Guidance on the Use of Alternative Test Methods for the Safety Assessment of Cosmetics and Quasi-drugs

Abstract

In accordance with a notification issued by Japan's Ministry of Health, Labour and Welfare (MHLW) in 2011, the Japanese Center for the Validation of Alternative Methods (JaCVAM) has accelerated applications for new test methods developed as alternatives to animal testing for the safety assessment of the manufacture and sales of cosmetic products and quasi-drug products that contain new ingredients. Taking advantage of this opportunity to strongly impact testing throughout Japan, researchers have been coordinating guidance on the use of such alternative test methods since 2012. Based on test guidelines issued by the Organisation for Economic Co-operation and Development (OECD) and JaCVAM evaluation documents, dermatologists and representatives of cosmetic companies as well as specialists from both the Pharmaceuticals and Medical Devices Agency (PMDA) and the National Institute of Health Sciences (NIHS) have drafted guidance documents for a number of alternative test methods.