TEETH WHITENING LEGISLATION FOR NON-DENTAL PRACTITIONERS
The regulations for teeth whitening products only allow the sale of products containing 6% or less hydrogen peroxide or 18% or less carbamide peroxide for non dental practitioners.
TEETH WHITENING PACKAGING REQUIREMENTS
Non-dental practitioners must issue clients with their own DIY self administered teeth whitening kit to be compliant with Australian regulations. Peroxide at levels of 6% hydrogen peroxide or 18% carbamide peroxide requires a Schedule S5 Caution on the front of the packaging label. All teeth whitening products are also required to have a list of ingredients. Our teeth whitening treatment packs offer s Australian compliant labelling.
LEGISLATION ON APPLICATION
As a non dental practitioner your may only offer a self-administered teeth whitening treatment with the use of an accelerator lamp. This means you must let your client apply the whitening gel themselves. You must not at any time touch your client’s teeth or mouth or provide any dental diagnoses.
It is important to note that the policy on teeth whitening developed by the Dental Board of Australia (DBA) under Section 39 of the Health Practitioner Regulation National Law Act (National Law), as in force in each state and territory, states that teeth whitening products should only be used by a registered dental practitioner with education, training and competence in teeth whitening.
Below are the official document by the ACCC and ADIA relating to teeth whitening practices and regulations:
Current Regulatory Standards:
The regulatory standards for teeth whitening products are set out in the SUSMP (also commonly referred to as the Poisons Standard) that are given effect by the following state and territory government legislation:
• Medicines, Poisons and Therapeutic Goods Act (ACT) 2012
• Poisons and Therapeutic Goods Act (NSW) 1966
• Medicines, Poisons and Therapeutic Goods Act (NT) 2012
• Health Act (Qld) 1937
• Controlled Substances Act (SA) 1984
• Poisons Act (Tas) 1971
• Drugs, Poisons and Controlled Substances Act (Vic)1981
• Poisons Act (WA) 1964
Product Safety Bulletin
WHAT YOU NEED TO KNOW ABOUT:
Safety of do-it-yourself (DIY) teeth whitening products for at home use
This bulletin provides information for consumers about hydrogen peroxide and carbamide peroxide in DIY teeth whitening products for use at home including hazards associated with their use.
It also assists suppliers of these cosmetic goods to ensure products they supply are safe and comply with the law.
If you are a manufacturer, importer, wholesaler, retailer (whether online or shop front) or teeth whitening service provider in the business of supplying DIY teeth whitening products for homeâ€‘use into the Australian market, this bulletin applies to you. This includes all cosmetic retailers, pharmacists, beauty salons and dentists who supply DIY teeth whiteners for homeâ€‘use.
Note: This does not apply to teeth whitening services provided by appropriately registered practitioners using chemicals and equipment on patients or clients in a surgery or commercial premises.
However, this does apply to those service providers that also supply DIY teeth whiteners to their clients or patients for homeâ€‘use.
The provision of teeth whitening services is subject to other regulations which are administered by the Australian Health Practitioner Regulation Agency. The Dental Board of Australia Interim Policy on Teeth/Whitening Bleaching states:
“Teeth whitening/bleaching, is an irreversible procedure on the human teeth and any tooth whitening/bleaching products containing more than 6% concentration of the active whitening/bleaching agent, should only be used by a registered dental practitioner with education, training and competence in teeth whitening/bleaching.”
For more information, visit the Dental Board of Australia website on www.dentalboard.gov.au/Codes-Guidelines/Policies-Codes-Guidelines.aspx
What is hydrogen peroxide and carbamide peroxide?
Hydrogen peroxide (H2O2) is a clear liquid, slightly more viscous than water. With its oxidising properties, hydrogen peroxide is often used as a bleach or cleaning agent. The oxidising capacity of hydrogen peroxide is so strong that it is considered a highly reactive oxygen species. It is a potent antibacterial agent and is toxic to living cells at high concentrations.
Carbamide peroxide is a solid comprising a oneâ€‘toâ€‘one ratio of urea and hydrogen peroxide and is a more stable way to deliver hydrogen peroxide in products. Approximately 10 per cent carbamide peroxide is equivalent to 3.62 per cent of hydrogen peroxide. Carbamide peroxide releases hydrogen peroxide which oxidises on contact with moist tissues. It can be used to treat infections of the ear, mouth, skin and mucous membranes, and for softening and removal of ear wax.
In excessive amounts, hydrogen peroxide and carbamide peroxide can cause serious damage to the teeth, oral cavity, oesophagus and stomach. Direct exposure of the skin, eyes and mucous membranes to high concentrations of hydrogen peroxide and carbamide peroxide may cause severe irritation or chemical burns with permanent adverse effects.
Ingestion may cause irritation and damage to the oesophagus and stomach resulting in ulceration, bleeding or sudden distension. Ingestion of hydrogen peroxide has been known to cause death.
In late 2011, the ACCC became aware of various media reports citing injuries associated with DIY teeth whitening products. The ACCC subsequently identified a significant trend in injury cases. Since 2005, the Australian Poisons Information Centres had received at least 63 reports of injuries involving teeth whiteners and the Australian Dental Association also reported that dentists were seeing an increasing number of patients presenting mouth injuries attributed to teeth whitening by nonâ€‘dentists.
Your responsibility to provide safe and legal products.
DIY teeth whitening products supplied for home use are consumer goods and cosmetics and are subject to the Australian Consumer Law (which forms Schedule 2 to the Competition and Consumer Act 2010).
The ACCC’s position is that DIY teeth whitening products containing concentrations of more than 6 per cent hydrogen peroxide or more than 18 per cent carbamide peroxide are unsafe for selfâ€‘administered home use.
The Poisons Standard 2012, enforced by all Australian state and territory health authorities, requires preparations containing more than 6 per cent hydrogen peroxide or 18 per cent carbamide peroxide to be clearly labelled as Schedule 6 ‘POISONS’. The Poisons Standard also requires prominent warnings about ingestion and contact with skin, including Poisons Information Centre contact details. For more details see the Poisons Standard at www.comlaw.gov.au/Details/F2012L01200.
Cosmetics, including teeth-whitening kits, must also declare the ingredients on the label according to the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. This mandatory information standard is intended to enable consumers to identify the presence of ingredients to which they may be allergic or sensitive, or otherwise concerned about, and to allow comparison of different products. For more information visit www.productsafety.gov.au/ingredientslabelling.
Cosmetic ingredients must be legally permitted for use in Australia and meet requirements under the Industrial Chemicals (Notification and Assessment) Act 1989 and comply with the Cosmetics Standards 2007. For more details see www.nicnas.gov.au (National Industrial Chemicals Notification & Assessment Scheme).
Hydrogen peroxide at concentrations of over 5 per cent is also listed as a hazardous substance on the SafeWork Australia Hazardous Substances Information System with regulations around its use in the workplace.
The Australian Consumer Law provides statutory consumer guarantees that require suppliers to remedy consumers if teeth whitening products or services are unfit for purpose or of unacceptable quality, including if they are unsafe.
The Australian Consumer Law also requires that all representations or claims made in relation to the supply of consumer goods or services are truthful. It is an offence to engage in misleading and deceptive conduct.
More detailed information on the requirements of the Australian Consumer Law is available from the ACCC website at www.accc.gov.au/ACL.
Your mandatory reporting responsibilities:
As a supplier of consumer goods, you also need to meet your mandatory reporting obligations.
Under the Australian Consumer Law, suppliers—including wholesalers, retailers and service providers such as health and beauty salonists—are required to report consumer goods associated with death, serious injury or illness of any person within two days of becoming aware of a reportable incident.
A supplier who fails to fulfil this mandatory requirement may be found guilty of a criminal offence and be liable for a penalty of up to $16 500 for a body corporate or $3330 for a person other than a body corporate.
You can submit a mandatory report and find out more about your requirements via the Product Safety Australia website: www.productsafety.gov.au/mandatoryreporting.
Recalls of teeth whiteners:
Since December 2011 a number of DIY at-home teeth whitening products were recalled because they contained unsafe levels of hydrogen peroxide/carbamide peroxide. For more information on recalled teeth whitening products visit the Recalls Australia Website at www.recalls.gov.au.
Note: some suppliers may have reformulated their products so that they now do not exceed 6 per cent hydrogen peroxide or 18 per cent carbamide peroxide.
You can register to receive automatic email alerts from this site any time a new recall is listed. This will help ensure you keep up-to-date with the latest product safety recall information and can act to keep yourself, your staff and your clients safe.
Ensuring safe use of products:
As a supplier, you may wish to add value to your customer service by encouraging consumers to follow some simple tips when buying these products:
• Do not use DIY teeth whitening products that contain more than 6 per cent hydrogen peroxide or 18 per cent carbamide peroxide.
• If you are uncertain what concentration of bleaching agent is in a teeth whitening product or what ingredients it contains, do not purchase it. If you have purchased it, do not use it—return it to the supplier.
• Always follow product instructions for use.
• If you are unsure whether DIY teeth whitening is safe or suitable for you consult your dentist first.
Ensuring safe supply of products
• Do not supply DIY teeth whitening products for home use that contain more than 6 per cent hydrogen peroxide or 18 per cent carbamide peroxide.
• Only supply DIY teeth whitening products that comply with the Poisons Standard 2012, including all necessary warnings.
• Only supply DIY teeth whitening products for home use that declare all ingredients on the label in accordance with Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.
• Allow consumers and clients to see the ingredients list and all product information. Material safety datasheets should be available from all suppliers of potentially hazardous products (including you).
• Do not supply recalled products. Stay up-to-date with product recalls via the Recalls Australia website, and follow instructions for dealing with any recalled products you may have supplied.
• Report death, serious injury or illness as required under the Australian Consumer Law.
It is both illegal and irresponsible for anyone to supply any product that does not comply with the law and is unsafe. Substantial penalties including fines of up to $1.1 million apply to companies that fail to comply with provisions of the Australian Consumer Law.
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For more information about mandatory standards, bans, recalls and emerging issues—and to subscribe to email alerts and RSS—visit our websites:
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Voice-only (speak and listen) users phone 1300 555 727 and ask for 1300 302 502.
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Australian Competition and Consumer Commission
23 Marcus Clarke Street, Canberra, Australian Capital Territory 2601
© Commonwealth of Australia 2013
The information in this publication is for general guidance only. It does not constitute legal or other professional advice, and should not be relied on as a statement of the law in any jurisdiction. Because it is intended only as a general guide, it may contain generalisations. You should obtain professional advice if you have any specific concern.
The ACCC has made every reasonable effort to provide current and accurate information, but it does not make any guarantees regarding the accuracy, currency or completeness of that information.
ISBN 978 1 921973 19 2
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