DMDM hydantoin: how much formaldehyde it releases, and the label rule
The EU allows DMDM hydantoin up to 0.6% (Annex V No 33) and requires a “releases formaldehyde” statement on any cosmetic releasing more than 0.001% (10 ppm) total formaldehyde. The US sets no federal cap.
Short answer: in the EU, DMDM hydantoin is limited to 0.6% (Regulation 1223/2009, Annex V No 33, consolidated 18.05.2026), and any cosmetic that releases more than 0.001% (10 ppm) total formaldehyde must carry a “releases formaldehyde” statement on the label (Annex V preamble). The US sets no federal cap.
The numbers
| Rule | EU | US |
|---|---|---|
| Max DMDM hydantoin concentration | 0.6% | No federal limit |
| Formaldehyde labeling threshold | > 0.001% (10 ppm) total released formaldehyde | No federal requirement for cosmetics |
| Label wording | “releases formaldehyde” | — |
US vs EU
The US has no federal concentration ceiling for DMDM hydantoin, and it is not on the FDA's prohibited-restricted list. The EU cap of 0.6% is generous — a shampoo at 0.2% is well inside it — but the labeling trigger is what catches brands: DMDM hydantoin is a formaldehyde releaser, and the 10 ppm labeling threshold applies to the total formaldehyde released in the finished product, not to the DMDM hydantoin percentage.
That matters when formaldehyde releasers are combined. Two releasers at individually "safe" percentages can push the finished product's total released formaldehyde over 10 ppm, triggering the statement requirement.
Common mistakes
- Reading the 0.6% cap as the only EU requirement and missing the labeling trigger.
- Summing nothing: using two formaldehyde releasers and never estimating total released formaldehyde.
- Assuming the EU banned formaldehyde releasers. It restricted them — the "ban" headlines refer to other substances or to retail chain policies, not to Annex V No 33.
- Copying the US label to the EU verbatim and missing the “releases formaldehyde” statement.
Sources
- Regulation (EC) No 1223/2009, Annex V No 33 and preamble — 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 adds the formaldehyde statement to the label draft when a releaser is present. It returns an issue list, not a print-ready label.
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