The Institute for In Vitro Sciences, Inc. (IIVS) on January 8 announced a collaboration with BASF to import a non-animal, cell based, safety test into China. The LuSens test, developed by BASF, is an in vitro test to detect the sensitization potential of chemicals to human skin. The test was developed to be license free and shared with the scientific community at-large. It has recently been incorporated into the Organization for Economic Co-operation and Development (OECD) Test Guideline Program.

LuSens, along with the associated protocols and training video, will be imported through the Chinese Academy of Inspection and Quarantine, and distributed by the National Institute of Food and Drug Control of the China Food and Drug Administration (CFDA) to key government testing laboratories for implementation.

"BASF developed LuSens to assist industry and government scientists to assess the skin sensitization potential of chemicals without the use of animals," said Dr. Robert Landsiedel, Vice President, Experimental Toxicology and Ecology, at BASF. "IIVS participated in the validation of LuSens and we are pleased to further collaborate with them and their network in the Chinese regulatory system to distribute the technology."

In recent years, key agencies in China responsible for the supervision of cosmetic registration and importation have invested significant efforts to consider non-animal approaches into their regulations. Both the CFDA and the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) systems have a responsibility to protect consumer health through testing, including toxicology studies, on domestically produced and imported cosmetics and ingredients.

Historically, these agencies have relied on traditional animal studies. In recent years, they have explored the utility of non-animal (in vitro) tests. To modernize their regulations, CFDA has developed a plan to build capacity and proficiency within its government laboratories and works collaboratively with IIVS to provide hands-on training to national and provincial regulatory scientists. A common hurdle to adoption and implementation of non-animal tests in China is the availability of a test method or associated equipment.

"We appreciate BASF's assistance in helping to provide methods and training in China," says Erin Hill, President of IIVS. "As stated by the CFDA, only after new technologies have been implemented in proficient laboratories will regulations change to incorporate non-animal methods. We feel that the distribution of LuSens is another step toward that goal."