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

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Determination of Nitarsone in Pork, Egg, Milk, Halibut, Shrimp, and Eel Using QuEChERS and LC-MRM

  • Kim, Jin Hee;Jang, Yong Jin;Kim, Dong Yoon;Lee, Hyo Chun;Choi, Yong Seok
    • Mass Spectrometry Letters
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    • v.12 no.1
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    • pp.11-15
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    • 2021
  • Nitarsone is an organoarsenic antiprotozoal drug widely used to treat blackhead disease in turkeys and chickens. However, since its biological conversion into inorganic arsenic, a carcinogen was known, its residue in foods should be regulated. Thus, here, a novel method to determine residual nitarsone in various food commodities (pork, milk, egg, halibut, eel, and shrimp) using QuEChERS and LC-MRM was developed. The developed method was successfully validated through specificity, linearity (coefficient of determination, at least 0.991), recovery (R, 63.6 - 85.6%), precision (the relative standard deviation of R, 0.5 - 10.6%), and sensitivity (the lower limit of quantitation, 5 ppb) by following the Ministry of food and drug safety (MFDS) guidelines. The present method is the first mean to quantitate nitarsone using LC-MRM, and it was designed to be conveniently merged into a new method to quantitate multiple veterinary drugs for the positive list system (PLS). Therefore, the present method could contribute to fortify the food safety system in South Korea.

A Study on the Improvement of Domestic Medical Device Product Classification through Analysis of Medical Device Classification System in the U.S. and Europe (미국 및 유럽 의료기기 품목분류 체계 분석을 통한 국내 의료기기 품목분류 개선 연구)

  • Kang Hyeon, You;Ji Min, Son;Gyeong Min, Kwon;You Rim, Kim;Hui Sung, Lee;Won Seuk, Jang
    • Journal of Biomedical Engineering Research
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    • v.44 no.1
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    • pp.73-79
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    • 2023
  • The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

Present Status on the Pesticide Residue Monitoring Program of South Korea and Its Improvement (한국의 잔류농약 모니터링 프로그램 현황과 개선)

  • Lee, Mi-Gyung
    • Journal of Food Hygiene and Safety
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    • v.34 no.3
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    • pp.219-226
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    • 2019
  • This study was conducted to understand the overall status of the monitoring program for pesticide residues in foods of South Korea. Further propositions for its improvement were made, and from this study, the status on this program can be summarized as follows. In South Korea, the Ministry of Food and Drug Safety (MFDS) is responsible for overall control of pesticide residue monitoring. Depending on the time of monitoring (sampling at distribution or production step), the government agency responsible for monitoring is different: MFDS, Regional Offices of Food and Drug Safety and local governments are responsible for monitoring of foods at the distribution step, while the National Agricultural Products Quality Management Service (NAQS) and local governments are responsible for monitoring of foods in the production step (partially at sale and distribution steps). According to purpose of monitoring, domestic monitoring programs could be divided into two types: MFDS's "Residue Survey" and NAQS's "National Residue Survey" are conducted mainly for risk assessment purposes and various monitoring programs by the Regional Offices of Food and Drug Safety and local governments are conducted mainly for regulation purposes. For imported foods, monitoring should be conducted at both steps of customs clearance and distribution: the MFDS and the Regional Offices of Food and Drug Safety are responsible for the former, and for the latter, local governments are also responsible. However, it appeared that systematic and consistent monitoring programs are not being conducted for imported foods at the distribution step. Based on the information described above and more detailed information included in this paper, the following proposals for improving the monitoring program were forwarded: i) further clarification of monitoring program purpose, ii) strengthening of the monitoring program for imported foods, iii) providing the public with monitoring results by publication of an annual report and database. It is thought that exhaustive review on the pesticide residue monitoring program and efforts for its improvement are needed in order to assure both food safety and the success of the recently begun positive list system (PLS).

Physical Phenotype Analysis in Obesity Study in vivo (마우스를 이용한 비만연구에서 활용되는 물리적 표현형 분석 기술)

  • Kim, Hyunkyung;Go, Gwang-woong
    • Food Science and Industry
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    • v.51 no.1
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    • pp.37-44
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    • 2018
  • The prevalence of obesity is continually increasing in South Korea; about 1/3 of adults are diagnosed with obesity and 1/2 of adults are overweight in 2016. Abnormal body fat mass increased the risk factors of metabolic syndrome (including hypertension, type II diabetes, dyslipidemia), chronic kidney failure, osteoarthritis, and cardiovascular disease. Ministry of Food and Drug Safety (MFDS) in Korea established the validation and approval system for "functional food" based on related laws and regulations. According to the guideline of MFDS, the biomarkers for obesity study in vitro, in vivo, and clinical trial are well summarized. The analysis of physical phenotypes is necessary condition to study further molecular phenotypes and pathway analysis in vivo study. Thus, we will review currently available physical phenotype analysis; dual energy X-ray absorptiometry (DEXA) and Oxylet gas analysis will be examined in-depth.

Multi-sectoral Coordination Strategy for Policies and Programs on Nutrition Service and Obesity Prevention (국가 영양사업과 비만예방관리에서의 부문간 연계협력 방안 탐색)

  • Kim, Hye-Ryun
    • Korean Journal of Health Education and Promotion
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    • v.30 no.4
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    • pp.57-67
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    • 2013
  • Objectives: The purpose of this study was to explore coordination strategy through reviewing policies, action plans and acts related to diet, nutrition and obesity from many sectors in Korea, and to develop a possible multi-sectoral approach. Methods: Literature reviews and empirical findings for ongoing international and domestic policies/programs on diet, nutrition and obesity in Korea. Results: Central and local governments have various policies/programs and related acts to improve nutrition and to reduce obesity. Meanwhile, those governments' activities are frequently criticized to be more coordinated in order to achieve their aims. Activities on nutrition and obesity prevention have interdepartmental characteristics but are scattered through six Ministries (including the Ministry of Health and Welfare, Ministry of Education, Ministry of Agriculture, Ministry of Employment and Labor, Ministry of Culture and Sports, and Ministry of Food/Drug Safety) and 27 Acts such as 'Nutrition Management Act', 'Health Promotion Act', 'Diet Education Support Act'. As a result, a number of areas, especially dietary guidance, nationwide surveys, education programs seem to overlap. Conclusions: Inter-ministerial coordination mechanism should be established to enforce multi-sectoral engagement and cooperation in implementing policies/programs on nutrition and obesity prevention. Furthermore, functions of the Ministries should be reorganized and coordinated in reference to other countries' experiences.

Quantitative Analysis of Flavonoid Glycosides in Sophora japonica and Sophora flavescens by HPLC-DAD

  • Kim, Soo Sung;Park, SeonJu;Kim, Nanyoung;Kim, Seung Hyun
    • Natural Product Sciences
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    • v.27 no.4
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    • pp.284-292
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    • 2021
  • Recently, a phytoestrogenic functional food has been developed using the fruits of Sophora japonica. Phytochemical investigation of fruits of S. japonica led to the isolation of eight flavonoid glycosides using various chromatographic techniques. The isolated compounds were identified as genistin (1), sophoricoside (2), genistein 7,4'-di-O-β-D-glucopyransoide (3), sophorabioside (4), genistein-7-O-β-D-glucopyranoside-4'-O-[(α-L-rhamnopyranosyl)-(1→2)-β-D-glucopyranoside] (5), sophoraflavonoloside (6), nicotiflorin (7) and kaempferol-3-O-α-L-rhamnopyranosyl-(1→6)-β-D-glucopyranosyl-(1→3)-β-D-glucopyranoside (8), respectively, by comparison of their spectroscopic data with those reported in the literature. In addition, a new HPLC-DAD method for simultaneous determination of the isolated compounds was developed to quantitate the contents of flavonoids in S. japonica and S. flavescens. The method was validated in terms of limit of detection, limit of quantitation, specificity, linearity, precision and accuracy. The validated method was successfully applied to determine eight flavonoids in two Sophora species. The contents of eight flavonoids varied according to the parts and species. Particularly, it was found that only the fruits of S. japonica contained sophoricoside, a phytoestrogenic isoflavone.

Measuring Efficiency of National R&D Programs within Nanotechnology Field Using DEA Model (DEA모형을 활용한 나노기술 분야 국가 R&D 과제의 효율성 분석)

  • Bae, Seoung-Hun;Kim, Jun-Hyun;Yoon, Jin-Seon;Kang, Sang-Kyu;Shin, Kwang-Min;Cho, Su-Ji;Lee, Ki-Kwang
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.39 no.2
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    • pp.64-71
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    • 2016
  • Recently, nanotechnology has grown as one of the leading science technology along with other converging technologies such as biology, information, medicine etc., bringing the continuous investment of the government in nano-related field. However, it is difficult to measure and evaluate the performance of the national research and development programs because of the multidimensional character of the expected outcomes. This study aims to measuring efficiency of the national nanotechnology research and development programs using DEA model. The decision making units are nine nano-related ministries including the Ministry of Science, ICT and Future Planning. The input variables are total expenditure, number of the programs and average expenditure per program. The output variables are science, technology and economic indicator, and the combination of these outputs are respectively measured as seven different DEA cases. The Ministry of Science, ICT and Future was the first efficient ministry in total technical efficiency. Ministry of Agriculture, Food and Rural Affairs and the Ministry of Food and Drug Safety were efficient in pure technical efficiency, when the Ministry of Commerce Industry and Energy took the first in the scale efficiency. The program efficiency was affected by organizational characteristics such as the institution's scale, the concentration of the research paper or the patent, technology transfer or the commercialization. The result of this study could be utilized in development of the policy in the nanotechnology and the related field. Furthermore, it could be applied for the modification of expenditure management or the adjustment of the research and development programs' input and output scale for each ministry.

Investigation on the Safety of Hydroquinone and Preservatives among Whitening Functional Cosmetics Containing Albutin in Korea (국내 유통 알부틴 함유 미백 기능성화장품 중 히드로퀴논 및 살균보존제 안전성 조사)

  • Cho, Joong Hee;Kim, Ji Hyeung;Eom, Sun Ah;Kang, Min Jeong;Han, Young Sun;Hur, Myong Je
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.45 no.4
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    • pp.399-408
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    • 2019
  • Arbutin, which is used as a whitening ingredient, can produce hydroquinone, known as causing skin disease and carcinogen. Preservatives are essential to prevent microbial contamination during long-term storage and use of cosmetics, but safety issues such as toxicity and skin irritation are being raised. This study was conducted to determine hydroquinone and 21 preservatives levels in 40 arbutin-containing whitening functional cosmetics sold on-line and off-line. Result showed that 9 products contained hydroquinone. The concentrations in 7 products were ranged from 0.3 to 0.9 ppm, which were within the maximum allowed amount established by the Ministry of Food and Drug Safety. However, 2 products were 8.4 and 50.5 ppm and exceeded the allowed amount. Preservatives were detected 20 products. Detected items and ranges were phenoxy ethanol 0.1 ~ 0.7% (N = 15), Methyl paraben 0.19 ~ 0.21% (N = 2), Chlorphenesin 0.13% (N = 1), chlorhexidine 0.006% (N = 1), Propyl paraben 0.06% (N = 1), which were within maximum allowed amount established by the Ministry of Food and Drug Safety. Also, in cases of functional cosmetics the phrase "functional cosmetics" should be expressed on the primary or secondary package of cosmetics by cosmetics act. However, 1 product did not state the phrase as functional cosmetics. This study suggest that preservatives were safely managed. However, hydroquinone in hydroquinone-detected products could be produced by the decomposition of arbutin. Thus, further studies on the decomposition of arbutin are required to improve the quality control of the cosmetics.

Analysis of 3-MCPD and 1,3-DCP in Various Foodstuffs Using GC-MS

  • Kim, Wooseok;Jeong, Yun A;On, Jiwon;Choi, Ari;Lee, Jee-yeon;Lee, Joon Goo;Lee, Kwang-Geun;Pyo, Heesoo
    • Toxicological Research
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    • v.31 no.3
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    • pp.313-319
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    • 2015
  • 3-Monochloro-1,2-propanediol (3-MCPD) and 1,3-dichloro-2-propanol (1,3-DCP) are not only produced in the manufacturing process of foodstuffs such as hydrolyzed vegetable proteins and soy sauce but are also formed by heat processing in the presence of fat and low water activity. 3-MCPD exists both in free and ester forms, and the ester form has been also detected in various foods. Free 3-MCPD and 1,3-DCP are classified as Group 2B by the International Agency for Research on Cancer. Although there is no data confirming the toxicity of either compound in humans, their toxicity was evidenced in animal experimentation or in vitro. Although few studies have been conducted, free 3-MCPD has been shown to have neurotoxicity, reproductive toxicity, and carcinogenicity. In contrast, 1,3-DCP only has mutagenic activity. The purpose of this study was to analyze 3-MCPD and 1,3-DCP in various foods using gas chromatography-mass spectrometry. 3-MCPD and 1,3-DCP were analyzed using phenyl boronic acid derivatization and the liquid-liquid extraction method, respectively. The analytical method for 3-MCPD and 1,3-DCP was validated in terms of linearity, limit of detection (LOD), limit of quantitation, accuracy and precision. Consequently, the LODs of 3-MCPD and 1,3-DCP in various matrices were identified to be in the ranges of 4.18~10.56 ng/g and 1.06~3.15 ng/g, respectively.

Validation and Determination of the Contents of Acetaldehyde and Formaldehyde in Foods

  • Jeong, Hye-Seung;Chung, Hyun;Song, Sang-Hoon;Kim, Cho-Il;Lee, Joon-Goo;Kim, Young-Suk
    • Toxicological Research
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    • v.31 no.3
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    • pp.273-278
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    • 2015
  • The aim of this study was to develop an efficient quantitative method for the determination of acetaldehyde (AA) and formaldehyde (FA) contents in solid and liquid food matrices. The determination of those compounds was validated and performed using gas chromatography-mass spectrometry combined by solid phase micro-extraction after derivatization with O-(2,3,4,5,6-pentafluoro-benzyl)-hydroxylamine hydrochloride. Validation was carried out in terms of limit of detection, limit of quantitation, linearity, precision, and recovery. Then their contents were analyzed in various food samples including 15 fruits, 22 milk products, 31 alcohol-free beverages, and 13 alcoholic beverages. The highest contents of AA and FA were determined in a white wine (40,607.02 ng/g) and an instant coffee (1,522.46 ng/g), respectively.