KFDA Policies on Food Import 2009 11

KFDA Policies on Food Import 2009. 11.

CONTENTS

VISION Establishment of Food safety control system assuring consumer confidence at any stage of the food supply chain

ORGANIZATION Officials : 1, 413 - KFDA : 636 - Institute : 238 - Regional KFDA : 539 Comissioner Spokesperson Criminal investigations Officer General Services Division Director General For Planning & Cooperation Risk Prevention Policy Bureau Deputy Commisioner Food Safety Bureau Audit and Inspection Officer Pharmaceutical Safety Bureau Biopharma -ceuticals and Herbal Medicine Bureau Medical Device Safety Bureau Director General for Food Standar Nutrition Policy -dization Department Food Safety Food Management Foodborne Disease Food Import Prevention Division Policy Division National Institute of Food and Drug Safety Evaluation Foreign Inspection Division Regional KFDA Seoul, Busan, Gyeongin Daejeon, Daegu, Gwangju

INSPECTION AGENCY REGIONAL KFDA Agricultural/Forestry Products, Processed Foods, Food Additives, Apparatus, Container, Package, Health Functional Foods [Food Sanitation Act, Act on Health Functional Food] NATIONAL FISHERIES PRODUCTS QUALITY INSPECTION SERVICE Fresh and Simply Processed Fishery Product [Food Sanitation Act] NATIONAL VETERINARY RESEARCH & QUARANTINE SERVICE Meat and Poultry Product, Dairy Product [Livestock Infectious disease Prevention Act]

INSPECTION RESULTS Imported Foods from Thailand in ’ 08(wt) • Imported amounts for classification 21 % 69 %

INSPECTION RESULTS Inspection results in 2008(cases) Country Total (cases) Agricultural Processed foods Food additives Equipments. Container, Packaging Health Functional Food Thailand (%) 7, 117 (100%) 806 (11%) 4, 747 (67%) 602 (8%) 895 (13%) 67 (1%) Inspection results in 2008(weight) Country Total (cases) Thailand (%) 314, 251 (100%) Agricultural Processed foods Food additives Equipments. Container, Packaging Health Functional Food 65, 563 (21%) 217, 180 (69%) 18, 221 (6%) 10, 865 (3%) √ 2, 422 (1%)

INSPECTION RESULTS Major Items exported to Korea(‘ 08) Agricultural Products - Brown rice (62, 151 ton) * 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)

INSPECTION RESULTS 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

KFDA Policy on Food Import(1/2) Strengthening food safety control system Ensure food safety control system from farm to table ※ Preregistration system, Officially authorized laboratory in foreign countries Visiting overseas food processing facilities, conducting presentation seminar 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 border Increasing laboratory test frequency focusing on hazardous substances ※ according to food safety information or rejection records(max 100%)

KFDA Policy on Food Import(2/2) Management of Food Import System Registration of Good Importer system Ø Conducting sanitary inspections on manufacturers of exporting country to be listed as Good importer and leading imported food safety assurance Imported Food traceability System Ø Putting an importer under an obligation to file business deal records Strengthen Management of Imported OEM Food Products Ø 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 Ø Manufacturer report corrective actions to the importer

Regulations on Food Import(1/7) Inspection of Imported Foods Verifying constituents, manufacturing process, usage, labeling, taste, color, appearance, standards and specifications for food products to be imported ü ü ü ü 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 Ø Released to market for Compliance, Return/Discard for Violation

Regulations on Food Import(2/7) Types of Inspection Document Inspection : subject to documentary check only Ø Preregistered Foods Ø Foods with test certificates issued by overseas officially authorized inspection organization Ø Reimported foods with conformation record for Laboratory inspection Ø food imported to manufacture importer’s own products in his own facilities in Korea Identity Inspection : based on description, taste, flavor, color and package Ø Reimported agricultural/forestry/fishery products with conformation record for Laboratory inspection

Regulations on Food Import(3/7) Types of Inspection Laboratory Inspection : conducted using physical, chemical or microbiological methods including document and identity inspection Ø Imported foods at the very first time Ø Imported foods known as foods containing hazardous substances Ø Imported foods found as noncompliant at the stage of import or distribution Ø 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 Ø Reimported foods repeatedly

Regulations on Food Import(4/7) Preregistration System Scope Ø Processed foods to be exported to Korea Procedure Ø file application form with documents on constituents, manufacturing process, test certificate and prescribing facilities(Applicant) Ø Review documents(KFDA) Ø On-site inspection of manufacturing facilities: whether complied with HACCP(KFDA) Ø Issue a registration certificate(KFDA) Advantage Ø be exempted from laboratory or random sampling inspection

Regulations on Food Import(5/7) Registration of Good Importer system Introduction Ø Registration system where importers conduct sanitary inspections on the manufacturer in the exporting country to be listed as Good Importer Ø The sanitary inspection should be carried out by the importer, and then confirmed by the KFDA Scope Ø Food, Food additives, Equipment, Containers and Package Procedure Ø On-site inspection of manufacturing facilities in exporting country by importer Ø File application form Ø Review filed documents and on-site inspection by KFDA for confirmation as compliant Ø Issue registration certificate Advantage Ø Be exempted from random sampling inspection, Rapid pass

Regulations on Food Import(6/7) Management of Imported OEM Food Products Introduction Ø 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 Ø Processed foods, food additives Main points Ø 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

Regulations on Food Import(7/7) Officially Authorized Inspection Organization Qualifications Ø Official inspection organization established by exporting country government Ø Official inspection organization recognized by exporting country government Inspection Organization recognized by KFDA Advantage Ø subject to documentary inspection with test certificate issued by Officially authorized inspection organization Ø save costs and time for passing through customs

Food Code Article 1. General Provisions Article 2. Common Standards & Specifications for General Foods Article 3. Specifications for Long Shelf-life Foods Article 4. Standards & Specifications for General Processed Foods outside the scope of Article 5. Standards & Specifications for Each Food Product ü 5. Sugars, . . 11. Processed Meat and Egg Products, . . 12. Fish Products, . . 21 -2 Sauces, . . Article 6. Specifications for Marine Products Article 7. Standards & Specifications for Equipments, Containers and Packages Article 8. Standards & Specifications for Cooked foods in a Restaurant Article 9. Sampling and Handling Methods

Standards for major food items Sugars - Food Type : White sugar, Brown Sugar, Other Sugars - Specifications : ü 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 ü 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 ü Artificial sweetener : should not be detected ü Lead(mg/kg) : Less than 1. 0(0. 5 for white sugar) ü Sulfate dioxide(mg/kg) : Less than 20. 0

Standards for major food items Processed Meat and Egg Products - Food Type : meat and egg product, Processed meat product, processed egg product - Specifications : ü Nitrite ion(g/kg): Not more than 0. 07(Limited to meat product) ü Volatile basic nitrogen (mg %) : Less than 20 (Limited to meat product) ü Tar color : Should not be detected (Limited to processed meat product) ü Coliform group : Less than 10 per 1 g (Limited to pasteurized products: in case of processed meat product, it should be negative) ü The number of bacteria : Negative (Limited to sterilization: but less than 10, 000 per 1 g in case of pasteurization) ü Salmonella : Negative (Limited to pasteurized products) ü Preservatives (g/kg) : Any preservative except the followings should not be detected ü Sorbic acid, Potassium sorbate, calcium sorbate ü Not more than 2. 0 (as sorbic acid, limited to meat and processed meat (except seasoned meat, minced meat, processed rib product))

Standards for major food items Fish products - Food Type : Fish cake, Fish sausage, Half-finished fish, Fish flesh, Fish paste, Other processed fish products - Specifications : ü Nitrite Ion (g/kg) : Less than 0. 05 (Limited to fish sausage) ü Tar color : Should not be detected (Excluding fish sausage) ü Coliform group : Negative (Excluding non-heated products) ü The number of bacteria : Negative (Limited to sterilized products) ü Preservatives (g/kg) : Any preservative except the followings should not be detected ü Sorbic Acid, Potassium sorbate, Calcium sorbate ü Not more than 2. 0(Based on Sorbic acid)

Standards for major food items Sauces - Food Type : No category - Specifications : ü Coliform group : Negative ü The number of bacteria : Negative(Limited to pasteurized products) ü Tar color : Should not be detected ü Preservatives (g/kg) : Any preservative except the followings should not be detected ü Methyl p-Hydroxybenzoate, Ethyl p-Hydroxybenzoate ü Not more than 0. 2(as p-Hydroxybenzoate) ü Bacillus Cereus : Less than 10, 000/ 1 g(Excluding pasteurized products)

Standards for major food items Salted and Fermented Seafoods(Jeotgal) - Food Type : Classified into Salted and Fermented Seafood, Spiced Salted and Fermented Seafood, Jeot, Spiced/Seasoned Joet, Sikhae - Specifications : ü Total Nitrogen(%): 1. 0 and less for jeot(0. 8 for jeot with Mysidacea), 0. 5 and less for Spiced/Seasoned Joet ü Coliform group: Negative (Limited to Jeot and spiced/seasoned Joet) ü Tar Color: Should not be detected ü 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%) ü E. Coli: Should be Negative(Excluding Jeot and spiced/seasoned Jeot)

Standards for major food items Processed Fruit/Vegetable Products - Food Type : Processed Fruit/Vegetable Product, Fruit/Vegetable Puree and Paste - Specifications : ü Soluble solid content excepting free salt(%) : 8~24 for Fruit/vegetable puree and paste(24 and more in case of fruit & vegetable paste) ü Coliform: Negative ü Tar color: Not be detected Brown rice - Specifications : ü 192 Pesticides MRLs including 2, 4 -D ü Aflatoxin B 1(ug/kg): 10 and less ü Aflatoxin B 1+B 2+G 1+G 2(ug/kg): 15 and less

Food additives permitted Major Non-Permissible Synthetic Sweetner ü Cyclamate Permissible Artificial Sweetener ü Sodium Saccharin, Aspartame, Sucralose, Acesulfame Potassium, Disodium Glycyrrhizinate, Trisodium Glycyrrhizinate Preservatives ü 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)

Standards for Equipments, Container, Package 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 ü Migration Specifications(mg/L): Pb(0. 4), Ni(0. 1), Cr(0. 1), As(0. 2) Synthetic Polymer(40 subclasses including PVC, etc. ) ü Migration Specifications for 37 subclasses(mg/L) : Potassium permanganate titration (10 and less) Papers ü Migration Specifications(mg/L): Non-volatile residues (30 and less) ü Arsenic, Heavy metal, Formaldehyde, Fluorescence Whitening Agent

Labeling on Genetically Modified 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%

No GM labeling is required 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.

GM Food Labeling Standard revision Old New Processed food using GMO as as major ingredient should be labeled and containing recombinant (ex : soybean oil manufactured by DNA should be labeled. 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