Triclosan
What is it?
Triclosan is an ingredient used as a preservative, disinfectant or antiseptic in clinical settings and in various consumer products. These include toothpastes, handwashes, deodorants and household cleaning products. Triclosan is also found in some kitchenware, nappies and clothing.
Preservatives play an important role in protecting cosmetic and personal care products against microbial growth and from contamination by consumer use. Preservatives also extend product shelf life, thereby protecting consumer health and product quality.
Antimicrobials play an important role in handwashing and surface disinfection, helping to prevent cross-contamination that could lead to illness.
Antiseptics are vital in clinical settings where sterile procedures are performed.
What’s the myth?
It has been suggested that products containing triclosan cause a range of adverse human health impacts. Concerns have also been raised that because triclosan has been found at low levels in breast milk, it could therefore harm breast-fed infants.
There is also a myth that triclosan-containing products, and other antibacterial products, contribute to antibiotic resistance.
FACT: Public health authorities have reviewed triclosan for human health impacts
The Australian regulator NICNAS (now AICIS), reviewed the safety of triclosan after it was declared a Priority Existing Chemical in 2003 due to environmental concerns. NICNAS conducted a full risk assessment on public health, occupational health and safety, and environmental effects of industrial uses of triclosan, releasing their final Report in 2009.
In this Report, NICNAS concluded that:[1]
- “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 risk to the public of inhalation toxicity, skin, eye or respiratory irritation is low because of the low concentrations of triclosan in cosmetic and personal care products.”
- “The available data in humans and animals provide no evidence that triclosan has the potential to cause harm to breastfed babies.” NICNAS also emphasised that breast milk was likely to be the lowest source of exposure to babies.
NICNAS recommended that a maximum level of triclosan in cosmetics and personal care products be established. This level was set to 0.3% by the Advisory Committee on Chemicals Scheduling, with triclosan included on Schedule 6 of the Poisons Standard.[2] The 0.3% limit is in line with the European Union’s maximum concentration level in cosmetic and personal care products.
Other major international health authorities have reviewed the safety of triclosan. Health Canada and Environment Canada concluded that triclosan-containing products do not constitute a danger to human life or health. In 2011 the European Commission’s independent expert committee supported the safe use of triclosan in cosmetic products, up to certain levels. In 2015 the European Chemicals Agency (ECHA) published their Opinion on triclosan, finding that this ingredient posed no threat to human health at the levels used, but that it should not be approved for use in antibacterial consumer hygiene products for the skin or scalp due to environmental concerns.[3]
FACT: The recent decision to remove triclosan from antibacterial hand wash products sold in the USA is not based on new evidence of safety concerns
In September 2016, the US Food and Drug Administration (FDA) announced that triclosan (and some other ingredients) would be banned in consumer antibacterial hand wash products sold in the USA from September 2017.[4] In December 2017, this rule was extended to include products used in clinical settings. Consumer hand wipes are still permitted to contain triclosan.
The FDA's decision was based on lack of information rather than any new evidence of safety concerns. The FDA stated that “[A]ntibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking”. As a result, the FDA decided that “manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections".[4]
Australian regulators are aware of the US decision for products sold locally that contain triclosan. Strict regulatory controls already exist, so there is no ban on this ingredient in Australia.
The bottom line: Triclosan-containing products pose no threat to human health at the levels used, and play a vital role in clinical healthcare settings. Health authorities around the world continue to review the safety and efficacy of triclosan.
Click here for more information on antibacterial products, including those containing triclosan.
Sources
[1] National Industrial Chemicals Notification and Assessment Scheme 2009, PEC Assessment Report 30, Triclosan.
[2] Department of Health and Ageing, Poisons Standard 2016. https://www.tga.gov.au/publication/poisons-standard-susmp
[3] Biocidal Products Committee (BPC), 17 June 2015, "Opinion on the application for approval of the active substance: Triclosan Product-type: 1". https://echa.europa.eu/documents/10162/efc985e4-8802-4ebb-8245-29708747a358
[4] FDA News Release, 2 September 2016, "FDA issues final rule on safety and effectiveness of antibacterial soaps". www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm