• Journal of the Korea Safety Management & Science
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• v.12 no.2
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• pp.133-138
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• 2010

The environmental regulation of a product is a global trend. The environmental regulation directives such as RoHS, WEEE, ELV and REACH have impacted Korean export-oriented auto parts manufacturer and affects the export of the product to aboard. In electronics manufacture and auto parts manufacturer, there are different systems for environmental regulation compliance. Nowadays the automotive mechatronics parts in a car are increasing. The HEV and intelligent car will need more mechatronics parts. It is necessary to apply the environmental regulation system of electronics to the automotive parts. In this paper, we proposed the application of PDX standard used in electronic industry to the BOM of the auto parts manufactures and showed an example of generated BOM for selected auto part using PDX. The PDX-based BOM can be used for the recording of environmental substances of the automotive mechatronics part and help the collaboration across auto parts manufactures in accordance with environmental regulation.

• 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.

• Proceedings of the Korean Society of Precision Engineering Conference
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• 2009.06a
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• pp.777-778
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• 2009

• 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.

• Journal of the Korean Society of Marine Environment & Safety
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• v.8 no.2
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• pp.1-8
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• 2002

Government is willing to abolish half of whole administration regulations and put emphasis to improve them. There was criticism that taper by bureaucracies' form and interest group's repulsion does not reach here upon in spite of these result. Therefore, need to ready diversified regulation adaptation administration countermeasure so that can observe because propel regulation innovation until now continuously and people, corporation, public official understand definitely contents of regulation. Contents of question regulation awareness about regulation adaptation and degree. On the basis of Question investigation about persons concerned of leisure safety law and wish to grasp observance degree, and produce synthetic Contents and field conformity degree, and draw solution plan of reformable item in leisure safety law and present development direction of leisure safety law.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.20
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• pp.153-179
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• 2003

Deregulation is not a matter or problem to be resolved simply by revising a law or a system in a short period of time. Rather, it should be implemented at a steady pace on the basis of a full understanding of the relationships between government regulation and the government's role, taking into account the inherent functions of the market. Moreover, arguments about government regulation and its deregulation vary according to viewpoints and approaches on the part of parties concerned. This makes it more difficult to form a consensus or reach a conclusion in recognizing and resolving the basis of problems at issue. This paper aims to review the shipping industry deregulation of major countries, to analyze Korea's situation and problems of shipping regulation, and to suggest it's improving methods. Although government regulation is a sensitive policy issue, this paper remains relatively at the basic research. Regulation problems should be tackled by interdisciplinary approach. A specific approach in regulation study could not explain exactly the causes and results of government policy

• Clean Technology
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• v.16 no.3
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• pp.155-161
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• 2010

Product-based environmental regulations, such as RoHS, REACH, EuP, etc., on electrical and electronic equipments, chemicals, and so on, initiated by the European Union, are becoming a global trend. These regulations can create barriers to trade among nations worldwide and may thereby have a direct impact on the function of internal market. If domestic companies utilize well the international environmental regulations in advance, they will get good opportunity for expanding overseas market. In this paper the current status of countermeasure for overcoming the international environmental regulations in domestic industries was investigated and the future plans were discussed.

• Journal of Information Science Theory and Practice
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• v.9 no.3
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• pp.14-30
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• 2021

Data innovation is at the core of the Fourth Industrial Revolution. While the catastrophic COVID-19 pandemic has accelerated the societal shift toward a data-driven society, the direction of overall data regulation remains unclear and data policy experts have yet to reach a consensus. This study identifies and examines the ideal regulator models of data-policy experts and suggests an appropriate method for developing policy in the data economy. To identify different typologies of data regulation, this study used Q methodology with 42 data policy experts, including public officers, researchers, entrepreneurs, and professors, and additional focus group interviews (FGIs) with six data policy experts. Using a Q survey, this study discerns four types of data policy regulators: proactive activists, neutral conservatives, pro-protection idealists, and pro-protection pragmatists. Based on the results of the analysis and FGIs, this study suggests three practical policy implications for framing a nation's data policy. It also discusses possibilities for exploring diverse methods of data industry regulation, underscoring the value of identifying regulatory issues in the data industry from a social science perspective.

• 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 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.