Sound Science: A prerequisite for advancing alternative methods and protecting public health

WS Stokes¹

1. NIEHS, RTP, NC, USA

Current laws and regulations protect human health by requiring the safety assessment of new products such as cosmetics prior to their marketing and subsequent human exposure. Such laws were enacted in response to public outrage following blindness, severe injuries and deaths caused by untested cosmetics and other products. Subsequent safety evaluations of cosmetic ingredients and products using animals and in vitro methods have now largely eliminated adverse health effects. Nevertheless, public pressures have led to recent adoption of the 7th Amendment to the European Union Cosmetics Directive, which now bans the use of animals for testing finished cosmetic products and will ban the use of animals for most testing for ingredients in 2009. In order for in vitro methods to gain acceptance as complete replacements for animals, there must be scientific evidence that the use of these methods will provide for equivalent or improved protection of human health. ICCVAM, which is charged by law with evaluating the scientific validity of new, revised, and alternative test methods, has evaluated several alternative test methods applicable to cosmetics testing that have now achieved regulatory acceptance and is currently evaluating several other applicable methods. These methods have or will significantly reduce animal numbers and animal pain and distress; however, none have been found to be scientifically valid as complete replacements for animals. Despite the legislated testing bans, alternative methods will only be able to fully replace animal use and ensure adequate protection of the public when supported by sound science.

Date: Tuesday, August 23, 2005, 14.00Ð16.00 h, ECC Hall D

5.14 Workshop: Meeting the Challenge of the 7th Amendment to the EU Cosmetics Directive