Caffeine Anhydrous

CIR Expert Panel (2024, Int J Toxicol) concluded safe in present practices of use and concentration. EU: not listed in Annexes II, III, V, or VI — permitted without restriction (EU Reg 1223/2009). MOIE 27-fold confirmed adequate (Bury et al. 2021). Genotoxicity: Ames positive in vitro without S9 but negative with metabolic activation; NTP 2-year bioassays negative; IARC inadequate evidence — not classifiable as carcinogen.

FDA permits in cosmetics without restriction — no pre-approval required. GRAS as food additive in cola beverages ≤0.02% (21 CFR 182.1180). Approved OTC stimulant drug (100–200 mg oral). NOT a GRASE sunscreen active — not listed in FDA sunscreen monograph; only zinc oxide and titanium dioxide hold full GRASE status for UV protection. MoCRA: no specific caffeine designation.