Colgate recognizes the importance of continuous scientific study. We conduct and commission research, publish papers, closely investigate newly published information, and actively participate in expert symposia on an ongoing basis. We remain confident that ongoing independent scientific reviews will continue to add to the substantial body of research that affirms the safety and effectiveness of Colgate Total® with triclosan.
The U.S. Food and Drug Administration (FDA), leading health regulatory agencies around the world, and other independent sources have reviewed and confirmed triclosan’s safe and effective use in Colgate Total® toothpaste.
Colgate Total®, with its active ingredient triclosan, has been approved as safe and effective by the U.S. FDA via its rigorous New Drug Application (NDA) process. This is the same process used by the FDA to approve prescription medications, and Colgate Total® is the only toothpaste on the market that has undergone the FDA's NDA review process. The NDA approval process requires a comprehensive evaluation of human safety. All new drug assessments include a review of nonclinical studies covering a wide array of toxicological endpoints, such as carcinogenicity, reproductive and developmental toxicity, eye and skin irritation, and short term and long term toxicity. The FDA's NDA approval also requires ongoing monitoring and updating, and we regularly provide the FDA with safety updates.
On September 6, 2016, the FDA issued final rules on consumer antibacterial hand soaps that prohibited the continued use of triclosan and 18 other antibacterial ingredients, effective from September 6, 2017. The FDA concluded that soap manufacturers had not submitted adequate safety evidence for use in these products; the agency did not conclude that triclosan in soap is unsafe. The FDA’s rules with respect to consumer antibacterial hand soaps do not impact Colgate Total's® NDA approval, which has not changed. Colgate Total® is also the only toothpaste that is both approved by the FDA and accepted by the American Dental Association as safe and effective in helping to prevent gingivitis.
Independent scientific committees of the European Commission have also evaluated triclosan several times (the Scientific Committee on Cosmetic Products and Non-food Products in 2002, the Scientific Committee on Consumer Products in 2002 and 2006, and the Scientific Committee on Consumer Safety in 2011.) Each concluded that triclosan use at 0.3% in toothpaste, the level found in Colgate Total®, is considered safe. Accordingly, an April 2014 amendment to the EU Cosmetic Regulation confirmed triclosan's continued use in cosmetic toothpastes up to the approved 0.3% level. The European Chemicals Agency (ECHA) is conducting a review of triclosan under the REACH regulation and determined that additional studies are necessary to complete its assessment regarding potential endocrine effects and persistence in the environment. This determination is currently under review. In a separate review under the Biocides Regulation, ECHA determined that the sale of surgical hand scrubs containing a significantly higher level of triclosan are to be phased out as of January 2018. ECHA's action under the EU Biocide regulation does not impact the continued sale of Colgate Total as a cosmetic toothpaste under the EU Cosmetic Regulation.
In addition to US FDA and the EU Commission reviews, the two EU medicinal authorities who have reviewed Colgate Total® with triclosan, the UK & Irish Medicinal Authorities (MHRA and HPRA), have both approved it as a safe and effective medicinal toothpaste, as have the comparable health authorities in Canada, Australia, and New Zealand.
In addition, Canadian health and environmental authorities finalized a review of triclosan in November 2016. The review found that triclosan exposure from all sources did not pose a risk to human health in Canada.
We will continue to share scientific research with regulatory bodies responsible for public health around the world, and remain confident that ongoing independent scientific reviews will continue to add to the substantial body of research that affirms the safety and effectiveness of Colgate Total®.
Our vigilance in carefully scrutinizing the safety of Colgate Total® includes assessing any potential harm triclosan might cause in the environment. Colgate is committed to reducing our impact on the environment and strengthening the sustainability profile of our products, including the ingredients we use.
We understand the questions being asked about triclosan, have reviewed existing research, and have sponsored studies and assessments with others and on our own. We are confident in the science that demonstrates that triclosan in our toothpaste is safe for the environment.
Why should you share our confidence?
A very small amount of triclosan enters the environment. After being used and rinsed down the drain, up to 98% of triclosan is removed in modern wastewater treatment plants. The remaining amount that is then released into the aquatic environment will continue to break down, since triclosan is biodegradable and breaks down in sunlight.
To assess the potential for environmental harm, detailed assessments based on real-world exposures and concentrations have been conducted. These assessments show triclosan does not accumulate in the bodies of fish and other aquatic animals. Instead, triclosan is rapidly processed through the digestive system and then excreted as waste. These risk assessments utilizing environmental data from Europe and the US show no evidence of harm from the small amount of triclosan entering the environment.
In addition, Health Canada and Environment and Climate Change Canada both finalized a review of triclosan in November of 2016. The review found that triclosan did not pose a risk to human health in Canada, and that while it may have negative environmental impact above an identified level, this impact can be managed by limiting the release of triclosan into the environment.
Colgate continues to review all relevant studies and supports continued inquiry into the potential environmental impact of triclosan. We are confident in the scientific assessment that triclosan is safe at the low levels found in the environment today. And we foresee even less triclosan in the environment tomorrow as companies increasingly formulate products with triclosan only where it provides a recognized health benefit of importance to consumers – as is the case with Colgate Total®.
* In addition to containing 1450ppm fluoride for cavity protection, Colgate Total® contains triclosan/copolymer to provide 12-hour antibacterial protection for teeth, gums, cheeks, and tongue.
† Over time, triclosan is slowly released from the copolymer to provide sustained antibacterial activity for 12 hours.
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2 Fine DH, Sreenivasan PK, McKiernan M, et al. J Clin Periodontal. 2012; 39:1056 – 1064.
3 Kraivaphan P, Armonchat C, Triratana T. J Clin Dent. 2013:24:20 – 24.
4 Boneta AE et al. (2010) J Clin Dent; 21(spec Iss):117-123.