Retinol(Vitamin A)

Retinol (CAS 68-26-8) is EU-restricted under Regulation 2024/996 with maximum concentrations of 0.05% RE in body lotions and 0.3% RE in other leave-on and rinse-off products. SCCS opinion SCCS/1639/21 found worst-case modeling reaches approximately 97% of the EFSA UL from cosmetics alone, creating meaningful concern for high consumers already at UL from diet or supplements. Products must carry mandatory label warnings for children under 12 years and pregnancy considerations.

No federal concentration limits for retinol in OTC cosmetics. FDA classifies retinol as a cosmetic ingredient (not drug) at typical cosmetic use levels. No mandatory pregnancy or age warnings required under US law, unlike EU Regulation 2024/996. Safety guidance relies on industry self-regulation (CIR); CIR has affirmed retinol safe as used. Aggregate exposure concern (diet + supplements + topical) applies equally but is not regulated at federal level.