유럽연합의 나노물질 규제와 개선안에 관한 소고 (REACH와 특정 제품군 규정들 중심으로)

정혁 한국외국어대학교 EU연구소 2020 EU연구 Vol.- No.55

Due to the lack of concreteness in terms of definition and the weak legal basis, EU REACH needs to strengthen its legal basis and its concreteness in definition to enhance its rigidness. Regulations for specific product lines using nanomaterials should apply definitions considering the transformed nature and characteristics after use of the nanomaterials rather than the ones recommended by the Commission. The Commission needs to take into consideration drawing on an article in the REACH mandating companies dealing with most nanomaterials manufactured or imported below 1ton to put into place system for safety evaluation and control of the nanomaterials. And it seems to be necessary to have a labelling policy direction emphasizing benefits and strength of nanomaterials to enhance awarness regarding nanomaterials for the general public. Given that currently there is no specific and sole law regarding regulation of nanomaterials put in place in the EU, it is most likely that REACH and Regulations for specific product lines using nanomaterials will be implemented in parallel in regulating nanomaterials in the EU. To consistently strengthen the regulations for specific product lines using nanomaterials, the Commission can consider putting into an article in the regulations for specific product lines using nanomaterials mandating member states to do safety assessment on their companies that deal with most nanomaterials in the specific product line using nanomaterials. South Korean Government is currently pursuing introducing and institutionalizing system for safety and control of nanomaterials. It can contemplate the set up of the competent watch committee by specific product line, and mandate the committee to do safety management assessment on companies that import or manufacture most nanomaterials in the line. 유럽연합의 REACH는 나노물질에 대한 구체성이 결여된 정의와 가이던스 성격의 규제형태로 그 규제에 있어 정의상의 구체성과 법적 기반의 강화를 통해 엄격성을 강화할 필요가 있다. 유럽의 나노물질 사용 주요 특정 제품군들의 규정들 내의 정의도 집행위가 권고한 나노물질들의 일반적인 정의 적용보다는 나노물질의 특정 용도 제조 후의 성상 및 특성 변화를 고려한 정의에 대한 재설정이 이루어져야 한다. 집행위원회는 회원국들에게 REACH 내 자국의 1t이하 소량 나노물질 최다 취급 업체들을 대상으로 나노물질에 대한 관리 및 안전 평가 시스템 마련을 의무화하는 조항도 고려해 볼 필요가 있다. 역내 시민들의 나노물질에 대한 인식 함양을 위해서는 나노물질의 혜택이나 장점 등을 부각시키는 레벨링 정책 방향도 필요할 것으로 보인다. 유럽연합 내 나노물질 규제에 관한 단독적인 법의 정립이 아직은 이루어지지 않은 이상 유럽연합의 나노물질에 관한 규제는 가이던스 성격의 REACH와 특정 제품군을 위한 규정들의 시행이 병행적으로 그리고 지속적으로 시행될 가능성이 크다. 지속적인 나노물질 사용 특정 제품군 규정 강화를 위해 집행위원회는 제품군 내 나노물질 별 제조 및 수입량이 가장 많은 업체들에 대한 나노물질의 안전성 평가를 해당 업체 소속 회원국에게 의무화 하는 조항을 각 특정 제품군 규정안에 신설하는 것도 고려해 볼만한 접근일 것이다. 나노물질에 대한 안전관리제도 도입과 그 제도화를 추진 중인 한국정부도 나노물질 사용 제품군 별 나노물질 관리 주무 감시 위원회 등을 두어 해당 제품군 내 최다량 나노물질 수입업체 및 제조업체들을 대상으로 취급 나노물질의 안전 관리 평가를 의무화하는 정책 추진을 제고해 볼 수 있을 것으로 사료된다.

Evaluation of information in nanomaterial safety data sheets and development of international standard for guidance on preparation of nanomaterial safety data sheets

Lee, Ji Hyun,Kuk, Won Kwen,Kwon, Miran,Lee, Jong Han,Lee, Kwon Sub,Yu, Il Je Informa UK, Ltd. 2013 Nanotoxicology Vol.7 No.3

<P>Safety data sheets (SDSs) and labelling are the basic hazard communication tools for hazardous chemicals as regards their manufacture, storage, transport and other handling activities. Thus, in the context of the growing use of nanomaterials and nanomaterial-containing materials, this study evaluated the information provided in 97 nanomaterial-related SDSs according to the criteria set by the GHS (Globally Harmonized System of Classification and Labelling of Chemicals) and found that most of the SDSs did not include sufficient information on the safety of nanomaterials, such as their toxicity and physicochemical properties. The reasons for this lack of information in the nanomaterial SDSs can mainly be attributed to (1) a lack of toxicity and physicochemical property information on nanomaterials, (2) unawareness of the effectiveness of conventional exposure controls, such as local exhaust ventilation and encapsulation, and personal protective equipment (PPE), in protecting against nanomaterial exposure, (3) a lack of information on emergency and firefighting measures and (4) a lack of knowledge on how existing regulations apply to nanomaterials. Therefore, to create a consistent standard for the information provided on safety, health and environmental matters for manufactured nanomaterial-containing products, guidance for the preparation of nanomaterial-specific SDSs, including both nanomaterials and mixtures of nanomaterials with conventional non-nanoscale materials, was recently initiated by the ISO TC 229. Their guidance, in the form of a technical report, recommends that nanomaterial-related SDSs should be prepared based on a precautionary approach in terms of the toxicity and other risks associated with the nanomaterial contents within the mixture in question. One of the key recommendations in the technical report is to include additional physicochemical properties, including the particle size (average and range), size distribution aggregation/agglomeration state, shape and aspect ratio, crystallinity, specific surface area, dispersibility and dustiness, which help to distinguish the characteristics of nanomaterials from those of non-nanoscale materials. The technical report also recommends the preparation of SDSs for all nanomaterials and mixtures that meet the GHS criteria for physical, health or environmental hazards, and for all mixtures containing nanomaterials that meet the criteria for carcinogenic, toxic to reproduction or specific target organ toxicity in concentrations exceeding the cut-off limits for an SDS specified by the criteria for mixtures. Finally, the technical report recommends that SDSs be prepared for all nanomaterials, unless there is evidence that they are not hazardous.</P>

Overview of the Application of Flow Microreactors in the Synthesis of Silver Nanomaterials

Xiaoai He,Aijuan Lu,Jin Cheng,Junfang Chen,Qianhui Song,Wenfang Liu,Chuanpin Chen 성균관대학교(자연과학캠퍼스) 성균나노과학기술원 2017 NANO Vol.12 No.11

The unique electrical, optical and biological properties of silver nanomaterials have attracted significant attention of many researchers. Since the size and shape of silver nanomaterials have significant effects on the properties of silver nanomaterials, extensive research has focused on synthesis and characterization of silver nanomaterials. However, almost all of the syntheses of silver nanomaterials were carried out in traditional batch reactors, which typically suffer from inhomogeneous mixing and corresponding spatial variations under reaction conditions, ultimately leading to poor quality of the final nanomaterials. Recently, the emerging microfluidic technology not only furnishes novel strategies for the synthesis of silver nanomaterials but also brings great opportunities and impetus to improve the quality and yield of silver nanomaterials due to enhanced mass and heat transfer. The current paper reviews recent achievements in the synthesis of silver nanomaterials in flow microreactors. Various strategies adopted for the synthesis of silver nanomaterials in microreactors are presented and compared, including synthesis in single-phase and multi-phase flow microreactors. In addition, the factors that affect the size and size distribution of silver nanomaterials in flow microreactors synthesis are also discussed briefly.

Smart nanomaterials for cancer diagnosis and treatment

Singh Ragini,Sharma Ayush,Saji Joel,Umapathi Akhela,Kumar Santosh,Daima Hemant Kumar 나노기술연구협의회 2022 Nano Convergence Vol.9 No.21

Innovations in nanomedicine has guided the improved outcomes for cancer diagnosis and therapy. However, frequent use of nanomaterials remains challenging due to specific limitations like non-targeted distribution causing low signal-to-noise ratio for diagnostics, complex fabrication, reduced-biocompatibility, decreased photostability, and systemic toxicity of nanomaterials within the body. Thus, better nanomaterial-systems with controlled physicochemical and biological properties, form the need of the hour. In this context, smart nanomaterials serve as promising solution, as they can be activated under specific exogenous or endogenous stimuli such as pH, temperature, enzymes, or a particular biological molecule. The properties of smart nanomaterials make them ideal candidates for various applications like biosensors, controlled drug release, and treatment of various diseases. Recently, smart nanomaterial-based cancer theranostic approaches have been developed, and they are displaying better selectivity and sensitivity with reduced side-effects in comparison to conventional methods. In cancer therapy, the smart nanomaterials-system only activates in response to tumor microenvironment (TME) and remains in deactivated state in normal cells, which further reduces the side-effects and systemic toxicities. Thus, the present review aims to describe the stimulus-based classification of smart nanomaterials, tumor microenvironment-responsive behaviour, and their up-to-date applications in cancer theranostics. Besides, present review addresses the development of various smart nanomaterials and their advantages for diagnosing and treating cancer. Here, we also discuss about the drug targeting and sustained drug release from nanocarriers, and different types of nanomaterials which have been engineered for this intent. Additionally, the present challenges and prospects of nanomaterials in effective cancer diagnosis and therapeutics have been discussed.

나노물질(物質)의 환경침해책임(環境侵害責任)에 관(關)한 소고(小考)

소재선 ( Jae Seon So ),이창규 ( Chang Kyu Lee ) 단국대학교 법학연구소 2012 법학논총 Vol.36 No.1

Nanotechnology is the study of manipulating matter on an atomic and molecular scale. Generally, nanotechnology deals with developing materials, devices, or other structures possessing at least one dimension sized from 1 to 100 nanometres. Nanotechnology is very diverse, ranging from extensions of conventional device physics to completely new approaches based upon molecular self-assembly, from developing new materials with dimensions on the nanoscale to investigating whether we can directly control matter on the atomic scale. Nanotechnology entails the application of fields of science as diverse as surface science, organic chemistry, molecular biology, semiconductor physics, microfabrication, etc. There is much debate on the future implications of nanotechnology. Nanotechnology may be able to create many new materials and devices with a vast range of applications, such as in medicine, electronics, biomaterials and energy production. On the other hand, nanotechnology raises many of the same issues as any new technology, including concerns about the toxicity and environmental impact of nanomaterials, and their potential effects on global economics, as well as speculation about various doomsday scenarios. These concerns have led to a debate among advocacy groups and governments on whether special regulation of nanotechnology is warranted. Calls for tighter regulation of nanotechnology have occurred alongside a growing debate related to the human health and safety risks of nanotechnology. A nanomaterials have a potential risk, the proposed regulation must be prepared for it, Proposed regulation of translation in risk of nanomaterials. Nanomaterials are very small, if the person enters the body, can be applied to environmental liability law. Up to now, for damage due to the risk of nanomaterials has not occurred, a discussion of the proposed discipline is the actual situation is not enough this. Remedy is necessary due to limitations of the application of liability law, with the damage of nanomaterials, especially as ex-post remedy. Bailout of nanomaterials damage, must be carefully explored to the extent that it does not inhibit the development of nanotechnology. This is the sense of being able to recognize the economic value added with nanotechnology, to harmonize and Regulations. Thus, the enactment of the doctrine of discipline about the dangers of nanomaterials, it is necessary to the accumulation of information through a number of studies. Reason that the risk of nanomaterials revealed to date, which is to prevent all aspects of research or development of nanotechnology, there is no effectiveness. Therefore, upon to provide a remedy to prepare for the damage of nanomaterials, without interfering with the promotion of the development of nanotechnology, must be able to regulate risk. For this reason, the presentation of the proposed remedy, shall be fully reflects the professional opinions of scientists related to nanotechnology

나노물질의 환경 매질별 노출 사례 조사

엄하늬 ( Ha Nee Umh ),노진규 ( Jin Kyu Roh ),이병천 ( Byoung Cheun Lee ),박수민 ( Su Min Park ),이종협 ( Jong Heop Yi ),김영훈 ( Young Hun Kim ) 한국화학공학회 2012 Korean Chemical Engineering Research(HWAHAK KONGHA Vol.50 No.6

최근 나노기술의 급격한 발전은 산업 및 바이오의약 등 다양한 분야에 새로운 활용 가능성을 제시하고 있다. 나노 물질을 이용한 나노소비재의 증가와 함께 환경으로의 나노물질 노출 가능성이 제기되고 있으며, 최근 나노물질의 인 체 및 환경 영향이 주요 현안으로 떠오르고 있다. 환경 중에 비의도적으로 노출된 나노물질은 다양한 환경 매질에 축 적되고 언젠가는 우리들에게 재영향을 미치게 된다. 따라서, 환경 매질(대기, 수계, 토양)에 노출된 나노물질의 영향을 이해하기 위해서는 나노물질의 환경 내 거동을 이해하는 것이 중요하다. 이에 본 연구에서는 나노물질의 환경 매질별 노출 사례를 조사하고, 향후 연구 방향을 제시하고자 하였다. 작업장(실험실)에서는 주로 대기 노출이 지배적이지만, 환경중으로 노출될 경우 최종적으로 수계 및 토양으로 노출되는 것으로 파악되었다. 또한 기존의 하수처리장 설비로 는 완벽하게 나노물질을 제거하기가 어렵다는 것을 확인하여, 나노폐기물 처리에 관한 새로운 방법론 개발이 절실함을 확인하였다. 보다 다양하고 깊이있는 환경 노출 연구를 위해서는 현장 모니터링 장비의 개발이 필요함을 확인할 수 있었으며, 이에 추가적으로 다양한 분석법을 제안하였다. 본 총설에서 정리한 나노물질의 환경 매질별 노출 사례 연구 들은 향후 나노물질의 환경 거동 평가 및 나노폐기물의 적절한 처리방법 모색에 기본 자료로 활용될 것이다. Recent rapidly growth in nanotechnolgies is promised novel benefits through the exploitation of their unique industrial and biomedical applications. With increasing utilization of nanomaterials in consumer products, the potential release of nanomaterials into the environment and their impacts on the ecosystem and human health have been the issues of concern, Nanomaterials that was exposed unintentionally in environment might be accumulated in various environmental media, and finally it will be influenced to human and ecosystems. Therefore, it is important to understand the fate and behavior of nanoparticles for understanding effects on environmental media (air, water, and soil phase). Therefore, in this work, we investigated the several cases for environmental exposure of nanomaterials and suggested the direction of further research. In workplace, exposure to air media is dominant, but finally waste and wastewater was moved to the water and soil phase. In addition, we found the existing sewage treatment plant was not suitable to remove completely nanomaterials in wastewater flow. To deeper study, environmental monitoring tool must be developed additionally and we suggested the several analyzing method for aged and pristine physicochemical properties of nanomaterials exposed into environmental media. This review for nanomaterials` exposure to environmental media will be helpful to investigate the envrionmental fate of nanomaterials and define the suitable treatment method for nano-waste.

나노물질의 위험성 및 나노물질 피해에 관한 법적 대응의 방향

피용호 ( Yong Ho Phi ) 한남대학교 과학기술법연구소 2009 과학기술법연구 Vol.15 No.1

Even though it is not yet understood sufficiently and thoroughly, nobody can deny we`re living in the age of nanotechnology. Nanotechnology promises to revolutionize innovation in nearly every industry, The National Science Foundation in the United States predicts that nanotechnology will represent a one trillion dollar market by 2015 in the United States alone, and almost 800 nanoproducts are already commercially available. However, nanomaterials` novel properties pose potentially significant health and environmental risks several studies point. Nanoparticles can enter the human body through skin absorption, ingestion or inhalation, because of the small size, once they enter the body they can be carried past the blood-brain barrier into brain cells and can pass through lung an liver tissue, and cause oxidative stress and localized immune lesions, and may lead to other tissue and cellular damage, and are also linked to dangerous air, soil and water pollutants. Views in the current debate over nanotechnology regulation range from halting all research and development to allowing virtually unregulated innovation, this article treats one viable legal measure to prepare for nanomaterials compensation related with the damage from occupational, living and environmental nanomaterials exposures. Current regulatory and remedial methods for nanomaterials damage case are not sufficient and appropriate, in order to prevent the second asbestos nightmare, Nanomaterials Compensation Fund could be taken as a solution, which could be a practical way to balance benefit and risk concerns.

Rational engineering of physicochemical properties of nanomaterials for biomedical applications with nanotoxicological perspectives

Navya P. N.,Daima Hemant Kumar 나노기술연구협의회 2016 Nano Convergence Vol.3 No.1

Innovative engineered nanomaterials are at the leading edge of rapidly emerging fields of nanobiotechnology and nanomedicine. Meticulous synthesis, unique physicochemical properties, manifestation of chemical or biological moieties on the surface of materials make engineered nanostructures suitable for a variety of biomedical applications. Besides, tailored nanomaterials exhibit entirely novel therapeutic applications with better functionality, sensitivity, efficiency and specificity due to their customized unique physicochemical and surface properties. Additionally, such designer made nanomaterials has potential to generate series of interactions with various biological entities including DNA, proteins, membranes, cells and organelles at nano-bio interface. These nano-bio interactions are driven by colloidal forces and predominantly depend on the dynamic physicochemical and surface properties of nanomaterials. Nevertheless, recent development and atomic scale tailoring of various physical, chemical and surface properties of nanomaterials is promising to dictate their interaction in anticipated manner with biological entities for biomedical applications. As a result, rationally designed nanomaterials are in extensive demand for bio-molecular detection and diagnostics, therapeutics, drug and gene delivery, fluorescent labelling, tissue engineering, biochemical sensing and other pharmaceuticals applications. However, toxicity and risk associated with engineered nanomaterials is rather unclear or not well understood; which is gaining considerable attention and the field of nanotoxicology is evolving promptly. Therefore, this review explores current knowledge of articulate engineering of nanomaterials for biomedical applications with special attention on potential toxicological perspectives.

Influence of dual ceramic nanomaterials on the solderability and interfacial reactions between lead-free Sn-Ag-Cu and a Cu conductor

Jung, Do-Hyun,Sharma, Ashutosh,Jung, Jae-Pil Elsevier 2018 JOURNAL OF ALLOYS AND COMPOUNDS Vol.743 No.-

<P><B>Abstract</B></P> <P>This study examined the addition of dual ceramic nanomaterials, TiO<SUB>2</SUB> and graphene (0, 0.03, 0.12, 0.21, and 0.60 wt %), to a lead-free Sn-3.0 wt %Ag-0.5 wt %Cu (SAC305) solder alloy. TiO<SUB>2</SUB> and graphene nanomaterials were mixed simultaneously at equal weight fractions into the SAC305 molten solder by mechanical mixing and melting to produce a bulk nanocomposite solder. The effects of the dual nanomaterials on the melting point, microstructure, solderability, and intermetallic compound (IMC) growth were conducted. The structural and morphological features of the samples were characterized by field emission scanning electron microscopy, energy dispersive spectroscopy, and transmission electron microscopy. In addition, the melting behavior of the nanocomposite solder was characterized by differential scanning calorimetry. The nanocomposite solder with 0.21 wt % nanomaterials showed 33.67% enhancement in wettability and an 8.66% increase in spreadability due to the increased fluidity and decreased surface tension of molten solder in the presence of dual nanomaterials. In addition, the thickness of the IMCs was reduced after adding the dual nanomaterials to the monolithic SAC alloy. The optimal concentration of the dual nanomaterials in the monolithic SAC alloy was found to be 0.21 wt %.</P> <P><B>Highlights</B></P> <P> <UL> <LI> The nano-sized TiO<SUB>2</SUB> and graphene were successfully synthesized into the solder. </LI> <LI> The IMC of dual-nanocomposite solders is lower than that of the monolithic ones. </LI> <LI> The optimal amount of nanomaterials is SAC-0.21% (TiO<SUB>2</SUB> + graphene) in the matrix. </LI> </UL> </P>

Charge-Transport Behavior in Shape-Controlled Poly(3,4-ethylenedioxythiophene) Nanomaterials: Intrinsic and Extrinsic Factors

Yoon, Hyeonseok,Hong, Jin-Yong,Jang, Jyongsik WILEY-VCH Verlag 2007 Small Vol.3 No.10

<P>The charge-transport behavior in one-dimensional (1D) poly (3,4-ethylenedioxythiophene) (PEDOT) nanomaterials of three different shapes is described. Both intrinsic and extrinsic factors are considered from the viewpoint of a single nanoparticle and nanoparticle assembly. Intrinsically, the oxidation level of the 1D PEDOT nanomaterials becomes higher with increasing aspect ratio of the nanomaterials, which is closely linked to the conjugation length. This result implies that the transport properties of the nanomaterials are significantly dependent on their shape. Extrinsically, the 1D PEDOT nanomaterials make an ohmic contact with gold interdigitated microelectrodes. In addition, a strong correlation is observed between the interparticle contact resistance and the shape of the nanomaterials. Lastly, the intrinsic and extrinsic factors related to charge transport are further illustrated by the resistance changes of nanomaterial-based chemical sensors. As a result, judicious tailoring of the dimensional and geometrical characteristics of the conducting-polymer nanomaterials may enable precise control over their transport properties as well as the characteristics of the nanomaterial-based devices.</P> <B>Graphic Abstract</B> <P>Shaping up: Significant factors governing the charge-transport behavior in one-dimensional conducting-polymer nanomaterials of different shapes (nanoellipsoids, nanorods, and nanotubes) are systematically investigated. Their influences on the performance of sensor devices, such as interdigitated microelectrodes (see picture), are also examined. <img src='wiley_img/16136810-2007-3-10-SMLL200700245-content.gif' alt='wiley_img/16136810-2007-3-10-SMLL200700245-content'> </P>