Product Categories
Oral & Dental Care
Toothpaste, mouthwash and whitening products are defined by oral exposure and by two strict controls: the fluoride limit and the hydrogen peroxide tooth-whitening regime. Plus the sharp line between a cosmetic and a medicine.
Oral and dental care covers toothpaste, mouthwash and tooth-whitening products. They are applied to the teeth and the oral mucosa, which the Cosmetics Regulation explicitly includes, and they are partly ingested, so the assessment models oral exposure. Two controls dominate the category, fluoride and hydrogen peroxide, and both sit close to the medicine line.
Fluoride
Fluoride compounds are permitted in oral products through Annex III, and the cosmetic ceiling for fluoride in toothpaste is 0.15% (1500 ppm) expressed as fluorine. A toothpaste containing fluoride must carry the prescribed child guidance on the label, advising that children of six and under use a pea-sized amount under supervision to minimise swallowing. Above the cosmetic limit, high-fluoride toothpastes at 2800 or 5000 ppm are not cosmetics at all but medicines, supplied on prescription. In the United States the line is drawn differently again: anticavity fluoride toothpaste is an over-the-counter drug under the FDA monograph, not a cosmetic, so the same product changes regulatory category across markets.
Tooth whitening and hydrogen peroxide
Whitening is the category’s sharpest control. Under the Annex III entry for hydrogen peroxide, a product containing or releasing 0.1% hydrogen peroxide or less may be sold directly to consumers as a cosmetic. Between more than 0.1% and 6%, the product may only be supplied through a dental practitioner, with the first use in each cycle carried out by or under the supervision of a dentist, and it must not be used on anyone under eighteen. At 6% or above it is not permitted as a cosmetic at all. Carbamide peroxide is assessed on the hydrogen peroxide it releases, roughly a third of its weight, so a kit quoting carbamide peroxide can still exceed the limit once converted. UK Trading Standards actively seize illegal high-peroxide kits sold online, which makes correct classification a real enforcement risk, not a technicality.
Oral exposure and the medicine line
Because oral products are partly swallowed, the assessment treats ingestion as well as mucosal exposure, and mouthwash alcohol content is considered. The medicine line is never far away: claims to treat gingivitis, prevent caries as a therapeutic effect, or otherwise act on a disease can move a product into the medicinal regime, where a cosmetic CPSR is no longer the right document.
How we help
We assess oral products on their real ingestion and mucosal exposure, keep fluoride within the cosmetic limit and correctly labelled, classify whitening products against the hydrogen peroxide tiers so they are sold through the right channel, and hold the claims on the cosmetic side of the medicine line. Where a product genuinely belongs in the medicinal or US drug regime, we say so before it reaches the market.
Relevant services
CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →Labelling
From £195 · from receipt of artwork
Independent review of packaging artwork against Article 19, and of product claims against the six Common Criteria of Regulation (EU) 655/2013. Label review £195; per-claim review from £125; substantiation dossiers from £1,495.
Learn more →Testing
From £75
Stability, microbiology, photoprotection and analytical testing carried out in our three in-house laboratories. Analytical work is not contracted out; results pass directly to the assessor preparing your CPSR.
Learn more →Frequently asked questions
What is the fluoride limit in toothpaste?
In the EU and UK, a cosmetic toothpaste may contain up to 0.15% fluoride (1500 ppm) under Annex III, and fluoride toothpastes must carry the prescribed child-supervision warning. Above that, high-fluoride toothpastes (2800 or 5000 ppm) are medicines, not cosmetics, and in the US fluoride toothpaste is an over-the-counter drug.
What are the rules on hydrogen peroxide in tooth-whitening products?
In the EU and UK, under Annex III a product containing or releasing up to 0.1% hydrogen peroxide can be sold to consumers as a cosmetic. Between more than 0.1% and 6% it may only be supplied through a dental practitioner and not used on under-18s. At 6% or more it is not permitted as a cosmetic.
What is a CPSR?
A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.
When is a product a cosmetic and when is it a medicine in the EU and UK?
In the EU and UK, a cosmetic is defined by Article 2 of Regulation 1223/2009. A product becomes a medicinal product under Directive 2001/83/EC either by presentation (its claims) or by function (a pharmacological, immunological or metabolic action), and where it could be both, the medicines regime takes precedence.
Which cosmetics are regulated as OTC drugs in the United States?
Sunscreens, anti-dandruff shampoos, anticavity (fluoride) toothpastes, antiperspirants, acne treatments and skin protectants are over-the-counter drugs in the US, regulated under FDA monographs rather than as cosmetics, so they fall outside the cosmetic MoCRA pathway.