Biotin/Folic Acid/Cyanocobalamin/Niacinamide/Pantothenic Acid/Pyridoxine/Riboflavin/Thiamine/Yeast Polypeptide

Biotin (CAS 58-85-5) is a water-soluble B-complex vitamin (Vitamin B7/H) with CIR safe as used status, first assessed in 2001 and reaffirmed in the 2017 re-review, unrestricted across all major markets including EU, US, UK, Canada, Japan, Korea, China, and ASEAN with no Annex listings under EU Cosmetics Regulation EC No 1223/2009. No formal MoS was calculated due to absent dermal absorption data; safety is justified by low use concentrations (max leave-on 0.1% per 2015 industry survey) and comparison to dietary intake. The critical regulatory risk is claims-related, not safety-related: the FDA explicitly classifies topical biotin as NOT GRAS for hair growth or hair loss prevention drug claims under 21 CFR 310.527, meaning such labeling converts a cosmetic into an unapproved drug.

Dual regulatory identity in the US. (1) GRAS as a food/dietary nutrient under 21 CFR 182.8159; RDI 30 ug/day for adults. (2) CIR concluded safe as used in cosmetics (2001, reaffirmed 2017); reported cosmetic uses grew from 71 (1998) to 506 (2017); max leave-on concentration 0.1% (2015 industry data); spray/aerosol use at 0.009-0.1% with minimal inhalation risk (95-99% of particles >10 um). (3) CRITICAL: Under 21 CFR 310.527, biotin is explicitly listed as NOT GRAS for external OTC use as a hair grower or hair loss prevention drug — topical hair growth claims trigger unapproved drug status. (4) FDA issued safety communications in 2017 and 2019 warning that high-dose biotin supplementation (5-10 mg/day) can interfere with immunoassay-based lab tests causing false-positive or false-negative results; at least one death reported from a missed MI diagnosis due to falsely low troponin; cessation recommended at least 2 days before blood tests (up to 1 week for high-dose therapy). Standard multivitamin doses (30-60 ug/day) generally below interference thresholds. No VCRP-specific concentration restrictions apply to cosmetic use.