Cosmetic claims must be truthful and substantiated. Anything that promises medical effects turns a cosmetic into a medicinal product and triggers the Medicinal Products Advertising Act (HWG).
Legal framework
- Art. 20 Cosmetics Regulation (EC) 1223/2009: no claims implying characteristics or functions the product does not have
- Regulation (EU) 655/2013: common criteria – legal compliance, truthfulness, evidential support, honesty, fairness, informed decision-making
- Borderline: therapeutic claims (“treats eczema”) make the product a medicinal product
Case law
- BGH, 28 Jan 2016, I ZR 36/14 – Art. 20 is a rule on market conduct; efficacy must be substantiated but need not be “scientifically certain”
- BGH, 18 June 2025, I ZR 78/24 – referral to the CJEU on whether retailers must check manufacturers’ claims
Case examples
“Reduces wrinkles by 40 %” based on a small in-house study without control group: the claim is not adequately substantiated.
A shampoo is advertised “stops hair loss”. This is a therapeutic claim beyond the cosmetic purpose and unlawful.

