Statutory Instrument 396 of 2012 came into effect on 31 October 2012. Dentists have received the joint statement issued by the Dental Council and the Health Products Regulatory Authority (formerly the Irish Medicines Board) regarding the implementation of the new Regulations. The Regulations increase the percentage of hydrogen peroxide allowed in tooth whitening or bleaching products to 6%, subject to conditions which include first use by a dental practitioner.
The new Regulations allow the use, for tooth whitening, of hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide. The maximum concentration that may be used for tooth whitening under the Regulations is 6% present or released. This is the equivalent of 16.62% carbamide peroxide, which, in Ireland, has been rounded up to 17%. If using a compound or mixture other than hydrogen peroxide the dentist should check the levels of hydrogen peroxide released from the product with the supplier.
The Regulations stipulate that products containing or releasing up to 6% hydrogen peroxide can be used, subject to conditions:
- To only be sold to dental practitioners
- For each cycle of use, first use by a dental practitioner
- Afterwards to be provided to the consumer to complete the cycle of use
- Not to be used on a person under 18 years of age.
The Dental Council has issued a guidance document to the profession to assist with compliance to the new Regulations. This document together with the joint Dental Council / Health Products Regulatory Authority (HPRA) statement and Statutory Instrument 396 of 2012 are available to download below.