Salicylic acid limits: EU vs US for cosmetics
The EU caps salicylic acid at 3.0%, 2.0% or 0.5% depending on product type (Annex III No 98). The US sets no cosmetic limit but treats acne claims as a drug at 0.5–2%. Side-by-side table and label rules.
Short answer: the EU limit depends on the product: 3.0% for rinse-off hair products, 2.0% for most other products, and 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant (Annex III No 98, consolidated 18.05.2026). The US sets no federal cosmetic limit.
The numbers
| Product type | EU limit | US |
|---|---|---|
| Rinse-off hair products | 3.0% | No federal cosmetic limit |
| Other products, except the list below | 2.0% | No federal cosmetic limit |
| Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant | 0.5% | No federal cosmetic limit |
| Used as a preservative | 0.5% as acid (Annex V No 3) | No federal cosmetic limit |
| Acne treatment claim | Not a cosmetic claim in the EU either; medicinal route may apply | OTC drug: 0.5–2% salicylic acid, Drug Facts required |
Conditions attached to Annex III No 98:
- Not for children under 3 years of age.
- Not in oral products.
- Not in applications that may expose the user’s lungs by inhalation.
- Only for purposes other than inhibiting micro-organisms in the product; that purpose must be apparent from the presentation.
- The levels are inclusive of any use of salicylic acid. Salts and other forms count toward the same number.
US vs EU: the difference that catches brands
The EU has one number per product category and a list of forbidden uses. The US has no cosmetic number at all, which makes people assume “any percentage is fine”.
That reading breaks the moment the label says acne. A product claiming to treat acne with salicylic acid is an over-the-counter drug in the US, and the monograph range is 0.5–2% (21 CFR 333.310(d)). Below 0.5% or above 2% the product is outside that monograph. The label then needs Drug Facts, with salicylic acid as the active ingredient, not just a cosmetic ingredient statement.
So a 2.5% salicylic acid serum is:
- a cosmetic in the US if it makes no drug claim, and
- over the EU limit for a face serum (2.0%) and outside the US acne monograph if it claims acne treatment.
Common mistakes
- Using 2% as a universal EU cap. It is not: body lotion and lip products are 0.5%.
- Missing the “inclusive of any use” line when the formula contains a salicylate salt.
- Writing “treats acne” on a 2.5% product with a cosmetic label.
- Forgetting the age restriction when the product is a baby or family line.
Sources
- Regulation (EC) No 1223/2009, Annex III No 98 and Annex V No 3 — consolidated text 18.05.2026
- 21 CFR 333.310, acne active ingredients — eCFR, up to date 2026-11-06
- 21 CFR 701.3 — eCFR, issue 2026-11-06
Last verified: 2026-11-10.
Not legal advice, and not a guarantee of compliance or of acceptance by any authority.
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