The use of triclosan is safe in "common use" products such as toothpastes, hand soaps and shower gels but not in all products due to the "magnitude of the aggregate exposure," a European Commission panel says.

The ingredient is not safe at levels up to 0.3 percent in mouthwashes and leave-on products such as body lotion due to its higher absorption rate, according to the EC Scientific Committee on Consumer Products.

The SCCP published its opinion Jan. 21 following reviews of toxicological and absorption data submitted by industry representatives as well as a risk assessment report by the Norwegian Food Safety Authority.

In October 2006, SCCP requested information on consumer exposure to triclosan "from all sources, including cosmetic products."

Dermal and absorption data show triclosan is "well absorbed" through skin in all species tested; "the extent of absorption [is] dependent on the formulations in which it was delivered," according to the opinion.

Percutaneous absorption was high - about 23 percent to 28 percent of the applied dose - in ethanol, ethanol/water soap suspension or cream formulations, SCCP says.

Triclosan also is highly absorbed via oral administration with "no species-related differences," but absorption from normal tooth-brushing (expectoration and rinsing) is limited - approximately 5 percent to 10 percent of the dose.

Before a final conclusion on the safety of triclosan in cosmetic products can be reached, "the potential development of resistance to triclosan and cross-resistance by certain micro-organisms must be assessed," SCCP says.

In the U.S., triclosan with fluoride is approved for use in Colgate Total toothpaste with a claim to help prevent tooth decay, plaque and gingivitis, according to FDA. The agency also permits the use of triclosan in antibacterial soaps, as an antiseptic drug preparation, in antibacterial surgical sutures and in antibacterial pre-operative mouth cleansers to prepare for dental work.

- Eileen Francis (e.francis@elsevier.com)

Preservative Triclosan Safe In “Common Use” Products, Not Mouthwash

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