• Title/Summary/Keyword: Ministry of Food and Drug Safety in Korea

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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices : Bone Absorptiometric X-ray System (엑스선골밀도측정기의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Kim, Eun-Rim;Lee, Jun-ho;Lee, Chang-Hyung;Park, Chang Won
    • Journal of radiological science and technology
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    • v.39 no.2
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    • pp.263-271
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    • 2016
  • The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

Analysis of key performance indicator for smart HACCP (스마트 HACCP 핵심 성과지표 분석)

  • Seo, Yeon-Beom;Park, Jung-Il;Go, Ji-Hun;Lee, Je-Myung;Hwang, Su-Jin
    • Food Science and Industry
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    • v.54 no.2
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    • pp.73-81
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    • 2021
  • Korea Agency of HACCP Accreditation and Services(KAHAS) has been focused on strengthen food safety management and competitiveness of the food industry. As a solution, the institution has launched the smart HACCP project, which is highly praised to be an innovation in food safety management system. KAHAS try to analysis of food manufacturing company, candidate of supporting about construction of smart factory from Small and Medium venture Business Department and confirm the effect of smart HACCP introduction. Korea Agency of HACCP Accreditation and Services will use these results for widespread of smart HACCP

Monitoring of Heavy Metals Migrated from Polylactide (PLA) Food Contact Materials in Korea (국내 유통 폴리락타이드(PLA) 식품용 기구 및 용기·포장의 중금속 이행량 모니터링)

  • Kim, Hyeonuk;Park, So-Yeon;Jo, Ye-Eun;Park, Yongchjun;Park, Se-Jong;Kim, Meehye
    • Journal of Food Hygiene and Safety
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    • v.33 no.2
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    • pp.102-109
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    • 2018
  • In the present study, a variety of polylactide (PLA) articles (n = 211) were tested for migration of lead (Pb), cadmium (Cd) and arsenic (As) into the food simulant (4% v/v acetic acid). Pb, Cd, and As were analyzed by inductively coupled plasma mass spectrometry (ICP-MS). Migration tests were performed at $70^{\circ}C$ and $100^{\circ}C$ for 30 min. The amounts of Pb, Cd, and As increased at $100^{\circ}C$ for 30 min compared with levels at $70^{\circ}C$. However, the migration at both conditions was very low. The maximum level of Pb at $100^{\circ}C$ for 30 min corresponded to 1% of the migration limit. The estimated daily intakes (EDI) based on safety evaluation ranged from $2.5{\times}10^{-5}$ to $2.0{\times}10^{-3}{\mu}g/kg\;bw/day$ for Pb, Cd, and As. The EDI calculated from migration of Pb at $100^{\circ}C$ for 30 min in PLA was the maximum value, $2.0{\times}10^{-3}{\mu}g/kg\;bw/day$, which corresponded to 0.055% of provisional tolerable weekly intake (PTWI, $25{\mu}g/kg\;bw/week$). The data from this study represent a valuable source for science-based safety control and management of hazardous heavy metals migrating from polylactide food contact materials.

Perception of Food Safety and Risk of Foodborne Illness with Consumption of Meat and Processed Meat Products (식육 및 식육가공품 섭취에 따른 안전성 및 식중독 위험성 인식)

  • Choi, So Jeong;Park, Jin Hwa;Kim, Han Sol;Cho, Joon Il;Joo, In Sun;Kwak, Hyo Sun;Heo, Jin Jae;Yoon, Ki Sun
    • Korean journal of food and cookery science
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    • v.32 no.4
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    • pp.476-491
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    • 2016
  • Purpose: This study investigated consumers' perception of food safety and risk from foodborne illness and consumption pattern of meat and processed meat products in Korea. Methods: A quantitative survey was performed by trained interviewers, surveying 1,500 adults who were randomly selected from six major provinces in Korea. Results: Most of the respondents reported foodborne illness risk related to the consumption of raw meat but not related to heated meat and processed meat products. As respondents perceived the risk of food poisoning from raw meat, the purchase and intake decreased (p<0.001). Most of the respondents considered a low possibility of foodborne illness at home. Seventy-seven percent of the respondents thought that bacteria and virus are the main causes of foodborne illness. Improper storage practice (40.7%) and unsafe food material (29.3%) were the main risk factors contributing to foodborne illness. Perception and practice of food safety was significantly different by the residency area. The most preferred meat, processed meat, and processed ground meat products were pork (58%), ham (31.1%), and pork cutlet (40.4%), respectively. The most preferred cooking method was roasting, regardless of the type of meat, but the second preference for cooking method was significantly affected by the type of meat (p<0.001): stir-fried pork, beef with seasoning, fried-chicken and boiled duck. Frequency of eating out was 0.75/day on weekdays and 0.78/day on weekends at the mainly Korean BBQ restaurant. Conclusion: The results of this study could be used to develop science-based education materials for consumer and the specific guideline of risk management of meat and processed meat products.

Monitoring of Heavy Metals Migrated from Glassware, Ceramics, Enamelware, and Earthenware (유리제, 도자기제, 법랑 및 옹기류 재질의 식품용 기구 및 용기·포장의 중금속 이행량 모니터링)

  • Cho, Kyung Chul;Jo, Ye-Eun;Park, So-Yeon;Park, Yongchjun;Park, Se-Jong;Lee, Hye Young
    • Journal of Food Hygiene and Safety
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    • v.35 no.1
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    • pp.23-30
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    • 2020
  • This study investigated the migration levels of lead (Pb), cadmium (Cd), and arsenic (As) from food contact articles (glassware, ceramics, enamelware, and earthenware) into a food stimulant (4% v/v, acetic acid). Migration tests were performed at 25℃ for 24 h and all analyses were performed using Inductively-Coupled Plasma Mass Spectrometry (ICP-MS). The method was validated by linearity of calibration curves, limit of detection (LOD), limit of quantification (LOQ), recovery, precision, and uncertainty. In glassware, the migration concentrations ranged from not-detected (N.D.) to 752.21 ㎍/L and N.D. to 1.99 ㎍/L for Pb and Cd, respectively. In ceramics, the migration concentrations ranged from N.D. to 1,955.86 ㎍/L, N.D. to 74.06 ㎍/L, and N.D. to 302.40 ㎍/L for Pb, Cd, and As, respectively. In enamelware, the migration concentrations ranged from N.D. to 4.48 ㎍/L, N.D. to 7.00 ㎍/L, and N.D. to 52.00 ㎍/L for Pb, Cd, and Sb, respectively. In earthenware, the migration concentrations ranged from N.D. to 13.68 ㎍/L, N.D. to 0.04 ㎍/L, and N.D. to 6.71 ㎍/L for Pb, Cd, and As, respectively. All results were below the migration limits of Korea standards and specifications for food utensils, containers, and packages.

Antimicrobial Resistance Profile of Acinetobacter spp. Isolates from Retail Meat Samples under Campylobacter-Selective Conditions

  • Cha, Min-Hyeok;Kim, Sun Hee;Kim, Seokhwan;Lee, Woojung;Kwak, Hyo-Sun;Chi, Young-Min;Woo, Gun-Jo
    • Journal of Microbiology and Biotechnology
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    • v.31 no.5
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    • pp.733-739
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    • 2021
  • Acinetobacter strains are widely present in the environment. Some antimicrobial-resistant strains of this genus have been implicated in infections acquired in hospitals. Genetic similarities have been reported between Acinetobacter strains in nosocomial infections and those isolated from foods. However, the antimicrobial resistance of Acinetobacter strains in foods, such as meat, remains unclear. This study initially aimed to isolate Campylobacter strains; instead, strains of the genus Acinetobacter were isolated from meat products, and their antimicrobial resistance was investigated. In total, 58 Acinetobacter strains were isolated from 381 meat samples. Of these, 32 strains (38.6%) were from beef, 22 (26.5%) from pork, and 4 (4.8%) from duck meat. Antimicrobial susceptibility tests revealed that 12 strains were resistant to more than one antimicrobial agent, whereas two strains were multidrug-resistant; both strains were resistant to colistin. Cephalosporin antimicrobials showed high minimal inhibitory concentration against Acinetobacter strains. Resfinder analysis showed that one colistin-resistant strain carried mcr-4.3; this plasmid type was not confirmed, even when analyzed with PlasmidFinder. Analysis of the contig harboring mcr-4.3 using BLAST confirmed that this contig was related to mcr-4.3 of Acinetobacter baumannii. The increase in antimicrobial resistance in food production environments increases the resistance rate of Acinetobacter strains present in meat, inhibits the isolation of Campylobacter strains, and acts as a medium for the transmission of antimicrobial resistance in the environment. Therefore, further investigations are warranted to prevent the spread of antimicrobial resistance in food products.

Risk Assessment of Polychrorinated Biphenyls (PCBs) through Food Intake for the Korean Population (식품 중 폴리염화비페닐 위해평가)

  • Paek, Ockjin;Suh, Junghyuk;Park, Heera;Oh, Keumsoon;Hong, Selyung;Lee, Hyunkyung;Kim, Meehye
    • Korean Journal of Food Science and Technology
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    • v.45 no.3
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    • pp.364-369
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    • 2013
  • Polychlorinated biphenyls (PCBs) have been studied during the past few decades because of their potential impacts on the environment and human health. PCBs are toxic environmental pollutants and persistent organic pollutants (POPs). This study was carried out to assess the dietary exposure and risk to PCBs for the general Korean population through food intake. Various samples (n=389) covering 28 kinds of food were collected from 5 cities in Korea. The PCB content was not detected-$182.4{\mu}g/kg$ (mean of $5.4{\mu}g/kg$) in the food. The mean dietary exposure of PCBs for the general population was 9.54 ng/kg bw/day with an intake of 0.19% of tolerable daily intake (TDI) ($5{\mu}g/kg$ bw/day). Therefore, the level of overall dietary exposure to PCBs for the Korean population through food intake is below the recommended TDI levels.

Development of Guidelines for Preventing COVID-19 in Childcare Centers, Institutional Foodservices and Restaurants (COVID-19 확산방지를 위한 보육시설, 집단급식소 및 식품접객업소 생활방역 매뉴얼 개발)

  • Lee, Seung-Wan;Chang, Hye-Ja;Han, Areum;Lee, Sun-Young;Kim, Sung-Il;Bahn, Kyeong-Nyeo
    • Journal of the FoodService Safety
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    • v.1 no.1
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    • pp.37-44
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    • 2020
  • The virus isolated from patients with severe pneumonia of unknown etiology in Wuhan City, Hubei province in China was termed SARS-CoV-2 and the World Health Organization (WHO) named the disease caused by this virus as coronavirus disease 2019 (COVID-19). The COVID-19 infection has spread rapidly and become a pandemic. In July 2020, there were 13.25 million infected patients and over 570,000 deaths worldwide, and 13,711 infected patients and 294 deaths were reported in South Korea. Since the primary mode of transmission of COVID-19 is through respiratory droplets, the importance of preventive measures, including social distancing, has become important in daily life. In response to the continuous spread of COVID-19, this study developed three guidelines for preventing COVID-19 for the food service industry including childcare centers, institutional foodservices and restaurants by the integration of the manual of controlling foodborne illness. These are included the COVID-19 prevention action methods for food deliverers, for food service administrator, for foodservice works and for customers. All guidelines were designed for easy understanding using illustrations and have been systematically explained subject wise. Thus, these COVID-19 prevention guidelines can be appropriately applied depending on the specific situation and workplace. In addition, they are worthy as educational materials that contribute to the food safety.

Analytical Method to Quantify Sodium Metasilicate in Shark Fins (샥스핀 가공 중 사용된 메타규산나트륨 분석)

  • Park, Se-Jong;Jang, Su-Jin;Choi, Jae-Chon;Kim, Meehye
    • Korean Journal of Food Science and Technology
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    • v.47 no.2
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    • pp.145-148
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    • 2015
  • According to the Korea Food Additives Code, sodium metasilicate is permitted for use as a filtering agent for edible oils and fats. Sodium metasilicate is currently used as a food additives to increase the weight of shark fins. In this study, we developed an analytical method to quantify sodium metasilicate in food. Sodium metasilicate content was estimated by measuring the moisture content, pH and silicon content of shark fins. Silicon content was analyzed using inductively coupled plasma-optical emission spectrometry (ICP-OES) following microwave-assisted digestion with $HNO_3$ (65%) and $H_2O_2$ (30%). Shark fin total silicon content was $7.17{\pm}8.92mg/kg$, while the soluble silicon content was $2.34{\pm}3.80mg/kg$. After soaking raw shark fin in an aqueous solution of sodium metasilicate, fin weight, pH and silicon content were measured. These results would be used as the basic information for shark fins safety management.