Alpha-arbutin in the EU: 2% face cream, 0.5% body lotion
The EU caps alpha-arbutin at 2% in face cream and 0.5% in body lotion, with hydroquinone allowed only at unavoidable trace level (Annex III No 377). The US has no federal cosmetic limit.
Short answer: in the EU, alpha-arbutin is limited to 2% in face cream and 0.5% in body lotion (Regulation 1223/2009, Annex III No 377, consolidated 18.05.2026), and hydroquinone in the formula must stay at the unavoidable trace level. The US sets no federal cosmetic limit.
The numbers
| Product type | EU limit | Extra rule | US |
|---|---|---|---|
| Face cream | 2% | Hydroquinone only at unavoidable trace level | No federal limit |
| Body lotion | 0.5% | Same | No federal limit |
The 4× split between face and body is the detail that decides most cases. A 1.5% alpha-arbutin serum is compliant; a 1.5% body lotion is not.
US vs EU
The US has no federal concentration ceiling for alpha-arbutin, and it is not on the FDA's prohibited-restricted list. What travels with the ingredient into the US market is the claim question: alpha-arbutin formulas marketed as skin-lightening drugs fall under FD&C Act §201(g). Sell the same formula as "brightening" (appearance) and it stays a cosmetic; sell it as "treats melasma" and it is a drug.
Common mistakes
- Treating alpha-arbutin and beta-arbutin (arbutin) as the same entry. They have separate Annex III entries — this article covers Alpha-Arbutin (No 377).
- Using a "2% is the max" summary for a body product. The body cap is 0.5%.
- Ignoring the hydroquinone trace clause: a supplier spec that tolerates hydroquinon impurities above trace level fails the entry.
- Marketing "fades dark spots" in the US without checking whether the wording is an appearance claim or a drug claim.
Do this now
Check the two numbers on your alpha-arbutin line: the percentage, and the product type it goes into. If the product is a body lotion, the number that matters is 0.5%.
FAQ
What is the EU limit for alpha-arbutin?
2% in face cream and 0.5% in body lotion (Annex III No 377).
Does the EU allow hydroquinone in alpha-arbutin formulas?
Only at the unavoidable trace level — hydroquinone must not be higher than that.
Is alpha-arbutin the same entry as arbutin?
No. Alpha-Arbutin has its own Annex III entry (No 377), separate from arbutin.
Sources
- Regulation (EC) No 1223/2009, Annex III No 377 — 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 2%/0.5% split by product type and flags the claim words that change the US category. It returns an issue list, not a print-ready label.
Related: Kojic acid: 1%, face and hands only · Hydroquinone is banned in the EU