When used as directed, triclosan is a safe and effective product with many benefits to offer. Over more than 40 years, Ciba has invested millions of dollars to evaluate triclosan and its safety has been proven time and time again. As part of our commitment to Responsible Care® and product stewardship, we have provided data to global regulatory agencies such as the US Food and Drug Administration, the US Environmental Protection Agency, the European Commission and Japanese authorities among many others. On the basis of this wealth of data, triclosan is registered for use in personal care, household and industrial products throughout the global market and has not been removed from the marketplace by regulatory restrictions in any country.

Specific Examples of Safety Reviews:

New Scientific Assessment Confirms Safety of triclosan
A recent assessment of triclosan by the Australian National Industrial Chemicals Notification and Assessment Scheme concluded that:

• Under normal conditions of consumer use, the risk of adults and children being exposed to levels of triclosan that would lead to chronic health effects is low;
• The available data in humans and animals provide no evidence that triclosan has the potential to cause harm to breastfed babies;
• There is also no evidence that the use of triclosan is leading to an increase in triclosan-resistant bacterial populations or that there is any increased risk to humans regarding antibiotic resistance.

For more information on this assessment by the Australian Department of Health and Aging, please click here.

++++++++++++++++

EPA re-reviews all pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that they meet current scientific and regulatory standards. This process, called reregistration, considers the human health and ecological effects of pesticides and results in actions to reduce risks that are of concern. Decisions are summarized in documents known as REDs, IREDs, and TREDs.

Triclosan was initially registered with the EPA in 1969. In October 2008, the agency completed the RED concluding that all uses, with the exception of the paint preservative use, are elibigle for Reregistration. The reregistration review documents are available at http://www.epa.gov/oppsrrd1/reregistration/status_page_t.htm.

The successful reregistration of triclosan was possible because of its exemplary record of safety and efficacy. The data on triclosan was determined to meet all current scientific and regulatory standards there were no data gaps and no risks of concerns identified. In conclusion, the EPA has confirmed that based on its use patterns, triclosan does not pose a risk to human health or the environment.

++++++++++++++++

Triclosan was approved by the U.S. Food and Drug Administration (FDA) as an oral care drug product to prevent gingivitis under NDA#020231, as such triclosan had to undergo an extensive new drug application (NDA) review, just like any other over-the-counter or prescription drugs.

Triclosan was approved as an active antimicrobial in surgical sutures by the U.S. FDA Center for Devices and Radiological Health under Medical Device Registration (510K) #K983966.