Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices

Abstract

ObjectivesKorea’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.MethodsBackground 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.ResultsDepending 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.ConclusionsAlternative 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.

Electron configuration-based neural network model to predict physicochemical properties of inorganic compounds

“…2 In the registration process, (eco)toxicological and physicochemical properties of chemicals are to be reported if they are manufactured, imported or used over one ton per year. 3,4 Since experimental testing to measure physicochemical properties of chemicals is time consuming and high cost, it is allowed to use quantitative structure-activity/property relationship (QSAR/QSPR) models in their measurements. 5 QSAR/ QSPR models are expected to signicantly decrease redundant experimental testing and to make the most out of data by exploiting accumulated chemical data.…”

Determination of phthalates in particulate matter and gaseous phase emitted into the air of the working environment

“…PAEs concentrations can be expected to be quite high at such locations. For example, in Korea, Kim (2016) carried out a risk assessment of workers producing or operating DEHP in workplaces where this phthalate was used as plasticizer, insecticide and printing ink solvent. The results of this study indicate an average DEHP exposure of 0.158 ± 0.306 mg/m 3 at workplaces in manufacturing industry, while at workplaces of handling DEHP at an average exposure of 0.210 ± 0.257 mg/m 3 .…”

Chemical Risk in Hospital Settings: Overview on Monitoring Strategies and International Regulatory Aspects

“…The Act on Registration, Evaluation, Authorization and restriction of CHemicals, established in 2015 and named K-REACH, is the Korean version of the regulation and aligns with the European model. 7 Preventive measures for workers must refer to the Good Manufacturing Practice and Good Laboratory Practice. 8,9 In these guidelines, specific suggestions for each class of compounds are continuously updated, according to novel classifications.…”