Parabens in the EU: the 0.4%, 0.8% and 0.14% limits
The EU caps methyl- and ethylparaben at 0.4% each (0.8% combined, as acid) and propyl-/butylparaben at 0.14% combined, with a nappy-area ban for products for children under three (Annex V No 12 and 12a). The US sets no federal limit.
Short answer: in the EU, methylparaben and ethylparaben are limited to 0.4% each as acid, or 0.8% in combination (Annex V No 12), while propylparaben and butylparaben are limited to 0.14% combined as acid (Annex V No 12a) — Regulation 1223/2009, consolidated 18.05.2026. The US sets no federal limit.
The numbers
| Paraben group | EU limit (as acid) | Extra rules | US |
|---|---|---|---|
| Methylparaben / ethylparaben | 0.4% single ester; 0.8% total for mixtures of esters | — | No federal limit |
| Propylparaben / butylparaben | 0.14% total for the group | Not in leave-on products for the nappy area of children under three; such products must state “Do not use on the nappy area” | No federal limit |
The two groups are separate pools. A face cream with 0.3% methylparaben plus 0.1% propylparaben is within both caps, but each group is measured against its own number — the 0.8% and 0.14% do not add into one shared budget.
US vs EU
The US has no federal concentration ceiling for parabens in cosmetics, and the FDA's prohibited-restricted list does not name them. The EU entries above are the binding constraint for the same formula sold in the EU — the propyl-/butylparaben pool (0.14%) and its nappy-area clause are the parts most often missed.
Common mistakes
- Treating all parabens as one pool with a single limit. There are two pools with different numbers.
- Counting methylparaben at 0.5% because "0.8% is the total". The 0.8% is for combinations of No 12 esters; the single-ester cap is 0.4%.
- Shipping a diaper-rash or baby cream with propylparaben to the EU without checking the nappy-area clause.
- Reading pre-2014 summaries (which still allow propylparaben at 0.4%). Those are outdated — the current figure is 0.14% for the group.
Sources
- Regulation (EC) No 1223/2009, Annex V No 12 and No 12a — consolidated text 18.05.2026
- FDA, prohibited & restricted ingredients in cosmetics — fda.gov
- 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 both paraben pools separately and adds the nappy-area statement where required. It returns an issue list, not a print-ready label.
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