• Title/Summary/Keyword: food safety regulation

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Development of Standards of Tattoo Machine for Safety and Performance Evaluation (의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구)

  • Kim, Y.G.;Cho, S.K.;Lee, T.W.;Yeo, C.M.;Jung, B.J.;Kwon, Y.M.;Cha, J.H.;Hur, C.H.;Park, K.J.;Kim, D.S.;Kim, H.S.
    • Journal of Biomedical Engineering Research
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    • v.32 no.2
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    • pp.151-157
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    • 2011
  • Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

Development of Rapid, Safe Analytical Techniques of Aflatoxins and Their Current Regulation (Aflacxin에 대한 최신 분석법과 규제동향)

  • 정덕화
    • Journal of Food Hygiene and Safety
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    • v.5 no.3
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    • pp.131-138
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    • 1990
  • Aflatoxins is a chemically diverse group of toxic secondary metabolites that are produced by fungi and often occur in agricultural commodities. Because of their wide range of toxic effects, Aflatoxins cause severe economic losses to farmers and livestock producers and pose a health to human consuming contaminated foods. Long term prospects for biotechnological control of Aflatoxins require elucidation of the specific steps and regulation of their biosynthetic pathways . Aflatoxin determinations can be approached many ways. It is essential to safely handle all experimental materials associated with aflatoxin analysis or aflatoxigenic fungi Visual screening of suspect samples, base on the presence of conidial head of the aspergillus flavus group, and screening samples for the presence of bright greenish yellow flourescence are not chemical tests and such screening techniques may allow aflactoxin contaminated lots into commerce. Microcolumn screening procedures should always be used in conjunction with a quantitative method. Several thin layer chromatography(TLC) and high performance liquid chromatography(HPLC) methods are suitable for quantitation and are in general use. Immunochemical Methods such as the ELISA or affinity column chromatography methods are being rapidly developed. The chemical and immunochemical methods can be reliable if care is taken, using suitable controls and personnel that are well trained . All analytical laboratories should stress safety and include suitable analytical validation procedure. Especially a worldwide enquiry was undertaken in recent to obtain up-to-date information about aflatoxin legislation in as many countries of the world as possible. The information concerns aflatoxin in foodstuffs. aflatoxin MI in dairy products, aflatoxins in animal feedstuffs. Limits and regulations for aflatoxin have been expended in recent with more countries having legislation on subject, more products, and more aflatoxins covered by this legislation.

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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.

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).

Assessment of Biomarkers in Acetaminophen-Induced Hepatic Toxicity by siRNA

  • Kang, Jin-Seok;Yum, Young-Na;Kim, Joo-Hwan;Park, Sue-Nie
    • Biomolecules & Therapeutics
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    • v.17 no.4
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    • pp.438-445
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    • 2009
  • We investigated global gene expression from both mouse liver and mouse hepatic cell lines treated with acetaminophen (APAP) in order to compare in vivo and in vitro profiles and to assess the feasibility of the two systems. During our analyses of gene expression profiles, we picked up several down-regulated genes, such as the cytochrome P450 family 51 (Cyp51), sulfotransferase family cytosolic 1C member 2 (Sult1c2), 3-hydroxy-3-methylglutaryl-Coenzyme A synthase 1 (Hmgcs1), and several genes that were up-regulated by APAP, such as growth arrest and DNA-damage-inducible 45 alpha (Gadd45a), transformation related protein 53 inducible nuclear protein 1 (Trp53inp1) and zinc finger protein 688 (Zfp688). For validation of gene function, synthesized short interfering RNAs (siRNAs) for these genes were transfected in a mouse hepatic cell line, BNL CL.2, for investigation of cell viability and mRNA expression level. We found that siRNA transfection of these genes induced down-regulation of respective mRNA expression and decreased cell viability. siRNA transfection for Cyp51 and others induced morphological alterations, such as membrane thickening and nuclear condensation. Taken together, siRNA transfection of these six genes decreased cell viability and induced alteration in cellular morphology, along with effective inhibition of respective mRNA, suggesting that these genes could be associated with APAP-induced toxicity. Furthermore, these genes may be used in the investigation of hepatotoxicity, for better understanding of its mechanism.

Establishment of Microbial Criteria by Investigation of Microbial Contamination in Ready-to-Eat Foods (즉석섭취·편의식품류의 미생물 오염도 조사를 통한 기준·규격 재평가)

  • Song, Bo Ra;Kim, Soon Han;Kim, Jin-Kwang;Han, Jeong-A;Kwak, Hyo Sun;Chung, Kyung-Tae;Heo, Eun Jeong
    • Journal of Food Hygiene and Safety
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    • v.32 no.5
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    • pp.348-354
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    • 2017
  • Internationally different food safety regulation and standards could cause troubles in trade unless those are built on scientific knowledge. In this research, we monitored the microbial population and analyzed the results to determine the level of microbial contamination in foodstuffs using relatively new statistical analysis (microbiological sampling plan, International Commission on Microbiological Specification for Foods). The goal of this research falls on establishing entirely new standards for various food categories addressed in the Korean "Food Code". Targets for monitoring were indicator organisms (i.e. total aerobic count, coliform and Escherichia coli) and foodborne pathogens (i.e. Bacillus cereus, Staphylococcus aureus and Clostridium perfringens) in ready-to-eat (RTE) products. As the result of the monitoring, total aerobic count, coliform, E. coli, and B. cereus in RTE products were found at the mean values of 2.10 log CFU/g, -0.60 log CFU/g, -1.33 log CFU/g and -1.23 log CFU/g, respectively. S. aureus was detected with the level of -1.35 log CFU/g only in fresh-cut food, while C. perfringens was -1.37 log CFU/g only in ready-to-cook food. Other samples did not have any food borne pathogens. Total aerobic count, B. cereus, S. aureus and C. perfringens satisfied the Food Code (the MFDS). On the basis of the analysis, we proposed a draft of microbial criteria for RTE products.

Implications of Feed Withdrawal in Broiler Meat Safety and Quality (출하 전 절식과 닭고기 안전성 및 품질)

  • 김동훈;채현석;장경만
    • Food Science of Animal Resources
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    • v.24 no.2
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    • pp.202-208
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    • 2004
  • This review is summarized the importance of feed withdrawal treatment before slaughter based on the related recent research literature. Practical feed withdrawal program is required to prevent from carcass contamination when broilers are slaughtered. The feed withdrawal is more important in countries where regulate the microbial contamination. The feed withdrawal treatment for broiler has also advantage to reduce the carcass contamination from intestinal tract at slaughtering plant. Most researches were conducted to focus on proving the feed withdrawal effect on the efficiency of slaughtering and processing, proper duration and safety of broiler carcass. However, it is pointed out that the feed withdrawal programs are different depending on the production capability, feeding and slaughtering methods, inspection regulation of each country.

Probabilistic exposure assessment, a risk-based sampling plan and food safety performance evaluation of common vegetables (tomato and brinjal) in Bangladesh

  • Mazumder, Mohammad Nurun-Nabi;Bo, Aung Bo;Shin, Seung Chul;Jacxsens, Liesbeth;Akter, Tahmina;Bir, Md. Shahidul Haque;Aktar, Most Mohshina;Rahman, Md. Habibur;WeiQiang, Jia;Park, Kee Woong
    • Korean Journal of Agricultural Science
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    • v.48 no.1
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    • pp.33-43
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    • 2021
  • Along with the widespread use of pesticides in the world, concerns over human health impacts are rapidly growing. There is a large body of evidence on the relationship between the exposure to pesticides and the elevated rate of chronic diseases such as different types of cancers, diabetes, neurodegenerative disorders like Parkinson, Alzheimer, and amyotrophic lateral sclerosis (ALS), birth defects, and reproductive disorders. This research assessed the health risk of pesticide residues by the dietary intake of vegetables collected from the agro-based markets of Dhaka, Bangladesh. As some of the banned pesticides were also found in vegetable samples, they may pose a higher risk because of cheaper availability and hence the government of Bangladesh should take strong measures to control these banned pesticides. Five organo phosphorus (chlorpyrifos, parathion, ethion, acephate, fenthion) and two carbamate (carbaryl and carbofuran) pesticide residues were identified in twenty four samples of two common vegetables (tomato and brinjal). The pesticide residues ranged from below a detectable limit (< 0.01) to 0.36 mg·kg-1. Acephate, chlorpyrifos, ethion, and carbaryl were detected in only one sample, while co-occurrence occurred twice for parathion. Continuous monitoring and strict regulation should be enforced regarding the control of pesticide residues in fresh vegetables and other food commodities in Bangladesh.

Dietary Exposure of Aflatoxin$B_1$ and Cancer Risk Assessment (아플라톡식 $B_1$ 노출에 의한 발암 위해성 평가)

  • 이병무;최문정;변수현;김형식
    • Journal of Food Hygiene and Safety
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    • v.10 no.2
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    • pp.81-87
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    • 1995
  • Daily exposure of aflatoxin B1 (AFB1) was estimated in foods (rice, barley, soybean, peanut, soysauce, soybean paste) by ELISA (enzyme linked immunosorbent assay) using polyclonal antibody R101. Before ELISA, a simple extraction method was applied for the quantitation of AFB1 in foods using chloroform which showed high recovery (70$\pm$12%). AFB1 levels in foods were 0.32 ng/ml (rice), 0.24ng/ml (barley), 0.22 ng/ml (peanut), 0.30~0.78 ng/ml (soysauce), and 0.2 ng/ml (soybean paste). Based on food consumption, we estimated that Koreans were exposed to AFB1 at the level of 1.86$\pm$0.46 ng/kg/day and liver cancer incidence attributed to AFB1 exposure (assuming that AFB1 as a single hepatocarcinogenic agent) might be calculated to be 13.1 per 100, 000 population. Our data demonstrate that AFB1 levels in foods were below the regulation of 10 ppb in foods and might not be the major risk factor for the high incidence of lover cancer in Korea.

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Safety of Saccharin and Its Current Status of Regulation in the World (삭카린의 안전성과 각국의 관리 현황)

  • Kim, Jeong-Weon;Baek, Hyung-Hee
    • Korean Journal of Food Science and Technology
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    • v.43 no.6
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    • pp.659-674
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    • 2011
  • Saccharin was reported to cause urinary bladder cancer in male rats when fed at high doses in a two-generation study, which led to a ban on the use of saccharin in Canada. However, no carcinogenic effect has been observed in other animal experiments conducted with mice, hamsters, or monkeys. Furthermore, numerous epidemiological studies have indicated that there was no relationship between saccharin consumption and the risk of bladder cancer in the human population. Sodium saccharin produces urothelial bladder tumors in rats by the formation of a urinary calcium phosphatecontaining precipitate, which is not relevant to humans because of critical interspecies difference in urine composition. Consequently, in 1999 IARC (International Agency for Research on Cancer) concluded that saccharin and its salts cannot be classified as to their carcinogenicity in humans. In 2010, the EPA (Environmental Protection Agency) of the United States removed saccharin from its list of hazardous substances. It is expected that the use of saccharin in foods might be expanded because saccharin is currently considered safe.