Phenoxyethanol in EU cosmetics: the 1% limit
Phenoxyethanol is capped at 1.0% in EU cosmetics when used as a preservative (Annex V No 29). The US has no federal cap. Here is the exact rule, the labelling, and the mistakes we see in formula sheets.
Short answer: in the EU, phenoxyethanol may be used as a preservative at up to 1.0% in the finished product (Regulation 1223/2009, Annex V No 29, consolidated 18.05.2026). The US sets no federal concentration limit under 21 CFR 701.3.
The numbers
| Product type | EU limit | Conditions | Label wording |
|---|---|---|---|
| Any cosmetic, phenoxyethanol as preservative | 1.0% | Finished product concentration; declared by INCI name | Phenoxyethanol |
| US cosmetic | No federal cap | Manufacturer must hold safety substantiation (MoCRA) | Phenoxyethanol |
| EU, used for a non-preservative function | Not covered by Annex V | Function must be apparent from the presentation; the safety assessment still applies | Phenoxyethanol |
Two details that decide most cases:
- The limit applies to the finished product, not to the raw material. If phenoxyethanol arrives inside a supplier blend, its share of that blend counts.
- Annex V is the preservative list. The entry limits phenoxyethanol as a preservative; calling it a solvent or a fragrance fixative does not automatically remove the 1% figure from a reviewer's checklist, so keep the function documented in the PIF.
US vs EU
The US does not publish a maximum for phenoxyethanol. That is not permission to use any amount: under MoCRA the responsible person must keep records that substantiate safety, and a formula far above common use levels invites questions.
The EU is a hard ceiling. 1.2% is not a rounding difference; it is a non-compliant product. Independent brands hit this most often when a preservative booster (phenoxyethanol plus ethylhexylglycerin, for example) is added on top of an already-preserved base.
Common mistakes
- 1.2% “because the supplier said it is fine.” Supplier safety data does not override Annex V.
- Counting only the neat preservative. Blends and boosters carry phenoxyethanol too.
- Assuming the EU limit is a recommendation. It is a restriction; the product may not be placed on the EU market above it.
- Forgetting the label name. The INCI name is Phenoxyethanol; “phenoxyethanol” in lower case is acceptable on the ingredient statement but the spelling must match.
Sources
- Regulation (EC) No 1223/2009, Annex V No 29 — consolidated text 18.05.2026
- 21 CFR 701.3, ingredient designation — eCFR, issue 2026-11-06
- FDA, Prohibited & Restricted Ingredients in Cosmetics — fda.gov
- FDA, Modernization of Cosmetics Regulation Act overview — fda.gov
Last verified: 2026-11-10.
Not legal advice, and not a guarantee that a product will be accepted by any authority. Check the rule text for your exact product before you print.
Want this checked against your own formula? Run the free label check. It returns an issue list, not a print-ready label.
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