Retinol in EU cosmetics: the 0.3% limit
The EU caps vitamin A in cosmetics at 0.05% retinol equivalent in body lotion and 0.3% in other leave-on and rinse-off products (Annex III No 376), and mandates a vitamin A warning on the label. The US has no federal cap.
Short answer: in the EU, retinol is limited to 0.05% retinol equivalent (RE) in body lotion and 0.3% RE in other leave-on and rinse-off products (Regulation 1223/2009, Annex III No 376, consolidated 18.05.2026). The US sets no federal cosmetic limit.
The numbers
| Product type | EU limit | Extra label rule | US |
|---|---|---|---|
| Body lotion | 0.05% RE | “Contains Vitamin A. Consider your daily intake before use” | No federal limit |
| Other leave-on and rinse-off products | 0.3% RE | Same warning | No federal limit |
Three details that decide most cases:
- The limit is in retinol equivalent, and the entry covers Retinol, Retinyl Acetate and Retinyl Palmitate together. A blend of retinol plus retinyl palmitate counts as one pool, not two ingredients judged separately.
- The warning sentence is obligatory for any product containing Retinol, Retinyl Acetate or Retinyl Palmitate — at any concentration, not only near the cap.
- The body-lotion cap is 6× tighter than the general one. A 0.25% retinol face serum can be compliant while a 0.25% body lotion is not.
US vs EU
The US has no concentration ceiling for retinol in cosmetics. What the US does have is the intended-use test: a product claiming to treat acne, wrinkles as a medical condition, or anything else that affects structure or function can fall into drug territory regardless of concentration. Retinoids marketed as drugs (tretinoin, for example) are a different regime from cosmetic retinol.
The EU number is a hard ceiling, and since the 2024 tightening it is the binding constraint for most “retinol body care” launches. If a supplier dossier quotes an older Regulation text without the 0.05%/0.3% split, it is out of date.
Common mistakes
- Adding retinyl palmitate on top of retinol and treating each as within its own cap.
- Shipping a body lotion at 0.2% RE because a 2019 supplier document says 0.3% is the limit.
- Forgetting the vitamin A warning sentence even at low concentrations.
- Copying a US label for the EU market and missing both the cap and the warning.
Sources
- Regulation (EC) No 1223/2009, Annex III No 376 — consolidated text 18.05.2026
- 21 CFR 701.3, ingredient designation — eCFR, issue 2026-11-06
- FDA, MoCRA overview (safety substantiation) — fda.gov
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 sums retinol equivalents, applies the right cap by product type, and adds the warning to the label draft. It returns an issue list, not a print-ready label.
Related: The EU 1% phenoxyethanol limit · MoCRA label requirements