Teeth Whitening Products: Hydrogen Peroxide Limits
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Quick Answer
Teeth whitening products can be cosmetics, but they are among the most tightly controlled. The key control is the amount of hydrogen peroxide (present or released): up to 0.1% is the general limit for oral products, and products above 0.1% and up to 6% are restricted to dental practitioners, with an under-18 ban and mandatory label wording. The rules below come from the EU Directive that set them, in the version held on legislation.gov.uk. Always check the current Annex III entry before you formulate or label.
The Three Bands
| Hydrogen peroxide (present or released) | What the Directive says |
|---|---|
| Up to 0.1% | The limit for oral products such as mouth rinse, toothpaste and tooth whitening or bleaching products |
| Above 0.1% and up to 6% | Tooth whitening or bleaching products only; sold only to dental practitioners; first use in each cycle by a dental practitioner or under their direct supervision; not for anyone under 18 |
| Above 6% | Outside the limits set for tooth whitening in this entry |
These figures are taken from Council Directive 2011/84/EU, which replaced the hydrogen peroxide entry (reference 12) in Annex III of the old Cosmetics Directive. It covers hydrogen peroxide and compounds that release it, including carbamide peroxide and zinc peroxide. The page notes that the text is the EU version as it stood at the end of the post-Brexit transition period with no later amendments applied. Today's rules sit in Annex III of Regulation 1223/2009, so check that entry before relying on any number here. Our guide to Annexes II to VI explains how to look it up.
Why "Present or Released" Matters
The limit is not just for hydrogen peroxide as an ingredient. It applies to the amount present or released, which brings in compounds that release it, such as carbamide peroxide. A formula that lists no hydrogen peroxide can still be over the limit, so your assessor needs the calculated hydrogen peroxide equivalent for every peroxide source. Record this in the formula section of your PIF.
Mandatory Label Wording
For products above 0.1% and up to 6%, the Directive requires the label to carry:
- The concentration of hydrogen peroxide present or released, shown as a percentage.
- The statement "Not to be used on a person under 18 years of age."
- The dentist-only sale and first-use wording: sale to dental practitioners only, with the first use in each cycle by a dental practitioner or under their direct supervision if equivalent safety is ensured.
After that first use, the Directive allows the product to be given to the consumer to complete the cycle. Use the exact wording from the current Annex III entry, not a paraphrase. For the wider label requirements, see our labelling guide.
Why the Limits Exist
The Directive's recitals say the EU's scientific committee found 0.1% hydrogen peroxide safe in oral products, and considered concentrations above 0.1% up to 6% potentially safe if a clinical examination is carried out and exposure is limited. That is why the higher band is tied to dental practitioners. If you sell directly to consumers, stay within the general limit and make sure your claims do not imply more.
Claims and Borderline Risks
Strong whitening or "medical" language can push a product towards a different legal category. Our guide to borderline products explains the line, and claims substantiation covers evidence for "whitens in 7 days"-type claims.
Checklist for a Whitening Product
- List every peroxide source and calculate hydrogen peroxide present or released.
- Place the product in the correct band and confirm it against the current Annex III entry.
- Decide who the product is sold to; above 0.1% means dental practitioners.
- Add the concentration, under-18 statement and dentist-only wording where required.
- Brief your safety assessor on application method, contact time and mouth exposure.
- Check claims against your evidence and keep it in the PIF.
Common Mistakes
Mistake #1 — Counting only "hydrogen peroxide" on the ingredient list. Carbamide peroxide and other releasing compounds count toward the limit.
Mistake #2 — Selling a stronger kit directly to consumers. Above 0.1%, the Directive restricts sale to dental practitioners.
Mistake #3 — Missing the under-18 statement. It is required wording, not optional advice.
Mistake #4 — Relying on a 2011 number without checking the current entry. Annex entries are amended over time.
Frequently Asked Questions
What is the hydrogen peroxide limit for tooth whitening products?
Under Council Directive 2011/84/EU, oral products are limited to 0.1% hydrogen peroxide present or released. Tooth whitening or bleaching products above 0.1% and up to 6% are restricted and may only be sold to dental practitioners. Check the current Annex III entry before relying on these figures.
Can under-18s use whitening products above 0.1%?
No. The Directive says products above 0.1% and up to 6% must not be used on anyone under 18, and the label must state: "Not to be used on a person under 18 years of age."
Do carbamide peroxide products count?
Yes. The limits apply to hydrogen peroxide present or released, and the entry covers compounds that release it, including carbamide peroxide and zinc peroxide.
Can I give a stronger whitening kit to consumers after the dentist's first use?
The Directive says the first use in each cycle must be by a dental practitioner or under their direct supervision, and after that the product can be given to the consumer to complete the cycle. Confirm the current wording and national rules with your assessor.
Final Word
Whitening is a category where one number on a data sheet decides who may buy the product and what the label must say. Calculate hydrogen peroxide from every source, confirm the band against the current annex, and put the required wording on the pack before anything else.
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Sources
- Council Directive 2011/84/EU amending Directive 76/768/EEC (hydrogen peroxide, Annex III) — legislation.gov.uk
- Related guides on this site: Annexes II to VI, borderline products, claims substantiation
This article is for general information and does not constitute legal advice. Figures are from a 2011 EU Directive as held on legislation.gov.uk and may have been amended or implemented differently since; always check the current Annex III entry and national rules for your market with a qualified safety assessor or Responsible Person.