Download Proposals for amendments to Specified Dental Products Group Standards (PDf kb)
20 January 2011
ERMA New Zealand
Proposals for amendments to Specified Dental Products Group Standards
Thank you for your request for comment from the Health and Disability Commissioner (HDC) on the draft proposal for amendments to the Specified Dental Products Group Standards (the standards).
Background
The Dental Council of New Zealand and Ministry of Health have requested amendments to the standards as follows:
- A restriction on the concentration of hydrogen peroxide permitted in dental products, where such products can be obtained from sources other than a dentist (commonly known as over the counter, OTC);
- New identification requirements provided in leaflets for dental products which contain/release hydrogen peroxide.
My response
I commend the proposed amendments as I consider there is a potential risk of harm to consumers through the use of hydrogen peroxide products for tooth whitening in circumstances where there is no adequate supervision by a registered dentist.
Dental products containing or releasing more than 3.6% hydrogen peroxide
It is proposed that the standard will state that such products can only be obtained by a member of the public "from a dentist". However I am aware of organisations which operate tooth whitening clinics with the support of a dentist. However, the organisations have no dentist on site at the time the tooth whitening products are supplied and/or applied to the consumer's teeth.
I recommend that the proposed standard is amended to clarify that the sale of such products containing more than 3.6% hydrogen peroxide must be made directly by a dentist or if a person under the supervision of a dentist the oversight by the dentist must be practicable and meaningful.
I consider that products containing or releasing more than should also have a precautionary statement provided by means of a product leaflet.
Implementation date
In light of a potential risk of harm from these products I recommend that the changes be implemented as soon as practically possible.