Whether a teeth whitening gel is a cosmetic is one of the few borderline questions in EU law with a genuinely bright line, and it is drawn by a number: 0.1% hydrogen peroxide. Below it, you have a consumer cosmetic. Above it and up to 6%, you have a product that can only be supplied through a dental practitioner. Above 6%, you have a product that cannot lawfully be placed on the EU market at all as a tooth whitening product.
That clarity has not stopped the category from being one of the most heavily enforced in Europe. Whitening kits sold online at 12% or 35% peroxide, “peroxide-free” gels containing sodium perborate or chlorine dioxide, and salon services offered by non-dentists all remain common — and all are unlawful. This guide sets out exactly where the lines are, what a compliant consumer whitening product looks like, and what your safety file needs to contain.
Key takeaways
- Annex III, entry 12 of Regulation (EC) No 1223/2009 governs hydrogen peroxide in oral products — the framework introduced by Directive 2011/84/EU.
- Up to 0.1% H₂O₂ present or released: freely sold consumer cosmetic.
- Above 0.1% up to 6%: sale to dental practitioners only; first application by or under the direct supervision of a dentist; not for under-18s.
- Above 6%: not permitted in cosmetic tooth whitening products in the EU.
- The limit covers peroxide released from other compounds — carbamide peroxide, sodium perborate and sodium percarbonate all count.
- Sodium perborate is prohibited (Annex II) as a borate CMR; “peroxide-free” does not mean “compliant”.
- Whitening by removing extrinsic stains is cosmetic; altering intrinsic tooth colour or treating a condition moves toward medical device or medicinal classification.
The concentration thresholds
Entry 12 of Annex III sets out conditions for hydrogen peroxide and “other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide”. For oral products, the tiers are:
| H₂O₂ present or released | Status | Conditions |
|---|---|---|
| Up to 0.1% | Consumer cosmetic | Freely sold; standard cosmetic requirements apply |
| Above 0.1% to 6% | Restricted cosmetic | Sold to dental practitioners only; first application by or under direct supervision of a dentist; then supplied to the consumer to complete the cycle; not for persons under 18 |
| Above 6% | Not permitted | Cannot be placed on the EU market as a cosmetic tooth whitening product |
| Other oral hygiene products (e.g. toothpaste, mouthwash) | Consumer cosmetic | Up to 0.1% H₂O₂ |
The mandatory warning for the 0.1–6% tier must appear on the label, stating the concentration of hydrogen peroxide present or released, that the product is not to be used on persons under 18, and that it is to be sold only to dental practitioners with the first use per cycle carried out by or under a dentist’s supervision.
“Present or released” is the phrase that catches people out. Carbamide peroxide releases roughly one third of its weight as hydrogen peroxide, so a gel at 16% carbamide peroxide delivers around 5.7% H₂O₂ — inside the professional tier but nowhere near a consumer product. A “10% carbamide peroxide” gel sold direct to consumers online is releasing about 3.6% H₂O₂ and is unlawful in that channel. Do the conversion before you decide what you are selling.
“Peroxide-free” is not a compliance strategy
Faced with the 0.1% consumer ceiling, a large part of the market moved to alternative oxidising agents marketed as peroxide-free. Several are worse.
Sodium perborate and perboric acid are prohibited under Annex II. Borates carrying reproductive toxicity classifications were added to the prohibited list, and sodium perborate is both a borate and a peroxide releaser — so it fails twice over. It still appears in imported whitening kits with regularity.
Sodium percarbonate releases hydrogen peroxide on contact with water and therefore falls squarely within the “or released” wording of entry 12. Marketing it as peroxide-free is simply inaccurate.
Chlorine dioxide and sodium chlorite-based systems are not covered by entry 12, but they are strongly acidic in use and there is well-documented concern about enamel erosion. They are not a free pass — Article 3 still requires the product to be safe, and an assessor will want erosion data.
PAP (phthalimidoperoxycaproic acid) is a peracid oxidiser used increasingly as a peroxide alternative. It is not listed in entry 12, but as with any unlisted active the burden sits entirely on your safety assessment to demonstrate safety at the intended concentration and use pattern.
Non-bleaching whiteners — abrasives, hydrated silica, activated charcoal, blue covarine optical brighteners — do not chemically bleach at all. They remove or mask extrinsic stains, which keeps them uncontroversially cosmetic, though abrasivity (RDA) then becomes the safety question.
Activated charcoal whitening products deserve particular care. They are cosmetically straightforward but frequently highly abrasive, and dental bodies have raised concerns about enamel wear with regular use. An assessor will expect an abrasivity measure and appropriate usage instructions.
Cosmetic, medical device or medicinal?
Concentration is not the only classification driver. What the product claims to do matters just as much.
A tooth whitening product is a cosmetic under Article 2(1)(a) when it is applied to the teeth and oral mucosa with a view to cleaning them, changing their appearance or keeping them in good condition. Removing coffee, tea, wine and tobacco staining to restore natural tooth colour sits comfortably here.
It moves toward a medicinal product under Directive 2001/83/EC if it is presented as treating or preventing disease, or if it modifies a physiological function by pharmacological, immunological or metabolic action. Claims about treating discoloration caused by tetracycline, fluorosis or pulpal necrosis are disease-treatment claims.
It can be a medical device under Regulation (EU) 2017/745 if its intended purpose is medical and its principal action is not pharmacological — some professional whitening systems and desensitising components sit here, and devices used in dentistry are regulated accordingly.
| Cosmetic claim | Reclassifying claim |
|---|---|
| “Removes surface stains from coffee and tea” | “Treats tetracycline staining” |
| “Restores your natural tooth shade” | “Corrects dental fluorosis” |
| “Whiter-looking teeth in 14 days” | “Treats gum disease” |
| “Helps prevent new stains forming” | “Kills oral bacteria” (potentially biocidal) |
| “Gentle on enamel” | “Repairs enamel” / “remineralises decay” |
Our broader guide to classifying borderline products covers how national authorities apply these tests, and permitted cosmetic claims covers substantiation.
The oral exposure problem in your CPSR
Oral care is the only mainstream cosmetic category where ingestion is expected rather than accidental. That changes the safety assessment substantially — a point it shares with lip products, which we cover in our guide to CPSR requirements for lipsticks.
Your assessor will work through:
Systemic exposure via ingestion
The SCCS Notes of Guidance provide oral care exposure figures, and for whitening gels applied in trays or strips and left in contact with the mouth, the assessment must account for swallowed fractions. Because the toxicological point of departure for most substances comes from oral studies anyway, this is a direct comparison — there is no dermal absorption step to reduce the exposure. Our guide to how the margin of safety is calculated explains why that matters.
Local effects on hard and soft tissue
Enamel and dentine effects, gingival irritation and mucosal tolerance all need to be addressed. Tooth sensitivity is the most commonly reported effect of peroxide whitening and needs to be reflected in warnings and usage instructions.
pH and erosion potential
Enamel demineralises below roughly pH 5.5. Acidic whitening formulations — common with chlorine dioxide and some PAP systems — need erosion data, not just an assurance that the active is peroxide-free.
Contact time and use pattern
A 30-second brush-on is a fundamentally different exposure from a strip worn for 30 minutes or a tray worn overnight. The intended use pattern is a core input, and “as directed” is not a specification.
Fluoride, if present, is regulated separately under Annex III with its own limits and mandatory warning wording for oral products. If you are combining whitening with fluoride, check both entries — brands frequently get the whitening side right and miss the fluoride labelling requirement.
Selling channel and enforcement
For the 0.1–6% tier, the restriction is on the supply chain, not just the label. The product may be sold only to dental practitioners, and the first application in each cycle must be performed by the dentist or under their direct supervision, after which the product may be given to the consumer to finish the cycle.
That has real consequences online. Listing a 6% carbamide-based gel on a consumer marketplace is non-compliant regardless of a warning in the description or an age-gate at checkout. Non-dental beauty salons offering whitening services above 0.1% are similarly outside the framework — a point dental regulators in several Member States have pursued directly.
Enforcement in this category is unusually active. Products are seized at customs, delisted by marketplaces, and pulled through national alert systems, most often for exceeding 6%, containing sodium perborate, or being supplied to consumers within the professional tier. A brand importing whitening product from outside the EU should treat the peroxide content declaration on the supplier’s specification as a claim to be verified, not a fact.
What a compliant consumer whitening product looks like
If you are building for the open consumer market, the specification is well defined:
- Hydrogen peroxide present or released at 0.1% or below, or a non-peroxide system whose safety you can demonstrate.
- No sodium perborate, no borates, nothing else on Annex II.
- pH and abrasivity data supporting enamel safety.
- A CPSR addressing oral and ingestion exposure specifically — see the documents needed to order a CPSR.
- Preservative efficacy (ISO 11930) and microbiological limits (ISO 17516) for any water-containing gel.
- Stability and packaging compatibility — peroxide systems are notoriously unstable and lose activity over shelf life.
- Claims limited to appearance and extrinsic stain removal, with substantiation on file.
- CPNP notification before market entry — see our CPNP submission guide.
- An EU-established Responsible Person named on the pack.
Peroxide stability is a genuine commercial risk here, not just a regulatory one. Hydrogen peroxide degrades with heat, light, pH and metal ion contamination, so a gel formulated at 0.1% can drift out of specification in either direction over shelf life. Stability testing with peroxide assay at time points — not just appearance and pH — is what tells you whether the number on your label is still true at month 18.
Bringing it all together
Tooth whitening is one of the clearest borderline categories in EU cosmetics precisely because the legislator gave it numbers. Below 0.1% hydrogen peroxide present or released you have a consumer product; between 0.1% and 6% you have a dental-channel product with mandatory warnings and an under-18 restriction; above 6% you have nothing you can lawfully sell.
Where brands come unstuck is on the details around those numbers: forgetting that carbamide peroxide and sodium percarbonate release peroxide and count toward the limit, assuming “peroxide-free” means compliant when the alternative is a prohibited borate, or building a consumer e-commerce business around a product that legally belongs in a dental surgery. Get the chemistry and the channel right and the rest of the file is a normal, if exposure-heavy, cosmetic assessment.
Lexora prepares safety assessments for oral care and borderline products, including the ingestion exposure and enamel safety analysis whitening products need. Start with our CPSR service, or have the claims and mandatory warnings checked with a cosmetic label review before you print.
Frequently asked questions
What is the legal limit for hydrogen peroxide in teeth whitening in the EU?
Under Annex III, entry 12 of Regulation (EC) No 1223/2009, consumer tooth whitening products may contain up to 0.1% hydrogen peroxide present or released. Products above 0.1% and up to 6% may only be sold to dental practitioners, with the first application per cycle carried out by or under the direct supervision of a dentist, and not for use on persons under 18. Above 6% is not permitted at all.
Does carbamide peroxide count toward the limit?
Yes. The restriction covers hydrogen peroxide “present or released”, and carbamide peroxide releases approximately one third of its weight as hydrogen peroxide. A 10% carbamide peroxide gel therefore releases roughly 3.6% H₂O₂, which places it firmly in the dental-practitioner-only tier rather than the consumer tier.
Are “peroxide-free” whitening products automatically compliant?
No. Sodium perborate is prohibited under Annex II as a borate with reproductive toxicity concerns. Sodium percarbonate releases hydrogen peroxide in water and so falls within entry 12 anyway. Chlorine dioxide and PAP systems are not covered by entry 12 but still require full safety demonstration under Article 3, particularly on enamel erosion.
Can a beauty salon offer teeth whitening in the EU?
Only using products at or below 0.1% hydrogen peroxide present or released. Anything above that threshold and up to 6% may only be supplied to dental practitioners, with the first application performed by or under the direct supervision of a dentist. Non-dental providers offering higher-concentration whitening are operating outside the framework, and this has been actively enforced in several Member States.
Is a whitening product a cosmetic or a medical device?
It depends on intended purpose. Removing extrinsic stains to restore natural tooth colour is a cosmetic function. Claiming to treat discoloration from tetracycline, fluorosis or pulpal conditions is a disease-treatment claim, which points to medicinal product classification, while some professional systems with a medical intended purpose can fall under the Medical Devices Regulation. Our guide to borderline product classification explains the tests.
What extra work does a CPSR for an oral product need?
Ingestion is an expected rather than accidental route of exposure, so the assessment must account for swallowed fractions and compare directly against oral toxicological data. It also needs local tolerance for enamel, dentine and gingival tissue, pH and erosion potential, and an exposure model reflecting the real contact time — a brush-on gel and an overnight tray are very different products from a safety perspective.
Do I still need CPNP notification for a whitening gel?
Yes, provided it is a cosmetic. Every cosmetic product must be notified through the CPNP by the Responsible Person before being placed on the EU market, including professional-tier products supplied only to dentists. See our step-by-step CPNP submission guide and common CPNP mistakes.
