• Title/Summary/Keyword: REACH(Registration Evaluation Authorization of Chemicals)

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Counterplan Status and Policy Suggestion on REACH (REACH 대응현황 조사 밑 정책제언)

  • Kim, Sang-Yong;Yang, Jeong-Mok;Cho, Jin-Ku;Lee, Do-Hoon
    • Clean Technology
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    • v.14 no.4
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    • pp.225-231
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    • 2008
  • In recent years, the extensive expansion of environmental regulations is led by advanced countries. In particular, REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) effective from 2007 issues a serious threat to export-dependent Korean economy because the principal exports of Korea may infringe upon the regulation. Here, we introduce a general comprehension and current situation of REACH in order to cope with possible crisis caused by REACH. Furthermore, we indicate a trouble in counter-plan prepared by companies and government and wish to suggest appropriate measures on the basis of experts opinions.

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Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices

  • Ha, Soojin;Seidle, Troy;Lim, Kyung-Min
    • Environmental Analysis Health and Toxicology
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    • v.31
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    • pp.26.1-26.9
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    • 2016
  • Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

Applicability of QSAR Models for Acute Aquatic Toxicity under the Act on Registration, Evaluation, etc. of Chemicals in the Republic of Korea (화평법에 따른 급성 수생독성 예측을 위한 QSAR 모델의 활용 가능성 연구)

  • Kang, Dongjin;Jang, Seok-Won;Lee, Si-Won;Lee, Jae-Hyun;Lee, Sang Hee;Kim, Pilje;Chung, Hyen-Mi;Seong, Chang-Ho
    • Journal of Environmental Health Sciences
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    • v.48 no.3
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    • pp.159-166
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    • 2022
  • Background: A quantitative structure-activity relationship (QSAR) model was adopted in the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, EU) regulations as well as the Act on Registration, Evaluation, etc. of Chemicals (AREC, Republic of Korea). It has been previously used in the registration of chemicals. Objectives: In this study, we investigated the correlation between the predicted data provided by three prediction programs using a QSAR model and actual experimental results (acute fish, daphnia magna toxicity). Through this approach, we aimed to effectively conjecture on the performance and determine the most applicable programs when designating toxic substances through the AREC. Methods: Chemicals that had been registered and evaluated in the Toxic Chemicals Control Act (TCCA, Republic of Korea) were selected for this study. Two prediction programs developed and operated by the U.S. EPA - the Ecological Structure-Activity Relationship (ECOSAR) and Toxicity Estimation Software Tool (T.E.S.T.) models - were utilized along with the TOPKAT (Toxicity Prediction by Komputer Assisted Technology) commercial program. The applicability of these three programs was evaluated according to three parameters: accuracy, sensitivity, and specificity. Results: The prediction analysis on fish and daphnia magna in the three programs showed that the TOPKAT program had better sensitivity than the others. Conclusions: Although the predictive performance of the TOPKAT program when using a single predictive program was found to perform well in toxic substance designation, using a single program involves many restrictions. It is necessary to validate the reliability of predictions by utilizing multiple methods when applying the prediction program to the regulation of chemicals.

An Empirical Study on Relationship between Environmental Management and Sustainable Development (기업의 환경경영이 지속가능한 발전에 미치는 실증분석)

  • Jang, Kee-Yoon
    • Journal of Environmental Policy
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    • v.8 no.3
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    • pp.81-113
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    • 2009
  • This study conducted a regulatory impact analysis regarding the introduction of the Korean version of REACH(Registration, Evaluation and Authorization of Chemicals). The direct cost of the Korean REACH is estimated at a total of 101 billion Korean won over the 11 year period. The cost includes pre-registration, testing, registration, Chemical Safety Assessment(CSA) and Chemical Safety Report(CSR), evaluation, and the authorization costs of 15,223 chemical substances produced and imported more than 1 ton per year in Korea in 2006. With regard to the benefit, the only public health benefit is included in the estimation. Based on the available foreign and domestic data, this study estimated that the economic values of public health benefits are in the range of 33.2~138.6 billion Korean won if only the savings of the National Health Expenditures are considered and it reaches 203.9~1,640.3 billion Korean won if the willingness to pay(WTP) for disease prevention is included. This study proved that the Korean REACH passed the cost/benefit criteria. The benefit-cost ratio of the Korean REACH, however, is estimated to be lower than its EU counterpart. Thus it is suggested that a rigorous study to reduce the costs to industry be required before the Korean government introduces the Korean REACH.

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A study on importance of MSDS education (MSDS 교육의 중요성에 관한 연구)

  • Choi, Sung-Jai
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.15 no.6
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    • pp.209-215
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    • 2015
  • Following the semiconductor industry's growing, various types of toxic gases and caustic chemicals, HF(Hydrofluoric acid), HCI (Hydochloric acid), $H_2O_2$ (Hydrogen peroxide), $H_2SO_4$ (Sulfuric acid), and Piranha, were using on the semiconductor manufacturing process. Therefore many gas leakage accidents that produce huge losses of lives were caused by the processes. This research deeply considers two basic solutions that the necessity of MSDS education on university for reducing damage of lives and protecting life from chemical leak accidents such as a HF accident in Gumi, Korea and the use of GHS, REACH and the comprehension of propriety about using MSDS for keeping safety from conflagrations by released poison chemical materials.

A Cost-Benefit Analysis on the Introduction of EU REACH to Korea (EU 신화학물질정책(REACH) 도입에 대한 비용편익 분석)

  • Cheong, Hoe-Seog
    • Journal of Environmental Policy
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    • v.8 no.3
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    • pp.53-79
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    • 2009
  • This study conducted a regulatory impact analysis regarding the introduction of the Korean version of REACH(Registration, Evaluation and Authorization of Chemicals). The direct cost of the Korean REACH is estimated at a total of 101 billion Korean won over the 11 year period. The cost includes pre-registration, testing, registration, Chemical Safety Assessment(CSA) and Chemical Safety Report(CSR), evaluation, and the authorization costs of 15,223 chemical substances produced and imported more than 1 ton per year in Korea in 2006. With regard to the benefit, the only public health benefit is included in the estimation. Based on the available foreign and domestic data, this study estimated that the economic values of public health benefits are in the range of 33.2~138.6 billion Korean won if only the savings of the National Health Expenditures are considered and it reaches 203.9~1,640.3 billion Korean won if the willingness to pay(WTP) for disease prevention is included. This study proved that the Korean REACH passed the cost/benefit criteria. The benefit-cost ratio of the Korean REACH, however, is estimated to be lower than its EU counterpart. Thus it is suggested that a rigorous study to reduce the costs to industry be required before the Korean government introduces the Korean REACH.

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EU Environmental Prohibition on Hazardous Substances and Its Impacts on International Trades of Korea Companies (국제환경규제 유해물질의 최근 동향 및 국내 수출기업에 미치는 영향)

  • Cho, Young-Dal;Byun, Sung-Won;Choe, Eun-Kyung;Kim, Sang-Hun
    • Clean Technology
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    • v.18 no.1
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    • pp.1-13
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    • 2012
  • Starting with textile products in the middle of 1990, environmental requirements on prohibition of hazardous substances in products have been led by EU member countries and expanded to electrical and electronic equipment with implementaion of RoHS (Restriction of the use of certain hazardous substances in electrical and electronic equipment) in 2006. Under EU REACH (Registration, Evaluation and Authorization of CHemicals), the concept of SVHC (Substances of Very High Concern) and resulting regulatory duties regarding it have been introduced to the supply chain of almost all industry sectors. In this technical review, kinds of hazardous substances, reasons for restrictions and related directives and regulations are reviewed with its influence on the international market. Suggestions are made how to cope with environmental regulations as well as mid-to-long term market strategy to secure global market competitiveness.

Perspective on substance identification in REACH (EU REACH의 물질확인 방법론 고찰)

  • Ra, Jin-Sung;Park, Kwang Seo;Choe, Eun Kyung;Kim, Sanghun
    • Analytical Science and Technology
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    • v.34 no.3
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    • pp.99-114
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    • 2021
  • Substance identification is the first step in implementing chemical legislation, such that subsequent hazard and risk assessments can be accurately followed. Based on the web page and related guidance documents of the European Chemicals Agency and available consortia information, the procedure for substance identification carried out in Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is surveyed. In this study, the importance of substance identification and substance sameness check, as well as the necessity of generating a substance identity profile (SIP) are considered. In addition, the SIPs of several substance types are presented, which focused on information utilization in the instrumental analysis results and organization of information to generate the SIP. Analytical science can contribute to the accurate and effective implementation of chemical regulation at the starting stage of substance identification. However, understanding of the regulation and consequent final wrap-up of analytical results as a SIP should be followed for communication among registrants in Substance Information Exchange Forum (SIEF) as well as with related authorities.

Improving the Reliability of the National Database for Chemical Hazard Information (국가 화학물질 유해성정보 데이터베이스 구축 과정의 신뢰도 제고 방안에 관한 연구)

  • Lee, Somin;Lee, Minhyeok;Kang, Mijin;Kwon, Soon-Kwang;Ra, Jin-Sung;Park, Beaksoo
    • Journal of Environmental Health Sciences
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    • v.46 no.4
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    • pp.410-422
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    • 2020
  • Objectives: According to the Act on Registration, Evaluation, Etc. of Chemicals, new and existing chemicals must be registered by 2030. In addition, industries need to submit hazard data as an attachment during the registration process. Therefore, we constructed a nationwide chemical database to support small industry by providing hazard data and original sources. During the process, we developed a new standard procedure for minimizing errors and increasing reliability. Methods: We analyzed the categories of errors and the cause of the errors through the verification results of the 2019 project. We present an improved database construction methodology and system. Results: Errors are categorized according to their causative factors into simple, technical, and structural type errors. Simple errors arise simply because of decreased concentration or negligence in following the instructions. Technical errors are caused by a discrepancy between the professional field and the type of data. Structural errors indicate systemic errors such as incomplete forms on the excel database or ambiguity in the guidelines. Lessons from the errors collected in the 2019 project are used to update the procedures for database authorization and technical guidelines. The main update points are as follows; 'supplementation of review process', 'giving regular training to external reviewers', 'giving additional information to authors, like physico-chemical properties of substances, degradability, etc.', 'amendment of excel form', and 'guideline upgrades'. Conclusions: We conducted this study with the aim of improving the accuracy and reliability of the database of hazard information for chemical substances. The new procedures and guidelines are now being used in the 2020 project for construction of a hazard information database for Korea.

Evaluation of the Application of a European Chemical Risk Assessment Tool in Korea (외국 노출량 산정 프로그램(ECETOC TRA)의 국내 적용을 위한 입력변수의 보정에 관한 연구)

  • Lee, Jong Han;Lee, Kown Seob;Hong, Mun Ki
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.22 no.3
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    • pp.191-199
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    • 2012
  • Objectives: The study aim was to evaluate the application of a chemical exposure assessment tool for the Korean workplace. The Ministry of Employment and Labor in Korea (KMOEL) introduced the need for workplace risk assessments in 2011, requiring the Korean chemical industry to consider both domestic and international chemical regulation policies (e.g., estimations of exposure scenarios). Exposure scenarios are required in the European Union as part of material safety data sheets (MSDS) under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) system. Methods: Although many programs for the estimation of exposure have been developed worldwide, to date there is no standard for the Korean workplace. To develop programs suitable for the Korean workplace, we examined the applicability of the European Center for Ecotoxicology and Toxicology of Chemicals target risk assessment (ECETOC TRA), which is recommended by the European Chemical Agency (ECHA). Results: To investigate the applicability of the ECETOC TRA to Korean industry, this study simulated 15 industrial processes. The predicted respiratory exposures for four processes using origin input parameters were underestimated compared to the measured respiratory exposure. Using calibrated input parameters, results for two processes were underestimated compared to the measured respiratory exposure. This result suggests that the use of calibrated input parameters reduces the differences between predicted and measured respiratory exposure. Conclusions: we developed applicable exposure estimating method by modifying the ECETOC TRA program; one suggested the development of exposure estimating program that explains Korea domestic workplace exposure scenario.This study will support the introduction of exposure scenario in MSDS system and protect health of worker from hazardous chemical.