• Title/Summary/Keyword: EFSA

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LMO 위해성과 환경모니터링 (EU 사례)

  • 김동헌
    • Proceedings of the Korean Society of Crop Science Conference
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    • 2022.04a
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    • pp.8-8
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    • 2022
  • 지난25년간 유전자변형 생물체(LMO)는 가장 성공적인 농업 기술의 하나로 자리잡았다. 그러나 동시에 LMO가 격렬한 찬반 논란의 중심에 있었고 이로 인한 엄격한 규제의 대상이 되어 왔다. 카르타헤나 바이오안전성의정서와 LMO 위해성 심사 및 승인 등은 이러한 엄격한 규제를 대표하는 국제 혹은 국가 수준의 정책사례라고 할 수 있다. 특히 유럽연합은 역내의 반-LMO 정서를 반영하여 스페인 등 일부 국가를 제외하고는 거의 모라토리움 수준의 LMO 규제를 실시하고 있다. 유럽식품안전청(EFSA)는 유럽연합의 이러한 정책 결정에 따라 역내의 LMO 재배 및 사용에 대해 엄격한 심사업무를 담당하고 있는 기관이다. 최근EFSA는 그 동안의 심사 경험을 바탕으로 LMO의 심사 경험과 LMO환경 방출에 대한 모니터링 결과를 공유하기 위한 자료를 발간했다. 이들 자료는 EU에 비견될 수 있을 정도로 LMO에 대해 부정적인 정책적 입장을 취하고 있는 우리에게 다양한 시사점을 제공할 것으로 판단된다. 본 발표에서는 최근의 LMO 정책 환경 변화를 돌아보고, EFSA 보고서의 시사점을 살펴봄으로써 우리의 LMO 규제 정책이 합리적으로 개선될 수 있는 방향을 제시하고자 했다.

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Calibrating Electrode Misplacement in Underwater Electric Field Sensor Arrays for the Electric Field-Based Localization of Underwater Vessels (수중 이동체의 전기장 신호 기반 위치추정을 위한 수중 전기장 배열센서의 전극 부설 위치 오차 보정 방법)

  • Kim, Jason;Lee Ingyu;Bae, Ki-Woong;Yu, Son-Cheol
    • Journal of Sensor Science and Technology
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    • v.31 no.5
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    • pp.330-336
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    • 2022
  • This paper proposes a method to calibrate the electrode misplacement in underwater electric field sensor arrays (EFSAs) for accurate measurements of underwater electric field signatures. The electrode misplacement of an EFSA was estimated by measuring the electric field signatures generated by a known electric source and by comparing the measurements with the theoretical calculations under similar measurement conditions. When the EFSA measured the electric field signatures induced by an unknown electric source, the electric properties of the unknown electric source were approximated by considering the optimized estimation of the electrode misplacement of the EFSA. Finally, the measured electric field signatures were calibrated by calculating the theoretical electric field signatures to be measured with an ideally installed EFSA without electrode misplacement; the approximated electric properties of the unknown electric source were also taken into account. Simulations were conducted to test the proposed calibration method. The results showed that the electrode misplacement could be estimated. Further, the electric field measurements and the electric field-based localization of underwater vessels became more accurate after the application of the proposed calibration method. The proposed method will contribute to applications such as the detection and localization of underwater electric sources, which require accurate measurements of underwater electric field signatures.

Comparative Estimation of Exposure Level and Health Risk Assessment of Highly Produced Pesticides to Agriculture Operators by Using Default Dermal Absorption Rate or Actual Measurement Values

  • Kim, Su-Hyeon;Lee, Chang-Hun;Kim, Ki-Hun;Jeong, Sang-Hee
    • Biomedical Science Letters
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    • v.22 no.4
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    • pp.199-206
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    • 2016
  • Pesticides are widely used to prevent loss of agricultural production but extensive exposure can induce health problems to pesticide operators. This study was performed to evaluate the health risk of highly produced pesticides used in fruit growing farm land by comparison of estimated exposure level with AOEL using KO-POEM program. AOEL was driven based on NOAEL of each pesticide evaluated by JMPR, EFSA or KRDA. In calculation of exposure level, types of formulation, dilution factors, spraying duration and motor type and exposure protection device were allocated according to actual condition of use. Dermal absorption rate was differently applied among EFSA default values (25% or 75%), general default value (10%) or real test result values to know the plausibility of default values and safety of pesticide to operators in outline. Twenty pesticide ingredients (fungicides and insecticides) were produced more than 30 tons per year, which were mancozeb, chlorothalonil, imidaclopirid and etc in order. Dermal absorption rates obtained from studies were various from 0.07 to 81% but mostly under 10%. The estimated exposure levels showed big differences more than 10 times higher when using EFSA default rate and up to 5 times higher when using general rate of 10% comparing using rates of test results. Mancozeb, chlorthalonil, diazinon and chlorpyrifos presented still higher exposure level than AOEL even when using test absorption rate from study, which suggests that re-evaluation of AOEL or dermal exposure absorption rate or strict management are required for health protection of operators who use those four pesticides in farm land.

Safety Assessment of Bifidobacterium breve BB077 as Probiotics (프로바이오틱스 Bifidobacterium breve BB077 안전성 평가)

  • Woo, Jang-Bin;Han, Ji Yoon;Seo, Eunsol;Seo, MinYeong;Kim, Byung-Yong
    • Journal of Food Hygiene and Safety
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    • v.37 no.5
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    • pp.306-309
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    • 2022
  • Probiotics are live microorganisms that confer health benefits onto the host when administered at adequate doses. Most widely used probiotics, such as lactobacilli and bifidobacteria, are known to be elements of healthy gut microflora and hence are not considered a threat to the host. However, probiotics may pose a risk in certain populations with compromised immune systems or defects in gut barrier functions. Herein, we evaluated the safety of Bifidobacterium breve BB077, according to the safety evaluation guidelines for probiotics produced by the National Institute of Food and Drug Safety Evaluation (NIFDS). The results show that B. breve BB077 is both non-hemolytic and non-cytolytic. In contrast, B. breve BB077 exhibited higher streptomycin and tetracycline resistance than the suggested NIFDS standard cut-off values. Hence, a genetic analysis of the streptomycin and tetracycline resistance genes was performed to determine the origin of antimicrobial resistance. Streptomycin and tetracycline resistance was shown have arisen from chromosomal mutations and considered intrinsic to the taxonomic group. In conclusion, the B. breve BB077 strain might be safe for human consumption.

Determining a BMDL of Blood Lead Based on ADHD Scores Using a Semi-Parametric Regression

  • Kim, Ah-Hyoun;Ha, Min-A;Kim, Byung-Soo
    • The Korean Journal of Applied Statistics
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    • v.25 no.3
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    • pp.389-401
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    • 2012
  • This paper derives a benchmark dose(BMD) and its 95% lower confidence limit(BMDL) using a semi-parametric regression model for small lead based changes in attention-deficit hyperactivity disorder(ADHD) scores in the first wave of the Children's Health and Environment Research(CHEER) survey data, which have been regularly collected in South Korea since 2005. Ha et al. (2009) showed that the appearance of ADHD symptoms had a borderline trend of increasing with the blood lead concentration. Butdz-J${\o}$rgensen (EFSA, 2010a) derived the BMDL of lead corresponding to a benchmark region of 1 full intelligent quotient (IQ) score using the raw data in Lanphear et al. (2005, EHP). European Food Safety Authority (EFSA, 2010b) determined the BMDL of $1.2{\mu}g/dl$ as a reference point for the characterization of lead when assessing the risk of the intellectual deficit measured by IQ scores. Kim et al. (2011) indicated that an even lower BMDL could be obtained based on the ADHD score; however, the BMDLs depended heavily upon the model assumptions. We show in this paper that a semi-parametric approach resolves the model dependence of BMDLs.

In vitro safety and efficacy of probiotics mixture on carbohydrate digestion inhibition (프로바이오틱스 혼합물의 in vitro에서의 안전성 및 탄수화물 소화 저해 효능 평가)

  • Eunsol Seo;Jang-Bin Woo;MinYeong Seo;Jeongmin Woo
    • Food Science and Preservation
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    • v.30 no.3
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    • pp.538-545
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    • 2023
  • This study aimed to assess the in vitro safety of a probiotics mixture (Lactobacillus acidophilus PBS066, Lactiplantibacillus plantarum PBS067, and Limosilactobacillus reuteri PBS072), along with its inhibitory effect on carbohydrate digestion. All three strains met the antibiotic resistance profile of the European Food Safety Authority (EFSA) guidelines. None of the strains exhibited hemolytic activity or cytotoxicity against Caco-2 cells. Strains PBS067 and PBS072 inhibited α-amylase activity, whereas all three strains suppressed α-glucosidase activity, indicating that the mixture might limit carbohydrate digestion in the gastrointestinal tract. These findings support the safety of this probiotics mixture and its potential to modulate carbohydrate metabolism in the gut.

Establishment of an Analytical Method for Azorubine, an Undesignated Food Colorant in Korea

  • Kim, Min-ji;Park, Ju-hee;Suh, Hee-Jae;Lee, Chan
    • Journal of Food Hygiene and Safety
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    • v.31 no.5
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    • pp.311-318
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    • 2016
  • Azorubine is a synthetic tar color containing azo-bond in the molecular structure. This food colorant has been allowed to be used for beverages, cheese and dried fruits in the European Union and for some food in Australia. Even though it is applicable as a food color in many countries, this compound has not been permitted in Korea so far as a food additive. Thus, this study was performed to establish an analysis method for azorubine in Korea by comparison of three HPLC analysis methods for azorubine and other azo-compounds which are officially used in the European Food Safety Authority (EFSA, EU), the Food Standard Agency (FSA, England) and the National Institute of Food and Drug Safety Evaluation (NIFDS, Korea). The analysis method of the FSA for azorubine showed the best linearity ($r^2=0.999$), limit of detection (LOD, $0.07{\mu}g/mL$), limit of quantification (LOQ, $0.20{\mu}g/mL$), precision (0~0.5%) and accuracy (98.6~100.7%) among tested HPLC methods using a C-18 column and diode array detector (DAD) with ammonium acetate solution and acetonitrile as an eluent solution. Finally selected method of FSA was further verified by inter-day and intra-day experiments with linearity, LOD, LOQ, precision and accuracy. Recovery test showed the recover ratios of 97~103%, 95~101%, and 93~102% in beverages, breads/snacks and other foods, respectively. Inter-laboratory test represented the absolute value of z-score of less than 2 which means satisfactory levels in this test. Selected method of FSA showed reliable analytical results in application test using food samples collected in commercial markets in Europe.

Safety Assessment of Starters for Traditional Korean Fermented Foods (전통발효식품용 종균의 안전성 평가 필요성)

  • Jeong, Do-Won;Lee, Jong-Hoon
    • Microbiology and Biotechnology Letters
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    • v.42 no.1
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    • pp.1-10
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    • 2014
  • Most microorganisms have been used for foods for such a long period of time with no question posed for their safety. However, the progress of food processing technology has activated international food trades, and the consumers and authorities of import countries have come to question the safety of microorganisms used in foods. At present, the most widely known safety standards are Generally Recognized as Safe (GRAS) status from the US Food and Drug Administration (FDA) and Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). GRAS status is not for the safety of microorganisms themselves but for the permissibility of strains or cultures in specific food uses. QPS provides a qualified generic approval to a defined taxonomic unit. The increase of commercialized traditional fermented foods in Korea has spurred the starter development for traditional food fermentations. However, starter development in Korea has been carried out based on the technological properties of microorganisms with no research on developing a standardized tool for safety assessment. In the globalization of traditional Korean fermented foods, technological properties as well as safety of future starters should be guaranteed, and establishment of the safety assessment regulation for microorganisms used for foods is necessary.

Comparison of International Guidelines of Dermal Absorption Tests Used in Pesticides Exposure Assessment for Operators

  • So, Jaehwan;Ahn, Junyoung;Lee, Tae-Hee;Park, Kyung-Hun;Paik, Min-Kyoung;Jeong, Mihye;Cho, Myung-Haing;Jeong, Sang-Hee
    • Toxicological Research
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    • v.30 no.4
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    • pp.251-260
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    • 2014
  • The number of farmers who have suffered from non-fatal acute pesticide poisoning has been reported to vary from 5.7% to 86.7% in South Korea since 1975. Absorption through the skin is the main route of exposure to pesticides for farmers who operate with them. Several in vitro tests using the skins of humans or animal and in vivo tests using laboratory animals are introduced for the assessment of human dermal absorption level of pesticides. The objective of this study is to evaluate and compare international guidelines and strategies of dermal absorption assessments and to propose unique approaches for applications into pesticide registration process in our situation. Until present in our situation, pesticide exposure level to operator is determined just using default value of 10 as for skin absorption ratio because of data shortage. Dermal absorption tests are requested to get exposure level of pesticides and to ultimately know the safety of pesticides for operators through the comparison with the value of AOEL. When the exposure level is higher than AOEL, the pesticide cannot be approved. We reviewed the skin absorption test guidelines recommended by OECD, EFSA and EPA. The EPA recommends assessment of skin absorption of pesticides for humans through the TPA which includes all the results of in vitro human and animal and animal in vivo skin absorption studies. OECD and EFSA, employ a tiered approach, which the requirement of further study depends on the results of the former stage study. OECD guidelines accept the analysis of pesticide level absorbed through skin without radioisotope when the recovery using the non-labeled method is within 80~120%. Various factors are reviewed in this study, including the origin of skin (gender, animal species and sites of skin), thickness, temperature and, etc., which can influence the integrity of results.