Teeth whitening products have certainly gained popularity in recent years.
Tooth whitening was performed only in a dental office by a qualified healthcare professional. But in recent years, teeth whitening has become more accessible as many brands are now making teeth whitening kits that consumers can use at home, offering an inexpensive and easy alternative to professional teeth whitening procedures.
As the demand for such products continues to grow, it is important to be aware of regulatory restrictions and to ensure that products are safe and compliant.
Teeth whitening products are considered cosmetic in the EU and must comply with the Regulation (EC) 1223/2009on cosmetic products. The use of a common ingredient for teeth whitening, hydrogen peroxide, is limited to use in cosmetics in the EU and can be found in Annex III (entry 12) of the Cosmetics Regulation. The following two restrictions apply to the use of hydrogen peroxide in bleaches or bleaching products:
- Products with 0.1% hydrogen peroxide (present or released) or not, can be sold as cosmetics directly to consumers, without any specific restrictions.
- Products with 0.1% to 6% hydrogen peroxide (present or released) can only be sold to dentists, which means that retail is not allowed. The product label must indicate the concentration of hydrogen peroxide in the product (percentage) and the following warnings:
- ” Not for use on persons under the age of 18. ”
- ” For sale only to dentists. For each cycle of use, in the first place, use by dentists or under their direct supervision if an equivalent level of safety is guaranteed. ”
- ” After being provided to the consumer to complete the use cycle. ”
- Products with more than 6% hydrogen peroxide are banned for sale as cosmetics in the EU.
These restrictions also apply to other compounds and mixtures that release hydrogen peroxide, such as carbamide peroxide, zinc peroxide, magnesium peroxide, etc.
The restrictions set by the regulation are based on the scientific opinion on hydrogen peroxide, published by the European Scientific Committee for Consumer Safety (SCCS) on 18 December 2007. In its opinion, the SCCS concluded that the use of hydrogen peroxide in a concentration of up to 0.1% poses no risk to consumers under normal and reasonably foreseeable conditions of use. However, for concentrations between 0.1% and 6%, the SCCS was unable to establish a level and frequency of use at which the use of products with these concentrations would be safe. With increasing concentrations and frequency of application, the use of such products is associated with an increased risk. By limiting the use of these higher concentrations of hydrogen peroxide to professional use only, you can reduce the potential risk associated with the use of the products. Products with 6% or more hydrogen peroxide are unsafe for consumers due to the increasing risks of acute and long-term effects.
United States of America
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), teeth whitening products can be considered drugs and / and cosmetics, depending on the ingredients of the product, the mechanism of action, the conditions of use and the safety. Based on the FDA’s Citizen Petition Response to the American Dental Association (ADA) on peroxide-containing teeth whitening products, published in 2014, the FDA believes that most peroxide-containing teeth whiteners meet the definition of cosmetic written in the FD&C law . In its citizen petition, the ADA asked the FDA to review and establish an appropriate classification of peroxide-containing teeth whitening products, which work by chemical means to lighten the color of the teeth. They expressed concern about the safe use of such products without proper professional advice. However, the FDA rejected the petition and concluded that the ADA did not provide enough information, which would allow peroxide-containing teeth whitening products to be classified as drugs. To do this, the FDA said they would need more information, such as which ingredients and which concentrations of peroxide-containing teeth whiteners can affect the structure and function of the body, and also their intended use.
Cosmetic products in the United States do not require FDA approval; product safety and regulatory compliance is the responsibility of the manufacturers. However, it is highly recommended that cosmetic brands participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP). VCRP is a reporting system for cosmetics that are already in commercial distribution in the United States. The program does not apply to cosmetics for professional use only, non-retail products and home-made cosmetics.
In the event that a whitening product is considered a drug, registration of the product with the FDA is mandatory. The product must receive FDA pre-marketing approval through the New Drug Application (NDA) process or comply with the appropriate over-the-counter (OTC) monograph.
Teeth whitening products sold in Canada are cosmetic, unless they contain fluoride. In this case, the products would be considered drugs.
Teeth whitening products usually contain hydrogen peroxide or other peroxide-generating compounds. As in the EU, these ingredients are also restricted for use in cosmetics in Canada and can be found on Canada’s Cosmetic Ingredients Hotlist. For these ingredients the following conditions of use apply:
- The pH of the product must be equal to or greater than 4.0
- For oral cosmetics that contain more than 3% hydrogen peroxide, proof must be provided that the product is safe for use when used as directed
- The label must include all warnings required by Health Canada:
- “If irritation (such as redness, swelling, soreness) of the gums or mouth occurs, discontinue use and consult an oral health professional.”
- “Products containing peroxides are not recommended for use by children under the age of 12.”
- “Consult your oral health professional before prolonged use of this product.”
- “Avoid ingesting the cosmetic or part of it.”
- “Avoid contact of the product with the eyes.”
- “Avoid direct contact of the active surface of the dental whitening product with the gums and / or the salivary flow.”
Manufacturers must ensure the safety of their cosmetic products and comply with all relevant requirements for teeth whitening products. They must also notify Health Canada of the product within 10 days of the first sale in Canada. This should be done by submitting the Cosmetic Notification Form (CNF), which can be found on the Health Canada website.