• Environmental Analysis Health and Toxicology
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• v.30 no.sup
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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.

• Journal of Environmental Health Sciences
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• v.50 no.1
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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.

• 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.

• 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.

• Clean Technology
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• v.17 no.4
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• pp.285-299
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• 2011

As one of the REACH obligations, the extended safety data sheet (eSDS) should be communicated within the supply chain under the REACH Regulation. Based on technical guidance documents published on the ECHAs website and survey of EU's recent REACH-related informations, this paper includes a study on details of how to develop exposure scenarios (ES) such as structure of ES, process of ES develpoment, standard workflows and key input data to develop ES with an introduction of eSDS concept. This paper also contains an overview on operational conditions (OCs) and risk management measures (RMMs) that are what to consider when building an ES. The structure of Chesar (Chemical Safety Assessment and Report tool) developed by European Chemicals Agency (ECHA) is studied with a review of the available exposure estimation tools for workers, environment and consumers. Case example of generic exposure scenario (GES) for organic solvent is presented. To guide Korean EU-exporting companies, their participating roles in three steps of preparing ES are addressed.