Hydroquinone
Also known as: 1,4-Dihydroxybenzene, Benzene-1,4-diol
Last updated:
Hydroquinone is a skin-lightening agent used to treat hyperpigmentation. It is listed in EU Annex II (prohibited substances) for use in cosmetic products (with narrow exceptions for hair products and artificial nail systems). In the United States, hydroquinone at 2% was previously available OTC; FDA's 2020 CARES Act removed OTC marketing of hydroquinone drug products with limited exceptions, so most current US hydroquinone products are dispensed by prescription.
Regulatory status by market
| Market | Status | Detail | Source |
|---|---|---|---|
| European Union | Prohibited | Banned in cosmetics; narrow Annex III exceptions for hair products and nails | Annex II #1339; Annex III |
| United Kingdom | Prohibited | Mirrors EU prohibition | UK Cosmetics Regulation |
| United States | Approval required | Prescription drug; OTC marketing largely removed by CARES Act 2020 | 21 CFR; FDA CARES Act guidance |
| Canada | Restricted | On Hotlist with concentration limits | Health Canada Hotlist |
Safety profile
Hydroquinone can cause skin irritation, sensitization, and in rare cases ochronosis (a blue-black skin discoloration from prolonged use). It is photosensitizing and should be combined with sun protection. The EU prohibition reflects concerns about long-term use and reproductive toxicity at higher exposures. The CIR has reviewed hydroquinone and concluded it is safe for skin lightening at concentrations up to 2% under appropriate use conditions.
Common uses
- Skin-lightening creams (regulated as drug in most markets)
- Hair dye intermediate (Annex III)
- Artificial nail systems (Annex III)
Primary sources
Regulatory status is current to the "Last updated" date above. Always verify against the regulator's authoritative publication for the specific market and product category before relying on this summary for compliance decisions.
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