Hydrogen Peroxide Teeth Whitening Limits by Country — the 0.1% and 6% Rules
In the UK and EU, a whitening product you can buy over the counter may contain no more than 0.1% hydrogen peroxide; up to 6% only through a dentist; above that, not as a cosmetic. The US and Canada do it differently. Every rule here links to its source, dated.
In the UK and the EU, a tooth whitening product sold freely to consumers may contain or release no more than 0.1% hydrogen peroxide. Products between 0.1% and 6% may be sold only to dental practitioners, must not be used on anyone under 18, and above 6% are not allowed as cosmetic whitening at all.
Other countries draw the line differently, which is why the same online shop can sell a 15% kit in one place that would be unlawful in another. This guide sets out each rule we could read at the regulator's own text, when we read it, and what it means for a reader choosing a product.
The rule in the UK and the EU
The rule comes from Council Directive 2011/84/EU of 20 September 2011, which amended the EU's cosmetics rules on hydrogen peroxide and told member states to apply the change from 31 October 2012. The same entry now sits in Annex III of the EU Cosmetics Regulation, and the UK kept it when it left the EU.
The entry sets two bands for teeth, measured as hydrogen peroxide "present or released", so it also covers carbamide peroxide and other compounds that release hydrogen peroxide.
| Band | Who may buy it | Conditions |
|---|---|---|
| Up to 0.1% (oral products incl. toothpaste, mouth rinse and whitening products) | Anyone, over the counter | Standard cosmetic rules |
| More than 0.1% and up to 6% (tooth whitening or bleaching products) | Only dental practitioners | First use of each cycle by or under the direct supervision of a dental practitioner; then provided to the consumer to finish the cycle; not to be used on anyone under 18; strength shown as a percentage on the label |
| More than 6% | Not permitted as a cosmetic | The GDC says supplying or administering it for cosmetic purposes is illegal in the UK |
The practical meaning is simple. A whitening product on a UK or EU shop shelf should be 0.1% or less. If a kit sold directly to you states a higher figure, it is outside the rule, whatever the seller calls it.
What the UK regulator adds
The UK's General Dental Council adds two things the annex alone does not say. First, it treats tooth whitening as the practice of dentistry, so only registered dental professionals may provide it; people who are not registered cannot offer whitening, and the GDC prosecutes those who do under the Dentists Act 1984.
Second, it sets out how the 0.1% to 6% products should be used: after an appropriate clinical examination for risk factors, with exposure limited to the intended frequency and duration, and never made directly available to the consumer. The GDC's position statement, dated 11 July 2016, notes that breaching the regulations is a criminal offence, enforced by Trading Standards.
The under-18 rule has one exception the GDC spells out: products in the 0.1% to 6% band may not be used on anyone under 18 "except where such use is intended wholly for the purpose of treating or preventing disease". Cosmetic whitening for teenagers is not that. The NHS says whitening is not done if you are 17 or younger.
The position in the United States
We found no US federal limit on hydrogen peroxide in whitening products comparable to the EU and UK bands. According to a 2014 report by the Regulatory Affairs Professionals Society, the FDA answered an ADA petition by saying most peroxide whiteners would meet the definition of a cosmetic and that it would consider products case by case; the report describes no concentration limit.
The ADA's own policy asks the FDA "to properly classify tooth whitening/bleaching agents", and it supports treating the application of whitening chemicals, other than lawful self-application, as the practice of dentistry. Its Seal of Acceptance is a voluntary programme for over-the-counter products, not a legal limit.
The effect shows in what US shops sell. Some sellers publish their strengths: BURST states 6% hydrogen peroxide for its strips, 9% for its whitening pen and 15% for its prefilled trays. By our arithmetic that is sixty and one hundred and fifty times the 0.1% UK and EU over-the-counter ceiling for the strips and the trays.
The position in Canada
Health Canada treats peroxide whitening products as cosmetics with conditions. Its Cosmetic Ingredient Hotlist says that if an oral cosmetic contains more than 3% hydrogen peroxide or equivalent, the notifier must submit a clinical study showing salivary peroxide levels do not exceed 3% when the product is used as directed.
The hotlist also requires cautionary statements, including that products containing peroxides "are not recommended for use by children under 12 years of age", that users should consult an oral health professional before prolonged use, and that they should stop and seek advice if the gums or mouth become red, swollen or sore.
Where published strengths sit against the rules
Hydrogen peroxide, present or released, on a 0–18% scale. The bands are the EU and UK rule; the tabs are strengths BURST prints on its own product pages.
- EU/UK over the counter: up to 0.1%
- EU/UK: over 0.1% to 6%, dentist-supplied only, never under 18
- EU/UK: over 6%, not permitted as a cosmetic
- Canada: above 3%, a clinical study is required
- BURST strips: 6% (60× the EU/UK over-the-counter limit, our arithmetic)
- BURST pen: 9% (90× the EU/UK over-the-counter limit, our arithmetic)
- BURST prefilled trays: 15% (150× the EU/UK over-the-counter limit, our arithmetic)
How carbamide peroxide fits in
Carbamide peroxide is counted by the hydrogen peroxide it releases, which is why the rules say "present or released". The ADA explains that carbamide peroxide releases about one-third of its content as hydrogen peroxide.
That matters when you read a label. The ADA says dentist-supervised take-home gels typically range from 10% to 38% carbamide peroxide, which sounds far stronger than a 6% hydrogen peroxide strip but is a different measure. When comparing products, check which peroxide the percentage refers to; a figure without the chemical named is not comparable with anything.
What this means when you buy online
If you live in the UK or EU, the rule protects you only if the product is sold under it. An online seller shipping from elsewhere may not follow the 0.1% limit, and the NHS warns that kits bought from a pharmacy or online "may harm your teeth and gums" and do not work as well as a dentist's kit.
- Look for a stated strength. Under the EU and UK rule, products in the 0.1% to 6% band must show their concentration as a percentage. Several US products we read state none.
- Check what the percentage measures. Hydrogen peroxide and carbamide peroxide are not the same number.
- Be wary of anything above 0.1% sold directly to you, if you are in the UK or EU; above 6% it is not permitted as a cosmetic at all.
- For teenagers, stop at 0.1%, and follow each product's own age guidance.
Our ranking of the best teeth whitening kits gives the most weight to disclosure for exactly this reason: a seller that tells you its strength lets you check it against the rule where you live. For how strength relates to side effects, see our guide to whether whitening strips are bad for your teeth.
Where we could not confirm the rule
We have not printed limits for countries whose rules we could not read at the regulator's own text, including Australia. We also could not read the current consolidated EU regulation directly, because the official EU site blocked automated access; the table above comes from the directive's annex and the retained Annex III published on legislation.gov.uk, both read on 22 September 2026. Rules change, so if you are relying on one for a purchase or a business decision, check the regulator's current text yourself.
The sources, with the date we read them
Each rule above comes from one of these pages, all read on 22 September 2026.
- Council Directive 2011/84/EU, annex and Articles 2 and 3, as published on legislation.gov.uk.
- Annex III of the Cosmetics Regulation as retained in UK law, entry 12.
- General Dental Council tooth whitening position statement, dated 11 July 2016.
- NHS: Teeth whitening, last reviewed 19 August 2025.
- Health Canada Cosmetic Ingredient Hotlist, hydrogen peroxide entry.
- ADA Oral Health Topics: Whitening, last updated 16 August 2022.
- The RAPS report of the FDA's 2014 response to the ADA's petition.
Questions about peroxide limits
What is the legal limit of hydrogen peroxide in teeth whitening in the UK?
Is there a hydrogen peroxide limit for teeth whitening in the US?
Why can't under-18s use professional teeth whitening in the UK?
Is 10% carbamide peroxide stronger than 6% hydrogen peroxide?
Choosing a product? Our ranking of teeth whitening kits by what their labels disclose starts with the option that pays us nothing. Weighing a dentist against a box? Read professional versus at-home whitening.