Kojic acid in the EU: 1%, face and hand products only
The EU limits kojic acid to 1% and only in face and hand products (Annex III No 375). Body lotions and neck-below products cannot use it. The US bans it from cosmetics nowhere — but skin-lightening claims change the product's category.
Short answer: in the EU, kojic acid is limited to 1% and only in face and hand products (Regulation 1223/2009, Annex III No 375, consolidated 18.05.2026). In the US there is no federal cosmetic limit — but the claims decide the category.
The numbers
| Product type | EU | US |
|---|---|---|
| Face cream, hand cream | ≤ 1% | No federal limit |
| Body lotion, neck or below | Not permitted | No federal limit |
| Skin-lightening / bleaching claim | Not a cosmetic claim | Triggers drug territory |
US vs EU
A 1% kojic acid face serum clears the EU entry. The same kojic acid percentage in a body moisturizer does not — No 375 restricts the product type, not just the number. In the US, the ingredient itself is unrestricted, but a formula marketed to bleach or lighten skin is treated as a drug (FD&C Act §201(g) intended use), so the claim sheet decides what the US product legally is.
Common mistakes
- Putting kojic acid in a "full body brightening lotion" for the EU. The entry covers face and hand products only.
- Combining kojic acid with hydroquinone for the US market without re-reading the claim language.
- Assuming 0.5% is fine anywhere. Below 1% is still limited to face and hands in the EU.
- Copying a Korean or Japanese supplier dossier: those markets cap kojic acid differently.
Do this now
Take the kojic acid line in your formula table and write down which product type you sell it in — if the answer is not "face" or "hand", the EU entry blocks it.
FAQ
What is the EU limit for kojic acid?
1%, and only in face and hand products (Annex III No 375).
Can kojic acid go in a body lotion in the EU?
No. The entry restricts the product type to face and hand products.
Is kojic acid limited in the US?
There is no federal cosmetic limit, but skin-lightening or bleaching claims move the product into US drug territory.
Sources
- Regulation (EC) No 1223/2009, Annex III No 375 — consolidated text 18.05.2026
- FD&C Act §201(g), intended use — fda.gov, “Is It a Cosmetic, a Drug, or Both?”
- 21 CFR 701.3, ingredient designation — 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.
Want this checked against your own formula? Run the free label check. It applies the face-and-hands restriction by product type and flags US claim words. It returns an issue list, not a print-ready label.
Related: Alpha-arbutin limits in the EU · Hydroquinone is banned in the EU