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In the US, a product intended to treat or prevent acne — or any disease, or to affect the structure or function of the body — is a drug under FD&C Act §201(g), whatever its ingredients. The claim on the label decides, not the formula.

FDA classifies a product by intended use: cleanse and beautify is a cosmetic; treat, prevent disease, or affect body structure or function is a drug (FD&C Act §201). The claims you make decide the category.

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.

Named fragrance allergens must appear in the EU ingredient list when they exceed 0.001% in leave-on and 0.01% in rinse-off products (Annex III, per Article 19(1)(g)), and Regulation (EU) 2023/1545 expanded the list beyond the classic 26. The US has no allergen-specific rule.

Only cosmetic products with a designated ‘responsible person’ established in the EU may be placed on the EU market (Regulation 1223/2009, Article 4), and the label must carry that person's name and EU address (Article 19(1)(a)). A US brand must appoint one.

Yes. Hydroquinone is on the EU Annex II prohibited list (No 1339), with one narrow exception for professional artificial nail systems. Arbutin and alpha-arbutin formulas also have trace-level hydroquinone conditions. What the rule actually says.