2022 EU, USA, Canada teeth whitening regulations for the oral care industry

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.

European Union

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.

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