• Journal of Biomedical Engineering Research
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• v.42 no.6
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• pp.277-286
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• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• Environmental and Resource Economics Review
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• v.31 no.4
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• pp.777-799
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• 2022

This study examined the latest EU regulatory strengthening trends for refrigerant gases with very large global warming potential (GWP) and derived implications for carbon neutrality. The European Commission recently unveiled an amendment that significantly strengthens the F-gas Regulation. This study presented the meaning of the main contents related to refrigerants in the amendment by comparing them with the current regulations. The main contents of the amendment include drastically reducing the maximum amount of HFCs that can be placed on the market, strengthening regulations related to HFCs allocation, adding products and equipment that use high GWP refrigerants, adding regulated F-gas and updating the GWP of existing gases, and other stricter regulatory designs. This movement of the EU will affect the policy stance of advanced countries such as the United States and Japan, and Korea's policy will also be further strengthened. Therefore, it will be inevitable for related industries to change to next-generation refrigerant gas. Meanwhile, this study also analyzed the latest policy trends related to per- and polyfluoralkyl substances (PFAS) regulation, which were not noted in previsou studies on refrigerants and F-gas. If PFAS's registration of REACH restricted substances, which are being promoted by five European countries, is made, it will have a very big impact on the industry regarding refrigerant gas. In addition, it will be inevitable to thoroughly review each country's greenhouse gas reduction strategies related to F-gas materials, including refrigerants.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.25 no.2
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• pp.115-125
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• 2015

Objectives: The major objectives of this study are to review the EU CLP Regulations to propose ways of improving the reliability of MSDS and labels. Methods: To review the EU CLP Regulations, we used EU documents including directives and regulations on chemical management. In addition, we used EU governmental agency reports to illuminate the history and background of the CLP. We found the EU CLP's instruments for reliable hazard communication and evaluated the operations of the instruments. Results: EU CLP Regulations have four instruments for the EU CLP Regulations to make hazard communication reliable. These instruments are GHS, the harmonized CMR and respiratory sensitive substances classification list, C&L inventory and restriction of trade secrets. These are highly useful for achieving the objectives of REACH and CLP(no data-no market and changing the burden of proof). Conclusions: Changing the burden of proof is a key principle for achieving a society safe from hazardous chemicals. Chemical manufacturers and importers alone should bear the responsibility for reliable MSDS. We recommend benchmarking the EU CLP Regulations in order to change efficiently the burden of proof. Trade secrets should be limited to low-hazard substances and be approved by the government before the chemical product is on the market. Like the C&L inventory, chemical product information including substances identification and hazard properties should be notified, aggregated and be opened to public on the Internet. Finally, we recommend a MSDS registration system once again.

• Environmental Analysis Health and Toxicology
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• v.30
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• pp.17.1-17.6
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• 2015

Objectives In this study, the possibility of using existing test data provided in Korea and elsewhere for the registration of chemical substances was examined. Data on 510 chemical substances that are among the first subject to registration under the "Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)" were analyzed. Methods The possibility of using existing data from 16 reference databases was examined for 510 chemical substances notified in July 2015 as being subject to registration. Results Test data with the reliability required for the registration of chemical substances under the K-REACH constituted 48.4% of the required physicochemical characteristics, 6.5% of the required health hazards, and 9.4% of the required environmental hazards. Conclusions Some existing test data were not within the scope of this research, including data used for registration in the European Union (EU). Thus, considering that 350 of these 510 species are registered in EU Registration, Evaluation, Authorisation & Restriction of Chemicals, more test data may exist that can be utilized in addition to the data identified in this study. Furthermore, the K-REACH states that non-testing data (test results predicted through Read Across, Quantitative Structure-Activity Relationships) and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized for registration data. Therefore, if methods for using such data were actively reviewed, it would be possible to reduce the cost of securing test data required for the registration of chemical substances.

• Korean Journal of Materials Research
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• v.29 no.6
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• pp.356-362
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• 2019

$BaSiO_3:RE^{3+}$ (RE = Sm or Eu) phosphor powders with different concentrations of activator ions are synthesized using the solid-state reaction method. The effects of the concentration of activator ions on the structural, photoluminescent, and morphological properties of the barium silicate phosphors are investigated. X-ray diffraction data reveals that the crystal structure of all the phosphors, regardless of the type and the concentration of the activator ions, is an orthorhombic system with a main (111) diffraction peak. The grain particles agglomerate together to form larger clusters with increasing concentrations of activator ions. The emission spectra of the $Sm^{3+}$-doped $BaSiO_3$ phosphors under excitation at 406 nm consist of an intense orange band at 604 nm and three weak bands centered at 567, 651, and 711 nm, respectively. As the concentration of $Sm^{3+}$ increases from 1 to 5 mol%, the intensities of all the emission bands gradually increase, reach maxima at 5 mol% of $Sm^{3+}$ ions, and then decrease significantly with further increases in the $Sm^{3+}$ concentration due to the concentration quenching phenomenon. For the $Eu^{3+}$-doped $BaSiO_3$ phosphors, a strong red emission band at 621 nm and several weak bands are observed. The optimal orange and red light emissions of the $BaSiO_3$ phosphors are obtained when the concentrations of $Sm^{3+}$ and $Eu^{3+}$ ions are 5 mol% and 15 mol%, respectively.

• Journal of Environmental Health Sciences
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• v.47 no.5
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• pp.432-445
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• 2021

Background: The European Centre for Ecotoxicology and Toxicology of Chemicals' Targeted Risk Assessment (ECETOC TRA) tool has been recognized by EU REACH as a preferred approach for calculating worker health risks from chemicals. Objectives: The applicability of the ECETOC TRA to occupational exposure estimation from industrial uses of methanol was studied by inputting surveyed and varied parameters for TRA estimation as well as through comparison with measured data. Methods: Information on uses of methanol was collected from seven working environment monitoring reports along with the measured exposure data. Input parameters for TRA estimation such as operating conditions (OCs), risk management measures (RMMs) and process categories (PROCs) were surveyed. To compare with measured exposures, parameters from the surveyed conditions of ventilation but no use of respiratory protection were applied. Results: PROCs 4, 5, 8a, 10, and 15 were assigned to ten uses of methanol. The uses include as a solvent for manufacturing sun cream, surfactants, dyestuffs, films and adhesives. Methanol was also used as a component in a release agent, hardening media and mold wash for cast products as well as a component of hard-coating solution and a viscosity-controlling agent for manufacturing glass lenses. PROC 8a and PROC 10 of a cast product manufacturer without LEV (local exhaust ventilation) and general ventilation as well as no respiratory protection resulted in the highest exposure to methanol. Assuming the identical worst OCs and RMMs for all uses, exposures from PROC 5, 8a, and 10 were the same and the highest followed by PROC 4 and 15. The estimation resulted in higher exposures in nine uses except one use where measured exposure approximated exposures without RMMs. Conclusions: The role of ECETOC TRA as a conservative exposure assessment tool was confirmed by comparison with measured data. Moreover, it can guide which RMMs should be applied for the safe use of methanol.

• International Commerce and Information Review
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• v.16 no.4
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• pp.191-225
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• 2014

Most of all, this paper analyzes the current situation of EU(European Union) and ascertain EU's economic condition in terms of tariff lines and non-tariff barriers. and the purpose of this article is to find out the problems of EU's tariff lines and non-tariff barriers. Next, We suggest some future direction of export promotion from Korea to EU more largely for our companies. First, this paper describes the characteristics and outline of EU. The EU is a politico-economic union of 28 member states that are primarily located in Europe. The EU traces its origins from the European Coal and Steel Community(ECSC) and the European Economic Community(EEC), formed by the Inner Six countries in 1951 and 1958, respectively. After that, The Maastricht Treaty established the European Union under its current name in 1993. The latest major amendment to the constitutional basis of the EU, the Treaty of Lisbon, came into force in 2009. There are a combined population of over 500 million inhabitants and generated a nominal gross domestic product(GDP) of 16.692 trillion US dollars in EU. The results are as follows ; First of all, In terms of tariff lines and customs duties, Our companies have to know precisely EU's real tariff lines and other customs duties, and such as value added tax and exercise tax, corporate tax regulated by EU commission and EU's 28 members. second, our companies have to confirm EU's non-tariff barriers. such as RoHS, WEEE, REACH. These non-tariff barriers could be hindrances or obstacles to trade with foreign companies in other countries. We perceive all companies exporting to EU are related with these Technical Barriers to Trade irrespective of their nationality. So, Our companies fulfill the requirements of EU Commission concerning safety, health, environment etc. Also, Our companies choose market-driven strategy to export more largely than before in the field of marketing and logistics.

• 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.

• International Area Studies Review
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• v.16 no.1
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• pp.123-146
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• 2012

In this paper, we did on the new theory, policy, institution and legal research on the international competition order and justice society for 21st century. At first, we introduced the basic of competition law for fairness of trade in the new international market order under WTO. Secondly, we are researched on the economic approach of the competition law, market competition order and justice society in the new globalism. Third, we studied the international circumstance through the analysis of the patterns of the anti-competition practices and the regulation systems for competition order. We also reviewed the execution criteria and precedents of the fairness theory and competition laws in the USA, EU, Japan, and Korea, briefly. Finally, we presented to the alternative policies that based on our study about the new theory, policy, institution, competition law in opinion from reach the international market competition, fairness society and economic justice for 21st century under WTO.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.24 no.2
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• pp.208-218
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• 2014

Objectives: The major objective of this study was to develop and validate a tier 1 exposure model utilizing worker exposure monitoring data and characteristics of worker activities routinely performed at construction sites, in order to estimate worker exposures without sampling. Methods: The Registration, Evaluation, Authorization and Restriction of Chemicals(REACH) system of the European Union(EU) allows the usage of exposure models for anticipating chemical exposure of manufacturing workers and consumers. Several exposure models have been developed such as Advanced REACH Tools(ART). The ART model is based on structured subjective assessment model. Using the same framework, a tier 1 exposure model has been developed. Worker activities at construction sites have been analyzed and modifying factors have been assigned for each activity. Korean Occupational Safety and Health Agency(KOSHA) accrued work exposure monitoring data for the last 10 years, which were retrieved and converted into exposure scores. A separate set of sampling data were collected to validate the developed exposure model. These algorithm have been realized on Excel spreadsheet for convenience and easy access. Results: The correlation coefficient of the developed model between exposure scores and monitoring data was 0.36, which is smaller than those of EU models(0.6~0.7). One of the main reasons explaining the discrepancy is poor description on worker activities in KOSHA database. Conclusions: The developed tier 1 exposure model can help industrial hygienists judge whether or not air sampling is required or not.