Industry urged to take precautions with triclosan

source cosmetics design-europe.com

By Andrew McDougall, 03-Dec-2010

Following various studies on the use of the antibacterial agent triclosan in consumer products, including oral care, experts are urging companies to remove it from their formulations as a precaution.

Elizabeth Salter Green, director of ChemTrust, a health and environmental body, explained that on a precautionary basis the chemical may not be safe to use at any level.

“It is important to stress that triclosan is not a dioxin, however concerns are that under certain circumstances it can develop the ability to disrupt hormones,” she told CosmeticsDesign-Europe.com.

Found in many consumer products

Triclosan is an ingredient added to many consumer products as an antibacterial ingredient.

It may be found in products such as antibacterial soaps and body washes, toothpastes, and some cosmetics. It is regulated by the U.S. Food and Drug Administration (FDA), and the European Union.

At this time, the FDA does not have evidence that triclosan added to antibacterial soaps and body washes provides extra health benefits over soap and water. However it stated that in 1997, reviewed extensive effectiveness data on triclosan in Colgate Total toothpaste showing that triclosan in this product was effective in preventing gingivitis.

Salter Green suggested that whilst one toxin may be harmless in a product individually, they may be dangerous if reacting together, suggesting that if there was no benefit for the toxin, it should be left out of the formulation.

Removed from GSK’s oral products

Oral care giant, GlaxoSmithKline, has removed triclosan from its Aquafresh and Sensodyne toothpastes, as well as its Corsodyl mouthwash, according to the University of Florida which has performed a study on the ingredient in sheep.

“If one eats the right foods and maintains correct dental hygiene, then triclosan, or other antibacterial agents are not needed,” explained Salter Green.

In the study by the University of Florida, researchers found that levels of triclosan were potentially damaging to the unborn foetus, if ingested by the carrying mother.

“We know it's a problem. But we just don't know how much of a problem. Triclosan can affect blood flow to the uterus, meaning the baby’s brain does not get the oxygen it needs,” said Professor Margaret James, who is the lead-author of the present study.

Discussing this particular study, Salter Green mentioned that a developing foetus in the uterus is extremely sensitive, and may be affected by disrupted hormone affecting brain development, metabolism, or the reproductive system.

Although this test was carried out on sheep, she explained that if the triclosan disrupts the hormone activity in an animal, whilst not being 100 per cent comparable, preserved hormonal evolution would suggest possible dangers to humans, and that the agent should be avoided if possible purely from a precautionary level.

comment

after wide spread use in sanitizers an increase in dioxine levels was experienced, leading to the conclusion that under some circumstances dioxines may be formed from triclosan.

FDA-fact sheet triclosan

What is triclosan?

Triclosan is an ingredient added to many consumer products to reduce or prevent bacterial contamination. It may be found in products such as clothing, kitchenware, furniture, and toys. It also may be added to antibacterial soaps and body washes, toothpastes, and some cosmetics—products regulated by the U.S. Food and Drug Administration (FDA).

What is known about the safety of triclosan?

Triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review.

Animal studies have shown that triclosan alters hormone regulation. However, data showing effects in animals don’t always predict effects in humans. Other studies in bacteria have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics.

In light of these studies, FDA is engaged in an ongoing scientific and regulatory review of this ingredient. FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

Does triclosan provide a benefit in consumer products?

For some consumer products, there is clear evidence that triclosan provides a benefit. In 1997, FDA reviewed extensive effectiveness data on triclosan in Colgate Total toothpaste. The evidence showed that triclosan in this product was effective in preventing gingivitis.

For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.

What consumers should know:

• Triclosan is not known to be hazardous to humans.
• FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.
• In light of questions raised by recent animal studies of triclosan, FDA is reviewing all of the available evidence on this ingredient’s safety in consumer products. FDA will communicate the findings of its review to the public in spring 2011.
• At this time, FDA does not have evidence that triclosan added to antibacterial soaps and body washes provides extra health benefits over soap and water. Consumers concerned about using hand and body soaps with triclosan should wash with regular soap and water.
• Consumers can check product labels to find out whether products contain triclosan.

How can I tell if there is triclosan in a product that I am using?

Antibacterial soaps and body washes, and toothpastes are considered over-the-counter drugs. If an over-the-counter drug contains triclosan, it will be listed as an ingredient on the label, in the Drug Facts box. If a cosmetic contains triclosan, it will be included in the ingredient list on the product label.

What is FDA doing to evaluate the safety of triclosan?

We are engaged in an ongoing scientific and regulatory review of the safety of triclosan in FDA-regulated products. We also have partnered with other Federal Agencies to study the effects of this substance on animal and environmental health (see http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm; http://www.epa.gov/endo/).

FDA is working to incorporate the most up-to-date data and information into the regulations that govern the use of triclosan in consumer products. FDA will communicate the findings of its review to the public in spring 2011.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: April 8, 2010