Food and Agricultural Import Regulations and Standards

An Expert's View about Agriculture and Animal Husbandry in South Korea

Posted on: 15 Feb 2012

Newly established requirement mandating overseas laboratories conducting biotech testing on foods destined for Korea be accredited by the Korea Food and Drug Administration (KFDA).

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 2/3/2012 GAIN Report Number: KS1206 Korea - Republic of Food and Agricultural Import Regulations and Standards - Narrative 2011 FAIRS Country Report Approved By: M. Kathryn Ting, Minister-Counselor Prepared By: Seung-Ah Chung / Michael G. Francom Report Highlights: Sections Updated: Section I, II, IV, V, VI, VII, IX and Appendix I, II. Several of the key updates include: the creation of a consolidated Quarantine and Inspection Agency (QIA) under the Ministry of Food, Agriculture, Forestry & Fisheries (MIFAFF); revised caffeine labeling requirements; and a newly established requirement mandating overseas laboratories conducting biotech testing on foods destined for Korea be accredited by the Korea Food and Drug Administration (KFDA). Section I. Food Laws: Korea is well equipped with a modern legal system that is based on a fixed hierarchy. Based on this framework, an Act or law, legislated by the National Assembly, gives the legal basis for government regulations. The draft bill may be submitted by an individual National Assembly member or the competent government ministry for National Assembly consideration. Under each Act, a Decree and Rule are drawn up by the responsible ministry to implement the law. At about the same time, the competent ministry or agency also promulgates notices and guidelines in order to provide more detailed guidance. The adjacent pyramid, albeit an oversimplification, shows how this legal hierarchy fits together. New and/or revised Acts, Decrees, Rules, and the implementing guidelines are published in the government gazette for public comments. These changes are also notified to the WTO for international comments. In addition, over the last decade, the Korea Legislation Research Institute has translated many of these laws into English in order to strengthen cooperation with trading partners and multinational firms doing business in Korea. Over the past decade, Korea has moved generally towards more science-based food laws. However, at times the Korean regulations lack specificity, which in turn generates confusion because of multiple interpretations. The regulatory process is also heavily influenced by vocal industry and consumer groups, as well as politicians. In some cases, regulators sometimes give way to these outside, populist-driven influences when drafting regulations. The best example of this was right after the candlelight beef protests in 2008 when the government embarked on a campaign to win back consumer confidence in the nation‟s food safety system. Although the plan included some needed science-based improvements, there were several proposed measures like the ban on certain tar colors used in processed foods and beverages that clearly went beyond the realms of established science. In the tar color case and several others since that time, Korea has pointed to the European Union as the basis for its action. Historically, Korea modeled its regulatory system after the U.S. system. But, in recent years has been influenced by the European-based food safety model. Regulators also cite the consumers‟ right to know as the reason for proposing new regulations, such as the draft measure to expand biotech labeling for processed products like sugar, oils, and syrups derived from biotech crops even though these products do not contain any modified protein. While this particular measure has stalled within the Regulatory Reform Committee within the Prime Minister‟s Office due to concerns voiced by trading partners and local food manufacturers, the justification of consumers‟ right to know will continue to be bandied about by Korean regulators for the foreseeable future. In addition, some proposed measures sometimes are seemingly developed without regard for the impact on trade. As a result, regulators spend a great deal of time revising draft regulations such that they are consistent with international standards or in some cases the proposal is completely abandoned. The major ministries and agencies involved with the Korean food system are the Ministry of Health and Welfare (MHW), the Korean Food & Drug Administration, and the Ministry of Agriculture, Food, Forestry & Fisheries (MIFAFF), the Ministry of Knowledge & Economy (MKE), and the Prime Minister‟s Office (PMO). The following is a brief description of each organization‟s role and the relevant laws and regulations that govern their respective operations. A. Ministry of Health and Welfare (MHW): The MWH‟s main role is to protect public health and safety, including food safety. MHW oversees KFDA and both work together to ensure that both domestic and imported food are safe. Key MHW laws follow below. Food Sanitation Act: is the legal basis for the food safety-related work conducted by MHW and the Korea Food & Drug Administration (KFDA). Among other things, pesticide and veterinary drug standards are governed under this law. Functional Food Act: provides the legal basis for MHW and KFDA oversight of functional foods, such as health foods and nutritional supplements. Special Act on Children‟s Dietary Life Safety Management: provides the legal basis for MHW and KFDA's determination and oversight of food products preferred by children. This Act restricts the sales and advertisements of high calorie low nutrient food products and introduces a voluntary color-coded labeling system. B. Korea Food & Drug Administration (KFDA): KFDA with its six regional offices is responsible for setting and enforcing standards and specifications for domestic and imported foods, functional foods, food additives, food packaging, containers and equipment. KFDA establishes the guidelines for implementing the Hazard Analysis of Critical Control Point (HACCP) program and recall systems for food products, excluding livestock and dairy products, which are regulated by MIFAFF. In addition, KFDA sets and implements regulations governing safety evaluations of agricultural products enhanced through biotechnology and labeling requirements for processed food products manufactured using GMO ingredients. Several of the key KFDA regulations are listed below. Food Code: stipulates standards and specifications for manufacturing, processing, usage, cooking, storage of food and equipment, containers and packaging for food products. It specifies the standards for maximum residue levels of agricultural chemicals, antibiotics, synthetic antibiotics, hormones, radioactive ray standards, testing methods, etc. The Food Code contains general standards and specifications governing food products and individual standards and specifications. Food Additive Code (English): defines standard specifications for individual food additives and usage standards. See Section IV for more details on additive requirements. Labeling Standards for Food: provides guidance on how to meet KFDA‟s Korean language labeling requirements for imported food products. See Section II for details on labeling requirements. Labeling Standards for Recombinant Food: provides standards required for labeling of processed food products containing corn, soybeans, cotton, canola, and sugar beets with 3 percent or higher GMO content. See Section II for details. Functional Food Code: contains general standards and specifications governing functional foods, and individual standards and specifications for functional food categories. Inspection Guidelines for Imported Food: checklist for imported food products detailing testing, sampling and other pertinent inspection standards. C. Ministry for Food, Agriculture, Forestry and Fisheries: The Ministry for Food, Agriculture, Forestry and Fisheries (MIFAFF) establishes and enforces regulations and standards pertaining to agricultural products, including livestock and dairy products as well as forestry and fishery products. Several of the key MIFAFF regulations are listed below. On June 15, 2011, the Animal, Plant and Fisheries Products Quarantine Inspection Agency (QIA) was created by merging the National Veterinary Research & Quarantine Service, the National Plant Quarantine Service, and the National Fisheries Products into one single agency. The purpose behind the consolidation was to make the Ministry more efficient and effective in managing food safety and animal health issues. QIA is responsible for establishing sanitary controls, standards, specifications and labeling requirements for domestic and imported livestock and dairy products, HACCP, and recalls for meat, poultry, eggs and dairy products. QIA is also responsible for preventing the introduction of harmful weeds, pests and disease originating from imported plants, fruits and vegetables. The Agency‟s organization chart (English) shows the various subdivisions and their respective areas of responsibility. The National Agricultural Product Quality Management Service (NAQS) is responsible for setting quality standards and grades for agricultural products, enforcing country of origin marks, GMO labeling, and organic labeling for fresh fruits, vegetables, and grains in the marketplace, and organic certifier accreditation for non-processed organic produce. In addition, NAQS collects samples from retail markets and tests products for GMO content with RDA-developed testing methods. Livestock Product Sanitary Management Act: specifies requirements for the slaughter and handling of livestock and the processing, distribution and inspection of livestock products. The Act is the legal basis for setting health standards provided in the Livestock Code. Livestock Code (Processing Criteria and Ingredient Specifications for Livestock Products): provides health standards for meat, poultry and dairy products, such as microorganism standards, criteria and standards for livestock products, etc. Labeling Standards for Livestock Products: provides the labeling standards for livestock products, containers, equipment, as well as packaging requirements. Import Health Requirements for Various Animals: MIFAFF‟s Quarantine Policy Division (QPD) sets quarantine requirements for live animals and animal products. The certification requirements for U.S. livestock products are available on the USDA‟s Food Safety & Inspection Service (FSIS) website. Plant Protection Act (Excerpts in English): safeguards agricultural and forestry production by establishing quarantine regulations for imported and domestic plants. Import Plant Inspection Guideline: defines inspection procedures for imported plants and plant materials and establishes specific principles for the inspection and disposition of imported plants. Agricultural Products Quality Management Act: includes provisions governing GMO labeling for bulk grains, country of origin marks, geographical indication (GI), trace-back, etc. . Guideline for Labeling of Genetically Modified Agricultural Products: provides details on labeling requirements for unprocessed GMO commodities. See Section II for details. Environment-Friendly Agriculture Promotion Act: promotes environmentally sustainable “organic” agriculture. This Act is the legal basis for MIFAFF‟s organic certification program for fresh food products. Food Industry Promotion Act: promotes the development of the food industry and to improve its competitiveness by ensuring a stable supply of quality agricultural goods for the domestic industry. This Act is the legal basis for MIFAFF‟s organic certification program for processed food products. Guideline for Country of Origin (COO) for Agricultural Products: provides COO labeling requirements for domestic agricultural products and raw materials used in domestically processed agricultural products. COO labeling of imported agricultural products is required under Article 53 of the Presidential Decree of the Foreign Trade Act. D. Ministry of Knowledge Economy The Ministry of Knowledge Economy (MKE) is the national competent authority for implementation of the Cartagena Protocol on Biosafety (CPB). Korea ratified the Cartagena Protocol on Biosafety (CPB) on October 2, 2007. Shortly thereafter, on January 1, 2008, Korea implemented the Act on Living Modified Organisms, or LMO Act, which is the implementing legislation for the CPB and the overarching law governing the country‟s biotechnology related rules and regulations. For more information on Korea‟s biotech regulatory system, please refer to the 2011 Biotech Annual Report for Korea. The LMO Act and its subordinate regulations are identified below. LMO Act: implements the Cartagena Protocol on Biosafety and to ensure the safe development, production, importation, exportation, commercialization, etc., of living modified organisms. This Act provides guidance on import approval, mandatory risk assessment, labeling, etc., of living modified organisms (LMO) or GMO commodities. Of note, MKE is in the process of revising the Act, which is now pending approval in the National Assembly. o Enforcement Decree of the LMO Act: establishes the responsibilities of the relevant government agencies; the procedures for the importation, production, export notification, transit report, etc., of LMOs; procedures for designating the agencies responsible for risk assessments and specialized review agencies; labeling and handling requirements; the creation and operation of a bio-safety clearing house, etc. o Enforcement Rule of the LMO Act: stipulates the provisions delegated by the LMO Act and its Enforcement Decree and the provisions deemed necessary to implement the Act and Decree. This Rule includes document requirements for import approval of LMOs, safety assessments, environmental risk assessments, production approval, etc. o Consolidated Notice: This notice provides guidelines for export and import of LMOs for intended for agricultural use, intended for environmental release, intended for food, feed and processing and other use. E. Prime Minister’s Office In the wake of the beef protests in 2008, the National Assembly passed the Framework Act on Food Safety. Under this law, the Prime Minister‟s Office was given the lead to coordinate the country‟s food safety controls across the various ministries and agencies. According to the new Act, each relevant agency was tasked with developing a comprehensive 3-year food safety plan. In order to facilitate integration of these various plans, the law called for the establishment of a food safety committee with the Prime Minister serving as the chairperson. Committee members include: the Minister of Strategy and Finance, the Minister of Education, Science and Technology, the Minister of Justice, the Minister for Food, Agriculture, Forestry and Fisheries, the Minister of Health and Welfare, the Minister of Environment, the Commissioner of the Korea Food and Drug Administration, and Minister of the Prime Minister‟s Office. Section II. Labeling Requirements: A. KFDA Labeling Standards KFDA‟s Food Safety Policy Division develops labeling standards, while the regional offices inspect imported foods and enforce labeling requirements upon arrival. As an aside, provincial authorities also have the authority to verify labeling of domestic and imported goods in the marketplace. All imported food products are required to carry legible Korean language labels. Stickers may be used, but should not be easily removable nor should they cover the original label. Labels must contain the following information listed below. Product name. The product name should be identical to the product name declared to the licensing/inspection authority. Product type. This is mandatory for specially designated products, such as teas, other beverages, extract products, special purpose foods, etc. Importer's name and address, and the address where products may be returned or exchanged in the event of defects. Manufacture date (date, month, and year). This is mandatory for specially designated products, such as boxed lunches, rice roll in seaweed, hamburgers, sandwiches, sugar, liquor (excluding beer and Korean traditional rice liquor since they are required to indicate shelf life), and salts. For liquors, a manufacture number (lot number) or bottling date can substitute for the manufacture date. Shelf life or best before date. Food product labels should indicate the manufacturer-determined shelf life. Products including: jams, saccharide products (e.g. dextrin, oligosaccharide, and fructose), teas, coffee, sterilized beverages, bean based sauce and paste, sterilized curry products, vinegar, beer, starch, honey, wheat flour, etc. can use either a best before date or a shelf life date on the product label. If various kinds of products are packaged together, the shelf life expiration date of the product with the shortest life should be noted on the label. Contents (Calories). Weight, volume or number of pieces should be indicated. If the number of pieces is shown, the weight or volume must be indicated in parentheses. Calories are only required for food products subject to nutritional labeling. Ingredient names and content. The names of all ingredients are required on the Korean language label. However, for those products with a principal display panel smaller than 30 cm2, only the top five ingredients are required. Composite Ingredients. Artificially added purified water and names of ingredients used to make a composite raw ingredient amounting to less than five percent of the product in weight will be excluded from the requirement. In case of a composite raw ingredient amounting to less than five percent of the product by weight, only the name of the composite raw ingredient must be listed on the Korean language label. In the case of a composite raw ingredient amounting to over five percent of the product by weight, the names of all ingredients contained in the composite raw ingredient must be listed on the Korean language label. Ingredients must be listed in order of predominance by weight, that is, the ingredient that weighs the most is listed first, and the ingredient that weighs the least is listed last. Additives. Food additives must also be listed by full name, abbreviated name, or purpose on the label (e.g. Ferric Citrate, FECitrate, or nutrient fortified substance). Allergens. Food items known to be food allergens must be indicated on the label even if they are added as part of a mix at minimal levels. Food items considered as food allergens include eggs, milk, buckwheat, peanuts, soybeans, wheat, mackerel, crab, shrimp, pork, peaches, tomatoes and excessive levels of SO2. Any food product containing one or more of these allergens as a raw ingredient(s) must be indicated on the Korean language label. Nutrients. Only designated products are subject to nutritional labeling. Please see nutritional labeling section below for more details. Other items designated by the detailed labeling standards for food. This includes cautions and standards for use or preservation (e.g., drained weight for canned products, radiation-processed products, etc.). Of note, effective April 30, 2010, the use of photos or pictures of fruit is no longer permitted on the label unless the product contained the corresponding natural flavor or ingredient. Inner packaging labeling is voluntary for products when the area of the largest side is over 30cm2. Product name, net content, calories, shelf life or the best before date, and nutrients may be included on the inner package label. There are several categories exempted from the abovementioned labeling requirements. Agricultural products such as grains; fishery items, such as whole frozen fish; and fruits, that are not contained in a container or package, etc. Foods to be used for manufacturing for a company‟s own use. Appropriate documentation must be provided to verify end-use. In this case, the name of the product, the name of the manufacturer, and manufacture date or shelf life or best before date shall be indicated on the original package either in English or in a language of an exporting country. Products imported for the purpose of acquisition of foreign currency, under the provisions of Article 34 of the Ministerial Ordinance to the Foreign Trade Act. Nutritional Labeling Requirements In accordance with Article 6-1 of the Enforcement Rule of the Food Sanitation Act, nutritional labeling (example below) is required for the four food categories listed below. In addition, nutritional labels must be in Korean and must also use the nutrient reference values provided below. Special purpose food products Bread (cake, doughnuts, bread loaf, other bakery goods), noodles, retort foods, edible oil and fats and dumplings Candy, chocolate, confectionary goods such as cookies, biscuits, and snacks, jam, and beverages (Note: Nutritional labeling on an outer container or a package that contains retail sales unit products of candies, gums, and chocolates is voluntary.) Frozen dessert (ice candies), fish sausages, rice roll, hamburgers, and sandwiches The above products are exempt from labeling if used as an ingredient. Products not included in these four categories are not subject to mandatory nutritional labeling, but are allowed to use the standard U.S. nutritional fact panel if it is part of the original product label. In addition, if a specific nutrient is emphasized, the exact content must be labeled. For example, if a yogurt is labeled as “calcium enriched”, the exact content must be indentified on the label. Nutrition Facts Serving size 00 (00 g) Total serving size (00g) Amount per serving *% daily value Calories 000kcal Carbohydrat 00g 00% e Sugars 00g Protein 00g 00% Fat 00g 00% Saturated 00g 00% Trans fat 00g Cholesterol 00mg 00% Sodium 00mg 00% % daily values: percentages of daily reference values Note: This information is included here in English for the reader. The actual label, though, must be in Korean. Nutrient Reference Daily Values Nutrients Values Nutrients Values Carbohydrate (g) 328 Vitamin B2 (mg) 1.2 Dietary fiber (g) 25 Niacin (mg NE) 13 Protein (g) 60 Vitamin B6 (mg) 1.5 Fat (g) 50 Folic acid (μg) 250 Saturated fat (g) 15 Vitamin B12 (μg) 1.0 Cholesterol (mg) 300 Biotin (μg) 30 Sodium (mg) 2,000 Pantothenic acid (mg) 5 Potassium (mg) 3,500 Phosphorus (mg) 700 Vitamin A (μg RE) 700 Iodine (μg) 75 Vitamin C (mg) 100 Magnesium (mg) 220 Calcium (mg) 700 Zinc (mg) 12 Iron (mg) 15 Selenium (μg) 50 Vitamin D (μg) 5 Copper (mg) 1.5 Vitamin E (mga – TE) 10 Manganese (mg) 2.0 Vitamin K (μg) 55 Chrome (μg) 50 Vitamin B1 (mg) 1.0 Molybdenum (μg) 25 Vitamin A, Vitamin D, and Vitamin E must be expressed in the units specified above, but the values in International Units (IU) may be stated in parentheses. Voluntary Color Coded Labeling System The May 21, 2009 revision to the Special Act on Children‟s Dietary Life Safety Management finalized a voluntary color coded labeling system, which is also referred to as a traffic light label, for children‟s preferred food products. The National Assembly had originally aimed to make the system mandatory. However, due to concerns raised by industry, the proposed system was finalized as a voluntary system. Food products may label the total fat, saturated fat, sugar, sodium and other nutrients using the traffic light system. This new system started from January 1, 2011. High Caffeine Content Labeling Requirements The March 7, 2005 revision to the labeling standards for food introduced a “high caffeine content” declaration requirement for beverages containing high levels of caffeine. Products with artificially added caffeine and liquid products made from raw material containing caffeine where the level of caffeine in the liquid product exceeds 0.15 mg/ml are required to state that the product has “high caffeine content” on the principal display panel with the exception coffee or tea. However, the November 7, 2011 revision expands the aforementioned requirement to coffee and tea. It also requires high caffeine caution label for children, pregnant women and people sensitive to caffeine and mandates the caffeine content to be stated on the label. This requirement will be enforced beginning January 1, 2013. Functional Food Labeling Requirements Labeling Standards for Functional Food were established January 31, 2004. The latest version was published in May 2011. In accordance with these standards, a manufacturer‟s printed Korean language label must be on the product. It should have the following information, in addition to those required for general food products listed above: (1) functional food to be indicated;( 2) information on the efficacy claim;(3) intake directions and cautions; (4) a statement that the product is not a pharmaceutical product that prevents or heals disease; and, (5) other points as required in the detailed labeling guidelines for functional food. As for a simple minor error in the printed label, such as a typo, a sticker can be affixed to correct the error. KFDA’s Processed Organic Food Certification & Labeling Requirements The certification and labeling standards for processed organic products are defined in KFDA‟s Labeling Standards for Food. Please note that these requirements will remain effective until December 31, 2012 at which time MIFAFF will assume full regulatory authority over organic products. More information on MIFAFF‟s organic certification system is available in the next section. Organic raw materials of imported food products must be equal to or better than the quality standards specified in Article 17 of the Environmental Agricultural Promotion Act and Article 9, Annex 3, Paragraph 2 and 3 of the Enforcement Regulations of the Act. If organic raw materials of imported food products are not subject to the quality standards specified in the above Korean regulations, such products must meet the relevant quality standards of the exporting country. Organic and non-organic agricultural products cannot be mixed. Only raw materials on the permitted list (Table 3 of KFDA‟s Labeling Standards for Food) can be used in the manufacture or processing of organic food products. In accordance with the Labeling Standards for Food, “raw material” is defined as a material, except for purified water purposely applied to the product, that is used for the manufacturing, processing or cooking of food or food additives and that are contained in the final product. Irradiated raw materials are prohibited. Genetically modified foods or food additives cannot be used or detected. The determination as to whether an imported food meets the standards may be based on a certificate issued by a competent certification body, such as the government authority of the exporting country or an internationally recognized entity like IFOAM. (Note: KFDA recognizes U.S. organic products certified by certifying agents located in the United States accredited under the USDA/AMS National Organic Program). Labeling of processed organic products may be done in the following manner depending on the content of the ingredients. 100%: when the finished food product does not contain any other food or food additive except for organic agricultural ingredients, the label “100% organic agricultural product” or similar labels may be used. Not less than 95%: when not less than 95 percent of the raw materials contained in the finished food product are organic agricultural ingredients, the term “organic” or similar terms may be used as a part of the product name and stated on the main labeling panel of the container or package; and the name, seal and logo of the organization that certified the organic agricultural produce used in the product, as well as other certification information, may be stated. In this case, the content of the organic agricultural ingredients must be stated in percentage terms on the raw material section of the label. Less than 95% but more than 70%: when 70 percent or more but less than 95 percent of raw materials contained in the finished food product are organic agricultural ingredients, the term “organic” or similar terms may be stated on a labeling surface of the container or package other than the main labeling panel. In this case, the content of the organic agricultural ingredients must be stated in percentage terms on the raw materials section of the label. Others: for other organic foods, the term “organic” or similar terms may be used as a part of the names of such ingredients on the raw materials section of the label. In this case, the content of individual organic agricultural ingredients must be stated as a percentage. B.MIFAFF Labeling Standards MIFAFF’s Certification and Labeling Requirements for Processed Organic Foods Under the Food Industry Promotion Act, MIFAFF introduced a mandatory organic certification program for processed organic food products in June 2008. This program, which will be fully implemented starting January 1, 2013, will require all domestic and imported organic processed products to be certified by a MIFAFF-accredited certifying agent. (Note: Processed organic products produced according to KFDA‟s labeling requirements, which clear customs on or before December 31, 2012, will be eligible to be sold in the marketplace until their shelf life expires.) MIFAFF‟s accreditation and certification system will operate as shown in the flow diagrams below. Accreditation Procedures for Organic Certifiers To date, five Korean certifying agencies and four foreign certifying agencies have been accredited by MIFAFF. Although no U.S. certifier has been accredited, the United States plans to work with Korea towards equivalence in hthat Korea would recognize products certified under USDA‟s National Organic Program (NOP). Certification Procedures for Organic Producers 1. Application for certification: A person who desires certification should apply to a certifying agency using the form in Attachment 13 of the Enforcement Rule of the Food Industry Promotion Act accompanied by a copy of a food item manufacturing report, an organic handling plan, documents evidencing that the raw materials and additives meet the certification standards. At the time of application, the applicant should also pay the fee as determined by the certifying agency. 2. Documentation review: Once the documents have been submitted, the certifying agency reviews the documents to determine whether the content of the documents is in compliance with the standards set forth under the Act. If any non-compliance is identified during the review, the applicant is notified of the fact and requested to correct the non- compliance. 3. On-site inspection: If no problems are identified during the document review, the certifying agency sends inspectors (usually two people) to the applicant‟s production facility. An inspector should not have a conflict of interest with regard to the certification of the applicant. He or she conducts the evaluation based on objective facts to determine whether the organic handling system of the applicant‟s production facility complies with the standards set forth under the Act and then prepares a report on the results of the review. 4. Certification decision: Once the review report is submitted, the certifying agency takes into consideration the review report and all other relevant information from the applicant. The inspectors who conducted the on-site inspection of the applicant are not allowed to participate in the decision-making process, nor can they provide opinions on the decision. 5. Certificate issuance: If the applicant is determined as having an organic handling system in compliance with the standards set forth under the Act at his/her production facility, the certifying agency issues a certificate. In the case of non-compliance, the applicant will be notified and another review will be conducted after corrections have been made. Depending on the severity of the non-compliance, other actions may be taken. 6. Annual inspections: After issuance of a certificate, the applicant's production facilities will need to be regularly inspection at least once every year. The procedures are the same as those of the initial certification. Three months before the validity of the certification expires, the applicant should submit a regular inspection application (using the form in Attachment 12 of the Enforcement Rule of the Act) with required documents to the head of the certifying agency. MIFAFF’s Labeling Regulations for Organic Agricultural Products Under the Environment-Friendly Agriculture Promotion Act, a mandatory organic labeling system was instituted for both fresh (unprocessed) produce and livestock products. The certification for organic produce is classified into three categories: organic, no-pesticide, and low-pesticide (to be discontinued by 2016). For livestock products, two categories of certification are available: organic livestock and no antibiotic livestock. Unlike KFDA‟s labeling regulations for organic processed products, organic agricultural produce and livestock products complying with the U.S. organic standards or international standards still require certification from a MIFAFF-accredited certification agency. Of note, MIFAFF is currently in the process of consolidating the Environment-Friendly Agriculture Promotion Act and the Food Industries Promotion Act to simplify and streamline the rules and regulations covering both processed and fresh organic products. After this process is complete, the United States and Korea plan to work towards negotiating an equivalence arrangement that will cover both processed and fresh organic products, including livestock and dairy products. C. Labeling Standards for Livestock Products (Administered by MIFAFF) QIA develops labeling guidelines for livestock products including meat, dairy and egg products, which are similar to KFDA‟s labeling guidelines. According to Article 4 of the Labeling Standards for Livestock Products, the items below are required to be listed on the Korean language label. Product name Type of livestock product Name and address of company Manufacture date – month and year (only required for certain products) Shelf life Content Names of ingredients or raw materials and the percentage content by weight (percentage content is required if any ingredients are part of the product name or indicated on the principal display panel) Nutritional labeling is required for milk, fermented milk, processed milk, ice cream, milk formula, milk powder and sausages Other items specified in Article 7 of the Labeling Standards for Livestock Products, according to the “Detailed Labeling Standards for Livestock Product et al.” Imported livestock products may be exempt from the Korean language labeling requirements if the product falls into one of the following categories: Carcasses Large packaged products (bulk type), limited only to raw materials to be repackaged prior to sale Raw materials for manufacturing processed livestock products (i.e., frozen turkey to be used in manufacturing sausages. In this case, the original foreign label must bear product name, manufacturer‟s name, shelf life or manufacturing date) Products permitted to be imported for the purpose of earning foreign currency per the Foreign Trade Management Regulations D. Labeling Regulations for Unprocessed GMO products (Administered by MIFAFF) Biotech labeling for unprocessed biotech food grade commodities includes all crops approved by KFDA for human consumption. These types of shipments must comply with the MIFAFF labeling requirements outlined below. To be exempt from mandatory GMO labeling, either full IP documentation or a government issued certificate proving the products in question are non-GMO is necessary. 1. Raw GMO agricultural commodities must be labeled as “Genetically Modified XX (insert the name of the agricultural product).” 2. Agricultural commodities containing a GMO component must be labeled as “Containing Genetically Modified XX (insert the name of the agricultural product).” 3. Agricultural commodities that possibly may contain a GMO agricultural component must be labeled as “May contain Genetically Modified XX (insert the name of the agricultural product).” 4. Raw unprocessed agricultural commodities that are 100-percent GMO free may be labeled as “Non-GMO” or “GMO Free” on a voluntary basis. The usage of these terms is limited to products under MIFAFF‟s purview. KFDA discourages the use of such terms on processed products. See GAIN Report KS1004 for details. E. Labeling Standards for Recombinant Food (Administered by KFDA) In August 2000, KFDA announced the Labeling Standards for Recombinant Food, which refers to processed food products containing ingredients enhanced through biotechnology. The list of products subject to GMO labeling includes any crop that is approved by KFDA as safe. If these crops are among the top five ingredients, and recombinant DNA or foreign protein DNA is present in the final product, GMO labeling is required. Of note, foods containing refined ingredients derived from GM crops, such as cotton and canola oils, and raw sugar are currently exempt from the labeling requirement since a foreign protein is not present in the finished products. “Recombinant Food” or “Food Containing Recombinant XX” (e.g., “Food Containing Recombinant Corn”) must be used for a food known to contain 100 percent biotech-enhanced ingredients. The text is to be indicated on the principle display panel in such a way that the consumer may easily recognize the label. “Recombinant” or “Recombinant XX” (e.g., “Recombinant Corn”) must be used for a food known to contain a biotech-enhanced ingredient. The text is to be indicated in parentheses beside the name of the GMO ingredient listed as a raw material of the food. “May contain Recombinant XX” must be used for a product if an exporter or importer is unsure whether it contains a GMO ingredient or not. Colors used to label the recombinant nature of the food shall be clearly distinguishable from the color of the container or package. Indelible ink, a stamp, brand, etc., shall be used so that the consumer may easily find the label. Non-detachable stickers may be used for imported foods or food additives. Indelible ink, stamp or brand, etc., must be used. The use of "Non-GMO" and "GMO Free" labels on processed foods is discouraged. A test certificate issued by an accredited domestic laboratory, foreign government or foreign commercial laboratory is acceptable if it confirms the absence of recombinant DNA or foreign protein in the final product. Please refer to KS 6064 for details about testing methods. A list of approved laboratories is found in Appendix I of this report. If the imported product arrives without appropriate test certificate, it can be tested in Korea prior to customs clearance. If the product tests positive, it must carry be labeled as GM. F. Liquor Labeling (Administered by Korea Tax Administration) Liquor product usage must be labeled on the main label or the supplementary label. For soju, beer, whisky, and brandy, the label should state “for home use” or “for large size stores”. These liquors must also carry a statement on the main label or supplementary label that reads: “Not allowed to be sold in restaurants and bars”. For wine products, only home consumption use must be labeled, whereas a label is no longer required for other uses. The table below shows which usage label is required for each particular liquor product. Soju, Beer, Whiskey, Brandy Fruit Wine Rice Wine Others (1) “for large size stores” (1) “for home use” No label is required (1) “For home use” (2) “for home use” As noted in the section on KFDA‟s labeling standards, the use of a photo or a picture of fruit or ingredients on the product label for products that contain only synthetic flavors is prohibited, effective April 30, 2010. This restriction applies to liquor products as well. G. Country of Origin Labeling (COOL) - (Administered by MIFAFF) According to COOL guidelines, many agricultural products, including most imported products, must carry of country of origin marking. As for imported products, the Korea Customs Service (KCS) enforces COOL requirements at customs clearance. The National Agricultural Product Quality Management Service (NAQS) enforces COOL requirements in the marketplace. There have been some notable COOL developments over the last few years. In 2006, KCS tightened the enforcement of COOL for meat products, requiring inner package labeling. The following statements are acceptable: “Made in U.S.A.”, “Made in U.S.”, or the U.S. mark of inspection – “U.S. inspected and passed”. In 2008, KCS agreed that imported fruit such as oranges, bananas, did not require COOL on the individual pieces of fruit. H. Other Labeling Requirements The Korean government requires beef retailers and distributors to keep the track of all transactions from the importing stage to the final retail level. Imported beef is required to be traceable via a distribution identification number up to the retail store level. See GAIN Report KS1033 for further details. In July 2010, the KFDA and MIFAFF labeling requirements were revised to allow the use of a tag as an acceptable means of labeling certain products. In addition, the revision permits the use of a statement „contains irradiated ingredients‟ for those products with multiple irradiated ingredients. Section III. Packaging and Container Regulations: KFDA‟s “Standards & Specifications for Equipment and Container/Packaging” in Chapter 7 of the Korean Food Code, includes general standards for equipment, container and packaging for food products and specifications for individual packaging materials. Containers or packages that can be recycled must carry a “separation and discharge” marking. In accordance with the Act on the Promotion of Saving and Recycling of Resources and its corresponding Decree, containers or packages that are made using paper, metal, glass, plastic materials, and synthetic resins must be marked with a “separation and discharge” sign. The mark is to facilitate the recycling of wastes. The sign should indicate the type of material the package is composed of. For example, PET, HDPE, LDPE, PP, PS, PVC, or Other should be indicated for containers or packaging made of plastic materials. For metals, either iron or aluminum should be indicated. Either a printed label or a sticker label is acceptable. This requirement has been in place since January 1, 2003. Section IV. Food Additives Regulations: KFDA‟s Food Additive Code stipulates how additives should be used in foods. As of December 2011, Korea had a positive list of 653 approved food additives. Food additives are grouped into four categories: (a) chemical synthetics, (b) natural additives, (c) mixed substances, and (d) sanitizers. Most additives and/or preservatives are approved and tolerance levels are established on a product-by-product basis. This sometimes creates difficulties as tolerances can vary from product to product. Even though there may be an established CODEX standard for a given food additive, if that food additive is not registered in the Korean Food Additive Code, or even if it is registered but usage in a certain food product is not specified, use of that food additive in the given food product is prohibited. Getting a new additive added to the approved list usually takes about a year. The “Guidelines for Designation of Food Additives” explains the detailed information required for the approval of a new additive. Section V. Pesticides and Other Contaminants: Three government agencies – the Korea Food & Drug Administration (KFDA), the Ministry for Food, Agriculture, Forestry and Fisheries (MIFAFF) and the Ministry of Environment (MOE) – handle pesticide related matters. KFDA regulates pesticide residues in foodstuffs. MIFAFF is responsible for pesticide registration and MOE is responsible for testing pesticide levels in water, soil and agricultural products. KFDA is responsible for regulating pesticide residues in foodstuffs, in accordance with the maximum residue levels (MRLs) set in the Food Code. As of December 2011, KFDA has set MRLs for 425 pesticides in agricultural products and 67 pesticides in ginseng products. The Food Code also lists MRLs for 83 pesticides and 110 veterinary drugs in meat, fish, eggs and milk products. In addition to the Food Code, KFDA has set-up an MRL Database for agricultural products with English subtitles. If an MRL is established in the Food Code for a pesticide on a particular agricultural product, other tolerance levels, such as CODEX, etc., are not accepted. However, for pesticides where tolerance levels have not been established in the Korean Food Code, rules described below are applied. For details about regulations for MRLs for agricultural products, please refer to GAIN report KS 4040. 1. The CODEX standards set for a particular agricultural product (excluding crop groupings) in question shall apply. 2. If the provision in (1) is not applicable, the lowest residue limit for the pesticide in question for a similar agricultural product shall apply. 3. If provisions in (1) and (2) are not applicable, the lowest of the residue limits of the pesticide for any agricultural crop shall apply. Pesticide Registration The Rural Development Administration (RDA) under MIFAFF is responsible for the registration of pesticides, safety usage standards and notification of pesticides. All pesticides used in Korea should be registered with RDA. The registration process, which is shown in the diagram below, can take several years to complete. At the end of 2010, there were a total of 1,431 registered agrochemicals. A list of all registered agrochemical items can be obtained from the Korea Crop Protection Agency. KCPA also has an English Pesticide Handbook listing the chemical and commercial names for the registered compounds. Source: Korea Crop Protection Association Section VI. Other Regulations and Requirements: A. Product Registration & Import Inspection No product registration is required to import food products into Korea. However, all new to market products are subject to mandatory laboratory testing conducted by the relevant inspection agency. Subsequent shipments of the product that have passed the first laboratory testing will be exempt from additional testing. For more details about import inspection, see Section IX. B. Sanitary and Phytosanitary Certification Requirements – Animals, Meat, Plant, etc. In accordance with the Livestock Epidemics Prevention & Control Act, the Plant Protection Act, and the Livestock Products Sanitary Management Act, sanitary and phyto-sanitary certificates issued by the exporting country‟s inspection authority are required for live animals, plants and meat products, such as beef, pork, poultry, etc. For the United States, the U.S. Department of Agriculture (USDA), Animal & Plant Health Inspection Service (APHIS), issues sanitary and phytosanitary certificates for live animals and plants, while the USDA, Food Safety & Inspection Service (FSIS), issues health certificates for meat products. More details on certification requirements are found in the annual FAIRS Export Certificate Report. C. StarLink Free Certification In March 2008, KFDA eliminated mandatory requirements for a StarLink free certificate for U.S. origin corn and corn based products. However, KFDA still maintains 100 percent testing of all corn shipments declared as biotech to confirm the absence of StarLink. KFDA does not test non-biotech corn shipments. D. Bt 10 Free Certification In March 2008, KFDA eliminated mandatory requirements for a Bt 10 free certificate for U.S. origin corn shipments. In April, 2010, KFDA also eliminated 100 percent testing for all corn imports to confirm the absence of Bt 10. E. LLRice Statement and Test Certification After the discovery by U.S. authorities of trace amounts of Liberty Link Rice (LLRice) 601 in the U.S. rice supply in August 2006, the Ministry for Food, Agriculture, Forestry and Fisheries requires a statement issued by the USDA/GIPSA about laboratories participating in GIPSA‟s proficiency program and a non-GMO certificate issued by one of the participating laboratories. In addition to the statement and test certificate requirement, the Korean government instituted multiple testing requirements to verify the absence of all LLRice events in shipments of U.S. rice. After the first test conducted by the laboratory participating in the USDA/GIPSA‟s Liberty Link Rice Proficiency Program, the Overseas Merchandise Inspection Company (OMIC) will conduct the second test prior to loading. KFDA requires all incoming shipments of U.S. rice to be tested upon arrival and NAQS is conducting monitoring testing after the shipment passes KFDA inspection. Please refer to GAIN Report KS 7044 for details about LLRice testing requirements. Beginning in 2012, KFDA-accredited laboratories can conduct LLRice testing prior to departure. Rice shipments accompanied by a test certificate will be exempt from mandatory arrival testing. To date, no laboratories have been accredited, though several are reportedly interested. F. Samples General processed food products are not subject to import requirements as long as they are considered as samples. For sample shipments, the invoice should be marked as having no commercial value. If the volume or the market value is not considered a sample, it will be subject to import requirements. A phytosanitary certificate and a meat export certificate are required for products subject to quarantine inspection even if they are shipped as samples. G. Monitoring at Retail & Wholesale Levels KFDA conducts monitoring at retail and wholesale levels for processed food products including processed meat products such as canned meat, while QIA/MIFAFF conducts monitoring for non-processed meat products in the retail and wholesale markets. In addition to KFDA and QIA/MIFAFF, the municipal government also conducts monitoring for any food products distributed at the retail and wholesale levels. Section VII. Other Specific Standards: On March 5, 2002, the Korean Fair Trade Commission (FTC) announced new advertisement requirements for food containing a biotech-enhanced ingredient that became effective July 1, 2002. The FTC, in its revision of the “Notification of Principle Information on Labeling & Advertisement” guideline, defines the “presence” of a biotech component as principal information that must be provided in an advertisement for any food product that requires biotech labeling. According to FTC‟s advertisement notification rules, anyone who manufactures or sells biotech-enhanced foods, and advertises such products in one of the identified forms below, needs to indicate the presence of the biotech component: Newspapers or magazines; T.V. commercials (when its running time is greater than two minutes); and, Cable T.V. commercials. The pertinent information must be noted as follows: "Contains biotech-enhanced food" when the presence of a biotech-enhanced component is certain; "May contain biotech-enhanced food" when the presence of a biotech-enhanced component is uncertain. Starting January 1, 2010, the KFDA Commissioner has the discretion to limit or prohibit TV advertisements of high calorie- low nutrient food products as designated by KFDA. According to the Special Act on Children‟s Dietary Life Safety Management, TV advertisements of the designated products are prohibited during the hours between 5:00 p.m. and 7:00 p.m. Also, commercials during children‟s programs may be restricted. KFDA has uploaded a computer program on its website where industry can verify whether a product is classified as high calorie-low nutrient food products. KFDA also posts a list of food products that are classified as high calorie-low nutrient food products on its website. For more details about restrictions on children‟s preferred food products and high calorie-low nutrient food products, please refer to GAIN report KS 9020. Section VIII. Copyright and/or Trademark Laws: The Korea Industrial Property Office is responsible for registration of trademarks and for review of petitions related to trademark registration. In accordance with the Trademark Law, the trademark registration system in Korea is based on a “first-to-file” principle. A person who registers a trademark first has a preferential right to that trademark and Korean law protects the person who has the right over the trademark. To prevent trademark disputes, U.S. companies considering conducting business in Korea are encouraged to register their trademarks prior to beginning their business operations. Section IX. Import Procedures: A. Customs Clearance Imports of agricultural products generally must receive clearance from several agencies and are, thus, more likely to encounter port delays than other imported products. The Korea Customs Service (KCS), KFDA, the National Quarantine Office (for ports that do not have KFDA regional offices), and the Quarantine Inspection Agency (QIA) are the agencies involved in the import clearance process. KCS is responsible for ensuring that all necessary documentation is in place before the product is released from the bonded area. The respective quarantine inspection authorities must clear products subject to plant or animal quarantine inspection before KCS will clear them. The import inspection application must be filled-out in Korean and submitted to the relevant agency. KCS Import Clearance Procedures Source: Korea Customs Service B. KFDA Import Procedures KFDA‟s import procedures are shown in the flow chart and points below. Source: Korea Food & Drug Administration 1. The importer or the importer‟s representative submits the “Import Declaration for Food, etc.” 2. The type of inspection to be conducted is determined in accordance with the guidelines for inspection of imported food products. The types of inspection that a given food product may be subject to include: document inspection, organoleptic inspection, laboratory inspection, and random sampling examination. (Note: Third country residue violations can trigger heightened testing.) 3. If a product is subject to organoleptic inspection, laboratory inspection and random sampling examination, the KFDA inspector will conduct a field examination and take samples for the laboratory test. 4. KFDA conducts the conformity assessment from the information collected, using such items as test results, document inspection results, etc. For perishable agricultural products, such as fresh vegetable, fruits, etc., an importer can clear the products prior to completion of the laboratory test with a pre-certification authorization from KFDA. In this case, however, the importer needs to be able to track distribution of the given product so the products can be recalled should the laboratory test indicate a violation. 5. If a product complies with the Korean standards, KFDA issues a certificate for import. An importer can then clear products through Customs. 6. If a product does not comply with the Korean standards, KFDA will notify the applicant and the regional customs office about the nature of the violation. The importer decides whether to destroy the product, return the shipment to the exporting country, or use it for non-edible purposes. If a minor violation can be corrected, as with labels, the importer can reapply for inspection after making the corrections. KFDA Inspection Duration Document Inspection 2 days Visual Inspection 3 days Laboratory Inspection 10 days Incubation Test 14 days Random Inspection 5 days C. QIA Inspection Procedures for Animal & Livestock Products Meat, dairy and egg products are subject to quarantine inspection and the quarantine certificate issued by the Animal, Plant and Fisheries Quarantine & Inspection Agency (QIA) is required for Customs clearance. The QIA quarantine inspection procedures for livestock products are outlined in the flowchart below. For details please refer to QIA‟s Animal & Livestock Product Inspection (English) requirements. Source: Animal, Plant and Fisheries Quarantine & Inspection Agency QIA Inspection Duration for Livestock Products: Document Inspection 3 days Visual Inspection 5 days Laboratory Inspection 18 days Incubation Test 18 days D. QIA Inspection Procedures for Plant Products In addition to KFDA inspection, plant products, including fresh vegetables, fruits and grains are subject to plant quarantine inspection. The plant quarantine certificate issued by the Animal, Plant and Fisheries Quarantine & Inspection Agency (QIA) and the KFDA certificate are required for customs clearance. QIA and KFDA inspection can occur simultaneously. Unless subject to further testing, QIA inspection generally is completed within 10-days. The QIA quarantine inspection procedures for plant products are outlined in the flowchart below. Additional details are available in QIA‟s Plant Quarantine (English) requirements. Source: Animal, Plant and Fisheries Quarantine & Inspection Agency Appendix I: Accredited Laboratories A. U.S. Laboratories Accredited by KFDA KFDA authorizes foreign laboratories to conduct inspection and testing, and to issue the necessary certifications. This enhances the efficiency of conducting inspection of imported foods and reduces the likelihood of rejection. There are currently only two accredited U.S. laboratories – Oregon Department of Agriculture (ODA) and OMIC. For GMO testing, KFDA had formerly been accepting test certificates from foreign laboratories. However, effective January 1, 2012, KFDA now will only accept GMO test certificates from KFDA-accredited laboratories. To date, no foreign laboratory has been accredited for GMO testing, though several are reportedly working toward that end. Oregon Department of Agriculture Export Service Center 1200 N.W. Naito Parkway, Suite 204 Portland, Oregon 97209-2835 Tel: 503-872-6644; Fax: 503-872-6615 E-mail: Authorized for food-related testing, such as residue and microbiological testing on food and beverages, food package, and health functional food, which are bound for Korea OMIC, USA Inc. Mr. Ryuichi Kurosawa, President 1200 N.W. Naito Parkway Portland, Oregon 97209 Tel: 503-224-5929; Fax: 503-223-9436 Authorized for food-related testing, such as residue and microbiological testing on food, beverages, and health functional food, which are bound for Korea B. Korean Laboratories Accredited by KFDA There are 14 Korean laboratories that have been accredited by KFDA for testing of imported food products. No. Name Web Address Accredited Testing 1 Korea Advanced Food Research Institute Food, Health functional food, Qualitative GMO testing, irradiated food testing 2 Korea Health Industry Development Food & Health functional food, Institute Parasite eggs in food 3 Korea Advanced Food Research Institute – Food & Health functional food Pusan Branch 4 Korea Food Research Institute Food & Health functional food 5 Korea Basic Science Institute – Seoul Dioxin Center 6 Korea Testing Laboratory Dioxin 7 Korea Research Institute of Analytical Food & Health functional food, Technology Qualitative GMO testing 8 Korea Health Supplement Institute Food & Health functional food, irradiated food testing 9 Kogene Biotech Qualitative GMO testing 10 Takara Korea Biomedical Qualitative GMO testing 11 SGS Testing Korea Qualitative GMO testing 12 JPNC Qualitative GMO testing 13 Advanced Radiation Technology Institute in Irradiated food testing Jungeup, Korea Atomic Energy Research Institute 14 Korea Institute of Nuclear Safety Radioactivity testing in food 15 Korea Atomic Energy Research Institute Radioactivity testing in food 16 Korea Basic Science Institute – Ochang Radioactivity testing in food Center 17 Nuclear Physics & Radiation Technology Radioactivity testing in food Institute, Pusan National University 18 Industry-Academic Cooperation Radioactivity testing in food Foundation, Chosun University Appendix II. Government Regulatory Agency Contacts: A. Primary Korean Food Agencies Ministry for Food, Agriculture, Forestry and Fisheries: Overall agricultural policy Bilateral Negotiation and Cooperation Division MIFAFF # 1 Choongang-dong, Kwacheon City Kyunggi-do, Korea 427-760 Phone: 82-2-500-1877; Fax: 82-2-504-6659 Korea Food & Drug Administration: Processed food products International Trade and Statistics Office KFDA #643 Yeonje-ri, Gangoe-myeon, Cheongwon-gun Chungcheongbukdo, Korea 363-951 Phone: 82-43-719-1551~1553 Fax: 82-43-719-1550 E-mail: Animal, Plant and Fisheries Quarantine & Inspection Agency (Headquarters) # 175 Anyangro, Manan-gu, Anyang City Kyunggi-do, Korea 430-757 Phone: 82-31-467-1700: Fax: 82-31-467-1717 B. WORLD TRADE ORGANIZATION (WTO) Enquiry Point Names of the SPS Enquiry Point are as follows; Animal or plant health or zoonosis (including aquatic animals) General Division of International Cooperation International Cooperation Bureau Ministry for Food, Agriculture, Forestry and Fisheries # 1 Choongang-dong, Kwacheon City Kyunggi-do, Korea 427-760 Phone: 82-2-500-1859; Fax: 82-2-504-6659 Food Safety Division of Trade Affairs Ministry of Health and Welfare # 75 Yulgong-ro, Jongno-gu, Seoul, Korea Phone: 82-2- 2023-7250 or 7244; Fax: 82-2-2023-7240 International Trade and Statistics Office Korea Food & Drug Administration #643 Yeonje-ri, Gangoe-myeon, Cheongwon-gun Chungcheongbukdo, Korea 363-951 Phone: 82-43-719-1551~1553 Fax: 82-43-719-1550 E-mail: Aquatic Animal Health and Sanitation Bilateral Negotiation and General Division of International Cooperation Division International Cooperation Agriculture Bureau Ministry for Food, Agriculture, Forestry and Fisheries # 1 Choongang-dong, Kwacheon City Kyunggi-do, Korea 427-760 Phone: 82-2-500-185976; Fax: 82-2-504-6659 C. Websites fo
Posted: 15 February 2012

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