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Tooth Whiteners & Oral Hygiene Products containing hydrogen peroxide

8. Conclusion – Are oral hygiene products and tooth whiteners containing hydrogen peroxide safe and should they be freely available to consumers?

    The SCCP opinion states:


    In response to the questions asked, the SCCP is of the opinion that for practical reasons, the following concentration limits of hydrogen peroxide, when used in oral hygiene and tooth whitening products, should be considered: up to 0.1%, up to 6% (Higher concentrations may be used provided that the total amount of hydrogen peroxide is equal or lower than in products using 6% hydrogen peroxide and 0.2 g gel load and that studies have demonstrated that the concentration of hydrogen peroxide in the saliva and on the gingiva is not higher than in products containing 6% hydrogen peroxide), and more than 6%. The limit of 0.1% is based on a level at which there is no risk to the consumer from the use of hydrogen peroxide in oral hygiene and tooth whitening products under normal or reasonable foreseeable conditions of use. In toothpastes and mouth rinses, the hydrogen peroxide concentration should not exceed 0.1% (SCCNFP/0158/99). The limit of 6% for tooth whitening products refers to the limit given in the Terms of Reference in relation to the Opinion SCCP/0844/04. It should also be noted that for hydrogen peroxide concentrations above 6%, the MOS will be below 100; therefore, products containing more than 6% hydrogen peroxide are not safe for use by the consumer.

    The present opinion refers to the concentration of hydrogen peroxide in its free form or when released (some hydrogen peroxide releasing substances may not be specifically mentioned in this opinion). In the case of the substances discussed in Appendix (sodium percarbonate, sodium perborate, and potassium peroxymonosulphate), it refers to the concentrations of the substances that will result in the same amount of hydrogen peroxide or reactive oxygen species being available as the specified concentrations of hydrogen peroxide above.

    Sodium perborate fulfils the criteria of a classification of toxic to reproduction category 2 (R61). Additionally, there is a current proposal that sodium perborate should be so classified (  (Search Working Database)).

    The available data does not permit a distinction between the different tooth whitening products (e.g. tray-based gel, gel strips, paint-on gel) with regards to adverse effects.

    This opinion only concerns the cosmetic use of oral hygiene and tooth whitening products.

    toothpastes, mouth-rinses, and tooth whitening products containing up to 0.1% hydrogen peroxide

    • The use of toothpastes, mouth-rinses, and tooth whitening products containing up to 0.1% hydrogen peroxide does not pose a risk to the health of the consumer.

    tooth whitening products containing > 0.1% and ≤ 6% hydrogen peroxide

    • Based on the available data, the SCCP is not in a position to define a level of hydrogen peroxide and a frequency of application that would result in exposure which would be considered safe for the consumer.
    • With increasing concentration of hydrogen peroxide and frequency of application there will be an increasing risk associated with the use of these products. It cannot be anticipated what the exposure would be if the products were to be freely and directly available to the consumer.
    • Potential risks associated with the use of products containing more than 0.1% and up to 6% hydrogen peroxide may be reduced if:
    • Potential risks associated with the use of products containing more than 0.1% and up to 6% hydrogen peroxide may be reduced if:

    a) used only after clinical examination to ensure the absence of risk factors identified below or other oral pathology of concern.

    • Particular care should be taken in using tooth whitening products by persons with gingivitis and other periodontal diseases or defective restorations. Conditions such as pre-existing oral tissue injury or concurrent use of tobacco and/or alcohol may exacerbate the toxic effects of hydrogen peroxide (see e.g. section 3.3.15).
    • Their use is not recommended prior to or immediately after dental restoration.

    b) exposure to tooth whitening products containing 0.1 to 6% hydrogen peroxide is to be limited in a manner that ensures that the products are used only as intended in terms of frequency and duration of application to avoid reasonably foreseeable misuse

    • There is an absence of good clinical data and long-term epidemiological studies that assess the possible adverse effects within the oral cavity (see SCCP/0974/06). The SCCP recommends that, in consideration of public health, independent long-term safety evaluations should be performed (see SCCP/0974/06).
    • In the absence of specific data on the safety of tooth whitening products in children/adolescents, the SCCP is not in a position to assess the potential health risks associated with their use in this population subgroup.

    Tooth whitening products containing > 6 % hydrogen peroxide

    Because of the increasing risks of acute and long-term effects, tooth whitening products containing > 6.0% hydrogen peroxide are not considered safe for use by the consumer.

    Source & ©: SCCP,  Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products (2007), 4. Conclusion, p.70-71

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