Mulberry Fruit Extract

EU: permitted without concentration restrictions under Regulation (EC) 1223/2009; not listed in Annex II (prohibited) or Annex III (restricted); not captured by 2024/996 restrictions applied to kojic acid and arbutin; no SCCS opinion. US: FDA permits cosmetic use without pre-market approval; not a sunscreen monograph active; subject to MoCRA. Efficacy: 29% improvement in MASI score vs 2% placebo at 75% extract concentration over 8 weeks. Primary function: tyrosinase inhibition via oxyresveratrol. Regulatory-compliant alternative to restricted arbutin and kojic acid.

FDA permits use as a cosmetic ingredient without pre-market approval. Not classified as a sunscreen active under OTC Drug Monograph. No CIR safety assessment published specifically for Morus alba root extract. Subject to MoCRA (2022) requirements. Any therapeutic claims would require drug approval pathway.