Food Standar-dization Department

Director GeneralFor Planning & Cooperation

Food Safety Bureau

Pharmaceutical Safety Bureau

Biopharma-ceuticals

and Herbal MedicineBureau

Medical Device Safety Bureau

General Service

s Division

Director General forNutrition Policy

Comissioner

Deputy Commisioner

Spokesperson

Audit and InspectionOfficer

Officials : 1,413 - KFDA : 636 - Institute : 238 - Regional KFDA : 539

Criminal investigations Officer

Risk Prevention

Policy Bureau

National Institute of Food and Drug Safety Evaluation

Food Safety Policy Division

Food ManagementDivision

Foodborne Disease Prevention Division

Food Import Division

Foreign InspectionDivision

Regional KFDASeoul, Busan, Gyeongin

Daejeon, Daegu, Gwangju

REGIONAL KFDA

NATIONAL FISHERIES PRODUCTS QUALITY INSPECTION SERVICE

NATIONAL VETERINARY RESEARCH & QUARANTINE SERVICE

Agricultural/Forestry Products, Processed Foods, Food Additives, Apparatus, Container, Package, Health Functional Foods

[Food Sanitation Act, Act on Health Functional Food]

Fresh and Simply Processed Fishery Product [Food Sanitation Act]

Meat and Poultry Product, Dairy Product [Livestock Infectious disease Prevention Act]

Imported Foods from Thailand in ’08(wt)

• Imported amounts for classification

69 %

21 %

Inspection results in 2008(weight)

Country Total(cases)

Agricultural

Processedfoods

Food additive

s

Equipments. Container, Packaging

Health Functiona

l Food

Thailand(%)

314,251(100%)

65,563(21%)

217,180(69%)

18,221(6%)

10,865(3%)

√ 2,422(1%)

Inspection results in 2008(cases)

Country Total(cases)

Agricultural

Processedfoods

Food additives

Equipments.

Container, Packaging

Health Functional

Food

Thailand(%)

7,117(100%)

806(11%)

4,747(67%)

602(8%)

895(13%)

67(1%)

Major Items exported to Korea(‘08)

Agricultural Products - Brown rice (62,151ton) * The Ratio of Brown rice from Thailand is 24% out of entire imported amount.

Processed Foods - Sugars(125,956 ton), Processed cereal products(17,034 ton) Processed meat products(5,857), Sauces(2,431 ton), Other processed fish products(125 ton)

Major Rejection Records

Sauces, Processed fish products, Noodles : Synthetic Preservatives(Benzoic acid, Propionic acid, Sorbic acid)

Sugaring food, Starch products : Sulfate Dioxide

Sauces, Beverage base, Canned products : Bacteria

Biscuits, Sauces : Artificial sweetener(Na Saccharin, Acesulfame K)

Processed meat products : Nitrofuran metabloites(AMOZ)

Foreign metallic materials : Natural spice, Red pepper powder

Strengthening food safety control systemEnsure food safety control system from farm to table

※ Preregistration system, Officially authorized laboratory in foreign countries

Visiting overseas food processing facilities, conducting presentation seminar for food exporters, figuring out a cause of violation, and trying to find a resolution to a problem

MOU with major exporting countries including China, Chile, Vietnam

Inspection at borderIncreasing laboratory test frequency focusing on hazardous substances

※ according to food safety information or rejection records(max 100%)

Management of Food Import System

Registration of Good Importer system

Conducting sanitary inspections on manufacturers of exporting country to be listed as Good importer and leading imported food safety assurance

Imported Food traceability System

Putting an importer under an obligation to file business deal records

Strengthen Management of Imported OEM Food Products

Putting an importer under an obligation to inspect facilities in exporting country and assure quality of food

Ban on Import of Food Product with risk/hazard

Manufacturer report corrective actions to the importer

Inspection of Imported FoodsVerifying constituents, manufacturing process, usage, labeling, taste, color, appearance, standards and specifications for food products to be imported

Whether the product meets the requirements according to Food Code, Food Additives Code

Whether the manufacturing methods are appropriate Whether the product has a proper combination of food

constituents Whether the required certificates were filed and

correct(GMO, BSE, organic) Whether the product got rotten or deteriorated Whether the product is properly Labeled in Korean Whether the product has any exaggerated

advertisement/package or misleading labeling

Notify to the applicant and Regional Customs Director Released to market for Compliance, Return/Discard

for Violation

Types of InspectionDocument Inspection : subject to documentary check only

Preregistered Foods Foods with test certificates issued by overseas officially

authorized inspection organization

Reimported foods with conformation record for Laboratory inspection

food imported to manufacture importer’s own products in his own facilities in Korea

Identity Inspection : based on description, taste, flavor, color and package

Reimported agricultural/forestry/fishery products with conformation record for Laboratory inspection

Types of InspectionLaboratory Inspection : conducted using physical, chemical or microbiological methods including document and identity inspection

Imported foods at the very first time

Imported foods known as foods containing hazardous substances

Imported foods found as noncompliant at the stage of import or distribution

Food products with standards/specifications established or amended

Random Sampling Inspection: applied to food products according to the sampling plan and frequency increased with rejection records or hazard potential

Reimported foods repeatedly

Preregistration SystemScope

Processed foods to be exported to Korea

Procedure file application form with documents on constituents,

manufacturing process, test certificate and prescribing facilities(Applicant)

Review documents(KFDA) On-site inspection of manufacturing facilities: whether

complied with HACCP(KFDA) Issue a registration certificate(KFDA)

Advantage be exempted from laboratory or random sampling

inspection

Registration of Good Importer system

Introduction Registration system where importers conduct sanitary

inspections on the manufacturer in the exporting country to be listed as Good Importer

The sanitary inspection should be carried out by the importer, and then confirmed by the KFDA

Scope Food, Food additives, Equipment, Containers and Package

Procedure On-site inspection of manufacturing facilities in exporting

country by importer File application form Review filed documents and on-site inspection by KFDA for

confirmation as compliant Issue registration certificate

Advantage Be exempted from random sampling inspection, Rapid pass

Management of Imported OEM Food ProductsIntroduction

Put an importer of OEM food products manufactured in exporting countries under obligation to manage relevant manufacturers, processors, facilities and Originally Equipment Manufacturing(OEM) products

Scope Processed foods, food additives

Main points Require an importer or a seller of OEM products to conduct

sanitary inspection on manufacturers or processors in exporting country and assure quality of OEM food

Officially Authorized Inspection OrganizationQualifications

Official inspection organization established by exporting country government

Official inspection organization recognized by exporting country government

Advantage subject to documentary inspection with test

certificate issued by Officially authorized inspection organization

save costs and time for passing through customs

Inspection Organization recognized by KFDA

Article 1. General ProvisionsArticle 2. Common Standards & Specifications for General FoodsArticle 3. Specifications for Long Shelf-life FoodsArticle 4. Standards & Specifications for General Processed

Foods outside the scope of Article 5Article 5. Standards & Specifications for Each Food Product

5. Sugars, .. 11. Processed Meat and Egg Products, .. 12. Fish Products, .. 21-2 Sauces, ..

Article 6. Specifications for Marine ProductsArticle 7. Standards & Specifications for Equipments,

Containers and PackagesArticle 8. Standards & Specifications for Cooked foods in a

RestaurantArticle 9. Sampling and Handling Methods

Sugars - Food Type : White sugar, Brown Sugar, Other Sugars - Specifications :

Description: It should be colorless, white crystals or crystalline powdery products with sweet taste for white sugar and brownish crystals or crystalline powdery products with sweet taste for brown sugar

Sugar content(%) : Not less than 99.7% for white sugar, Not less than 97.0% for brown

sugar, Not more than 86.0% for other

sugars Artificial sweetener : should not be detected Lead(mg/kg) : Less than 1.0(0.5 for white sugar) Sulfate dioxide(mg/kg) : Less than 20.0

Standards for major food itemsProcessed Meat and Egg Products

- Food Type : meat and egg product, Processed meat product, processed egg product

- Specifications : Nitrite ion(g/kg): Not more than 0.07(Limited to meat product) Volatile basic nitrogen (mg %) : Less than 20 (Limited to meat

product) Tar color : Should not be detected (Limited to processed meat

product) Coliform group : Less than 10 per 1 g (Limited to pasteurized

products: in case of processed meat product, it should be negative)

The number of bacteria : Negative (Limited to sterilization: but less than 10,000 per 1 g in case of pasteurization)

Salmonella : Negative (Limited to pasteurized products) Preservatives (g/kg) : Any preservative except the followings

should not be detected Sorbic acid, Potassium sorbate, calcium sorbate Not more than 2.0 (as sorbic acid, limited to meat and

processed meat (except seasoned meat, minced meat, processed rib product))

Fish products - Food Type : Fish cake, Fish sausage, Half-finished fish, Fish

flesh, Fish paste, Other processed fish products - Specifications :

Nitrite Ion (g/kg) : Less than 0.05 (Limited to fish sausage) Tar color : Should not be detected (Excluding fish sausage) Coliform group : Negative (Excluding non-heated products) The number of bacteria : Negative (Limited to sterilized

products) Preservatives (g/kg) : Any preservative except the

followings should not be detected Sorbic Acid, Potassium sorbate, Calcium sorbate Not more than 2.0(Based on Sorbic acid)

Sauces - Food Type : No category - Specifications :

Coliform group : Negative The number of bacteria : Negative(Limited to pasteurized

products) Tar color : Should not be detected Preservatives (g/kg) : Any preservative except the

followings should not be detected Methyl p-Hydroxybenzoate, Ethyl p-Hydroxybenzoate Not more than 0.2(as p-Hydroxybenzoate)

Bacillus Cereus : Less than 10,000/ 1g(Excluding pasteurized products)

Salted and Fermented Seafoods(Jeotgal) - Food Type : Classified into Salted and Fermented Seafood,

Spiced Salted and Fermented Seafood, Jeot, Spiced/Seasoned Joet, Sikhae

- Specifications : Total Nitrogen(%): 1.0 and less for jeot(0.8 for jeot with

Mysidacea), 0.5 and less for Spiced/Seasoned Joet Coliform group: Negative (Limited to Jeot and

spiced/seasoned Joet) Tar Color: Should not be detected Preservatives(g/kg): Any preservative except Sorbic

acid(1.0 and less) should not be detected (limited to products in which edible salt is contained not more than 8%)

E. Coli: Should be Negative(Excluding Jeot and spiced/seasoned Jeot)

Processed Fruit/Vegetable Products - Food Type : Processed Fruit/Vegetable Product,

Fruit/Vegetable Puree and Paste - Specifications :

Soluble solid content excepting free salt(%) : 8~24 for Fruit/vegetable puree and paste(24 and more in case of fruit & vegetable paste)

Coliform: Negative Tar color: Not be detected

Brown rice - Specifications :

192 Pesticides MRLs including 2, 4-D Aflatoxin B1(ug/kg): 10 and less Aflatoxin B1+B2+G1+G2(ug/kg): 15 and less

Major Non-Permissible Synthetic Sweetner Cyclamate

Permissible Artificial Sweetener Sodium Saccharin, Aspartame, Sucralose, Acesulfame

Potassium, Disodium Glycyrrhizinate, Trisodium Glycyrrhizinate

Preservatives Sorbic acid & its salt(K, Ca), Benzoic acid & its

salt(Na, K, Ca), Propionic acid & its salt(Na, Ca), Dehydroacetic acid & its salt(Na), ρ-Hydroxybenzoate(methyl, ethyl)

Classified into Synthetic Polymers, Cellophane, Rubber, Paper or Processed Paper, Metal-base, Metal-cans, Wood, Glass, Ceramic Ware, Porcelain Enamel and Earthenware, Starch-Base

Specifications are classified into Material and Migration

Metal-Base Migration Specifications(mg/L): Pb(0.4), Ni(0.1), Cr(0.1),

As(0.2)Synthetic Polymer(40 subclasses including PVC, etc.)

Migration Specifications for 37 subclasses(mg/L) : Potassium permanganate titration (10 and less)

Papers Migration Specifications(mg/L): Non-volatile residues (30 and

less) Arsenic, Heavy metal, Formaldehyde, Fluorescence Whitening

Agent

Foods manufactured or processed with agricultural, livestock or fishery products grown or raised by recombinant DNA techniques

Designated food containing or consisting of GMO materials as major raw ingredients which contain any residual recombinant DNA after manufacturing or processing

- “Major Raw Ingredients” means top five raw ingredients use most in the manufacture or processing of food

Adventitious threshold level : 3%

When using Identity Preserved(IP) agricultural product as raw materials

- IP certification system is required : below 3% of adventitious threshold level

※ Threshold level is not established for processed food

Submit the Certificates recognized by relevant governments - Any local, state, provincial government certificates stating that

particular GMO agricultural crops are not used for manufacture of the particular products

- Any local, state, provincial government certificates stating that a country does not produce and import any GMO crops in that country

For processed food which do not contain recombinant DNA - Qualitative test result is required - No test results are required for Soybean oils, corn oils, soy sauces,

corn syrup etc.

Old NewProcessed food using GMO as major ingredient and containing recombinant DNA should be labeled.

Processed food using GMO as ingredient should be labeled(ex : soybean oil manufactured by GM soybean)

-irrespective of 1) ingredient ranking (enforcement after about 1 year), 2) residual recombinant DNA (enforcement after about 3 years)※ Revised Standard will be notified soon