Toothpaste Cosmetic Regulation: Testing and Compliance Guide

Toothpaste feels like a household staple rather than a regulated product, but in the EU and UK it sits squarely under cosmetics law, and it is a cosmetic that people put in their mouths twice a day, children included. If you are asking about toothpaste cosmetic regulation, this guide explains what the law expects, which tests make sense and where oral care products cross the line into medicines.

The short answer

In the EU and UK, toothpaste, mouthwash and other products applied to the teeth and the mucous membranes of the mouth are cosmetic products. They need a signed CPSR, a product information file, CPNP notification (or the UK equivalent), stability and microbiological data and, for water-based pastes, a preservation efficacy test. Because part of every dose is swallowed, the safety assessor looks at oral and ingested exposure, and fluoride, abrasives, whiteners and flavours get particular scrutiny.

Is toothpaste a cosmetic or a medicine?

Regulation (EC) No 1223/2009 defines a cosmetic product as a substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity, exclusively or mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours. Toothpaste that cleans teeth, freshens breath and, with fluoride, helps to prevent caries is treated as a cosmetic in the EU. A product that claims to treat or cure a disease, such as gum disease or an infection, moves towards medicinal law. In other markets the boundary falls elsewhere: in the United States, for example, fluoride toothpastes are regulated as over-the-counter drugs. Decide your target markets before you write claims.

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What the safety assessor looks at

The CPSR has two parts: Part A collects the formula, physical and chemical properties, microbiological quality, impurities, packaging and exposure data; Part B is the assessor’s reasoned conclusion. For oral care products the assessor typically considers:

• the amount used per brushing, how often, and the share that is swallowed, including by children;
• fluoride compounds and their total fluoride content;
• abrasives and their effect on enamel and dentine;
• whitening agents, such as peroxides, and surfactants;
• flavours, sweeteners and cooling agents;
• preservatives and impurities.

At Cosmetic Testing Lab the signed CPSR takes about 10 business days after complete data. Tiers follow formula complexity: Simple up to 10 ingredients, Standard 11–25, Complex 26 or more or when a fragrance is present. Many toothpastes carry 15 to 25 ingredients and a flavour, so they commonly land in Standard or Complex.

Fluoride and other restricted ingredients

Fluoride compounds are listed in Annex III of Regulation (EC) No 1223/2009 with a maximum concentration for oral products, typically expressed as total fluorine, and labelling conditions. Whitening ingredients based on hydrogen peroxide are also restricted, with higher levels allowed only in tooth whitening products with conditions such as dentist involvement and a minimum age. Check the current entries yourself or have your assessor confirm them: the annexes are updated regularly and exact limits depend on the product type. Preservatives, colourants and UV filters have their own annexes, and some colourants are restricted for products applied to the mucous membranes.

Microplastic particles are another point to check. Regulation (EU) 2023/2055 restricts intentionally added synthetic polymer microparticles with phased dates by product type; rinse-off products such as toothpaste are affected early. Ask your supplier whether any abrasive, bead or polymer in the formula falls within the definition.

Aluminium and the SCCS

The SCCS has looked at aluminium in cosmetic products, and considered toothpaste among the main contributors to exposure. If your formula contains an aluminium compound, tell the assessor, so the aggregate exposure is considered. This is a good example of why a signed assessment is more than a checklist.

Read also Wet Wipes Regulation in the EU: Tests and Rules for Cosmetic Wipes

Abrasivity, fluoride and ISO 11609

ISO 11609 is the international standard for dentifrices: it sets requirements, test methods and marking, including characteristics such as fluoride content and abrasivity. It does not cover biological or toxicological safety, which is the job of the safety assessment. Toothpastes are therefore usually checked against two sets of expectations: cosmetic law for safety and the dentifrice standard for performance and quality. Ask your manufacturer which analyses they run and add the reports to the product file.

Microbiology and preservation

Toothpaste is water-based, rich in humectants and used with a wet brush, which makes it a classic “needs a challenge test” product. The challenge test challenges the formula with five reference microorganisms over 28 days according to ISO 11930:2019 or USP 51 and results in a signed PDF report. Pastes that are fully self-preserving through low water activity or high alcohol are rare, and any waiver should be a documented decision by the assessor under ISO 29621. The microbiological specifications test checks the quality of the finished product, with results about 5 days after we receive the samples. Mouthwashes, with their large water phase, deserve the same treatment.

Stability and packaging compatibility

A toothpaste has to stay smooth, keep its flavour and keep its active ingredients available throughout its life. The stability and compatibility test uses accelerated plans (Basic, Standard or Full) to examine:

• separation of water and humectants, or hardening and cracking of the paste;
• changes in viscosity and in the ease of dispensing from tube or pump;
• colour, odour and flavour drift, especially with natural flavours and essential oils;
• pH and, where appropriate, interaction between actives and abrasives;
• compatibility with the laminate tube, cap liner or pump.

The results support the shelf life, either a best-before date (for products lasting up to 30 months) or a PAO.

Read also Intimate Hygiene Products Regulation: Testing and Borderlines

Is a patch test enough for the mouth?

The oral mucosa differs from skin, and a 48-hour occlusive patch test is a skin test, not an oral irritation study. It still has value: it can show that the flavours, surfactants and actives do not cause skin sensitisation or irritation, for example around the lips. Our single patch test takes about two weeks in total and delivers a signed PDF. For oral tolerance claims such as “gentle on gums”, you need evidence that matches the claim, and your assessor can advise on what is credible.

Labelling and claims for oral care

• INCI ingredient list, batch number, PAO or best-before date, responsible person name and address.
• Fluoride-specific warnings and guidance for children where the annexes or the assessor require them.
• Claims such as “whitens”, “strengthens enamel” or “fights plaque” must be substantiated and meet the common criteria of Regulation (EU) No 655/2013.
• Avoid “treats gingivitis”, “cures” and other medical wording on a cosmetic.
• “Natural” and “fluoride free” claims must be true and consistent with the formula.

Common mistakes with toothpaste

1. Relying on a contract manufacturer’s generic documents instead of a formula-specific safety assessment.
2. Forgetting to count the swallowed share for children’s products.
3. Skipping the challenge test for a natural paste with a weak preservative system.
4. Making whitening claims without checking the peroxide limits.
5. Using the same file for markets outside the EU without checking local drug rules.

A simple plan for toothpaste compliance

1. Decide the target markets and the claims.
2. Check every ingredient against the annexes, including fluoride and whitening limits.
3. Order stability, microbiology, challenge and, where useful, patch tests; DHL collects the samples free from your door.
4. Obtain the signed CPSR, assemble the product information file (PIF) and notify in CPNP.
5. Finalise labelling and claims with the assessor’s notes in hand.

Frequently asked questions

Does a fluoride-free natural toothpaste need a CPSR?

Yes. Every toothpaste placed on the EU market needs a safety assessment, whatever its marketing positioning.

Can I sell homemade toothpaste?

Not without the same file as any other cosmetic. Homemade products need a CPSR, notification and labelling, and oral products demand particular care.

Do I need a challenge test if my toothpaste has no preservative?

Probably yes. Without a preservative the product must prove that it protects itself, or the assessor must document why the risk is low.

Key takeaways

• Toothpaste is a cosmetic in the EU and UK: signed CPSR, PIF and notification are required.
• Swallowed exposure, fluoride, abrasives and whiteners are the assessor’s focus.
• Water-based pastes need a challenge test and microbiological check, and stability should be proven in the real tube or pump.
• Keep claims cosmetic and check local drug rules for other markets.