• Environmental Analysis Health and Toxicology
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• 제30권sup호
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• pp.7.1-7.10
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• 2015

Objectives For successful adoption of legislation controlling registration and assessment of chemical substances, it is important to obtain sufficient toxicological experimental evidence and other related information. It is also essential to obtain a sufficient number of predicted risk and toxicity results. Particularly, methods used in predicting toxicities of chemical substances during acquisition of required data, ultimately become an economic method for future dealings with new substances. Although the need for such methods is gradually increasing, the-required information about reliability and applicability range has not been systematically provided. Methods There are various representative environmental and human toxicity models based on quantitative structure-activity relationships (QSAR). Here, we secured the 10 representative QSAR-based prediction models and its information that can make predictions about substances that are expected to be regulated. We used models that predict and confirm usability of the information expected to be collected and submitted according to the legislation. After collecting and evaluating each predictive model and relevant data, we prepared methods quantifying the scientific validity and reliability, which are essential conditions for using predictive models. Results We calculated predicted values for the models. Furthermore, we deduced and compared adequacies of the models using the Alternative non-testing method assessed for Registration, Evaluation, Authorization, and Restriction of Chemicals Substances scoring system, and deduced the applicability domains for each model. Additionally, we calculated and compared inclusion rates of substances expected to be regulated, to confirm the applicability. Conclusions We evaluated and compared the data, adequacy, and applicability of our selected QSAR-based toxicity prediction models, and included them in a database. Based on this data, we aimed to construct a system that can be used with predicted toxicity results. Furthermore, by presenting the suitability of individual predicted results, we aimed to provide a foundation that could be used in actual assessments and regulations.

• 한국환경보건학회지
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• 제50권1호
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• pp.54-65
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• 2024

Background: There is growing international recognition of the need for improvements to national chemical management systems for hazardous chemicals. The European Union has recently introduced the concept of 'essential uses' as a new approach to the management hazardous chemicals by limiting their uses. Objectives: This paper examines the concept of essential uses in chemical management and how to apply it through a case study of essential use. This approach is distinct from the current chemical management system, but seeks to improve its potential benefits by effectively restricting or gradually decreasing the use of hazardous substances. Methods: The concept of essential uses was introduced by reviewing the Montreal Protocol on Substances that Deplete the Ozone Layer, Cousins's three essentiality categories applied to PFAS, restriction options assessed in the PFAS restriction proposal under REACH, and the California Safer Consumer Products regulations prioritizing 6PPD in motor vehicle tires. Based on these essential uses concepts for PFAS and 6PPD, uses of benzene were classified in accordance with the essential uses approach for products using benzene in South Korea. Results: The essential use concept is able to manage the restriction and authorization of substances of concern through essential uses and non-essential uses and the feasible substitution of uses and substances. Conclusions: If the concept and methodology of essential uses are clearly established, they can be expected to shift the national chemical management paradigm from regulating substances to limiting uses under the existing substance management system.

• 청정기술
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• 제18권1호
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• pp.1-13
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• 2012

2000년 중반기 이후, 산업 경쟁력에서 환경 규제, 특히 제품 함유 유해물질 규제가 EU를 중심으로 점차 강화되어 큰 영향을 미쳐왔고, 이는 1990년 초 섬유산업에서 시작하여 전기전자산업을 거쳐 전 산업으로 확장되고 있다. 본 총설에서는 EU의 제품 함유 유해물질 규제 흐름을 알아보고, EU에서 규제하고 있는 유해물질의 종류, 규제 사유, 관련 근거 및 법령을 주요 섬유제품 에코라벨인 Oeko-Tex Standard, 전기전자 제품의 RoHS (Restriction of the use of certain hazardous substances in electrical and electronic equipment) 및 REACH (Registration, Evaluation and Authorization of CHemicals)의 SVHC (Substances of Very High Concern, 고위험성 물질)를 중심으로 고찰해 보면서 NGO (Non-Governmental Organization) 단체들의 활동으로 도출되고 있는 ChemSec (the International Chemical Secretariat)의 SIN (Substitute It Now) list와 그 의미를 조사해보았다. 또한, 국내 수출기업이 국제시장에서 받고 있는 클레임 사례를 통해 규제 유해물질이 시장에 주는 영향을 살펴보고, 유해물질로 인한 국제환경규제의 단기 및 중장기 대응 방안을 고찰해 보기로 한다.

• Environmental Analysis Health and Toxicology
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• 제31권
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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.

• 청정기술
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• 제17권4호
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• pp.285-299
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• 2011

2007년 6월 시행된 유럽 신(新)화학물질관리제도(REACH, Registration, Evaluation, Authorization and Restriction of CHemicals)에서 물질 제조자가 공급망 상 제공해야 하는 법적 의무 사항인 확장된물질안전보건자료(eSDS, extended Safety Data Sheet)에 대하여, 본 총설에서는 eSDS의 개념 파악과 함께 노출시나리오(ES, Exposure Scenario) 작성 방법에 대한 유럽의 개발 동향을 기반으로 노출시나리오의 구성요소 및 각 구성요소별 주요 입력정보 그리고 단계별 노출시나리오 작성 방법을 알아보았다. 노출시나리오 작성에 필요한 정보로는 용도기술어 시스템(UDS, Use Descriptor System), 작업조건(OC, Operational Condition) 및 위해성관리대책(RMM, Risk Management Measure)이 조사되어 이에 대해 구체적인 이해를 도모하였다. 근로자, 환경, 소비자를 평가 대상으로 하는 기존의 주요 노출 평가 툴의 특징을 살펴보고, REACH 하의 노출시나리오 생성을 실행하기 위해 유럽화학물질청(ECHA, European Chemicals Agency)에서 최종 개발하여 발표한 노출 평가 툴인 Chesar (Chemical Safety Assessment and Report tool)의 구성을 알아보았다. EU 집행위에서 개발한 유기용매 분야의 일반 노출시나리오 (GES, Generic Exposure Scenario) 사례를 소개하였고, 3단계로 구분할 수 있는 노출시나리오 작성 과정 중에서 국내 수출 중소기업에서 담당할 부분 및 활용 방안을 제시하였다.