The continued use of triclosan as a preservative at levels up to 0.3 percent is not safe "in all cosmetic products" due to the "magnitude of the aggregate exposure," the European Commission's Scientific Committee on Consumer Products states in a Jan. 21 opinion.

The ingredient at the given concentration is safe in "common use" products including toothpastes, hand soaps and shower gels.

However, it is not safe in mouthwashes and leave-on products such as body lotion due to its higher absorption rate, according to the committee.

The SCCP reached that conclusion after reviewing 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" (¹ Also see "EC Solicits Scientific Perspective On Preservatives Triclosan, Climbazole" - HBW Insight, 28 April, 2008., p. 6).

Dermal and absorption data reveal that 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, according to the committee.

It notes that absorption from normal toothbrushing (expectoration and rinsing), however, 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.

The Commission's Scientific Committee on Emerging and Newly Identified Health Risks recently released a draft report concluding that more research is needed to establish a precise correlation between the extensive use of biocides in cosmetics and the development of antibiotic-resistant strains (² Also see "Cosmetic Biocides’ Role In Antibiotic Resistance Addressed In EU Report" - HBW Insight, 15 December, 2008., p. 5).

SCCP Not Sure About Citric Acid, Silver Citrate

SCCP also evaluated new cosmetic preservatives citric acid and silver citrate in concentrations of 0.2 percent in cosmetic products. The critical concern with regard to the ingredients' safety is the possibility for long-term effects due to the silver released - specifically argyria, a dangerous condition associated with the ingestion of silver.

On the basis of the submitted data, SCCP determined that the safety of citric acid and silver citrate cannot be assessed. Before a final position can be reached, an in vitro mammalian gene mutation assay "to exclude gene mutations potential" is necessary, according to the committee.

Additionally, "new data specifically addressing the end point of argyria is necessary," SCCP says.

The committee notes in the opinion that its considerations are limited to silver in cosmetic products. With evidence suggesting increased exposure to silver from sources other than cosmetics, SCCP recommends that an aggregate exposure and risk assessment be undertaken.

SCCP also evaluated data on hair dye actives as part of the EC's mission to establish a list of hair-dye ingredients that are considered safe. In the now third and final step of the hair-dye strategy, the committee evaluated industry data to assess reaction products actually formed when dyeing hair.

However, the panel determined it is not able to confidently assess the risk of reactions created during the dyeing process because the dossier is incomplete.

SCCP considered a number of other cosmetic ingredients during its Jan. 21 plenary meeting, including cosmetic preservative climbazole and UV filter camphor benzalkodium methosulfate (see chart: " ³ SCCP Safety Opinions "). Additionally, the committee clarified its stance on several previous opinions.

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

Preservative Triclosan Not Safe In Leave-On Products, Mouthwashes – SCCP

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