title: Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Mechanistic Toxicology, Ewha Womans University College of Pharmacy, Seoul, Korea.
authors.forename: Soojin
authors.identifier: 0000-0002-4410-4405
authors.initials: S
authors.lastname: Ha
authors.affiliation: Research and Toxicology Department, Humane Society International, Toronto, Canada.
authors.forename: Troy
authors.identifier: 0000-0002-1341-2181
authors.initials: T
authors.lastname: Seidle
authors.affiliation: Department of Mechanistic Toxicology, Ewha Womans University College of Pharmacy, Seoul, Korea.|Research and Toxicology Department, Humane Society International, Toronto, Canada.
authors.forename: Kyung-Min
authors.identifier: 0000-0002-1517-7680
authors.initials: KM
authors.lastname: Lim
keywords: Alternative to animal test; Korea’s Act on the Registration and Evaluation of Chemicals; Reduction; Refinement; Replacement; Safety evaluation