Cosmetic Ingredient Hotlist. Under Canadian legislation, it is illegal to sell cosmetics that contain substances that may cause injury to the health of the user when the cosmetic is used according to the directions or under usual conditions.Triclosan is an antibacterial and antifungal agent.
Triclosan is used as a material preservative and antimicrobial active ingredient in a wide range of cosmetics and personal care products, non-prescription drug products and natural health products. It is also registered in Canada as a pesticide for use as a material preservative in the manufacture of textiles, leather, paper, plastic and rubber to stop the growth of bacteria, fungus, mildew, and to prevent odours.
The registrants of triclosan pesticide products have indicated their intention to discontinue the registration of their products. After the expiry date of December 31, 2014, triclosan will no longer be permitted for use as a pesticide in Canada and cannot be contained in any treated articles imported into Canada unless a new triclosan product is registered in Canada. Examples of articles subject to this regulation include treated building materials, cutting boards, and clothing such as socks.
The Government of Canada is proposing that triclosan is safe for human health within identified maximum limits, but can be harmful to the environment.
Triclosan was assessed for health and environmental risks as part of the Chemicals Management Plan. The preliminary assessment shows that while personal care products, non-prescription drug products and natural health products containing triclosan do not pose a risk to human health, as toothpastes, soaps and other items are rinsed off and washed down the drain, the amount of triclosan that is released into the environment can affect plants and animals in lakes, streams and rivers.
It is important to remember that the health risks associated with a chemical depend on the hazard (its potential to cause health effects) and the dose (the amount of chemical to which you are exposed).
In order to determine if a substance is harmful to human health, the levels Canadians may be exposed to are compared to the lowest levels that can cause health effects. The Government reviewed available information, including Canadian and international studies, as part of the assessment process. The preliminary assessment shows that current levels of triclosan in products such as toothpaste, shampoo and soap do not pose a risk to human health and Canadians can continue to safely use these products.
We would expect to see that most Canadians have some level of triclosan in their bodies. This is consistent with measurements from the U.S. where over 80% of Americans had detectable levels of triclosan in their urine.
The presence of a chemical in a person's body does not necessarily mean that it will affect health. Factors such as the amount to which a person is exposed, the duration and timing of exposure, and the toxicity of the chemical are important factors to consider when determining whether adverse health effects will occur. For triclosan, levels of exposure for most Canadians are well below those that could cause health effects.
Yes. In most cases antibacterial soap is not necessary for safe, effective hand hygiene. Alcohol-based hand cleansers are useful when soap and water are not available.
The Government specifically considered exposure of vulnerable populations, including children and pregnant women, in its assessment. The preliminary assessment shows that current levels of triclosan in products such as toothpaste, shampoo and soap do not pose a risk to human health and Canadians- including children and pregnant women - can continue to safely use these products.
Yes. Health Canada has recommended maximum acceptable limits for triclosan in cosmetics and this is reflected in the Cosmetic Ingredient Hotlist. Under Canadian legislation, it is illegal to sell cosmetics that contain substances that may cause injury to the health of the user when the cosmetic is used according to the directions or under usual conditions.
The Hotlist suggests a concentration of triclosan of no more than 0.03% in mouthwashes, and 0.3% in other cosmetics, such as soaps. These limits are consistent with other jurisdictions like the United States and the European Union.
Additionally, all cosmetics must have ingredient labels, which let consumers identify and avoid cosmetics with ingredients that are of concern to them. Directions for the safe use of cosmetics are also required.
Health Canada also has regulations for other products containing triclosan. In order to sell a drug product in Canada, including those containing triclosan as an active ingredient, a manufacturer must submit an application for a Drug Identification Number (DIN) to Health Canada. These applications are reviewed to determine if the product meets safety, efficacy and quality standards before permitting the product to be sold in Canada.
Triclosan can be used as an anti-microbial preservative in natural health products. Limits for triclosan in natural health products are specified in the Natural Health Products Ingredient Database and are identical to the limits in the Cosmetic Ingredient Hotlist.
Triclosan is also currently registered as a pesticide under the Pest Controls Products Act for use as a material preservative during the manufacture of textiles, leather, paper and rubber to stop the growth of bacteria, fungus, mildew, and to prevent odours. The registrants of triclosan pesticide products have indicated their intention to discontinue the registration of their products. After the expiry date of December 31, 2014, triclosan will no longer be permitted for use as a pesticide in Canada and cannot be contained in any treated articles imported into Canada unless a new triclosan product is registered in Canada.
Health Canada has been notified of about 1,600 cosmetics and personal care products, more than 130 non-prescription drug products with an assigned Drug Identification Number or "DIN" (primarily antiseptic skin cleansers), about 13 natural health products and six pest control products containing triclosan. However, not all of these products may currently be sold in Canada. To determine if a product contains triclosan, check the label for "triclosan".
A company that has notified Health Canada about cosmetics and personal care products must provide a revised notification when the original becomes inaccurate.
When a company discontinues sale of a non-prescription drug in Canada that has an assigned DIN, the company must notify Health Canada within 30 days that it is no longer selling the drug.
The registrants of triclosan pesticide products have indicated their intention to discontinue the registration of their products. After the expiry date of December 31, 2014, triclosan will no longer be permitted for use as a pesticide in Canada and cannot be contained in any treated articles imported into Canada unless a new triclosan product is registered in Canada.
No. Under the Cosmetic Regulations of the Food and Drugs Act, a manufacturer must notify Health Canada that it is selling a product and provide a list of the product's ingredients. All cosmetics must include a list of ingredients on the label, enabling consumers to identify and avoid any cosmetics containing ingredients that are of concern to them.
Triclosan provides some health benefits in non-prescription drug products, such as its use in toothpaste to protect against gingivitis. Triclosan is also used as a preservative in cosmetics and personal care products, non-prescription drugs and natural health products to prevent or slow down bacterial growth and protect products from spoilage.
Yes. Triclosan is an antibacterial/antimicrobial ingredient found in some cosmetics in Canada. Health Canada suggests that it be restricted to a concentration of 0.03% in mouthwashes and 0.3% in other cosmetic products (such as soaps).
All cosmetic products in Canada - including soaps - are required to disclose ingredients on the product label, allowing consumers to identify and avoid any cosmetics containing ingredients that are of concern to them. If a cosmetic contains triclosan it must be disclosed on the ingredient label.
In addition, if a non-prescription drug product contains triclosan as a medicinal ingredient (for instance, in anti-gingivitis toothpaste) it must be listed on the product label.
No. Current levels in cosmetics and personal care products are well below levels that could cause health effects.
As part of the proposed risk management strategy, the Government will work with industry to reduce the amount of triclosan that is released to the environment, by potentially substituting triclosan with another ingredient that provides the same benefits but with less risk to the environment, or using only the minimum quantity of triclosan necessary to achieve the desired results if a substitute is not available.
The majority of triclosan-containing non-prescription drug products (not cosmetics) sold in Canada are antiseptic skin cleansers where the concentration of triclosan is restricted to 0.1 to 1.0%. Should triclosan be used as a non-medicinal ingredient in drug products, the concentration is expected to be lower.
Health Canada has very strict regulations for cosmetics. All cosmetics sold to consumers in Canada must meet the requirements of the Food and Drugs Act, the Cosmetic Regulations, and all other applicable legislation. Section 16 of the Food and Drugs Act states: "No person shall sell any cosmetic that has in or on it any substance that may cause injury to the health of the user". Under these provisions, it is the manufacturer's responsibility to make sure the products they sell are safe.
Under the Cosmetic Regulations of the Food and Drugs Act, the manufacturer must also notify Health Canada that it is selling a product and provide a list of the product's ingredients. All cosmetics must include a list of ingredients on the label, enabling consumers to identify and avoid any cosmetics containing ingredients that are of concern to them.
Health Canada also conducts regular sampling and testing to verify that these requirements are being met, and takes steps to remove unsafe products from the market when necessary.
No. The preliminary assessment shows that current levels of triclosan in products such as cosmetics, personal care products or other products do not pose a risk to human health and Canadians, including children, can continue to safely use these products.
Governments in Europe and Australia recently evaluated current information and concluded there is no clear link between products containing triclosan and increased antibacterial resistance.
Health Canada will continue to monitor the scientific literature and will take further action if warranted.
Yes. Triclosan may be present in a variety of consumer products including children's clothing, bedding and toys. The Government took these potential sources of exposure into consideration as part of its preliminary assessment, and is proposing that triclosan does not pose a risk to human health at current levels of exposure.
Triclosan is not registered for use on food crops. Its use as a pesticide is limited to a material preservative for textiles, leather, paper, plastics and rubber.
There are alternatives to triclosan for some uses. Not all of the alternatives have been reviewed by the government to determine the potential risk to human health and the environment.
Health Canada advises Canadians to always read and follow label directions carefully. If you are concerned about using cosmetics or personal care products containing triclosan, check the product label.
The assessment and other technical information are available on our Triclosan Webpage.