3.162.  Korea's regulatory system takes into account the opinions of consumers and industry, and reflects them in the decision-making process.[338] The main laws affecting food standards and specification are the Food Sanitation Act (last amended by Act No. 16431, 30 April 2019), the Food Code, and the Food Additive Code. Since 2008, a Food Safety Policy Committee has comprehensively revised and coordinated food safety management tasks dispersed across the various ministries and agencies; so far, each relevant agency has developed comprehensive three-year food safety plans (2008-11, 2012-14, and 2015-16) to carry out food safety control schemes to prevent hazardous food at all stages of the food chain from production to distribution. Under the amended Special Act on Imported Food Safety Control, published on 7 April 2020, MFDS applies mandatory Hazard Analysis of Critical Control Point (HACCP) certification to imported foods prescribed by Ordinance of the Prime Minister in an effort to enhance control over imported food hazards. This requirement applies to the foreign food facilities that manufacture food products and that are highly likely to incorporate hazardous substances or be contaminated during raw material storage or the manufacturing.[339]

3.163.  The responsibility of implementing the HACCP programme and the recall systems for food, livestock, and dairy products remains under MFDS. During the review period, the programme's coverage and implementation continued to rise. In 2020, the HACCP system was expanded to cover up to about 87.5% of all processed foods (86.5% in 2019).[340] The number of HACCP-certified businesses increased significantly from 13,991 firms in 2015 to 17,152 in 2017 and 21,665 in 2020 (7,685 food; 13,980 livestock). MFDS blanket inspections without notice on companies requiring HACCP compliance showed an increasing non-conformity rate that stood at 8.4% for the period January-December 2020 (4.4% in 2018). In order to secure efficiency of HACCP-related tasks, on 13 February 2017 MFDS established the Korea Institute for Food Safety Management Accreditation (KIFSMA) by integrating HACCP certification organizations for foods and livestock products that had been individually operated; this development also addressed inconveniences of businesses by unifying the HACCP certification process. In 2020, MFDS planned to support expenses (KRW 6 billion) for the setting of a smart HACCP system in connection with the MSS Smart Factory Project by signing an MFDS-MSS MOU for building 60 smart factories.[341] In addition, MFDS sets and implements regulations governing safety evaluations of agricultural products that have been enhanced through biotechnology and labelling requirements for both agricultural products and processed food products manufactured using GMO ingredients (see below). Maximum residue levels (MRLs)

3.164.  MFDS remains responsible for regulating pesticide residues in foodstuff, in accordance with the MRLs set in the Food Code and the Regulation on Pesticide and Veterinary Drug Residue and applied for both domestic and foreign products.[342] The authorities indicate that MRLs are established based on the scientific residue data. Korea maintains three categories of MRLs in its Food Code: (i) national MRLs based upon domestic registration; (ii) import tolerances based upon residue data from a third country; and (iii) several thousand temporary MRLs set for a smooth implementation of the Positive List System (PLS) (see below).[343] The temporary MRLs would be deleted after the end of 2021, unless national MRLs or import tolerances are set by that time.[344] As of December 2020, MFDS had set MRLs for 516 pesticides in agricultural products compared to 454 in June 2016. The Food Code also listed MRLs for 101 pesticides (82 in 2016) and 212 veterinary drugs in meat, fish, eggs and milk products (185 in 2016).[345] In addition to the Food Code, MFDS maintains an MRLs database (Pesticide Residue Database) for agricultural products, in Korean with English subtitles

3.165.  As from 1 January 2019, MFDS fully implemented the PLS that to all pesticides in agricultural products except for those with MRLs set in Korea.[346] In addition, to minimize possible damage from non‑standardized pesticides, MFDS set 5,320 MRLs for 314 pesticides that are needed at home and abroad; the limits were set at a level considered safe for the human body. Under the PLS, Korea would no longer allow imports of food containing agro-chemical residues unless the substance has been approved for the commodity in question and an MRL has been established. Korea implemented the PLS for tropical fruits, oilseeds, and tree nuts in December 2016

3.166.  Korea plans to introduce a PLS for veterinary drugs in fish and five livestock products, including beef, pork, chicken, egg, and milk, which is to be implemented as from 2024. In 2019, the first stage in laying the ground for a PLS on residues present in livestock/fishery products was launched. Prior to implementing this PLS, the default MRL for antimicrobials that have no MRL set in the Korea Food Code is to be lowered from 0.03 mg/kg to 0.01 mg/kg as from 2022; Korea maintains import tolerances based on residue data from exporting countries to help them export livestock/fishery products to Korea.[347] To push ahead with the PLS for residues in livestock/fishery products, MFDS also operated a Pan-Ministry Council on the Safe Control of Residues, consisting of nine agencies, including MAFRA. Food additives

3.167.  All food additives require prior approval. Food importers have to provide lists of all food ingredients and additives to MFDS and the Animal and Plant Quarantine Agency (QIA) (Section 3.3.3.2) for customs clearance; the ingredient content ratio (mixture ratio of materials) is not required. As of December 2020, Korea had a positive list of 619 approved food additives (605 in 2015). During the review period, Korea integrated chemical synthetics and natural additives into food additives and reorganized the classification system with 32 uses. Food additives and related items are now grouped into 2 categories (previously 3): food additives (619 items) and mixed substances (7 categories of mixture of approved additives).[348] Most additives and/or preservatives are approved and tolerance levels are established on a product-by-product basis, therefore tolerances can vary from product to product. Reportedly, even though there may be an established CODEX standard for a given food additive, domestic or imported foods with "reasonable" levels of a food additive may not be marketed, either because their food additive is not registered in the Korean Food Additives Standards Code, or because it failed to comply with item-specific standards specified in the Code or its usage in a certain food product is not specified in the existing Food Additive Code.[349] Getting a new additive added to the approved list usually takes a year or more. In 2019 MFDS established a rule for banning direct consumption of food additives to prevent safety accidents, amended the definition of natural flavours, allowed gilt for external decoration of food, expanded the standards for the sorbic acid or sorbate routinely utilized in mayonnaise, established the scope and use standards for food additives available for culturing microbes, and eased requirements for safety data submission while applying for new designation of food additives (e.g. enzymes) made using those microbes.[350]

3.168.  A 2009 system of managing safety of original equipment manufacturing (OEM) food imports in the Food Sanitation Act mandates OEM food importers to perform on-the-spot inspection and self‑quality control for OEM food products.[351] OEM product importers are subject to on-site sanitation audits of foreign food facilities/establishments conducted by imported food sanitation audit institutions according to the sanitation inspection standards prescribed by MFDS. MFDS and city/province authorities conduct regular on-site inspections for domestically produced food products. If imported OEM food products prove to be safe, their imports are to increase once consumer confidence is gained. Genetically modified products and LMOs

3.169.  During the review period, legislation on the marketing of genetically modified agricultural products (GMAPs) remained unchanged and continues to apply equally to domestic and imported GMAPs. The 2008 Act on Transboundary Movement of Living Modified Organisms (LMO Act) implements the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Imports of biotech grains, as well as genetically engineered animals, are regulated under the Food Sanitation Act and the LMO Act, which was revised in December 2017 and became effective in December 2018, to amend the scope of "Contained Use" to expand from GM microorganisms to GMOs (including animals and plants); in December 2018, the Enforcement Decree, the Enforcement Regulations, and the Consolidated Notice were revised simultaneously to reflect the revised LMO Act. The LMO Act was last revised in December 2018 to improve the composition of the Bio-Safety Commission and became effective in June 2019

3.170.  Food safety and environmental risk assessments (ERAs) are mandatory on biotechnology crops and LMOs. As indicated by the authorities at the previous Review, in accordance with CODEX guidelines and OECD Biosafety Consensus Documents, safety of LMOs for food is evaluated under the principle of substantial equivalence based on scientifically valid and justified data, such as comparison of toxicity, allergenicity, and the nutrients of the GM food in question and its non-GM counterpart. The authorities consider that the approval procedure is legitimate and does not lead to unnecessary delays. MFDS remains responsible for risk assessment for human health of food‑related GMAPs. It has authority to conduct mandatory safety assessments to evaluate GMOs in products used for human consumption. The Rural Development Administration (crop cultivation environment), the National Institute of Ecology overseen by the MOE (natural ecosystem), and the National Fisheries Research and Development Institute (marine ecosystem) are responsible for ERAs. In accordance with the LMO Act, MFDS conducts risk assessment for human health on food, and the Korea Centers for Disease Control and Prevention (KCDC) carries out the same on feed for industrial use. As indicated at the previous Review, the authorities consider that there were neither overlaps of data requirements nor unnecessary delays in the LMO food-approval process. As of 31 December 2020, 193 GMAP applications were submitted, and 178 events (corn (92), cotton (30), beans (29), canola (17), potato (4), sugar beets (1), and alfalfa (5)) were approved; in addition, GM microorganisms (7) and food additives derived from GM microorganisms (26) were approved for food safety.[352] So far, no GM crops have been grown in Korea and, therefore, the process for crop and food-approval has been applied only to imported products. By 31 March 2021, MAFRA had completed 169 applications for review of environmental risks of LMOs for industrial use in agroforestry and livestock sectors, including soybeans (29), maize (87), cotton (31), canola (17), and alfalfa (5)

3.171.  Korea implements the Advance Informed Agreement Procedure for the first intentional transboundary movement of an LMO for intentional introduction into the environment of a country, as well as labelling requirements for GMOs and LMOs (Section 3.3.2.6)

3.172.  During the review period, the main laws on quarantine requirements for imports (and exports), the Plant Protection Act (last amended by Act No. 16784, 10 December 2019), the Contagious Animal Disease Prevention Act (last amended by Act No. 17653, 22 December 2020), and the Aquatic Creatures Disease Control Act (last amended by Act No. 17036, 18 February 2020) were revised. SPS measures are taken mainly against diseases that are foreign/unknown to Korea and that are subject to strict domestic control measures. Animal and plant quarantine and inspection continue to be handled by the Animal and Plant Quarantine Agency (APQA) under MAFRA, and fisheries by the National Fishery Products Quality Management Service (NFQS) under the MOF

3.173.  Imports of plants and plant products must have a phytosanitary certificate issued by the competent authority in the exporting country. Imports of soil, plants with soil, and certain plants or vegetable materials are banned. Imports of rice in the husk, chaff, and rice straw from all origins, except Japan and Chinese Taipei, are prohibited for pest reasons. Plants for planting from countries with prohibited quarantine pests, such as Citrus huanglongbing (greening) disease and Radopholus similis, etc., are also prohibited or restricted

3.174.  Animal and animal products are subject to inspection and quarantine. Document and organoleptic inspections and laboratory testing, if necessary, are undertaken to verify that no contagious animal disease is brought into Korea and that no hazard is posed to public health. Korea bans the import of animals and their products from countries affected by exotic animal diseases, such as foot-and-mouth disease and African swine fever (ASF). Upon request of the exporting country, the import ban may be lifted depending on the outcome of import risk analysis. Imports from countries affected by highly pathogenic avian influenza (HPAI) are banned, but those of poultry meat that is heat‑processed to inactivate the HPAI virus are allowed. Suspension of imports because of an ASF outbreak in several countries was also enforced during the review period. The comprehensive list of all HPAI-, ASF-, and bovine spongiform encephalopathy (BSE)-related import suspensions by product and origin is available on the APQA website (https://www.qia.go.kr/english/html/Animal_livestock/02AnimalLivestock_quar_ins_info_eng.jsp). Cheese imports must meet Korea's pasteurization requirements.[353]

3.175.  In May 2019, Korea lifted import restrictions on beef from the Netherlands and Denmark in place since 2000 in response to the outbreak of BSE in Europe; applications from some other EU Member States concerning the lifting of these restrictions are being considered.[354]

3.176.  As of June 2021, Korea maintained the import restriction on Japanese foods, such as fishery products from Fukushima, and planned a pan-government response in preparation for circumstances like contaminated water released into the sea from the Fukushima nuclear plant.[355] Following the disaster at the Fukushima nuclear plant, since March 2011 Korea has prohibited imports of 27 agricultural products from 14 prefectures that were under distribution restriction in Japan (Section 3.1.5).[356] Since May 2011, food products with possible radioactive contamination from these prefectures have been subject to certificate of origin requirements and a test certificate issued by the Japanese Government proving that the food products in question were not contaminated. In April 2011, Korea imposed an import ban on 50 fishery products from 8 prefectures (Aomori, Chiba, Fukushima, Gunma, Ibaraki, Iwate, Miyagi, and Tochigi) that were under distribution restriction in Japan. Following the discovery of continuing leakages of contaminated water, in September 2013 Korea implemented temporary measures including testing requirements; in 2013, it also extended this import ban to all Japanese fishery products from the eight prefectures, and the ban remains in place. Some of these measures led to a WTO dispute settlement case in 2015 that was settled as of 30 May 2019.[357]

3.177.  During the review period, the demand for simplifying sanitary conditions for import has increased in the wake of growing multilateral trade agreements such as the Regional Comprehensive Economic Partnership (RCEP) and the Comprehensive and Progressive Trans-Pacific Partnership (CPTPP).[358] In November 2019, MFDS introduced a Rapid Clearance System for Planned Import, allowing reliable business operators with a long-time record of importing food safely with no record of non-compliance to pass the customs clearance procedure immediately after import declaration; in 2020, 72 planned import items of 23 firms were to benefit from this facility. As from April 2020, rapidly blocking customs clearance of food (and medicine) by linking information on hazardous products with the KSA's Integrated Risk Management-PASS (IRM-PASS) has been possible. Furthermore, in 2019, MFDS introduced an Inspection Order System for the Distribution Stage, requiring business operators to voluntarily examine distributed food imports that may pose harm and prove the safety of their products; orders to inspect distributed barley bud powder products (content more than 50%) with many non-conformity records at the customs clearance stage were issued

3.178.  Between January 2016 and 17 February 2021, 227 notifications (161 in 2012-June 2016) were submitted under the WTO Agreement on Sanitary and Phytosanitary Measures (SPS Agreement). This number includes 177 regular notifications, 7 emergency notifications, and 43 addenda/corrigenda. Korea maintains MOUs on food safety and quality standards with China's General Administration of Quality Supervision, Inspection and Quarantine (signed October 2003, revised December 2013), Chile (June 2006), Viet Nam (May 2018), Food Standards Australia New Zealand (FSANZ) (July 2011), and the Philippines (Manila) WHO Western Pacific Regional Office (WPRO) (July 2011, revised June 2016)

3.132.  During the review period, the institutional setting in this area remained unchanged.[300] The Korean Agency for Technology and Standards (KATS), under MOTIE, develops, manages, and implements Korean Industrial Standards (KS), based on the Framework Act on National Standards and the Industrial Standardization Act, jointly with nine ministries including the Ministry of Science and ICT (MSIT), Ministry of Environment (MOE), and Ministry of Oceans and Fisheries (MOF). KATS, the official enquiry point on industrial products under the WTO Agreement on Technical Barriers to Trade (TBT Agreement), is in charge of planning and coordinating national standards policy; MAFRA's Quarantine Policy Division is the enquiry point on agricultural products. The Korea Standards Association (KSA), a KATS affiliate with public- and private-sector membership, provides comprehensive knowledge services (standardization, standards, certification, and training), and several private bodies perform standardization-related tasks.[301] Other bodies performing standards‑related work include the Korea Research Institute of Standards and Science (KRISS) (responsible for metrology), affiliated with the National Research Council of Science and Technology under the MSIT as from July 2017 (previously with the Ministry of Education, Science and Technology), and the Telecommunications Technology Association (TTA), an agency affiliated with the MSIT, which is responsible for group standards for telecommunications, IT, radio communications, and broadcasting.[302] The National Standards Council reviews general plans for the introduction of national standards and coordinates the standards‑related activities of the different ministries

3.133.  Standard development remains government-led and a significant element of Korea's industrial policy. Under the inter-ministerial fourth National Standards Plan (2016-20), key policy goals included the development of standards for new growth-engine activities for improving people's daily life and the eradication of redundant certification systems. The Plan aimed to advance the national standards system, strengthen the standard technology infrastructure, promote active participation in international standardization activities, and assist the private sector in increasing its capacity to develop standards.[303] A fifth National Standards Plan will be established in the second quarter of 2021. During the review period, KATS implemented standardization strategies required for competitiveness in emerging industries and adaption to technological changes of the Fourth Industrial Revolution; efforts for KS to be reflected in the fields of the Fourth Industrial Revolution, such as a smart factory, a smart city, the Internet of Things (IoT), and big data, were undertaken

3.134.  Under the Framework Act on Administrative Regulations (last amended by Act No. 16954, 4 February 2020), a regulatory impact analysis (RIA), including a cost-benefit analysis, has been required since 1997, prior to introducing a new regulation or reinforcing existing regulations.[304] The RIA continues to be carried out by three divisions of ministries in different fields. KATS, as one of them, is implementing a technical regulatory impact assessment (TRIA) aiming to comprehensively review costs, advantages, impacts, and compatibility of regulations for technical regulation issues. In 2020, of 79 cases suggested for adjustment 72% were adjusted, compared to 102 and 52% in 2015

3.135.  The Korean standardization system consists of technical regulations (mandatory standards) developed by ministries and government agencies, as well as standards (voluntary) set by KATS (KSs) and the Radio Research Agency (Korea Communications Standards (KCSs)). The KCSs, set on the basis of the Framework Act on Broadcasting and Communications Development and operated by the MSIT, are "consolidated" into KSs. Seven ministries and two agencies (the MSIT; the MOE; MAFRA; the MOEL; the Ministry of Land, Infrastructure and Transport; the MOF; MFDS; the Korea Forest Service; and the Korea Meteorological Administration) continue to participate in the development of KSs. KATS performs the role of general management and adjustment in developing and operating standards in each sector and cooperating with each government ministry; as of 2020, it transferred 3,867 KSs, such as food products, medical devices, wood, and paper, to the seven ministries.[305] As from 2008, KATS has progressively been transferring its standards development role to the Cooperation Organization for Standards Development (COSD), thus enhancing private-led standards development. All categories of KSs have been entrusted to the COSD, covering more than 90% of KSs.[306]

3.136.  KATS prepares the roadmap for standardization and carries forward standard development in connection with government policies and R&D. In 2016, KATS was to proceed with national standards coordination projects in the fields of smart factory, smart health, next-generation steel, next-generation material, and wearable smart equipment. In practice, projects in the field of smart cities, autonomous vehicles, and AI/big data were carried out during the review period

3.137.  As of 2016, about 15% of all KSs (3,072) were contained in 5,470 technical regulations issued by 19 government ministries. No recent data were available from the authorities

3.138.  As at 2020, 20,916 KSs had been adopted (20,495 in 2016) and mainly allocated as follows: chemicals, textiles, and ceramics (4,564, 21.8%); machinery (3,206, 15.3%); electricity (3,733, 17.8%); metal, mining, and construction (2,310, 11%); transportation machines, shipbuilding, and the aerospace industry (1,456, 7%); IT (1,811, 8.7%); and food, environment, etc. (1,339, 6.4%). Roughly 3% (same as in 2016) of KSs have been established without any reference to international standards. As at 2020, 20,280 (97%) of KSs had been harmonized with corresponding international standards, compared to 19,880 (97%) in 2016. Non‑harmonized standards, i.e. those that are either unique to Korea, with no corresponding international norm (e.g. for kimchi and domestic services for customers), or cannot be harmonized because of their link to other domestic regulations, remain in place.[307] In 2020, approximately 67% (66% in 2016) of all KSs were subject to international ISO/IEC harmonization

3.139.  In 2020, Korea maintained bilateral MOUs with 76 agencies (42 in 2016) from 41 countries (31 in 2016) for mutual cooperation in global standardization activities, exchange of technical information related to standards and conformity assessment, organization of standardization meetings, operation of joint education programmes, and exchange of experts.[308]

3.140.  Legislative responsibility for food safety and quality remains divided between several ministries. MFDS regulates food safety (including foods of plant, animal, and aquatic origin), whereas MAFRA deals with animal and plant health (including import quarantine measures for animal, livestock products, and plants). The MOF deals with aquatic health including import quarantine measures for live aquatic animals and their products. Safety of foods, pharmaceuticals, medical devices, and cosmetics is governed by MFDS, whose main role is to protect public health and safety, including the safety of food such as agricultural, fishery, and livestock products. MFDS, with its six regional offices, and the National Institute of Food and Drug Safety Evaluation are responsible for establishing and enforcing basic legislation and its implementing regulations, as well as setting standards and specifications for domestic and imported foods, including livestock products, functional foods, food additives, food packaging, containers, and equipment (Sections 3.3.2.6 and 3.3.3.1). Standards and specifications for meat, dairy, and egg products are handled by MFDS, whereas quarantine standards for animals and animal products are handled by MAFRA (Section 3.3.3.2)

3.141.  MFDS 2020 policy objectives involved communication and cooperation with all stakeholders, support to innovative growth by reforming regulations, making Korea a global powerhouse in food and drug safety (Section 3.3.3), and preparation for the future through pre‑emptive R&D.[309] Shifting from product-centred to people-centred approaches, MFDS in 2020 pursued the following objectives: enhancing food safety for betterment of the public health, creating an environment for safer use of drug and medical devices, and introducing food and drug safety measures that are innovative yet resonate with people

3.142.  During the review period, several initiatives were undertaken to, inter alia, improve drug safety and align with international standards.[310] The entire Korean Pharmacopoeia was amended to reflect international standards and new technologies; furthermore, in November 2019, an integrated information system ranging from licensing of medical devices based on standard codes to their distribution and usage was established. In 2019, MFDS prepared 19 guidelines and guidances, including the "Questions and answers (Q&As) for structure and content of clinical study results" based on International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines; while in 2020, MFDS prepared a total of 13 guidelines and guidances including the "Guideline on Clinical Evaluation of Cardiovascular Safety" based on the ICH guidelines. Fifty-one subjects of its Good Review Practices Manuals of Policies and Practices (GRPMaPP) were newly prepared or revised to improve predictability and consistency of the clinical study process. MFDS continues to develop and revise guidelines regarding drug evaluation (e.g. implementing ICH guidelines) to harmonize with international standards. In 2019, the preliminary registration of overseas manufacturing facilities of pharmaceuticals, etc. and on-site inspection were strengthened to enable systematic and effective post-management of the facilities on par with those of domestic pharmaceuticals for which inspection was enhanced to prevent potential hazards. MFDS registered overseas manufacturing facilities and in 2019, inspected 20 facilities where potential risks were found in evaluation.[311] The safety in biopharmaceuticals, such as vaccines and cells, was enhanced. MFDS registered Korean drugs with the EU Whitelist (7th country doing so) in May 2019, signed the Korea-Switzerland Mutual Trust Agreement (December 2019), and maintained a national bidding grade in Viet Nam (July 2019)

3.143.  Imports of pharmaceuticals continue to require a free sale certificate, issued by an authority of the exporting country (the Medical Device Act Enforcement Regulations, revised as of May 2009). Any person intending to import medical devices or pharmaceuticals must obtain an item‑specific approval from, or file a notification with, MFDS in accordance with the relevant law. Item-specific pre-approval involves the submission of extensive clinical trial data and other safety and efficacy-related data as prescribed by the Regulation on Safety of Pharmaceuticals.[312] Manufacturers must submit detailed data on certain active pharmaceutical ingredients under MFDS's Drug Master File

3.144.  Imported biological drugs remains subject to batch release testing by MFDS, even if the drugs have already been tested and released by the manufacturer and the health authority of the country of origin. The authorities indicate that the same rules and regulations continue to be applied in accordance with the Pharmaceutical Affairs Act to domestically distributed biological drugs (locally and foreign produced), and results of tests conducted by foreign manufacturers or health authorities of the exporting country must not substitute results of batch or lot release tests conducted by MFDS. For some medical devices used for medical practice, the Government needs to determine whether they are eligible for reimbursement before they are used at healthcare institutions including hospitals, since all healthcare institutions in Korea are reimbursed by the Government for medical services provided to patients. With regard to medical devices subject to health technology assessment, under the relevant laws, it now takes up to 14.3 months or 430 days (17 months or 510 days in 2016) from the date of application for MFDS approval by a device manufacturer to the date when MFDS approval is granted and the product is launched onto the market: approval continues to take 80 days; health technology assessment takes 250 days (280 in 2016); and as from 2017 listing the product for reimbursement takes 100 days (150 in 2016).[313]

3.145.  Cosmetics are regulated by MFDS and fall under two categories: "functional" cosmetics and regular cosmetics.[314] Functional cosmetics include whitening, anti-wrinkle, and sunscreen and tanning products. MFDS reviews only functional cosmetics for pre-market approval. For all other regular cosmetics, the Korea Pharmaceutical Traders Association (KPTA) has been authorized by MFDS to review and certify import permission requests submitted by the Korean importer. MFDS administers registration requirements on imported and domestically produced functional cosmetics. Importers must conduct "self-regulated" quality inspections for each product type to ensure conformity with the cosmetic standards and test methods.[315] MFDS determines compliance of cosmetic manufacturers to Cosmetic Good Manufacturing Practices (CGMP) through inspection and evaluation prior to awarding them with the certification; as of end-December 2020, 165 companies were registered as CGMP-compliant firms.[316] Cosmetics importers are required to file a customs report to, and obtain prior approval from, the KPTA on all products. Test results submitted by overseas manufacturers using quality standards that are internationally accepted or certified, or that are more stringent than the Korea Cosmetic Good Manufacturing Practice (KCGMP) standards, are accepted without any additional quality testing in Korea. Quality inspection by the importer of cosmetics is required, according to manufacturing serial/batch number. Certain products classified as cosmetics overseas are not considered as such in Korea; reportedly, this makes it hard to harmonize regulations with other countries. Depilatory and hair dye products were placed under the category of cosmetics pursuant to the amendment of the Enforcement Rule of the Cosmetics Act on 12 January 2017, enforced from 30 May 2017. Among industrial or uncontrolled products, the chemicals directly used on the human body, such as cosmetic soaps (solid soaps) for cleaning the human body, instant hair thickeners, and hair removal wax, were placed under the category of cosmetics by the amendment of the Enforcement Rule of the Cosmetics Act on 31 December 2018, enforced from 31 December 2019.[317]

3.146.  During the review period, further action was taken in the areas of registering and notification of toxic chemicals. The amendments of the 2015 Act on Registration and Evaluation, etc. of Chemical Substances (AREC or K-REACH), which went into effect on 1 January 2019, brought a significant deviation from the regulatory mechanisms outlined in the previous version.[318] They provide existing substances (≥1 t/a) with the corresponding grace period – from 2021 to 2030 – according to manufacturing or importing quantity if their pre-registration is made before 30 June 2019. All new chemical substances are required to be registered. Pre-registration of existing chemical substances (≥1 t/a) before 30 June 2019 has been necessary to be eligible for the corresponding grace period. All new chemical substances are required to be registered. However, new chemical substances (<100 kg/a) only require notification rather than registration. AREC requires manufacturers and importers of chemical substances to register or notify it before manufacture or import. Concerns relating to the lack of guidance around implementation, the insufficient time for companies to implement the requirements, and AREC's lack of protection for confidential business information have been raised (Section 3.3.2.5).[319]

3.147.  The Chemicals Control Act (CCA), which protects public health and prevents environmental harm caused by chemical substances by strengthening the criteria for the handling and management of chemicals, previously managed under the Toxic Chemicals Control Act (TCCA), was amended in and enforced from 2015. Several additional revisions of the amended CCA were enforced from April 2021.[320] It now requires that business places handling hazardous chemicals shall prepare and implement a chemical accident prevention management plan, comply with standards of handling facility, undergo regular inspections, and fulfil other obligations such as business permission and regular education programs. MFDS's Standards & Specifications for Equipment and Container/Packaging (Packaging and Container Code) provides general standards for equipment, containers, and packaging for food products and specifications for individual packaging materials.[321] In 2019, the MOE published partial amendments to the Rule of the Act on the Promotion of Saving and Recycling of Resources to promote recycling and reduce unnecessary waste. These amendments require packages to be evaluated, graded, and labelled for the recyclability of packaging materials

3.148.  KATS remains responsible for conformity assessment, certification, registration, and testing of industrial products for voluntary (KS) standards. It runs the Korea Laboratory Accreditation Scheme (KOLAS), which accredits testing, calibration, and medical testing laboratories, as well as the Korea Accreditation System (KAS), which accredits product certification bodies. Accreditation accords with internationally recognized standards. As of end-March 2021, there were 613 testing laboratories (496 in 2016), 260 calibration laboratories (212 in 2016), 12 medical testing laboratories accredited by KOLAS (6 in 2016), and 23 product certification bodies accredited by KAS (20 in 2016).[322]

3.149.  Korea maintains a single national integrated certification mark, the Korea Certification (KC) mark, which has been fully implemented since January 2011. The KC mark and the corresponding KC certificate are valid for 730 different products, such as automotive parts, machines, and many electronic products.[323] This test mark confirms that the product meets the relevant Korean Safety Standard, called K Standard. K Standard requirements are often similar to the respective IEC Standard (Standard of International Electrotechnical Commission)

3.150.  The 4th Comprehensive Plan on Quality Management for 2016-20 consisted of four main projects: fundamental establishment on smart quality management, global trend on quality management, capability reinforcement for enhancing quality management of small and medium‑sized manufacturing companies, and advancement of quality management infrastructure

3.151.  Certification authorities are encouraged to negotiate MRAs with foreign counterparts. KOLAS is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Multilateral Recognition Arrangement (MLA) for testing, calibration, and medical testing; as of March 2021, 103 accreditation bodies from 105 economies had signed the ILAC MRA MLA. KAS is a signatory to the International Accreditation Forum (IAF) MLA for product certification. The Korean Accreditation Board (KAB) is a signatory to the IAF MLA for management systems certification and certification of persons. KOLAS, KAS, and KAB are the signatories to the APAC (Asia-Pacific Accreditation Cooperation) MRA. The main scope of KOLAS under the APAC MRA is testing, calibration, and medical testing, while the main scope of KAS is product certification, and those of KAB are management systems certification and certification of persons. Korea is also a member of the Asia-Pacific Economic Cooperation (APEC) MRA on Conformity Assessment of Telecommunications Equipment (Phases I and II) and of Part I of the APEC Electrical MRA; it does not intend to participate in Parts II and III of the latter. It joined the MRA on Conformity Assessment of Electrical and Electronic Equipment in 2015

3.152.  Korea maintains an APEC-TEL MRA Phase I with Canada (1997), the United States (2005), Viet Nam (2006), and Chile (2007) on recognition of test results for telecommunications equipment and Phase II with Canada (2017) on recognition of certification results for telecommunications equipment; RTAs with the European Union (2011) and the United Kingdom (2021) with provisions on recognition of conformity assessment for electronics equipment; and an MRA with Singapore (2006) on electrical and electronic appliances under the Korea–Singapore RTA. Under the Industrial Technology Innovation Promotion Act, the New Excellent Product (NEP) certification system continues to cover products manufactured with new technologies developed first in Korea or improved with innovative technologies.[324] The certificate is valid for three years. NEP‑certified products receive government support to expand sales channels and accelerate technology development. NEP-certified products receive an additional qualification point in procurement by government and public organizations. According to the authorities, the NEP system does not affect international trade

3.153.  MFDS facilitates food imports through the "authorization of foreign testing laboratories" system, which covers inspection agencies authorized by the Government of the exporting countries and MFDS; it includes 60 agencies in 8 countries. As of 31 December 2020, the total number of agencies classified by categories were as follows: food (163 including 60 foreign institutions and 25 statutory institutions), livestock (80 including 26 statutory institutions), pharmaceuticals (47 including 24 statutory institutions), cosmetics (41 including 24 statutory institutions), medical devices (14 including 1 statutory institution), and sanitary goods (36 including 24 statutory institutions).[325] Test results issued by foreign agencies are recognized by MFDS, and therefore, relevant imports are exempt from laboratory inspection when they are imported for the first time to Korea. Korea has not joined the APEC MRA on Conformity Assessment of Foods and Food Products

3.154.  Under the Act on the Management and Support for the Promotion of Eco‑Friendly Agriculture/Fisheries and Organic Foods (New Organic Act) (last amended by Act No. 18026, 13 April 2021), as from 2 June 2013 a mandatory organic certification programme requires all domestic and imported organic fresh (unprocessed) and processed produce and livestock products to be certified by a MAFRA National Agricultural Products Quality Management Service (NAQS).[326] As of December 2020, 29 Korean certifying agencies (15 in 2015) and 2 foreign certifying agencies (4 in 2015) were accredited by MAFRA's NAQS for certification of organic processed food products.[327] Korea maintains a zero-tolerance policy for the inadvertent presence of biotech content in processed organic products (Sections 3.3.2.6 and 3.3.3.1); for any organic products that test positive for genetically modified organisms (GMOs), importers/producers can be instructed to remove an organic claim from the product label, and NAQS may investigate the case to see if there is any intentional violation. In lieu of certification by accredited certifying agents, the Act allows MAFRA to have an equivalency agreement on processed organic products with foreign trade partners; two bilateral equivalency arrangements (Korea–United States (2014), Korea-European Union (2015)) allow for processed food products certified as organic in the United States, the European Union, or Korea to be sold as organic in any of the three markets without having to go through another costly certification process under the importing country's standards

3.155.  New and/or revised legislation and the implementing guidelines are published in the government gazette for public comments; these changes are also notified regularly to the WTO for Members' comments. Between 2016 and 12 February 2021, Korea made 348 new notifications (281 in 2012-15), of which 323 were regular, under the WTO TBT Agreement; the majority remained under Article 2.9 of the Agreement, and in 83.3% of the notified cases (91.1% in 2012-15) the timeliness of the submission allowed for a comment period of 60 days or more, while in only 9% of cases (11% in 2012-15) the period was less than 45 days.[328] To help Korean companies respond to technical barriers to trade, KATS maintains a TBT division, which is exclusively responsible for WTO/TBT-related affairs. KATS maintains an online information service on technical regulations of respective countries, which are notified to the WTO.[329] KATS runs a TBT Notifications Alert Service, which transmits TBT notifications to stakeholders by email and encourages them to submit their comments

3.156.  During the review period, Members raised specific trade concerns (STCs) at the Committee on Technical Barriers to Trade regarding several measures under consideration or taken by Korea (e.g. ballast water, textile products for infants, warning on alcoholic beverages drinking, package recycling, energy efficiency management equipment, household chemical and biocidal products, and wood products).[330]

3.157.  MFDS continues to develop labelling standards for food including livestock products, while regional offices inspect imported foods and enforce labelling requirements upon arrival; provincial authorities verify labelling of domestic and imported goods in the marketplace.[331] All imported food products are required to carry legible Korean language labels. Labelling requirements include nutritional labelling, voluntary colour-coded labelling, high caffeine content labelling for liquid products, functional food labelling, liquor labelling, country of origin labelling (COOL) (by MAFRA), and genetically modified (GM) labelling for unprocessed agricultural products and processed food (see below).[332]

3.158.  Beef retailers and distributors remain required to keep track of all transactions from the importing stage to the final retail level.[333] A traceability system for infant/baby food, health functional food, and milk formula is also required. In December 2019, MFDS introduced a four‑part traceability system for food for pregnant/lactating woman, special medical-purpose food, and weight-control food depending on the annual sales value; its fourth phase covering all manufacturers of these products is to be implemented in December 2021.[334] Importers are required to establish a traceability system from the point when imported products arrive in Korea throughout distribution

3.159.  GM corn, soybeans, cotton, rapeseed, sugar beets, and alfalfa (including sprouts originating from these items), as well as foods suitable for consumption containing these products and notified as such by MFDS, remain subject to mandatory GMO labelling requirements. GMO foods for which identity preservation documents or government-issued certificates were submitted are exempted from GMO labelling requirements. Concerning food from the United States, Korea accepts a notarized self-declaration, instead of requiring full documentation, to certify products that are exempt from biotechnology requirements. Importers must keep records for up to two years to prove that unlabelled foods subject to GMO labelling requirements are GMO free. The Living Modified Organisms (LMO) Act (Section 3.3.3.1) continues to provide standards required for the labelling of biotech crops and food, including processed food products containing corn, soybeans, cotton, canola, and sugar beets with 3% or higher GMO content. In 2017, MFDS implemented new biotech labelling requirements that expanded mandatory labelling to all detectable products.[335] Soy, corn, cotton, canola, sugar beets, alfalfa, and any newly approved GM crops or food products containing these crops are subject to the biotech labelling requirement. If detectable biotech DNA is present in the final product, biotech labelling is required. If an imported product arrives without appropriate supporting documents or a test certificate, it can either be labelled as GM food or tested by MFDS‑accredited laboratories in Korea prior to customs clearance. If the product tests negative, it may be exempt from biotech labelling. In 2020, MFDS planned to introduce a use-by-date labelling system that informs consumers of a safe consumption period (instead of sell-by date of food) and submit the draft of the amendment to the Act on Labelling and Advertising of Foods to the National Assembly.[336]

3.160.  Origin labelling remains mandatory for food and many other imports of 681 four-digit tariff lines (674 in 2015) in 2021. The use of the term "Assembled in Country X" has been allowed since October 2010. The KCS's Origin Mark Registration and Retrieval System enables users to check origin markings by trader or item

3.161.  MFDS's Packaging and Container Code provides general standards for equipment, containers, and packaging for food products and specifications for individual packaging materials.[337] In 2019, the MOE published partial amendments to the Rule of the Act on the Promotion of Saving and Recycling of Resources to promote recycling and reduce unnecessary waste. These amendments require packages to be evaluated, graded, and labelled for the recyclability of packaging materials