Title: Guidance on the Use of Alternative Test Methods for the Safety Assessment of Cosmetics and Quasi-Drugs

Hajime Kojima

National Institute of Health Sciences (NIHS), Japan


Hajime Kojima, Ph.D.,is the secretary general of Japanese Center for the Validation of Alternative methods (JaCVAM) and the section chief of Division of risk assessment, Biological Safety Research Center (BSRC) in National Institute of Health Sciences (NIHS) contributing to the identification and evaluation of in vitro test methods for their potential validation, in the field of genotoxicity and local toxicity (skin and eye). He holds several publications in refereed journals dealing with in vitro toxicity assay as well as validation study. Until now, he has contributed to be approved more than 10 test methods developed by Japanese in the OECD Test Guidelines.


Japanese cosmetic companies have largely stopped animal testing voluntarily and now hope that the use of new ingredients without it will be approved by the Ministry of Health, Labour and Welfare (MHLW).  Many procedures for regulatory acceptance still require animal testing, and it is difficult to gain approval even for additives to quasi-drug products without data from animal testing. Given the current situation, Japanese Center for the Validation of Alternative Methods (JaCVAM) has attempted to promote the development of guidance for the use of alternatives to animal testing.

In accordance with a notification issued by Japan’s MHLW in 2011, the JaCVAM has accelerated applications for new in vitro test methods. To take advantage of this opportunity to strongly impact testing throughout Japan, researchers have been coordinating guidance on the use of alternative test methods for the safety assessment of cosmetics and quasi-drugs since 2012. 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 based on OECD test guidelines and JaCVAM evaluation documents. 

Unfortunately, there are still many types of testing for which in vitro test methods are limited. In particular, we have no in vitro test methods to evaluate weak or moderate skin irritation and big concerns to do human voluntary tests without animal testings. The time has come to accelerate the development of and guidance for the use of in vitro test methods for cosmetic and quasi-drug ingredients.

Audience take away:

  • Explain current situation of cosmetic industries in associated with 3Rs
  • Explain applicability and limitation of alternative to animal testings
  • A human voluntary test is useful to evaluate skin irritation and skin sensitization of a cosmetic ingredient and product?
  • A human voluntary test without animal testings is acceptable ethically?