Salicylic Acid in a Nail Cream: The 2% Limit and What It Means for Your Product
Salicylic acid is the functional ingredient in our nail care cream, at 1.6%–2.0%. That level was chosen to sit inside the European cosmetic limit, and it sits at the top of it. This page sets out the rule, what “at the top” means in practice for a brand owner, and the product feature a safety assessor has to address separately.
The rule by market
| Market | What applies | Limit for a leave-on nail cream | What decides the category |
|---|---|---|---|
| European Union | Regulation 1223/2009, Annex III entry 98 | 2.0% | Concentration limit, plus claims under the cosmetic definition |
| Great Britain | Retained cosmetics regulation, same Annex III structure | 2.0% (check the GB text for later divergence) | As in the EU |
| United States | Federal Food, Drug, and Cosmetic Act; MoCRA | No cosmetic concentration limit | Intended use, shown by the claims |
The EU entry in full
- 3.0% in rinse-off hair products.
- 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant.
- 2.0% in other products. Nail and foot creams are not in the 0.5% list, so this is the figure that applies to ours.
- Not for products for children under three years of age, and not for oral products or applications that could expose the lungs by inhalation.
- Only for purposes other than preserving the product, and that purpose has to be apparent from how the product is presented. Preservative use is a separate Annex V entry at 0.5%.
The limits and conditions follow the entry as amended in 2021. Reading the 2.0% figure as the one for nail products is our interpretation of the exception list. Your safety assessor confirms it against the consolidated regulation on EUR-Lex.
What 1.6–2.0% means for a brand owner
There is no stronger cosmetic version
Buyers sometimes ask whether we can raise the salicylic acid for a “maximum strength” variant. In the EU and the UK no cosmetic can exceed 2.0%. Products that soften thick nails or remove corns with higher salicylic acid exist, but they are sold as medicines or medical devices, with the evidence and the timelines that come with that. The regulatory routes guide compares them.
The assay has to land inside the limit, every batch
A formula that targets the top of a legal range has to be checked against it. Ask for the salicylic acid assay on the certificate of analysis of each batch you receive, and if you commission your own testing, an HPLC assay of salicylic acid is routine for any cosmetics laboratory. Our sample evaluation guide lists it among the first tests to run.
The exposure question: five to seven days under a wrap
Every EU cosmetic needs a safety assessment signed by a qualified assessor, and that assessment is built on how the product is used. For most leave-on creams, use means a thin layer on open skin that wears off over hours.
This product is used differently. The instruction leaflet has the user apply a thin layer to the nail and the skin around it, then cover it with tape or a breathable bandage and leave it for five to seven days. The area is small and the amount is tiny, both of which help. But occlusion raises penetration through the skin, and the contact time is far longer than a typical cream.
Where US drug rules begin
The US sets no cosmetic concentration limit for salicylic acid. The line it draws is about intended use, which the FDA reads from the claims on the label, the listing and the marketing around it.
| Claim on the label | Category | What it brings |
|---|---|---|
| Softens, smooths or conditions nails and hard skin | Cosmetic | MoCRA duties: registered facility, product listing, adverse event reporting, safety substantiation |
| Exfoliates rough, thickened-looking skin around the nail | Cosmetic | As above |
| Treats acne | OTC drug (salicylic acid is a monograph acne active) | Drug labelling, drug manufacturing rules and drug listing |
| Removes corns, calluses or warts | OTC drug | As above, under a different monograph |
| Treats, kills or prevents nail fungus | Drug, with no OTC monograph route for nails | In practice, a prescription-drug development programme |
The US over-the-counter antifungal rules cover the skin, and products made under them carry a statement that they are not effective on the scalp or nails. The topical nail-fungus treatments approved in the US are prescription products. A brand that wants to say “treats nail fungus” on an American shelf is not choosing between cosmetic and OTC. It is choosing between cosmetic and a drug approval.
Common questions
What is the maximum salicylic acid in a leave-on nail cream in the EU?
2.0%. Annex III entry 98 of Regulation 1223/2009 sets 3.0% for rinse-off hair products, 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant, and 2.0% for other products. Nail and foot creams are not in the 0.5% list, so the 2.0% figure applies. That is our reading of the entry; your safety assessor confirms it against the consolidated text.
Can the salicylic acid be increased for a stronger product?
Not in a cosmetic sold in the EU or UK. Our formula already runs at 1.6–2.0%, the top of the permitted range. Going above 2.0% leaves the cosmetic category, and corn, callus and wart products with higher salicylic acid are sold as medicines or medical devices.
Does salicylic acid make the cream a drug in the US?
Not by itself. In the US the category follows the intended use shown by the claims. Salicylic acid is an over-the-counter drug active for acne and for corn, callus and wart removal, so a label that claims any of those makes the product a drug. A label that claims to soften, smooth or exfoliate keeps it a cosmetic.
Why does the wrap matter for the safety assessment?
Because occlusion increases skin penetration. The cream is used on a small area, which helps, but the leaflet keeps it under a wrap for five to seven days. An assessment written for an ordinary leave-on cream does not cover that, so it should be addressed explicitly.
Is the cream suitable for children?
No. The EU entry excludes products for children under three years of age, and the product is intended for adults. Your label has to reflect the restriction in the form your safety assessor specifies.
Is salicylic acid a preservative in this formula?
No. It is there as a keratolytic, to soften hardened keratin. Preservative use is regulated separately, at 0.5% in Annex V, and the Annex III entry applies only where the non-preservative purpose is apparent from the presentation of the product.
Get the documents your assessor needs
We issue the full ingredient breakdown and the batch salicylic acid assay to buyers preparing a notification. Tell us the market and we will send them with a sample.
More sourcing guides
Sources and where to check
- Regulation (EC) No 1223/2009 on cosmetic products — Annex III entry 98 and Annex V; read the consolidated version
- European Commission — CosIng entry for salicylic acid
- US FDA — Is it a cosmetic, a drug, or both? — intended use and claims
- US FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Sourcing this product for your brand?
We are the factory. The pages below cover manufacturing terms rather than consumer advice — minimum quantities, customisation, formulation and distribution.
Looking for a herbal toenail fungus cream?
Our herbal nail care formula is available for sample orders, wholesale supply, OEM packaging and distributor cooperation. Contact us to get started.