Selling a deodorant or antiperspirant in the EU looks like one of the simpler cosmetic categories until you look at the detail. Both product types are cosmetics, both are notified through the CPNP, and neither needs any special authorisation. The complications come from three directions: the aluminium exposure question, claims that drift towards medicinal or biocidal territory, and the format you choose, because an aerosol brings a completely separate set of rules with it.
This guide covers what an assessor looks at in a deodorant or antiperspirant file, the concentration benchmarks used for aluminium salts, the claims that cause reclassification, and the extra obligations attached to sprays, roll-ons, sticks and creams.
Key takeaways
- Both deodorants and antiperspirants are cosmetics in the EU. Correcting body odours is an explicit cosmetic function in the definition.
- Aluminium salts are not restricted by name in Annex III, so assessors work from the SCCS opinion, which supports around 6.25% aluminium in non-spray and around 10.60% in spray antiperspirants.
- Total aluminium exposure across the whole routine matters, since the opinion also covers toothpaste and lipstick contributions.
- An antibacterial or germ killing claim pushes a deodorant towards the Biocidal Products Regulation.
- Claiming to treat hyperhidrosis presents the product as a medicine and takes it outside the cosmetic regime.
- Aerosols carry extra law: the Aerosol Dispensers Directive sets its own marking and safety phrases, and flammable aerosols carry hazard labelling elements through that directive rather than through CLP.
- Long duration claims such as 48 hour protection need substantiation held in the product information file.
Deodorant, antiperspirant and where each one sits
A deodorant works on odour, usually by masking it, by absorbing it or by limiting the bacterial breakdown of sweat. An antiperspirant reduces the amount of sweat reaching the skin surface, normally with an aluminium salt that forms a temporary plug in the sweat duct.
Both fall within the cosmetic definition, which includes correcting body odours among the permitted functions. That is why the EU treats antiperspirants as cosmetics while some other jurisdictions treat them as over the counter drugs. The distinction matters if you are importing a formula and its documentation from outside the EU, because the assessment you were given may have been written for a different regime entirely.
An imported antiperspirant dossier written for a market that classifies the product as a drug will not contain what an EU safety assessor needs. You still need a full quantitative formula, raw material specifications, stability and compatibility information, and an assessment carried out by a suitably qualified assessor under Annex I of Regulation (EC) 1223/2009.
Aluminium salts and the exposure question
Aluminium based antiperspirant actives, principally aluminium chlorohydrate and aluminium zirconium complexes, have been reviewed repeatedly at EU level. The current position rests on an SCCS opinion that assessed systemic exposure from cosmetic use and concluded that use is safe below certain concentrations.
| Product type | Benchmark aluminium concentration | Note |
|---|---|---|
| Non-spray antiperspirant (roll-on, stick, cream) | Around 6.25% | Direct application, higher deposition on skin |
| Spray antiperspirant | Around 10.60% | Only part of the dose reaches the skin |
| Toothpaste | Around 2.65% | Contributes to total aluminium exposure |
| Lipstick | Around 14.50% | Aluminium based colour lakes |
Two practical points follow. First, these are opinion based benchmarks rather than annex limits, so your safety assessor applies them to your specific formula and use pattern rather than treating them as a fixed ceiling. Second, the counterintuitive direction of the spray figure is deliberate: a spray deposits only part of the dose on the skin, so a higher concentration in the can produces comparable exposure.
Aluminium free positioning built on alum crystal deodorants deserves a note of its own. Potassium alum is an aluminium salt, so a crystal deodorant marketed as aluminium free is factually wrong, and the claim will not survive scrutiny. The correct description is aluminium salt free only where no aluminium containing material is present at all.
Claims that change the regime
Two claim families move a deodorant out of the cosmetic category.
Antibacterial claims
Deodorants often work by limiting odour causing bacteria, and it is tempting to say so. Presenting the product as antibacterial, as killing bacteria or as protecting against germs identifies a biocidal purpose, which brings the product under Regulation (EU) 528/2012 with authorisation obligations that no cosmetic budget anticipates. The same analysis we set out for hand sanitiser as cosmetic or biocide applies directly here.
Odour focused wording keeps you cosmetic: neutralises odour, keeps you fresh, prevents odour forming. Bacteria focused wording does not.
Medical claims
Hyperhidrosis is a medical condition. A product presented as treating it is presented as a medicine, regardless of the formula. High strength antiperspirants sold with clinical positioning are the usual candidates, and referencing dermatological prescription products in the marketing makes the problem worse. Our note on the cosmetic, medicinal and biocidal borderline covers how authorities weigh presentation.
Duration claims are the most commonly unsupported statements in this category. If the pack says 48 hour protection, the substantiation for that specific figure has to be in the product information file before launch, in line with Regulation (EU) 655/2013. Inheriting the claim from a contract manufacturer’s marketing sheet is not substantiation.
Format decides how much extra law applies
The same active in four formats produces four different compliance workloads.
- Aerosol. The Aerosol Dispensers Directive applies alongside cosmetic law, with its own labelling requirements including the reverse epsilon marking, capacity information and pressure warnings. Flammable aerosols also carry hazard labelling elements, required by that directive rather than by CLP, since cosmetics in finished form sit outside the scope of CLP.
- Pump spray. No aerosol legislation, but inhalation exposure becomes a central part of the safety assessment, and the spray pattern and droplet size have to be described in the file.
- Roll-on. Usually a water based emulsion or solution, so preservation and packaging compatibility dominate the assessment.
- Stick and cream. Often anhydrous, which changes the preservation question considerably, as our note on anhydrous cosmetics explains.
Choose the format before you commission the assessment, because switching from roll-on to aerosol after the file is written means redoing the exposure work and adding a separate chemical compliance track.
What the assessment file contains
For a deodorant or antiperspirant, expect the assessor to work through:
- The quantitative formula with the aluminium content expressed as elemental aluminium, not as the salt, since that is how the exposure benchmarks are written.
- Application site considerations, including use on freshly shaved skin, which is the standard consumer behaviour that drives irritation questions.
- Fragrance allergen declarations from the fragrance house, since deodorants are heavily fragranced and the declarable allergen list expanded recently. Our guide to fragrance allergen labelling covers what has to appear on the pack.
- Packaging compatibility, particularly for aluminium salts in contact with metal components, which can corrode.
- Claim substantiation for efficacy and duration statements.
Bringing it all together
Deodorants and antiperspirants are cosmetics, and the core route is the familiar one: safety assessment, product information file, CPNP notification and compliant labelling. The risk sits in the details that are specific to this category. Aluminium content needs to be expressed and justified against the published exposure benchmarks. Claims need to stay on odour rather than on bacteria, and on freshness rather than on medical conditions. And the format decision quietly determines whether you also need aerosol marking, pressure warnings and flammability labelling under the Aerosol Dispensers Directive.
Decide the format and the claim set first, then build the file around them. Reversing that order is what turns a straightforward category into a relaunch.
Lexora prepares safety assessments for deodorants and antiperspirants in every format, checks claim wording for borderline risk and covers the aerosol labelling obligations where the format triggers them. Start with the water-based cosmetic safety package, use the anhydrous and alcohol-based package for sticks and sprays, or check the wording with a cosmetic claims compliance check.
Frequently asked questions
Are antiperspirants cosmetics or medicines in the EU?
They are cosmetics. Correcting body odours is one of the functions listed in the cosmetic definition, and reducing perspiration is treated as part of that function. Claiming to treat hyperhidrosis, however, presents the product as a medicine and takes it outside the cosmetic regime.
Is aluminium banned in EU deodorants?
No. Aluminium salts remain permitted and are not restricted by name in Annex III. Safety assessors work from the SCCS opinion, which supports use at around 6.25% aluminium in non-spray antiperspirants and around 10.60% in sprays, taking total exposure from other cosmetic sources into account.
Can I call my deodorant antibacterial?
Not without moving into the biocidal regime. An antibacterial or germ killing claim identifies a biocidal purpose, which requires product authorisation under Regulation (EU) 528/2012. Odour focused wording such as neutralises odour keeps the product cosmetic.
Is a crystal deodorant aluminium free?
No. Alum crystal deodorants are based on potassium alum, which is an aluminium salt. Marketing them as aluminium free is inaccurate and fails the truthfulness criterion for cosmetic claims. Describe the difference in the type of aluminium compound instead, if that is the point you want to make.
What extra rules apply to aerosol deodorants?
The Aerosol Dispensers Directive applies alongside cosmetic law. It requires the reverse epsilon marking, the nominal capacity, pressure related safety phrases such as the warning that the container may burst if heated, and, for flammable aerosols, hazard labelling elements. Those elements come through the aerosol directive, because cosmetics in the finished state are outside the scope of CLP.
Do I need evidence for a 48 hour protection claim?
Yes. Duration claims are performance claims and must be substantiated under Regulation (EU) 655/2013, with the evidence held in the product information file. The substantiation has to relate to your finished product, not to a similar formula or to a supplier’s general marketing material.
