food Sanitation Act

(1962)

“Food”is all to eat

(exclusive drugs)

• Functional Foods for

Health Claim (2004)

“Health functional food” is

food containing functional

ingredients

?

DefinitionTerm

Foods are in forms of tablet, capsule,

powder, granule, liquid, pill, paste, syrup,

gel, jelly, bar etc. which contains

functional ingredient

Provide nutrients for body structure or

function or effectively control metabolism

for health

HFF

Health claim

Functional Food for Health Act III. Definition

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Dose

Functional ingredients

Health calim approved by KFDA

Ingredients which is helpful to maintain health

Suggested dose for safety and efficiency

Nutrients / Health claim / disease reduction

HFF Characteristics

HFF Importer (7일)

Product (10일)

No need for approval

HFF Code

HFF coded

Need for approval

Functional ingredient: 120daysFunctional products: 90days

HFF approved by request

HFF Manufacturer

Imported product

판매 및 유통

Managements of HFF

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「HFF CODE」

KFDA approved Functional ingredients

- Standard for manufacturing, specification, prerequisites for HFF, test methods

No need to approval for processing or importing

KFDA establish standards and regulations for manufacturing, use, storage etc. of HFF to be sold

KFDA establish functional ingredients and materials of HFF to be sold

XIV. 1 XV. 1

HFF Coded

HFF Code

1. General provisions

2. Common standards and specifications

3. Standards and specifications for each functional ingredients

4. Test methods

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HFF Code. General provisions

1. Purpose of the Code

2. Scope of the Code

3. Contents of the Code

4. Scientific evaluation for safety and claims and setting the

standard and specification

5. Adding functional ingredients in this code

6. This 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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HFF Code. Common standards and specifications

Nutrients

Functional ingredients

Other materials

• Processed materials originated form animal, plant, microorganism, Extract of those, mixture of those, chemically processed materials

• Coded or approved functional ingredients

• Coded chemically processed materials, extracts from plants

• Chemically processed materials should be fit to standards and regulations of Food Additives Code

• Materials used without health claims

• Food, food Additives or functional ingredients(less than suggested dose for health claim)

Vitamins/Minerals

Dietary fiber

Protein

Essential Fatty acids

Terpenes

Fatty acid/lipids

Fermentation microbes

Phenols

Functional ingredients

Nutrients

Cate

gory

Sugar/Carbohydrates

Amino acid/Proteins

Ginseng etc.

ω-3 Fatty acid etc.

Glucosamine etc.

Probiotics etc.

Green tea extracts etc.

Soybean protein etc.

HFF code. Standards and specifications for each functional ingredients

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Fatty acids/Lipids

Products specification

Functional ingredients standards

Contents of standards and specifications

2011-04-04

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HFF Importer (7일)

Product (10일)

No need for approval

HFF Code

HFF coded

Need for approval

Functional ingredient: 120daysFunctional products: 90days

HFF approved by request

HFF Manufacturer

Imported product

판매 및 유통

Managements of HFF

Functional ingredients not on the list of 「HFF Code」should be approved their claims for manufacturing or importing of HFF

KFDA establish functional ingredients and materials of HFF to be sold

XIV. 1

HFF approved

Evaluation of safety, health claim and material standardization

Approval is a requirement for manufacturing or importation

「 Rules for Approval of Functional Ingredients 」

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1. Summary of submission

2. Origin, approval and use of ingredient

3. Manufacturing process

4. Characteristics of ingredient

5. Standards and test methods of active components

6. Standards and qualifications of possible hazardous chemicals

7. Safety documents

8. Health claim documents

9. Suggested dose and directions and warnings

10. Proof it not categorized as a drug

(Rules for approval 12.)

Requirements for approval of functional ingredient

http://hfoodi.kfda.go.kr

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Food Code

KFDA Food Standards DivisionTel) 8243-719-2417~21Http://hfoodi.kfda.go.kr

Food Code

1. General Provisions

2. Common Standards & Specificationsfor General Foods

3. Specifications for Long Shelf-life Foods

4. Standards & Specifications for General Processed Foods Outside the scope of 'Standards & Specifications for Each Food Product (Article 5)'

5. Standards and Specifications for Each Food Product

Food Class

Food Species

Food Types

6. Standards and Specifications for Fishery Products

7. Standards and Specifications for packages and containers

8. Standards and Specifications for Ready-to-eat products

9. Sampling and Test methods

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Classification of processed foods

Food class(Large classification)

29 classes(Beverages, Seasonings...)

Food species(Medium classification)

48 species (Fruit and vegetable beverages, Vinegars ..)

Food type(Small classification)

223 types (Fruit/vegetable juice, fermented vinegars..)

Fats and edible oils

Contents of standards and specifications

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Fats and edible oils

Contents of standards and specifications

Fats and edible oils

Contents of standards and specifications

2011-04-04

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Fats and edible oils

Contents of standards and specifications

Fats and edible oils

Contents of standards and specifications

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